Cardiology

ILLUSTRATIVE CASE

A healthy 72-year-old man with well-controlled hypertension on amlodipine 10 mg/d presents to you for an annual exam. He has no history of coronary artery disease or stroke. Should you recommend that he start aspirin for primary prevention of cardiovascular disease?

Cardiovascular disease (CVD) remains the leading cause of death in the United States.² Aspirin therapy remains the standard of care for secondary prevention of CVD in patients with known coronary artery disease (CAD).³ Aspirin reduces the risk of atherothrombosis by irreversibly inhibiting platelet function. At the same time, it increases the risk of major bleeding, including gastrointestinal bleeds and hemorrhagic strokes. Even though the benefit of aspirin in patients with known CAD is well established, the benefit of aspirin as primary prevention is less certain.

Two recent large randomized controlled trials (RCTs) examined the benefits and risks of aspirin in a variety of patient populations. The ARRIVE trial looked at more than 12,000 patients with a mean age of 63 years with moderate risk of CVD (approximately 15% risk of a cardiovascular event in 10 years) and randomly assigned them to receive aspirin or placebo.⁴ After an average follow-up period of 5 years, researchers observed that actual cardiovascular event risk was < 10% in both groups, and there was no significant difference in the primary outcome of first cardiovascular event or all-cause mortality. There was, however, a significant increase in bleeding events in the group receiving aspirin.⁴

The ASCEND trial evaluated aspirin vs placebo in more than 15,000 adult patients with type 2 diabetes mellitus and a low risk of CVD (< 10% risk of cardiovascular event in 5 years). ⁵ The primary endpoint of the study was first cardiovascular event. The authors found a significantly lower rate of cardiovascular events in the aspirin group, as well as more major bleeding events. Additionally, there was no difference between the aspirin and placebo groups in all-cause ­mortality after 7 years. The authors concluded that the benefits of aspirin in this group were ­counterbalanced by the harms.⁵

Currently, several organizations offer recommendations on aspirin use in people 40 to 70 years of age based on a patient’s risk of bleeding and risk of CVD.^6-8 Recommendations regarding aspirin use as primary prevention have been less clear for patients < 40 and > 70 years of age.⁶

Elderly patients are at higher risk of CVD and bleeding, but until recently, few studies had evaluated elderly populations to assess the benefits vs the risks of aspirin for primary CVD prevention. As of 2016, the US Preventive Services Task Force (USPSTF) stated the evidence was insufficient to assess the balance of the benefits and harms of initiating aspirin use for primary prevention of CVD in patients older than 70 years of age.⁶ This trial focuses on aspirin use for primary prevention of CVD in healthy elderly adults.

STUDY SUMMARY

Don’t use aspirin as primary prevention of CVD in the elderly

This secondary analysis of a prior double-blind RCT, which found low-dose aspirin did not prolong survival in elderly patients, examined the effect of aspirin on CVD and hemorrhage in 19,114 elderly patients without known CVD.¹ The patients were ≥ 70 years of age (≥ 65 years for blacks and Hispanics) with a mean age of 74 years and were from Australia (87%) and the United States (13%). Approximately one-third of the patients were taking a statin, and 14% were taking a nonsteroidal anti-inflammatory drug (NSAID) regularly. Patients were randomized to either aspirin 100 mg/d or matching placebo and were followed for an average of 4.7 years.

Continue to: Outcomes

Outcomes. The outcome of CVD was a composite of fatal coronary heart disease, nonfatal myocardial infarction (MI), fatal or nonfatal ischemic stroke, or hospitalization for heart failure, and the outcome of major adverse cardiovascular event was a composite of fatal cardiovascular disease (excluding death from heart failure), nonfatal MI, or fatal and nonfatal ischemic stroke.

Results. No difference was seen between the aspirin and placebo groups in CVD outcomes (10.7 events per 1000 person-years vs 11.3 events per 1000 person-years, respectively; hazard ratio [HR] = 0.95; 95% confidence interval [CI], 0.83-1.08) or major cardiovascular events (7.8 events per 1000 person-years vs 8.8 events per 1000 person-years, respectively; HR = 0.89; 95% CI, 0.77-1.03). The composite and individual endpoints of fatal cardiovascular disease, heart failure hospitalizations, fatal and nonfatal MI, and ischemic stroke also did not differ significantly between the groups.

Because of this trial, the ACC and AHA have updated their guidelines on primary prevention of CVD to recommend against the routine use of aspirin in patients > 70 years of age.

The rate of major hemorrhagic events (composite of hemorrhagic stroke, intracranial bleed, or extracranial bleed), however, was higher in the aspirin vs the placebo group (8.6 events per 1000 person-years vs 6.2 events per 1000 person-years, respectively; HR = 1.4; 95% CI, 1.2-1.6; number needed to harm = 98).

WHAT’S NEW

Finding of more harm than good leads to change in ACC/AHA guidelines

Although the most recent USPSTF guidelines state the evidence is insufficient to assess the risks and benefits of aspirin for the primary prevention of cardiovascular disease in this age group, this trial reveals there is a greater risk of hemorrhagic events than there is prevention of cardiovascular outcomes with aspirin use in healthy elderly patients > 70 years of age.⁶ Because of this trial, the American College of Cardiology (ACC) and the American Heart Association (AHA) have updated their guidelines on the primary prevention of cardiovascular disease to recommend that aspirin not be used routinely in patients > 70 years of age.⁷

CAVEATS

Potential benefit to people at higher risk?

The rate of cardiovascular disease was lower than expected in this overall healthy population, so it is not known if cardiovascular benefits may outweigh the risk of bleeding in a higher-risk population. The trial also didn’t address the potential harms of deprescribing aspirin. Additionally, although aspirin may not be protective for cardiovascular events and may lead to more bleeding, there may be other benefits to aspirin in this patient population that were not addressed by this study.

Continue to: CHALLENGES TO IMPLEMENTATION

CHALLENGES TO IMPLEMENTATION

Popular beliefs and wide availability may make tide difficult to change

Patients have been told for years to take a daily aspirin to “protect their heart”; this behavior may be difficult to change. And because aspirin is widely available over the counter, patients may take it without their physician’s knowledge.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A healthy 72-year-old man with well-controlled hypertension on amlodipine 10 mg/d presents to you for an annual exam. He has no history of coronary artery disease or stroke. Should you recommend that he start aspirin for primary prevention of cardiovascular disease?

Cardiovascular disease (CVD) remains the leading cause of death in the United States.² Aspirin therapy remains the standard of care for secondary prevention of CVD in patients with known coronary artery disease (CAD).³ Aspirin reduces the risk of atherothrombosis by irreversibly inhibiting platelet function. At the same time, it increases the risk of major bleeding, including gastrointestinal bleeds and hemorrhagic strokes. Even though the benefit of aspirin in patients with known CAD is well established, the benefit of aspirin as primary prevention is less certain.

Two recent large randomized controlled trials (RCTs) examined the benefits and risks of aspirin in a variety of patient populations. The ARRIVE trial looked at more than 12,000 patients with a mean age of 63 years with moderate risk of CVD (approximately 15% risk of a cardiovascular event in 10 years) and randomly assigned them to receive aspirin or placebo.⁴ After an average follow-up period of 5 years, researchers observed that actual cardiovascular event risk was < 10% in both groups, and there was no significant difference in the primary outcome of first cardiovascular event or all-cause mortality. There was, however, a significant increase in bleeding events in the group receiving aspirin.⁴

The ASCEND trial evaluated aspirin vs placebo in more than 15,000 adult patients with type 2 diabetes mellitus and a low risk of CVD (< 10% risk of cardiovascular event in 5 years). ⁵ The primary endpoint of the study was first cardiovascular event. The authors found a significantly lower rate of cardiovascular events in the aspirin group, as well as more major bleeding events. Additionally, there was no difference between the aspirin and placebo groups in all-cause ­mortality after 7 years. The authors concluded that the benefits of aspirin in this group were ­counterbalanced by the harms.⁵

Currently, several organizations offer recommendations on aspirin use in people 40 to 70 years of age based on a patient’s risk of bleeding and risk of CVD.^6-8 Recommendations regarding aspirin use as primary prevention have been less clear for patients < 40 and > 70 years of age.⁶

Elderly patients are at higher risk of CVD and bleeding, but until recently, few studies had evaluated elderly populations to assess the benefits vs the risks of aspirin for primary CVD prevention. As of 2016, the US Preventive Services Task Force (USPSTF) stated the evidence was insufficient to assess the balance of the benefits and harms of initiating aspirin use for primary prevention of CVD in patients older than 70 years of age.⁶ This trial focuses on aspirin use for primary prevention of CVD in healthy elderly adults.

STUDY SUMMARY

Don’t use aspirin as primary prevention of CVD in the elderly

This secondary analysis of a prior double-blind RCT, which found low-dose aspirin did not prolong survival in elderly patients, examined the effect of aspirin on CVD and hemorrhage in 19,114 elderly patients without known CVD.¹ The patients were ≥ 70 years of age (≥ 65 years for blacks and Hispanics) with a mean age of 74 years and were from Australia (87%) and the United States (13%). Approximately one-third of the patients were taking a statin, and 14% were taking a nonsteroidal anti-inflammatory drug (NSAID) regularly. Patients were randomized to either aspirin 100 mg/d or matching placebo and were followed for an average of 4.7 years.

Continue to: Outcomes

Outcomes. The outcome of CVD was a composite of fatal coronary heart disease, nonfatal myocardial infarction (MI), fatal or nonfatal ischemic stroke, or hospitalization for heart failure, and the outcome of major adverse cardiovascular event was a composite of fatal cardiovascular disease (excluding death from heart failure), nonfatal MI, or fatal and nonfatal ischemic stroke.

Results. No difference was seen between the aspirin and placebo groups in CVD outcomes (10.7 events per 1000 person-years vs 11.3 events per 1000 person-years, respectively; hazard ratio [HR] = 0.95; 95% confidence interval [CI], 0.83-1.08) or major cardiovascular events (7.8 events per 1000 person-years vs 8.8 events per 1000 person-years, respectively; HR = 0.89; 95% CI, 0.77-1.03). The composite and individual endpoints of fatal cardiovascular disease, heart failure hospitalizations, fatal and nonfatal MI, and ischemic stroke also did not differ significantly between the groups.

Because of this trial, the ACC and AHA have updated their guidelines on primary prevention of CVD to recommend against the routine use of aspirin in patients > 70 years of age.

The rate of major hemorrhagic events (composite of hemorrhagic stroke, intracranial bleed, or extracranial bleed), however, was higher in the aspirin vs the placebo group (8.6 events per 1000 person-years vs 6.2 events per 1000 person-years, respectively; HR = 1.4; 95% CI, 1.2-1.6; number needed to harm = 98).

WHAT’S NEW

Finding of more harm than good leads to change in ACC/AHA guidelines

Although the most recent USPSTF guidelines state the evidence is insufficient to assess the risks and benefits of aspirin for the primary prevention of cardiovascular disease in this age group, this trial reveals there is a greater risk of hemorrhagic events than there is prevention of cardiovascular outcomes with aspirin use in healthy elderly patients > 70 years of age.⁶ Because of this trial, the American College of Cardiology (ACC) and the American Heart Association (AHA) have updated their guidelines on the primary prevention of cardiovascular disease to recommend that aspirin not be used routinely in patients > 70 years of age.⁷

CAVEATS

Potential benefit to people at higher risk?

The rate of cardiovascular disease was lower than expected in this overall healthy population, so it is not known if cardiovascular benefits may outweigh the risk of bleeding in a higher-risk population. The trial also didn’t address the potential harms of deprescribing aspirin. Additionally, although aspirin may not be protective for cardiovascular events and may lead to more bleeding, there may be other benefits to aspirin in this patient population that were not addressed by this study.

Continue to: CHALLENGES TO IMPLEMENTATION

CHALLENGES TO IMPLEMENTATION

Popular beliefs and wide availability may make tide difficult to change

Patients have been told for years to take a daily aspirin to “protect their heart”; this behavior may be difficult to change. And because aspirin is widely available over the counter, patients may take it without their physician’s knowledge.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A healthy 72-year-old man with well-controlled hypertension on amlodipine 10 mg/d presents to you for an annual exam. He has no history of coronary artery disease or stroke. Should you recommend that he start aspirin for primary prevention of cardiovascular disease?

Cardiovascular disease (CVD) remains the leading cause of death in the United States.² Aspirin therapy remains the standard of care for secondary prevention of CVD in patients with known coronary artery disease (CAD).³ Aspirin reduces the risk of atherothrombosis by irreversibly inhibiting platelet function. At the same time, it increases the risk of major bleeding, including gastrointestinal bleeds and hemorrhagic strokes. Even though the benefit of aspirin in patients with known CAD is well established, the benefit of aspirin as primary prevention is less certain.

Two recent large randomized controlled trials (RCTs) examined the benefits and risks of aspirin in a variety of patient populations. The ARRIVE trial looked at more than 12,000 patients with a mean age of 63 years with moderate risk of CVD (approximately 15% risk of a cardiovascular event in 10 years) and randomly assigned them to receive aspirin or placebo.⁴ After an average follow-up period of 5 years, researchers observed that actual cardiovascular event risk was < 10% in both groups, and there was no significant difference in the primary outcome of first cardiovascular event or all-cause mortality. There was, however, a significant increase in bleeding events in the group receiving aspirin.⁴

The ASCEND trial evaluated aspirin vs placebo in more than 15,000 adult patients with type 2 diabetes mellitus and a low risk of CVD (< 10% risk of cardiovascular event in 5 years). ⁵ The primary endpoint of the study was first cardiovascular event. The authors found a significantly lower rate of cardiovascular events in the aspirin group, as well as more major bleeding events. Additionally, there was no difference between the aspirin and placebo groups in all-cause ­mortality after 7 years. The authors concluded that the benefits of aspirin in this group were ­counterbalanced by the harms.⁵

Currently, several organizations offer recommendations on aspirin use in people 40 to 70 years of age based on a patient’s risk of bleeding and risk of CVD.^6-8 Recommendations regarding aspirin use as primary prevention have been less clear for patients < 40 and > 70 years of age.⁶

Elderly patients are at higher risk of CVD and bleeding, but until recently, few studies had evaluated elderly populations to assess the benefits vs the risks of aspirin for primary CVD prevention. As of 2016, the US Preventive Services Task Force (USPSTF) stated the evidence was insufficient to assess the balance of the benefits and harms of initiating aspirin use for primary prevention of CVD in patients older than 70 years of age.⁶ This trial focuses on aspirin use for primary prevention of CVD in healthy elderly adults.

STUDY SUMMARY

Don’t use aspirin as primary prevention of CVD in the elderly

This secondary analysis of a prior double-blind RCT, which found low-dose aspirin did not prolong survival in elderly patients, examined the effect of aspirin on CVD and hemorrhage in 19,114 elderly patients without known CVD.¹ The patients were ≥ 70 years of age (≥ 65 years for blacks and Hispanics) with a mean age of 74 years and were from Australia (87%) and the United States (13%). Approximately one-third of the patients were taking a statin, and 14% were taking a nonsteroidal anti-inflammatory drug (NSAID) regularly. Patients were randomized to either aspirin 100 mg/d or matching placebo and were followed for an average of 4.7 years.

Continue to: Outcomes

Outcomes. The outcome of CVD was a composite of fatal coronary heart disease, nonfatal myocardial infarction (MI), fatal or nonfatal ischemic stroke, or hospitalization for heart failure, and the outcome of major adverse cardiovascular event was a composite of fatal cardiovascular disease (excluding death from heart failure), nonfatal MI, or fatal and nonfatal ischemic stroke.

Results. No difference was seen between the aspirin and placebo groups in CVD outcomes (10.7 events per 1000 person-years vs 11.3 events per 1000 person-years, respectively; hazard ratio [HR] = 0.95; 95% confidence interval [CI], 0.83-1.08) or major cardiovascular events (7.8 events per 1000 person-years vs 8.8 events per 1000 person-years, respectively; HR = 0.89; 95% CI, 0.77-1.03). The composite and individual endpoints of fatal cardiovascular disease, heart failure hospitalizations, fatal and nonfatal MI, and ischemic stroke also did not differ significantly between the groups.

Because of this trial, the ACC and AHA have updated their guidelines on primary prevention of CVD to recommend against the routine use of aspirin in patients > 70 years of age.

The rate of major hemorrhagic events (composite of hemorrhagic stroke, intracranial bleed, or extracranial bleed), however, was higher in the aspirin vs the placebo group (8.6 events per 1000 person-years vs 6.2 events per 1000 person-years, respectively; HR = 1.4; 95% CI, 1.2-1.6; number needed to harm = 98).

WHAT’S NEW

Finding of more harm than good leads to change in ACC/AHA guidelines

Although the most recent USPSTF guidelines state the evidence is insufficient to assess the risks and benefits of aspirin for the primary prevention of cardiovascular disease in this age group, this trial reveals there is a greater risk of hemorrhagic events than there is prevention of cardiovascular outcomes with aspirin use in healthy elderly patients > 70 years of age.⁶ Because of this trial, the American College of Cardiology (ACC) and the American Heart Association (AHA) have updated their guidelines on the primary prevention of cardiovascular disease to recommend that aspirin not be used routinely in patients > 70 years of age.⁷

CAVEATS

Potential benefit to people at higher risk?

The rate of cardiovascular disease was lower than expected in this overall healthy population, so it is not known if cardiovascular benefits may outweigh the risk of bleeding in a higher-risk population. The trial also didn’t address the potential harms of deprescribing aspirin. Additionally, although aspirin may not be protective for cardiovascular events and may lead to more bleeding, there may be other benefits to aspirin in this patient population that were not addressed by this study.

Continue to: CHALLENGES TO IMPLEMENTATION

CHALLENGES TO IMPLEMENTATION

Popular beliefs and wide availability may make tide difficult to change

Patients have been told for years to take a daily aspirin to “protect their heart”; this behavior may be difficult to change. And because aspirin is widely available over the counter, patients may take it without their physician’s knowledge.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

The VOYAGER PAD results from more than 6,500 patients created the biggest evidence base by far ever collected from patients with symptomatic peripheral artery disease (PAD) who underwent a vascular intervention, and showed that the combination of twice-daily rivaroxaban and once-daily aspirin was safe and more effective than aspirin alone for reducing future thrombotic and ischemic events.

Following that report on March 28, a prespecified subgroup analysis presented the next day showed that adding clopidogrel to this two-drug combination produced no added efficacy but caused additional bleeding episodes, suggesting that the common practice of using clopidogrel plus aspirin in these patients, especially those who receive a stent in a peripheral artery, should either fall by the wayside or be used very briefly.

“In the absence of clear benefit, clopidogrel exposure along with aspirin and rivaroxaban should be minimized or avoided to reduce this risk,” William R. Hiatt, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. But he also cautioned that “we did not control for clopidogrel use, and so the patients who received clopidogrel look different [from patients who did not receive clopidogrel]. We must be cautious in interpreting differences between patients on or off clopidogrel,” warned Dr. Hiatt, a lead investigator for VOYAGER PAD, professor for cardiovascular research at the University of Colorado at Denver in Aurora and president of the affiliated Colorado Prevention Center.

In addition to this substantial caveat, the finding that clopidogrel appeared to add no extra benefit to the rivaroxaban/aspirin regimen “contradicts some dogmas that have been in the field for decades,” Dr. Hiatt said. Use of dual-antiplatelet therapy (DAPT), in this setting usually aspirin and clopidogrel, in patients who have just undergone lower-extremity revascularization is “current dogma,” even though it is not based on any direct evidence for efficacy, but instead came on the scene as “an extrapolation from the coronary artery literature, where it does have some benefit, particularly after percutaneous coronary intervention,” he explained.

The only reported study results to examine use of DAPT in patients who underwent peripheral artery revascularization focused entirely on patients who had a surgical procedure and showed no added benefit from DAPT over aspirin only in a multicenter, randomized trial with 851 patients (J Vasc Surg. 2010 Oct;52[4]:825-33), Dr. Hiatt noted. In VOYAGER PAD, two-thirds of all patients underwent an endovascular, not surgical, peripheral intervention, and among those treated with clopidogrel, 91% had endovascular treatment.

“We’re not saying don’t use DAPT, but patients on three drugs are at higher bleeding risk than patients on two drugs. I think our data also suggest starting rivaroxaban immediately after a procedure [as was done in VOYAGER PAD], and not waiting to complete a course of DAPT,” Dr. Hiatt said.

Other experts embraced Dr. Hiatt’s take on these findings, while warning that it may take some time for the message to penetrate into practice.

The overall VOYAGER PAD results “are practice changing for vascular interventions; it was by an order of magnitude the largest vascular intervention trial ever conducted,” commented Sahil A. Parikh, MD, a designated discussant, interventional cardiologist, and director of endovascular services at New York–Presbyterian Medical Center. “The data suggest that the value of clopidogrel is questionable, but the added hazard is not questionable” when given to patients on top of rivaroxaban and aspirin. The results “certainly beg the question of whether one should use DAPT at all, and if so, for how long.”

Use of DAPT in patients undergoing peripheral revascularization, especially patients receiving a stent, has been “dogma,” Dr. Parikh agreed. “It’s been pounded into our heads that DAPT is standard care, so it will take some time to penetrate into the practicing community.”

“Could there be patients who could benefit from triple therapy? That’s possible, but it needs testing,” commented Mark A. Creager, MD, professor of medicine and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. “We’ve made terrific strides with the results from VOYAGER PAD,” and from the earlier COMPASS trial, which proved the benefit of rivaroxaban and aspirin in patients with stable atherosclerotic vascular disease including many PAD patients (N Engl J Med. 2017 Oct 5;377[14]:1319-30). Use of rivaroxaban and aspirin in PAD patients based on the COMPASS results “is beginning to make an impact, but has a long way to go,” Dr. Creager said in an interview.

In late 2018, the Food and Drug Administration gave rivaroxaban a revised labeling that included an indication for patients with PAD based on the COMPASS findings. The VOYAGER PAD and COMPASS trials are especially noteworthy because “they opened a whole area [of study] in patients with peripheral vascular disease, ” he added.

The prespecified analysis that Dr. Hiatt reported analyzed outcomes among the 51% of patients enrolled in VOYAGER PAD (Vascular Outcomes Study of Acetylsalicylic Acid Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) who received clopidogrel during follow-up at the discretion of their treating physician and the outcomes among the remainder who did not. The two subgroups showed several statistically significant differences in the prevalence of various comorbidities and in some baseline demographic and clinical metrics, and the analyses that Dr. Hiatt reported did not attempt to correct for these differences. Patients who received clopidogrel had the drug on board for a median of 29 days, and about 58% received it for 30 days or less.

The main finding of his analysis was that “adding clopidogrel did not modify benefit at all” from the perspective of the primary endpoint of VOYAGER PAD, the incidence of a five-item list of adverse events (acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke, and cardiovascular death) during a median follow-up of 28 months (N Engl J Med. 2020 Mar 28. doi: 10.1056/NEJMoa2000052), said Dr. Hiatt. Among patients on clopidogrel, those treated with both rivaroxaban and aspirin had a 16.0% incidence of the primary endpoint, compared with an 18.3% rate among patients on aspirin only, for a 15% relative risk reduction, identical to the study’s primary result. Among patients not on clopidogrel, the primary endpoint occurred in 18.7% of patients on rivaroxaban plus aspirin and in 21.5% of those on aspirin only, a 14% relative risk reduction. The analyses also showed that adding clopidogrel appeared to increase the rate of bleeding episodes, particularly the incidence of major bleeds by the criteria of the International Society on Thrombosis and Haemostasis (ISTH), which rose among patients on aspirin alone from 3.3% without clopidogrel treatment to 4.9% with clopidogrel, and in patients on rivaroxaban plus aspirin these major bleeds increased from 5.4% with no clopidogrel to 6.5% with clopidogrel.

An especially revealing further analysis showed that, among those who also received rivaroxaban and aspirin, clopidogrel treatment for more than 30 days led to substantially more bleeding problems, compared with patients who received the drug for 30 days or less. Patients who received clopidogrel for more than 30 days as part of a triple-drug regimen had a 3.0% rate of major ISTH bleeds during 180 days of follow-up, compared with a 0.9% rate for patients in the aspirin-alone group who also received clopidogrel, a 2.1% between-group difference. In contrast, the difference in major ISTH bleeds between the two treatment arms in the subgroup who received clopidogrel for 30 days or less was 0.7%.

“What’s inarguable is that the course of clopidogrel should be as short as possible, probably not more than 30 days unless there is a real extenuating rationale,” commented designated discussant Gregory Piazza, MD, a cardiologist at Brigham and Women’s Hospital in Boston.

VOYAGER PAD was sponsored by Bayer and Janssen, the companies that market rivaroxaban (Xarelto). The institution that Dr. Hiatt leads has received research funding from Bayer and Janssen and from Amgen. Dr. Parikh has been a consultant to Terumo; has received research funding from Shockwave, Surmodics, and Trireme; has worked on trial monitoring for Boston Scientific and Silk Road; and has had other financial relationships with Abbott, Boston Scientific, and Medtronic. Dr. Creager had no disclosures. Dr. Piazza has received research grants from Bayer and Janssen, as well as Bristol-Myers Squibb, Diiachi, EKOS, and Portola, and he has been a consultant to Optum, Pfizer, and Thrombolex.

mzoler@mdedge.com

SOURCE: Hiatt WR et al. ACC 20, Abstract 406-13.

The VOYAGER PAD results from more than 6,500 patients created the biggest evidence base by far ever collected from patients with symptomatic peripheral artery disease (PAD) who underwent a vascular intervention, and showed that the combination of twice-daily rivaroxaban and once-daily aspirin was safe and more effective than aspirin alone for reducing future thrombotic and ischemic events.

Following that report on March 28, a prespecified subgroup analysis presented the next day showed that adding clopidogrel to this two-drug combination produced no added efficacy but caused additional bleeding episodes, suggesting that the common practice of using clopidogrel plus aspirin in these patients, especially those who receive a stent in a peripheral artery, should either fall by the wayside or be used very briefly.

“In the absence of clear benefit, clopidogrel exposure along with aspirin and rivaroxaban should be minimized or avoided to reduce this risk,” William R. Hiatt, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. But he also cautioned that “we did not control for clopidogrel use, and so the patients who received clopidogrel look different [from patients who did not receive clopidogrel]. We must be cautious in interpreting differences between patients on or off clopidogrel,” warned Dr. Hiatt, a lead investigator for VOYAGER PAD, professor for cardiovascular research at the University of Colorado at Denver in Aurora and president of the affiliated Colorado Prevention Center.

In addition to this substantial caveat, the finding that clopidogrel appeared to add no extra benefit to the rivaroxaban/aspirin regimen “contradicts some dogmas that have been in the field for decades,” Dr. Hiatt said. Use of dual-antiplatelet therapy (DAPT), in this setting usually aspirin and clopidogrel, in patients who have just undergone lower-extremity revascularization is “current dogma,” even though it is not based on any direct evidence for efficacy, but instead came on the scene as “an extrapolation from the coronary artery literature, where it does have some benefit, particularly after percutaneous coronary intervention,” he explained.

The only reported study results to examine use of DAPT in patients who underwent peripheral artery revascularization focused entirely on patients who had a surgical procedure and showed no added benefit from DAPT over aspirin only in a multicenter, randomized trial with 851 patients (J Vasc Surg. 2010 Oct;52[4]:825-33), Dr. Hiatt noted. In VOYAGER PAD, two-thirds of all patients underwent an endovascular, not surgical, peripheral intervention, and among those treated with clopidogrel, 91% had endovascular treatment.

“We’re not saying don’t use DAPT, but patients on three drugs are at higher bleeding risk than patients on two drugs. I think our data also suggest starting rivaroxaban immediately after a procedure [as was done in VOYAGER PAD], and not waiting to complete a course of DAPT,” Dr. Hiatt said.

Other experts embraced Dr. Hiatt’s take on these findings, while warning that it may take some time for the message to penetrate into practice.

The overall VOYAGER PAD results “are practice changing for vascular interventions; it was by an order of magnitude the largest vascular intervention trial ever conducted,” commented Sahil A. Parikh, MD, a designated discussant, interventional cardiologist, and director of endovascular services at New York–Presbyterian Medical Center. “The data suggest that the value of clopidogrel is questionable, but the added hazard is not questionable” when given to patients on top of rivaroxaban and aspirin. The results “certainly beg the question of whether one should use DAPT at all, and if so, for how long.”

Use of DAPT in patients undergoing peripheral revascularization, especially patients receiving a stent, has been “dogma,” Dr. Parikh agreed. “It’s been pounded into our heads that DAPT is standard care, so it will take some time to penetrate into the practicing community.”

“Could there be patients who could benefit from triple therapy? That’s possible, but it needs testing,” commented Mark A. Creager, MD, professor of medicine and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. “We’ve made terrific strides with the results from VOYAGER PAD,” and from the earlier COMPASS trial, which proved the benefit of rivaroxaban and aspirin in patients with stable atherosclerotic vascular disease including many PAD patients (N Engl J Med. 2017 Oct 5;377[14]:1319-30). Use of rivaroxaban and aspirin in PAD patients based on the COMPASS results “is beginning to make an impact, but has a long way to go,” Dr. Creager said in an interview.

In late 2018, the Food and Drug Administration gave rivaroxaban a revised labeling that included an indication for patients with PAD based on the COMPASS findings. The VOYAGER PAD and COMPASS trials are especially noteworthy because “they opened a whole area [of study] in patients with peripheral vascular disease, ” he added.

The prespecified analysis that Dr. Hiatt reported analyzed outcomes among the 51% of patients enrolled in VOYAGER PAD (Vascular Outcomes Study of Acetylsalicylic Acid Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) who received clopidogrel during follow-up at the discretion of their treating physician and the outcomes among the remainder who did not. The two subgroups showed several statistically significant differences in the prevalence of various comorbidities and in some baseline demographic and clinical metrics, and the analyses that Dr. Hiatt reported did not attempt to correct for these differences. Patients who received clopidogrel had the drug on board for a median of 29 days, and about 58% received it for 30 days or less.

The main finding of his analysis was that “adding clopidogrel did not modify benefit at all” from the perspective of the primary endpoint of VOYAGER PAD, the incidence of a five-item list of adverse events (acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke, and cardiovascular death) during a median follow-up of 28 months (N Engl J Med. 2020 Mar 28. doi: 10.1056/NEJMoa2000052), said Dr. Hiatt. Among patients on clopidogrel, those treated with both rivaroxaban and aspirin had a 16.0% incidence of the primary endpoint, compared with an 18.3% rate among patients on aspirin only, for a 15% relative risk reduction, identical to the study’s primary result. Among patients not on clopidogrel, the primary endpoint occurred in 18.7% of patients on rivaroxaban plus aspirin and in 21.5% of those on aspirin only, a 14% relative risk reduction. The analyses also showed that adding clopidogrel appeared to increase the rate of bleeding episodes, particularly the incidence of major bleeds by the criteria of the International Society on Thrombosis and Haemostasis (ISTH), which rose among patients on aspirin alone from 3.3% without clopidogrel treatment to 4.9% with clopidogrel, and in patients on rivaroxaban plus aspirin these major bleeds increased from 5.4% with no clopidogrel to 6.5% with clopidogrel.

An especially revealing further analysis showed that, among those who also received rivaroxaban and aspirin, clopidogrel treatment for more than 30 days led to substantially more bleeding problems, compared with patients who received the drug for 30 days or less. Patients who received clopidogrel for more than 30 days as part of a triple-drug regimen had a 3.0% rate of major ISTH bleeds during 180 days of follow-up, compared with a 0.9% rate for patients in the aspirin-alone group who also received clopidogrel, a 2.1% between-group difference. In contrast, the difference in major ISTH bleeds between the two treatment arms in the subgroup who received clopidogrel for 30 days or less was 0.7%.

“What’s inarguable is that the course of clopidogrel should be as short as possible, probably not more than 30 days unless there is a real extenuating rationale,” commented designated discussant Gregory Piazza, MD, a cardiologist at Brigham and Women’s Hospital in Boston.

VOYAGER PAD was sponsored by Bayer and Janssen, the companies that market rivaroxaban (Xarelto). The institution that Dr. Hiatt leads has received research funding from Bayer and Janssen and from Amgen. Dr. Parikh has been a consultant to Terumo; has received research funding from Shockwave, Surmodics, and Trireme; has worked on trial monitoring for Boston Scientific and Silk Road; and has had other financial relationships with Abbott, Boston Scientific, and Medtronic. Dr. Creager had no disclosures. Dr. Piazza has received research grants from Bayer and Janssen, as well as Bristol-Myers Squibb, Diiachi, EKOS, and Portola, and he has been a consultant to Optum, Pfizer, and Thrombolex.

mzoler@mdedge.com

SOURCE: Hiatt WR et al. ACC 20, Abstract 406-13.

The VOYAGER PAD results from more than 6,500 patients created the biggest evidence base by far ever collected from patients with symptomatic peripheral artery disease (PAD) who underwent a vascular intervention, and showed that the combination of twice-daily rivaroxaban and once-daily aspirin was safe and more effective than aspirin alone for reducing future thrombotic and ischemic events.

Following that report on March 28, a prespecified subgroup analysis presented the next day showed that adding clopidogrel to this two-drug combination produced no added efficacy but caused additional bleeding episodes, suggesting that the common practice of using clopidogrel plus aspirin in these patients, especially those who receive a stent in a peripheral artery, should either fall by the wayside or be used very briefly.

“In the absence of clear benefit, clopidogrel exposure along with aspirin and rivaroxaban should be minimized or avoided to reduce this risk,” William R. Hiatt, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. But he also cautioned that “we did not control for clopidogrel use, and so the patients who received clopidogrel look different [from patients who did not receive clopidogrel]. We must be cautious in interpreting differences between patients on or off clopidogrel,” warned Dr. Hiatt, a lead investigator for VOYAGER PAD, professor for cardiovascular research at the University of Colorado at Denver in Aurora and president of the affiliated Colorado Prevention Center.

In addition to this substantial caveat, the finding that clopidogrel appeared to add no extra benefit to the rivaroxaban/aspirin regimen “contradicts some dogmas that have been in the field for decades,” Dr. Hiatt said. Use of dual-antiplatelet therapy (DAPT), in this setting usually aspirin and clopidogrel, in patients who have just undergone lower-extremity revascularization is “current dogma,” even though it is not based on any direct evidence for efficacy, but instead came on the scene as “an extrapolation from the coronary artery literature, where it does have some benefit, particularly after percutaneous coronary intervention,” he explained.

The only reported study results to examine use of DAPT in patients who underwent peripheral artery revascularization focused entirely on patients who had a surgical procedure and showed no added benefit from DAPT over aspirin only in a multicenter, randomized trial with 851 patients (J Vasc Surg. 2010 Oct;52[4]:825-33), Dr. Hiatt noted. In VOYAGER PAD, two-thirds of all patients underwent an endovascular, not surgical, peripheral intervention, and among those treated with clopidogrel, 91% had endovascular treatment.

“We’re not saying don’t use DAPT, but patients on three drugs are at higher bleeding risk than patients on two drugs. I think our data also suggest starting rivaroxaban immediately after a procedure [as was done in VOYAGER PAD], and not waiting to complete a course of DAPT,” Dr. Hiatt said.

Other experts embraced Dr. Hiatt’s take on these findings, while warning that it may take some time for the message to penetrate into practice.

The overall VOYAGER PAD results “are practice changing for vascular interventions; it was by an order of magnitude the largest vascular intervention trial ever conducted,” commented Sahil A. Parikh, MD, a designated discussant, interventional cardiologist, and director of endovascular services at New York–Presbyterian Medical Center. “The data suggest that the value of clopidogrel is questionable, but the added hazard is not questionable” when given to patients on top of rivaroxaban and aspirin. The results “certainly beg the question of whether one should use DAPT at all, and if so, for how long.”

Use of DAPT in patients undergoing peripheral revascularization, especially patients receiving a stent, has been “dogma,” Dr. Parikh agreed. “It’s been pounded into our heads that DAPT is standard care, so it will take some time to penetrate into the practicing community.”

“Could there be patients who could benefit from triple therapy? That’s possible, but it needs testing,” commented Mark A. Creager, MD, professor of medicine and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. “We’ve made terrific strides with the results from VOYAGER PAD,” and from the earlier COMPASS trial, which proved the benefit of rivaroxaban and aspirin in patients with stable atherosclerotic vascular disease including many PAD patients (N Engl J Med. 2017 Oct 5;377[14]:1319-30). Use of rivaroxaban and aspirin in PAD patients based on the COMPASS results “is beginning to make an impact, but has a long way to go,” Dr. Creager said in an interview.

In late 2018, the Food and Drug Administration gave rivaroxaban a revised labeling that included an indication for patients with PAD based on the COMPASS findings. The VOYAGER PAD and COMPASS trials are especially noteworthy because “they opened a whole area [of study] in patients with peripheral vascular disease, ” he added.

The prespecified analysis that Dr. Hiatt reported analyzed outcomes among the 51% of patients enrolled in VOYAGER PAD (Vascular Outcomes Study of Acetylsalicylic Acid Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) who received clopidogrel during follow-up at the discretion of their treating physician and the outcomes among the remainder who did not. The two subgroups showed several statistically significant differences in the prevalence of various comorbidities and in some baseline demographic and clinical metrics, and the analyses that Dr. Hiatt reported did not attempt to correct for these differences. Patients who received clopidogrel had the drug on board for a median of 29 days, and about 58% received it for 30 days or less.

The main finding of his analysis was that “adding clopidogrel did not modify benefit at all” from the perspective of the primary endpoint of VOYAGER PAD, the incidence of a five-item list of adverse events (acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke, and cardiovascular death) during a median follow-up of 28 months (N Engl J Med. 2020 Mar 28. doi: 10.1056/NEJMoa2000052), said Dr. Hiatt. Among patients on clopidogrel, those treated with both rivaroxaban and aspirin had a 16.0% incidence of the primary endpoint, compared with an 18.3% rate among patients on aspirin only, for a 15% relative risk reduction, identical to the study’s primary result. Among patients not on clopidogrel, the primary endpoint occurred in 18.7% of patients on rivaroxaban plus aspirin and in 21.5% of those on aspirin only, a 14% relative risk reduction. The analyses also showed that adding clopidogrel appeared to increase the rate of bleeding episodes, particularly the incidence of major bleeds by the criteria of the International Society on Thrombosis and Haemostasis (ISTH), which rose among patients on aspirin alone from 3.3% without clopidogrel treatment to 4.9% with clopidogrel, and in patients on rivaroxaban plus aspirin these major bleeds increased from 5.4% with no clopidogrel to 6.5% with clopidogrel.

An especially revealing further analysis showed that, among those who also received rivaroxaban and aspirin, clopidogrel treatment for more than 30 days led to substantially more bleeding problems, compared with patients who received the drug for 30 days or less. Patients who received clopidogrel for more than 30 days as part of a triple-drug regimen had a 3.0% rate of major ISTH bleeds during 180 days of follow-up, compared with a 0.9% rate for patients in the aspirin-alone group who also received clopidogrel, a 2.1% between-group difference. In contrast, the difference in major ISTH bleeds between the two treatment arms in the subgroup who received clopidogrel for 30 days or less was 0.7%.

“What’s inarguable is that the course of clopidogrel should be as short as possible, probably not more than 30 days unless there is a real extenuating rationale,” commented designated discussant Gregory Piazza, MD, a cardiologist at Brigham and Women’s Hospital in Boston.

VOYAGER PAD was sponsored by Bayer and Janssen, the companies that market rivaroxaban (Xarelto). The institution that Dr. Hiatt leads has received research funding from Bayer and Janssen and from Amgen. Dr. Parikh has been a consultant to Terumo; has received research funding from Shockwave, Surmodics, and Trireme; has worked on trial monitoring for Boston Scientific and Silk Road; and has had other financial relationships with Abbott, Boston Scientific, and Medtronic. Dr. Creager had no disclosures. Dr. Piazza has received research grants from Bayer and Janssen, as well as Bristol-Myers Squibb, Diiachi, EKOS, and Portola, and he has been a consultant to Optum, Pfizer, and Thrombolex.

mzoler@mdedge.com

SOURCE: Hiatt WR et al. ACC 20, Abstract 406-13.

PHOENIX, ARIZ. – Diabetes patients in China who were enrolled in a team-based care intervention with clinical decision support systems significantly reduced their hemoglobin A_1c, systolic blood pressure, and LDL cholesterol over 18 months, compared with those who received team-based care alone.

Doug Brunk/MDedge News

The finding comes from the Diabetes Complication Control in Community Clinics (D4C), a cluster randomized trial conducted in 38 community health centers in Xiamen, China.

“Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries where populations are large and growing and health care resources are limited,” Jiang He, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

According to Dr. He, chair and professor of epidemiology at Tulane School of Public Health and Tropical Medicine, New Orleans, the prevalence of diabetes has increased rapidly in recent decades in China, from 2.5% in 1994 to 11.6% in 2010. “It was estimated that 114 million Chinese adults had diabetes in 2010,” he said. “Hyperglycemia, high blood pressure, and elevated LDL cholesterol are major risk factors for cardiovascular disease and premature death. The majority of patients with diabetes have multiple uncontrolled CVD risk factors due to suboptimal care. Diabetes and its complications further strain an already overburdened and overwhelmed health care system, especially tertiary care facilities, in China. On the other hand, community health centers are underutilized.”

In D4C, Dr. He and colleagues set out to evaluate changes in CVD risk factors among patients with diabetes after implementing a team-based care model at community health centers in Xiamen, China. They compared the effectiveness of team-based care with clinical decision support systems versus team-based care alone on CVD risk factor control among patients with diabetes at these community health centers.

The study population consisted of 10,942 patients aged 50 years and older with uncontrolled diabetes and at least one of the following three additional CVD risk factors: systolic BP of at least 140 mm Hg and/or diastolic BP of at least 90 mm Hg; LDL cholesterol of at least 100 mg/dL, or clinical atherosclerotic cardiovascular disease (ASCVD). At the intervention clinics, team-based care was delivered by a team of primary care physicians, nurses, and diabetes specialists. The researchers trained the primary care physicians and nurses, and a clinical decision support system was integrated with guideline-based treatment algorithms for controlling glycemia, blood pressure, and lipids.

At the enhanced care control clinics, team-based care was delivered by a team of primary care physicians, nurses, and diabetes specialists. The city health commission trained the primary care physicians and nurses. The intervention lasted for 18 months in both groups.

Dr. He, the D4C study chair, reported findings from 10,942 patients: 5,394 in the intervention group and 5,548 in the enhanced care group. The mean baseline age was similar between the intervention group and the enhanced care group (a mean of 63 years), as was body mass index (a mean of 24.9 kg/m²), hemoglobin A_1c (a mean of 8.8 vs. 8.7%, respectively), LDL cholesterol (121.2 vs. 121.1 mg/dL), systolic blood pressure (136.6 vs. 136.9 mm Hg), and diastolic blood pressure (79.7 vs. 79.8 mm Hg).

The researchers found patients in both groups experienced significant reductions in HbA_1c, LDL cholesterol, and BP over the 18-month follow-up, but those in the intervention group fared better in all measures. Specifically, the mean change in HbA_1c from baseline was –.85% in the intervention group, compared with –.66% in the enhanced care group, while the change in LDL was –19 mg/dL, compared with –12.8 mg/dL, respectively; the change in systolic blood pressure was –8.9 mm Hg vs. –7.7 mm Hg, and the change in 10-year ASCVD risk was .57% vs. .28% (P < .0001 for all associations).

The researchers also observed that the proportions of controlled HbA_1c, LDL, and blood pressure at 18 months were higher in the intervention group, compared with the enhanced care group. Specifically, 38% of patients in the intervention group achieved glycemic control, compared with 35% of those in the enhanced care group (P =. 0006), while 48% vs. 39%, respectively, achieved control of LDL cholesterol (P < .0001), and 78% vs. 75% achieved control of blood pressure (P = .0009). In addition, 15% vs. 12% achieved control of all three risk factors at 18 months (P < .0001).

“Implementing team-based care with a clinical decision support system is an effective and sustainable strategy for diabetes control in primary care settings,” Dr. He said at the meeting, which was sponsored by the American Heart Association. “This implementation strategy could be scaled up within primary care settings in China and other low- to middle-income countries to improve CVD risk factor control in patients with diabetes.”

In an interview, session moderator Joshua J. Joseph, MD, of Ohio State University, Columbus, pointed out that since only 12%-15% of study participants achieved control of all three CVD risk factors, “that leaves a great opportunity for [figuring out] how to we get the other 88% or 85% of patients to target levels. That’s going to be important as we think about cardiovascular disease prevention in type 2 diabetes. The more we can use team-based care along with clinical decision support tools, the more we will continue to improve the lives of patients.”

The study was supported by the Xiamen City Health Commission. Dr. He reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: He J et al. EPI/LIFESTYLE 2020, session 7A, abstract 17.

PHOENIX, ARIZ. – Diabetes patients in China who were enrolled in a team-based care intervention with clinical decision support systems significantly reduced their hemoglobin A_1c, systolic blood pressure, and LDL cholesterol over 18 months, compared with those who received team-based care alone.

Doug Brunk/MDedge News

The finding comes from the Diabetes Complication Control in Community Clinics (D4C), a cluster randomized trial conducted in 38 community health centers in Xiamen, China.

“Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries where populations are large and growing and health care resources are limited,” Jiang He, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

According to Dr. He, chair and professor of epidemiology at Tulane School of Public Health and Tropical Medicine, New Orleans, the prevalence of diabetes has increased rapidly in recent decades in China, from 2.5% in 1994 to 11.6% in 2010. “It was estimated that 114 million Chinese adults had diabetes in 2010,” he said. “Hyperglycemia, high blood pressure, and elevated LDL cholesterol are major risk factors for cardiovascular disease and premature death. The majority of patients with diabetes have multiple uncontrolled CVD risk factors due to suboptimal care. Diabetes and its complications further strain an already overburdened and overwhelmed health care system, especially tertiary care facilities, in China. On the other hand, community health centers are underutilized.”

In D4C, Dr. He and colleagues set out to evaluate changes in CVD risk factors among patients with diabetes after implementing a team-based care model at community health centers in Xiamen, China. They compared the effectiveness of team-based care with clinical decision support systems versus team-based care alone on CVD risk factor control among patients with diabetes at these community health centers.

The study population consisted of 10,942 patients aged 50 years and older with uncontrolled diabetes and at least one of the following three additional CVD risk factors: systolic BP of at least 140 mm Hg and/or diastolic BP of at least 90 mm Hg; LDL cholesterol of at least 100 mg/dL, or clinical atherosclerotic cardiovascular disease (ASCVD). At the intervention clinics, team-based care was delivered by a team of primary care physicians, nurses, and diabetes specialists. The researchers trained the primary care physicians and nurses, and a clinical decision support system was integrated with guideline-based treatment algorithms for controlling glycemia, blood pressure, and lipids.

At the enhanced care control clinics, team-based care was delivered by a team of primary care physicians, nurses, and diabetes specialists. The city health commission trained the primary care physicians and nurses. The intervention lasted for 18 months in both groups.

Dr. He, the D4C study chair, reported findings from 10,942 patients: 5,394 in the intervention group and 5,548 in the enhanced care group. The mean baseline age was similar between the intervention group and the enhanced care group (a mean of 63 years), as was body mass index (a mean of 24.9 kg/m²), hemoglobin A_1c (a mean of 8.8 vs. 8.7%, respectively), LDL cholesterol (121.2 vs. 121.1 mg/dL), systolic blood pressure (136.6 vs. 136.9 mm Hg), and diastolic blood pressure (79.7 vs. 79.8 mm Hg).

The researchers found patients in both groups experienced significant reductions in HbA_1c, LDL cholesterol, and BP over the 18-month follow-up, but those in the intervention group fared better in all measures. Specifically, the mean change in HbA_1c from baseline was –.85% in the intervention group, compared with –.66% in the enhanced care group, while the change in LDL was –19 mg/dL, compared with –12.8 mg/dL, respectively; the change in systolic blood pressure was –8.9 mm Hg vs. –7.7 mm Hg, and the change in 10-year ASCVD risk was .57% vs. .28% (P < .0001 for all associations).

The researchers also observed that the proportions of controlled HbA_1c, LDL, and blood pressure at 18 months were higher in the intervention group, compared with the enhanced care group. Specifically, 38% of patients in the intervention group achieved glycemic control, compared with 35% of those in the enhanced care group (P =. 0006), while 48% vs. 39%, respectively, achieved control of LDL cholesterol (P < .0001), and 78% vs. 75% achieved control of blood pressure (P = .0009). In addition, 15% vs. 12% achieved control of all three risk factors at 18 months (P < .0001).

“Implementing team-based care with a clinical decision support system is an effective and sustainable strategy for diabetes control in primary care settings,” Dr. He said at the meeting, which was sponsored by the American Heart Association. “This implementation strategy could be scaled up within primary care settings in China and other low- to middle-income countries to improve CVD risk factor control in patients with diabetes.”

In an interview, session moderator Joshua J. Joseph, MD, of Ohio State University, Columbus, pointed out that since only 12%-15% of study participants achieved control of all three CVD risk factors, “that leaves a great opportunity for [figuring out] how to we get the other 88% or 85% of patients to target levels. That’s going to be important as we think about cardiovascular disease prevention in type 2 diabetes. The more we can use team-based care along with clinical decision support tools, the more we will continue to improve the lives of patients.”

The study was supported by the Xiamen City Health Commission. Dr. He reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: He J et al. EPI/LIFESTYLE 2020, session 7A, abstract 17.

PHOENIX, ARIZ. – Diabetes patients in China who were enrolled in a team-based care intervention with clinical decision support systems significantly reduced their hemoglobin A_1c, systolic blood pressure, and LDL cholesterol over 18 months, compared with those who received team-based care alone.

Doug Brunk/MDedge News

The finding comes from the Diabetes Complication Control in Community Clinics (D4C), a cluster randomized trial conducted in 38 community health centers in Xiamen, China.

“Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries where populations are large and growing and health care resources are limited,” Jiang He, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.

According to Dr. He, chair and professor of epidemiology at Tulane School of Public Health and Tropical Medicine, New Orleans, the prevalence of diabetes has increased rapidly in recent decades in China, from 2.5% in 1994 to 11.6% in 2010. “It was estimated that 114 million Chinese adults had diabetes in 2010,” he said. “Hyperglycemia, high blood pressure, and elevated LDL cholesterol are major risk factors for cardiovascular disease and premature death. The majority of patients with diabetes have multiple uncontrolled CVD risk factors due to suboptimal care. Diabetes and its complications further strain an already overburdened and overwhelmed health care system, especially tertiary care facilities, in China. On the other hand, community health centers are underutilized.”

In D4C, Dr. He and colleagues set out to evaluate changes in CVD risk factors among patients with diabetes after implementing a team-based care model at community health centers in Xiamen, China. They compared the effectiveness of team-based care with clinical decision support systems versus team-based care alone on CVD risk factor control among patients with diabetes at these community health centers.

The study population consisted of 10,942 patients aged 50 years and older with uncontrolled diabetes and at least one of the following three additional CVD risk factors: systolic BP of at least 140 mm Hg and/or diastolic BP of at least 90 mm Hg; LDL cholesterol of at least 100 mg/dL, or clinical atherosclerotic cardiovascular disease (ASCVD). At the intervention clinics, team-based care was delivered by a team of primary care physicians, nurses, and diabetes specialists. The researchers trained the primary care physicians and nurses, and a clinical decision support system was integrated with guideline-based treatment algorithms for controlling glycemia, blood pressure, and lipids.

At the enhanced care control clinics, team-based care was delivered by a team of primary care physicians, nurses, and diabetes specialists. The city health commission trained the primary care physicians and nurses. The intervention lasted for 18 months in both groups.

Dr. He, the D4C study chair, reported findings from 10,942 patients: 5,394 in the intervention group and 5,548 in the enhanced care group. The mean baseline age was similar between the intervention group and the enhanced care group (a mean of 63 years), as was body mass index (a mean of 24.9 kg/m²), hemoglobin A_1c (a mean of 8.8 vs. 8.7%, respectively), LDL cholesterol (121.2 vs. 121.1 mg/dL), systolic blood pressure (136.6 vs. 136.9 mm Hg), and diastolic blood pressure (79.7 vs. 79.8 mm Hg).

The researchers found patients in both groups experienced significant reductions in HbA_1c, LDL cholesterol, and BP over the 18-month follow-up, but those in the intervention group fared better in all measures. Specifically, the mean change in HbA_1c from baseline was –.85% in the intervention group, compared with –.66% in the enhanced care group, while the change in LDL was –19 mg/dL, compared with –12.8 mg/dL, respectively; the change in systolic blood pressure was –8.9 mm Hg vs. –7.7 mm Hg, and the change in 10-year ASCVD risk was .57% vs. .28% (P < .0001 for all associations).

The researchers also observed that the proportions of controlled HbA_1c, LDL, and blood pressure at 18 months were higher in the intervention group, compared with the enhanced care group. Specifically, 38% of patients in the intervention group achieved glycemic control, compared with 35% of those in the enhanced care group (P =. 0006), while 48% vs. 39%, respectively, achieved control of LDL cholesterol (P < .0001), and 78% vs. 75% achieved control of blood pressure (P = .0009). In addition, 15% vs. 12% achieved control of all three risk factors at 18 months (P < .0001).

“Implementing team-based care with a clinical decision support system is an effective and sustainable strategy for diabetes control in primary care settings,” Dr. He said at the meeting, which was sponsored by the American Heart Association. “This implementation strategy could be scaled up within primary care settings in China and other low- to middle-income countries to improve CVD risk factor control in patients with diabetes.”

In an interview, session moderator Joshua J. Joseph, MD, of Ohio State University, Columbus, pointed out that since only 12%-15% of study participants achieved control of all three CVD risk factors, “that leaves a great opportunity for [figuring out] how to we get the other 88% or 85% of patients to target levels. That’s going to be important as we think about cardiovascular disease prevention in type 2 diabetes. The more we can use team-based care along with clinical decision support tools, the more we will continue to improve the lives of patients.”

The study was supported by the Xiamen City Health Commission. Dr. He reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: He J et al. EPI/LIFESTYLE 2020, session 7A, abstract 17.

Older adults exposed to air pollution long term – even at fairly low levels – have an increased risk of dementia, and cardiovascular disease (CVD) appears to both modify and mediate this association, according to the results of the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K) study.

Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.

In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).

The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.

Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.

Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m³ in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m³ in nitrogen oxide during that time period.

Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.

In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).

Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.

The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.

Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.

SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
 

Older adults exposed to air pollution long term – even at fairly low levels – have an increased risk of dementia, and cardiovascular disease (CVD) appears to both modify and mediate this association, according to the results of the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K) study.

Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.

In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).

The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.

Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.

Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m³ in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m³ in nitrogen oxide during that time period.

Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.

In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).

Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.

The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.

Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.

SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
 

Older adults exposed to air pollution long term – even at fairly low levels – have an increased risk of dementia, and cardiovascular disease (CVD) appears to both modify and mediate this association, according to the results of the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K) study.

Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.

In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).

The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.

Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.

Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m³ in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m³ in nitrogen oxide during that time period.

Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.

In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).

Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.

The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.

Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.

SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
 

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

Evinacumab, the first agent from a new class of lipid-lowering drugs, showed a “remarkable” and unprecedented level of LDL-cholesterol lowering in a pivotal trial with 65 patients with homozygous familial hypercholesterolemia.

Monthly intravenous infusions of evinacumab cut LDL cholesterol levels by an average of 135 mg/dL from baseline, a 47% mean reduction, after 24 weeks of treatment in 43 homozygous familial hypercholesterolemia (HoFH) patients, Frederick Raal, MBChB, said on March 30 in a video presentation of his research at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

Evinacumab is a human monoclonal antibody inhibitor of angiopoietin-like 3, a liver protein that boosts levels of LDL cholesterol and triglycerides (TG).

Another notable effect of the novel agent was that it was equally effective in the roughly one-third of patients with a minimal residual level of LDL receptor activity, patients know as having “null/null” mutations. “For the first time, we see HoFH patients getting to [lipid] targets that we never thought would be possible,” said Dr. Raal, professor and head of endocrinology and metabolism at the University of Witwatersrand in Johannesburg, South Africa. “This works in patients without residual LDL receptor function.” The drug was also generally very well tolerated, he said, causing no treatment-related serious adverse events during the brief treatment period of 24 weeks.

“One of the major, remarkable findings in this study was the effect on null/null patients,” which contrasts with the effects of other, more established drugs for treating dyslipidemia like statins and PCSK9 inhibitors, which work by increasing the number of LDL receptors on cells. The demonstrated efficacy and safety of evinacumab in null/null patients “is a definite advance,” commented Anne C. Goldberg, MD, a lipidologist and professor of medicine at Washington University in St. Louis.

The placebo-controlled trial randomized patients at 30 sites in 11 countries who were at least 12 years old and had documented mutations in both of their LDL receptor genes and a serum level of LDL cholesterol that was at least 500 mg/dL on no treatment. Patients averaged about 40 years of age; about 30% had null/null mutations, more than 90% were on statin treatment, and about three-quarters were receiving regular treatment with a PCSK9 inhibitor. At baseline, LDL cholesterol levels averaged about 250 mg/dL.

The study’s primary endpoint was the between-group percentage change in LDL cholesterol level after 24 weeks, which fell by 47% from baseline with evinacumab treatment and increased by an average of 2% among 22 patients who received placebo injections; so evinacumab cut this measure by 49%, compared with placebo after 24 weeks, a statistically significant difference. A cut of baseline LDL cholesterol by at least 50% occurred in 56% of the evinacumab-treated patients and in 5% of controls.

In addition to its LDL reduction, another notable effect of evinacumab was that it trimmed baseline triglyceride levels by half, consistent with prior reports of the drug’s effect on this measure, although average triglyceride levels in the enrolled patients fell within the normal range prior to treatment.

Evinacumab “will probably be very effective in treating patients with hypertriglyceridemia; those studies are ongoing,” noted Dr. Raal. But, he added, “this drug will probably be reserved for severe” dyslipidemia cases, not for “the garden variety of moderate hypertriglyceridemia or hypercholesterolemia.”

Evinacumab “may be a fairly broad-spectrum lipid-lowering drug, but it should be reserved for severe cases,” agreed Dirk Blom, MBChB, head of lipidology at the University of Capetown, South Africa. “This will likely remain a fairly expensive drug, and we wouldn’t want to use it across the board, but for difficult to treat patients with either severe hypercholesterolemia or hypertriglyceridemia, I think this will have very significant advantages,” he commented.

“Drugs that reduce triglycerides by large amounts may prove to have cardiovascular disease benefits, but that remains to be proven in large, long-term outcome trials,” commented Deepak Bhatt, MD, professor of medicine at Harvard Medical School and executive director of interventional cardiology programs at Brigham and Women’s Hospital, both in Boston. “But for right now, for most patients with more common forms of elevated LDL cholesterol, the treatment options include statins, ezetimibe [Zetia], and PCSK9 inhibitors, and for more common levels of elevated triglycerides, it’s icosapent ethyl [Vascepa],” Dr. Bhatt said.

The study was sponsored by Regeneron, the company developing evinacumab and which is partially owned by Sanofi. Dr. Raal has received personal fees and/or research funding from Regeneron, Sanofi Aventis, Amgen, and The Medicines Company. Dr. Goldberg has received research funding and/or consulting fees from Regeneron and Sanofi, Akcea, Amarin, Amgen, Esperion, Ionis, Merck, Novartis, and Pfizer. Dr. Blom has been a consultant to and/or received research funding from Regeneron, Sanofi, Aegerium, Akcea, Amgen, Amryt, AstraZeneca, Eli Lilly, Esperion, Gemphire, MSD, and Novo Nordisk. Dr. Bhatt has received research funding from many companies including Regeneron and Sanofi.

mzoler@mdedge.com

SOURCE: Raal F. ACC 20. Abstract 411-12.

Evinacumab, the first agent from a new class of lipid-lowering drugs, showed a “remarkable” and unprecedented level of LDL-cholesterol lowering in a pivotal trial with 65 patients with homozygous familial hypercholesterolemia.

Monthly intravenous infusions of evinacumab cut LDL cholesterol levels by an average of 135 mg/dL from baseline, a 47% mean reduction, after 24 weeks of treatment in 43 homozygous familial hypercholesterolemia (HoFH) patients, Frederick Raal, MBChB, said on March 30 in a video presentation of his research at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

Evinacumab is a human monoclonal antibody inhibitor of angiopoietin-like 3, a liver protein that boosts levels of LDL cholesterol and triglycerides (TG).

Another notable effect of the novel agent was that it was equally effective in the roughly one-third of patients with a minimal residual level of LDL receptor activity, patients know as having “null/null” mutations. “For the first time, we see HoFH patients getting to [lipid] targets that we never thought would be possible,” said Dr. Raal, professor and head of endocrinology and metabolism at the University of Witwatersrand in Johannesburg, South Africa. “This works in patients without residual LDL receptor function.” The drug was also generally very well tolerated, he said, causing no treatment-related serious adverse events during the brief treatment period of 24 weeks.

“One of the major, remarkable findings in this study was the effect on null/null patients,” which contrasts with the effects of other, more established drugs for treating dyslipidemia like statins and PCSK9 inhibitors, which work by increasing the number of LDL receptors on cells. The demonstrated efficacy and safety of evinacumab in null/null patients “is a definite advance,” commented Anne C. Goldberg, MD, a lipidologist and professor of medicine at Washington University in St. Louis.

The placebo-controlled trial randomized patients at 30 sites in 11 countries who were at least 12 years old and had documented mutations in both of their LDL receptor genes and a serum level of LDL cholesterol that was at least 500 mg/dL on no treatment. Patients averaged about 40 years of age; about 30% had null/null mutations, more than 90% were on statin treatment, and about three-quarters were receiving regular treatment with a PCSK9 inhibitor. At baseline, LDL cholesterol levels averaged about 250 mg/dL.

The study’s primary endpoint was the between-group percentage change in LDL cholesterol level after 24 weeks, which fell by 47% from baseline with evinacumab treatment and increased by an average of 2% among 22 patients who received placebo injections; so evinacumab cut this measure by 49%, compared with placebo after 24 weeks, a statistically significant difference. A cut of baseline LDL cholesterol by at least 50% occurred in 56% of the evinacumab-treated patients and in 5% of controls.

In addition to its LDL reduction, another notable effect of evinacumab was that it trimmed baseline triglyceride levels by half, consistent with prior reports of the drug’s effect on this measure, although average triglyceride levels in the enrolled patients fell within the normal range prior to treatment.

Evinacumab “will probably be very effective in treating patients with hypertriglyceridemia; those studies are ongoing,” noted Dr. Raal. But, he added, “this drug will probably be reserved for severe” dyslipidemia cases, not for “the garden variety of moderate hypertriglyceridemia or hypercholesterolemia.”

Evinacumab “may be a fairly broad-spectrum lipid-lowering drug, but it should be reserved for severe cases,” agreed Dirk Blom, MBChB, head of lipidology at the University of Capetown, South Africa. “This will likely remain a fairly expensive drug, and we wouldn’t want to use it across the board, but for difficult to treat patients with either severe hypercholesterolemia or hypertriglyceridemia, I think this will have very significant advantages,” he commented.

“Drugs that reduce triglycerides by large amounts may prove to have cardiovascular disease benefits, but that remains to be proven in large, long-term outcome trials,” commented Deepak Bhatt, MD, professor of medicine at Harvard Medical School and executive director of interventional cardiology programs at Brigham and Women’s Hospital, both in Boston. “But for right now, for most patients with more common forms of elevated LDL cholesterol, the treatment options include statins, ezetimibe [Zetia], and PCSK9 inhibitors, and for more common levels of elevated triglycerides, it’s icosapent ethyl [Vascepa],” Dr. Bhatt said.

The study was sponsored by Regeneron, the company developing evinacumab and which is partially owned by Sanofi. Dr. Raal has received personal fees and/or research funding from Regeneron, Sanofi Aventis, Amgen, and The Medicines Company. Dr. Goldberg has received research funding and/or consulting fees from Regeneron and Sanofi, Akcea, Amarin, Amgen, Esperion, Ionis, Merck, Novartis, and Pfizer. Dr. Blom has been a consultant to and/or received research funding from Regeneron, Sanofi, Aegerium, Akcea, Amgen, Amryt, AstraZeneca, Eli Lilly, Esperion, Gemphire, MSD, and Novo Nordisk. Dr. Bhatt has received research funding from many companies including Regeneron and Sanofi.

mzoler@mdedge.com

SOURCE: Raal F. ACC 20. Abstract 411-12.

Evinacumab, the first agent from a new class of lipid-lowering drugs, showed a “remarkable” and unprecedented level of LDL-cholesterol lowering in a pivotal trial with 65 patients with homozygous familial hypercholesterolemia.

Monthly intravenous infusions of evinacumab cut LDL cholesterol levels by an average of 135 mg/dL from baseline, a 47% mean reduction, after 24 weeks of treatment in 43 homozygous familial hypercholesterolemia (HoFH) patients, Frederick Raal, MBChB, said on March 30 in a video presentation of his research at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

Evinacumab is a human monoclonal antibody inhibitor of angiopoietin-like 3, a liver protein that boosts levels of LDL cholesterol and triglycerides (TG).

Another notable effect of the novel agent was that it was equally effective in the roughly one-third of patients with a minimal residual level of LDL receptor activity, patients know as having “null/null” mutations. “For the first time, we see HoFH patients getting to [lipid] targets that we never thought would be possible,” said Dr. Raal, professor and head of endocrinology and metabolism at the University of Witwatersrand in Johannesburg, South Africa. “This works in patients without residual LDL receptor function.” The drug was also generally very well tolerated, he said, causing no treatment-related serious adverse events during the brief treatment period of 24 weeks.

“One of the major, remarkable findings in this study was the effect on null/null patients,” which contrasts with the effects of other, more established drugs for treating dyslipidemia like statins and PCSK9 inhibitors, which work by increasing the number of LDL receptors on cells. The demonstrated efficacy and safety of evinacumab in null/null patients “is a definite advance,” commented Anne C. Goldberg, MD, a lipidologist and professor of medicine at Washington University in St. Louis.

The placebo-controlled trial randomized patients at 30 sites in 11 countries who were at least 12 years old and had documented mutations in both of their LDL receptor genes and a serum level of LDL cholesterol that was at least 500 mg/dL on no treatment. Patients averaged about 40 years of age; about 30% had null/null mutations, more than 90% were on statin treatment, and about three-quarters were receiving regular treatment with a PCSK9 inhibitor. At baseline, LDL cholesterol levels averaged about 250 mg/dL.

The study’s primary endpoint was the between-group percentage change in LDL cholesterol level after 24 weeks, which fell by 47% from baseline with evinacumab treatment and increased by an average of 2% among 22 patients who received placebo injections; so evinacumab cut this measure by 49%, compared with placebo after 24 weeks, a statistically significant difference. A cut of baseline LDL cholesterol by at least 50% occurred in 56% of the evinacumab-treated patients and in 5% of controls.

In addition to its LDL reduction, another notable effect of evinacumab was that it trimmed baseline triglyceride levels by half, consistent with prior reports of the drug’s effect on this measure, although average triglyceride levels in the enrolled patients fell within the normal range prior to treatment.

Evinacumab “will probably be very effective in treating patients with hypertriglyceridemia; those studies are ongoing,” noted Dr. Raal. But, he added, “this drug will probably be reserved for severe” dyslipidemia cases, not for “the garden variety of moderate hypertriglyceridemia or hypercholesterolemia.”

Evinacumab “may be a fairly broad-spectrum lipid-lowering drug, but it should be reserved for severe cases,” agreed Dirk Blom, MBChB, head of lipidology at the University of Capetown, South Africa. “This will likely remain a fairly expensive drug, and we wouldn’t want to use it across the board, but for difficult to treat patients with either severe hypercholesterolemia or hypertriglyceridemia, I think this will have very significant advantages,” he commented.

“Drugs that reduce triglycerides by large amounts may prove to have cardiovascular disease benefits, but that remains to be proven in large, long-term outcome trials,” commented Deepak Bhatt, MD, professor of medicine at Harvard Medical School and executive director of interventional cardiology programs at Brigham and Women’s Hospital, both in Boston. “But for right now, for most patients with more common forms of elevated LDL cholesterol, the treatment options include statins, ezetimibe [Zetia], and PCSK9 inhibitors, and for more common levels of elevated triglycerides, it’s icosapent ethyl [Vascepa],” Dr. Bhatt said.

The study was sponsored by Regeneron, the company developing evinacumab and which is partially owned by Sanofi. Dr. Raal has received personal fees and/or research funding from Regeneron, Sanofi Aventis, Amgen, and The Medicines Company. Dr. Goldberg has received research funding and/or consulting fees from Regeneron and Sanofi, Akcea, Amarin, Amgen, Esperion, Ionis, Merck, Novartis, and Pfizer. Dr. Blom has been a consultant to and/or received research funding from Regeneron, Sanofi, Aegerium, Akcea, Amgen, Amryt, AstraZeneca, Eli Lilly, Esperion, Gemphire, MSD, and Novo Nordisk. Dr. Bhatt has received research funding from many companies including Regeneron and Sanofi.

mzoler@mdedge.com

SOURCE: Raal F. ACC 20. Abstract 411-12.

Alirocumab achieved a mean 63-mg/dL reduction in LDL cholesterol in the ODYSSEY HoFH study, the largest-ever randomized, placebo-controlled clinical trial of lipid-lowering in adults with homozygous familial hypercholesterolemia (HoFH), Dirk Blom, MD, said in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

bjancin@mdedge.com

Alirocumab achieved a mean 63-mg/dL reduction in LDL cholesterol in the ODYSSEY HoFH study, the largest-ever randomized, placebo-controlled clinical trial of lipid-lowering in adults with homozygous familial hypercholesterolemia (HoFH), Dirk Blom, MD, said in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

bjancin@mdedge.com

Alirocumab achieved a mean 63-mg/dL reduction in LDL cholesterol in the ODYSSEY HoFH study, the largest-ever randomized, placebo-controlled clinical trial of lipid-lowering in adults with homozygous familial hypercholesterolemia (HoFH), Dirk Blom, MD, said in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

bjancin@mdedge.com

AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.

DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.

The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.

Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.

“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.

lfranki@mdedge.com

AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.

DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.

The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.

Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.

“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.

lfranki@mdedge.com

AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.

DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.

The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.

Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.

“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.

lfranki@mdedge.com

From the University of North Carolina at Wilmington School of Nursing (Dr. Smith and Dr. Turrise), the New Hanover Regional Medical Center Heart Center (Mr. Jordan), the Coastal Carolinas Health Alliance and Coastal Connect Health Information Exchange (Ms. Robertson), and Coastal Thoracic Surgical Associates (Dr. Kane), Wilmington, NC.

Abstract

Objective: Cardiothoracic (CT) surgeons at our medical center were not receiving timely notification when their coronary artery bypass graft (CABG) surgery patients were admitted to the medical center or to other hospitals. The CT surgical team worked with a health alliance in southeastern North Carolina to implement health information exchange (HIE) real-time electronic notifications for their CABG patients who presented to the hospital’s emergency department (ED) or any ED affiliated with the medical center. The alert tool notifies team members about patient encounters, driving timely clinical engagement.

Methods: The CT team provided the HIE team with the names of CABG surgery patients, which were loaded into the alert tool. When a patient on the list presented to the hospital ED or its affiliates, the alert tool sent a real-time electronic notification to the Cardiac Surgical Services nurse coordinator. This intervention prompted the assessment and disposition of CABG patients, while in the ED, by the CT surgical team.

Results: Over a 16-month period (September 2017-December 2018), the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; 44 were readmitted for inpatient care; and 492 did not have a qualifying event requiring a notification alert. Following implementation of this practice change, the 30-day readmission rate for patients who underwent CABG at our institution decreased from 10% to 7.2%.

Conclusion: Utilizing a real-time alert tool resulted in immediate notification of the CT team when 1 of their patients presented to the ED. This afforded the CT surgical team an opportunity to intervene in the care of their patients, which in turn led to improved quality of care, physician communication and collaboration, and patient outcomes, such as preventable 30-day readmissions.

Keywords: electronic health record; real-time electronic notification; CABG; process improvement.

Unplanned 30-day hospital readmissions of patients who have undergone coronary artery bypass graft (CABG) surgery contribute to higher overall health care costs. CABG is 1 of the conditions/procedures that the Centers for Medicare and Medicaid Services (CMS) monitors for excess readmissions.¹ Readmission rates for CABG-related conditions at 30 days post-surgery are reported to be between 16% and 20% for US hospitals.² Readmissions are not only financially costly, but also have been associated with worse patient outcomes and decreased patient satisfaction.³ Common diagnoses for post-CABG admission include atrial fibrillation, pleural effusion, and wound infection.

The facility where this project was implemented had a 10% post-CABG admission rate for patients across all payers. While this rate is below the national average of 13.2%, the cardiothoracic (CT) surgical team was not being notified in a timely manner when their post-CABG patients were readmitted. The Lean team used the A3 problem-solving process to develop strategies that would reduce these readmissions and improve the care of their patients.

We explored the use of electronic alerts in managing post-CABG patients by conducting a literature search using the terms electronic alerts in patient care, patient engagement in the emergency department, electronic alerts in CABG, real-time notifications to prevent readmission, and CABG readmission. Databases searched were PubMed, Google Scholar, Cumulative Index of Nursing and Allied Health Literature, ProQuest, and ScienceDirect. This search resulted in studies focused on the use of electronic health record (EHR) alerts as a clinical decision-support tool; for example, patient demographic and assessment data are entered into the EHR, and the clinician is prompted with “performance” recommendations (eg, consider electrocardiogram and aspirin).⁴ In a paper by Engelman and Benjamin,⁵ the authors discuss the importance of the engaged physician and note that, in their emergency department (ED), an electronic notification is sent when a postoperative patient presents; however, the notification goes to the inpatient service for timely review and disposition. There was no literature that discussed the use of an electronic alert tool as a real-time patient engagement strategy that resulted in a practice change specific to the CT surgical team.

Our process improvement project focused on alerting the CT surgical team when a post-CABG patient presented to the ED, allowing them to evaluate the patient in real time and determine whether the chief complaint was related to the CABG and whether further evaluation by the CT surgeon was required. Specifically, we wanted to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. During this project, alerts were sent to the CT surgical team notifying them of a post-CABG patient presenting to the ED or being directly admitted from home on physician orders, a provider’s office, or inpatient rehabilitation; however, the focus of this article is specifically on the notification regarding post-CABG patients presenting to the ED.

Prior to implementing the electronic notification project, the team developed and implemented several internal and external readmission reduction and prevention strategies for CABG patients. An in-house strategy involved a process whereby patients would receive their discharge medications prior to being discharged from the hospital post-CABG, thereby avoiding potential delays in the patient obtaining medications. When examining post-CABG patient readmissions, the primary conditions that led to readmission were fluid overload, pleural effusion, and atrial fibrillation. As such, a second in-house strategy was developed for post-CABG patients presenting to the ED with atrial fibrillation. The newly established protocol allowed patients to be monitored and treated in the cardiac observation unit. In addition, external strategies, including an outpatient furosemide protocol for home health nurses and an outpatient thoracentesis program and order set, were established (eg, for patients with congestive heart failure, shortness of breath).

Methods

Setting

The regional medical center where this project was implemented is the ninth largest hospital in North Carolina and the largest county-owned public hospital in the state. It is a tertiary care center and teaching hospital with 3 hospital campuses and 855 licensed beds. The medical center was included in the 100 Safecare Hospitals list by the Safecare Group; received a grade “A” Hospital Safety Score from the Leapfrog Group; and is 1 of America’s Top 100 Hospitals for Patient Experience.

Real-Time Notification Project

A regional hospital alliance in southeastern North Carolina established a health information exchange (HIE) with its member hospitals and office-based physicians to enable electronic exchange of patient information to improve quality, safety, and efficiency in health care delivery. Our medical center is part of this alliance. The HIE is a digital platform that facilitates the sharing of information between disparate connected EHR systems, and offers a portal for practices and hospitals to access patient information across North Carolina, South Carolina (via SC HIE), and nationwide (select dialysis centers). More specifically, approved providers and team members are able to access, in real time, patient-care encounter documents from other care settings (eg, acute, post-acute, ambulatory) via the HIE. Additionally, approved care entities can query-retrieve web portal information to support patient outcome improvement strategies. A partnership discussion highlighted the opportunity to utilize the HIE’s capabilities, such as real-time notification, to facilitate workflow (eg, when a patient presents to the ED, the HIE can provide access to health information at the point of care). In this capacity, the alert tool notifies care team members about patient encounters to drive timely clinical engagement for care transitions.

In January 2017, we began discussions on using the HIE to facilitate real-time electronic tracking in the Cardiac Surgical Services department at our medical center. Persons involved in these discussions included the cardiovascular (CV) team (comprised of case managers, department managers and coordinators, program coordinators, administrators, and support services [eg, pre-admission testing and home health staff]) and CT surgeons. At that time, CABG readmissions were manually tracked, and the real-time notification tool was being used in other departments (eg, in case management for tracking readmissions). The entire team was part of the initial decision meeting to pursue this possibility. The CV team reached consensus in June 2017 and proposed extending the use of the alert tool to the post-CABG population presenting to the ED (or any ED affiliated with the medical center) or admitted directly to the medical center.

The HIE staff met with the Cardiac Surgical Services team to tailor and develop the logistics of the project, such as who would be notified and how. The goals of the project were to support appropriate care intervention, reduce preventable hospital readmissions, and improve quality of care through enhanced provider communication and engagement. To achieve these goals, on the day of discharge the Cardiac Surgical Services coordinator provided the HIE team with the names of patients who had undergone CABG surgery. This patient list was loaded into the alert tool and continually updated. At 31 days, patient names were removed from the list. When a patient on the list presented to the hospital ED, the alert tool sent 2 real-time electronic notifications, an email and a text message, to the Cardiac Surgical Services coordinator, noting that a patient event occurred. Personal information was not included in the alert in order to protect patient information and comply with Health Insurance Portability and Accountability Act regulations.

The alert prompted the Cardiac Surgical Services coordinator to securely access patient information to identify and, if necessary, visit the patient. Then, based on the information gathered by the Cardiac Surgical Services coordinator, a Situation-Background-Assessment-Recommendation report was relayed to the CT surgeon, who then determined whether intervention by the CT surgical team was warranted. This process, on average, took approximately 30 minutes to complete. This was a key change in processes, one that allowed post-CABG patients to be seen by the CT surgical team while in the ED. If the issue was related to the CABG surgery, the CT surgeons could then determine an appropriate course of action, including admission or implementation of another protocol, such as the home furosemide protocol. For patients directly admitted, the surgeon contacted the admitting provider to discuss the level of care required (ie, observation or inpatient admission and treatment).

Biweekly CV team meetings were conducted during the implementation of the real-time notification alert tool. At each meeting, updates were provided on notifications received, patients who were missed by the notification process, and how well the real-time alerts were working to enhance care and appropriate disposition.

Measurements

Clinical performance data included total notifications, total number of ED visits, ED disposition (inpatient admission, observation, discharge), total number of direct admissions, direct admissions to observation, direct inpatient admissions, and patients missed by the notification process (eg, due to data entry errors, omissions of information [suffix of junior or senior], as well as programming bugs). Finally, the number of observation admissions converted to inpatient admissions was collected and further analyzed to inform needed process changes.

The Cardiac Surgical Services coordinator collected, entered, and maintained data using Excel. Data were obtained from the EHR, recorded in Excel, and analyzed using basic descriptive statistics in an ongoing fashion. Particular attention was focused on problems with the notification process (eg, patients being missed due to errors in data entry) and summarizing information to keep the Cardiac Surgical Services team updated on the progress of the process improvement. This project did not require staff protections or considerations, and because this was not a research study Institutional Review Board approval was not required.

Results

This practice change was implemented in September 2017 and led to improvements in care quality, as evidenced by improved physician communication and collaboration. In the 16-month period from implementation through December 2018, the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; and 44 were readmitted for inpatient care. The remaining 492 patients did not have a qualifying event requiring a notification alert. Clinical performance data from this period included 70 ED visits, 21 direct admissions, 19 direct admissions to observation, 5 patients missed by the notification process, and 4 observation admissions converted to inpatient admissions. A reduction in the CABG readmission rate from 10% in September 2017 to 7.2% in December 2018 was also noted.

Discussion

The aim of this process improvement project was to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. This practice change has been successful, following 16 months of implementation and process refinement. Integrating a real-time electronic alert with a supporting action plan and care protocols resulted in timely patient engagement and avoidance of readmission of post-CABG patients.

Early notification of possible post-CABG readmissions became a standard-of-care process within the Cardiac Surgical Services department, with expansion to all CT post-op patients. Leveraging HIE technology to support quality improvement processes was also viewed by other departments as relevant and beneficial. For example, the hospital stroke and orthopedic-spine teams established their own processes for receiving real-time alerts.

There were several lessons learned during this project. First, gaining 100% physician buy-in to collaborative communication proved to be critical to the project’s success. The CV team was surprised by the length of time (approximately 8-10 months) it took for the practice change to be adopted by the physicians. In part, some of this delay in adoption resulted from medical staff turnover, primarily in the medical resident training rotations. Collaborative communication was key. The CT surgeons spoke with ED leadership and hospitalist services to explain the readmission reduction project and the use of an electronic alert tool. The CT surgeons also communicated to the ED physicians, hospitalists, and cardiologists that the Cardiac Surgical Services coordinator would be involved in the process and discussions regarding patientss care. Additionally, the CT surgeons authored the furosemide protocol and then committed to its use in the home health setting, further highlighting the role of collaborative communication in avoiding readmissions.

Another key step in this quality improvement project was determining who should receive the alert notifications. At the onset of the project, all notifications were sent to 1 person, the Cardiac Surgical Services coordinator. While this seemed logical in the initial stage of the project, it was unsustainable, as the receipt of the alert and the subsequent notification of the CT surgeon depended on 1 person and their availability. Approximately 10 months into the project, the notification process was further refined, with the cardiovascular intensive care unit charge nurse becoming the point of contact for the alerts. The Cardiac Surgical Services coordinator, in collaboration with nursing leaders and CT surgeons, completed a Lean Standard Work template outlining the major steps and the associated responsibilities (for the cardiovascular intensive care unit charge nurse, CT surgeon and on-call surgeon, Cardiac Surgical Services coordinator) in the process of receiving notifications, collecting patient assessment data, and reporting notifications to the CT surgeons.

Establishing adequate support mechanisms during a practice change is also important. For instance, we had to dedicate personnel time for data collection and analysis and involve additional nursing or other qualified personnel in the new process to avoid depending on a single person for the project’s success. Additional considerations were establishing criteria for surgeon notification and defining an appropriate time frame for notification (eg, urgent versus next-day notifications). We accomplished these activities approximately 10 months into the project, after it became apparent at CV team meeting discussions that further clarification of criteria and timelines was needed.

Some aspects of the project unfolded as planned, while others presented opportunities for improvement. For example, the alert notification process worked as envisioned; however, as previously mentioned, the process needed to be more inclusive to ensure there is always a charge nurse on duty to receive the alert notification, rather than just the Cardiac Surgical Services coordinator, who may not always be at the hospital. The outpatient thoracentesis program was well planned and effectively implemented. This program provided an avenue for patients who had symptoms of pleural effusion to be treated in an outpatient setting, rather than requiring an inpatient stay. Opportunities for improvement included addressing the inconsistent use of the home health furosemide protocol (developed in 2016), and the need for continued interprofessional and interdepartmental communication and coordination. For example, we had to inform the ED physicians and staff who rotate or are new to the ED about established processes and protocols in place for managing post-CABG patients who present to the ED.

The primary limitation of this project was the inability to measure the enhanced patient experience, which was 1 of the stated project goals. This goal became secondary because of more pressing issues, specifically, interorganizational collaboration (eg, hospital EHR, HIE, and CT surgical team) and tailoring the functionality of the electronic alert tool to the project. Developing and implementing measures of enhanced patient experience were not feasible during this implementation. Additionally, because this was not a research study, it was not possible to determine cause and effect or to control for confounders, such as a sicker, older cohort with more comorbid conditions, during the comparison period. Finally, although this process improvement project was conducted at a regional medical center that is the only facility performing CABG within the region, patients may have presented to another facility for an event that led to a readmission. Because readmissions to other facilities could not be captured, it is possible that the actual readmission rate was higher than the rate reported here.

Conclusions and Implications

Utilizing a real-time alert from the HIE to the CT surgical team resulted in CT surgeons being immediately made aware when their patients presented to the ED, allowing the CT surgical team the opportunity to intervene, as appropriate, in the care of their patients. Furthermore, this real-time notification and intervention resulted in timely patient engagement and, in some cases, avoidance of readmissions. Currently, patients are monitored for readmission within 30 days of discharge. In the future, the time will expand to 91 days, in preparation for participation in the CMS bundle payment program for CABG surgery.

This practice change can be used in organizations that do not have or participate in a HIE. In fact, these real-time alert applications may be available through an EHR already in use within the organization. The use of the alert requires collaborative communication and having supporting protocols in place to guide decision-making and care of post-CABG patients presenting to the ED.

There appears to be a gap in the literature discussing the use of an electronic alert tool as a real-time patient engagement strategy for post-CABG patients presenting to the ED. As such, this project contributes important results and lessons learned for other hospital service lines/departments that might consider implementing a similar process. Next steps include designing and conducting methodologically rigorous research studies based on this process improvement project to examine mortality rates as an outcome, and designing a more specific measure of patient experience, as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey only provides hospital-level data.

Corresponding author: Stephanie D. Smith, PhD, RN, UNCW School of Nursing, 601 South College Road, Wilmington, NC 28403; smithsd@uncw.edu.

Funding disclosures: None.

From the University of North Carolina at Wilmington School of Nursing (Dr. Smith and Dr. Turrise), the New Hanover Regional Medical Center Heart Center (Mr. Jordan), the Coastal Carolinas Health Alliance and Coastal Connect Health Information Exchange (Ms. Robertson), and Coastal Thoracic Surgical Associates (Dr. Kane), Wilmington, NC.

Abstract

Objective: Cardiothoracic (CT) surgeons at our medical center were not receiving timely notification when their coronary artery bypass graft (CABG) surgery patients were admitted to the medical center or to other hospitals. The CT surgical team worked with a health alliance in southeastern North Carolina to implement health information exchange (HIE) real-time electronic notifications for their CABG patients who presented to the hospital’s emergency department (ED) or any ED affiliated with the medical center. The alert tool notifies team members about patient encounters, driving timely clinical engagement.

Methods: The CT team provided the HIE team with the names of CABG surgery patients, which were loaded into the alert tool. When a patient on the list presented to the hospital ED or its affiliates, the alert tool sent a real-time electronic notification to the Cardiac Surgical Services nurse coordinator. This intervention prompted the assessment and disposition of CABG patients, while in the ED, by the CT surgical team.

Results: Over a 16-month period (September 2017-December 2018), the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; 44 were readmitted for inpatient care; and 492 did not have a qualifying event requiring a notification alert. Following implementation of this practice change, the 30-day readmission rate for patients who underwent CABG at our institution decreased from 10% to 7.2%.

Conclusion: Utilizing a real-time alert tool resulted in immediate notification of the CT team when 1 of their patients presented to the ED. This afforded the CT surgical team an opportunity to intervene in the care of their patients, which in turn led to improved quality of care, physician communication and collaboration, and patient outcomes, such as preventable 30-day readmissions.

Keywords: electronic health record; real-time electronic notification; CABG; process improvement.

Unplanned 30-day hospital readmissions of patients who have undergone coronary artery bypass graft (CABG) surgery contribute to higher overall health care costs. CABG is 1 of the conditions/procedures that the Centers for Medicare and Medicaid Services (CMS) monitors for excess readmissions.¹ Readmission rates for CABG-related conditions at 30 days post-surgery are reported to be between 16% and 20% for US hospitals.² Readmissions are not only financially costly, but also have been associated with worse patient outcomes and decreased patient satisfaction.³ Common diagnoses for post-CABG admission include atrial fibrillation, pleural effusion, and wound infection.

The facility where this project was implemented had a 10% post-CABG admission rate for patients across all payers. While this rate is below the national average of 13.2%, the cardiothoracic (CT) surgical team was not being notified in a timely manner when their post-CABG patients were readmitted. The Lean team used the A3 problem-solving process to develop strategies that would reduce these readmissions and improve the care of their patients.

We explored the use of electronic alerts in managing post-CABG patients by conducting a literature search using the terms electronic alerts in patient care, patient engagement in the emergency department, electronic alerts in CABG, real-time notifications to prevent readmission, and CABG readmission. Databases searched were PubMed, Google Scholar, Cumulative Index of Nursing and Allied Health Literature, ProQuest, and ScienceDirect. This search resulted in studies focused on the use of electronic health record (EHR) alerts as a clinical decision-support tool; for example, patient demographic and assessment data are entered into the EHR, and the clinician is prompted with “performance” recommendations (eg, consider electrocardiogram and aspirin).⁴ In a paper by Engelman and Benjamin,⁵ the authors discuss the importance of the engaged physician and note that, in their emergency department (ED), an electronic notification is sent when a postoperative patient presents; however, the notification goes to the inpatient service for timely review and disposition. There was no literature that discussed the use of an electronic alert tool as a real-time patient engagement strategy that resulted in a practice change specific to the CT surgical team.

Our process improvement project focused on alerting the CT surgical team when a post-CABG patient presented to the ED, allowing them to evaluate the patient in real time and determine whether the chief complaint was related to the CABG and whether further evaluation by the CT surgeon was required. Specifically, we wanted to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. During this project, alerts were sent to the CT surgical team notifying them of a post-CABG patient presenting to the ED or being directly admitted from home on physician orders, a provider’s office, or inpatient rehabilitation; however, the focus of this article is specifically on the notification regarding post-CABG patients presenting to the ED.

Prior to implementing the electronic notification project, the team developed and implemented several internal and external readmission reduction and prevention strategies for CABG patients. An in-house strategy involved a process whereby patients would receive their discharge medications prior to being discharged from the hospital post-CABG, thereby avoiding potential delays in the patient obtaining medications. When examining post-CABG patient readmissions, the primary conditions that led to readmission were fluid overload, pleural effusion, and atrial fibrillation. As such, a second in-house strategy was developed for post-CABG patients presenting to the ED with atrial fibrillation. The newly established protocol allowed patients to be monitored and treated in the cardiac observation unit. In addition, external strategies, including an outpatient furosemide protocol for home health nurses and an outpatient thoracentesis program and order set, were established (eg, for patients with congestive heart failure, shortness of breath).

Methods

Setting

The regional medical center where this project was implemented is the ninth largest hospital in North Carolina and the largest county-owned public hospital in the state. It is a tertiary care center and teaching hospital with 3 hospital campuses and 855 licensed beds. The medical center was included in the 100 Safecare Hospitals list by the Safecare Group; received a grade “A” Hospital Safety Score from the Leapfrog Group; and is 1 of America’s Top 100 Hospitals for Patient Experience.

Real-Time Notification Project

A regional hospital alliance in southeastern North Carolina established a health information exchange (HIE) with its member hospitals and office-based physicians to enable electronic exchange of patient information to improve quality, safety, and efficiency in health care delivery. Our medical center is part of this alliance. The HIE is a digital platform that facilitates the sharing of information between disparate connected EHR systems, and offers a portal for practices and hospitals to access patient information across North Carolina, South Carolina (via SC HIE), and nationwide (select dialysis centers). More specifically, approved providers and team members are able to access, in real time, patient-care encounter documents from other care settings (eg, acute, post-acute, ambulatory) via the HIE. Additionally, approved care entities can query-retrieve web portal information to support patient outcome improvement strategies. A partnership discussion highlighted the opportunity to utilize the HIE’s capabilities, such as real-time notification, to facilitate workflow (eg, when a patient presents to the ED, the HIE can provide access to health information at the point of care). In this capacity, the alert tool notifies care team members about patient encounters to drive timely clinical engagement for care transitions.

In January 2017, we began discussions on using the HIE to facilitate real-time electronic tracking in the Cardiac Surgical Services department at our medical center. Persons involved in these discussions included the cardiovascular (CV) team (comprised of case managers, department managers and coordinators, program coordinators, administrators, and support services [eg, pre-admission testing and home health staff]) and CT surgeons. At that time, CABG readmissions were manually tracked, and the real-time notification tool was being used in other departments (eg, in case management for tracking readmissions). The entire team was part of the initial decision meeting to pursue this possibility. The CV team reached consensus in June 2017 and proposed extending the use of the alert tool to the post-CABG population presenting to the ED (or any ED affiliated with the medical center) or admitted directly to the medical center.

The HIE staff met with the Cardiac Surgical Services team to tailor and develop the logistics of the project, such as who would be notified and how. The goals of the project were to support appropriate care intervention, reduce preventable hospital readmissions, and improve quality of care through enhanced provider communication and engagement. To achieve these goals, on the day of discharge the Cardiac Surgical Services coordinator provided the HIE team with the names of patients who had undergone CABG surgery. This patient list was loaded into the alert tool and continually updated. At 31 days, patient names were removed from the list. When a patient on the list presented to the hospital ED, the alert tool sent 2 real-time electronic notifications, an email and a text message, to the Cardiac Surgical Services coordinator, noting that a patient event occurred. Personal information was not included in the alert in order to protect patient information and comply with Health Insurance Portability and Accountability Act regulations.

The alert prompted the Cardiac Surgical Services coordinator to securely access patient information to identify and, if necessary, visit the patient. Then, based on the information gathered by the Cardiac Surgical Services coordinator, a Situation-Background-Assessment-Recommendation report was relayed to the CT surgeon, who then determined whether intervention by the CT surgical team was warranted. This process, on average, took approximately 30 minutes to complete. This was a key change in processes, one that allowed post-CABG patients to be seen by the CT surgical team while in the ED. If the issue was related to the CABG surgery, the CT surgeons could then determine an appropriate course of action, including admission or implementation of another protocol, such as the home furosemide protocol. For patients directly admitted, the surgeon contacted the admitting provider to discuss the level of care required (ie, observation or inpatient admission and treatment).

Biweekly CV team meetings were conducted during the implementation of the real-time notification alert tool. At each meeting, updates were provided on notifications received, patients who were missed by the notification process, and how well the real-time alerts were working to enhance care and appropriate disposition.

Measurements

Clinical performance data included total notifications, total number of ED visits, ED disposition (inpatient admission, observation, discharge), total number of direct admissions, direct admissions to observation, direct inpatient admissions, and patients missed by the notification process (eg, due to data entry errors, omissions of information [suffix of junior or senior], as well as programming bugs). Finally, the number of observation admissions converted to inpatient admissions was collected and further analyzed to inform needed process changes.

The Cardiac Surgical Services coordinator collected, entered, and maintained data using Excel. Data were obtained from the EHR, recorded in Excel, and analyzed using basic descriptive statistics in an ongoing fashion. Particular attention was focused on problems with the notification process (eg, patients being missed due to errors in data entry) and summarizing information to keep the Cardiac Surgical Services team updated on the progress of the process improvement. This project did not require staff protections or considerations, and because this was not a research study Institutional Review Board approval was not required.

Results

This practice change was implemented in September 2017 and led to improvements in care quality, as evidenced by improved physician communication and collaboration. In the 16-month period from implementation through December 2018, the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; and 44 were readmitted for inpatient care. The remaining 492 patients did not have a qualifying event requiring a notification alert. Clinical performance data from this period included 70 ED visits, 21 direct admissions, 19 direct admissions to observation, 5 patients missed by the notification process, and 4 observation admissions converted to inpatient admissions. A reduction in the CABG readmission rate from 10% in September 2017 to 7.2% in December 2018 was also noted.

Discussion

The aim of this process improvement project was to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. This practice change has been successful, following 16 months of implementation and process refinement. Integrating a real-time electronic alert with a supporting action plan and care protocols resulted in timely patient engagement and avoidance of readmission of post-CABG patients.

Early notification of possible post-CABG readmissions became a standard-of-care process within the Cardiac Surgical Services department, with expansion to all CT post-op patients. Leveraging HIE technology to support quality improvement processes was also viewed by other departments as relevant and beneficial. For example, the hospital stroke and orthopedic-spine teams established their own processes for receiving real-time alerts.

There were several lessons learned during this project. First, gaining 100% physician buy-in to collaborative communication proved to be critical to the project’s success. The CV team was surprised by the length of time (approximately 8-10 months) it took for the practice change to be adopted by the physicians. In part, some of this delay in adoption resulted from medical staff turnover, primarily in the medical resident training rotations. Collaborative communication was key. The CT surgeons spoke with ED leadership and hospitalist services to explain the readmission reduction project and the use of an electronic alert tool. The CT surgeons also communicated to the ED physicians, hospitalists, and cardiologists that the Cardiac Surgical Services coordinator would be involved in the process and discussions regarding patientss care. Additionally, the CT surgeons authored the furosemide protocol and then committed to its use in the home health setting, further highlighting the role of collaborative communication in avoiding readmissions.

Another key step in this quality improvement project was determining who should receive the alert notifications. At the onset of the project, all notifications were sent to 1 person, the Cardiac Surgical Services coordinator. While this seemed logical in the initial stage of the project, it was unsustainable, as the receipt of the alert and the subsequent notification of the CT surgeon depended on 1 person and their availability. Approximately 10 months into the project, the notification process was further refined, with the cardiovascular intensive care unit charge nurse becoming the point of contact for the alerts. The Cardiac Surgical Services coordinator, in collaboration with nursing leaders and CT surgeons, completed a Lean Standard Work template outlining the major steps and the associated responsibilities (for the cardiovascular intensive care unit charge nurse, CT surgeon and on-call surgeon, Cardiac Surgical Services coordinator) in the process of receiving notifications, collecting patient assessment data, and reporting notifications to the CT surgeons.

Establishing adequate support mechanisms during a practice change is also important. For instance, we had to dedicate personnel time for data collection and analysis and involve additional nursing or other qualified personnel in the new process to avoid depending on a single person for the project’s success. Additional considerations were establishing criteria for surgeon notification and defining an appropriate time frame for notification (eg, urgent versus next-day notifications). We accomplished these activities approximately 10 months into the project, after it became apparent at CV team meeting discussions that further clarification of criteria and timelines was needed.

Some aspects of the project unfolded as planned, while others presented opportunities for improvement. For example, the alert notification process worked as envisioned; however, as previously mentioned, the process needed to be more inclusive to ensure there is always a charge nurse on duty to receive the alert notification, rather than just the Cardiac Surgical Services coordinator, who may not always be at the hospital. The outpatient thoracentesis program was well planned and effectively implemented. This program provided an avenue for patients who had symptoms of pleural effusion to be treated in an outpatient setting, rather than requiring an inpatient stay. Opportunities for improvement included addressing the inconsistent use of the home health furosemide protocol (developed in 2016), and the need for continued interprofessional and interdepartmental communication and coordination. For example, we had to inform the ED physicians and staff who rotate or are new to the ED about established processes and protocols in place for managing post-CABG patients who present to the ED.

The primary limitation of this project was the inability to measure the enhanced patient experience, which was 1 of the stated project goals. This goal became secondary because of more pressing issues, specifically, interorganizational collaboration (eg, hospital EHR, HIE, and CT surgical team) and tailoring the functionality of the electronic alert tool to the project. Developing and implementing measures of enhanced patient experience were not feasible during this implementation. Additionally, because this was not a research study, it was not possible to determine cause and effect or to control for confounders, such as a sicker, older cohort with more comorbid conditions, during the comparison period. Finally, although this process improvement project was conducted at a regional medical center that is the only facility performing CABG within the region, patients may have presented to another facility for an event that led to a readmission. Because readmissions to other facilities could not be captured, it is possible that the actual readmission rate was higher than the rate reported here.

Conclusions and Implications

Utilizing a real-time alert from the HIE to the CT surgical team resulted in CT surgeons being immediately made aware when their patients presented to the ED, allowing the CT surgical team the opportunity to intervene, as appropriate, in the care of their patients. Furthermore, this real-time notification and intervention resulted in timely patient engagement and, in some cases, avoidance of readmissions. Currently, patients are monitored for readmission within 30 days of discharge. In the future, the time will expand to 91 days, in preparation for participation in the CMS bundle payment program for CABG surgery.

This practice change can be used in organizations that do not have or participate in a HIE. In fact, these real-time alert applications may be available through an EHR already in use within the organization. The use of the alert requires collaborative communication and having supporting protocols in place to guide decision-making and care of post-CABG patients presenting to the ED.

There appears to be a gap in the literature discussing the use of an electronic alert tool as a real-time patient engagement strategy for post-CABG patients presenting to the ED. As such, this project contributes important results and lessons learned for other hospital service lines/departments that might consider implementing a similar process. Next steps include designing and conducting methodologically rigorous research studies based on this process improvement project to examine mortality rates as an outcome, and designing a more specific measure of patient experience, as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey only provides hospital-level data.

Corresponding author: Stephanie D. Smith, PhD, RN, UNCW School of Nursing, 601 South College Road, Wilmington, NC 28403; smithsd@uncw.edu.

Funding disclosures: None.

From the University of North Carolina at Wilmington School of Nursing (Dr. Smith and Dr. Turrise), the New Hanover Regional Medical Center Heart Center (Mr. Jordan), the Coastal Carolinas Health Alliance and Coastal Connect Health Information Exchange (Ms. Robertson), and Coastal Thoracic Surgical Associates (Dr. Kane), Wilmington, NC.

Abstract

Objective: Cardiothoracic (CT) surgeons at our medical center were not receiving timely notification when their coronary artery bypass graft (CABG) surgery patients were admitted to the medical center or to other hospitals. The CT surgical team worked with a health alliance in southeastern North Carolina to implement health information exchange (HIE) real-time electronic notifications for their CABG patients who presented to the hospital’s emergency department (ED) or any ED affiliated with the medical center. The alert tool notifies team members about patient encounters, driving timely clinical engagement.

Methods: The CT team provided the HIE team with the names of CABG surgery patients, which were loaded into the alert tool. When a patient on the list presented to the hospital ED or its affiliates, the alert tool sent a real-time electronic notification to the Cardiac Surgical Services nurse coordinator. This intervention prompted the assessment and disposition of CABG patients, while in the ED, by the CT surgical team.

Results: Over a 16-month period (September 2017-December 2018), the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; 44 were readmitted for inpatient care; and 492 did not have a qualifying event requiring a notification alert. Following implementation of this practice change, the 30-day readmission rate for patients who underwent CABG at our institution decreased from 10% to 7.2%.

Conclusion: Utilizing a real-time alert tool resulted in immediate notification of the CT team when 1 of their patients presented to the ED. This afforded the CT surgical team an opportunity to intervene in the care of their patients, which in turn led to improved quality of care, physician communication and collaboration, and patient outcomes, such as preventable 30-day readmissions.

Keywords: electronic health record; real-time electronic notification; CABG; process improvement.

Unplanned 30-day hospital readmissions of patients who have undergone coronary artery bypass graft (CABG) surgery contribute to higher overall health care costs. CABG is 1 of the conditions/procedures that the Centers for Medicare and Medicaid Services (CMS) monitors for excess readmissions.¹ Readmission rates for CABG-related conditions at 30 days post-surgery are reported to be between 16% and 20% for US hospitals.² Readmissions are not only financially costly, but also have been associated with worse patient outcomes and decreased patient satisfaction.³ Common diagnoses for post-CABG admission include atrial fibrillation, pleural effusion, and wound infection.

The facility where this project was implemented had a 10% post-CABG admission rate for patients across all payers. While this rate is below the national average of 13.2%, the cardiothoracic (CT) surgical team was not being notified in a timely manner when their post-CABG patients were readmitted. The Lean team used the A3 problem-solving process to develop strategies that would reduce these readmissions and improve the care of their patients.

We explored the use of electronic alerts in managing post-CABG patients by conducting a literature search using the terms electronic alerts in patient care, patient engagement in the emergency department, electronic alerts in CABG, real-time notifications to prevent readmission, and CABG readmission. Databases searched were PubMed, Google Scholar, Cumulative Index of Nursing and Allied Health Literature, ProQuest, and ScienceDirect. This search resulted in studies focused on the use of electronic health record (EHR) alerts as a clinical decision-support tool; for example, patient demographic and assessment data are entered into the EHR, and the clinician is prompted with “performance” recommendations (eg, consider electrocardiogram and aspirin).⁴ In a paper by Engelman and Benjamin,⁵ the authors discuss the importance of the engaged physician and note that, in their emergency department (ED), an electronic notification is sent when a postoperative patient presents; however, the notification goes to the inpatient service for timely review and disposition. There was no literature that discussed the use of an electronic alert tool as a real-time patient engagement strategy that resulted in a practice change specific to the CT surgical team.

Our process improvement project focused on alerting the CT surgical team when a post-CABG patient presented to the ED, allowing them to evaluate the patient in real time and determine whether the chief complaint was related to the CABG and whether further evaluation by the CT surgeon was required. Specifically, we wanted to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. During this project, alerts were sent to the CT surgical team notifying them of a post-CABG patient presenting to the ED or being directly admitted from home on physician orders, a provider’s office, or inpatient rehabilitation; however, the focus of this article is specifically on the notification regarding post-CABG patients presenting to the ED.

Prior to implementing the electronic notification project, the team developed and implemented several internal and external readmission reduction and prevention strategies for CABG patients. An in-house strategy involved a process whereby patients would receive their discharge medications prior to being discharged from the hospital post-CABG, thereby avoiding potential delays in the patient obtaining medications. When examining post-CABG patient readmissions, the primary conditions that led to readmission were fluid overload, pleural effusion, and atrial fibrillation. As such, a second in-house strategy was developed for post-CABG patients presenting to the ED with atrial fibrillation. The newly established protocol allowed patients to be monitored and treated in the cardiac observation unit. In addition, external strategies, including an outpatient furosemide protocol for home health nurses and an outpatient thoracentesis program and order set, were established (eg, for patients with congestive heart failure, shortness of breath).

Methods

Setting

The regional medical center where this project was implemented is the ninth largest hospital in North Carolina and the largest county-owned public hospital in the state. It is a tertiary care center and teaching hospital with 3 hospital campuses and 855 licensed beds. The medical center was included in the 100 Safecare Hospitals list by the Safecare Group; received a grade “A” Hospital Safety Score from the Leapfrog Group; and is 1 of America’s Top 100 Hospitals for Patient Experience.

Real-Time Notification Project

A regional hospital alliance in southeastern North Carolina established a health information exchange (HIE) with its member hospitals and office-based physicians to enable electronic exchange of patient information to improve quality, safety, and efficiency in health care delivery. Our medical center is part of this alliance. The HIE is a digital platform that facilitates the sharing of information between disparate connected EHR systems, and offers a portal for practices and hospitals to access patient information across North Carolina, South Carolina (via SC HIE), and nationwide (select dialysis centers). More specifically, approved providers and team members are able to access, in real time, patient-care encounter documents from other care settings (eg, acute, post-acute, ambulatory) via the HIE. Additionally, approved care entities can query-retrieve web portal information to support patient outcome improvement strategies. A partnership discussion highlighted the opportunity to utilize the HIE’s capabilities, such as real-time notification, to facilitate workflow (eg, when a patient presents to the ED, the HIE can provide access to health information at the point of care). In this capacity, the alert tool notifies care team members about patient encounters to drive timely clinical engagement for care transitions.

In January 2017, we began discussions on using the HIE to facilitate real-time electronic tracking in the Cardiac Surgical Services department at our medical center. Persons involved in these discussions included the cardiovascular (CV) team (comprised of case managers, department managers and coordinators, program coordinators, administrators, and support services [eg, pre-admission testing and home health staff]) and CT surgeons. At that time, CABG readmissions were manually tracked, and the real-time notification tool was being used in other departments (eg, in case management for tracking readmissions). The entire team was part of the initial decision meeting to pursue this possibility. The CV team reached consensus in June 2017 and proposed extending the use of the alert tool to the post-CABG population presenting to the ED (or any ED affiliated with the medical center) or admitted directly to the medical center.

The HIE staff met with the Cardiac Surgical Services team to tailor and develop the logistics of the project, such as who would be notified and how. The goals of the project were to support appropriate care intervention, reduce preventable hospital readmissions, and improve quality of care through enhanced provider communication and engagement. To achieve these goals, on the day of discharge the Cardiac Surgical Services coordinator provided the HIE team with the names of patients who had undergone CABG surgery. This patient list was loaded into the alert tool and continually updated. At 31 days, patient names were removed from the list. When a patient on the list presented to the hospital ED, the alert tool sent 2 real-time electronic notifications, an email and a text message, to the Cardiac Surgical Services coordinator, noting that a patient event occurred. Personal information was not included in the alert in order to protect patient information and comply with Health Insurance Portability and Accountability Act regulations.

The alert prompted the Cardiac Surgical Services coordinator to securely access patient information to identify and, if necessary, visit the patient. Then, based on the information gathered by the Cardiac Surgical Services coordinator, a Situation-Background-Assessment-Recommendation report was relayed to the CT surgeon, who then determined whether intervention by the CT surgical team was warranted. This process, on average, took approximately 30 minutes to complete. This was a key change in processes, one that allowed post-CABG patients to be seen by the CT surgical team while in the ED. If the issue was related to the CABG surgery, the CT surgeons could then determine an appropriate course of action, including admission or implementation of another protocol, such as the home furosemide protocol. For patients directly admitted, the surgeon contacted the admitting provider to discuss the level of care required (ie, observation or inpatient admission and treatment).

Biweekly CV team meetings were conducted during the implementation of the real-time notification alert tool. At each meeting, updates were provided on notifications received, patients who were missed by the notification process, and how well the real-time alerts were working to enhance care and appropriate disposition.

Measurements

Clinical performance data included total notifications, total number of ED visits, ED disposition (inpatient admission, observation, discharge), total number of direct admissions, direct admissions to observation, direct inpatient admissions, and patients missed by the notification process (eg, due to data entry errors, omissions of information [suffix of junior or senior], as well as programming bugs). Finally, the number of observation admissions converted to inpatient admissions was collected and further analyzed to inform needed process changes.

The Cardiac Surgical Services coordinator collected, entered, and maintained data using Excel. Data were obtained from the EHR, recorded in Excel, and analyzed using basic descriptive statistics in an ongoing fashion. Particular attention was focused on problems with the notification process (eg, patients being missed due to errors in data entry) and summarizing information to keep the Cardiac Surgical Services team updated on the progress of the process improvement. This project did not require staff protections or considerations, and because this was not a research study Institutional Review Board approval was not required.

Results

This practice change was implemented in September 2017 and led to improvements in care quality, as evidenced by improved physician communication and collaboration. In the 16-month period from implementation through December 2018, the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; and 44 were readmitted for inpatient care. The remaining 492 patients did not have a qualifying event requiring a notification alert. Clinical performance data from this period included 70 ED visits, 21 direct admissions, 19 direct admissions to observation, 5 patients missed by the notification process, and 4 observation admissions converted to inpatient admissions. A reduction in the CABG readmission rate from 10% in September 2017 to 7.2% in December 2018 was also noted.

Discussion

The aim of this process improvement project was to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. This practice change has been successful, following 16 months of implementation and process refinement. Integrating a real-time electronic alert with a supporting action plan and care protocols resulted in timely patient engagement and avoidance of readmission of post-CABG patients.

Early notification of possible post-CABG readmissions became a standard-of-care process within the Cardiac Surgical Services department, with expansion to all CT post-op patients. Leveraging HIE technology to support quality improvement processes was also viewed by other departments as relevant and beneficial. For example, the hospital stroke and orthopedic-spine teams established their own processes for receiving real-time alerts.

There were several lessons learned during this project. First, gaining 100% physician buy-in to collaborative communication proved to be critical to the project’s success. The CV team was surprised by the length of time (approximately 8-10 months) it took for the practice change to be adopted by the physicians. In part, some of this delay in adoption resulted from medical staff turnover, primarily in the medical resident training rotations. Collaborative communication was key. The CT surgeons spoke with ED leadership and hospitalist services to explain the readmission reduction project and the use of an electronic alert tool. The CT surgeons also communicated to the ED physicians, hospitalists, and cardiologists that the Cardiac Surgical Services coordinator would be involved in the process and discussions regarding patientss care. Additionally, the CT surgeons authored the furosemide protocol and then committed to its use in the home health setting, further highlighting the role of collaborative communication in avoiding readmissions.

Another key step in this quality improvement project was determining who should receive the alert notifications. At the onset of the project, all notifications were sent to 1 person, the Cardiac Surgical Services coordinator. While this seemed logical in the initial stage of the project, it was unsustainable, as the receipt of the alert and the subsequent notification of the CT surgeon depended on 1 person and their availability. Approximately 10 months into the project, the notification process was further refined, with the cardiovascular intensive care unit charge nurse becoming the point of contact for the alerts. The Cardiac Surgical Services coordinator, in collaboration with nursing leaders and CT surgeons, completed a Lean Standard Work template outlining the major steps and the associated responsibilities (for the cardiovascular intensive care unit charge nurse, CT surgeon and on-call surgeon, Cardiac Surgical Services coordinator) in the process of receiving notifications, collecting patient assessment data, and reporting notifications to the CT surgeons.

Establishing adequate support mechanisms during a practice change is also important. For instance, we had to dedicate personnel time for data collection and analysis and involve additional nursing or other qualified personnel in the new process to avoid depending on a single person for the project’s success. Additional considerations were establishing criteria for surgeon notification and defining an appropriate time frame for notification (eg, urgent versus next-day notifications). We accomplished these activities approximately 10 months into the project, after it became apparent at CV team meeting discussions that further clarification of criteria and timelines was needed.

Some aspects of the project unfolded as planned, while others presented opportunities for improvement. For example, the alert notification process worked as envisioned; however, as previously mentioned, the process needed to be more inclusive to ensure there is always a charge nurse on duty to receive the alert notification, rather than just the Cardiac Surgical Services coordinator, who may not always be at the hospital. The outpatient thoracentesis program was well planned and effectively implemented. This program provided an avenue for patients who had symptoms of pleural effusion to be treated in an outpatient setting, rather than requiring an inpatient stay. Opportunities for improvement included addressing the inconsistent use of the home health furosemide protocol (developed in 2016), and the need for continued interprofessional and interdepartmental communication and coordination. For example, we had to inform the ED physicians and staff who rotate or are new to the ED about established processes and protocols in place for managing post-CABG patients who present to the ED.

The primary limitation of this project was the inability to measure the enhanced patient experience, which was 1 of the stated project goals. This goal became secondary because of more pressing issues, specifically, interorganizational collaboration (eg, hospital EHR, HIE, and CT surgical team) and tailoring the functionality of the electronic alert tool to the project. Developing and implementing measures of enhanced patient experience were not feasible during this implementation. Additionally, because this was not a research study, it was not possible to determine cause and effect or to control for confounders, such as a sicker, older cohort with more comorbid conditions, during the comparison period. Finally, although this process improvement project was conducted at a regional medical center that is the only facility performing CABG within the region, patients may have presented to another facility for an event that led to a readmission. Because readmissions to other facilities could not be captured, it is possible that the actual readmission rate was higher than the rate reported here.

Conclusions and Implications

Utilizing a real-time alert from the HIE to the CT surgical team resulted in CT surgeons being immediately made aware when their patients presented to the ED, allowing the CT surgical team the opportunity to intervene, as appropriate, in the care of their patients. Furthermore, this real-time notification and intervention resulted in timely patient engagement and, in some cases, avoidance of readmissions. Currently, patients are monitored for readmission within 30 days of discharge. In the future, the time will expand to 91 days, in preparation for participation in the CMS bundle payment program for CABG surgery.

This practice change can be used in organizations that do not have or participate in a HIE. In fact, these real-time alert applications may be available through an EHR already in use within the organization. The use of the alert requires collaborative communication and having supporting protocols in place to guide decision-making and care of post-CABG patients presenting to the ED.

There appears to be a gap in the literature discussing the use of an electronic alert tool as a real-time patient engagement strategy for post-CABG patients presenting to the ED. As such, this project contributes important results and lessons learned for other hospital service lines/departments that might consider implementing a similar process. Next steps include designing and conducting methodologically rigorous research studies based on this process improvement project to examine mortality rates as an outcome, and designing a more specific measure of patient experience, as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey only provides hospital-level data.

Corresponding author: Stephanie D. Smith, PhD, RN, UNCW School of Nursing, 601 South College Road, Wilmington, NC 28403; smithsd@uncw.edu.

Funding disclosures: None.

Catheter-based renal denervation took a step closer to attaining legitimacy as a nonpharmacologic treatment for hypertension with presentation of the primary results of the SPYRAL HTN-OFF MED pivotal trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Mohammed Haneefa Nizamudeen/Getty Images

“We saw clinically meaningful blood pressure reductions at 3 months,” reported Michael Boehm, MD, chief of cardiology at Saarland University Hospital in Homburg, Germany.

That’s encouraging news, as renal denervation (RDN) was nearly abandoned as a potential treatment for hypertension in the wake of the unexpectedly negative results of the SYMPLICITY HTN-3 trial (N Engl J Med. 2014;370:1393-401). However, post hoc analysis of the trial revealed significant shortcomings in design and execution, and a more rigorous development program for the percutaneous device-based therapy is well underway.

The SPYRAL HTN-OFF MED pivotal trial was designed under Food and Drug Administration guidance to show whether RDN reduces blood pressure in patients with untreated hypertension. The prospective study included 331 off-medication patients in nine countries who were randomized to RDN or a sham procedure, then followed in double-blind fashion for 3 months.

The primary outcome was change in 24-hour ambulatory systolic blood pressure from baseline to 3 months. From a mean baseline 24-hour ambulatory blood pressure of 151.4/98 mm Hg, patients in the RDN group averaged a 4.7 mm Hg decrease in 24-hour SBP, which was 4 mm Hg more than in sham-treated controls. Statistically, this translated to a greater than 99.9% probability that RDN was superior to sham therapy. The RDN group also experienced a mean 3.7–mm Hg reduction in 24-hour DBP, compared with a 0.8–mm Hg decrease in controls.

Office SBP – the secondary endpoint – decreased by a mean of 9.2 mm Hg with RDN, compared with 2.5 mm Hg in controls.

These results probably understate the true antihypertensive effect of RDN for two reasons, Dr. Boehm noted. For one, previous studies have shown that the magnitude of blood pressure lowering continues to increase for up to 1-2 years following the procedure, whereas the off-medication assessment in SPYRAL HTN-OFF MED ended at 3 months for ethical and safety reasons. Also, 17% of patients in the control arm were withdrawn from the study and placed on antihypertensive medication because their office SBP reached 180 mm Hg or more, as compared to 9.6% of the RDN group.

A key finding was that RDN lowered blood pressure around the clock, including nighttime and early morning, the hours of greatest cardiovascular risk and a time when some antihypertensive medications are less effective at blood pressure control, the cardiologist observed.

The RDN safety picture was reassuring, with no strokes, myocardial infarctions, major bleeding, or acute deterioration in kidney function.

A surprising finding was that, even though participants underwent blood and urine testing for the presence of antihypertensive drugs at baseline to ensure they were off medication, and were told they would be retested at 3 months, 5%-9% nonetheless tested positive at the second test.

That elicited a comment from session chair Richard A. Chazal, MD, of Fort Myers, Fla.: “I must say, as a clinician who sometimes has trouble getting his patients to take antihypertensives, it’s fascinating that some of the people that you asked not to take the medications were taking them.”

While the primary outcome in SPYRAL HTN-OFF MED was the 3-month reduction in blood pressure while off of antihypertensive medication, the ongoing second phase of the trial may have greater clinical relevance. At 3 months, participants are being placed on antihypertensive medication and uptitrated to target, with unblinding at 6 months. The purpose is to see how many RDN recipients don’t need antihypertensive drugs, as well as whether those that do require less medication than the patients who didn’t undergo RDN.

Dr. Boehm characterized RDN as a work in progress. Two major limitations that are the focus of intense research are the lack of a predictor as to which patients are most likely to respond to what is after all an invasive procedure, and the current inability intraprocedurally to tell if sufficient RDN has been achieved.

“Frankly speaking, there is no technology during the procedure to see how efficacious the procedure was,” he explained.

Discussant Dhanunaja Lakkireddy, MD, deemed the mean 4.7–mm Hg reduction in 24-hour SBP “reasonably impressive – that’s actually a pretty good number for an antihypertensive clinical trial.” He was also favorably impressed by RDN’s safety in a 44-site study.

“The drops in blood pressure are not enough to really make a case for renal denervation to be a standalone therapy. But adding it as an adjunct to standard medications may be a very reasonable strategy to adopt. This is a fantastic signal for something that can be brought along as a long-term add-on to antihypertensive medications,” commented Dr. Lakkireddy, chair of the ACC Electrophysiology Council and medical director of the Kansas City Heart Rhythm Institute.

Simultaneous with Dr. Boehm’s presentation, the SPYRAL HTN-OFF MED Pivotal Trial details were published online (Lancet 2020 Mar 29. doi: 10.1016/S0140-6736(20)30554-7).

The study was sponsored by Medtronic. Dr. Boehm reported serving as a consultant to that company and Abbott, Amgen, Astra, Boehringer-Ingelheim, Cytokinetics, Novartis, ReCor, Servier, and Vifor.

bjancin@mdedge.com

SOURCE: Boehm M. ACC 2020, Abstract 406-15.

Catheter-based renal denervation took a step closer to attaining legitimacy as a nonpharmacologic treatment for hypertension with presentation of the primary results of the SPYRAL HTN-OFF MED pivotal trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Mohammed Haneefa Nizamudeen/Getty Images

“We saw clinically meaningful blood pressure reductions at 3 months,” reported Michael Boehm, MD, chief of cardiology at Saarland University Hospital in Homburg, Germany.

That’s encouraging news, as renal denervation (RDN) was nearly abandoned as a potential treatment for hypertension in the wake of the unexpectedly negative results of the SYMPLICITY HTN-3 trial (N Engl J Med. 2014;370:1393-401). However, post hoc analysis of the trial revealed significant shortcomings in design and execution, and a more rigorous development program for the percutaneous device-based therapy is well underway.

The SPYRAL HTN-OFF MED pivotal trial was designed under Food and Drug Administration guidance to show whether RDN reduces blood pressure in patients with untreated hypertension. The prospective study included 331 off-medication patients in nine countries who were randomized to RDN or a sham procedure, then followed in double-blind fashion for 3 months.

The primary outcome was change in 24-hour ambulatory systolic blood pressure from baseline to 3 months. From a mean baseline 24-hour ambulatory blood pressure of 151.4/98 mm Hg, patients in the RDN group averaged a 4.7 mm Hg decrease in 24-hour SBP, which was 4 mm Hg more than in sham-treated controls. Statistically, this translated to a greater than 99.9% probability that RDN was superior to sham therapy. The RDN group also experienced a mean 3.7–mm Hg reduction in 24-hour DBP, compared with a 0.8–mm Hg decrease in controls.

Office SBP – the secondary endpoint – decreased by a mean of 9.2 mm Hg with RDN, compared with 2.5 mm Hg in controls.

These results probably understate the true antihypertensive effect of RDN for two reasons, Dr. Boehm noted. For one, previous studies have shown that the magnitude of blood pressure lowering continues to increase for up to 1-2 years following the procedure, whereas the off-medication assessment in SPYRAL HTN-OFF MED ended at 3 months for ethical and safety reasons. Also, 17% of patients in the control arm were withdrawn from the study and placed on antihypertensive medication because their office SBP reached 180 mm Hg or more, as compared to 9.6% of the RDN group.

A key finding was that RDN lowered blood pressure around the clock, including nighttime and early morning, the hours of greatest cardiovascular risk and a time when some antihypertensive medications are less effective at blood pressure control, the cardiologist observed.

The RDN safety picture was reassuring, with no strokes, myocardial infarctions, major bleeding, or acute deterioration in kidney function.

A surprising finding was that, even though participants underwent blood and urine testing for the presence of antihypertensive drugs at baseline to ensure they were off medication, and were told they would be retested at 3 months, 5%-9% nonetheless tested positive at the second test.

That elicited a comment from session chair Richard A. Chazal, MD, of Fort Myers, Fla.: “I must say, as a clinician who sometimes has trouble getting his patients to take antihypertensives, it’s fascinating that some of the people that you asked not to take the medications were taking them.”

While the primary outcome in SPYRAL HTN-OFF MED was the 3-month reduction in blood pressure while off of antihypertensive medication, the ongoing second phase of the trial may have greater clinical relevance. At 3 months, participants are being placed on antihypertensive medication and uptitrated to target, with unblinding at 6 months. The purpose is to see how many RDN recipients don’t need antihypertensive drugs, as well as whether those that do require less medication than the patients who didn’t undergo RDN.

Dr. Boehm characterized RDN as a work in progress. Two major limitations that are the focus of intense research are the lack of a predictor as to which patients are most likely to respond to what is after all an invasive procedure, and the current inability intraprocedurally to tell if sufficient RDN has been achieved.

“Frankly speaking, there is no technology during the procedure to see how efficacious the procedure was,” he explained.

Discussant Dhanunaja Lakkireddy, MD, deemed the mean 4.7–mm Hg reduction in 24-hour SBP “reasonably impressive – that’s actually a pretty good number for an antihypertensive clinical trial.” He was also favorably impressed by RDN’s safety in a 44-site study.

“The drops in blood pressure are not enough to really make a case for renal denervation to be a standalone therapy. But adding it as an adjunct to standard medications may be a very reasonable strategy to adopt. This is a fantastic signal for something that can be brought along as a long-term add-on to antihypertensive medications,” commented Dr. Lakkireddy, chair of the ACC Electrophysiology Council and medical director of the Kansas City Heart Rhythm Institute.

Simultaneous with Dr. Boehm’s presentation, the SPYRAL HTN-OFF MED Pivotal Trial details were published online (Lancet 2020 Mar 29. doi: 10.1016/S0140-6736(20)30554-7).

The study was sponsored by Medtronic. Dr. Boehm reported serving as a consultant to that company and Abbott, Amgen, Astra, Boehringer-Ingelheim, Cytokinetics, Novartis, ReCor, Servier, and Vifor.

bjancin@mdedge.com

SOURCE: Boehm M. ACC 2020, Abstract 406-15.

Catheter-based renal denervation took a step closer to attaining legitimacy as a nonpharmacologic treatment for hypertension with presentation of the primary results of the SPYRAL HTN-OFF MED pivotal trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Mohammed Haneefa Nizamudeen/Getty Images

“We saw clinically meaningful blood pressure reductions at 3 months,” reported Michael Boehm, MD, chief of cardiology at Saarland University Hospital in Homburg, Germany.

That’s encouraging news, as renal denervation (RDN) was nearly abandoned as a potential treatment for hypertension in the wake of the unexpectedly negative results of the SYMPLICITY HTN-3 trial (N Engl J Med. 2014;370:1393-401). However, post hoc analysis of the trial revealed significant shortcomings in design and execution, and a more rigorous development program for the percutaneous device-based therapy is well underway.

The SPYRAL HTN-OFF MED pivotal trial was designed under Food and Drug Administration guidance to show whether RDN reduces blood pressure in patients with untreated hypertension. The prospective study included 331 off-medication patients in nine countries who were randomized to RDN or a sham procedure, then followed in double-blind fashion for 3 months.

The primary outcome was change in 24-hour ambulatory systolic blood pressure from baseline to 3 months. From a mean baseline 24-hour ambulatory blood pressure of 151.4/98 mm Hg, patients in the RDN group averaged a 4.7 mm Hg decrease in 24-hour SBP, which was 4 mm Hg more than in sham-treated controls. Statistically, this translated to a greater than 99.9% probability that RDN was superior to sham therapy. The RDN group also experienced a mean 3.7–mm Hg reduction in 24-hour DBP, compared with a 0.8–mm Hg decrease in controls.

Office SBP – the secondary endpoint – decreased by a mean of 9.2 mm Hg with RDN, compared with 2.5 mm Hg in controls.

These results probably understate the true antihypertensive effect of RDN for two reasons, Dr. Boehm noted. For one, previous studies have shown that the magnitude of blood pressure lowering continues to increase for up to 1-2 years following the procedure, whereas the off-medication assessment in SPYRAL HTN-OFF MED ended at 3 months for ethical and safety reasons. Also, 17% of patients in the control arm were withdrawn from the study and placed on antihypertensive medication because their office SBP reached 180 mm Hg or more, as compared to 9.6% of the RDN group.

A key finding was that RDN lowered blood pressure around the clock, including nighttime and early morning, the hours of greatest cardiovascular risk and a time when some antihypertensive medications are less effective at blood pressure control, the cardiologist observed.

The RDN safety picture was reassuring, with no strokes, myocardial infarctions, major bleeding, or acute deterioration in kidney function.

A surprising finding was that, even though participants underwent blood and urine testing for the presence of antihypertensive drugs at baseline to ensure they were off medication, and were told they would be retested at 3 months, 5%-9% nonetheless tested positive at the second test.

That elicited a comment from session chair Richard A. Chazal, MD, of Fort Myers, Fla.: “I must say, as a clinician who sometimes has trouble getting his patients to take antihypertensives, it’s fascinating that some of the people that you asked not to take the medications were taking them.”

While the primary outcome in SPYRAL HTN-OFF MED was the 3-month reduction in blood pressure while off of antihypertensive medication, the ongoing second phase of the trial may have greater clinical relevance. At 3 months, participants are being placed on antihypertensive medication and uptitrated to target, with unblinding at 6 months. The purpose is to see how many RDN recipients don’t need antihypertensive drugs, as well as whether those that do require less medication than the patients who didn’t undergo RDN.

Dr. Boehm characterized RDN as a work in progress. Two major limitations that are the focus of intense research are the lack of a predictor as to which patients are most likely to respond to what is after all an invasive procedure, and the current inability intraprocedurally to tell if sufficient RDN has been achieved.

“Frankly speaking, there is no technology during the procedure to see how efficacious the procedure was,” he explained.

Discussant Dhanunaja Lakkireddy, MD, deemed the mean 4.7–mm Hg reduction in 24-hour SBP “reasonably impressive – that’s actually a pretty good number for an antihypertensive clinical trial.” He was also favorably impressed by RDN’s safety in a 44-site study.

“The drops in blood pressure are not enough to really make a case for renal denervation to be a standalone therapy. But adding it as an adjunct to standard medications may be a very reasonable strategy to adopt. This is a fantastic signal for something that can be brought along as a long-term add-on to antihypertensive medications,” commented Dr. Lakkireddy, chair of the ACC Electrophysiology Council and medical director of the Kansas City Heart Rhythm Institute.

Simultaneous with Dr. Boehm’s presentation, the SPYRAL HTN-OFF MED Pivotal Trial details were published online (Lancet 2020 Mar 29. doi: 10.1016/S0140-6736(20)30554-7).

The study was sponsored by Medtronic. Dr. Boehm reported serving as a consultant to that company and Abbott, Amgen, Astra, Boehringer-Ingelheim, Cytokinetics, Novartis, ReCor, Servier, and Vifor.

bjancin@mdedge.com

SOURCE: Boehm M. ACC 2020, Abstract 406-15.