Checkpoint inhibitor linked to antiphospholipid syndrome in melanoma patient

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A patient with melanoma experienced antiphospholipid syndrome following multiple infusions of the PD-1 inhibitor pembrolizumab, according to authors of a recent case report.

Presence of Raynaud phenomenon and high levels of antiphospholipid antibodies led to the diagnosis of antiphospholipid syndrome in the patient, who had stage IIIB unresectable melanoma.

This report provides additional evidence that this syndrome is an immune-related adverse event associated with checkpoint inhibitor therapy, said Alexandra Picard, MD, of Hôpital Archet, Nice, France, and coauthors.

“Due to the increased use of anti PD-1 therapies, clinicians should be aware of this new potential immune-mediated toxic effect that manifests as antiphospholipid syndrome,” the researchers wrote. The report is in JAMA Dermatology.

“Great caution” should be exercised when considering use of immune checkpoint inhibitors in patients with a history of antiphospholipid syndrome, the authors added.

The woman in this report was over 60 years of age and had first presented with superficial melanoma on her right calf, followed by recurrent lymph node metastases over the next few years, all of which were surgically treated.

Following a PET-CT scan showing a new metastatic lymph node, the woman started pembrolizumab 2 mg/kg every 3 weeks and had a partial response within 3 months, the investigators reported.

After the tenth infusion, however, the patient developed bilateral secondary Raynaud phenomenon that followed a typical discoloration sequence and resulted in a necrotic lesion at the tip of one finger.

The patient had no personal or family history of Raynaud phenomenon.

While beta2-glycoprotein 1 antibodies were not elevated, laboratory tests did show anticardiolipin antibodies and lupus anticoagulants at elevated levels, the investigators said, noting that repeat testing at 12 weeks confirmed positivity of antiphospholipid antibodies.

The Raynaud phenomenon disappeared and the necrotic lesion healed after pembrolizumab was stopped and prednisolone treatment was started, they added.

No recurrence of either was noted at the last follow-up.

Previous reports have described antiphospholipid syndrome in advanced melanoma patients treated with alfa-2b interferon alone or in combination with anti-interleukin 2, the authors said in their discussion of the case.

In addition, there has been another recent report of antiphospholipid syndrome associated with the CTLA4 inhibitor ipilimumab and the PD-1 inhibitor nivolumab, they said. In that case, testing for antiphospholipid antibodies revealed elevated beta2-glycoprotein 1 antibody levels.

“We hypothesize that [antiphospholipid syndrome] is a kind of autoimmunity induced by anti–PD-1 due to the expansive expression of the immune system against tumor cells,” the researchers wrote.

Although a case of cancer-associated antiphospholipid syndrome could not be ruled out in the present report, the rapid and complete resolution of symptoms after treatment discontinuation suggested that pembrolizumab, a “known immunostimulant,” was the cause, they said.

While antibodies against PD-1 have improved melanoma prognosis, they are associated with a wide range of immune-related adverse effects in the skin, gastrointestinal tract, liver, and endocrine system, Dr. Picard and coauthors noted.

They reported having no conflicts of interest.

SOURCE: Sanchez A, et al. JAMA Derm. 2018 Sep 19. doi: 10.1001/jamadermatol.2018.2770.

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A patient with melanoma experienced antiphospholipid syndrome following multiple infusions of the PD-1 inhibitor pembrolizumab, according to authors of a recent case report.

Presence of Raynaud phenomenon and high levels of antiphospholipid antibodies led to the diagnosis of antiphospholipid syndrome in the patient, who had stage IIIB unresectable melanoma.

This report provides additional evidence that this syndrome is an immune-related adverse event associated with checkpoint inhibitor therapy, said Alexandra Picard, MD, of Hôpital Archet, Nice, France, and coauthors.

“Due to the increased use of anti PD-1 therapies, clinicians should be aware of this new potential immune-mediated toxic effect that manifests as antiphospholipid syndrome,” the researchers wrote. The report is in JAMA Dermatology.

“Great caution” should be exercised when considering use of immune checkpoint inhibitors in patients with a history of antiphospholipid syndrome, the authors added.

The woman in this report was over 60 years of age and had first presented with superficial melanoma on her right calf, followed by recurrent lymph node metastases over the next few years, all of which were surgically treated.

Following a PET-CT scan showing a new metastatic lymph node, the woman started pembrolizumab 2 mg/kg every 3 weeks and had a partial response within 3 months, the investigators reported.

After the tenth infusion, however, the patient developed bilateral secondary Raynaud phenomenon that followed a typical discoloration sequence and resulted in a necrotic lesion at the tip of one finger.

The patient had no personal or family history of Raynaud phenomenon.

While beta2-glycoprotein 1 antibodies were not elevated, laboratory tests did show anticardiolipin antibodies and lupus anticoagulants at elevated levels, the investigators said, noting that repeat testing at 12 weeks confirmed positivity of antiphospholipid antibodies.

The Raynaud phenomenon disappeared and the necrotic lesion healed after pembrolizumab was stopped and prednisolone treatment was started, they added.

No recurrence of either was noted at the last follow-up.

Previous reports have described antiphospholipid syndrome in advanced melanoma patients treated with alfa-2b interferon alone or in combination with anti-interleukin 2, the authors said in their discussion of the case.

In addition, there has been another recent report of antiphospholipid syndrome associated with the CTLA4 inhibitor ipilimumab and the PD-1 inhibitor nivolumab, they said. In that case, testing for antiphospholipid antibodies revealed elevated beta2-glycoprotein 1 antibody levels.

“We hypothesize that [antiphospholipid syndrome] is a kind of autoimmunity induced by anti–PD-1 due to the expansive expression of the immune system against tumor cells,” the researchers wrote.

Although a case of cancer-associated antiphospholipid syndrome could not be ruled out in the present report, the rapid and complete resolution of symptoms after treatment discontinuation suggested that pembrolizumab, a “known immunostimulant,” was the cause, they said.

While antibodies against PD-1 have improved melanoma prognosis, they are associated with a wide range of immune-related adverse effects in the skin, gastrointestinal tract, liver, and endocrine system, Dr. Picard and coauthors noted.

They reported having no conflicts of interest.

SOURCE: Sanchez A, et al. JAMA Derm. 2018 Sep 19. doi: 10.1001/jamadermatol.2018.2770.

A patient with melanoma experienced antiphospholipid syndrome following multiple infusions of the PD-1 inhibitor pembrolizumab, according to authors of a recent case report.

Presence of Raynaud phenomenon and high levels of antiphospholipid antibodies led to the diagnosis of antiphospholipid syndrome in the patient, who had stage IIIB unresectable melanoma.

This report provides additional evidence that this syndrome is an immune-related adverse event associated with checkpoint inhibitor therapy, said Alexandra Picard, MD, of Hôpital Archet, Nice, France, and coauthors.

“Due to the increased use of anti PD-1 therapies, clinicians should be aware of this new potential immune-mediated toxic effect that manifests as antiphospholipid syndrome,” the researchers wrote. The report is in JAMA Dermatology.

“Great caution” should be exercised when considering use of immune checkpoint inhibitors in patients with a history of antiphospholipid syndrome, the authors added.

The woman in this report was over 60 years of age and had first presented with superficial melanoma on her right calf, followed by recurrent lymph node metastases over the next few years, all of which were surgically treated.

Following a PET-CT scan showing a new metastatic lymph node, the woman started pembrolizumab 2 mg/kg every 3 weeks and had a partial response within 3 months, the investigators reported.

After the tenth infusion, however, the patient developed bilateral secondary Raynaud phenomenon that followed a typical discoloration sequence and resulted in a necrotic lesion at the tip of one finger.

The patient had no personal or family history of Raynaud phenomenon.

While beta2-glycoprotein 1 antibodies were not elevated, laboratory tests did show anticardiolipin antibodies and lupus anticoagulants at elevated levels, the investigators said, noting that repeat testing at 12 weeks confirmed positivity of antiphospholipid antibodies.

The Raynaud phenomenon disappeared and the necrotic lesion healed after pembrolizumab was stopped and prednisolone treatment was started, they added.

No recurrence of either was noted at the last follow-up.

Previous reports have described antiphospholipid syndrome in advanced melanoma patients treated with alfa-2b interferon alone or in combination with anti-interleukin 2, the authors said in their discussion of the case.

In addition, there has been another recent report of antiphospholipid syndrome associated with the CTLA4 inhibitor ipilimumab and the PD-1 inhibitor nivolumab, they said. In that case, testing for antiphospholipid antibodies revealed elevated beta2-glycoprotein 1 antibody levels.

“We hypothesize that [antiphospholipid syndrome] is a kind of autoimmunity induced by anti–PD-1 due to the expansive expression of the immune system against tumor cells,” the researchers wrote.

Although a case of cancer-associated antiphospholipid syndrome could not be ruled out in the present report, the rapid and complete resolution of symptoms after treatment discontinuation suggested that pembrolizumab, a “known immunostimulant,” was the cause, they said.

While antibodies against PD-1 have improved melanoma prognosis, they are associated with a wide range of immune-related adverse effects in the skin, gastrointestinal tract, liver, and endocrine system, Dr. Picard and coauthors noted.

They reported having no conflicts of interest.

SOURCE: Sanchez A, et al. JAMA Derm. 2018 Sep 19. doi: 10.1001/jamadermatol.2018.2770.

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Key clinical point: Antiphospholipid syndrome appears to be an immune-related adverse event associated with anti-PD-1 therapy.

Major finding: A melanoma patient receiving pembrolizumab was diagnosed with antiphospholipid syndrome that resolved following discontinuation of that treatment.

Study details: Case report of a woman in her 60s with stage IIIB unresectable melanoma who was treated with pembrolizumab 2 mg/kg every 3 weeks.

Disclosures: The authors reported no conflicts of interest.

Source: Sanchez A et al. JAMA Derm. 2018 Sep 19. doi: 10.1001/jamadermatol.2018.2770.

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Previous psychiatric admissions predict suicide attempts

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– Among patients presenting to the emergency department with suicidal ideation, the number of previous psychiatric admissions is the most important predictor of a subsequent suicide attempt, results from a 2-year-long study showed.

Doug Brunk/MDedge News
Anne C. Knorr

Momentary measures – significant current difficulties with sleep, energy, or appetite, and anhedonia – “are important considerations during suicide risk assessment, regardless of whether the patient meets the threshold for major depressive disorder, lead study author Anne C. Knorr said in an interview in advance of the annual meeting of the American College of Emergency Physicians.

“Many traditionally studied psychiatric risk factors do not significantly differ between individuals who think about suicide and those who act on their suicidal thoughts, an important distinction as only one-third of those who think about suicide carry out a suicide attempt. While there is support for some psychiatric factors – for example, anxiety, substance use disorders, sleep disturbance – being useful in differentiating these groups, the current study is unique in its use of a longitudinal design to identify influential risk factors that predict future suicide attempt among those with suicidal ideation,” she said.

Ms. Knorr, a research project manager at Geisinger Medical Center, Danville, Pa., and her colleagues collected electronic medical record data from 908 patients who had received a psychiatric evaluation at an index emergency department visit for suicidal ideation over a 2-year period. The mean age of patients was 39 years. The target sample was 30 patients who had returned to the ED following a suicide attempt within 6 months of their index ED visit.

The researchers analyzed 32 predictor variables from patient charts, including demographics, psychiatric history, and current psychiatric presentation. The evaluation was done with “a machine learning statistical approach which is more capable than traditional statistical approaches in handling a large number of predictor variables,” Ms. Knorr said.

The number of previous psychiatric admissions was the most important predictor of a subsequent suicide attempt. The next nine most important variables were sleep disturbance, history of family suicide, low energy, patient age, psychiatrist determination of severe suicide risk, psychiatrist determination of moderate suicide risk, appetite issues, presence of a support system, and loss of interest/pleasure.

These symptoms may not typically be weighed heavily in risk assessments, Ms. Knorr said. “Additionally, given that research suggests that the clinical determination of suicide risk is historically poor, it was interesting that psychiatrist determination of moderate or high risk was influential in predicting a return visit for suicide attempt. Finally, we were surprised that a past history of suicide attempt, often viewed as the strongest predictor of a future suicide attempt, did not emerge as one of the top 10 influential predictors.

“Limitations of this study include the use of a return visit to a Geisinger emergency department as the only measure of a future suicide attempt and the utilization of data from only one health system,” she noted.

The study was funded by the Geisinger Clinic Research Fund. One of the coauthors, Andrei Nemoianu, MD, reported receipt of a research grant from Takeda Pharmaceuticals for a separate study.

dbrunk@mdedge.com

SOURCE: Knorr A et al. Ann Emerg Med. 2018 Oct;72;4:S23. doi. 10.1016/j.annemergmed.2018.08.055.

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– Among patients presenting to the emergency department with suicidal ideation, the number of previous psychiatric admissions is the most important predictor of a subsequent suicide attempt, results from a 2-year-long study showed.

Doug Brunk/MDedge News
Anne C. Knorr

Momentary measures – significant current difficulties with sleep, energy, or appetite, and anhedonia – “are important considerations during suicide risk assessment, regardless of whether the patient meets the threshold for major depressive disorder, lead study author Anne C. Knorr said in an interview in advance of the annual meeting of the American College of Emergency Physicians.

“Many traditionally studied psychiatric risk factors do not significantly differ between individuals who think about suicide and those who act on their suicidal thoughts, an important distinction as only one-third of those who think about suicide carry out a suicide attempt. While there is support for some psychiatric factors – for example, anxiety, substance use disorders, sleep disturbance – being useful in differentiating these groups, the current study is unique in its use of a longitudinal design to identify influential risk factors that predict future suicide attempt among those with suicidal ideation,” she said.

Ms. Knorr, a research project manager at Geisinger Medical Center, Danville, Pa., and her colleagues collected electronic medical record data from 908 patients who had received a psychiatric evaluation at an index emergency department visit for suicidal ideation over a 2-year period. The mean age of patients was 39 years. The target sample was 30 patients who had returned to the ED following a suicide attempt within 6 months of their index ED visit.

The researchers analyzed 32 predictor variables from patient charts, including demographics, psychiatric history, and current psychiatric presentation. The evaluation was done with “a machine learning statistical approach which is more capable than traditional statistical approaches in handling a large number of predictor variables,” Ms. Knorr said.

The number of previous psychiatric admissions was the most important predictor of a subsequent suicide attempt. The next nine most important variables were sleep disturbance, history of family suicide, low energy, patient age, psychiatrist determination of severe suicide risk, psychiatrist determination of moderate suicide risk, appetite issues, presence of a support system, and loss of interest/pleasure.

These symptoms may not typically be weighed heavily in risk assessments, Ms. Knorr said. “Additionally, given that research suggests that the clinical determination of suicide risk is historically poor, it was interesting that psychiatrist determination of moderate or high risk was influential in predicting a return visit for suicide attempt. Finally, we were surprised that a past history of suicide attempt, often viewed as the strongest predictor of a future suicide attempt, did not emerge as one of the top 10 influential predictors.

“Limitations of this study include the use of a return visit to a Geisinger emergency department as the only measure of a future suicide attempt and the utilization of data from only one health system,” she noted.

The study was funded by the Geisinger Clinic Research Fund. One of the coauthors, Andrei Nemoianu, MD, reported receipt of a research grant from Takeda Pharmaceuticals for a separate study.

dbrunk@mdedge.com

SOURCE: Knorr A et al. Ann Emerg Med. 2018 Oct;72;4:S23. doi. 10.1016/j.annemergmed.2018.08.055.

– Among patients presenting to the emergency department with suicidal ideation, the number of previous psychiatric admissions is the most important predictor of a subsequent suicide attempt, results from a 2-year-long study showed.

Doug Brunk/MDedge News
Anne C. Knorr

Momentary measures – significant current difficulties with sleep, energy, or appetite, and anhedonia – “are important considerations during suicide risk assessment, regardless of whether the patient meets the threshold for major depressive disorder, lead study author Anne C. Knorr said in an interview in advance of the annual meeting of the American College of Emergency Physicians.

“Many traditionally studied psychiatric risk factors do not significantly differ between individuals who think about suicide and those who act on their suicidal thoughts, an important distinction as only one-third of those who think about suicide carry out a suicide attempt. While there is support for some psychiatric factors – for example, anxiety, substance use disorders, sleep disturbance – being useful in differentiating these groups, the current study is unique in its use of a longitudinal design to identify influential risk factors that predict future suicide attempt among those with suicidal ideation,” she said.

Ms. Knorr, a research project manager at Geisinger Medical Center, Danville, Pa., and her colleagues collected electronic medical record data from 908 patients who had received a psychiatric evaluation at an index emergency department visit for suicidal ideation over a 2-year period. The mean age of patients was 39 years. The target sample was 30 patients who had returned to the ED following a suicide attempt within 6 months of their index ED visit.

The researchers analyzed 32 predictor variables from patient charts, including demographics, psychiatric history, and current psychiatric presentation. The evaluation was done with “a machine learning statistical approach which is more capable than traditional statistical approaches in handling a large number of predictor variables,” Ms. Knorr said.

The number of previous psychiatric admissions was the most important predictor of a subsequent suicide attempt. The next nine most important variables were sleep disturbance, history of family suicide, low energy, patient age, psychiatrist determination of severe suicide risk, psychiatrist determination of moderate suicide risk, appetite issues, presence of a support system, and loss of interest/pleasure.

These symptoms may not typically be weighed heavily in risk assessments, Ms. Knorr said. “Additionally, given that research suggests that the clinical determination of suicide risk is historically poor, it was interesting that psychiatrist determination of moderate or high risk was influential in predicting a return visit for suicide attempt. Finally, we were surprised that a past history of suicide attempt, often viewed as the strongest predictor of a future suicide attempt, did not emerge as one of the top 10 influential predictors.

“Limitations of this study include the use of a return visit to a Geisinger emergency department as the only measure of a future suicide attempt and the utilization of data from only one health system,” she noted.

The study was funded by the Geisinger Clinic Research Fund. One of the coauthors, Andrei Nemoianu, MD, reported receipt of a research grant from Takeda Pharmaceuticals for a separate study.

dbrunk@mdedge.com

SOURCE: Knorr A et al. Ann Emerg Med. 2018 Oct;72;4:S23. doi. 10.1016/j.annemergmed.2018.08.055.

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Key clinical point: A number of factors representing momentary experiences such as low energy emerged as predictors of suicide attempts among suicidal ideators following an ED visit.

Major finding: The number of past psychiatric admissions was the most influential predictor of a subsequent suicide attempt.

Study details: A study of 30 patients who had returned to the ED following a suicide attempt within 6 months of their index ED visit.

Disclosures: The Geisinger Clinic Research Fund supported the study. A coauthor, Andrei Nemoianu, MD, reported receipt of a research grant from Takeda Pharmaceuticals for a separate study.

Source: Knorr A et al. Ann Emerg Med. 2018 Oct;72;4:S23.

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Hospital-level care coordination strategies and the patient experience

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Clinical question: Does patient experience correlate with specific hospital care coordination and transition strategies, and if so, which strategies most strongly correlate with higher patient experience scores?

Background: Patient experience is an increasingly important measure in value-based payment programs. However, progress has been slow in improving patient experience, and little empirical data exist regarding which strategies are effective. Care transitions are critical times during a hospitalization, with many hospitals already implementing measures to improve the discharge process and prevent readmission of patients. It is not known whether those measures also influence patient experience scores, and if they do improve scores, which measures are most effective at doing so.

Study design: An analytic observational survey design.

Dr. Margaret Tsien

Setting: Hospitals eligible for the Hospital Readmissions Reduction Program (HRRP) between June 2013 and December 2014.

Synopsis: A survey was developed and given to chief medical officers at 1,600 hospitals between June 2013 and December 2014; the survey assessed care coordination strategies employed by these institutions. 992 hospitals (62% response rate) were subsequently categorized as “low-strategy,” “mid-strategy,” or “high-strategy” hospitals. Patient satisfaction scores from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey in 2014 were correlated to the number of strategies and the specific strategies each hospital employed. In general, the higher-strategy hospitals had significantly higher HCAHPS survey scores than did low-strategy hospitals (+2.23 points; P less than .001). Specifically, creating and sharing a discharge summary prior to discharge (+1.43 points; P less than .001), using a discharge planner (+1.71 points; P less than .001), and calling patients 48 hours post discharge (+1.64 points; P less than .001) all resulted in overall higher hospital ratings by patients.
 

One limitation of this study is that no causal inference can be made between the specific strategies associated with higher HCAHPS scores and care coordination strategies.

Bottom line: Hospital-led care transition strategies with direct patient interactions led to higher patient satisfaction scores.

Citation: Figueroa JF et al. Hospital-level care coordination strategies associated with better patient experience. BMJ Qual Saf. 2018 Apr 4. doi: 10.1136/bmjqs-2017-007597.

Dr. Tsien is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.

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Clinical question: Does patient experience correlate with specific hospital care coordination and transition strategies, and if so, which strategies most strongly correlate with higher patient experience scores?

Background: Patient experience is an increasingly important measure in value-based payment programs. However, progress has been slow in improving patient experience, and little empirical data exist regarding which strategies are effective. Care transitions are critical times during a hospitalization, with many hospitals already implementing measures to improve the discharge process and prevent readmission of patients. It is not known whether those measures also influence patient experience scores, and if they do improve scores, which measures are most effective at doing so.

Study design: An analytic observational survey design.

Dr. Margaret Tsien

Setting: Hospitals eligible for the Hospital Readmissions Reduction Program (HRRP) between June 2013 and December 2014.

Synopsis: A survey was developed and given to chief medical officers at 1,600 hospitals between June 2013 and December 2014; the survey assessed care coordination strategies employed by these institutions. 992 hospitals (62% response rate) were subsequently categorized as “low-strategy,” “mid-strategy,” or “high-strategy” hospitals. Patient satisfaction scores from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey in 2014 were correlated to the number of strategies and the specific strategies each hospital employed. In general, the higher-strategy hospitals had significantly higher HCAHPS survey scores than did low-strategy hospitals (+2.23 points; P less than .001). Specifically, creating and sharing a discharge summary prior to discharge (+1.43 points; P less than .001), using a discharge planner (+1.71 points; P less than .001), and calling patients 48 hours post discharge (+1.64 points; P less than .001) all resulted in overall higher hospital ratings by patients.
 

One limitation of this study is that no causal inference can be made between the specific strategies associated with higher HCAHPS scores and care coordination strategies.

Bottom line: Hospital-led care transition strategies with direct patient interactions led to higher patient satisfaction scores.

Citation: Figueroa JF et al. Hospital-level care coordination strategies associated with better patient experience. BMJ Qual Saf. 2018 Apr 4. doi: 10.1136/bmjqs-2017-007597.

Dr. Tsien is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.

Clinical question: Does patient experience correlate with specific hospital care coordination and transition strategies, and if so, which strategies most strongly correlate with higher patient experience scores?

Background: Patient experience is an increasingly important measure in value-based payment programs. However, progress has been slow in improving patient experience, and little empirical data exist regarding which strategies are effective. Care transitions are critical times during a hospitalization, with many hospitals already implementing measures to improve the discharge process and prevent readmission of patients. It is not known whether those measures also influence patient experience scores, and if they do improve scores, which measures are most effective at doing so.

Study design: An analytic observational survey design.

Dr. Margaret Tsien

Setting: Hospitals eligible for the Hospital Readmissions Reduction Program (HRRP) between June 2013 and December 2014.

Synopsis: A survey was developed and given to chief medical officers at 1,600 hospitals between June 2013 and December 2014; the survey assessed care coordination strategies employed by these institutions. 992 hospitals (62% response rate) were subsequently categorized as “low-strategy,” “mid-strategy,” or “high-strategy” hospitals. Patient satisfaction scores from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey in 2014 were correlated to the number of strategies and the specific strategies each hospital employed. In general, the higher-strategy hospitals had significantly higher HCAHPS survey scores than did low-strategy hospitals (+2.23 points; P less than .001). Specifically, creating and sharing a discharge summary prior to discharge (+1.43 points; P less than .001), using a discharge planner (+1.71 points; P less than .001), and calling patients 48 hours post discharge (+1.64 points; P less than .001) all resulted in overall higher hospital ratings by patients.
 

One limitation of this study is that no causal inference can be made between the specific strategies associated with higher HCAHPS scores and care coordination strategies.

Bottom line: Hospital-led care transition strategies with direct patient interactions led to higher patient satisfaction scores.

Citation: Figueroa JF et al. Hospital-level care coordination strategies associated with better patient experience. BMJ Qual Saf. 2018 Apr 4. doi: 10.1136/bmjqs-2017-007597.

Dr. Tsien is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.

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Cervical cancer: Who should you screen?

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US Preventive Services Task Force. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686. https://jamanetwork.com/journals/jama/fullarticle/2697704. Accessed September 14, 2018.

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Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The speaker reported no potential conflicts of interest relevant to this audiocast.

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Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The speaker reported no potential conflicts of interest relevant to this audiocast.

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Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The speaker reported no potential conflicts of interest relevant to this audiocast.

 

Resource

US Preventive Services Task Force. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686. https://jamanetwork.com/journals/jama/fullarticle/2697704. Accessed September 14, 2018.

 

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US Preventive Services Task Force. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686. https://jamanetwork.com/journals/jama/fullarticle/2697704. Accessed September 14, 2018.

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ULTIMATE: IVUS-guided stent placement bests angiography

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– Clinical outcomes were better when stent placement was guided by intravascular ultrasound rather than angiography, based on the results of a trial conducted in China. Unlike previous comparative studies, which focused on patients with more complex lesions, this trial included all patients undergoing drug-eluting stent (DES) placement.

In the ULTIMATE trial, 1,448 all-comer patients receiving DES were randomized to either intravascular ultrasound (IVUS)–guided or angiography-guided implantation, reported Junjie Zhang, PhD, of Nanjing Medical University in China, and colleagues. The study excluded patients who had a life expectancy shorter than 12 months, who were intolerant of dual antiplatelet therapy, and who had severe calcification needing rotational atherectomy.

At 30 days after stent placement, the incidence of target vessel failure was 0.8% in the IVUS group and 1.9% in the angiography group, a nonsignificant trend. However, outcomes were significantly different at 1 year, with target vessel failure occurring in 2.9% of IVUS patients and 5.4% of angiography patients (hazard ratio, 0.530; 95% confidence interval, 0.312-0.901; P = .019).

The work was simultaneously published in the Journal of the American College of Cardiology (2018 Sept. doi: 10.1016/j.jacc.2018.09.013) .

Despite good results in this and prior studies, uptake of the IVUS procedure is not high in the United States or Europe, according to members of a panel that reviewed the results at the Transcatheter Cardiovascular Therapeutics annual meeting.

“How can people continue to ignore the importance of imaging-guided stent optimization? Even with second-generation DES, the results are consistent across the studies. This is just another piece of irrefutable evidence,” said Gary S. Mintz, MD, chief medical officer at the Cardiovascular Research Foundation, and a discussant at the meeting, sponsored by the Cardiovascular Research Foundation.

Jim Kling/MDedge News
Dr. Ron Waksman


That sentiment was generally echoed by the rest of the panel. John M. Hodson, MD, a professor of medicine at MetroHealth Medical Center in Cleveland, pointed out that the study included a variety of cases, and angiography was performed to a high standard in that arm of the study. “It shows that, even with a good angiographic approach, IVUS still wins. I’m amazed that there’s still some resistance to [IVUS] image guidance,” said Dr. Hodgson.

The ULTIMATE study also found that the procedural time was longer (60.88 minutes vs. 45.49 minutes; P less than .001), and the contrast volume was higher (178.29 mL vs. 161.96 mL; P less than .001) in the IVUS than in the angiography group.

A postprocedure IVUS assessment was performed to determine whether the stent was optimally deployed. The criteria for optimal deployment included minimal lumen area in the stented segment of at least 5 mm2, or 90% of the minimal lumen area at distal reference segment meeting that criteria; a less than 50% plaque burden at the 5 mm of vessel proximal or distal to the stent edge; and no edge dissection involving media greater than 3 mm in length.

In the IVUS group, 53% of patients had optimal placement. The rate of target vessel failure was 1.6% of patients with optimal placement and 4.4% of patients who failed to achieve all optimal criteria (HR, 0.349; 95% CI, 0.135-0.898; P = 0.029). Compared with angiography guidance, IVUS guidance was of similar benefit for patients with either American College of Cardiology/American Heart Association–defined B2/C lesions or A/B1 lesions in terms of the composite endpoint. The significant reduction of clinically driven target lesion revascularization or definite stent thrombosis (HR, 0.407; 95% CI: 0.188-0.880; P = 0.018) based on lesion-level analysis by IVUS guidance was not achieved when patient-level analysis was performed.

“I’m particularly impressed by the analysis of the optimal versus nonoptimal group. If you don’t use IVUS correctly, you don’t get a benefit. The ones [in the IVUS group] who did not get optimal stenting were very similar to the angiographic group,” said Dr. Mintz.

The study was funded by the National Science Foundation of China, Six Talent Peaks Project, Nanjing Health and Family Planning Commission, Nanjing Health Youth Talent Training Project, and the Nanjing Municipal Commission of Science & Technology. None of the study authors had relevant financial disclosures. Dr. Mintz reported received research support from Abbott Vascular and Boston Scientific. He has been a consultant for Boston Scientific, Volcano, and Infraredx. Dr. Hodgson reported received research support and consulted for Volcano.
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– Clinical outcomes were better when stent placement was guided by intravascular ultrasound rather than angiography, based on the results of a trial conducted in China. Unlike previous comparative studies, which focused on patients with more complex lesions, this trial included all patients undergoing drug-eluting stent (DES) placement.

In the ULTIMATE trial, 1,448 all-comer patients receiving DES were randomized to either intravascular ultrasound (IVUS)–guided or angiography-guided implantation, reported Junjie Zhang, PhD, of Nanjing Medical University in China, and colleagues. The study excluded patients who had a life expectancy shorter than 12 months, who were intolerant of dual antiplatelet therapy, and who had severe calcification needing rotational atherectomy.

At 30 days after stent placement, the incidence of target vessel failure was 0.8% in the IVUS group and 1.9% in the angiography group, a nonsignificant trend. However, outcomes were significantly different at 1 year, with target vessel failure occurring in 2.9% of IVUS patients and 5.4% of angiography patients (hazard ratio, 0.530; 95% confidence interval, 0.312-0.901; P = .019).

The work was simultaneously published in the Journal of the American College of Cardiology (2018 Sept. doi: 10.1016/j.jacc.2018.09.013) .

Despite good results in this and prior studies, uptake of the IVUS procedure is not high in the United States or Europe, according to members of a panel that reviewed the results at the Transcatheter Cardiovascular Therapeutics annual meeting.

“How can people continue to ignore the importance of imaging-guided stent optimization? Even with second-generation DES, the results are consistent across the studies. This is just another piece of irrefutable evidence,” said Gary S. Mintz, MD, chief medical officer at the Cardiovascular Research Foundation, and a discussant at the meeting, sponsored by the Cardiovascular Research Foundation.

Jim Kling/MDedge News
Dr. Ron Waksman


That sentiment was generally echoed by the rest of the panel. John M. Hodson, MD, a professor of medicine at MetroHealth Medical Center in Cleveland, pointed out that the study included a variety of cases, and angiography was performed to a high standard in that arm of the study. “It shows that, even with a good angiographic approach, IVUS still wins. I’m amazed that there’s still some resistance to [IVUS] image guidance,” said Dr. Hodgson.

The ULTIMATE study also found that the procedural time was longer (60.88 minutes vs. 45.49 minutes; P less than .001), and the contrast volume was higher (178.29 mL vs. 161.96 mL; P less than .001) in the IVUS than in the angiography group.

A postprocedure IVUS assessment was performed to determine whether the stent was optimally deployed. The criteria for optimal deployment included minimal lumen area in the stented segment of at least 5 mm2, or 90% of the minimal lumen area at distal reference segment meeting that criteria; a less than 50% plaque burden at the 5 mm of vessel proximal or distal to the stent edge; and no edge dissection involving media greater than 3 mm in length.

In the IVUS group, 53% of patients had optimal placement. The rate of target vessel failure was 1.6% of patients with optimal placement and 4.4% of patients who failed to achieve all optimal criteria (HR, 0.349; 95% CI, 0.135-0.898; P = 0.029). Compared with angiography guidance, IVUS guidance was of similar benefit for patients with either American College of Cardiology/American Heart Association–defined B2/C lesions or A/B1 lesions in terms of the composite endpoint. The significant reduction of clinically driven target lesion revascularization or definite stent thrombosis (HR, 0.407; 95% CI: 0.188-0.880; P = 0.018) based on lesion-level analysis by IVUS guidance was not achieved when patient-level analysis was performed.

“I’m particularly impressed by the analysis of the optimal versus nonoptimal group. If you don’t use IVUS correctly, you don’t get a benefit. The ones [in the IVUS group] who did not get optimal stenting were very similar to the angiographic group,” said Dr. Mintz.

The study was funded by the National Science Foundation of China, Six Talent Peaks Project, Nanjing Health and Family Planning Commission, Nanjing Health Youth Talent Training Project, and the Nanjing Municipal Commission of Science & Technology. None of the study authors had relevant financial disclosures. Dr. Mintz reported received research support from Abbott Vascular and Boston Scientific. He has been a consultant for Boston Scientific, Volcano, and Infraredx. Dr. Hodgson reported received research support and consulted for Volcano.

– Clinical outcomes were better when stent placement was guided by intravascular ultrasound rather than angiography, based on the results of a trial conducted in China. Unlike previous comparative studies, which focused on patients with more complex lesions, this trial included all patients undergoing drug-eluting stent (DES) placement.

In the ULTIMATE trial, 1,448 all-comer patients receiving DES were randomized to either intravascular ultrasound (IVUS)–guided or angiography-guided implantation, reported Junjie Zhang, PhD, of Nanjing Medical University in China, and colleagues. The study excluded patients who had a life expectancy shorter than 12 months, who were intolerant of dual antiplatelet therapy, and who had severe calcification needing rotational atherectomy.

At 30 days after stent placement, the incidence of target vessel failure was 0.8% in the IVUS group and 1.9% in the angiography group, a nonsignificant trend. However, outcomes were significantly different at 1 year, with target vessel failure occurring in 2.9% of IVUS patients and 5.4% of angiography patients (hazard ratio, 0.530; 95% confidence interval, 0.312-0.901; P = .019).

The work was simultaneously published in the Journal of the American College of Cardiology (2018 Sept. doi: 10.1016/j.jacc.2018.09.013) .

Despite good results in this and prior studies, uptake of the IVUS procedure is not high in the United States or Europe, according to members of a panel that reviewed the results at the Transcatheter Cardiovascular Therapeutics annual meeting.

“How can people continue to ignore the importance of imaging-guided stent optimization? Even with second-generation DES, the results are consistent across the studies. This is just another piece of irrefutable evidence,” said Gary S. Mintz, MD, chief medical officer at the Cardiovascular Research Foundation, and a discussant at the meeting, sponsored by the Cardiovascular Research Foundation.

Jim Kling/MDedge News
Dr. Ron Waksman


That sentiment was generally echoed by the rest of the panel. John M. Hodson, MD, a professor of medicine at MetroHealth Medical Center in Cleveland, pointed out that the study included a variety of cases, and angiography was performed to a high standard in that arm of the study. “It shows that, even with a good angiographic approach, IVUS still wins. I’m amazed that there’s still some resistance to [IVUS] image guidance,” said Dr. Hodgson.

The ULTIMATE study also found that the procedural time was longer (60.88 minutes vs. 45.49 minutes; P less than .001), and the contrast volume was higher (178.29 mL vs. 161.96 mL; P less than .001) in the IVUS than in the angiography group.

A postprocedure IVUS assessment was performed to determine whether the stent was optimally deployed. The criteria for optimal deployment included minimal lumen area in the stented segment of at least 5 mm2, or 90% of the minimal lumen area at distal reference segment meeting that criteria; a less than 50% plaque burden at the 5 mm of vessel proximal or distal to the stent edge; and no edge dissection involving media greater than 3 mm in length.

In the IVUS group, 53% of patients had optimal placement. The rate of target vessel failure was 1.6% of patients with optimal placement and 4.4% of patients who failed to achieve all optimal criteria (HR, 0.349; 95% CI, 0.135-0.898; P = 0.029). Compared with angiography guidance, IVUS guidance was of similar benefit for patients with either American College of Cardiology/American Heart Association–defined B2/C lesions or A/B1 lesions in terms of the composite endpoint. The significant reduction of clinically driven target lesion revascularization or definite stent thrombosis (HR, 0.407; 95% CI: 0.188-0.880; P = 0.018) based on lesion-level analysis by IVUS guidance was not achieved when patient-level analysis was performed.

“I’m particularly impressed by the analysis of the optimal versus nonoptimal group. If you don’t use IVUS correctly, you don’t get a benefit. The ones [in the IVUS group] who did not get optimal stenting were very similar to the angiographic group,” said Dr. Mintz.

The study was funded by the National Science Foundation of China, Six Talent Peaks Project, Nanjing Health and Family Planning Commission, Nanjing Health Youth Talent Training Project, and the Nanjing Municipal Commission of Science & Technology. None of the study authors had relevant financial disclosures. Dr. Mintz reported received research support from Abbott Vascular and Boston Scientific. He has been a consultant for Boston Scientific, Volcano, and Infraredx. Dr. Hodgson reported received research support and consulted for Volcano.
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REPORTING FROM TCT 2018

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Key clinical point: Intravascular ultrasound–guided placement of drug-eluting stents resulted in a lower target vessel failure rate than did angiography guidance.

Major finding: The 1-year target vessel failure rate was 2.9% in the intravascular ultrasound–guided group and 5.4% in the angiography group.

Study details: A randomized, controlled trial of 1,448 all-comer patients.

Disclosures: The study was funded by the National Science Foundation of China, Six Talent Peaks Project, Nanjing Health and Family Planning Commission, Nanjing Health Youth Talent Training Project, and the Nanjing Municipal Commission of Science & Technology. None of the study authors had relevant financial disclosures. Dr. Mintz reported receiving research support from Abbott Vascular and Boston Scientific. He has been a consultant for Boston Scientific, Volcano, and Infraredx. Dr. Hodgson reported receiving research support and consulted for Volcano.

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Refill disruptions for inhaled corticosteroids may mean more exacerbations

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Interruptions of patients’ refills for combination inhaled corticosteroid medication caused by the Medicare Part D formulary switch may have resulted in increased exacerbations and hospitalizations, according to a study that will be presented at the CHEST 2018 annual meeting.

Katie Devane, PhD, and her colleagues examined pharmacy records of 44,832 patients aged 12 years and older who had received a combination inhaled corticosteroid (budesonide/formoterol) and a long-acting beta-agonist medication in 2016-2017. They were followed to track their refills, medication switches, and use of other medications such as oral corticosteroids, antibiotics, and rescue inhalers.

After the Medicare Part D formulary switch on Jan. 1, 2017, many of these patients experienced disruption of their refills. About half of the patients attempted to get a refill of their inhaled corticosteroid prescription but only 46% were approved. One-third of the patients studied did not replace their medication, 12% switched to monotherapy, and 17% had no inhaled medication, the study found.

The investigators concluded that the formulary block resulted in many patients going without optimal medication and potentially led to more exacerbations and ER visits.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31877-4/fulltext

The study will be presented in the session Improving Care in COPD, Monday, Oct. 8, 2:15 p.m., Convention Center Room 207A.

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Interruptions of patients’ refills for combination inhaled corticosteroid medication caused by the Medicare Part D formulary switch may have resulted in increased exacerbations and hospitalizations, according to a study that will be presented at the CHEST 2018 annual meeting.

Katie Devane, PhD, and her colleagues examined pharmacy records of 44,832 patients aged 12 years and older who had received a combination inhaled corticosteroid (budesonide/formoterol) and a long-acting beta-agonist medication in 2016-2017. They were followed to track their refills, medication switches, and use of other medications such as oral corticosteroids, antibiotics, and rescue inhalers.

After the Medicare Part D formulary switch on Jan. 1, 2017, many of these patients experienced disruption of their refills. About half of the patients attempted to get a refill of their inhaled corticosteroid prescription but only 46% were approved. One-third of the patients studied did not replace their medication, 12% switched to monotherapy, and 17% had no inhaled medication, the study found.

The investigators concluded that the formulary block resulted in many patients going without optimal medication and potentially led to more exacerbations and ER visits.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31877-4/fulltext

The study will be presented in the session Improving Care in COPD, Monday, Oct. 8, 2:15 p.m., Convention Center Room 207A.

Interruptions of patients’ refills for combination inhaled corticosteroid medication caused by the Medicare Part D formulary switch may have resulted in increased exacerbations and hospitalizations, according to a study that will be presented at the CHEST 2018 annual meeting.

Katie Devane, PhD, and her colleagues examined pharmacy records of 44,832 patients aged 12 years and older who had received a combination inhaled corticosteroid (budesonide/formoterol) and a long-acting beta-agonist medication in 2016-2017. They were followed to track their refills, medication switches, and use of other medications such as oral corticosteroids, antibiotics, and rescue inhalers.

After the Medicare Part D formulary switch on Jan. 1, 2017, many of these patients experienced disruption of their refills. About half of the patients attempted to get a refill of their inhaled corticosteroid prescription but only 46% were approved. One-third of the patients studied did not replace their medication, 12% switched to monotherapy, and 17% had no inhaled medication, the study found.

The investigators concluded that the formulary block resulted in many patients going without optimal medication and potentially led to more exacerbations and ER visits.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31877-4/fulltext

The study will be presented in the session Improving Care in COPD, Monday, Oct. 8, 2:15 p.m., Convention Center Room 207A.

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Treatment adherence may trump environmental factors for children with asthma

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Children with asthma who are provided with care and medication per National Asthma Education and Prevention Program guidelines can improve over time, despite the presence of environmental factors such as second-hand tobacco smoke and domestic pets, according to a study presented at the CHEST 2018 annual meeting.

A study conducted at the Nationwide Children’s Hospital in Columbus, Ohio, included 395 children aged 2-17 years with a diagnosis of uncontrolled asthma. These children were then treated using the NAEPP guidelines for acute care needs and symptom control. In this sample of patients, 25% were exposed to second-hand smoke, and 55% had a cat or dog in the home.

The investigators followed these patients and observed improvement of symptoms. But in a comparison of those with and without the potentially problematic environmental factors, improvement was independent of the presence of these factors. The findings suggest that NAEPP-recommended treatment of asthma is more important than are some environmental factors.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31862-2/fulltext.

The findings will be presented in the session on Obstructive Lung Diseases, Wednesday, Oct. 10, at 1:00 p.m.
 

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Children with asthma who are provided with care and medication per National Asthma Education and Prevention Program guidelines can improve over time, despite the presence of environmental factors such as second-hand tobacco smoke and domestic pets, according to a study presented at the CHEST 2018 annual meeting.

A study conducted at the Nationwide Children’s Hospital in Columbus, Ohio, included 395 children aged 2-17 years with a diagnosis of uncontrolled asthma. These children were then treated using the NAEPP guidelines for acute care needs and symptom control. In this sample of patients, 25% were exposed to second-hand smoke, and 55% had a cat or dog in the home.

The investigators followed these patients and observed improvement of symptoms. But in a comparison of those with and without the potentially problematic environmental factors, improvement was independent of the presence of these factors. The findings suggest that NAEPP-recommended treatment of asthma is more important than are some environmental factors.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31862-2/fulltext.

The findings will be presented in the session on Obstructive Lung Diseases, Wednesday, Oct. 10, at 1:00 p.m.
 

Children with asthma who are provided with care and medication per National Asthma Education and Prevention Program guidelines can improve over time, despite the presence of environmental factors such as second-hand tobacco smoke and domestic pets, according to a study presented at the CHEST 2018 annual meeting.

A study conducted at the Nationwide Children’s Hospital in Columbus, Ohio, included 395 children aged 2-17 years with a diagnosis of uncontrolled asthma. These children were then treated using the NAEPP guidelines for acute care needs and symptom control. In this sample of patients, 25% were exposed to second-hand smoke, and 55% had a cat or dog in the home.

The investigators followed these patients and observed improvement of symptoms. But in a comparison of those with and without the potentially problematic environmental factors, improvement was independent of the presence of these factors. The findings suggest that NAEPP-recommended treatment of asthma is more important than are some environmental factors.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31862-2/fulltext.

The findings will be presented in the session on Obstructive Lung Diseases, Wednesday, Oct. 10, at 1:00 p.m.
 

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Adherence to follow-up lung cancer screening not optimal

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Former smokers’ adherence to annual follow-up screening for lung cancer was found to be less than optimal, according to a study to be presented at the CHEST 2018 annual meeting.

Paul B. Brasher, MD, and his colleagues from the Thoracic Oncology Research Group at the Medical University of South Carolina in Charleston studied adherence to recommended low-dose computed tomography (LDCT) among Veterans Affairs patients who were at high risk for lung cancer and whose baseline LDCTs were negative.

A total of 2,106 veterans aged 55-80 years who had at least a 30-pack year smoking history were initially screened within the Veterans Health Administration Lung Cancer Screening Demonstration Project. The study tracked 1,120 of these patients for 18 months to determine their adherence to annual LDCT screening; the rate of adherence was 77.6%.

View the abstract here: https://journal.chestnet.org/article/S0012-3692(18)31772-0/fulltext

The study will be presented in the session Lung Cancer Screening: New Questions and New Answers, Tuesday, Oct. 9, 8:45 a.m., Convention Center 207A.

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Former smokers’ adherence to annual follow-up screening for lung cancer was found to be less than optimal, according to a study to be presented at the CHEST 2018 annual meeting.

Paul B. Brasher, MD, and his colleagues from the Thoracic Oncology Research Group at the Medical University of South Carolina in Charleston studied adherence to recommended low-dose computed tomography (LDCT) among Veterans Affairs patients who were at high risk for lung cancer and whose baseline LDCTs were negative.

A total of 2,106 veterans aged 55-80 years who had at least a 30-pack year smoking history were initially screened within the Veterans Health Administration Lung Cancer Screening Demonstration Project. The study tracked 1,120 of these patients for 18 months to determine their adherence to annual LDCT screening; the rate of adherence was 77.6%.

View the abstract here: https://journal.chestnet.org/article/S0012-3692(18)31772-0/fulltext

The study will be presented in the session Lung Cancer Screening: New Questions and New Answers, Tuesday, Oct. 9, 8:45 a.m., Convention Center 207A.

Former smokers’ adherence to annual follow-up screening for lung cancer was found to be less than optimal, according to a study to be presented at the CHEST 2018 annual meeting.

Paul B. Brasher, MD, and his colleagues from the Thoracic Oncology Research Group at the Medical University of South Carolina in Charleston studied adherence to recommended low-dose computed tomography (LDCT) among Veterans Affairs patients who were at high risk for lung cancer and whose baseline LDCTs were negative.

A total of 2,106 veterans aged 55-80 years who had at least a 30-pack year smoking history were initially screened within the Veterans Health Administration Lung Cancer Screening Demonstration Project. The study tracked 1,120 of these patients for 18 months to determine their adherence to annual LDCT screening; the rate of adherence was 77.6%.

View the abstract here: https://journal.chestnet.org/article/S0012-3692(18)31772-0/fulltext

The study will be presented in the session Lung Cancer Screening: New Questions and New Answers, Tuesday, Oct. 9, 8:45 a.m., Convention Center 207A.

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CorMicA: Nonobstructive angina should trigger functional testing

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– Don’t be satisfied with a diagnosis of angina with no obstructive coronary artery disease; push for acetylcholine testing, the findings from a trial in Scotland suggest.

M. Alexander Otto/MDedge News
Dr. Tom Ford (L) and Dr. Colin Berry

Going a little further with an acetylcholine challenge in the cath lab will usually uncover microvascular or vasospastic heart problems, and this can lead to appropriate treatment. Patients will have less angina and a better quality of life at 6 months, according to investigators from the University of Glasgow (Scotland).

Invasive angiography usually ends on both sides of the Atlantic when no occlusions are found. There are concerns about the safety of going further with acetylcholine challenges, and until now, there had been no grade A evidence from a randomized trial that it improves outcomes. The Glasgow team filled the evidence gap with their presentation of the Coronary Microvascular Angina (CorMicA) trial at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, and there wasn’t a single serious adverse event (J Am Coll Cardiol. 2018 Sep 25. doi: 10.1016/j.jacc.2018.09.006).

“This was a proof-of-concept study, which we believe [should] substantiate a large, multicenter trial,” said senior investigator Colin Berry, PhD, a professor of cardiology and imaging at the university.

Acetylcholine was infused down the pressure wire in 151 subjects diagnosed with angina with no obstructive coronary artery diseases before they left the catheter lab. Of these patients, 76 were randomized to have their results shared with their treating cardiologist, and 75 were randomized to not have their results shared. Coronary functional testing is hardly ever done, so the no-share group was considered the standard-of-care control arm. The idea was to see whether it made a difference when treating physicians knew what was causing chest pain when their patients didn’t have occlusive disease.

It turned out to make a huge difference. The diagnosis of “chest pain of noncardiac origin” almost fell off the map. Once cardiologists knew what was going on, they switched up treatment according to European Society of Cardiology guidelines for functional heart pain. Patients with microvascular angina were given beta-blockers and switched off nitrates because these drugs make angina worse in microvascular disease. Subjects with vasospasms were shifted to calcium channel blockers and long-acting nitrates and away from beta-blockers because beta-blockers make vasospasms worse.

Cardiologists who didn’t know the results kept muddling along with what patients came in on at baseline – beta-blockers in two-thirds, long-acting nitrates in half, and calcium channel blockers in a third.

Subjects who got the right treatment because of acetylcholine testing outpaced the standard care group by almost 12 points on the Seattle Angina Questionnaire at 6 months; they could walk farther and didn’t have crushing angina almost every day (P = .001). They reported a statistically significant improvement in quality of life, and they were much happier with their doctors.

“This is the first randomized, sham-controlled trial in this space”; functional testing “was routinely safe and feasible. Therapy guided by the results of physiologic testing improved outcomes” and “treatment satisfaction,” said University of Glasgow interventional cardiologist Tom Ford, MD.

Acetylcholine was infused down the pressure wire into the radial artery, with the left anterior descending coronary artery as the target vessel. A final bolus of less than 100 mcg checked for coronary artery spasms; a symptomatic constriction of greater than 90% was considered positive. Glyceryl trinitrate was used to reverse the effects.

Three-quarters of the subjects were women, which Dr. Ford noted is unusual in an angina study. The mean age was 61 years, and subjects had about a 20% chance of a heart attack within 10 years. The whole procedure, including the angiogram, randomization, and functional testing, took a median of about 60 minutes.

There were no differences in major adverse cardiac events at 6 months, at 2.6% in both groups.

One patient developed persistent atrial fibrillation with acetylcholine testing that was converted to sinus rhythm with intravenous amiodarone, without a night in the hospital.

The work was funded by the British Heart Foundation. No companies were involved. The investigators didn’t have any relevant disclosures. The TCT meeting is sponsored by the Cardiovascular Research Foundation.

aotto@mdedge.com

SOURCE: Ford TG et al. TCT 2018, Late-Breaking Trial.

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– Don’t be satisfied with a diagnosis of angina with no obstructive coronary artery disease; push for acetylcholine testing, the findings from a trial in Scotland suggest.

M. Alexander Otto/MDedge News
Dr. Tom Ford (L) and Dr. Colin Berry

Going a little further with an acetylcholine challenge in the cath lab will usually uncover microvascular or vasospastic heart problems, and this can lead to appropriate treatment. Patients will have less angina and a better quality of life at 6 months, according to investigators from the University of Glasgow (Scotland).

Invasive angiography usually ends on both sides of the Atlantic when no occlusions are found. There are concerns about the safety of going further with acetylcholine challenges, and until now, there had been no grade A evidence from a randomized trial that it improves outcomes. The Glasgow team filled the evidence gap with their presentation of the Coronary Microvascular Angina (CorMicA) trial at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, and there wasn’t a single serious adverse event (J Am Coll Cardiol. 2018 Sep 25. doi: 10.1016/j.jacc.2018.09.006).

“This was a proof-of-concept study, which we believe [should] substantiate a large, multicenter trial,” said senior investigator Colin Berry, PhD, a professor of cardiology and imaging at the university.

Acetylcholine was infused down the pressure wire in 151 subjects diagnosed with angina with no obstructive coronary artery diseases before they left the catheter lab. Of these patients, 76 were randomized to have their results shared with their treating cardiologist, and 75 were randomized to not have their results shared. Coronary functional testing is hardly ever done, so the no-share group was considered the standard-of-care control arm. The idea was to see whether it made a difference when treating physicians knew what was causing chest pain when their patients didn’t have occlusive disease.

It turned out to make a huge difference. The diagnosis of “chest pain of noncardiac origin” almost fell off the map. Once cardiologists knew what was going on, they switched up treatment according to European Society of Cardiology guidelines for functional heart pain. Patients with microvascular angina were given beta-blockers and switched off nitrates because these drugs make angina worse in microvascular disease. Subjects with vasospasms were shifted to calcium channel blockers and long-acting nitrates and away from beta-blockers because beta-blockers make vasospasms worse.

Cardiologists who didn’t know the results kept muddling along with what patients came in on at baseline – beta-blockers in two-thirds, long-acting nitrates in half, and calcium channel blockers in a third.

Subjects who got the right treatment because of acetylcholine testing outpaced the standard care group by almost 12 points on the Seattle Angina Questionnaire at 6 months; they could walk farther and didn’t have crushing angina almost every day (P = .001). They reported a statistically significant improvement in quality of life, and they were much happier with their doctors.

“This is the first randomized, sham-controlled trial in this space”; functional testing “was routinely safe and feasible. Therapy guided by the results of physiologic testing improved outcomes” and “treatment satisfaction,” said University of Glasgow interventional cardiologist Tom Ford, MD.

Acetylcholine was infused down the pressure wire into the radial artery, with the left anterior descending coronary artery as the target vessel. A final bolus of less than 100 mcg checked for coronary artery spasms; a symptomatic constriction of greater than 90% was considered positive. Glyceryl trinitrate was used to reverse the effects.

Three-quarters of the subjects were women, which Dr. Ford noted is unusual in an angina study. The mean age was 61 years, and subjects had about a 20% chance of a heart attack within 10 years. The whole procedure, including the angiogram, randomization, and functional testing, took a median of about 60 minutes.

There were no differences in major adverse cardiac events at 6 months, at 2.6% in both groups.

One patient developed persistent atrial fibrillation with acetylcholine testing that was converted to sinus rhythm with intravenous amiodarone, without a night in the hospital.

The work was funded by the British Heart Foundation. No companies were involved. The investigators didn’t have any relevant disclosures. The TCT meeting is sponsored by the Cardiovascular Research Foundation.

aotto@mdedge.com

SOURCE: Ford TG et al. TCT 2018, Late-Breaking Trial.

– Don’t be satisfied with a diagnosis of angina with no obstructive coronary artery disease; push for acetylcholine testing, the findings from a trial in Scotland suggest.

M. Alexander Otto/MDedge News
Dr. Tom Ford (L) and Dr. Colin Berry

Going a little further with an acetylcholine challenge in the cath lab will usually uncover microvascular or vasospastic heart problems, and this can lead to appropriate treatment. Patients will have less angina and a better quality of life at 6 months, according to investigators from the University of Glasgow (Scotland).

Invasive angiography usually ends on both sides of the Atlantic when no occlusions are found. There are concerns about the safety of going further with acetylcholine challenges, and until now, there had been no grade A evidence from a randomized trial that it improves outcomes. The Glasgow team filled the evidence gap with their presentation of the Coronary Microvascular Angina (CorMicA) trial at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, and there wasn’t a single serious adverse event (J Am Coll Cardiol. 2018 Sep 25. doi: 10.1016/j.jacc.2018.09.006).

“This was a proof-of-concept study, which we believe [should] substantiate a large, multicenter trial,” said senior investigator Colin Berry, PhD, a professor of cardiology and imaging at the university.

Acetylcholine was infused down the pressure wire in 151 subjects diagnosed with angina with no obstructive coronary artery diseases before they left the catheter lab. Of these patients, 76 were randomized to have their results shared with their treating cardiologist, and 75 were randomized to not have their results shared. Coronary functional testing is hardly ever done, so the no-share group was considered the standard-of-care control arm. The idea was to see whether it made a difference when treating physicians knew what was causing chest pain when their patients didn’t have occlusive disease.

It turned out to make a huge difference. The diagnosis of “chest pain of noncardiac origin” almost fell off the map. Once cardiologists knew what was going on, they switched up treatment according to European Society of Cardiology guidelines for functional heart pain. Patients with microvascular angina were given beta-blockers and switched off nitrates because these drugs make angina worse in microvascular disease. Subjects with vasospasms were shifted to calcium channel blockers and long-acting nitrates and away from beta-blockers because beta-blockers make vasospasms worse.

Cardiologists who didn’t know the results kept muddling along with what patients came in on at baseline – beta-blockers in two-thirds, long-acting nitrates in half, and calcium channel blockers in a third.

Subjects who got the right treatment because of acetylcholine testing outpaced the standard care group by almost 12 points on the Seattle Angina Questionnaire at 6 months; they could walk farther and didn’t have crushing angina almost every day (P = .001). They reported a statistically significant improvement in quality of life, and they were much happier with their doctors.

“This is the first randomized, sham-controlled trial in this space”; functional testing “was routinely safe and feasible. Therapy guided by the results of physiologic testing improved outcomes” and “treatment satisfaction,” said University of Glasgow interventional cardiologist Tom Ford, MD.

Acetylcholine was infused down the pressure wire into the radial artery, with the left anterior descending coronary artery as the target vessel. A final bolus of less than 100 mcg checked for coronary artery spasms; a symptomatic constriction of greater than 90% was considered positive. Glyceryl trinitrate was used to reverse the effects.

Three-quarters of the subjects were women, which Dr. Ford noted is unusual in an angina study. The mean age was 61 years, and subjects had about a 20% chance of a heart attack within 10 years. The whole procedure, including the angiogram, randomization, and functional testing, took a median of about 60 minutes.

There were no differences in major adverse cardiac events at 6 months, at 2.6% in both groups.

One patient developed persistent atrial fibrillation with acetylcholine testing that was converted to sinus rhythm with intravenous amiodarone, without a night in the hospital.

The work was funded by the British Heart Foundation. No companies were involved. The investigators didn’t have any relevant disclosures. The TCT meeting is sponsored by the Cardiovascular Research Foundation.

aotto@mdedge.com

SOURCE: Ford TG et al. TCT 2018, Late-Breaking Trial.

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REPORTING FROM TCT 2018

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Key clinical point: A diagnosis of angina with no obstructive coronary artery disease is insufficient; acetylcholine testing should be considered.

Major finding: The diagnosis of “chest pain of noncardiac origin” almost fell off the map. At 6 months, patients could walk farther and didn’t have crushing angina almost every day (P = .001). They reported a statistically significant improvement in quality of life, and they were much happier with their doctors.

Study details: Randomized trial with 151 people who had chest pain but no coronary occlusions on angiography.

Disclosures: There was no industry funding, and the investigators had no relevant industry disclosures.

Source: Ford TG et al. TCT 2018, Late-Breaking Trial.

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Using aspirin across the board is not justified based on results of the ASPREE trial as well as on the equivocal results from other recent primary prevention trials. Also today, swings in four metabolic measures predicted death in healthy people, anticoagulation plus single antiplatelet fails noninferiority measure 1 year after stenting, and Behavioral checklist identifies children at risk of depressive and/or anxiety disorders.
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Using aspirin across the board is not justified based on results of the ASPREE trial as well as on the equivocal results from other recent primary prevention trials. Also today, swings in four metabolic measures predicted death in healthy people, anticoagulation plus single antiplatelet fails noninferiority measure 1 year after stenting, and Behavioral checklist identifies children at risk of depressive and/or anxiety disorders.
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Using aspirin across the board is not justified based on results of the ASPREE trial as well as on the equivocal results from other recent primary prevention trials. Also today, swings in four metabolic measures predicted death in healthy people, anticoagulation plus single antiplatelet fails noninferiority measure 1 year after stenting, and Behavioral checklist identifies children at risk of depressive and/or anxiety disorders.
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