MDedge Emergency Medicine

SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.

Bruce Jancin/MDedge News

“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.

Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.

Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).

The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.

Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
 

Hypertension

Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).

Atherosclerotic cardiovascular disease

Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.

Diabetes

Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.

Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.

“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.

In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).

More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).

“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”

He reported serving as a consultant to 10 pharmaceutical or medical device companies.

bjancin@mdedge.com

SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.

Bruce Jancin/MDedge News

“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.

Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.

Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).

The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.

Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
 

Hypertension

Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).

Atherosclerotic cardiovascular disease

Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.

Diabetes

Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.

Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.

“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.

In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).

More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).

“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”

He reported serving as a consultant to 10 pharmaceutical or medical device companies.

bjancin@mdedge.com

SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.

Bruce Jancin/MDedge News

“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.

Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.

Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).

The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.

Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
 

Hypertension

Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).

Atherosclerotic cardiovascular disease

Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.

Diabetes

Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.

Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.

“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.

In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).

More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).

“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”

He reported serving as a consultant to 10 pharmaceutical or medical device companies.

bjancin@mdedge.com

In 2017, roughly 3 years after evidence from several studies made endovascular thrombectomy first-line treatment for selected acute ischemic stroke patients, the treatment was available at barely more than one-third of all U.S. stroke centers, available within 30-minute access to just over 30% of Americans, and available within 15-minute access to one-fifth of U.S. residents, based on information in a comprehensive U.S. database.

Heba Sarraj

These numbers showed that “current direct EVT [endovascular thrombectomy] access in the United States is suboptimal under predominate EMS routing protocols,” Amrou Sarraj, MD, and his associates wrote in an article published online in Stroke on Feb. 12. “Only in eight states did the coverage exceed 25% of the population, and nine states had coverage for less than 10% of the population. These results reflect limited access to an effective treatment modality that would improve clinical outcomes in patients with large strokes and prevent potentially devastating disability,” wrote Dr. Sarraj, chief of the general neurology service at Memorial-Hermann Hospital in Houston and coauthors.

Their analysis of data collected in 2017 by the Medicare Provider Analysis and Review (MEDPAR) database, maintained by the Centers for Medicare & Medicaid Services, identified two apparently effective ways to improve EVT access for acute ischemic stroke patients: First, systematically divert patients to a nearby center that offers EVT even when it means bypassing a closer stroke center that does not perform EVT when the added travel time is less than 15 minutes. Second, convert selected stroke centers that currently do not perform EVT into centers that do. Between these two approaches, the strategy of having ambulances bypass stroke centers that do not perform EVT and continuing to ones that do generally has the greater potential to boost access, the authors found. They based their analysis exclusively on their calculations of expected consequences rather than actual experience.

The calculations showed that bypassing non-EVT centers when the added bypass time computed to less than 15 minutes linked with an anticipated overall U.S. gain in access of about 17%, or 52 million people, extending the ability of acute ischemic stroke patients able to quickly reach an EVT center to about 37% of the American public. The second approach to boost access, converting the top 10% of stroke centers based on case volume that currently do not provide EVT to centers that do offer it, would result in expanded access for about 23 million additional Americans, raising the total with access to about 27% of the public, the new report said.

As part of this analysis, the MEDPAR data identified 1,941 U.S. centers providing stroke services during 2017, of which 713 (37%) had performed at least one EVT procedure. By comparison, 2015 MEDPAR data showed 577 U.S. stroke centers performing EVT, indicating that during the 2-3 years following several reports in early 2015 on the net benefits of EVT for acute ischemic stroke patients, the number of U.S. stroke centers offering this treatment had grown by a relative 24%. Based on the locations of the stroke centers that made EVT available in 2017, Dr. Sarraj and coauthors calculated that the 713 EVT-capable stroke centers provided emergency access within a 15-minute ground-ambulance trip for 61 million Americans (20% of the U.S. population), and within a 30-minute ground-transport trip to 95 million residents (31%).

Boosting these numbers by implementing a systematic bypass of stroke patients past non-EVT stroke centers to nearby centers that are EVT capable “has the benefit of ease of implementation and requires less time and resources,” the authors said. However, they also noted the heterogeneity of circumstances based on variables like population density and stroke center distribution, which means that in some locations the most effective way to boost access would be by increasing the number of stroke centers that provide EVT.

In 2018, Dr. Sarraj and associates reported results from a similar analysis of MEDPAR data that used 30-minute and 60-minute ground-transport times as the criteria for their calculations.

The study received no commercial funding. Dr. Sarraj reported receiving research funding from Stryker Neurovascular outside of this work. One coauthor reported serving in roles for the University of Texas Health System for which the institution has been funded via various industry and government grants, and another coauthor reported receiving research funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, Genentech, and CSL Behring, as well as consulting fees from Frazer Ltd.

mzoler@mdedge.com

SOURCE: Sarraj A et al. Stroke. 2020 Feb 12. doi: 10.1161/STROKEAHA.120.028850.

In 2017, roughly 3 years after evidence from several studies made endovascular thrombectomy first-line treatment for selected acute ischemic stroke patients, the treatment was available at barely more than one-third of all U.S. stroke centers, available within 30-minute access to just over 30% of Americans, and available within 15-minute access to one-fifth of U.S. residents, based on information in a comprehensive U.S. database.

Heba Sarraj

These numbers showed that “current direct EVT [endovascular thrombectomy] access in the United States is suboptimal under predominate EMS routing protocols,” Amrou Sarraj, MD, and his associates wrote in an article published online in Stroke on Feb. 12. “Only in eight states did the coverage exceed 25% of the population, and nine states had coverage for less than 10% of the population. These results reflect limited access to an effective treatment modality that would improve clinical outcomes in patients with large strokes and prevent potentially devastating disability,” wrote Dr. Sarraj, chief of the general neurology service at Memorial-Hermann Hospital in Houston and coauthors.

Their analysis of data collected in 2017 by the Medicare Provider Analysis and Review (MEDPAR) database, maintained by the Centers for Medicare & Medicaid Services, identified two apparently effective ways to improve EVT access for acute ischemic stroke patients: First, systematically divert patients to a nearby center that offers EVT even when it means bypassing a closer stroke center that does not perform EVT when the added travel time is less than 15 minutes. Second, convert selected stroke centers that currently do not perform EVT into centers that do. Between these two approaches, the strategy of having ambulances bypass stroke centers that do not perform EVT and continuing to ones that do generally has the greater potential to boost access, the authors found. They based their analysis exclusively on their calculations of expected consequences rather than actual experience.

The calculations showed that bypassing non-EVT centers when the added bypass time computed to less than 15 minutes linked with an anticipated overall U.S. gain in access of about 17%, or 52 million people, extending the ability of acute ischemic stroke patients able to quickly reach an EVT center to about 37% of the American public. The second approach to boost access, converting the top 10% of stroke centers based on case volume that currently do not provide EVT to centers that do offer it, would result in expanded access for about 23 million additional Americans, raising the total with access to about 27% of the public, the new report said.

As part of this analysis, the MEDPAR data identified 1,941 U.S. centers providing stroke services during 2017, of which 713 (37%) had performed at least one EVT procedure. By comparison, 2015 MEDPAR data showed 577 U.S. stroke centers performing EVT, indicating that during the 2-3 years following several reports in early 2015 on the net benefits of EVT for acute ischemic stroke patients, the number of U.S. stroke centers offering this treatment had grown by a relative 24%. Based on the locations of the stroke centers that made EVT available in 2017, Dr. Sarraj and coauthors calculated that the 713 EVT-capable stroke centers provided emergency access within a 15-minute ground-ambulance trip for 61 million Americans (20% of the U.S. population), and within a 30-minute ground-transport trip to 95 million residents (31%).

Boosting these numbers by implementing a systematic bypass of stroke patients past non-EVT stroke centers to nearby centers that are EVT capable “has the benefit of ease of implementation and requires less time and resources,” the authors said. However, they also noted the heterogeneity of circumstances based on variables like population density and stroke center distribution, which means that in some locations the most effective way to boost access would be by increasing the number of stroke centers that provide EVT.

In 2018, Dr. Sarraj and associates reported results from a similar analysis of MEDPAR data that used 30-minute and 60-minute ground-transport times as the criteria for their calculations.

The study received no commercial funding. Dr. Sarraj reported receiving research funding from Stryker Neurovascular outside of this work. One coauthor reported serving in roles for the University of Texas Health System for which the institution has been funded via various industry and government grants, and another coauthor reported receiving research funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, Genentech, and CSL Behring, as well as consulting fees from Frazer Ltd.

mzoler@mdedge.com

SOURCE: Sarraj A et al. Stroke. 2020 Feb 12. doi: 10.1161/STROKEAHA.120.028850.

In 2017, roughly 3 years after evidence from several studies made endovascular thrombectomy first-line treatment for selected acute ischemic stroke patients, the treatment was available at barely more than one-third of all U.S. stroke centers, available within 30-minute access to just over 30% of Americans, and available within 15-minute access to one-fifth of U.S. residents, based on information in a comprehensive U.S. database.

Heba Sarraj

These numbers showed that “current direct EVT [endovascular thrombectomy] access in the United States is suboptimal under predominate EMS routing protocols,” Amrou Sarraj, MD, and his associates wrote in an article published online in Stroke on Feb. 12. “Only in eight states did the coverage exceed 25% of the population, and nine states had coverage for less than 10% of the population. These results reflect limited access to an effective treatment modality that would improve clinical outcomes in patients with large strokes and prevent potentially devastating disability,” wrote Dr. Sarraj, chief of the general neurology service at Memorial-Hermann Hospital in Houston and coauthors.

Their analysis of data collected in 2017 by the Medicare Provider Analysis and Review (MEDPAR) database, maintained by the Centers for Medicare & Medicaid Services, identified two apparently effective ways to improve EVT access for acute ischemic stroke patients: First, systematically divert patients to a nearby center that offers EVT even when it means bypassing a closer stroke center that does not perform EVT when the added travel time is less than 15 minutes. Second, convert selected stroke centers that currently do not perform EVT into centers that do. Between these two approaches, the strategy of having ambulances bypass stroke centers that do not perform EVT and continuing to ones that do generally has the greater potential to boost access, the authors found. They based their analysis exclusively on their calculations of expected consequences rather than actual experience.

The calculations showed that bypassing non-EVT centers when the added bypass time computed to less than 15 minutes linked with an anticipated overall U.S. gain in access of about 17%, or 52 million people, extending the ability of acute ischemic stroke patients able to quickly reach an EVT center to about 37% of the American public. The second approach to boost access, converting the top 10% of stroke centers based on case volume that currently do not provide EVT to centers that do offer it, would result in expanded access for about 23 million additional Americans, raising the total with access to about 27% of the public, the new report said.

As part of this analysis, the MEDPAR data identified 1,941 U.S. centers providing stroke services during 2017, of which 713 (37%) had performed at least one EVT procedure. By comparison, 2015 MEDPAR data showed 577 U.S. stroke centers performing EVT, indicating that during the 2-3 years following several reports in early 2015 on the net benefits of EVT for acute ischemic stroke patients, the number of U.S. stroke centers offering this treatment had grown by a relative 24%. Based on the locations of the stroke centers that made EVT available in 2017, Dr. Sarraj and coauthors calculated that the 713 EVT-capable stroke centers provided emergency access within a 15-minute ground-ambulance trip for 61 million Americans (20% of the U.S. population), and within a 30-minute ground-transport trip to 95 million residents (31%).

Boosting these numbers by implementing a systematic bypass of stroke patients past non-EVT stroke centers to nearby centers that are EVT capable “has the benefit of ease of implementation and requires less time and resources,” the authors said. However, they also noted the heterogeneity of circumstances based on variables like population density and stroke center distribution, which means that in some locations the most effective way to boost access would be by increasing the number of stroke centers that provide EVT.

In 2018, Dr. Sarraj and associates reported results from a similar analysis of MEDPAR data that used 30-minute and 60-minute ground-transport times as the criteria for their calculations.

The study received no commercial funding. Dr. Sarraj reported receiving research funding from Stryker Neurovascular outside of this work. One coauthor reported serving in roles for the University of Texas Health System for which the institution has been funded via various industry and government grants, and another coauthor reported receiving research funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, Genentech, and CSL Behring, as well as consulting fees from Frazer Ltd.

mzoler@mdedge.com

SOURCE: Sarraj A et al. Stroke. 2020 Feb 12. doi: 10.1161/STROKEAHA.120.028850.

Clinical trials supporting Food and Drug Adminstration approval of contemporary cancer therapies frequently failed to capture major adverse cardiovascular events (MACE) and, when they did, reported rates 2.6-fold lower than noncancer trials, new research shows.

Overall, 51.3% of trials did not report MACE, with that number reaching 57.6% in trials enrolling patients with baseline cardiovascular disease (CVD).

Nearly 40% of trials did not report any CVD events in follow-up, the authors reported online Feb. 10, 2020, in the Journal of the American College of Cardiology (2020;75:620-8).

“Even in drug classes where there were established or emerging associations with cardiotoxic events, often there were no reported heart events or cardiovascular events across years of follow-up in trials that examined hundreds or even thousands of patients. That was actually pretty surprising,” senior author Daniel Addison, MD, codirector of the cardio-oncology program at the Ohio State University Medical Center, Columbus, said in an interview.

The study was prompted by a series of events that crescendoed when his team was called to the ICU to determine whether a novel targeted agent played a role in the heart decline of a patient with acute myeloid leukemia. “I had a resident ask me a very important question: ‘How do we really know for sure that the trial actually reflects the true risk of heart events?’ to which I told him, ‘it’s difficult to know,’ ” he said.

“I think many of us rely heavily on what we see in the trials, particularly when they make it to the top journals, and quite frankly, we generally take it at face value,” Dr. Addison observed.
 

Lower Rate of Reported Events

The investigators reviewed CV events reported in 97,365 patients (median age, 61 years; 46% female) enrolled in 189 phase 2 and 3 trials supporting FDA approval of 123 anticancer drugs from 1998 to 2018. Biologic, targeted, or immune-based therapies accounted for 72.5% of drug approvals.

Over 148,138 person-years of follow-up (median trial duration, 30 months), there were 1,148 incidents of MACE (375 heart failure, 253 MIs, 180 strokes, 65 atrial fibrillation, 29 coronary revascularizations, and 246 CVD deaths). MACE rates were higher in the intervention group than in the control group (792 vs. 356; P less than .01). Among the 64 trials that excluded patients with baseline CVD, there were 269 incidents of MACE.

To put this finding in context, the researchers examined the reported incidence of MACE among some 6,000 similarly aged participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The overall weighted-average incidence rate was 1,408 per 100,000 person-years among MESA participants, compared with 542 events per 100,000 person-years among oncology trial participants (716 per 100,000 in the intervention arm). This represents a reported-to-expected ratio of 0.38 – a 2.6-fold lower rate of reported events (P less than .001) – and a risk difference of 866.

Further, MACE reporting was lower by a factor of 1.7 among all cancer trial participants irrespective of baseline CVD status (reported-to-expected ratio, 0.56; risk difference, 613; P less than .001).

There was no significant difference in MACE reporting between independent or industry-sponsored trials, the authors report.
 

No malicious intent

“There are likely some that might lean toward not wanting to attribute blame to a new drug when the drug is in a study, but I really think that the leading factor is lack of awareness,” Dr. Addison said. “I’ve talked with several cancer collaborators around the country who run large clinical trials, and I think often, when an event may be brought to someone’s attention, there is a tendency to just write it off as kind of a generic expected event due to age, or just something that’s not really pertinent to the study. So they don’t really focus on it as much.”

“Closer collaboration between cardiologists and cancer physicians is needed to better determine true cardiac risks among patients treated with these drugs.”

Breast cancer oncologist Marc E. Lippman, MD, of Georgetown University Medical Center and Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C., isn’t convinced a lack of awareness is the culprit.

“I don’t agree with that at all,” he said in an interview. “I think there are very, very clear rules and guidelines these days for adverse-event reporting. I think that’s not a very likely explanation – that it’s not on the radar.”

Part of the problem may be that some of the toxicities, particularly cardiovascular, may not emerge for years, he said. Participant screening for the trials also likely removed patients with high cardiovascular risk. “It’s very understandable to me – I’m not saying it’s good particularly – but I think it’s very understandable that, if you’re trying to develop a drug, the last thing you’d want to have is a lot of toxicity that you might have avoided by just being restrictive in who you let into the study,” Dr. Lippman said.

The underreported CVD events may also reflect the rapidly changing profile of cardiovascular toxicities associated with novel anticancer therapies.

“Providers, both cancer and noncancer, generally put cardiotoxicity in the box of anthracyclines and radiation, but particularly over the last decade, we’ve begun to understand it’s well beyond any one class of drugs,” Dr. Addison said.

“I agree completely,” Dr. Lippman said. For example, “the checkpoint inhibitors are so unbelievably different in terms of their toxicities that many people simply didn’t even know what they were getting into at first.”
 

One size does not fit all

Javid Moslehi, MD, director of the cardio-oncology program at Vanderbilt University, Nashville, Tenn., said echocardiography – recommended to detect changes in left ventricular function in patients exposed to anthracyclines or targeted agents like trastuzumab (Herceptin) – isn’t enough to address today’s cancer therapy–related CVD events.

Courtesy Joe Howell

“Initial drugs like anthracyclines or Herceptin in cardio-oncology were associated with systolic cardiac dysfunction, whereas the majority of issues we see in the cardio-oncology clinics today are vascular, metabolic, arrhythmogenic, and inflammatory,” he said in an interview. “Echocardiography misses the big and increasingly complex picture.”

His group, for example, has been studying myocarditis associated with immunotherapies, but none of the clinical trials require screening or surveillance for myocarditis with a cardiac biomarker like troponin.

The group also recently identified 303 deaths in patients exposed to ibrutinib, a drug that revolutionized the treatment of several B-cell malignancies but is associated with higher rates of atrial fibrillation, which is also associated with increased bleeding risk. “So there’s a little bit of a double whammy there, given that we often treat atrial fibrillation with anticoagulation and where we can cause complications in patients,” Dr. Moslehi noted.

Although there needs to be closer collaboration between cardiologists and oncologists on individual trials, cardiologists also have to realize that oncology care has become very personalized, he suggested.

“What’s probably relevant for the breast cancer patient may not be relevant for the prostate cancer patient and their respective treatments,” Dr. Moslehi said. “So if we were to say, ‘every person should get an echo,’ that may be less relevant to the prostate cancer patient where treatments can cause vascular and metabolic perturbations or to the patient treated with immunotherapy who may have myocarditis, where many of the echos can be normal. There’s no one-size-fits-all for these things.”

Wearable technologies like smartwatches could play a role in improving the reporting of CVD events with novel therapies but a lot more research needs to be done to validate these tools, Dr. Addison said. “But as we continue on into the 21st century, this is going to expand and may potentially help us,” he added.

In the interim, better standardization is needed of the cardiovascular events reported in oncology trials, particularly the Common Terminology Criteria for Adverse Events (CTCAE), said Dr. Moslehi, who also serves as chair of the American Heart Association’s subcommittee on cardio-oncology.

“Cardiovascular definitions are not exactly uniform and are not consistent with what we in cardiology consider to be important or relevant,” he said. “So I think there needs to be better standardization of these definitions, specifically within the CTCAE, which is what the oncologists use to identify adverse events.”

In a linked editorial (J Am Coll Cardiol. 2020;75:629-31), Dr. Lippman and cardiologist Nanette Bishopric, MD, of the Medstar Heart and Vascular Institute in Washington, D.C., suggested it may also be time to organize a consortium that can carry out “rigorous multicenter clinical investigations to evaluate the cardiotoxicity of emerging cancer treatments,” similar to the Thrombosis in Myocardial Infarction Study Group.

“The success of this consortium in pioneering and targeting multiple generations of drugs for the treatment of MI, involving tens of thousands of patients and thousands of collaborations across multiple national borders, is a model for how to move forward in providing the new hope of cancer cure without the trade-off of years lost to heart disease,” the editorialists concluded.

The study was supported in part by National Institutes of Health grants, including a K12-CA133250 grant to Dr. Addison. Dr. Bishopric reported being on the scientific board of C&C Biopharma. Dr. Lippman reports being on the board of directors of and holding stock in Seattle Genetics. Dr. Moslehi reported having served on advisory boards for Pfizer, Novartis, Bristol-Myers Squibb, Deciphera, Audentes Pharmaceuticals, Nektar, Takeda, Ipsen, Myokardia, AstraZeneca, GlaxoSmithKline, Intrexon, and Regeneron.

This article first appeared on Medscape.com.

Clinical trials supporting Food and Drug Adminstration approval of contemporary cancer therapies frequently failed to capture major adverse cardiovascular events (MACE) and, when they did, reported rates 2.6-fold lower than noncancer trials, new research shows.

Overall, 51.3% of trials did not report MACE, with that number reaching 57.6% in trials enrolling patients with baseline cardiovascular disease (CVD).

Nearly 40% of trials did not report any CVD events in follow-up, the authors reported online Feb. 10, 2020, in the Journal of the American College of Cardiology (2020;75:620-8).

“Even in drug classes where there were established or emerging associations with cardiotoxic events, often there were no reported heart events or cardiovascular events across years of follow-up in trials that examined hundreds or even thousands of patients. That was actually pretty surprising,” senior author Daniel Addison, MD, codirector of the cardio-oncology program at the Ohio State University Medical Center, Columbus, said in an interview.

The study was prompted by a series of events that crescendoed when his team was called to the ICU to determine whether a novel targeted agent played a role in the heart decline of a patient with acute myeloid leukemia. “I had a resident ask me a very important question: ‘How do we really know for sure that the trial actually reflects the true risk of heart events?’ to which I told him, ‘it’s difficult to know,’ ” he said.

“I think many of us rely heavily on what we see in the trials, particularly when they make it to the top journals, and quite frankly, we generally take it at face value,” Dr. Addison observed.
 

Lower Rate of Reported Events

The investigators reviewed CV events reported in 97,365 patients (median age, 61 years; 46% female) enrolled in 189 phase 2 and 3 trials supporting FDA approval of 123 anticancer drugs from 1998 to 2018. Biologic, targeted, or immune-based therapies accounted for 72.5% of drug approvals.

Over 148,138 person-years of follow-up (median trial duration, 30 months), there were 1,148 incidents of MACE (375 heart failure, 253 MIs, 180 strokes, 65 atrial fibrillation, 29 coronary revascularizations, and 246 CVD deaths). MACE rates were higher in the intervention group than in the control group (792 vs. 356; P less than .01). Among the 64 trials that excluded patients with baseline CVD, there were 269 incidents of MACE.

To put this finding in context, the researchers examined the reported incidence of MACE among some 6,000 similarly aged participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The overall weighted-average incidence rate was 1,408 per 100,000 person-years among MESA participants, compared with 542 events per 100,000 person-years among oncology trial participants (716 per 100,000 in the intervention arm). This represents a reported-to-expected ratio of 0.38 – a 2.6-fold lower rate of reported events (P less than .001) – and a risk difference of 866.

Further, MACE reporting was lower by a factor of 1.7 among all cancer trial participants irrespective of baseline CVD status (reported-to-expected ratio, 0.56; risk difference, 613; P less than .001).

There was no significant difference in MACE reporting between independent or industry-sponsored trials, the authors report.
 

No malicious intent

“There are likely some that might lean toward not wanting to attribute blame to a new drug when the drug is in a study, but I really think that the leading factor is lack of awareness,” Dr. Addison said. “I’ve talked with several cancer collaborators around the country who run large clinical trials, and I think often, when an event may be brought to someone’s attention, there is a tendency to just write it off as kind of a generic expected event due to age, or just something that’s not really pertinent to the study. So they don’t really focus on it as much.”

“Closer collaboration between cardiologists and cancer physicians is needed to better determine true cardiac risks among patients treated with these drugs.”

Breast cancer oncologist Marc E. Lippman, MD, of Georgetown University Medical Center and Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C., isn’t convinced a lack of awareness is the culprit.

“I don’t agree with that at all,” he said in an interview. “I think there are very, very clear rules and guidelines these days for adverse-event reporting. I think that’s not a very likely explanation – that it’s not on the radar.”

Part of the problem may be that some of the toxicities, particularly cardiovascular, may not emerge for years, he said. Participant screening for the trials also likely removed patients with high cardiovascular risk. “It’s very understandable to me – I’m not saying it’s good particularly – but I think it’s very understandable that, if you’re trying to develop a drug, the last thing you’d want to have is a lot of toxicity that you might have avoided by just being restrictive in who you let into the study,” Dr. Lippman said.

The underreported CVD events may also reflect the rapidly changing profile of cardiovascular toxicities associated with novel anticancer therapies.

“Providers, both cancer and noncancer, generally put cardiotoxicity in the box of anthracyclines and radiation, but particularly over the last decade, we’ve begun to understand it’s well beyond any one class of drugs,” Dr. Addison said.

“I agree completely,” Dr. Lippman said. For example, “the checkpoint inhibitors are so unbelievably different in terms of their toxicities that many people simply didn’t even know what they were getting into at first.”
 

One size does not fit all

Javid Moslehi, MD, director of the cardio-oncology program at Vanderbilt University, Nashville, Tenn., said echocardiography – recommended to detect changes in left ventricular function in patients exposed to anthracyclines or targeted agents like trastuzumab (Herceptin) – isn’t enough to address today’s cancer therapy–related CVD events.

Courtesy Joe Howell

“Initial drugs like anthracyclines or Herceptin in cardio-oncology were associated with systolic cardiac dysfunction, whereas the majority of issues we see in the cardio-oncology clinics today are vascular, metabolic, arrhythmogenic, and inflammatory,” he said in an interview. “Echocardiography misses the big and increasingly complex picture.”

His group, for example, has been studying myocarditis associated with immunotherapies, but none of the clinical trials require screening or surveillance for myocarditis with a cardiac biomarker like troponin.

The group also recently identified 303 deaths in patients exposed to ibrutinib, a drug that revolutionized the treatment of several B-cell malignancies but is associated with higher rates of atrial fibrillation, which is also associated with increased bleeding risk. “So there’s a little bit of a double whammy there, given that we often treat atrial fibrillation with anticoagulation and where we can cause complications in patients,” Dr. Moslehi noted.

Although there needs to be closer collaboration between cardiologists and oncologists on individual trials, cardiologists also have to realize that oncology care has become very personalized, he suggested.

“What’s probably relevant for the breast cancer patient may not be relevant for the prostate cancer patient and their respective treatments,” Dr. Moslehi said. “So if we were to say, ‘every person should get an echo,’ that may be less relevant to the prostate cancer patient where treatments can cause vascular and metabolic perturbations or to the patient treated with immunotherapy who may have myocarditis, where many of the echos can be normal. There’s no one-size-fits-all for these things.”

Wearable technologies like smartwatches could play a role in improving the reporting of CVD events with novel therapies but a lot more research needs to be done to validate these tools, Dr. Addison said. “But as we continue on into the 21st century, this is going to expand and may potentially help us,” he added.

In the interim, better standardization is needed of the cardiovascular events reported in oncology trials, particularly the Common Terminology Criteria for Adverse Events (CTCAE), said Dr. Moslehi, who also serves as chair of the American Heart Association’s subcommittee on cardio-oncology.

“Cardiovascular definitions are not exactly uniform and are not consistent with what we in cardiology consider to be important or relevant,” he said. “So I think there needs to be better standardization of these definitions, specifically within the CTCAE, which is what the oncologists use to identify adverse events.”

In a linked editorial (J Am Coll Cardiol. 2020;75:629-31), Dr. Lippman and cardiologist Nanette Bishopric, MD, of the Medstar Heart and Vascular Institute in Washington, D.C., suggested it may also be time to organize a consortium that can carry out “rigorous multicenter clinical investigations to evaluate the cardiotoxicity of emerging cancer treatments,” similar to the Thrombosis in Myocardial Infarction Study Group.

“The success of this consortium in pioneering and targeting multiple generations of drugs for the treatment of MI, involving tens of thousands of patients and thousands of collaborations across multiple national borders, is a model for how to move forward in providing the new hope of cancer cure without the trade-off of years lost to heart disease,” the editorialists concluded.

The study was supported in part by National Institutes of Health grants, including a K12-CA133250 grant to Dr. Addison. Dr. Bishopric reported being on the scientific board of C&C Biopharma. Dr. Lippman reports being on the board of directors of and holding stock in Seattle Genetics. Dr. Moslehi reported having served on advisory boards for Pfizer, Novartis, Bristol-Myers Squibb, Deciphera, Audentes Pharmaceuticals, Nektar, Takeda, Ipsen, Myokardia, AstraZeneca, GlaxoSmithKline, Intrexon, and Regeneron.

This article first appeared on Medscape.com.

Clinical trials supporting Food and Drug Adminstration approval of contemporary cancer therapies frequently failed to capture major adverse cardiovascular events (MACE) and, when they did, reported rates 2.6-fold lower than noncancer trials, new research shows.

Overall, 51.3% of trials did not report MACE, with that number reaching 57.6% in trials enrolling patients with baseline cardiovascular disease (CVD).

Nearly 40% of trials did not report any CVD events in follow-up, the authors reported online Feb. 10, 2020, in the Journal of the American College of Cardiology (2020;75:620-8).

“Even in drug classes where there were established or emerging associations with cardiotoxic events, often there were no reported heart events or cardiovascular events across years of follow-up in trials that examined hundreds or even thousands of patients. That was actually pretty surprising,” senior author Daniel Addison, MD, codirector of the cardio-oncology program at the Ohio State University Medical Center, Columbus, said in an interview.

The study was prompted by a series of events that crescendoed when his team was called to the ICU to determine whether a novel targeted agent played a role in the heart decline of a patient with acute myeloid leukemia. “I had a resident ask me a very important question: ‘How do we really know for sure that the trial actually reflects the true risk of heart events?’ to which I told him, ‘it’s difficult to know,’ ” he said.

“I think many of us rely heavily on what we see in the trials, particularly when they make it to the top journals, and quite frankly, we generally take it at face value,” Dr. Addison observed.
 

Lower Rate of Reported Events

The investigators reviewed CV events reported in 97,365 patients (median age, 61 years; 46% female) enrolled in 189 phase 2 and 3 trials supporting FDA approval of 123 anticancer drugs from 1998 to 2018. Biologic, targeted, or immune-based therapies accounted for 72.5% of drug approvals.

Over 148,138 person-years of follow-up (median trial duration, 30 months), there were 1,148 incidents of MACE (375 heart failure, 253 MIs, 180 strokes, 65 atrial fibrillation, 29 coronary revascularizations, and 246 CVD deaths). MACE rates were higher in the intervention group than in the control group (792 vs. 356; P less than .01). Among the 64 trials that excluded patients with baseline CVD, there were 269 incidents of MACE.

To put this finding in context, the researchers examined the reported incidence of MACE among some 6,000 similarly aged participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The overall weighted-average incidence rate was 1,408 per 100,000 person-years among MESA participants, compared with 542 events per 100,000 person-years among oncology trial participants (716 per 100,000 in the intervention arm). This represents a reported-to-expected ratio of 0.38 – a 2.6-fold lower rate of reported events (P less than .001) – and a risk difference of 866.

Further, MACE reporting was lower by a factor of 1.7 among all cancer trial participants irrespective of baseline CVD status (reported-to-expected ratio, 0.56; risk difference, 613; P less than .001).

There was no significant difference in MACE reporting between independent or industry-sponsored trials, the authors report.
 

No malicious intent

“There are likely some that might lean toward not wanting to attribute blame to a new drug when the drug is in a study, but I really think that the leading factor is lack of awareness,” Dr. Addison said. “I’ve talked with several cancer collaborators around the country who run large clinical trials, and I think often, when an event may be brought to someone’s attention, there is a tendency to just write it off as kind of a generic expected event due to age, or just something that’s not really pertinent to the study. So they don’t really focus on it as much.”

“Closer collaboration between cardiologists and cancer physicians is needed to better determine true cardiac risks among patients treated with these drugs.”

Breast cancer oncologist Marc E. Lippman, MD, of Georgetown University Medical Center and Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C., isn’t convinced a lack of awareness is the culprit.

“I don’t agree with that at all,” he said in an interview. “I think there are very, very clear rules and guidelines these days for adverse-event reporting. I think that’s not a very likely explanation – that it’s not on the radar.”

Part of the problem may be that some of the toxicities, particularly cardiovascular, may not emerge for years, he said. Participant screening for the trials also likely removed patients with high cardiovascular risk. “It’s very understandable to me – I’m not saying it’s good particularly – but I think it’s very understandable that, if you’re trying to develop a drug, the last thing you’d want to have is a lot of toxicity that you might have avoided by just being restrictive in who you let into the study,” Dr. Lippman said.

The underreported CVD events may also reflect the rapidly changing profile of cardiovascular toxicities associated with novel anticancer therapies.

“Providers, both cancer and noncancer, generally put cardiotoxicity in the box of anthracyclines and radiation, but particularly over the last decade, we’ve begun to understand it’s well beyond any one class of drugs,” Dr. Addison said.

“I agree completely,” Dr. Lippman said. For example, “the checkpoint inhibitors are so unbelievably different in terms of their toxicities that many people simply didn’t even know what they were getting into at first.”
 

One size does not fit all

Javid Moslehi, MD, director of the cardio-oncology program at Vanderbilt University, Nashville, Tenn., said echocardiography – recommended to detect changes in left ventricular function in patients exposed to anthracyclines or targeted agents like trastuzumab (Herceptin) – isn’t enough to address today’s cancer therapy–related CVD events.

Courtesy Joe Howell

“Initial drugs like anthracyclines or Herceptin in cardio-oncology were associated with systolic cardiac dysfunction, whereas the majority of issues we see in the cardio-oncology clinics today are vascular, metabolic, arrhythmogenic, and inflammatory,” he said in an interview. “Echocardiography misses the big and increasingly complex picture.”

His group, for example, has been studying myocarditis associated with immunotherapies, but none of the clinical trials require screening or surveillance for myocarditis with a cardiac biomarker like troponin.

The group also recently identified 303 deaths in patients exposed to ibrutinib, a drug that revolutionized the treatment of several B-cell malignancies but is associated with higher rates of atrial fibrillation, which is also associated with increased bleeding risk. “So there’s a little bit of a double whammy there, given that we often treat atrial fibrillation with anticoagulation and where we can cause complications in patients,” Dr. Moslehi noted.

Although there needs to be closer collaboration between cardiologists and oncologists on individual trials, cardiologists also have to realize that oncology care has become very personalized, he suggested.

“What’s probably relevant for the breast cancer patient may not be relevant for the prostate cancer patient and their respective treatments,” Dr. Moslehi said. “So if we were to say, ‘every person should get an echo,’ that may be less relevant to the prostate cancer patient where treatments can cause vascular and metabolic perturbations or to the patient treated with immunotherapy who may have myocarditis, where many of the echos can be normal. There’s no one-size-fits-all for these things.”

Wearable technologies like smartwatches could play a role in improving the reporting of CVD events with novel therapies but a lot more research needs to be done to validate these tools, Dr. Addison said. “But as we continue on into the 21st century, this is going to expand and may potentially help us,” he added.

In the interim, better standardization is needed of the cardiovascular events reported in oncology trials, particularly the Common Terminology Criteria for Adverse Events (CTCAE), said Dr. Moslehi, who also serves as chair of the American Heart Association’s subcommittee on cardio-oncology.

“Cardiovascular definitions are not exactly uniform and are not consistent with what we in cardiology consider to be important or relevant,” he said. “So I think there needs to be better standardization of these definitions, specifically within the CTCAE, which is what the oncologists use to identify adverse events.”

In a linked editorial (J Am Coll Cardiol. 2020;75:629-31), Dr. Lippman and cardiologist Nanette Bishopric, MD, of the Medstar Heart and Vascular Institute in Washington, D.C., suggested it may also be time to organize a consortium that can carry out “rigorous multicenter clinical investigations to evaluate the cardiotoxicity of emerging cancer treatments,” similar to the Thrombosis in Myocardial Infarction Study Group.

“The success of this consortium in pioneering and targeting multiple generations of drugs for the treatment of MI, involving tens of thousands of patients and thousands of collaborations across multiple national borders, is a model for how to move forward in providing the new hope of cancer cure without the trade-off of years lost to heart disease,” the editorialists concluded.

The study was supported in part by National Institutes of Health grants, including a K12-CA133250 grant to Dr. Addison. Dr. Bishopric reported being on the scientific board of C&C Biopharma. Dr. Lippman reports being on the board of directors of and holding stock in Seattle Genetics. Dr. Moslehi reported having served on advisory boards for Pfizer, Novartis, Bristol-Myers Squibb, Deciphera, Audentes Pharmaceuticals, Nektar, Takeda, Ipsen, Myokardia, AstraZeneca, GlaxoSmithKline, Intrexon, and Regeneron.

This article first appeared on Medscape.com.

In its first year of operation, a mobile stroke unit in Melbourne demonstrated substantial savings in time to commencement of both thrombolysis and endovascular thrombectomy (EVT), results from a prospective study showed.

“While previously published data from MSU [mobile stroke unit] services in Europe and North America show substantial reductions in time to thrombolysis of approximately 30-45 minutes, little is known about the clinical impact on EVT,” first author Henry Zhao, MBBS, and colleagues wrote in a study published in Stroke.

Launched in November 2017, the Melbourne MSU is based at a large comprehensive stroke center and operates with a 20-km radius, servicing about 1.7 million people within the city of Melbourne. It is staffed with an onboard neurologist or senior stroke fellow who provides primary assessment and treatment decisions, a stroke advanced practice nurse who provides clinical support and treatment administration, a clinician who provides CT imaging, and advanced life support and mobile intensive care paramedics who provide transport logistics and paramedicine support. For the current analysis, MSU patients who received reperfusion therapy were compared with control patients presenting to metropolitan Melbourne stroke units via standard ambulance within MSU operating hours. The primary outcome was median time difference in first ambulance dispatch to treatment, which the researchers used quantile regression analysis to determine. Time savings were subsequently converted to disability-adjusted life years (DALY) avoiding using published estimates.

Dr. Zhao of the Melbourne Brain Centre and department of neurology at Royal Melbourne Hospital and his colleagues reported that, in its first year of operation, the Melbourne MSU administered prehospital thrombolysis to 100 patients with a mean age of nearly 74 years. More than half of the patients (62%) were male. Compared with controls, the median time savings per MSU patient was 26 minutes for dispatch to hospital arrival and 15 minutes for hospital arrival to thrombolysis (P less than .0010 for both associations). The calculated overall time saving from dispatch to thrombolysis was 42.5 minutes.

Over the same time period, 41 MSU patients with a mean age of 76 years received EVT dispatch-to-treatment time saving of 51 minutes (P less than 0.001). This included a median time saving of 17 minutes for EVT hospital arrival to arterial puncture for MSU patients (P = .001). Overall estimated median DALYs saved through earlier provision of reperfusion therapies were 20.9 for thrombolysis and 24.6 for EVT.

“The benefit in EVT patients was primarily driven by prehospital MSU diagnosis of large vessel occlusion, which enabled bypass of a local non-EVT center directly to a comprehensive stroke center in almost 50% of patients with large vessel occlusion,” the researchers wrote. “Even when patients were located close to an EVT center, MSU pre-notification and facilitated workflows achieved a reduction in hospital arrival to arterial puncture by one-third. Furthermore, the time saving was seen despite the majority of EVT patients receiving repeat imaging in hospital to visualize the extracranial circulation.”

The study is scheduled to be presented at the International Stroke Conference on Feb. 20.

The Melbourne MSU received funding from the Australian Commonwealth Government, Victorian State Government, Royal Melbourne Hospital Neurosciences Foundation, Stroke Foundation, the Florey Institute of Neurosciences and Mental Health, the University of Melbourne, Boehringer Ingelheim, and private donation. Dr. Zhao disclosed that he has received grants from the Australian Commonwealth Government and the University of Melbourne and personal fees from Boehringer Ingelheim.

dbrunk@mdedge.com

SOURCE: Zhao H et al. Stroke. 2020 Feb 12. doi: 10.1161/strokeaha.119.027843.

In its first year of operation, a mobile stroke unit in Melbourne demonstrated substantial savings in time to commencement of both thrombolysis and endovascular thrombectomy (EVT), results from a prospective study showed.

“While previously published data from MSU [mobile stroke unit] services in Europe and North America show substantial reductions in time to thrombolysis of approximately 30-45 minutes, little is known about the clinical impact on EVT,” first author Henry Zhao, MBBS, and colleagues wrote in a study published in Stroke.

Launched in November 2017, the Melbourne MSU is based at a large comprehensive stroke center and operates with a 20-km radius, servicing about 1.7 million people within the city of Melbourne. It is staffed with an onboard neurologist or senior stroke fellow who provides primary assessment and treatment decisions, a stroke advanced practice nurse who provides clinical support and treatment administration, a clinician who provides CT imaging, and advanced life support and mobile intensive care paramedics who provide transport logistics and paramedicine support. For the current analysis, MSU patients who received reperfusion therapy were compared with control patients presenting to metropolitan Melbourne stroke units via standard ambulance within MSU operating hours. The primary outcome was median time difference in first ambulance dispatch to treatment, which the researchers used quantile regression analysis to determine. Time savings were subsequently converted to disability-adjusted life years (DALY) avoiding using published estimates.

Dr. Zhao of the Melbourne Brain Centre and department of neurology at Royal Melbourne Hospital and his colleagues reported that, in its first year of operation, the Melbourne MSU administered prehospital thrombolysis to 100 patients with a mean age of nearly 74 years. More than half of the patients (62%) were male. Compared with controls, the median time savings per MSU patient was 26 minutes for dispatch to hospital arrival and 15 minutes for hospital arrival to thrombolysis (P less than .0010 for both associations). The calculated overall time saving from dispatch to thrombolysis was 42.5 minutes.

Over the same time period, 41 MSU patients with a mean age of 76 years received EVT dispatch-to-treatment time saving of 51 minutes (P less than 0.001). This included a median time saving of 17 minutes for EVT hospital arrival to arterial puncture for MSU patients (P = .001). Overall estimated median DALYs saved through earlier provision of reperfusion therapies were 20.9 for thrombolysis and 24.6 for EVT.

“The benefit in EVT patients was primarily driven by prehospital MSU diagnosis of large vessel occlusion, which enabled bypass of a local non-EVT center directly to a comprehensive stroke center in almost 50% of patients with large vessel occlusion,” the researchers wrote. “Even when patients were located close to an EVT center, MSU pre-notification and facilitated workflows achieved a reduction in hospital arrival to arterial puncture by one-third. Furthermore, the time saving was seen despite the majority of EVT patients receiving repeat imaging in hospital to visualize the extracranial circulation.”

The study is scheduled to be presented at the International Stroke Conference on Feb. 20.

The Melbourne MSU received funding from the Australian Commonwealth Government, Victorian State Government, Royal Melbourne Hospital Neurosciences Foundation, Stroke Foundation, the Florey Institute of Neurosciences and Mental Health, the University of Melbourne, Boehringer Ingelheim, and private donation. Dr. Zhao disclosed that he has received grants from the Australian Commonwealth Government and the University of Melbourne and personal fees from Boehringer Ingelheim.

dbrunk@mdedge.com

SOURCE: Zhao H et al. Stroke. 2020 Feb 12. doi: 10.1161/strokeaha.119.027843.

In its first year of operation, a mobile stroke unit in Melbourne demonstrated substantial savings in time to commencement of both thrombolysis and endovascular thrombectomy (EVT), results from a prospective study showed.

“While previously published data from MSU [mobile stroke unit] services in Europe and North America show substantial reductions in time to thrombolysis of approximately 30-45 minutes, little is known about the clinical impact on EVT,” first author Henry Zhao, MBBS, and colleagues wrote in a study published in Stroke.

Launched in November 2017, the Melbourne MSU is based at a large comprehensive stroke center and operates with a 20-km radius, servicing about 1.7 million people within the city of Melbourne. It is staffed with an onboard neurologist or senior stroke fellow who provides primary assessment and treatment decisions, a stroke advanced practice nurse who provides clinical support and treatment administration, a clinician who provides CT imaging, and advanced life support and mobile intensive care paramedics who provide transport logistics and paramedicine support. For the current analysis, MSU patients who received reperfusion therapy were compared with control patients presenting to metropolitan Melbourne stroke units via standard ambulance within MSU operating hours. The primary outcome was median time difference in first ambulance dispatch to treatment, which the researchers used quantile regression analysis to determine. Time savings were subsequently converted to disability-adjusted life years (DALY) avoiding using published estimates.

Dr. Zhao of the Melbourne Brain Centre and department of neurology at Royal Melbourne Hospital and his colleagues reported that, in its first year of operation, the Melbourne MSU administered prehospital thrombolysis to 100 patients with a mean age of nearly 74 years. More than half of the patients (62%) were male. Compared with controls, the median time savings per MSU patient was 26 minutes for dispatch to hospital arrival and 15 minutes for hospital arrival to thrombolysis (P less than .0010 for both associations). The calculated overall time saving from dispatch to thrombolysis was 42.5 minutes.

Over the same time period, 41 MSU patients with a mean age of 76 years received EVT dispatch-to-treatment time saving of 51 minutes (P less than 0.001). This included a median time saving of 17 minutes for EVT hospital arrival to arterial puncture for MSU patients (P = .001). Overall estimated median DALYs saved through earlier provision of reperfusion therapies were 20.9 for thrombolysis and 24.6 for EVT.

“The benefit in EVT patients was primarily driven by prehospital MSU diagnosis of large vessel occlusion, which enabled bypass of a local non-EVT center directly to a comprehensive stroke center in almost 50% of patients with large vessel occlusion,” the researchers wrote. “Even when patients were located close to an EVT center, MSU pre-notification and facilitated workflows achieved a reduction in hospital arrival to arterial puncture by one-third. Furthermore, the time saving was seen despite the majority of EVT patients receiving repeat imaging in hospital to visualize the extracranial circulation.”

The study is scheduled to be presented at the International Stroke Conference on Feb. 20.

The Melbourne MSU received funding from the Australian Commonwealth Government, Victorian State Government, Royal Melbourne Hospital Neurosciences Foundation, Stroke Foundation, the Florey Institute of Neurosciences and Mental Health, the University of Melbourne, Boehringer Ingelheim, and private donation. Dr. Zhao disclosed that he has received grants from the Australian Commonwealth Government and the University of Melbourne and personal fees from Boehringer Ingelheim.

dbrunk@mdedge.com

SOURCE: Zhao H et al. Stroke. 2020 Feb 12. doi: 10.1161/strokeaha.119.027843.

The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.

Gregory Twachtman/MDedge News

The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.

The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.

“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.

Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.

“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.

She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.

With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.

In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.

Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.

She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.

“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.

Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.

gtwachtman@mdedge.com

The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.

Gregory Twachtman/MDedge News

The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.

The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.

“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.

Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.

“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.

She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.

With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.

In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.

Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.

She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.

“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.

Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.

gtwachtman@mdedge.com

The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.

Gregory Twachtman/MDedge News

The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.

The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.

“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.

Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.

“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.

She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.

With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.

In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.

Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.

She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.

“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.

Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.

gtwachtman@mdedge.com

Fear of negative events can drive changes in activity levels among patients with hemophilia A, results of the HemACTIVE study suggest.

Patients were more likely to adjust their level of physical activity due to fear of bleeding and joint damage rather than previously experienced bleeding or joint damage.

However, past experience was more likely than fear to make patients stop physical activities altogether.

Mark Skinner, of the Institute for Policy Advancement in Washington, D.C., and colleagues presented these findings in a poster from the annual congress of the European Association for Haemophilia and Allied Disorders.

Mr. Skinner, who is a hemophilia patient himself, said the goal of the HemACTIVE study is to better understand how hemophilia affects patients’ lives.

“We wanted to understand the limitations, challenges, and compromises of individuals living with hemophilia,” Mr. Skinner said. “What has motivated them or prevented them from living more full, active lives doing the kind of work, leisure, and social activities that those without hemophilia do? Is it treatment choice, is it satisfaction with treatment, is it fear?

“We wanted to do a comprehensive study that really looked at the intersection of treatment adherence and satisfaction, the emotional components that relate to those decisions, and the challenges and compromises so that we could better identify what we need to consider as patients think about either changing their therapy or changing their treatment regimen on existing therapy.”

Previous results from the HemACTIVE study showed that, although activity levels differed among hemophilia patients, all patients surveyed wanted greater activity levels, better protection from bleeding, better pain relief, and less-frequent infusions (EAHAD 2019, Abstract P084). In addition, patients who used factor VIII products with an extended half-life were more active and more likely to adhere to their prescribed treatment (ISTH 2019, Abstract PB0210).

The results reported at EAHAD 2020 focus on patients’ reasons for modifying physical activity. Patients and caregivers completed a screening phone interview, followed by a 25-minute, web-based questionnaire on patient activity.

There were 275 respondents – 194 patients with hemophilia A and 81 caregivers – from Canada, France, Germany, Italy, and the United States. Patients had severe (61%) or moderate (39%) hemophilia A, and most (67%) were receiving prophylaxis.

Most patients (70%) were “active” or “extremely/very active,” 77% of patients adjusted their activities because of their hemophilia, and nearly half of patients stopped activities because of their disease.

Fear drives adjustments in activity

Patients were sometimes more likely to adjust their activities based on fear of experiencing an event, as opposed to previously experiencing that event.

Specifically, 44% of patients adjusted their activities due to fear of joint damage, compared with 36% of patients who made adjustments because of past significant joint damage.

Similarly, 41% of patients adjusted activities due to fear of breakthrough bleeds, compared with 36% of patients who made adjustments because of past experience with bleeds and 25% who made adjustments because of significant past bleeds.

On the other hand, a similar percentage of patients adjusted activities because of past experience with pain (43%) and fear of pain (41%). And a similar percentage of patients adjusted activities because of existing joint damage restrictions (35%) and fear of joint deterioration (32%).

Past experience prompts discontinuation of activity

Overall, 47% of patients said anxiety was the most common emotional reason for stopping physical activities. However, patients were consistently more likely to stop activities because of past experience rather than fear or anxiety.

Specifically, 50% of patients stopped activities because of significant past joint damage, 46% stopped because of developing joint problems, and 38% stopped due to fear of joint damage.

More patients stopped activities because of significant past bleeds (41%) rather than fear of breakthrough bleeds (26%). More patients stopped activities because they developed chronic pain (38%) rather than fear of pain (less than 15%). And more patients stopped activities because of existing joint damage restrictions (62%) rather than fear of joint damage (34%).
 

Applying results to practice: Changing the conversation

Ideally, these findings would be used to promote individualized treatment of hemophilia driven by patients’ goals, Mr. Skinner said. By better understanding patients’ feelings and motivations, clinicians may devise more personalized treatment regimens that align with patients’ goals and improve their quality of life.

Rather than adjusting treatment based only on “hard metrics” such as bleeding events, “we need to take a more holistic approach to looking at outcomes that are more important to patients,” Mr. Skinner said. This type of approach is particularly important to Mr. Skinner as someone who has severe hemophilia A.

“Because hemophilia is a life-long disease, and you’re born with it, you make conscious or unconscious adaptations throughout your life,” he explained. “Your expectations or aspirations adjust to what you’ve been told you can or cannot do because of your hemophilia. The choices I made for my career, where I live, the type of vacations I go on, the type of sports I participate in have all been limited over the course of time, which has meant that I’ve made compromises. There are a lot of individuals with hemophilia who are making decisions that are not what their life goals are.

“What this research helps me understand is that we can change the conversation and build it around an individual patient and understand what their aspirations are. If a clinician understands what I’m wanting to achieve in life … we can build a treatment regime around helping me achieve those goals. That is known to improve adherence.

“The goal, really, is to have hemophilia as a secondary consideration. Instead of saying: ‘You have hemophilia, so these are the options available to you,’ you can say, ‘what is it that you would like to achieve, and then we’ll figure out how your treatment for hemophilia can be adjusted to help you achieve those goals.’ It may sound like a nuance, but it really is reversing the conversation. The goal setting first versus your disease comes first.”

The HemACTIVE study was supported by Bayer. Mr. Skinner disclosed relationships with Bayer and other pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Skinner M et al. EAHAD 2020, Abstract P304.

Fear of negative events can drive changes in activity levels among patients with hemophilia A, results of the HemACTIVE study suggest.

Patients were more likely to adjust their level of physical activity due to fear of bleeding and joint damage rather than previously experienced bleeding or joint damage.

However, past experience was more likely than fear to make patients stop physical activities altogether.

Mark Skinner, of the Institute for Policy Advancement in Washington, D.C., and colleagues presented these findings in a poster from the annual congress of the European Association for Haemophilia and Allied Disorders.

Mr. Skinner, who is a hemophilia patient himself, said the goal of the HemACTIVE study is to better understand how hemophilia affects patients’ lives.

“We wanted to understand the limitations, challenges, and compromises of individuals living with hemophilia,” Mr. Skinner said. “What has motivated them or prevented them from living more full, active lives doing the kind of work, leisure, and social activities that those without hemophilia do? Is it treatment choice, is it satisfaction with treatment, is it fear?

“We wanted to do a comprehensive study that really looked at the intersection of treatment adherence and satisfaction, the emotional components that relate to those decisions, and the challenges and compromises so that we could better identify what we need to consider as patients think about either changing their therapy or changing their treatment regimen on existing therapy.”

Previous results from the HemACTIVE study showed that, although activity levels differed among hemophilia patients, all patients surveyed wanted greater activity levels, better protection from bleeding, better pain relief, and less-frequent infusions (EAHAD 2019, Abstract P084). In addition, patients who used factor VIII products with an extended half-life were more active and more likely to adhere to their prescribed treatment (ISTH 2019, Abstract PB0210).

The results reported at EAHAD 2020 focus on patients’ reasons for modifying physical activity. Patients and caregivers completed a screening phone interview, followed by a 25-minute, web-based questionnaire on patient activity.

There were 275 respondents – 194 patients with hemophilia A and 81 caregivers – from Canada, France, Germany, Italy, and the United States. Patients had severe (61%) or moderate (39%) hemophilia A, and most (67%) were receiving prophylaxis.

Most patients (70%) were “active” or “extremely/very active,” 77% of patients adjusted their activities because of their hemophilia, and nearly half of patients stopped activities because of their disease.

Fear drives adjustments in activity

Patients were sometimes more likely to adjust their activities based on fear of experiencing an event, as opposed to previously experiencing that event.

Specifically, 44% of patients adjusted their activities due to fear of joint damage, compared with 36% of patients who made adjustments because of past significant joint damage.

Similarly, 41% of patients adjusted activities due to fear of breakthrough bleeds, compared with 36% of patients who made adjustments because of past experience with bleeds and 25% who made adjustments because of significant past bleeds.

On the other hand, a similar percentage of patients adjusted activities because of past experience with pain (43%) and fear of pain (41%). And a similar percentage of patients adjusted activities because of existing joint damage restrictions (35%) and fear of joint deterioration (32%).

Past experience prompts discontinuation of activity

Overall, 47% of patients said anxiety was the most common emotional reason for stopping physical activities. However, patients were consistently more likely to stop activities because of past experience rather than fear or anxiety.

Specifically, 50% of patients stopped activities because of significant past joint damage, 46% stopped because of developing joint problems, and 38% stopped due to fear of joint damage.

More patients stopped activities because of significant past bleeds (41%) rather than fear of breakthrough bleeds (26%). More patients stopped activities because they developed chronic pain (38%) rather than fear of pain (less than 15%). And more patients stopped activities because of existing joint damage restrictions (62%) rather than fear of joint damage (34%).
 

Applying results to practice: Changing the conversation

Ideally, these findings would be used to promote individualized treatment of hemophilia driven by patients’ goals, Mr. Skinner said. By better understanding patients’ feelings and motivations, clinicians may devise more personalized treatment regimens that align with patients’ goals and improve their quality of life.

Rather than adjusting treatment based only on “hard metrics” such as bleeding events, “we need to take a more holistic approach to looking at outcomes that are more important to patients,” Mr. Skinner said. This type of approach is particularly important to Mr. Skinner as someone who has severe hemophilia A.

“Because hemophilia is a life-long disease, and you’re born with it, you make conscious or unconscious adaptations throughout your life,” he explained. “Your expectations or aspirations adjust to what you’ve been told you can or cannot do because of your hemophilia. The choices I made for my career, where I live, the type of vacations I go on, the type of sports I participate in have all been limited over the course of time, which has meant that I’ve made compromises. There are a lot of individuals with hemophilia who are making decisions that are not what their life goals are.

“What this research helps me understand is that we can change the conversation and build it around an individual patient and understand what their aspirations are. If a clinician understands what I’m wanting to achieve in life … we can build a treatment regime around helping me achieve those goals. That is known to improve adherence.

“The goal, really, is to have hemophilia as a secondary consideration. Instead of saying: ‘You have hemophilia, so these are the options available to you,’ you can say, ‘what is it that you would like to achieve, and then we’ll figure out how your treatment for hemophilia can be adjusted to help you achieve those goals.’ It may sound like a nuance, but it really is reversing the conversation. The goal setting first versus your disease comes first.”

The HemACTIVE study was supported by Bayer. Mr. Skinner disclosed relationships with Bayer and other pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Skinner M et al. EAHAD 2020, Abstract P304.

Fear of negative events can drive changes in activity levels among patients with hemophilia A, results of the HemACTIVE study suggest.

Patients were more likely to adjust their level of physical activity due to fear of bleeding and joint damage rather than previously experienced bleeding or joint damage.

However, past experience was more likely than fear to make patients stop physical activities altogether.

Mark Skinner, of the Institute for Policy Advancement in Washington, D.C., and colleagues presented these findings in a poster from the annual congress of the European Association for Haemophilia and Allied Disorders.

Mr. Skinner, who is a hemophilia patient himself, said the goal of the HemACTIVE study is to better understand how hemophilia affects patients’ lives.

“We wanted to understand the limitations, challenges, and compromises of individuals living with hemophilia,” Mr. Skinner said. “What has motivated them or prevented them from living more full, active lives doing the kind of work, leisure, and social activities that those without hemophilia do? Is it treatment choice, is it satisfaction with treatment, is it fear?

“We wanted to do a comprehensive study that really looked at the intersection of treatment adherence and satisfaction, the emotional components that relate to those decisions, and the challenges and compromises so that we could better identify what we need to consider as patients think about either changing their therapy or changing their treatment regimen on existing therapy.”

Previous results from the HemACTIVE study showed that, although activity levels differed among hemophilia patients, all patients surveyed wanted greater activity levels, better protection from bleeding, better pain relief, and less-frequent infusions (EAHAD 2019, Abstract P084). In addition, patients who used factor VIII products with an extended half-life were more active and more likely to adhere to their prescribed treatment (ISTH 2019, Abstract PB0210).

The results reported at EAHAD 2020 focus on patients’ reasons for modifying physical activity. Patients and caregivers completed a screening phone interview, followed by a 25-minute, web-based questionnaire on patient activity.

There were 275 respondents – 194 patients with hemophilia A and 81 caregivers – from Canada, France, Germany, Italy, and the United States. Patients had severe (61%) or moderate (39%) hemophilia A, and most (67%) were receiving prophylaxis.

Most patients (70%) were “active” or “extremely/very active,” 77% of patients adjusted their activities because of their hemophilia, and nearly half of patients stopped activities because of their disease.

Fear drives adjustments in activity

Patients were sometimes more likely to adjust their activities based on fear of experiencing an event, as opposed to previously experiencing that event.

Specifically, 44% of patients adjusted their activities due to fear of joint damage, compared with 36% of patients who made adjustments because of past significant joint damage.

Similarly, 41% of patients adjusted activities due to fear of breakthrough bleeds, compared with 36% of patients who made adjustments because of past experience with bleeds and 25% who made adjustments because of significant past bleeds.

On the other hand, a similar percentage of patients adjusted activities because of past experience with pain (43%) and fear of pain (41%). And a similar percentage of patients adjusted activities because of existing joint damage restrictions (35%) and fear of joint deterioration (32%).

Past experience prompts discontinuation of activity

Overall, 47% of patients said anxiety was the most common emotional reason for stopping physical activities. However, patients were consistently more likely to stop activities because of past experience rather than fear or anxiety.

Specifically, 50% of patients stopped activities because of significant past joint damage, 46% stopped because of developing joint problems, and 38% stopped due to fear of joint damage.

More patients stopped activities because of significant past bleeds (41%) rather than fear of breakthrough bleeds (26%). More patients stopped activities because they developed chronic pain (38%) rather than fear of pain (less than 15%). And more patients stopped activities because of existing joint damage restrictions (62%) rather than fear of joint damage (34%).
 

Applying results to practice: Changing the conversation

Ideally, these findings would be used to promote individualized treatment of hemophilia driven by patients’ goals, Mr. Skinner said. By better understanding patients’ feelings and motivations, clinicians may devise more personalized treatment regimens that align with patients’ goals and improve their quality of life.

Rather than adjusting treatment based only on “hard metrics” such as bleeding events, “we need to take a more holistic approach to looking at outcomes that are more important to patients,” Mr. Skinner said. This type of approach is particularly important to Mr. Skinner as someone who has severe hemophilia A.

“Because hemophilia is a life-long disease, and you’re born with it, you make conscious or unconscious adaptations throughout your life,” he explained. “Your expectations or aspirations adjust to what you’ve been told you can or cannot do because of your hemophilia. The choices I made for my career, where I live, the type of vacations I go on, the type of sports I participate in have all been limited over the course of time, which has meant that I’ve made compromises. There are a lot of individuals with hemophilia who are making decisions that are not what their life goals are.

“What this research helps me understand is that we can change the conversation and build it around an individual patient and understand what their aspirations are. If a clinician understands what I’m wanting to achieve in life … we can build a treatment regime around helping me achieve those goals. That is known to improve adherence.

“The goal, really, is to have hemophilia as a secondary consideration. Instead of saying: ‘You have hemophilia, so these are the options available to you,’ you can say, ‘what is it that you would like to achieve, and then we’ll figure out how your treatment for hemophilia can be adjusted to help you achieve those goals.’ It may sound like a nuance, but it really is reversing the conversation. The goal setting first versus your disease comes first.”

The HemACTIVE study was supported by Bayer. Mr. Skinner disclosed relationships with Bayer and other pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Skinner M et al. EAHAD 2020, Abstract P304.

It is too early yet to explicitly determine the effects of the Novel Coronavirus (2019-nCoV) on pregnant women and their fetuses. This is a critical concern, because members of the coronavirus family, which have been responsible for previous outbreaks of severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV), have demonstrated their ability to cause severe complications during pregnancy, according to researchers.

The SARS virus outbreak and the more recent MERS virus outbreak provide the best available models with which to examine the potential impact of 2019-nCoV on pregnancy, according to a letter published online in the Lancet.

Twelve pregnant women were infected with SARS-CoV during the 2002-2003 pandemic. Three (25%) of these women died during pregnancy. Overall, four of seven women had a miscarriage in the first trimester. In the second or third trimester, two out of five women had fetal growth restriction, and four of the five had preterm birth (one case was spontaneous and three were induced because of the maternal condition), according to corresponding author David Baud, MD, PhD, of the maternal-fetal and obstetrics research unit at Lausanne (Switzerland) University Hospital, and colleagues.

A review of 11 pregnant women infected with the virus showed that 10 women (91%) presented with adverse outcomes. Six (55%) neonates were admitted to the ICU; three (27%) died. Two neonates were delivered prematurely because their mothers developed severe respiratory failure.

Because 2019-nCov has a potential for similar behavior, “we recommend systematic screening of any suspected 2019-nCoV infection during pregnancy. If 2019-nCoV infection during pregnancy is confirmed, extended follow-up should be recommended for mothers and their fetuses,” concluded Dr. Baud and colleagues.

Dr. Baud and associates are known for their previous research on the impacts of the Zika virus on pregnancy. They reported having no competing interests.

mlesney@mdedge.com

SOURCE: Baud D et al. Lancet. 2020 Feb 6. doi: 10.1016/S0140-6736(20)30311-1.

It is too early yet to explicitly determine the effects of the Novel Coronavirus (2019-nCoV) on pregnant women and their fetuses. This is a critical concern, because members of the coronavirus family, which have been responsible for previous outbreaks of severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV), have demonstrated their ability to cause severe complications during pregnancy, according to researchers.

The SARS virus outbreak and the more recent MERS virus outbreak provide the best available models with which to examine the potential impact of 2019-nCoV on pregnancy, according to a letter published online in the Lancet.

Twelve pregnant women were infected with SARS-CoV during the 2002-2003 pandemic. Three (25%) of these women died during pregnancy. Overall, four of seven women had a miscarriage in the first trimester. In the second or third trimester, two out of five women had fetal growth restriction, and four of the five had preterm birth (one case was spontaneous and three were induced because of the maternal condition), according to corresponding author David Baud, MD, PhD, of the maternal-fetal and obstetrics research unit at Lausanne (Switzerland) University Hospital, and colleagues.

A review of 11 pregnant women infected with the virus showed that 10 women (91%) presented with adverse outcomes. Six (55%) neonates were admitted to the ICU; three (27%) died. Two neonates were delivered prematurely because their mothers developed severe respiratory failure.

Because 2019-nCov has a potential for similar behavior, “we recommend systematic screening of any suspected 2019-nCoV infection during pregnancy. If 2019-nCoV infection during pregnancy is confirmed, extended follow-up should be recommended for mothers and their fetuses,” concluded Dr. Baud and colleagues.

Dr. Baud and associates are known for their previous research on the impacts of the Zika virus on pregnancy. They reported having no competing interests.

mlesney@mdedge.com

SOURCE: Baud D et al. Lancet. 2020 Feb 6. doi: 10.1016/S0140-6736(20)30311-1.

It is too early yet to explicitly determine the effects of the Novel Coronavirus (2019-nCoV) on pregnant women and their fetuses. This is a critical concern, because members of the coronavirus family, which have been responsible for previous outbreaks of severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV), have demonstrated their ability to cause severe complications during pregnancy, according to researchers.

The SARS virus outbreak and the more recent MERS virus outbreak provide the best available models with which to examine the potential impact of 2019-nCoV on pregnancy, according to a letter published online in the Lancet.

Twelve pregnant women were infected with SARS-CoV during the 2002-2003 pandemic. Three (25%) of these women died during pregnancy. Overall, four of seven women had a miscarriage in the first trimester. In the second or third trimester, two out of five women had fetal growth restriction, and four of the five had preterm birth (one case was spontaneous and three were induced because of the maternal condition), according to corresponding author David Baud, MD, PhD, of the maternal-fetal and obstetrics research unit at Lausanne (Switzerland) University Hospital, and colleagues.

A review of 11 pregnant women infected with the virus showed that 10 women (91%) presented with adverse outcomes. Six (55%) neonates were admitted to the ICU; three (27%) died. Two neonates were delivered prematurely because their mothers developed severe respiratory failure.

Because 2019-nCov has a potential for similar behavior, “we recommend systematic screening of any suspected 2019-nCoV infection during pregnancy. If 2019-nCoV infection during pregnancy is confirmed, extended follow-up should be recommended for mothers and their fetuses,” concluded Dr. Baud and colleagues.

Dr. Baud and associates are known for their previous research on the impacts of the Zika virus on pregnancy. They reported having no competing interests.

mlesney@mdedge.com

SOURCE: Baud D et al. Lancet. 2020 Feb 6. doi: 10.1016/S0140-6736(20)30311-1.

A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.

On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”

He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.

The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.

Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.

“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”

Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.

In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.

“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”

Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.

Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
 

How tail coverage works

Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.

One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.

However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.

Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.

Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.

But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.

Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.

So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.

Mr. Hursh says the tail is usually the most expensive potential cost in the contract.

There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
 

Can you negotiate your tail coverage?

Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.

Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.

Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.

Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.

Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.

Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.

“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
 

Coverage: Large employers vs. small employers

Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.

Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.

However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.

Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”

Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
 

Times you don’t need to pay for tail coverage

Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.

For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.

Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.

Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.

However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
 

Can you just go without tail coverage?

What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.

Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.

Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.

Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.

Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.

The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.

Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.

However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
 

How to lower your tail coverage cost

Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.

The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.

Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”

Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.

Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.

However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.

And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”

Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.

Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
 

This article first appeared on Medscape.com.

A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.

On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”

He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.

The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.

Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.

“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”

Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.

In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.

“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”

Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.

Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
 

How tail coverage works

Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.

One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.

However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.

Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.

Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.

But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.

Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.

So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.

Mr. Hursh says the tail is usually the most expensive potential cost in the contract.

There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
 

Can you negotiate your tail coverage?

Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.

Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.

Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.

Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.

Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.

Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.

“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
 

Coverage: Large employers vs. small employers

Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.

Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.

However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.

Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”

Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
 

Times you don’t need to pay for tail coverage

Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.

For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.

Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.

Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.

However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
 

Can you just go without tail coverage?

What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.

Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.

Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.

Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.

Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.

The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.

Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.

However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
 

How to lower your tail coverage cost

Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.

The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.

Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”

Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.

Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.

However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.

And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”

Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.

Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
 

This article first appeared on Medscape.com.

A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.

On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”

He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.

The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.

Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.

“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”

Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.

In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.

“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”

Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.

Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
 

How tail coverage works

Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.

One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.

However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.

Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.

Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.

But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.

Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.

So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.

Mr. Hursh says the tail is usually the most expensive potential cost in the contract.

There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
 

Can you negotiate your tail coverage?

Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.

Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.

Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.

Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.

Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.

Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.

“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
 

Coverage: Large employers vs. small employers

Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.

Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.

However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.

Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”

Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
 

Times you don’t need to pay for tail coverage

Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.

For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.

Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.

Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.

However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
 

Can you just go without tail coverage?

What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.

Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.

Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.

Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.

Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.

The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.

Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.

However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
 

How to lower your tail coverage cost

Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.

The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.

Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”

Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.

Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.

However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.

And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”

Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.

Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
 

This article first appeared on Medscape.com.

Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.

The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.

“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).

“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”

Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.

During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).

The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.

Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.

“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.

They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”

Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.

dbrunk@mdedge.com

SOURCE: Khera et al. BMJ 2020;368:l6831.

Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.

The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.

“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).

“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”

Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.

During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).

The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.

Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.

“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.

They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”

Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.

dbrunk@mdedge.com

SOURCE: Khera et al. BMJ 2020;368:l6831.

Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.

The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.

“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).

“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”

Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.

During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).

The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.

Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.

“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.

They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”

Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.

dbrunk@mdedge.com

SOURCE: Khera et al. BMJ 2020;368:l6831.

For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.

The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.

That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.

Those same data also show that, from 1997-1998 to 2018-2019, the United States has spent a total of 11 weeks above the 7.0% mark for ILI-related visits.

Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.

Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.

The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.

ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).

The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.

rfranki@mdedge.com

For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.

The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.

That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.

Those same data also show that, from 1997-1998 to 2018-2019, the United States has spent a total of 11 weeks above the 7.0% mark for ILI-related visits.

Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.

Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.

The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.

ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).

The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.

rfranki@mdedge.com

For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.

The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.

That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.

Those same data also show that, from 1997-1998 to 2018-2019, the United States has spent a total of 11 weeks above the 7.0% mark for ILI-related visits.

Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.

Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.

The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.

ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).

The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.

rfranki@mdedge.com