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A prescription for heart failure success: Change the name

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– Does heart failure’s name doom any progress against the disease?

That was the provocative premise advanced by Lynne Warner Stevenson, MD, who suggested that efforts to prevent, diagnose, and treat the disease would go better if it could only jettison that unfortunate word “failure,” its hard-wired albatross.

Dr. Stevenson offered several potentially superior alternatives, including cardiac insufficiency, heart dysfunction, and her favorite, cardiomyopathy.

Dr. Lynne Warner Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston
Mitchel L. Zoler/Frontline Medical News
Dr. Lynne Warner Stevenson
“I used to be a purist and felt you couldn’t call it cardiomyopathy if the patient also had coronary or valve disease, but now we see it all the time – ischemic cardiomyopathy or valvular cardiomyopathy,” she said at a meeting held by the Heart Failure Association of the ESC.

“Is heart failure still the best diagnosis” for the entire spectrum of disease that most patients progress through ,including the many patients in earlier stages of the disease who do not have a truly failing heart? “Perhaps cardiomyopathy is the condition and heart failure is the transition,” she proposed.

To Dr. Stevenson, it’s more than just semantics.

“Words are hugely powerful,” she explained in an interview following her talk. “I think patients do not want to be seen as having heart failure. They don’t want to think of themselves as having heart failure. I think it can make them delay getting care, and it makes them ignore the disease. I worry about that a lot. I also worry that patients don’t provide support to each other that they could. Patients tend to hide that they have heart failure. We need to come up with a term that does not make patients ashamed of their disease.”

Part of the problem, Dr. Stevenson said, is that the name heart failure can be very misleading depending on the stage of the disease that patients have. Patients with stage B (presymptomatic) disease and those with mild stage C disease “don’t see themselves as having heart failure,” as having a heart that has failed them. “We need to be able to convince these patients that they have a disease that we need to treat carefully and aggressively.”

Additionally, labeling tens of millions of people as having stage A heart failure, which is presymptomatic and occurs before the heart shows any sign of damage or dysfunction, is also counterproductive, maintained Dr. Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston.

“So many people are at risk of developing heart failure,” she noted, including patients with hypertension, diabetes, or coronary artery disease. To label them all as already also having heart failure at that stage “tends to make them ignore the disease that we are trying to get them to pay attention to. Telling patients they have the disease that we are trying to prevent doesn’t help.”

Calling the whole range of the disease heart failure also confuses patients and others. “Patients ask me, ‘How can I have heart failure without any symptoms?’ ‘My ejection fraction improved to almost normal; do I still have heart failure?’ and ‘I don’t understand how my heart muscle is strong but my heart is failing,’ ” she said

For Dr. Stevenson, perhaps the biggest problem is the stigma of failure and the way that word ties a huge weight to the disease that prompts patients and caregivers alike to relegate it to a hidden and neglected place.

“It’s failure. Who is proud to have heart failure? Where are the marches for heart failure? Where are the celebrity champions for heart failure? We have celebrities who are happy to admit that they have Parkinson’s disease, ALS [amyotrophic lateral sclerosis], drug addiction, and even erectile dysfunction, but no one wants to say they have heart failure. We can’t get any traction behind heart failure. It doesn’t sound very inspiring,” an issue that even percolates down to dissuading clinicians from pursuing a career in heart failure care. Young people do not aspire to go into failure, she said.

“We need to call it something else.”

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– Does heart failure’s name doom any progress against the disease?

That was the provocative premise advanced by Lynne Warner Stevenson, MD, who suggested that efforts to prevent, diagnose, and treat the disease would go better if it could only jettison that unfortunate word “failure,” its hard-wired albatross.

Dr. Stevenson offered several potentially superior alternatives, including cardiac insufficiency, heart dysfunction, and her favorite, cardiomyopathy.

Dr. Lynne Warner Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston
Mitchel L. Zoler/Frontline Medical News
Dr. Lynne Warner Stevenson
“I used to be a purist and felt you couldn’t call it cardiomyopathy if the patient also had coronary or valve disease, but now we see it all the time – ischemic cardiomyopathy or valvular cardiomyopathy,” she said at a meeting held by the Heart Failure Association of the ESC.

“Is heart failure still the best diagnosis” for the entire spectrum of disease that most patients progress through ,including the many patients in earlier stages of the disease who do not have a truly failing heart? “Perhaps cardiomyopathy is the condition and heart failure is the transition,” she proposed.

To Dr. Stevenson, it’s more than just semantics.

“Words are hugely powerful,” she explained in an interview following her talk. “I think patients do not want to be seen as having heart failure. They don’t want to think of themselves as having heart failure. I think it can make them delay getting care, and it makes them ignore the disease. I worry about that a lot. I also worry that patients don’t provide support to each other that they could. Patients tend to hide that they have heart failure. We need to come up with a term that does not make patients ashamed of their disease.”

Part of the problem, Dr. Stevenson said, is that the name heart failure can be very misleading depending on the stage of the disease that patients have. Patients with stage B (presymptomatic) disease and those with mild stage C disease “don’t see themselves as having heart failure,” as having a heart that has failed them. “We need to be able to convince these patients that they have a disease that we need to treat carefully and aggressively.”

Additionally, labeling tens of millions of people as having stage A heart failure, which is presymptomatic and occurs before the heart shows any sign of damage or dysfunction, is also counterproductive, maintained Dr. Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston.

“So many people are at risk of developing heart failure,” she noted, including patients with hypertension, diabetes, or coronary artery disease. To label them all as already also having heart failure at that stage “tends to make them ignore the disease that we are trying to get them to pay attention to. Telling patients they have the disease that we are trying to prevent doesn’t help.”

Calling the whole range of the disease heart failure also confuses patients and others. “Patients ask me, ‘How can I have heart failure without any symptoms?’ ‘My ejection fraction improved to almost normal; do I still have heart failure?’ and ‘I don’t understand how my heart muscle is strong but my heart is failing,’ ” she said

For Dr. Stevenson, perhaps the biggest problem is the stigma of failure and the way that word ties a huge weight to the disease that prompts patients and caregivers alike to relegate it to a hidden and neglected place.

“It’s failure. Who is proud to have heart failure? Where are the marches for heart failure? Where are the celebrity champions for heart failure? We have celebrities who are happy to admit that they have Parkinson’s disease, ALS [amyotrophic lateral sclerosis], drug addiction, and even erectile dysfunction, but no one wants to say they have heart failure. We can’t get any traction behind heart failure. It doesn’t sound very inspiring,” an issue that even percolates down to dissuading clinicians from pursuing a career in heart failure care. Young people do not aspire to go into failure, she said.

“We need to call it something else.”

 

– Does heart failure’s name doom any progress against the disease?

That was the provocative premise advanced by Lynne Warner Stevenson, MD, who suggested that efforts to prevent, diagnose, and treat the disease would go better if it could only jettison that unfortunate word “failure,” its hard-wired albatross.

Dr. Stevenson offered several potentially superior alternatives, including cardiac insufficiency, heart dysfunction, and her favorite, cardiomyopathy.

Dr. Lynne Warner Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston
Mitchel L. Zoler/Frontline Medical News
Dr. Lynne Warner Stevenson
“I used to be a purist and felt you couldn’t call it cardiomyopathy if the patient also had coronary or valve disease, but now we see it all the time – ischemic cardiomyopathy or valvular cardiomyopathy,” she said at a meeting held by the Heart Failure Association of the ESC.

“Is heart failure still the best diagnosis” for the entire spectrum of disease that most patients progress through ,including the many patients in earlier stages of the disease who do not have a truly failing heart? “Perhaps cardiomyopathy is the condition and heart failure is the transition,” she proposed.

To Dr. Stevenson, it’s more than just semantics.

“Words are hugely powerful,” she explained in an interview following her talk. “I think patients do not want to be seen as having heart failure. They don’t want to think of themselves as having heart failure. I think it can make them delay getting care, and it makes them ignore the disease. I worry about that a lot. I also worry that patients don’t provide support to each other that they could. Patients tend to hide that they have heart failure. We need to come up with a term that does not make patients ashamed of their disease.”

Part of the problem, Dr. Stevenson said, is that the name heart failure can be very misleading depending on the stage of the disease that patients have. Patients with stage B (presymptomatic) disease and those with mild stage C disease “don’t see themselves as having heart failure,” as having a heart that has failed them. “We need to be able to convince these patients that they have a disease that we need to treat carefully and aggressively.”

Additionally, labeling tens of millions of people as having stage A heart failure, which is presymptomatic and occurs before the heart shows any sign of damage or dysfunction, is also counterproductive, maintained Dr. Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston.

“So many people are at risk of developing heart failure,” she noted, including patients with hypertension, diabetes, or coronary artery disease. To label them all as already also having heart failure at that stage “tends to make them ignore the disease that we are trying to get them to pay attention to. Telling patients they have the disease that we are trying to prevent doesn’t help.”

Calling the whole range of the disease heart failure also confuses patients and others. “Patients ask me, ‘How can I have heart failure without any symptoms?’ ‘My ejection fraction improved to almost normal; do I still have heart failure?’ and ‘I don’t understand how my heart muscle is strong but my heart is failing,’ ” she said

For Dr. Stevenson, perhaps the biggest problem is the stigma of failure and the way that word ties a huge weight to the disease that prompts patients and caregivers alike to relegate it to a hidden and neglected place.

“It’s failure. Who is proud to have heart failure? Where are the marches for heart failure? Where are the celebrity champions for heart failure? We have celebrities who are happy to admit that they have Parkinson’s disease, ALS [amyotrophic lateral sclerosis], drug addiction, and even erectile dysfunction, but no one wants to say they have heart failure. We can’t get any traction behind heart failure. It doesn’t sound very inspiring,” an issue that even percolates down to dissuading clinicians from pursuing a career in heart failure care. Young people do not aspire to go into failure, she said.

“We need to call it something else.”

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EXPERT ANALYSIS FROM HEART FAILURE 2017

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Spironolactone’s HFpEF benefit happens mostly in women

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– Just when the aldosterone receptor antagonists spironolactone and eplerenone received official recognition in the 2017 U.S. heart failure guidelines as the only drug class that benefits patients with heart failure with preserved ejection fraction (HFpEF), a new post-hoc analysis of the pivotal evidence suggests the benefit is mostly in women, with little benefit to men.

 

The new analysis used data collected from TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), which randomized patients with HFpEF to treatment with spironolactone or placebo. Results from the overall study were neutral for the primary outcome of cardiovascular death, aborted cardiac arrest, and heart failure hospitalization (N Engl J Med. 2014 April 10;370[15]:1383-92). However, a series of post-hoc analyses showed that a high percentage of patients enrolled at centers in Russia or Georgia did not match the expected HFpEF profile, and these patients had poor responses to spironolactone. In contrast, patients enrolled at centers in the Americas more frequently matched the study’s target HFpEF profile, and they showed significant improvement for the primary endpoint (Circulation. 2015 Jan 6;131[1]:34-42).

Dr. David Kao, a cardiologist at the University if Colorado at Denver, Aurora.
Mitchel L. Zoler/Frontline Medical News
Dr. David Kao
The new analysis, focused on those patients from the Americas, shows that the primary efficacy outcome from the TOPCAT trial was a statistically significant 18% lower in women than in men, David Kao, MD, reported at a meeting of the Heart Failure Association of the ESC.

“The observation that most of the benefit [from spironolactone treatment] may have been in women is interesting, but I don’t think that it would stop me from using [an aldosterone receptor antagonist] in men,” said Dr. Kao while presenting his report. The outcomes in both men and women “head in the same direction. It’s just that the mortality benefit is much clearer in women,” said Dr. Kao, a cardiologist at the University of Colorado at Denver, Aurora.

Among the patients enrolled at centers in North and South America, 882 were women, and 885 were men. Dr. Kao used the data collected in TOPCAT to calculate the impact of spironolactone treatment relative to placebo on outcomes just among women in the Americas and just among men.

The difference in all-cause mortality associated with spironolactone treatment had an even sharper sex disparity that in the primary outcome. Overall, all-cause mortality was 28% less common among women, compared with men, in the Americas. Among women, spironolactone treatment linked with a 30% reduced all-cause mortality rate, compared with placebo. Among men, the survival curves of those on spironolactone or placebo superimposed.

Dr. Kao said that published study results in rats had suggested that eplerenone (Inspra), an aldosterone receptor antagonist like spironolactone, had a more potent effect in females rats, compared with male rats, for preserving left ventricular function and size following myocardial damage. In addition, women with HFpEF often have more left ventricular hypertrophy, while men often have more diastolic dysfunction, and prior findings had suggested that aldosterone plays a role in left ventricular hypertrophy.

TOPCAT received no commercial funding. Dr. Kao had no disclosures.

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– Just when the aldosterone receptor antagonists spironolactone and eplerenone received official recognition in the 2017 U.S. heart failure guidelines as the only drug class that benefits patients with heart failure with preserved ejection fraction (HFpEF), a new post-hoc analysis of the pivotal evidence suggests the benefit is mostly in women, with little benefit to men.

 

The new analysis used data collected from TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), which randomized patients with HFpEF to treatment with spironolactone or placebo. Results from the overall study were neutral for the primary outcome of cardiovascular death, aborted cardiac arrest, and heart failure hospitalization (N Engl J Med. 2014 April 10;370[15]:1383-92). However, a series of post-hoc analyses showed that a high percentage of patients enrolled at centers in Russia or Georgia did not match the expected HFpEF profile, and these patients had poor responses to spironolactone. In contrast, patients enrolled at centers in the Americas more frequently matched the study’s target HFpEF profile, and they showed significant improvement for the primary endpoint (Circulation. 2015 Jan 6;131[1]:34-42).

Dr. David Kao, a cardiologist at the University if Colorado at Denver, Aurora.
Mitchel L. Zoler/Frontline Medical News
Dr. David Kao
The new analysis, focused on those patients from the Americas, shows that the primary efficacy outcome from the TOPCAT trial was a statistically significant 18% lower in women than in men, David Kao, MD, reported at a meeting of the Heart Failure Association of the ESC.

“The observation that most of the benefit [from spironolactone treatment] may have been in women is interesting, but I don’t think that it would stop me from using [an aldosterone receptor antagonist] in men,” said Dr. Kao while presenting his report. The outcomes in both men and women “head in the same direction. It’s just that the mortality benefit is much clearer in women,” said Dr. Kao, a cardiologist at the University of Colorado at Denver, Aurora.

Among the patients enrolled at centers in North and South America, 882 were women, and 885 were men. Dr. Kao used the data collected in TOPCAT to calculate the impact of spironolactone treatment relative to placebo on outcomes just among women in the Americas and just among men.

The difference in all-cause mortality associated with spironolactone treatment had an even sharper sex disparity that in the primary outcome. Overall, all-cause mortality was 28% less common among women, compared with men, in the Americas. Among women, spironolactone treatment linked with a 30% reduced all-cause mortality rate, compared with placebo. Among men, the survival curves of those on spironolactone or placebo superimposed.

Dr. Kao said that published study results in rats had suggested that eplerenone (Inspra), an aldosterone receptor antagonist like spironolactone, had a more potent effect in females rats, compared with male rats, for preserving left ventricular function and size following myocardial damage. In addition, women with HFpEF often have more left ventricular hypertrophy, while men often have more diastolic dysfunction, and prior findings had suggested that aldosterone plays a role in left ventricular hypertrophy.

TOPCAT received no commercial funding. Dr. Kao had no disclosures.

– Just when the aldosterone receptor antagonists spironolactone and eplerenone received official recognition in the 2017 U.S. heart failure guidelines as the only drug class that benefits patients with heart failure with preserved ejection fraction (HFpEF), a new post-hoc analysis of the pivotal evidence suggests the benefit is mostly in women, with little benefit to men.

 

The new analysis used data collected from TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), which randomized patients with HFpEF to treatment with spironolactone or placebo. Results from the overall study were neutral for the primary outcome of cardiovascular death, aborted cardiac arrest, and heart failure hospitalization (N Engl J Med. 2014 April 10;370[15]:1383-92). However, a series of post-hoc analyses showed that a high percentage of patients enrolled at centers in Russia or Georgia did not match the expected HFpEF profile, and these patients had poor responses to spironolactone. In contrast, patients enrolled at centers in the Americas more frequently matched the study’s target HFpEF profile, and they showed significant improvement for the primary endpoint (Circulation. 2015 Jan 6;131[1]:34-42).

Dr. David Kao, a cardiologist at the University if Colorado at Denver, Aurora.
Mitchel L. Zoler/Frontline Medical News
Dr. David Kao
The new analysis, focused on those patients from the Americas, shows that the primary efficacy outcome from the TOPCAT trial was a statistically significant 18% lower in women than in men, David Kao, MD, reported at a meeting of the Heart Failure Association of the ESC.

“The observation that most of the benefit [from spironolactone treatment] may have been in women is interesting, but I don’t think that it would stop me from using [an aldosterone receptor antagonist] in men,” said Dr. Kao while presenting his report. The outcomes in both men and women “head in the same direction. It’s just that the mortality benefit is much clearer in women,” said Dr. Kao, a cardiologist at the University of Colorado at Denver, Aurora.

Among the patients enrolled at centers in North and South America, 882 were women, and 885 were men. Dr. Kao used the data collected in TOPCAT to calculate the impact of spironolactone treatment relative to placebo on outcomes just among women in the Americas and just among men.

The difference in all-cause mortality associated with spironolactone treatment had an even sharper sex disparity that in the primary outcome. Overall, all-cause mortality was 28% less common among women, compared with men, in the Americas. Among women, spironolactone treatment linked with a 30% reduced all-cause mortality rate, compared with placebo. Among men, the survival curves of those on spironolactone or placebo superimposed.

Dr. Kao said that published study results in rats had suggested that eplerenone (Inspra), an aldosterone receptor antagonist like spironolactone, had a more potent effect in females rats, compared with male rats, for preserving left ventricular function and size following myocardial damage. In addition, women with HFpEF often have more left ventricular hypertrophy, while men often have more diastolic dysfunction, and prior findings had suggested that aldosterone plays a role in left ventricular hypertrophy.

TOPCAT received no commercial funding. Dr. Kao had no disclosures.

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AT HEART FAILURE 2017

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Key clinical point: A post-hoc TOPCAT analysis showed that spironolactone’s benefit for heart failure patients with preserved ejection fraction mostly occurred in women.

Major finding: Women from the Americas in TOPCAT had an 18% lower rate of primary endpoint events, compared with men in the trial.

Data source: TOPCAT, a multicenter, randomized study with 3,445 patients.

Disclosures: TOPCAT received no commercial funding. Dr. Kao had no disclosures.

VIDEO: Lack of heart teams impact prevalence of PCI

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– Data show a marked bias in referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team.

More patients underwent percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery than patients at hospitals with on-site cardiac surgery, according to the analysis presented at the annual meeting of the American Association for Thoracic Surgery. The multivariate logistic regression analysis showed that the absence of on-site cardiac surgery and a heart team was an independent predictor for PCI.

In this video, Ehud Raanani, MD, of Tel Aviv University in Israel discusses referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team and how this phenomenon could affect patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Data show a marked bias in referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team.

More patients underwent percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery than patients at hospitals with on-site cardiac surgery, according to the analysis presented at the annual meeting of the American Association for Thoracic Surgery. The multivariate logistic regression analysis showed that the absence of on-site cardiac surgery and a heart team was an independent predictor for PCI.

In this video, Ehud Raanani, MD, of Tel Aviv University in Israel discusses referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team and how this phenomenon could affect patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Data show a marked bias in referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team.

More patients underwent percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery than patients at hospitals with on-site cardiac surgery, according to the analysis presented at the annual meeting of the American Association for Thoracic Surgery. The multivariate logistic regression analysis showed that the absence of on-site cardiac surgery and a heart team was an independent predictor for PCI.

In this video, Ehud Raanani, MD, of Tel Aviv University in Israel discusses referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team and how this phenomenon could affect patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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AT THE AATS ANNUAL MEETING

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VIDEO: Surgeon case volume linked to mitral valve repair outcomes

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– Individual surgeon case volume is a significant factor in degenerative mitral valve repair rates and overall patient survival, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.

The analysis, which reviewed the outcomes of 38,128 adult patients, found that higher surgeon volume of mitral cases is associated with better degenerative mitral repair rates and higher survival. In this video, Ralph Damiano Jr., MD, of Washington University, St. Louis, discusses the threshold of mitral cases that led to better repair rates and how further cardiac surgical subspecialization could improve outcomes in patients with degenerative mitral disease.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Individual surgeon case volume is a significant factor in degenerative mitral valve repair rates and overall patient survival, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.

The analysis, which reviewed the outcomes of 38,128 adult patients, found that higher surgeon volume of mitral cases is associated with better degenerative mitral repair rates and higher survival. In this video, Ralph Damiano Jr., MD, of Washington University, St. Louis, discusses the threshold of mitral cases that led to better repair rates and how further cardiac surgical subspecialization could improve outcomes in patients with degenerative mitral disease.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Individual surgeon case volume is a significant factor in degenerative mitral valve repair rates and overall patient survival, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.

The analysis, which reviewed the outcomes of 38,128 adult patients, found that higher surgeon volume of mitral cases is associated with better degenerative mitral repair rates and higher survival. In this video, Ralph Damiano Jr., MD, of Washington University, St. Louis, discusses the threshold of mitral cases that led to better repair rates and how further cardiac surgical subspecialization could improve outcomes in patients with degenerative mitral disease.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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AT THE AATS ANNUAL MEETING

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Statins: No benefit as primary prevention in elderly

Consider risks and lack of benefit
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Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Elderly woman pouring pills into her hand.
Creative-Family/Thinkstock
To clarify the issue, they performed a secondary analysis of data from the randomized, open-label ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack) trial. The investigators focused on several important outcomes among 2,867 older participants who had hypertension and moderate hypercholesterolemia but no atherosclerotic cardiovascular disease at baseline. A total of 1,467 were randomly assigned to receive pravastatin and 1,400 to usual care (no statin therapy), and they were followed for 6 years.

The primary outcome, all-cause mortality, was slightly higher in the statin group. For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care, for a hazard ratio of 1.08, and for those aged 75 and older, there were 92 deaths with pravastatin vs. 65 with usual care, for an HR of 1.34. This represents a nonsignificant trend toward increased mortality with statin therapy. The results were similar, with pravastatin providing no significant benefit, regarding coronary heart disease, stroke, heart failure, and cancer events.

These findings indicate that “statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit,” Dr. Han and his associates said (JAMA Intern Med. 2017 May 22. doi: 10.1001/jamainternmed.2017.1442).

One important limitation of this secondary analysis is that patients were allowed to cross over to the other study group during follow-up, at their own or their physicians’ discretion. By the end of the study, 29% of the control group were taking lipid-lowering drugs while 22% of the active-treatment group had discontinued pravastatin. “This level of crossover should be considered when interpreting our findings,” the investigators noted.

Body

 

Statins are commonly prescribed for primary prevention to older patients, particularly those older than age 75 years. And the prevalence of use in this patient population is increasing.

But statins are associated with a variety of musculoskeletal disorders – including myopathy, myalgias, muscle weakness, back conditions, injuries, and arthropathies – which may be particularly harmful in older people and contribute to their physical deconditioning and frailty. The drugs also have been linked to cognitive dysfunction, which can further raise the risk of falls and disability.

Physicians should take into consideration these multiple risks, in addition to the ALLHAT data showing no mortality benefit in this age group, before prescribing or continuing statin therapy in such patients.
 

Gregory Curfman, MD, is at Harvard Medical School, Boston, and is also the health care policy and law editor for JAMA Internal Medicine. Dr. Curfman reported having no relevant financial disclosures. He made these remarks in an Editor’s Note accompanying Dr. Han’s report.

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Statins are commonly prescribed for primary prevention to older patients, particularly those older than age 75 years. And the prevalence of use in this patient population is increasing.

But statins are associated with a variety of musculoskeletal disorders – including myopathy, myalgias, muscle weakness, back conditions, injuries, and arthropathies – which may be particularly harmful in older people and contribute to their physical deconditioning and frailty. The drugs also have been linked to cognitive dysfunction, which can further raise the risk of falls and disability.

Physicians should take into consideration these multiple risks, in addition to the ALLHAT data showing no mortality benefit in this age group, before prescribing or continuing statin therapy in such patients.
 

Gregory Curfman, MD, is at Harvard Medical School, Boston, and is also the health care policy and law editor for JAMA Internal Medicine. Dr. Curfman reported having no relevant financial disclosures. He made these remarks in an Editor’s Note accompanying Dr. Han’s report.

Body

 

Statins are commonly prescribed for primary prevention to older patients, particularly those older than age 75 years. And the prevalence of use in this patient population is increasing.

But statins are associated with a variety of musculoskeletal disorders – including myopathy, myalgias, muscle weakness, back conditions, injuries, and arthropathies – which may be particularly harmful in older people and contribute to their physical deconditioning and frailty. The drugs also have been linked to cognitive dysfunction, which can further raise the risk of falls and disability.

Physicians should take into consideration these multiple risks, in addition to the ALLHAT data showing no mortality benefit in this age group, before prescribing or continuing statin therapy in such patients.
 

Gregory Curfman, MD, is at Harvard Medical School, Boston, and is also the health care policy and law editor for JAMA Internal Medicine. Dr. Curfman reported having no relevant financial disclosures. He made these remarks in an Editor’s Note accompanying Dr. Han’s report.

Title
Consider risks and lack of benefit
Consider risks and lack of benefit

 

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Elderly woman pouring pills into her hand.
Creative-Family/Thinkstock
To clarify the issue, they performed a secondary analysis of data from the randomized, open-label ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack) trial. The investigators focused on several important outcomes among 2,867 older participants who had hypertension and moderate hypercholesterolemia but no atherosclerotic cardiovascular disease at baseline. A total of 1,467 were randomly assigned to receive pravastatin and 1,400 to usual care (no statin therapy), and they were followed for 6 years.

The primary outcome, all-cause mortality, was slightly higher in the statin group. For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care, for a hazard ratio of 1.08, and for those aged 75 and older, there were 92 deaths with pravastatin vs. 65 with usual care, for an HR of 1.34. This represents a nonsignificant trend toward increased mortality with statin therapy. The results were similar, with pravastatin providing no significant benefit, regarding coronary heart disease, stroke, heart failure, and cancer events.

These findings indicate that “statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit,” Dr. Han and his associates said (JAMA Intern Med. 2017 May 22. doi: 10.1001/jamainternmed.2017.1442).

One important limitation of this secondary analysis is that patients were allowed to cross over to the other study group during follow-up, at their own or their physicians’ discretion. By the end of the study, 29% of the control group were taking lipid-lowering drugs while 22% of the active-treatment group had discontinued pravastatin. “This level of crossover should be considered when interpreting our findings,” the investigators noted.

 

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Elderly woman pouring pills into her hand.
Creative-Family/Thinkstock
To clarify the issue, they performed a secondary analysis of data from the randomized, open-label ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack) trial. The investigators focused on several important outcomes among 2,867 older participants who had hypertension and moderate hypercholesterolemia but no atherosclerotic cardiovascular disease at baseline. A total of 1,467 were randomly assigned to receive pravastatin and 1,400 to usual care (no statin therapy), and they were followed for 6 years.

The primary outcome, all-cause mortality, was slightly higher in the statin group. For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care, for a hazard ratio of 1.08, and for those aged 75 and older, there were 92 deaths with pravastatin vs. 65 with usual care, for an HR of 1.34. This represents a nonsignificant trend toward increased mortality with statin therapy. The results were similar, with pravastatin providing no significant benefit, regarding coronary heart disease, stroke, heart failure, and cancer events.

These findings indicate that “statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit,” Dr. Han and his associates said (JAMA Intern Med. 2017 May 22. doi: 10.1001/jamainternmed.2017.1442).

One important limitation of this secondary analysis is that patients were allowed to cross over to the other study group during follow-up, at their own or their physicians’ discretion. By the end of the study, 29% of the control group were taking lipid-lowering drugs while 22% of the active-treatment group had discontinued pravastatin. “This level of crossover should be considered when interpreting our findings,” the investigators noted.

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Key clinical point: Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes.

Major finding: For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care (HR, 1.08), and for those aged 75 years and older, there were 92 deaths with pravastatin vs. 65 with usual care (HR, 1.34).

Data source: A secondary analysis of data in the randomized, open-label ALLHAT trial, focusing on 2,867 elderly participants followed for 6 years.

Disclosures: This work was supported by the National Institutes of Health. Pfizer, AstraZeneca, and Bristol-Myers Squibb provided study medications free of charge. Dr. Han and his associates reported having no relevant financial disclosures.

Novel Lotus valve outperforms CoreValve in REPRISE III

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PARIS– The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.

Dr. Ted E. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.
Bruce Jancin/Frontline Medical News
Dr. Ted E. Feldman
“This is a successful clinical trial for a novel mechanically expandable valve,” he declared. “The most novel feature of the system is that the valve can be completely deployed and locked and assessed in its final position before it’s released, with adjustments made in the position if needed.”

A key finding was that the Lotus valve group had a 1-year rate of moderate or greater PVL of just 2% as assessed in a central core lab, compared with an 11% rate in patients randomized to the classic CoreValve or the subsequent-generation Evolut R device, he observed.

“With the Lotus valve there was no or only trace PVL in over 85% of patients. This is probably even more important than the low rate of moderate or severe PVL. The valve really does result in virtually no PVL in the vast majority of patients. That’s unique to this platform,” the cardiologist said in an interview.

The unprecedented low rate of moderate or severe PVL at 1 year postprocedure is attributable to the polymer seal delivered via the Lotus system for that express purpose, he explained.

REPRISE III was the first large randomized comparative clinical trial featuring two TAVR valves, an event that reflects the rapid expansion of the field. All previous major trials had compared TAVR with surgical aortic valve replacement.

REPRISE III randomized 912 TAVR patients at 55 centers 2:1 to the Lotus valve in its 23-, 25-, or 27-mm configurations or to a CoreValve at 26, 29, or 31 mm. Roughly half of the CoreValve group got the newer repositionable and retrievable Evolut R valve, while the earlier enrollees received the nonrepositionable classic CoreValve.

The Lotus valve group proved noninferior to the CoreValve recipients for the primary safety endpoint, a 30-day composite of all-cause mortality, stroke, major or life-threatening bleeding, major vascular complications, and stage 2 or 3 acute kidney injury. The rates were 20.3% in the Lotus arm and 17.2% with CoreValve.

The 1-year rate of disabling stroke was 3.6% in the Lotus group versus 7.3% in the CoreValve group. Dr. Feldman downplayed the importance of this difference, even though it was statistically significant. The Lotus valve performed as expected, but the disabling stroke rate in the CoreValve group was higher than in earlier studies for reasons unknown, most likely simply the play of chance, he said.

“I think the real message here is that the Lotus valve performed very well,” the cardiologist said. “There have been concerns that repositioning the valve into a better position during the deployment process might create excess stroke. It appears clear that’s not the case.”

The ability to reposition the Lotus device resulted in a significantly lower rate of repeat procedures at 1 year: 0.2% versus 2% with the CoreValve, as well as zero cases of aortic valve malposition and valve-in-valve deployment.

The need for a new pacemaker within 30 days after TAVR was strikingly more common in the Lotus valve group: 36%, compared with 20% with the CoreValve. Dr. Feldman attributed the high new pacemaker rate in the Lotus arm partly to the operators’ limited experience with the novel valve along with the fact that REPRISE III used a first-iteration device deployment mechanism. An improved deployment mechanism designed to minimize problematic contact with the left ventricular outflow tract was developed too late for inclusion in the trial. But in a recent European study using this proprietary deployment system, known as Depth Guard, the new pacemaker rate was below 20%.

The learning curve for the new Lotus valve system is “not at all challenging,” according to the cardiologist. He noted that U.S. operators participating in REPRISE III, who had no prior experience with the device, were allowed only two initial cases in order to gain experience; after that, every patient counted in the clinical trial results.

The REPRISE III results will be offered to the Food and Drug Administration to support regulatory approval of the device in high-surgical-risk patients. Dr. Feldman said Boston Scientific plans to conduct an additional clinical trial of the Lotus valve, this time in intermediate-risk patients, with the goal of gaining an expanded indication. This, too, will be a head-to-head comparison with a commercially available TAVR valve, probably the Edwards Sapien 3 valve.

REPRISE III was sponsored by Boston Scientific. Dr. Feldman reported serving as a consultant to that company, Abbott, and Edwards Lifesciences, and having received institutional research grants from those companies as well.

bjancin@frontlinemedcom.com

 

 

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PARIS– The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.

Dr. Ted E. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.
Bruce Jancin/Frontline Medical News
Dr. Ted E. Feldman
“This is a successful clinical trial for a novel mechanically expandable valve,” he declared. “The most novel feature of the system is that the valve can be completely deployed and locked and assessed in its final position before it’s released, with adjustments made in the position if needed.”

A key finding was that the Lotus valve group had a 1-year rate of moderate or greater PVL of just 2% as assessed in a central core lab, compared with an 11% rate in patients randomized to the classic CoreValve or the subsequent-generation Evolut R device, he observed.

“With the Lotus valve there was no or only trace PVL in over 85% of patients. This is probably even more important than the low rate of moderate or severe PVL. The valve really does result in virtually no PVL in the vast majority of patients. That’s unique to this platform,” the cardiologist said in an interview.

The unprecedented low rate of moderate or severe PVL at 1 year postprocedure is attributable to the polymer seal delivered via the Lotus system for that express purpose, he explained.

REPRISE III was the first large randomized comparative clinical trial featuring two TAVR valves, an event that reflects the rapid expansion of the field. All previous major trials had compared TAVR with surgical aortic valve replacement.

REPRISE III randomized 912 TAVR patients at 55 centers 2:1 to the Lotus valve in its 23-, 25-, or 27-mm configurations or to a CoreValve at 26, 29, or 31 mm. Roughly half of the CoreValve group got the newer repositionable and retrievable Evolut R valve, while the earlier enrollees received the nonrepositionable classic CoreValve.

The Lotus valve group proved noninferior to the CoreValve recipients for the primary safety endpoint, a 30-day composite of all-cause mortality, stroke, major or life-threatening bleeding, major vascular complications, and stage 2 or 3 acute kidney injury. The rates were 20.3% in the Lotus arm and 17.2% with CoreValve.

The 1-year rate of disabling stroke was 3.6% in the Lotus group versus 7.3% in the CoreValve group. Dr. Feldman downplayed the importance of this difference, even though it was statistically significant. The Lotus valve performed as expected, but the disabling stroke rate in the CoreValve group was higher than in earlier studies for reasons unknown, most likely simply the play of chance, he said.

“I think the real message here is that the Lotus valve performed very well,” the cardiologist said. “There have been concerns that repositioning the valve into a better position during the deployment process might create excess stroke. It appears clear that’s not the case.”

The ability to reposition the Lotus device resulted in a significantly lower rate of repeat procedures at 1 year: 0.2% versus 2% with the CoreValve, as well as zero cases of aortic valve malposition and valve-in-valve deployment.

The need for a new pacemaker within 30 days after TAVR was strikingly more common in the Lotus valve group: 36%, compared with 20% with the CoreValve. Dr. Feldman attributed the high new pacemaker rate in the Lotus arm partly to the operators’ limited experience with the novel valve along with the fact that REPRISE III used a first-iteration device deployment mechanism. An improved deployment mechanism designed to minimize problematic contact with the left ventricular outflow tract was developed too late for inclusion in the trial. But in a recent European study using this proprietary deployment system, known as Depth Guard, the new pacemaker rate was below 20%.

The learning curve for the new Lotus valve system is “not at all challenging,” according to the cardiologist. He noted that U.S. operators participating in REPRISE III, who had no prior experience with the device, were allowed only two initial cases in order to gain experience; after that, every patient counted in the clinical trial results.

The REPRISE III results will be offered to the Food and Drug Administration to support regulatory approval of the device in high-surgical-risk patients. Dr. Feldman said Boston Scientific plans to conduct an additional clinical trial of the Lotus valve, this time in intermediate-risk patients, with the goal of gaining an expanded indication. This, too, will be a head-to-head comparison with a commercially available TAVR valve, probably the Edwards Sapien 3 valve.

REPRISE III was sponsored by Boston Scientific. Dr. Feldman reported serving as a consultant to that company, Abbott, and Edwards Lifesciences, and having received institutional research grants from those companies as well.

bjancin@frontlinemedcom.com

 

 

PARIS– The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.

Dr. Ted E. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.
Bruce Jancin/Frontline Medical News
Dr. Ted E. Feldman
“This is a successful clinical trial for a novel mechanically expandable valve,” he declared. “The most novel feature of the system is that the valve can be completely deployed and locked and assessed in its final position before it’s released, with adjustments made in the position if needed.”

A key finding was that the Lotus valve group had a 1-year rate of moderate or greater PVL of just 2% as assessed in a central core lab, compared with an 11% rate in patients randomized to the classic CoreValve or the subsequent-generation Evolut R device, he observed.

“With the Lotus valve there was no or only trace PVL in over 85% of patients. This is probably even more important than the low rate of moderate or severe PVL. The valve really does result in virtually no PVL in the vast majority of patients. That’s unique to this platform,” the cardiologist said in an interview.

The unprecedented low rate of moderate or severe PVL at 1 year postprocedure is attributable to the polymer seal delivered via the Lotus system for that express purpose, he explained.

REPRISE III was the first large randomized comparative clinical trial featuring two TAVR valves, an event that reflects the rapid expansion of the field. All previous major trials had compared TAVR with surgical aortic valve replacement.

REPRISE III randomized 912 TAVR patients at 55 centers 2:1 to the Lotus valve in its 23-, 25-, or 27-mm configurations or to a CoreValve at 26, 29, or 31 mm. Roughly half of the CoreValve group got the newer repositionable and retrievable Evolut R valve, while the earlier enrollees received the nonrepositionable classic CoreValve.

The Lotus valve group proved noninferior to the CoreValve recipients for the primary safety endpoint, a 30-day composite of all-cause mortality, stroke, major or life-threatening bleeding, major vascular complications, and stage 2 or 3 acute kidney injury. The rates were 20.3% in the Lotus arm and 17.2% with CoreValve.

The 1-year rate of disabling stroke was 3.6% in the Lotus group versus 7.3% in the CoreValve group. Dr. Feldman downplayed the importance of this difference, even though it was statistically significant. The Lotus valve performed as expected, but the disabling stroke rate in the CoreValve group was higher than in earlier studies for reasons unknown, most likely simply the play of chance, he said.

“I think the real message here is that the Lotus valve performed very well,” the cardiologist said. “There have been concerns that repositioning the valve into a better position during the deployment process might create excess stroke. It appears clear that’s not the case.”

The ability to reposition the Lotus device resulted in a significantly lower rate of repeat procedures at 1 year: 0.2% versus 2% with the CoreValve, as well as zero cases of aortic valve malposition and valve-in-valve deployment.

The need for a new pacemaker within 30 days after TAVR was strikingly more common in the Lotus valve group: 36%, compared with 20% with the CoreValve. Dr. Feldman attributed the high new pacemaker rate in the Lotus arm partly to the operators’ limited experience with the novel valve along with the fact that REPRISE III used a first-iteration device deployment mechanism. An improved deployment mechanism designed to minimize problematic contact with the left ventricular outflow tract was developed too late for inclusion in the trial. But in a recent European study using this proprietary deployment system, known as Depth Guard, the new pacemaker rate was below 20%.

The learning curve for the new Lotus valve system is “not at all challenging,” according to the cardiologist. He noted that U.S. operators participating in REPRISE III, who had no prior experience with the device, were allowed only two initial cases in order to gain experience; after that, every patient counted in the clinical trial results.

The REPRISE III results will be offered to the Food and Drug Administration to support regulatory approval of the device in high-surgical-risk patients. Dr. Feldman said Boston Scientific plans to conduct an additional clinical trial of the Lotus valve, this time in intermediate-risk patients, with the goal of gaining an expanded indication. This, too, will be a head-to-head comparison with a commercially available TAVR valve, probably the Edwards Sapien 3 valve.

REPRISE III was sponsored by Boston Scientific. Dr. Feldman reported serving as a consultant to that company, Abbott, and Edwards Lifesciences, and having received institutional research grants from those companies as well.

bjancin@frontlinemedcom.com

 

 

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Key clinical point: The novel investigational Lotus valve showed superior efficacy, compared with the commercially available CoreValve platform in a major randomized trial.

Major finding: The rate of the 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak was 17% in patients randomized to the investigational Lotus transcatheter aortic valve replacement system, compared with 29% in recipients of the CoreValve.

Data source: REPRISE III, a prospective, multicenter, international clinical trial randomized 912 patients with severe aortic stenosis who were at high surgical risk to TAVR with the investigational Lotus valve or a commercially available CoreValve.

Disclosures: REPRISE III was sponsored by Boston Scientific. The study presenter reported serving as a consultant to that company as well as for Abbott and Edwards Lifesciences. He has also received institutional research grants from those companies.

VIDEO: Sutureless aortic valve shows promise in IDE trial

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– A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).

The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).

The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).

The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Embolism major cause of stroke after open arch surgery in patients with carotid/intracranial stenosis

Lack of blood supply is the killer
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Embolization was the major cause of permanent stroke in patients with moderate or severe carotid or intracranial atherosclerosis who underwent elective open aortic arch surgery at a single institution, according to the results of a retrospective study.

Preoperative craniocervical and aortic screening may aid in modifying the operative strategy to reduce the incidence of stroke in these patients, according to a report published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

Preventing stroke in this patient population is an important consideration, because perioperative stroke is approximately 4 times more common in open aortic arch surgery (OAAS) than in coronary artery bypass grafting or valve surgery, according to Ken-ichi Imasaka, MD, and his colleagues at the National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.

The study population comprised 200 consecutive patients undergoing elective OAAS at the institution between October 2008 and October 2015, including 34% women and with a mean patient age of 71 years (J Thorac Cardiovasc Surg. 2017;153:1045-53).

After preoperative screening, 21% of patients were diagnosed with carotid or intracranial artery disease (CIAD). None of these patients were diagnosed with impaired cerebral perfusion reserve on brain SPECT (single-photon emission computed tomography). A total of 92% of patients underwent ascending aorta or aortic arch replacement through a median sternotomy, while the remaining 8% underwent extended aortic arch replacement via L-incision (15 patients) or combined median sternotomy and left posterior lateral thoracotomy (1 patient). Among the patients, 16% underwent ascending aorta replacement; 8% had partial arch replacement; and the remaining 76% had total arch replacement.

Shaggy aorta was present in 19% of the patients, with 51% of these showing CIAD (P less than .0001). A total of 30% of the patients with shaggy aorta had the total arch replacement through an L-incision or combined median sternotomy and left posterior lateral thoracotomy, a significant difference (P less than .0001).

Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza

The overall in-hospital mortality rate was 3.5%. The overall incidence of permanent stroke and paraplegia or paraparesis was 4% (8 patients) and 2% (4 patients), respectively. Three (37.5%) of the 8 permanent stroke patients died during the postoperative hospital stay, compared with 2.1% of the 192 patients without stroke.

Univariate analysis indicated that previous cerebrovascular accident (P = .0002), shaggy aorta (P less than .0001), cardiopulmonary bypass time (P = .003), selective antegrade cerebral perfusion time (P = .004), operation time (P = .02), and extended aortic repair through L-incision or combined median sternotomy and left posterior lateral thoracotomy (P = .0002) were significant risk factors for neurologic morbidity.

“Preoperative intensive screening of carotid and intracranial artery disease is a useful step to identify patients at higher risk of hemodynamic ischemic stroke. Advanced systemic atherosclerosis may be a crucial determinant of perioperative stroke due to atherothrombotic embolization. Antiembolic measures during surgery are essential to prevent perioperative stroke,” the researchers concluded.

The authors reported that they had no disclosures.

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During aortic arch surgery, the lack of blood supply as a result of emboli, rather than atherosclerosis itself, kills the cerebral neurons, according to Ourania Preventza, MD, and Joseph S. Coselli, MD, of the Baylor College of Medicine, Houston, in their invited commentary (J Thorac Cardiovasc Surg. 2017;153:1054-5).

Patients with carotid and intracranial disease should indeed have more intensive screening before undergoing major aortic surgery, they agreed, but pointed out that in the absence of carotid disease, large or complex aortic atheromas can be seen in the arch, indicating that, even though atherosclerosis is a systemic disease, using different sites of prediction can be uncertain.

Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza
“Emboli can result from the presence of aneurysm, iatrogenic manipulation, inflammation, or sheer forces caused by perioperative hypertension,” they added.

This requires a broader approach to prevent stroke, including careful selection of the cannulation site in patients with diffuse and heavy arch atherosclerosis or currently ulcerated plaque, they added.

“To minimize postoperative neurologic morbidities after aortic arch surgery, an individually tailored perioperative approach should be in the armamentarium of cardiac surgeons,” Dr. Preventza and Dr. Coselli concluded.

Dr. Preventza consults for Medtronic and W. L. Gore & Associates. Dr. Coselli participates in clinical research trials conducted by GlaxoSmithKline, Edwards Lifesciences, and Bolton Medical, and consults for various companies.

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During aortic arch surgery, the lack of blood supply as a result of emboli, rather than atherosclerosis itself, kills the cerebral neurons, according to Ourania Preventza, MD, and Joseph S. Coselli, MD, of the Baylor College of Medicine, Houston, in their invited commentary (J Thorac Cardiovasc Surg. 2017;153:1054-5).

Patients with carotid and intracranial disease should indeed have more intensive screening before undergoing major aortic surgery, they agreed, but pointed out that in the absence of carotid disease, large or complex aortic atheromas can be seen in the arch, indicating that, even though atherosclerosis is a systemic disease, using different sites of prediction can be uncertain.

Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza
“Emboli can result from the presence of aneurysm, iatrogenic manipulation, inflammation, or sheer forces caused by perioperative hypertension,” they added.

This requires a broader approach to prevent stroke, including careful selection of the cannulation site in patients with diffuse and heavy arch atherosclerosis or currently ulcerated plaque, they added.

“To minimize postoperative neurologic morbidities after aortic arch surgery, an individually tailored perioperative approach should be in the armamentarium of cardiac surgeons,” Dr. Preventza and Dr. Coselli concluded.

Dr. Preventza consults for Medtronic and W. L. Gore & Associates. Dr. Coselli participates in clinical research trials conducted by GlaxoSmithKline, Edwards Lifesciences, and Bolton Medical, and consults for various companies.

Body

 

During aortic arch surgery, the lack of blood supply as a result of emboli, rather than atherosclerosis itself, kills the cerebral neurons, according to Ourania Preventza, MD, and Joseph S. Coselli, MD, of the Baylor College of Medicine, Houston, in their invited commentary (J Thorac Cardiovasc Surg. 2017;153:1054-5).

Patients with carotid and intracranial disease should indeed have more intensive screening before undergoing major aortic surgery, they agreed, but pointed out that in the absence of carotid disease, large or complex aortic atheromas can be seen in the arch, indicating that, even though atherosclerosis is a systemic disease, using different sites of prediction can be uncertain.

Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza
“Emboli can result from the presence of aneurysm, iatrogenic manipulation, inflammation, or sheer forces caused by perioperative hypertension,” they added.

This requires a broader approach to prevent stroke, including careful selection of the cannulation site in patients with diffuse and heavy arch atherosclerosis or currently ulcerated plaque, they added.

“To minimize postoperative neurologic morbidities after aortic arch surgery, an individually tailored perioperative approach should be in the armamentarium of cardiac surgeons,” Dr. Preventza and Dr. Coselli concluded.

Dr. Preventza consults for Medtronic and W. L. Gore & Associates. Dr. Coselli participates in clinical research trials conducted by GlaxoSmithKline, Edwards Lifesciences, and Bolton Medical, and consults for various companies.

Title
Lack of blood supply is the killer
Lack of blood supply is the killer

 

Embolization was the major cause of permanent stroke in patients with moderate or severe carotid or intracranial atherosclerosis who underwent elective open aortic arch surgery at a single institution, according to the results of a retrospective study.

Preoperative craniocervical and aortic screening may aid in modifying the operative strategy to reduce the incidence of stroke in these patients, according to a report published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

Preventing stroke in this patient population is an important consideration, because perioperative stroke is approximately 4 times more common in open aortic arch surgery (OAAS) than in coronary artery bypass grafting or valve surgery, according to Ken-ichi Imasaka, MD, and his colleagues at the National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.

The study population comprised 200 consecutive patients undergoing elective OAAS at the institution between October 2008 and October 2015, including 34% women and with a mean patient age of 71 years (J Thorac Cardiovasc Surg. 2017;153:1045-53).

After preoperative screening, 21% of patients were diagnosed with carotid or intracranial artery disease (CIAD). None of these patients were diagnosed with impaired cerebral perfusion reserve on brain SPECT (single-photon emission computed tomography). A total of 92% of patients underwent ascending aorta or aortic arch replacement through a median sternotomy, while the remaining 8% underwent extended aortic arch replacement via L-incision (15 patients) or combined median sternotomy and left posterior lateral thoracotomy (1 patient). Among the patients, 16% underwent ascending aorta replacement; 8% had partial arch replacement; and the remaining 76% had total arch replacement.

Shaggy aorta was present in 19% of the patients, with 51% of these showing CIAD (P less than .0001). A total of 30% of the patients with shaggy aorta had the total arch replacement through an L-incision or combined median sternotomy and left posterior lateral thoracotomy, a significant difference (P less than .0001).

Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza

The overall in-hospital mortality rate was 3.5%. The overall incidence of permanent stroke and paraplegia or paraparesis was 4% (8 patients) and 2% (4 patients), respectively. Three (37.5%) of the 8 permanent stroke patients died during the postoperative hospital stay, compared with 2.1% of the 192 patients without stroke.

Univariate analysis indicated that previous cerebrovascular accident (P = .0002), shaggy aorta (P less than .0001), cardiopulmonary bypass time (P = .003), selective antegrade cerebral perfusion time (P = .004), operation time (P = .02), and extended aortic repair through L-incision or combined median sternotomy and left posterior lateral thoracotomy (P = .0002) were significant risk factors for neurologic morbidity.

“Preoperative intensive screening of carotid and intracranial artery disease is a useful step to identify patients at higher risk of hemodynamic ischemic stroke. Advanced systemic atherosclerosis may be a crucial determinant of perioperative stroke due to atherothrombotic embolization. Antiembolic measures during surgery are essential to prevent perioperative stroke,” the researchers concluded.

The authors reported that they had no disclosures.

 

Embolization was the major cause of permanent stroke in patients with moderate or severe carotid or intracranial atherosclerosis who underwent elective open aortic arch surgery at a single institution, according to the results of a retrospective study.

Preoperative craniocervical and aortic screening may aid in modifying the operative strategy to reduce the incidence of stroke in these patients, according to a report published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

Preventing stroke in this patient population is an important consideration, because perioperative stroke is approximately 4 times more common in open aortic arch surgery (OAAS) than in coronary artery bypass grafting or valve surgery, according to Ken-ichi Imasaka, MD, and his colleagues at the National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.

The study population comprised 200 consecutive patients undergoing elective OAAS at the institution between October 2008 and October 2015, including 34% women and with a mean patient age of 71 years (J Thorac Cardiovasc Surg. 2017;153:1045-53).

After preoperative screening, 21% of patients were diagnosed with carotid or intracranial artery disease (CIAD). None of these patients were diagnosed with impaired cerebral perfusion reserve on brain SPECT (single-photon emission computed tomography). A total of 92% of patients underwent ascending aorta or aortic arch replacement through a median sternotomy, while the remaining 8% underwent extended aortic arch replacement via L-incision (15 patients) or combined median sternotomy and left posterior lateral thoracotomy (1 patient). Among the patients, 16% underwent ascending aorta replacement; 8% had partial arch replacement; and the remaining 76% had total arch replacement.

Shaggy aorta was present in 19% of the patients, with 51% of these showing CIAD (P less than .0001). A total of 30% of the patients with shaggy aorta had the total arch replacement through an L-incision or combined median sternotomy and left posterior lateral thoracotomy, a significant difference (P less than .0001).

Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza of the Baylor College of Medicine, Houston
Dr. Ourania Preventza

The overall in-hospital mortality rate was 3.5%. The overall incidence of permanent stroke and paraplegia or paraparesis was 4% (8 patients) and 2% (4 patients), respectively. Three (37.5%) of the 8 permanent stroke patients died during the postoperative hospital stay, compared with 2.1% of the 192 patients without stroke.

Univariate analysis indicated that previous cerebrovascular accident (P = .0002), shaggy aorta (P less than .0001), cardiopulmonary bypass time (P = .003), selective antegrade cerebral perfusion time (P = .004), operation time (P = .02), and extended aortic repair through L-incision or combined median sternotomy and left posterior lateral thoracotomy (P = .0002) were significant risk factors for neurologic morbidity.

“Preoperative intensive screening of carotid and intracranial artery disease is a useful step to identify patients at higher risk of hemodynamic ischemic stroke. Advanced systemic atherosclerosis may be a crucial determinant of perioperative stroke due to atherothrombotic embolization. Antiembolic measures during surgery are essential to prevent perioperative stroke,” the researchers concluded.

The authors reported that they had no disclosures.

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Key clinical point: Antiembolic methods are critical to preventing perioperative stroke in this population.

Major finding: Previous cerebrovascular accident and shaggy aorta were significant determinants of neurologic morbidity.

Data source: Retrospective study of 200 consecutive patients undergoing elective aortic arch surgery at a single institution.

Disclosures: The authors reported having no conflicts of interest.

Spontaneous coronary artery dissection: New insights

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– Patients with spontaneous coronary artery dissection as their presentation of acute coronary syndrome have a markedly better long-term survival rate than do patients with ACS in its various other forms, Rahul Potluri, MD, reported at the annual meeting of the American College of Cardiology.

In his retrospective cohort study of 182 U.K. patients diagnosed with spontaneous coronary artery dissection (SCAD) as the cause of their ACS and 32,981 controls with ACS without SCAD, the 15-year all-cause mortality rate was 10.4% in the SCAD group vs. 32.1% in the controls.

Although SCAD was first described in 1931, half of the roughly 1,500 cases reported in the medical literature have been published within the past 5 years. That makes this series of 182 SCAD patients with 15-year outcome data unique in providing the longest follow-up to date reported in a sizable patient series, said Dr. Potluri of the University of Alberta, Edmonton, and Aston University in Birmingham, England.

Dr. Rahul Potluri
Bruce Jancin/Frontline Medical News
Dr. Rahul Potluri
For decades SCAD was thought to be rare, with an estimated prevalence of 0.1%-0.5% among patients presenting with ACS. But with increased use of high-resolution intracoronary imaging and growing physician awareness, more recent reports suggest that SCAD actually accounts for 2%-4% of all ACS cases. Moreover, among women with ACS before age 50, the prevalence of SCAD is now believed to be 20%-40%, Dr. Potluri noted.

SCAD is a rupture in a coronary artery wall not related to atherosclerotic heart disease, trauma, or iatrogenic causes. The dissection is thought to result from an intimal tear or medial hemorrhage from the vasa vasorum, with subsequent accumulation of blood in a false lumen.

It’s not entirely unexpected that patients with SCAD have a better long-term prognosis than do those with ACS without SCAD, Dr. Potluri said. After all, patients with SCAD tend to be considerably younger: In Dr. Potluri’s series, the average age was younger than 52 years, vs. 66 years in controls. Plus they had lower levels of cardiovascular risk factors, and by definition they were free of atherosclerotic heart disease. But SCAD often occurs in conjunction with fibromuscular dysplasia, and the long-term health implications of that combination have not been well studied.

In a multivariate logistic regression analysis adjusted for age, sex, ethnicity, and comorbid conditions, the likelihood of dying within 5 years was 89% greater in the non-SCAD group. During follow-up, the non-SCAD ACS group was 4.1-fold more likely to have another ACS and 32% more likely to be diagnosed with heart failure.

SCAD was typically managed conservatively in Dr. Potluri’s series: In the SCAD group, 11% underwent PCI and 2.7% had CABG, compared with 51% and 10.7%, respectively, of controls.

“Conservative treatment appears to be safe in the SCAD patient population,” he said.

The prevalence of SCAD in his series of more than 33,000 patients admitted for ACS to U.K. hospitals in 2000-2014 was 0.54%. Dr. Potluri said that low figure likely reflects considerable underreporting due to the fact that some data were from the early 2000s, when SCAD was still largely below physicians’ radar.

Dr. Potluri is an authority on big data analytics in medical research. He formed his 182-patient SCAD series using ACALM (Algorithm for Comorbidity, Associations, Length of Stay, and Mortality), an analytic tool he developed years ago as a medical student. At the time of his SCAD study, the ACALM registry included anonymous, deidentified data on 1.8 million U.K. patients. The ACALM methodology utilizes a form of artificial intelligence known as novel field derivation to analyze huge amalgamated data sets. This is made possible by the fact that all U.K. hospitals report patient data in an identical standardized way, which is not the case in the United States.

Dr. Potluri has previously applied the ACALM methodology to a variety of other health care issues, including studies of an association between hyperlipidemia and breast cancer, the relationship between cardiovascular disease and mental health, and the so-called weekend effect, whereby U.K. patients hospitalized for cardiovascular reasons on the weekend have higher mortality than do those admitted on weekdays.

THE ACALM registry now exceeds 4 million patients. Dr. Potluri said he plans to analyze this full group to develop a large, comprehensive SCAD patient registry. This will enable investigators to evaluate potential psychosocial risk factors for SCAD, the role of fibromuscular dysplasia and connective tissue diseases, and other practical questions.

He reported having no financial conflicts regarding his study.
 

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– Patients with spontaneous coronary artery dissection as their presentation of acute coronary syndrome have a markedly better long-term survival rate than do patients with ACS in its various other forms, Rahul Potluri, MD, reported at the annual meeting of the American College of Cardiology.

In his retrospective cohort study of 182 U.K. patients diagnosed with spontaneous coronary artery dissection (SCAD) as the cause of their ACS and 32,981 controls with ACS without SCAD, the 15-year all-cause mortality rate was 10.4% in the SCAD group vs. 32.1% in the controls.

Although SCAD was first described in 1931, half of the roughly 1,500 cases reported in the medical literature have been published within the past 5 years. That makes this series of 182 SCAD patients with 15-year outcome data unique in providing the longest follow-up to date reported in a sizable patient series, said Dr. Potluri of the University of Alberta, Edmonton, and Aston University in Birmingham, England.

Dr. Rahul Potluri
Bruce Jancin/Frontline Medical News
Dr. Rahul Potluri
For decades SCAD was thought to be rare, with an estimated prevalence of 0.1%-0.5% among patients presenting with ACS. But with increased use of high-resolution intracoronary imaging and growing physician awareness, more recent reports suggest that SCAD actually accounts for 2%-4% of all ACS cases. Moreover, among women with ACS before age 50, the prevalence of SCAD is now believed to be 20%-40%, Dr. Potluri noted.

SCAD is a rupture in a coronary artery wall not related to atherosclerotic heart disease, trauma, or iatrogenic causes. The dissection is thought to result from an intimal tear or medial hemorrhage from the vasa vasorum, with subsequent accumulation of blood in a false lumen.

It’s not entirely unexpected that patients with SCAD have a better long-term prognosis than do those with ACS without SCAD, Dr. Potluri said. After all, patients with SCAD tend to be considerably younger: In Dr. Potluri’s series, the average age was younger than 52 years, vs. 66 years in controls. Plus they had lower levels of cardiovascular risk factors, and by definition they were free of atherosclerotic heart disease. But SCAD often occurs in conjunction with fibromuscular dysplasia, and the long-term health implications of that combination have not been well studied.

In a multivariate logistic regression analysis adjusted for age, sex, ethnicity, and comorbid conditions, the likelihood of dying within 5 years was 89% greater in the non-SCAD group. During follow-up, the non-SCAD ACS group was 4.1-fold more likely to have another ACS and 32% more likely to be diagnosed with heart failure.

SCAD was typically managed conservatively in Dr. Potluri’s series: In the SCAD group, 11% underwent PCI and 2.7% had CABG, compared with 51% and 10.7%, respectively, of controls.

“Conservative treatment appears to be safe in the SCAD patient population,” he said.

The prevalence of SCAD in his series of more than 33,000 patients admitted for ACS to U.K. hospitals in 2000-2014 was 0.54%. Dr. Potluri said that low figure likely reflects considerable underreporting due to the fact that some data were from the early 2000s, when SCAD was still largely below physicians’ radar.

Dr. Potluri is an authority on big data analytics in medical research. He formed his 182-patient SCAD series using ACALM (Algorithm for Comorbidity, Associations, Length of Stay, and Mortality), an analytic tool he developed years ago as a medical student. At the time of his SCAD study, the ACALM registry included anonymous, deidentified data on 1.8 million U.K. patients. The ACALM methodology utilizes a form of artificial intelligence known as novel field derivation to analyze huge amalgamated data sets. This is made possible by the fact that all U.K. hospitals report patient data in an identical standardized way, which is not the case in the United States.

Dr. Potluri has previously applied the ACALM methodology to a variety of other health care issues, including studies of an association between hyperlipidemia and breast cancer, the relationship between cardiovascular disease and mental health, and the so-called weekend effect, whereby U.K. patients hospitalized for cardiovascular reasons on the weekend have higher mortality than do those admitted on weekdays.

THE ACALM registry now exceeds 4 million patients. Dr. Potluri said he plans to analyze this full group to develop a large, comprehensive SCAD patient registry. This will enable investigators to evaluate potential psychosocial risk factors for SCAD, the role of fibromuscular dysplasia and connective tissue diseases, and other practical questions.

He reported having no financial conflicts regarding his study.
 

 

– Patients with spontaneous coronary artery dissection as their presentation of acute coronary syndrome have a markedly better long-term survival rate than do patients with ACS in its various other forms, Rahul Potluri, MD, reported at the annual meeting of the American College of Cardiology.

In his retrospective cohort study of 182 U.K. patients diagnosed with spontaneous coronary artery dissection (SCAD) as the cause of their ACS and 32,981 controls with ACS without SCAD, the 15-year all-cause mortality rate was 10.4% in the SCAD group vs. 32.1% in the controls.

Although SCAD was first described in 1931, half of the roughly 1,500 cases reported in the medical literature have been published within the past 5 years. That makes this series of 182 SCAD patients with 15-year outcome data unique in providing the longest follow-up to date reported in a sizable patient series, said Dr. Potluri of the University of Alberta, Edmonton, and Aston University in Birmingham, England.

Dr. Rahul Potluri
Bruce Jancin/Frontline Medical News
Dr. Rahul Potluri
For decades SCAD was thought to be rare, with an estimated prevalence of 0.1%-0.5% among patients presenting with ACS. But with increased use of high-resolution intracoronary imaging and growing physician awareness, more recent reports suggest that SCAD actually accounts for 2%-4% of all ACS cases. Moreover, among women with ACS before age 50, the prevalence of SCAD is now believed to be 20%-40%, Dr. Potluri noted.

SCAD is a rupture in a coronary artery wall not related to atherosclerotic heart disease, trauma, or iatrogenic causes. The dissection is thought to result from an intimal tear or medial hemorrhage from the vasa vasorum, with subsequent accumulation of blood in a false lumen.

It’s not entirely unexpected that patients with SCAD have a better long-term prognosis than do those with ACS without SCAD, Dr. Potluri said. After all, patients with SCAD tend to be considerably younger: In Dr. Potluri’s series, the average age was younger than 52 years, vs. 66 years in controls. Plus they had lower levels of cardiovascular risk factors, and by definition they were free of atherosclerotic heart disease. But SCAD often occurs in conjunction with fibromuscular dysplasia, and the long-term health implications of that combination have not been well studied.

In a multivariate logistic regression analysis adjusted for age, sex, ethnicity, and comorbid conditions, the likelihood of dying within 5 years was 89% greater in the non-SCAD group. During follow-up, the non-SCAD ACS group was 4.1-fold more likely to have another ACS and 32% more likely to be diagnosed with heart failure.

SCAD was typically managed conservatively in Dr. Potluri’s series: In the SCAD group, 11% underwent PCI and 2.7% had CABG, compared with 51% and 10.7%, respectively, of controls.

“Conservative treatment appears to be safe in the SCAD patient population,” he said.

The prevalence of SCAD in his series of more than 33,000 patients admitted for ACS to U.K. hospitals in 2000-2014 was 0.54%. Dr. Potluri said that low figure likely reflects considerable underreporting due to the fact that some data were from the early 2000s, when SCAD was still largely below physicians’ radar.

Dr. Potluri is an authority on big data analytics in medical research. He formed his 182-patient SCAD series using ACALM (Algorithm for Comorbidity, Associations, Length of Stay, and Mortality), an analytic tool he developed years ago as a medical student. At the time of his SCAD study, the ACALM registry included anonymous, deidentified data on 1.8 million U.K. patients. The ACALM methodology utilizes a form of artificial intelligence known as novel field derivation to analyze huge amalgamated data sets. This is made possible by the fact that all U.K. hospitals report patient data in an identical standardized way, which is not the case in the United States.

Dr. Potluri has previously applied the ACALM methodology to a variety of other health care issues, including studies of an association between hyperlipidemia and breast cancer, the relationship between cardiovascular disease and mental health, and the so-called weekend effect, whereby U.K. patients hospitalized for cardiovascular reasons on the weekend have higher mortality than do those admitted on weekdays.

THE ACALM registry now exceeds 4 million patients. Dr. Potluri said he plans to analyze this full group to develop a large, comprehensive SCAD patient registry. This will enable investigators to evaluate potential psychosocial risk factors for SCAD, the role of fibromuscular dysplasia and connective tissue diseases, and other practical questions.

He reported having no financial conflicts regarding his study.
 

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Key clinical point: Conservative management is appropriate for patients with acute coronary syndrome due to spontaneous coronary artery dissection.

Major finding: The 15-year all-cause mortality rate was 10% in patients with spontaneous coronary artery dissection, compared with 32% in those with ACS without spontaneous coronary artery dissection.

Data source: A retrospective cohort study including 15-year outcomes for 182 patients with spontaneous coronary artery dissection and more than 32,000 controls with ACS without dissection.

Disclosures: The study presenter reported having no financial conflicts.

Noncardiovascular comorbidities spike in acute heart failure

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– Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.

During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.

Dr. Abhinav Sharma
Mitchel L. Zoler/Frontline Medical News
Dr. Abhinav Sharma
This time trend suggests that clinicians should be on the lookout for NCCs in patients admitted for heart failure, and that “strategies to address the growing burden of noncardiovascular comorbidities may be a way to improve outcomes,” said Dr. Sharma, a cardiologist at Duke University in Durham, N.C.

U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”

He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.

His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.

Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.

His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.

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– Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.

During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.

Dr. Abhinav Sharma
Mitchel L. Zoler/Frontline Medical News
Dr. Abhinav Sharma
This time trend suggests that clinicians should be on the lookout for NCCs in patients admitted for heart failure, and that “strategies to address the growing burden of noncardiovascular comorbidities may be a way to improve outcomes,” said Dr. Sharma, a cardiologist at Duke University in Durham, N.C.

U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”

He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.

His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.

Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.

His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.

 

– Patients hospitalized for heart failure increasingly present with a growing number of noncardiovascular comorbidities, according to registry data from more than 300 U.S. hospitals.

During the decade of 2005-2014, the percentage of patients hospitalized for heart failure diagnosed with three or more noncardiovascular comorbidities (NCCs) jumped from abut 17% of these patients in 2005 to about 28% in 2015, Abhinav Sharma, MD, said at a meeting held by the Heart Failure Association of the ESC. This increase occurred as the percentages of hospitalized heart failure patients with none or one NCC showed clear decreases.

Dr. Abhinav Sharma
Mitchel L. Zoler/Frontline Medical News
Dr. Abhinav Sharma
This time trend suggests that clinicians should be on the lookout for NCCs in patients admitted for heart failure, and that “strategies to address the growing burden of noncardiovascular comorbidities may be a way to improve outcomes,” said Dr. Sharma, a cardiologist at Duke University in Durham, N.C.

U.S. patients hospitalized for heart failure “appear to now be sicker and more medically complex. Probably, a large number of the noncardiovascular comorbidities are not being recognized when the focus is on treating the patient’s heart failure,” he said in an interview. “If we can identify the noncardiovascular comorbidities and target appropriate treatment, it may potentially decrease the risk of readmissions.”

He included five NCCs in his analysis: chronic obstructive pulmonary disease, anemia, diabetes, chronic kidney disease, and obesity.

His analysis showed that a higher rate of readmissions, as well as increased mortality both in hospital and during the 30 days following discharge, are outcomes that all connect with increased numbers of NCCs. Patients with three or more NCCs at the time of their heart failure admission were about 50% more likely to die in hospital, about 65% more likely to die during the 30 days following admission, about 35% more likely to be readmitted, and about half as likely to be discharged home following hospitalization, when compared with patients with no NCC in multivariate analyses that adjusted for demographic and other clinical variables. Patients with three or more NCCs were also about 67% more likely to have an index hospitalization of at least 4 days, compared with patients with no NCC.

Dr. Sharma speculated that the increased prevalence of multiple NCCs in acute heart failure patients may result, in part, from secular trends in the rates of diabetes and obesity and the noncardiovascular comorbidities associated with these conditions. All five of the NCCs included in his analysis showed increased prevalence rates from 2005 to 2014 in the patients he studied. The biggest jump occurred in the prevalence of chronic obstructive pulmonary disease, which rose from about 27% in 2005 to about 35% in 2014.

His study used data collected in the Get With the Guidelines–Heart Failure Registry, which began in 2005, and included just under 208,000 total patients. He acknowledged that it is hard to know how representative these patients are of the entire population of U.S. patients hospitalized for heart failure during the study period, because the patients he studied came from a self-selected group of more than 300 hospitals that opted to participate in the registry. “We need to see if this can be extrapolated to all U.S. hospitals,” Dr. Sharma said.

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Key clinical point: U.S. patients hospitalized for heart failure showed growing numbers of noncardiovascular comorbidities.

Major finding: The prevalence of three or more noncardiovascular comorbidities jumped from about 17% in 2005 to about 28% in 2014.

Data source: Review of 207,984 U.S. hospitalized heart failure patients included in the Get With the Guidelines–Heart Failure Registry during 2005-2014.

Disclosures: Dr. Sharma has received research support from Roche Diagnostics and Takeda.