When to screen asymptomatic diabetics for CAD

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Tue, 05/03/2022 - 15:31

 

– The use of coronary artery calcium screening in the subset of asymptomatic diabetes patients at higher clinical risk of CAD appears to offer a practical strategy for identifying a subgroup in whom costlier stress cardiac imaging may be justified, Marcelo F. di Carli, MD, said at the Annual Cardiovascular Conference at Snowmass.

The ultimate goal is to reliably identify those patients who have asymptomatic diabetes with significant CAD warranting revascularization or maximal medical therapy for primary cardiovascular prevention.

“Coronary artery calcium is a simple test that’s accessible and inexpensive and can give us a quick read on the extent of atherosclerosis in the coronary arteries,” said Dr. di Carli, professor of radiology and medicine at Harvard University in Boston. “There’s good data that in diabetic patients there’s a gradation of risk across the spectrum of calcium scores. Risk increases exponentially from a coronary artery calcium score of 0 to more than 400. The calcium score can also provide a snapshot of which patients are more likely to have flow-limiting coronary disease.”

Dr. Marcello di Carli, professor of radiology and medicine at Harvard University, Boston.
Bruce Jancin/Frontline Medical News
Dr. Marcello di Carli


Atherosclerotic cardiovascular disease is the biggest contributor to the direct and indirect costs of diabetes, and diabetes experts are eager to avoid jacking up those costs further by routinely ordering stress nuclear imaging, stress echocardiography, cardiac magnetic resonance, and other expensive noninvasive imaging methods unless they can be shown to lead to improved outcomes. There is general agreement on the value of noninvasive imaging in diabetic patients with CAD symptoms. However, the routine use of such testing in asymptomatic diabetic patients has been controversial.

Indeed, according to the 2017 American Diabetes Association Standards of Medical Care in Diabetes: “In asymptomatic patients, routine screening for coronary artery disease is not recommended as it does not improve outcomes as long as atherosclerotic cardiovascular disease risk factors are treated (Diabetes Care. 2017 Jan;40[Suppl. 1]:S75-87). That’s a Level A recommendation.

But Dr. di Carli is among many cardiologists who believe this statement paints with too broad a brush. He considers it an overgeneralization that’s based on the negative results of two randomized trials of routine screening in asymptomatic diabetics: DIAD, which utilized stress single-photon emission CT (SPECT) imaging (JAMA. 2009 Apr 15;301[15]:1547-55), and FACTOR-64, which relied upon coronary CT angiography (JAMA. 2014 Dec 3;312[21]: 2234-43). Both studies found relatively low yields of severe CAD and showed no survival benefit for screening. And of course, these are also costly and inconvenient tests.

The problem in generalizing from DIAD and FACTOR-64 to the overall population of asymptomatic diabetic patients is that both studies were conducted in asymptomatic patients at the lower end of the cardiovascular risk spectrum. They were young, with an average age of 60 years. They had a history of diabetes of less than 10 years, and their diabetes was reasonably well controlled. They had normal ECGs and preserved renal function. Peripheral artery disease (PAD) was present in only 9% of the DIAD population and no one in FACTOR-64. So this would not be expected to be a high-risk/high-yield population, according to Dr. di Carli, executive director of the cardiovascular imaging program at Brigham and Women’s Hospital, Boston.

An earlier study from the Mayo Clinic identified the clinical factors that can potentially be used to identify a higher-risk cohort of asymptomatic diabetic patients in whom high-tech noninvasive testing for significant CAD may be justified, he continued. This was a nonrandomized study of 1,427 asymptomatic diabetic patients without known CAD who underwent SPECT imaging. Compared with the study populations in DIAD and FACTOR-64, the Mayo Clinic patients had a longer duration of diabetes and substantially higher rates of poor diabetes control, renal dysfunction, hypertension, and dyslipidemia. One-third of them had PAD.

Fifty-eight percent of the 1,427 patients in the Mayo cohort proved to have an abnormal SPECT imaging scan, and 18% had a high-risk scan. In a multivariate analysis, the investigators identified several factors independently associated with a high-risk scan. Q waves were present on the ECGs of 9% of the asymptomatic diabetes patients, and 43% of that subgroup had a high-risk scan. Thirty-eight percent of patients had other ECG abnormalities, and 28% of them had a high-risk scan. Age greater than 65 was associated with an increased likelihood of a high-risk SPECT result. And 28% of patients with PAD had a high-risk scan.

On the other hand, the likelihood of a high-risk scan in the 69% of subjects without PAD was 14% (J Am Coll Cardiol. 2005 Jan 4;45[1]:43-9).

The 2017 ADA guidelines acknowledge this and similar evidence by providing as a relatively weak Level E recommendation: “Consider screening for CAD in the presence of any of the following: atypical cardiac symptoms (e.g., unexplained dyspnea, chest discomfort); signs of symptoms of associated vascular disease including carotid bruits, transient ischemic attack, stroke, claudication, or PAD; or electrogram abnormalities (e.g., Q waves).”

Dr. di Carli would add to that list age older than 65, diabetes duration of greater than 10 years, poor diabetes control, and a high burden of standard cardiovascular risk factors. And he proposed the coronary artery calcium (CAC) score as a sensible gateway to selective use of further screening tests, citing as support a report from the National Institutes of Health–sponsored Multi-Ethnic Study of Atherosclerosis (MESA).

The MESA investigators assessed CAC in 6,603 persons aged 45-84 free of known CAD at baseline, including 881 with diabetes. Participants were subsequently followed prospectively for an average of 6.4 years. Compared with diabetes patients who had a baseline CAC score of 0, those with a score of 1-99 were at a risk factor– and ethnicity-adjusted 2.9-fold increased risk for developing coronary heart disease during the follow-up period. The CHD risk climbed stepwise with an increasing CAC score such that subjects with a score of 400 or higher were at 9.5-fold increased risk (Diabetes Care. 2011 Oct;34[10]L2285-90).

Using CAC measurement in this way as a screening tool in asymptomatic diabetes patients with clinical factors placing them at higher risk of significant CAD is consistent with appropriate use criteria for the detection and risk assessment of stable ischemic heart disease. The criteria were provided in a 2014 joint report by the American College of Cardiology, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.

The report rates CAC testing as “May Be Appropriate” for asymptomatic patients of intermediate or high global risk. As such, CAC “can be an option for further evaluation of potential SIHD [stable ischemic heart disease] in an individual patient when deemed reasonable by the patient’s physician,” according to the appropriate use criteria guidance, which was created with the express purpose of developing standards to avoid overuse of costly cardiovascular testing (J Am Coll Cardiol. 2014 Feb 4;63[4]:380-406).

Dr. di Carli reported having no financial conflicts.

 

 

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– The use of coronary artery calcium screening in the subset of asymptomatic diabetes patients at higher clinical risk of CAD appears to offer a practical strategy for identifying a subgroup in whom costlier stress cardiac imaging may be justified, Marcelo F. di Carli, MD, said at the Annual Cardiovascular Conference at Snowmass.

The ultimate goal is to reliably identify those patients who have asymptomatic diabetes with significant CAD warranting revascularization or maximal medical therapy for primary cardiovascular prevention.

“Coronary artery calcium is a simple test that’s accessible and inexpensive and can give us a quick read on the extent of atherosclerosis in the coronary arteries,” said Dr. di Carli, professor of radiology and medicine at Harvard University in Boston. “There’s good data that in diabetic patients there’s a gradation of risk across the spectrum of calcium scores. Risk increases exponentially from a coronary artery calcium score of 0 to more than 400. The calcium score can also provide a snapshot of which patients are more likely to have flow-limiting coronary disease.”

Dr. Marcello di Carli, professor of radiology and medicine at Harvard University, Boston.
Bruce Jancin/Frontline Medical News
Dr. Marcello di Carli


Atherosclerotic cardiovascular disease is the biggest contributor to the direct and indirect costs of diabetes, and diabetes experts are eager to avoid jacking up those costs further by routinely ordering stress nuclear imaging, stress echocardiography, cardiac magnetic resonance, and other expensive noninvasive imaging methods unless they can be shown to lead to improved outcomes. There is general agreement on the value of noninvasive imaging in diabetic patients with CAD symptoms. However, the routine use of such testing in asymptomatic diabetic patients has been controversial.

Indeed, according to the 2017 American Diabetes Association Standards of Medical Care in Diabetes: “In asymptomatic patients, routine screening for coronary artery disease is not recommended as it does not improve outcomes as long as atherosclerotic cardiovascular disease risk factors are treated (Diabetes Care. 2017 Jan;40[Suppl. 1]:S75-87). That’s a Level A recommendation.

But Dr. di Carli is among many cardiologists who believe this statement paints with too broad a brush. He considers it an overgeneralization that’s based on the negative results of two randomized trials of routine screening in asymptomatic diabetics: DIAD, which utilized stress single-photon emission CT (SPECT) imaging (JAMA. 2009 Apr 15;301[15]:1547-55), and FACTOR-64, which relied upon coronary CT angiography (JAMA. 2014 Dec 3;312[21]: 2234-43). Both studies found relatively low yields of severe CAD and showed no survival benefit for screening. And of course, these are also costly and inconvenient tests.

The problem in generalizing from DIAD and FACTOR-64 to the overall population of asymptomatic diabetic patients is that both studies were conducted in asymptomatic patients at the lower end of the cardiovascular risk spectrum. They were young, with an average age of 60 years. They had a history of diabetes of less than 10 years, and their diabetes was reasonably well controlled. They had normal ECGs and preserved renal function. Peripheral artery disease (PAD) was present in only 9% of the DIAD population and no one in FACTOR-64. So this would not be expected to be a high-risk/high-yield population, according to Dr. di Carli, executive director of the cardiovascular imaging program at Brigham and Women’s Hospital, Boston.

An earlier study from the Mayo Clinic identified the clinical factors that can potentially be used to identify a higher-risk cohort of asymptomatic diabetic patients in whom high-tech noninvasive testing for significant CAD may be justified, he continued. This was a nonrandomized study of 1,427 asymptomatic diabetic patients without known CAD who underwent SPECT imaging. Compared with the study populations in DIAD and FACTOR-64, the Mayo Clinic patients had a longer duration of diabetes and substantially higher rates of poor diabetes control, renal dysfunction, hypertension, and dyslipidemia. One-third of them had PAD.

Fifty-eight percent of the 1,427 patients in the Mayo cohort proved to have an abnormal SPECT imaging scan, and 18% had a high-risk scan. In a multivariate analysis, the investigators identified several factors independently associated with a high-risk scan. Q waves were present on the ECGs of 9% of the asymptomatic diabetes patients, and 43% of that subgroup had a high-risk scan. Thirty-eight percent of patients had other ECG abnormalities, and 28% of them had a high-risk scan. Age greater than 65 was associated with an increased likelihood of a high-risk SPECT result. And 28% of patients with PAD had a high-risk scan.

On the other hand, the likelihood of a high-risk scan in the 69% of subjects without PAD was 14% (J Am Coll Cardiol. 2005 Jan 4;45[1]:43-9).

The 2017 ADA guidelines acknowledge this and similar evidence by providing as a relatively weak Level E recommendation: “Consider screening for CAD in the presence of any of the following: atypical cardiac symptoms (e.g., unexplained dyspnea, chest discomfort); signs of symptoms of associated vascular disease including carotid bruits, transient ischemic attack, stroke, claudication, or PAD; or electrogram abnormalities (e.g., Q waves).”

Dr. di Carli would add to that list age older than 65, diabetes duration of greater than 10 years, poor diabetes control, and a high burden of standard cardiovascular risk factors. And he proposed the coronary artery calcium (CAC) score as a sensible gateway to selective use of further screening tests, citing as support a report from the National Institutes of Health–sponsored Multi-Ethnic Study of Atherosclerosis (MESA).

The MESA investigators assessed CAC in 6,603 persons aged 45-84 free of known CAD at baseline, including 881 with diabetes. Participants were subsequently followed prospectively for an average of 6.4 years. Compared with diabetes patients who had a baseline CAC score of 0, those with a score of 1-99 were at a risk factor– and ethnicity-adjusted 2.9-fold increased risk for developing coronary heart disease during the follow-up period. The CHD risk climbed stepwise with an increasing CAC score such that subjects with a score of 400 or higher were at 9.5-fold increased risk (Diabetes Care. 2011 Oct;34[10]L2285-90).

Using CAC measurement in this way as a screening tool in asymptomatic diabetes patients with clinical factors placing them at higher risk of significant CAD is consistent with appropriate use criteria for the detection and risk assessment of stable ischemic heart disease. The criteria were provided in a 2014 joint report by the American College of Cardiology, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.

The report rates CAC testing as “May Be Appropriate” for asymptomatic patients of intermediate or high global risk. As such, CAC “can be an option for further evaluation of potential SIHD [stable ischemic heart disease] in an individual patient when deemed reasonable by the patient’s physician,” according to the appropriate use criteria guidance, which was created with the express purpose of developing standards to avoid overuse of costly cardiovascular testing (J Am Coll Cardiol. 2014 Feb 4;63[4]:380-406).

Dr. di Carli reported having no financial conflicts.

 

 

 

– The use of coronary artery calcium screening in the subset of asymptomatic diabetes patients at higher clinical risk of CAD appears to offer a practical strategy for identifying a subgroup in whom costlier stress cardiac imaging may be justified, Marcelo F. di Carli, MD, said at the Annual Cardiovascular Conference at Snowmass.

The ultimate goal is to reliably identify those patients who have asymptomatic diabetes with significant CAD warranting revascularization or maximal medical therapy for primary cardiovascular prevention.

“Coronary artery calcium is a simple test that’s accessible and inexpensive and can give us a quick read on the extent of atherosclerosis in the coronary arteries,” said Dr. di Carli, professor of radiology and medicine at Harvard University in Boston. “There’s good data that in diabetic patients there’s a gradation of risk across the spectrum of calcium scores. Risk increases exponentially from a coronary artery calcium score of 0 to more than 400. The calcium score can also provide a snapshot of which patients are more likely to have flow-limiting coronary disease.”

Dr. Marcello di Carli, professor of radiology and medicine at Harvard University, Boston.
Bruce Jancin/Frontline Medical News
Dr. Marcello di Carli


Atherosclerotic cardiovascular disease is the biggest contributor to the direct and indirect costs of diabetes, and diabetes experts are eager to avoid jacking up those costs further by routinely ordering stress nuclear imaging, stress echocardiography, cardiac magnetic resonance, and other expensive noninvasive imaging methods unless they can be shown to lead to improved outcomes. There is general agreement on the value of noninvasive imaging in diabetic patients with CAD symptoms. However, the routine use of such testing in asymptomatic diabetic patients has been controversial.

Indeed, according to the 2017 American Diabetes Association Standards of Medical Care in Diabetes: “In asymptomatic patients, routine screening for coronary artery disease is not recommended as it does not improve outcomes as long as atherosclerotic cardiovascular disease risk factors are treated (Diabetes Care. 2017 Jan;40[Suppl. 1]:S75-87). That’s a Level A recommendation.

But Dr. di Carli is among many cardiologists who believe this statement paints with too broad a brush. He considers it an overgeneralization that’s based on the negative results of two randomized trials of routine screening in asymptomatic diabetics: DIAD, which utilized stress single-photon emission CT (SPECT) imaging (JAMA. 2009 Apr 15;301[15]:1547-55), and FACTOR-64, which relied upon coronary CT angiography (JAMA. 2014 Dec 3;312[21]: 2234-43). Both studies found relatively low yields of severe CAD and showed no survival benefit for screening. And of course, these are also costly and inconvenient tests.

The problem in generalizing from DIAD and FACTOR-64 to the overall population of asymptomatic diabetic patients is that both studies were conducted in asymptomatic patients at the lower end of the cardiovascular risk spectrum. They were young, with an average age of 60 years. They had a history of diabetes of less than 10 years, and their diabetes was reasonably well controlled. They had normal ECGs and preserved renal function. Peripheral artery disease (PAD) was present in only 9% of the DIAD population and no one in FACTOR-64. So this would not be expected to be a high-risk/high-yield population, according to Dr. di Carli, executive director of the cardiovascular imaging program at Brigham and Women’s Hospital, Boston.

An earlier study from the Mayo Clinic identified the clinical factors that can potentially be used to identify a higher-risk cohort of asymptomatic diabetic patients in whom high-tech noninvasive testing for significant CAD may be justified, he continued. This was a nonrandomized study of 1,427 asymptomatic diabetic patients without known CAD who underwent SPECT imaging. Compared with the study populations in DIAD and FACTOR-64, the Mayo Clinic patients had a longer duration of diabetes and substantially higher rates of poor diabetes control, renal dysfunction, hypertension, and dyslipidemia. One-third of them had PAD.

Fifty-eight percent of the 1,427 patients in the Mayo cohort proved to have an abnormal SPECT imaging scan, and 18% had a high-risk scan. In a multivariate analysis, the investigators identified several factors independently associated with a high-risk scan. Q waves were present on the ECGs of 9% of the asymptomatic diabetes patients, and 43% of that subgroup had a high-risk scan. Thirty-eight percent of patients had other ECG abnormalities, and 28% of them had a high-risk scan. Age greater than 65 was associated with an increased likelihood of a high-risk SPECT result. And 28% of patients with PAD had a high-risk scan.

On the other hand, the likelihood of a high-risk scan in the 69% of subjects without PAD was 14% (J Am Coll Cardiol. 2005 Jan 4;45[1]:43-9).

The 2017 ADA guidelines acknowledge this and similar evidence by providing as a relatively weak Level E recommendation: “Consider screening for CAD in the presence of any of the following: atypical cardiac symptoms (e.g., unexplained dyspnea, chest discomfort); signs of symptoms of associated vascular disease including carotid bruits, transient ischemic attack, stroke, claudication, or PAD; or electrogram abnormalities (e.g., Q waves).”

Dr. di Carli would add to that list age older than 65, diabetes duration of greater than 10 years, poor diabetes control, and a high burden of standard cardiovascular risk factors. And he proposed the coronary artery calcium (CAC) score as a sensible gateway to selective use of further screening tests, citing as support a report from the National Institutes of Health–sponsored Multi-Ethnic Study of Atherosclerosis (MESA).

The MESA investigators assessed CAC in 6,603 persons aged 45-84 free of known CAD at baseline, including 881 with diabetes. Participants were subsequently followed prospectively for an average of 6.4 years. Compared with diabetes patients who had a baseline CAC score of 0, those with a score of 1-99 were at a risk factor– and ethnicity-adjusted 2.9-fold increased risk for developing coronary heart disease during the follow-up period. The CHD risk climbed stepwise with an increasing CAC score such that subjects with a score of 400 or higher were at 9.5-fold increased risk (Diabetes Care. 2011 Oct;34[10]L2285-90).

Using CAC measurement in this way as a screening tool in asymptomatic diabetes patients with clinical factors placing them at higher risk of significant CAD is consistent with appropriate use criteria for the detection and risk assessment of stable ischemic heart disease. The criteria were provided in a 2014 joint report by the American College of Cardiology, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.

The report rates CAC testing as “May Be Appropriate” for asymptomatic patients of intermediate or high global risk. As such, CAC “can be an option for further evaluation of potential SIHD [stable ischemic heart disease] in an individual patient when deemed reasonable by the patient’s physician,” according to the appropriate use criteria guidance, which was created with the express purpose of developing standards to avoid overuse of costly cardiovascular testing (J Am Coll Cardiol. 2014 Feb 4;63[4]:380-406).

Dr. di Carli reported having no financial conflicts.

 

 

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EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS

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New ACC guidance on periprocedural management of anticoagulation in A-fib falls short

To bridge or not to bridge
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Fri, 01/18/2019 - 16:32

 

– The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.

Dr. N.A. Mark Estes, professor of medicine at Tufts University, Boston.
Bruce Jancin/Frontline Medical News
Dr. N.A. Mark Estes
“I spent the last 2 weeks trying to understand this document. It’s very well thought out and uses the best available evidence, but the evidence is very limited. I applaud the ACC for getting this information together, but since the evidence is really lacking, I think one really has to rely on practical considerations of individualized risk and benefit,” said Dr. Estes, professor of medicine at Tufts University in Boston.

The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).

The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.

“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.

If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.

“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.

The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).

“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”

The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.

“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.

Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.

Body

In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.

Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.

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Body

In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.

Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.

Body

In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.

Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.

Title
To bridge or not to bridge
To bridge or not to bridge

 

– The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.

Dr. N.A. Mark Estes, professor of medicine at Tufts University, Boston.
Bruce Jancin/Frontline Medical News
Dr. N.A. Mark Estes
“I spent the last 2 weeks trying to understand this document. It’s very well thought out and uses the best available evidence, but the evidence is very limited. I applaud the ACC for getting this information together, but since the evidence is really lacking, I think one really has to rely on practical considerations of individualized risk and benefit,” said Dr. Estes, professor of medicine at Tufts University in Boston.

The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).

The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.

“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.

If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.

“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.

The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).

“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”

The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.

“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.

Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.

 

– The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.

Dr. N.A. Mark Estes, professor of medicine at Tufts University, Boston.
Bruce Jancin/Frontline Medical News
Dr. N.A. Mark Estes
“I spent the last 2 weeks trying to understand this document. It’s very well thought out and uses the best available evidence, but the evidence is very limited. I applaud the ACC for getting this information together, but since the evidence is really lacking, I think one really has to rely on practical considerations of individualized risk and benefit,” said Dr. Estes, professor of medicine at Tufts University in Boston.

The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).

The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.

“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.

If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.

“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.

The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).

“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”

The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.

“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.

Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.

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Trials refine device therapy options for heart failure

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– The indication for primary prophylactic implantable cardioverter-defibrillator therapy in patients with nonischemic heart failure is likely to be downgraded in the next iteration of the ACC/AHA heart failure guidelines as a consequence of the negative results of the DANISH trial, William T. Abraham, MD, predicted at the Annual Cardiovascular Conference at Snowmass.

In addition to outlining where the guideline recommendations for implantable cardioverter-defibrillator (ICD) therapy stand today, and how they’re likely to change in response to the DANISH findings, he highlighted the latest patient selection criteria for cardiac resynchronization therapy (CRT), which have grown considerably more complicated over time.

Dr. William T. Abraham is professor of medicine, physiology, and cell biology and director of the division of cardiovascular medicine at Ohio State University in Columbus.
Bruce Jancin/Frontline Medical News
Dr. William T. Abraham
During the past 15 or so years, CRT and ICDs have had a remarkable impact on the treatment of heart failure, observed Dr. Abraham, professor of medicine, physiology, and cell biology and director of the division of cardiovascular medicine at Ohio State University in Columbus.

“Following the success of neurohormonal inhibitors and antagonists, our only other breakthroughs for the management of heart failure have been CRT and ICDs,” he noted.

The two device therapies are complementary, and indeed are often employed in combination.

“CRT makes patients feel better and saves lives, while ICDs prolong survival without an effect on improving heart failure per se,” the cardiologist explained.

To put the quality of life benefits of CRT into perspective, studies show that the device therapy results in a placebo-subtracted improvement on the Minnesota Living With Heart Failure Questionnaire of 9-10 points.

“This is a large and clinically meaningful improvement in quality of life. Our best drugs for heart failure – beta blockers and ACE inhibitors – improve this same measure by 4 or 5 points,” Dr. Abraham said.

Current American College of Cardiology/American Heart Association heart failure guidelines give a class I, level of evidence: A, recommendation for prophylactic ICD therapy in patients with an left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association functional class II or III symptoms despite optimal medical therapy, regardless of whether their heart failure is attributable to ischemic heart disease or nonischemic dilated cardiomyopathy.

The DANISH trial investigators looked at the evidence base for primary prevention ICDs in nonischemic heart failure and concluded it needed shoring up. The recommendation relied mainly on subgroup analyses of larger landmark trials done about 15 years ago, before major improvements in medical therapy had occurred. These reservations were the impetus for the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care.

The primary outcome in the DANISH trial – all-cause mortality – occurred in 21.6% of patients in the ICD group and 23.4% of controls during a median follow-up of 68 months, a nonsignificant difference (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

Turning to the CRT guidelines, Dr. Abraham noted that the simple, broad, class I recommendation for this form of device therapy in patients with cardiac dyssynchrony as defined by a QRS duration greater than 120 msec contained in the 2005 ACC/AHA heart failure guidelines has been whittled down over time as new evidence has unfolded. The only class I recommendation in the current guidelines is in patients with an LVEF of 35% or less, sinus rhythm, left bundle branch block with a QRS duration of 150 msec or longer, and NYHA class II, III, or ambulatory IV symptoms while on guideline-directed medical therapy (Circulation. 2012 Oct 1;126:1784-800). “That’s the money group right there. That’s the group for whom we have the greatest confidence of producing the greatest benefit with the application of cardiac resynchronization therapy,” he explained.

Studies examining the use of CRT in heart failure patients with a non–left bundle branch morphology and a QRS duration of less than 150 msec have yielded negative findings. So have attempts to utilize echocardiographic evidence of mechanical dyssynchrony rather than ECG measurement of QRS duration to guide patient selection for CRT.

“In our practice, any patient with a left bundle branch block gets a CRT device. Our confidence in its efficacy is greater in patients with a QRS of at least 150 msec, but the studies demonstrate clear benefit for patients with left bundle branch block and a QRS of 120-149 msec as well,” according to the cardiologist.

Studies also show that patients who are dependent upon ventricular pacing benefit from CRT.

“If you have a patient who requires at least 40% or more ventricular pacing and also has reduced ejection fraction heart failure, that patient should have a CRT device rather than a dual chamber ICD or standard right-sided right ventricular pacemaker,” he said.

All of this presupposes that first and foremost the patient is already on optimized guideline-directed medical therapy.

“With optimal medical therapy, some of these patients may improve their left ventricular ejection fraction above 35%, or they may become asymptomatic and no longer have an indication for CRT,” Dr. Abraham added.

The rationale for utilizing CRT in combination with an ICD is a bit shaky, resting on a single older landmark study, the COMPANION trial (N Engl J Med. 2004; 350:2140-50).

“That study wasn’t powered to answer the question of whether CRT-D [a combined CRT/ICD device] is better than CRT. Really, this remains somewhat of an unanswered question. So where are we today? Essentially, if a patient has an indication for CRT and an indication for an ICD, we implant a combined device,” he said.

Dr. Abraham reported serving as a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical.

 

 

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– The indication for primary prophylactic implantable cardioverter-defibrillator therapy in patients with nonischemic heart failure is likely to be downgraded in the next iteration of the ACC/AHA heart failure guidelines as a consequence of the negative results of the DANISH trial, William T. Abraham, MD, predicted at the Annual Cardiovascular Conference at Snowmass.

In addition to outlining where the guideline recommendations for implantable cardioverter-defibrillator (ICD) therapy stand today, and how they’re likely to change in response to the DANISH findings, he highlighted the latest patient selection criteria for cardiac resynchronization therapy (CRT), which have grown considerably more complicated over time.

Dr. William T. Abraham is professor of medicine, physiology, and cell biology and director of the division of cardiovascular medicine at Ohio State University in Columbus.
Bruce Jancin/Frontline Medical News
Dr. William T. Abraham
During the past 15 or so years, CRT and ICDs have had a remarkable impact on the treatment of heart failure, observed Dr. Abraham, professor of medicine, physiology, and cell biology and director of the division of cardiovascular medicine at Ohio State University in Columbus.

“Following the success of neurohormonal inhibitors and antagonists, our only other breakthroughs for the management of heart failure have been CRT and ICDs,” he noted.

The two device therapies are complementary, and indeed are often employed in combination.

“CRT makes patients feel better and saves lives, while ICDs prolong survival without an effect on improving heart failure per se,” the cardiologist explained.

To put the quality of life benefits of CRT into perspective, studies show that the device therapy results in a placebo-subtracted improvement on the Minnesota Living With Heart Failure Questionnaire of 9-10 points.

“This is a large and clinically meaningful improvement in quality of life. Our best drugs for heart failure – beta blockers and ACE inhibitors – improve this same measure by 4 or 5 points,” Dr. Abraham said.

Current American College of Cardiology/American Heart Association heart failure guidelines give a class I, level of evidence: A, recommendation for prophylactic ICD therapy in patients with an left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association functional class II or III symptoms despite optimal medical therapy, regardless of whether their heart failure is attributable to ischemic heart disease or nonischemic dilated cardiomyopathy.

The DANISH trial investigators looked at the evidence base for primary prevention ICDs in nonischemic heart failure and concluded it needed shoring up. The recommendation relied mainly on subgroup analyses of larger landmark trials done about 15 years ago, before major improvements in medical therapy had occurred. These reservations were the impetus for the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care.

The primary outcome in the DANISH trial – all-cause mortality – occurred in 21.6% of patients in the ICD group and 23.4% of controls during a median follow-up of 68 months, a nonsignificant difference (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

Turning to the CRT guidelines, Dr. Abraham noted that the simple, broad, class I recommendation for this form of device therapy in patients with cardiac dyssynchrony as defined by a QRS duration greater than 120 msec contained in the 2005 ACC/AHA heart failure guidelines has been whittled down over time as new evidence has unfolded. The only class I recommendation in the current guidelines is in patients with an LVEF of 35% or less, sinus rhythm, left bundle branch block with a QRS duration of 150 msec or longer, and NYHA class II, III, or ambulatory IV symptoms while on guideline-directed medical therapy (Circulation. 2012 Oct 1;126:1784-800). “That’s the money group right there. That’s the group for whom we have the greatest confidence of producing the greatest benefit with the application of cardiac resynchronization therapy,” he explained.

Studies examining the use of CRT in heart failure patients with a non–left bundle branch morphology and a QRS duration of less than 150 msec have yielded negative findings. So have attempts to utilize echocardiographic evidence of mechanical dyssynchrony rather than ECG measurement of QRS duration to guide patient selection for CRT.

“In our practice, any patient with a left bundle branch block gets a CRT device. Our confidence in its efficacy is greater in patients with a QRS of at least 150 msec, but the studies demonstrate clear benefit for patients with left bundle branch block and a QRS of 120-149 msec as well,” according to the cardiologist.

Studies also show that patients who are dependent upon ventricular pacing benefit from CRT.

“If you have a patient who requires at least 40% or more ventricular pacing and also has reduced ejection fraction heart failure, that patient should have a CRT device rather than a dual chamber ICD or standard right-sided right ventricular pacemaker,” he said.

All of this presupposes that first and foremost the patient is already on optimized guideline-directed medical therapy.

“With optimal medical therapy, some of these patients may improve their left ventricular ejection fraction above 35%, or they may become asymptomatic and no longer have an indication for CRT,” Dr. Abraham added.

The rationale for utilizing CRT in combination with an ICD is a bit shaky, resting on a single older landmark study, the COMPANION trial (N Engl J Med. 2004; 350:2140-50).

“That study wasn’t powered to answer the question of whether CRT-D [a combined CRT/ICD device] is better than CRT. Really, this remains somewhat of an unanswered question. So where are we today? Essentially, if a patient has an indication for CRT and an indication for an ICD, we implant a combined device,” he said.

Dr. Abraham reported serving as a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical.

 

 

 

– The indication for primary prophylactic implantable cardioverter-defibrillator therapy in patients with nonischemic heart failure is likely to be downgraded in the next iteration of the ACC/AHA heart failure guidelines as a consequence of the negative results of the DANISH trial, William T. Abraham, MD, predicted at the Annual Cardiovascular Conference at Snowmass.

In addition to outlining where the guideline recommendations for implantable cardioverter-defibrillator (ICD) therapy stand today, and how they’re likely to change in response to the DANISH findings, he highlighted the latest patient selection criteria for cardiac resynchronization therapy (CRT), which have grown considerably more complicated over time.

Dr. William T. Abraham is professor of medicine, physiology, and cell biology and director of the division of cardiovascular medicine at Ohio State University in Columbus.
Bruce Jancin/Frontline Medical News
Dr. William T. Abraham
During the past 15 or so years, CRT and ICDs have had a remarkable impact on the treatment of heart failure, observed Dr. Abraham, professor of medicine, physiology, and cell biology and director of the division of cardiovascular medicine at Ohio State University in Columbus.

“Following the success of neurohormonal inhibitors and antagonists, our only other breakthroughs for the management of heart failure have been CRT and ICDs,” he noted.

The two device therapies are complementary, and indeed are often employed in combination.

“CRT makes patients feel better and saves lives, while ICDs prolong survival without an effect on improving heart failure per se,” the cardiologist explained.

To put the quality of life benefits of CRT into perspective, studies show that the device therapy results in a placebo-subtracted improvement on the Minnesota Living With Heart Failure Questionnaire of 9-10 points.

“This is a large and clinically meaningful improvement in quality of life. Our best drugs for heart failure – beta blockers and ACE inhibitors – improve this same measure by 4 or 5 points,” Dr. Abraham said.

Current American College of Cardiology/American Heart Association heart failure guidelines give a class I, level of evidence: A, recommendation for prophylactic ICD therapy in patients with an left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association functional class II or III symptoms despite optimal medical therapy, regardless of whether their heart failure is attributable to ischemic heart disease or nonischemic dilated cardiomyopathy.

The DANISH trial investigators looked at the evidence base for primary prevention ICDs in nonischemic heart failure and concluded it needed shoring up. The recommendation relied mainly on subgroup analyses of larger landmark trials done about 15 years ago, before major improvements in medical therapy had occurred. These reservations were the impetus for the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care.

The primary outcome in the DANISH trial – all-cause mortality – occurred in 21.6% of patients in the ICD group and 23.4% of controls during a median follow-up of 68 months, a nonsignificant difference (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

Turning to the CRT guidelines, Dr. Abraham noted that the simple, broad, class I recommendation for this form of device therapy in patients with cardiac dyssynchrony as defined by a QRS duration greater than 120 msec contained in the 2005 ACC/AHA heart failure guidelines has been whittled down over time as new evidence has unfolded. The only class I recommendation in the current guidelines is in patients with an LVEF of 35% or less, sinus rhythm, left bundle branch block with a QRS duration of 150 msec or longer, and NYHA class II, III, or ambulatory IV symptoms while on guideline-directed medical therapy (Circulation. 2012 Oct 1;126:1784-800). “That’s the money group right there. That’s the group for whom we have the greatest confidence of producing the greatest benefit with the application of cardiac resynchronization therapy,” he explained.

Studies examining the use of CRT in heart failure patients with a non–left bundle branch morphology and a QRS duration of less than 150 msec have yielded negative findings. So have attempts to utilize echocardiographic evidence of mechanical dyssynchrony rather than ECG measurement of QRS duration to guide patient selection for CRT.

“In our practice, any patient with a left bundle branch block gets a CRT device. Our confidence in its efficacy is greater in patients with a QRS of at least 150 msec, but the studies demonstrate clear benefit for patients with left bundle branch block and a QRS of 120-149 msec as well,” according to the cardiologist.

Studies also show that patients who are dependent upon ventricular pacing benefit from CRT.

“If you have a patient who requires at least 40% or more ventricular pacing and also has reduced ejection fraction heart failure, that patient should have a CRT device rather than a dual chamber ICD or standard right-sided right ventricular pacemaker,” he said.

All of this presupposes that first and foremost the patient is already on optimized guideline-directed medical therapy.

“With optimal medical therapy, some of these patients may improve their left ventricular ejection fraction above 35%, or they may become asymptomatic and no longer have an indication for CRT,” Dr. Abraham added.

The rationale for utilizing CRT in combination with an ICD is a bit shaky, resting on a single older landmark study, the COMPANION trial (N Engl J Med. 2004; 350:2140-50).

“That study wasn’t powered to answer the question of whether CRT-D [a combined CRT/ICD device] is better than CRT. Really, this remains somewhat of an unanswered question. So where are we today? Essentially, if a patient has an indication for CRT and an indication for an ICD, we implant a combined device,” he said.

Dr. Abraham reported serving as a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical.

 

 

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STICHES boosts CABG role in severe LV dysfunction

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Wed, 01/02/2019 - 09:46

 

– Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.

Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.

He went on to describe how he applies the key study findings to individual patients.

Dr. Vinod H. Thourani
Dr. Vinod H. Thourani
STICH (Surgical Treatment for Ischemic Heart Failure) was a National Institutes of Health–sponsored 22-nation trial involving 1,212 patients with a left ventricular ejection fraction of 35% or less, no or minimal angina, a mean age of 60 years, and coronary artery disease amenable to CABG. The patients were randomized to CABG plus optimal medical therapy or optimal medical therapy alone and followed via STICHES for a median of 9.8 years.

At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.

For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.

CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).

There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.

“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.

In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).

More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).

“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”

One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.

These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.

“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.

Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.

“I think that’s something we don’t think about enough, quite honestly,” he said.

Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.

 

 

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– Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.

Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.

He went on to describe how he applies the key study findings to individual patients.

Dr. Vinod H. Thourani
Dr. Vinod H. Thourani
STICH (Surgical Treatment for Ischemic Heart Failure) was a National Institutes of Health–sponsored 22-nation trial involving 1,212 patients with a left ventricular ejection fraction of 35% or less, no or minimal angina, a mean age of 60 years, and coronary artery disease amenable to CABG. The patients were randomized to CABG plus optimal medical therapy or optimal medical therapy alone and followed via STICHES for a median of 9.8 years.

At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.

For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.

CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).

There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.

“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.

In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).

More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).

“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”

One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.

These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.

“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.

Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.

“I think that’s something we don’t think about enough, quite honestly,” he said.

Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.

 

 

 

– Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.

Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.

He went on to describe how he applies the key study findings to individual patients.

Dr. Vinod H. Thourani
Dr. Vinod H. Thourani
STICH (Surgical Treatment for Ischemic Heart Failure) was a National Institutes of Health–sponsored 22-nation trial involving 1,212 patients with a left ventricular ejection fraction of 35% or less, no or minimal angina, a mean age of 60 years, and coronary artery disease amenable to CABG. The patients were randomized to CABG plus optimal medical therapy or optimal medical therapy alone and followed via STICHES for a median of 9.8 years.

At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.

For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.

CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).

There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.

“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.

In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).

More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).

“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”

One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.

These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.

“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.

Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.

“I think that’s something we don’t think about enough, quite honestly,” he said.

Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.

 

 

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Multivessel PCI in STEMI gains traction

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– The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.

Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.

Dr. Douglas E. Drachman
Bruce Jancin/Frontline Medical News
Dr. Douglas E. Drachman
The findings from three randomized trials demonstrated that multivessel PCI in STEMI patients is safe and may result in better outcomes.

Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.

He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”

The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.

Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.

One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).

When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.

Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.

“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.

Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.

Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).

The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).

Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).

Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.

Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.

“Be thoughtful about patients who have renal dysfunction,” he added.

Dr. Drachman reported having no financial conflicts of interest.

 

 

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– The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.

Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.

Dr. Douglas E. Drachman
Bruce Jancin/Frontline Medical News
Dr. Douglas E. Drachman
The findings from three randomized trials demonstrated that multivessel PCI in STEMI patients is safe and may result in better outcomes.

Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.

He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”

The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.

Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.

One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).

When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.

Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.

“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.

Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.

Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).

The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).

Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).

Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.

Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.

“Be thoughtful about patients who have renal dysfunction,” he added.

Dr. Drachman reported having no financial conflicts of interest.

 

 

 

– The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.

Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.

Dr. Douglas E. Drachman
Bruce Jancin/Frontline Medical News
Dr. Douglas E. Drachman
The findings from three randomized trials demonstrated that multivessel PCI in STEMI patients is safe and may result in better outcomes.

Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.

He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”

The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.

Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.

One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).

When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.

Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.

“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.

Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.

Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).

The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).

Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).

Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.

Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.

“Be thoughtful about patients who have renal dysfunction,” he added.

Dr. Drachman reported having no financial conflicts of interest.

 

 

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New thinking on septal myectomy vs. alcohol ablation for obstructive cardiomyopathy

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Tue, 02/14/2023 - 13:06

 

– The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.

Dr. Rick A. Nishimura speaks during the Cardiovascular Conference at Snowmass.
Bruce Jancin/Frontline Medical News
Dr. Rick A. Nishimura
But while the outcomes of myectomy are significantly better than for septal ablation when the two procedures are done in high-volume centers, the national study showed that 80% of myectomies performed in the United States during 2003-2011 actually took place at centers doing fewer than 20 cases in total over that 9-year period. And in-hospital mortality and other key outcomes in those low-volume centers were far, far worse than when the surgery was done at one of the nation’s roughly two dozen hypertrophic cardiomyopathy centers of excellence recognized by the Hypertrophic Cardiomyopathy Association.

Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).

“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.

At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.

“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”

In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.

“One in four treated patients will not benefit,” the cardiologist emphasized.

The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.

When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.

Dr. Nishimura reported having no financial conflicts.

 

 

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– The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.

Dr. Rick A. Nishimura speaks during the Cardiovascular Conference at Snowmass.
Bruce Jancin/Frontline Medical News
Dr. Rick A. Nishimura
But while the outcomes of myectomy are significantly better than for septal ablation when the two procedures are done in high-volume centers, the national study showed that 80% of myectomies performed in the United States during 2003-2011 actually took place at centers doing fewer than 20 cases in total over that 9-year period. And in-hospital mortality and other key outcomes in those low-volume centers were far, far worse than when the surgery was done at one of the nation’s roughly two dozen hypertrophic cardiomyopathy centers of excellence recognized by the Hypertrophic Cardiomyopathy Association.

Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).

“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.

At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.

“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”

In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.

“One in four treated patients will not benefit,” the cardiologist emphasized.

The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.

When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.

Dr. Nishimura reported having no financial conflicts.

 

 

 

– The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.

Dr. Rick A. Nishimura speaks during the Cardiovascular Conference at Snowmass.
Bruce Jancin/Frontline Medical News
Dr. Rick A. Nishimura
But while the outcomes of myectomy are significantly better than for septal ablation when the two procedures are done in high-volume centers, the national study showed that 80% of myectomies performed in the United States during 2003-2011 actually took place at centers doing fewer than 20 cases in total over that 9-year period. And in-hospital mortality and other key outcomes in those low-volume centers were far, far worse than when the surgery was done at one of the nation’s roughly two dozen hypertrophic cardiomyopathy centers of excellence recognized by the Hypertrophic Cardiomyopathy Association.

Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).

“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.

At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.

“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”

In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.

“One in four treated patients will not benefit,” the cardiologist emphasized.

The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.

When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.

Dr. Nishimura reported having no financial conflicts.

 

 

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Curb AF recurrences through risk factor modification

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– Overlooking the common modifiable risk factors in patients with atrial fibrillation is missing out on an excellent opportunity to help curb the growing global pandemic of the arrhythmia, Patrick T. O’Gara, MD, said at the Annual Cardiovascular Conference at Snowmass.

“My purpose here is a wake up call to improve screening for and treatment of modifiable risk factors in patients with atrial fibrillation,” declared Dr. O’Gara, professor of medicine at Harvard Medical School, Boston.

Dr. Patrick T. O'Gara
Dr. Patrick T. O'Gara
He focused on four of these risk factors: overweight/obesity, alcohol consumption, sleep apnea, and physical inactivity. “There’s a reasonable evidence base that demonstrates attention to these particular issues – and, especially, programs designed to improve the degree to which these risk factors are present – has been associated with reductions in the recurrence of atrial fibrillation over time,” according to the cardiologist.

Overweight/obesity: Investigators at the University of Adelaide (Australia) demonstrated in the LEGACY trial that patients with atrial fibrillation (AF) and a BMI of 27 kg/m2 or more reduced their AF symptom burden in a dose-response fashion as they shed excess pounds as part of an intensive weight management program. Those who shed at least 10% of their baseline body weight had a 46% rate of 5-year freedom from AF without resort to rhythm control medications or ablation procedures of 46%. With 3%-9% weight loss, the rate was 22%. And with 3% weight loss, it was 13%.

The best results came from sustained linear weight loss. Weight fluctuations of greater than 5% – the classic yoyo dieting pattern – partially offset the overall benefit of weight loss with respect to recurrent AF (J Am Coll Cardiol. 2015 May 26;65(20):2159-69).

In a separate study, the same team of Australian investigators offered an opportunity to participate in a risk factor management program to patients with AF and a BMI of 27 kg/m2 or more who were undergoing radiofrequency ablation for their arrhythmia. Participants had significantly fewer repeat ablation procedures during followup and were also less likely to be on antiarrhythmic drugs than the patients who opted for usual care (J Am Coll Cardiol. 2014 Dec 2;64(21):2222-31).

Alcohol: The ‘holiday heart’ syndrome is well known, but alcohol consumption beyond binging can increase risk for AF. Dr. O’Gara noted that in a recent review article entitled “Alcohol and Atrial Fibrillation: A Sobering Review,” investigators at the University of Melbourne showed that while the relationship between the number of standard drinks per week and risk of cardiovascular mortality is J-shaped, with a nadir at 14-21 drinks per week in men and fewer in women, the risk of developing AF is linear over time and appears to increase incrementally with every additional drink per week (J Am Coll Cardiol. 2016 Dec 13;68(23):2567-76).

Also, a prospective study of nearly 80,000 Swedes free from AF at baseline, coupled with a meta-analysis of seven prospective studies found that for each additional drink per day consumed the risk of developing AF rose over time by roughly a further 10% compared to that of teetotalers (J Am Coll Cardiol. 2014; Jul 22;64(3):281-9).

Physical inactivity: In the prospective Tromso Study, in which more than 20,000 Norwegian adults were followed for 20 years, leisure time physical activity displayed a J-shaped relationship with the risk of developing AF. Moderately active subjects were an adjusted 19% less likely to develop AF than those with low physical activity, while the risk in subjects who regularly engaged in vigorous physical activity was 37% higher than in the low-activity group (Eur Heart J. 2016 Aug 1;37(29):2307-13).

“This effect of moderate exercise might be due to the associated weight loss, improved endothelial function, better sleep, perhaps a better balance between the sympathetic and parasympathetic nervous systems,” Dr. O’Gara observed.

How much physical activity is right for patients with AF? Dr. O’Gara said one of the best reviews he’s seen came from the University of Adelaide group (Circulation. 2016 Feb 2;133(5):457-9). They recommended a total of 120-200 minutes of exercise per week spread over three to five sessions. While the research base is strongest for moderate-intensity exercise, the Australians also noted the effectiveness and safety of a novel program of repeated 4-minute intervals of high-intensity exercise at 85%-95% of peak heart rate as demonstrated in a randomized controlled trial by investigators at the Norwegian University of Science and Technology in Trondheim. They showed this approach resulted in reduced time in AF and decreased AF symptoms coupled with improved quality of life and left atrial and ventricular function (Circulation. 2016 Feb 2;133(5):466-73).

“I think you could look at this review and feel very confident that there is some evidence base to substantiate your strong recommendation that patients actively engage in exercise as treatment for their atrial fibrillation,” the cardiologist said.

Sleep apnea: Investigators at Brigham and Women’s Hospital in Boston have demonstrated that effective treatment of sleep apnea with continuous positive airway pressure in patients with atrial fibrillation is associated with smaller atrial size and ventricular mass, lower blood pressure, and a significantly reduced risk of recurrent AF following an AF ablation procedure (J Am Heart Assoc. 2013 Nov 25;2(6):e000421).

“Sleep hygiene is one of the least attended aspects of cardiovascular health,” according to Dr. O’Gara. “We need to ask the partner or spouse, ‘How well does your partner sleep? Do you hear thrashing about, snoring, gagging, or notice restless legs?’ Heart failure folks are really tuned into this, but in the practice of seeing patients come into the emergency room with new-onset atrial fibrillation, it’s tenth on the list of five questions one would ask.”

Dr. O’Gara reported having no financial conflicts.

 

 

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– Overlooking the common modifiable risk factors in patients with atrial fibrillation is missing out on an excellent opportunity to help curb the growing global pandemic of the arrhythmia, Patrick T. O’Gara, MD, said at the Annual Cardiovascular Conference at Snowmass.

“My purpose here is a wake up call to improve screening for and treatment of modifiable risk factors in patients with atrial fibrillation,” declared Dr. O’Gara, professor of medicine at Harvard Medical School, Boston.

Dr. Patrick T. O'Gara
Dr. Patrick T. O'Gara
He focused on four of these risk factors: overweight/obesity, alcohol consumption, sleep apnea, and physical inactivity. “There’s a reasonable evidence base that demonstrates attention to these particular issues – and, especially, programs designed to improve the degree to which these risk factors are present – has been associated with reductions in the recurrence of atrial fibrillation over time,” according to the cardiologist.

Overweight/obesity: Investigators at the University of Adelaide (Australia) demonstrated in the LEGACY trial that patients with atrial fibrillation (AF) and a BMI of 27 kg/m2 or more reduced their AF symptom burden in a dose-response fashion as they shed excess pounds as part of an intensive weight management program. Those who shed at least 10% of their baseline body weight had a 46% rate of 5-year freedom from AF without resort to rhythm control medications or ablation procedures of 46%. With 3%-9% weight loss, the rate was 22%. And with 3% weight loss, it was 13%.

The best results came from sustained linear weight loss. Weight fluctuations of greater than 5% – the classic yoyo dieting pattern – partially offset the overall benefit of weight loss with respect to recurrent AF (J Am Coll Cardiol. 2015 May 26;65(20):2159-69).

In a separate study, the same team of Australian investigators offered an opportunity to participate in a risk factor management program to patients with AF and a BMI of 27 kg/m2 or more who were undergoing radiofrequency ablation for their arrhythmia. Participants had significantly fewer repeat ablation procedures during followup and were also less likely to be on antiarrhythmic drugs than the patients who opted for usual care (J Am Coll Cardiol. 2014 Dec 2;64(21):2222-31).

Alcohol: The ‘holiday heart’ syndrome is well known, but alcohol consumption beyond binging can increase risk for AF. Dr. O’Gara noted that in a recent review article entitled “Alcohol and Atrial Fibrillation: A Sobering Review,” investigators at the University of Melbourne showed that while the relationship between the number of standard drinks per week and risk of cardiovascular mortality is J-shaped, with a nadir at 14-21 drinks per week in men and fewer in women, the risk of developing AF is linear over time and appears to increase incrementally with every additional drink per week (J Am Coll Cardiol. 2016 Dec 13;68(23):2567-76).

Also, a prospective study of nearly 80,000 Swedes free from AF at baseline, coupled with a meta-analysis of seven prospective studies found that for each additional drink per day consumed the risk of developing AF rose over time by roughly a further 10% compared to that of teetotalers (J Am Coll Cardiol. 2014; Jul 22;64(3):281-9).

Physical inactivity: In the prospective Tromso Study, in which more than 20,000 Norwegian adults were followed for 20 years, leisure time physical activity displayed a J-shaped relationship with the risk of developing AF. Moderately active subjects were an adjusted 19% less likely to develop AF than those with low physical activity, while the risk in subjects who regularly engaged in vigorous physical activity was 37% higher than in the low-activity group (Eur Heart J. 2016 Aug 1;37(29):2307-13).

“This effect of moderate exercise might be due to the associated weight loss, improved endothelial function, better sleep, perhaps a better balance between the sympathetic and parasympathetic nervous systems,” Dr. O’Gara observed.

How much physical activity is right for patients with AF? Dr. O’Gara said one of the best reviews he’s seen came from the University of Adelaide group (Circulation. 2016 Feb 2;133(5):457-9). They recommended a total of 120-200 minutes of exercise per week spread over three to five sessions. While the research base is strongest for moderate-intensity exercise, the Australians also noted the effectiveness and safety of a novel program of repeated 4-minute intervals of high-intensity exercise at 85%-95% of peak heart rate as demonstrated in a randomized controlled trial by investigators at the Norwegian University of Science and Technology in Trondheim. They showed this approach resulted in reduced time in AF and decreased AF symptoms coupled with improved quality of life and left atrial and ventricular function (Circulation. 2016 Feb 2;133(5):466-73).

“I think you could look at this review and feel very confident that there is some evidence base to substantiate your strong recommendation that patients actively engage in exercise as treatment for their atrial fibrillation,” the cardiologist said.

Sleep apnea: Investigators at Brigham and Women’s Hospital in Boston have demonstrated that effective treatment of sleep apnea with continuous positive airway pressure in patients with atrial fibrillation is associated with smaller atrial size and ventricular mass, lower blood pressure, and a significantly reduced risk of recurrent AF following an AF ablation procedure (J Am Heart Assoc. 2013 Nov 25;2(6):e000421).

“Sleep hygiene is one of the least attended aspects of cardiovascular health,” according to Dr. O’Gara. “We need to ask the partner or spouse, ‘How well does your partner sleep? Do you hear thrashing about, snoring, gagging, or notice restless legs?’ Heart failure folks are really tuned into this, but in the practice of seeing patients come into the emergency room with new-onset atrial fibrillation, it’s tenth on the list of five questions one would ask.”

Dr. O’Gara reported having no financial conflicts.

 

 

 

– Overlooking the common modifiable risk factors in patients with atrial fibrillation is missing out on an excellent opportunity to help curb the growing global pandemic of the arrhythmia, Patrick T. O’Gara, MD, said at the Annual Cardiovascular Conference at Snowmass.

“My purpose here is a wake up call to improve screening for and treatment of modifiable risk factors in patients with atrial fibrillation,” declared Dr. O’Gara, professor of medicine at Harvard Medical School, Boston.

Dr. Patrick T. O'Gara
Dr. Patrick T. O'Gara
He focused on four of these risk factors: overweight/obesity, alcohol consumption, sleep apnea, and physical inactivity. “There’s a reasonable evidence base that demonstrates attention to these particular issues – and, especially, programs designed to improve the degree to which these risk factors are present – has been associated with reductions in the recurrence of atrial fibrillation over time,” according to the cardiologist.

Overweight/obesity: Investigators at the University of Adelaide (Australia) demonstrated in the LEGACY trial that patients with atrial fibrillation (AF) and a BMI of 27 kg/m2 or more reduced their AF symptom burden in a dose-response fashion as they shed excess pounds as part of an intensive weight management program. Those who shed at least 10% of their baseline body weight had a 46% rate of 5-year freedom from AF without resort to rhythm control medications or ablation procedures of 46%. With 3%-9% weight loss, the rate was 22%. And with 3% weight loss, it was 13%.

The best results came from sustained linear weight loss. Weight fluctuations of greater than 5% – the classic yoyo dieting pattern – partially offset the overall benefit of weight loss with respect to recurrent AF (J Am Coll Cardiol. 2015 May 26;65(20):2159-69).

In a separate study, the same team of Australian investigators offered an opportunity to participate in a risk factor management program to patients with AF and a BMI of 27 kg/m2 or more who were undergoing radiofrequency ablation for their arrhythmia. Participants had significantly fewer repeat ablation procedures during followup and were also less likely to be on antiarrhythmic drugs than the patients who opted for usual care (J Am Coll Cardiol. 2014 Dec 2;64(21):2222-31).

Alcohol: The ‘holiday heart’ syndrome is well known, but alcohol consumption beyond binging can increase risk for AF. Dr. O’Gara noted that in a recent review article entitled “Alcohol and Atrial Fibrillation: A Sobering Review,” investigators at the University of Melbourne showed that while the relationship between the number of standard drinks per week and risk of cardiovascular mortality is J-shaped, with a nadir at 14-21 drinks per week in men and fewer in women, the risk of developing AF is linear over time and appears to increase incrementally with every additional drink per week (J Am Coll Cardiol. 2016 Dec 13;68(23):2567-76).

Also, a prospective study of nearly 80,000 Swedes free from AF at baseline, coupled with a meta-analysis of seven prospective studies found that for each additional drink per day consumed the risk of developing AF rose over time by roughly a further 10% compared to that of teetotalers (J Am Coll Cardiol. 2014; Jul 22;64(3):281-9).

Physical inactivity: In the prospective Tromso Study, in which more than 20,000 Norwegian adults were followed for 20 years, leisure time physical activity displayed a J-shaped relationship with the risk of developing AF. Moderately active subjects were an adjusted 19% less likely to develop AF than those with low physical activity, while the risk in subjects who regularly engaged in vigorous physical activity was 37% higher than in the low-activity group (Eur Heart J. 2016 Aug 1;37(29):2307-13).

“This effect of moderate exercise might be due to the associated weight loss, improved endothelial function, better sleep, perhaps a better balance between the sympathetic and parasympathetic nervous systems,” Dr. O’Gara observed.

How much physical activity is right for patients with AF? Dr. O’Gara said one of the best reviews he’s seen came from the University of Adelaide group (Circulation. 2016 Feb 2;133(5):457-9). They recommended a total of 120-200 minutes of exercise per week spread over three to five sessions. While the research base is strongest for moderate-intensity exercise, the Australians also noted the effectiveness and safety of a novel program of repeated 4-minute intervals of high-intensity exercise at 85%-95% of peak heart rate as demonstrated in a randomized controlled trial by investigators at the Norwegian University of Science and Technology in Trondheim. They showed this approach resulted in reduced time in AF and decreased AF symptoms coupled with improved quality of life and left atrial and ventricular function (Circulation. 2016 Feb 2;133(5):466-73).

“I think you could look at this review and feel very confident that there is some evidence base to substantiate your strong recommendation that patients actively engage in exercise as treatment for their atrial fibrillation,” the cardiologist said.

Sleep apnea: Investigators at Brigham and Women’s Hospital in Boston have demonstrated that effective treatment of sleep apnea with continuous positive airway pressure in patients with atrial fibrillation is associated with smaller atrial size and ventricular mass, lower blood pressure, and a significantly reduced risk of recurrent AF following an AF ablation procedure (J Am Heart Assoc. 2013 Nov 25;2(6):e000421).

“Sleep hygiene is one of the least attended aspects of cardiovascular health,” according to Dr. O’Gara. “We need to ask the partner or spouse, ‘How well does your partner sleep? Do you hear thrashing about, snoring, gagging, or notice restless legs?’ Heart failure folks are really tuned into this, but in the practice of seeing patients come into the emergency room with new-onset atrial fibrillation, it’s tenth on the list of five questions one would ask.”

Dr. O’Gara reported having no financial conflicts.

 

 

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EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS

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