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Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
AHA/ACC issue updated chronic coronary disease guidelines
The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.
Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.
It was published online in Circulation and the Journal of the American College of Cardiology .
Among the key recommendations were the following.
- Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
- Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
- Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
- Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
- The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
- Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
- Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
- Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
- Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
- Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
Living document
The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.
“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.
“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.
“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.
The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.
Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.
It was published online in Circulation and the Journal of the American College of Cardiology .
Among the key recommendations were the following.
- Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
- Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
- Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
- Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
- The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
- Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
- Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
- Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
- Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
- Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
Living document
The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.
“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.
“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.
“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.
The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.
Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.
It was published online in Circulation and the Journal of the American College of Cardiology .
Among the key recommendations were the following.
- Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
- Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
- Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
- Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
- The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
- Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
- Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
- Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
- Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
- Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
Living document
The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.
“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.
“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.
“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.
The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
New AHA/ACC performance, quality metrics for coronary revascularization
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
U.S. News ranks top cardiology, heart surgery hospitals
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
Rheumatoid arthritis may raise risk for aortic stenosis
Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.
RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote.
In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019.
The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively).
The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death.
Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA.
The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.
Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).
After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.
The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote.
Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.
The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status.
Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded.
The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.
A version of this article appeared on Medscape.com.
Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.
RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote.
In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019.
The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively).
The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death.
Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA.
The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.
Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).
After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.
The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote.
Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.
The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status.
Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded.
The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.
A version of this article appeared on Medscape.com.
Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.
RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote.
In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019.
The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively).
The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death.
Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA.
The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.
Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).
After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.
The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote.
Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.
The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status.
Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded.
The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.
A version of this article appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
PAD procedure overuse: A field in peril or ‘a few bad apples’?
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Class I recall of all Impella left-sided heart pumps
– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Statins post PCI: Moderate intensity plus ezetimibe may be preferable
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
FROM JACC
Class I recall of Abbott Amplatzer delivery sheath
because of an increased risk of air embolism, the Food and Drug Administration has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
A version of this article appeared on Medscape.com.
because of an increased risk of air embolism, the Food and Drug Administration has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
A version of this article appeared on Medscape.com.
because of an increased risk of air embolism, the Food and Drug Administration has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
A version of this article appeared on Medscape.com.
Same-session PCI rates ‘surprisingly high’
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
FROM JACC; CARDIOVASCULAR INTERVENTIONS