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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
Invasive test may cut health care costs related to angina without obstructive CAD
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION: CARDIOVASCULAR INTERVENTIONS
Aspirin not the best antiplatelet for CAD secondary prevention in meta-analysis
such as clopidogrel or ticagrelor rather than aspirin, suggests a patient-level meta-analysis of seven randomized trials.
The more than 24,000 patients in the meta-analysis, called PANTHER, had documented stable CAD, prior myocardial infarction (MI), or recent or remote surgical or percutaneous coronary revascularization.
About half of patients in each antiplatelet monotherapy trial received clopidogrel or ticagrelor, and the other half received aspirin. Follow-ups ranged from 6 months to 3 years.
Those taking a P2Y12 inhibitor showed a 12% reduction in risk (P = .012) for the primary efficacy outcome, a composite of cardiovascular (CV) death, MI, and stroke, over a median of about 1.35 years. The difference was driven primarily by a 23% reduction in risk for MI (P < .001); mortality seemed unaffected by antiplatelet treatment assignment.
Although the P2Y12 inhibitor and aspirin groups were similar with respect to risk of major bleeding, the P2Y12 inhibitor group showed significant reductions in risk for gastrointestinal (GI) bleeding, definite stent thrombosis, and hemorrhagic stroke; rates of hemorrhagic stroke were well under 1% in both groups.
The treatment effects were consistent across patient subgroups, including whether the aspirin comparison was with clopidogrel or ticagrelor.
“Taken together, our data challenge the central role of aspirin in secondary prevention and support a paradigm shift toward P2Y12 inhibitor monotherapy as long-term antiplatelet strategy in the sizable population of patients with coronary atherosclerosis,” Felice Gragnano, MD, PhD, said in an interview. “Given [their] superior efficacy and similar overall safety, P2Y12 inhibitors may be preferred [over] aspirin for the prevention of cardiovascular events in patients with CAD.”
Dr. Gragnano, of the University of Campania Luigi Vanvitelli, Caserta, Italy, who called PANTHER “the largest and most comprehensive synthesis of individual patient data from randomized trials comparing P2Y12 inhibitor monotherapy with aspirin monotherapy,” is lead author of the study, which was published online in the Journal of the American College of Cardiology.
Current guidelines recommend aspirin for antiplatelet monotherapy for patients with established CAD, Dr. Gragnano said, but “the primacy of aspirin in secondary prevention is based on historical trials conducted in the 1970s and 1980s and may not apply to contemporary practice.”
Moreover, later trials that compared P2Y12 inhibitors with aspirin for secondary prevention produced “inconsistent results,” possibly owing to their heterogeneous populations of patients with coronary, cerebrovascular, or peripheral vascular disease, he said. Study-level meta-analyses in this area “provide inconclusive evidence” because they haven’t evaluated treatment effects exclusively in patients with established CAD.
Most of the seven trials’ 24,325 participants had a history of MI, and some had peripheral artery disease (PAD); the rates were 56.2% and 9.1%, respectively. Coronary revascularization, either percutaneous or surgical, had been performed for about 70%. Most (61%) had presented with acute coronary syndromes, and the remainder had presented with chronic CAD.
About 76% of the combined cohorts were from Europe or North America; the rest were from Asia. The mean age of the patients was 64 years, and about 22% were women.
In all, 12,175 had been assigned to P2Y12 inhibitor monotherapy (62% received clopidogrel and 38% received ticagrelor); 12,147 received aspirin at dosages ranging from 75 mg to 325 mg daily.
The hazard ratio (HR) for the primary efficacy outcome, P2Y12 inhibitors vs. aspirin, was significantly reduced, at 0.88 (95% confidence interval [CI], 0.79-0.97; P = .012); the number needed to treat (NNT) to prevent one primary event over 2 years was 121, the report states.
The corresponding HR for MI was 0.77 (95% CI, 0.66-0.90; P < .001), for an NNT benefit of 136. For net adverse clinical events, the HR was 0.89 (95% CI, 0.81-0.98; P = .020), for an NNT benefit of 121.
Risk for major bleeding was not significantly different (HR, 0.87; 95% CI, 0.70-1.09; P = .23), nor were risks for stroke (HR, 0.84; 95% CI, 0.70-1.02; P = .076) or cardiovascular death (HR, 1.02; 95% CI, 0.86-1.20; P = .82).
Still, the P2Y12 inhibitor group showed significant risk reductions for the following:
- GI bleeding: HR, 0.75 (95% CI, 0.57-0.97; P = .027)
- Definite stent thrombosis: HR, 0.42 (95% CI, 0.19-0.97; P = .028)
- Hemorrhagic stroke: HR, 0.43 (95% CI, 0.23-0.83; P = .012)
The current findings are “hypothesis-generating but not definitive,” Dharam Kumbhani, MD, University of Texas Southwestern, Dallas, said in an interview.
It remains unclear “whether aspirin or P2Y12 inhibitor monotherapy is better for long-term maintenance use among patients with established CAD. Aspirin has historically been the agent of choice for this indication,” said Dr. Kumbhani, who with James A. de Lemos, MD, of the same institution, wrote an editorial accompanying the PANTHER report.
“It certainly would be appropriate to consider P2Y12 monotherapy preferentially for patients with prior or currently at high risk for GI or intracranial bleeding, for instance,” Dr. Kumbhani said. For the remainder, aspirin and P2Y12 inhibitors are both “reasonable alternatives.”
In their editorial, Dr. Kumbhani and Dr. de Lemos call the PANTHER meta-analysis “a well-done study with potentially important clinical implications.” The findings “make biological sense: P2Y12 inhibitors are more potent antiplatelet agents than aspirin and have less effect on gastrointestinal mucosal integrity.”
But for now, they wrote, “both aspirin and P2Y12 inhibitors remain viable alternatives for prevention of atherothrombotic events among patients with established CAD.”
Dr. Gragnano had no disclosures; potential conflicts for the other authors are in the report. Dr. Kumbhani reports no relevant relationships; Dr. de Lemos has received honoraria for participation in data safety monitoring boards from Eli Lilly, Novo Nordisk, AstraZeneca, and Janssen.
A version of this article first appeared on Medscape.com.
such as clopidogrel or ticagrelor rather than aspirin, suggests a patient-level meta-analysis of seven randomized trials.
The more than 24,000 patients in the meta-analysis, called PANTHER, had documented stable CAD, prior myocardial infarction (MI), or recent or remote surgical or percutaneous coronary revascularization.
About half of patients in each antiplatelet monotherapy trial received clopidogrel or ticagrelor, and the other half received aspirin. Follow-ups ranged from 6 months to 3 years.
Those taking a P2Y12 inhibitor showed a 12% reduction in risk (P = .012) for the primary efficacy outcome, a composite of cardiovascular (CV) death, MI, and stroke, over a median of about 1.35 years. The difference was driven primarily by a 23% reduction in risk for MI (P < .001); mortality seemed unaffected by antiplatelet treatment assignment.
Although the P2Y12 inhibitor and aspirin groups were similar with respect to risk of major bleeding, the P2Y12 inhibitor group showed significant reductions in risk for gastrointestinal (GI) bleeding, definite stent thrombosis, and hemorrhagic stroke; rates of hemorrhagic stroke were well under 1% in both groups.
The treatment effects were consistent across patient subgroups, including whether the aspirin comparison was with clopidogrel or ticagrelor.
“Taken together, our data challenge the central role of aspirin in secondary prevention and support a paradigm shift toward P2Y12 inhibitor monotherapy as long-term antiplatelet strategy in the sizable population of patients with coronary atherosclerosis,” Felice Gragnano, MD, PhD, said in an interview. “Given [their] superior efficacy and similar overall safety, P2Y12 inhibitors may be preferred [over] aspirin for the prevention of cardiovascular events in patients with CAD.”
Dr. Gragnano, of the University of Campania Luigi Vanvitelli, Caserta, Italy, who called PANTHER “the largest and most comprehensive synthesis of individual patient data from randomized trials comparing P2Y12 inhibitor monotherapy with aspirin monotherapy,” is lead author of the study, which was published online in the Journal of the American College of Cardiology.
Current guidelines recommend aspirin for antiplatelet monotherapy for patients with established CAD, Dr. Gragnano said, but “the primacy of aspirin in secondary prevention is based on historical trials conducted in the 1970s and 1980s and may not apply to contemporary practice.”
Moreover, later trials that compared P2Y12 inhibitors with aspirin for secondary prevention produced “inconsistent results,” possibly owing to their heterogeneous populations of patients with coronary, cerebrovascular, or peripheral vascular disease, he said. Study-level meta-analyses in this area “provide inconclusive evidence” because they haven’t evaluated treatment effects exclusively in patients with established CAD.
Most of the seven trials’ 24,325 participants had a history of MI, and some had peripheral artery disease (PAD); the rates were 56.2% and 9.1%, respectively. Coronary revascularization, either percutaneous or surgical, had been performed for about 70%. Most (61%) had presented with acute coronary syndromes, and the remainder had presented with chronic CAD.
About 76% of the combined cohorts were from Europe or North America; the rest were from Asia. The mean age of the patients was 64 years, and about 22% were women.
In all, 12,175 had been assigned to P2Y12 inhibitor monotherapy (62% received clopidogrel and 38% received ticagrelor); 12,147 received aspirin at dosages ranging from 75 mg to 325 mg daily.
The hazard ratio (HR) for the primary efficacy outcome, P2Y12 inhibitors vs. aspirin, was significantly reduced, at 0.88 (95% confidence interval [CI], 0.79-0.97; P = .012); the number needed to treat (NNT) to prevent one primary event over 2 years was 121, the report states.
The corresponding HR for MI was 0.77 (95% CI, 0.66-0.90; P < .001), for an NNT benefit of 136. For net adverse clinical events, the HR was 0.89 (95% CI, 0.81-0.98; P = .020), for an NNT benefit of 121.
Risk for major bleeding was not significantly different (HR, 0.87; 95% CI, 0.70-1.09; P = .23), nor were risks for stroke (HR, 0.84; 95% CI, 0.70-1.02; P = .076) or cardiovascular death (HR, 1.02; 95% CI, 0.86-1.20; P = .82).
Still, the P2Y12 inhibitor group showed significant risk reductions for the following:
- GI bleeding: HR, 0.75 (95% CI, 0.57-0.97; P = .027)
- Definite stent thrombosis: HR, 0.42 (95% CI, 0.19-0.97; P = .028)
- Hemorrhagic stroke: HR, 0.43 (95% CI, 0.23-0.83; P = .012)
The current findings are “hypothesis-generating but not definitive,” Dharam Kumbhani, MD, University of Texas Southwestern, Dallas, said in an interview.
It remains unclear “whether aspirin or P2Y12 inhibitor monotherapy is better for long-term maintenance use among patients with established CAD. Aspirin has historically been the agent of choice for this indication,” said Dr. Kumbhani, who with James A. de Lemos, MD, of the same institution, wrote an editorial accompanying the PANTHER report.
“It certainly would be appropriate to consider P2Y12 monotherapy preferentially for patients with prior or currently at high risk for GI or intracranial bleeding, for instance,” Dr. Kumbhani said. For the remainder, aspirin and P2Y12 inhibitors are both “reasonable alternatives.”
In their editorial, Dr. Kumbhani and Dr. de Lemos call the PANTHER meta-analysis “a well-done study with potentially important clinical implications.” The findings “make biological sense: P2Y12 inhibitors are more potent antiplatelet agents than aspirin and have less effect on gastrointestinal mucosal integrity.”
But for now, they wrote, “both aspirin and P2Y12 inhibitors remain viable alternatives for prevention of atherothrombotic events among patients with established CAD.”
Dr. Gragnano had no disclosures; potential conflicts for the other authors are in the report. Dr. Kumbhani reports no relevant relationships; Dr. de Lemos has received honoraria for participation in data safety monitoring boards from Eli Lilly, Novo Nordisk, AstraZeneca, and Janssen.
A version of this article first appeared on Medscape.com.
such as clopidogrel or ticagrelor rather than aspirin, suggests a patient-level meta-analysis of seven randomized trials.
The more than 24,000 patients in the meta-analysis, called PANTHER, had documented stable CAD, prior myocardial infarction (MI), or recent or remote surgical or percutaneous coronary revascularization.
About half of patients in each antiplatelet monotherapy trial received clopidogrel or ticagrelor, and the other half received aspirin. Follow-ups ranged from 6 months to 3 years.
Those taking a P2Y12 inhibitor showed a 12% reduction in risk (P = .012) for the primary efficacy outcome, a composite of cardiovascular (CV) death, MI, and stroke, over a median of about 1.35 years. The difference was driven primarily by a 23% reduction in risk for MI (P < .001); mortality seemed unaffected by antiplatelet treatment assignment.
Although the P2Y12 inhibitor and aspirin groups were similar with respect to risk of major bleeding, the P2Y12 inhibitor group showed significant reductions in risk for gastrointestinal (GI) bleeding, definite stent thrombosis, and hemorrhagic stroke; rates of hemorrhagic stroke were well under 1% in both groups.
The treatment effects were consistent across patient subgroups, including whether the aspirin comparison was with clopidogrel or ticagrelor.
“Taken together, our data challenge the central role of aspirin in secondary prevention and support a paradigm shift toward P2Y12 inhibitor monotherapy as long-term antiplatelet strategy in the sizable population of patients with coronary atherosclerosis,” Felice Gragnano, MD, PhD, said in an interview. “Given [their] superior efficacy and similar overall safety, P2Y12 inhibitors may be preferred [over] aspirin for the prevention of cardiovascular events in patients with CAD.”
Dr. Gragnano, of the University of Campania Luigi Vanvitelli, Caserta, Italy, who called PANTHER “the largest and most comprehensive synthesis of individual patient data from randomized trials comparing P2Y12 inhibitor monotherapy with aspirin monotherapy,” is lead author of the study, which was published online in the Journal of the American College of Cardiology.
Current guidelines recommend aspirin for antiplatelet monotherapy for patients with established CAD, Dr. Gragnano said, but “the primacy of aspirin in secondary prevention is based on historical trials conducted in the 1970s and 1980s and may not apply to contemporary practice.”
Moreover, later trials that compared P2Y12 inhibitors with aspirin for secondary prevention produced “inconsistent results,” possibly owing to their heterogeneous populations of patients with coronary, cerebrovascular, or peripheral vascular disease, he said. Study-level meta-analyses in this area “provide inconclusive evidence” because they haven’t evaluated treatment effects exclusively in patients with established CAD.
Most of the seven trials’ 24,325 participants had a history of MI, and some had peripheral artery disease (PAD); the rates were 56.2% and 9.1%, respectively. Coronary revascularization, either percutaneous or surgical, had been performed for about 70%. Most (61%) had presented with acute coronary syndromes, and the remainder had presented with chronic CAD.
About 76% of the combined cohorts were from Europe or North America; the rest were from Asia. The mean age of the patients was 64 years, and about 22% were women.
In all, 12,175 had been assigned to P2Y12 inhibitor monotherapy (62% received clopidogrel and 38% received ticagrelor); 12,147 received aspirin at dosages ranging from 75 mg to 325 mg daily.
The hazard ratio (HR) for the primary efficacy outcome, P2Y12 inhibitors vs. aspirin, was significantly reduced, at 0.88 (95% confidence interval [CI], 0.79-0.97; P = .012); the number needed to treat (NNT) to prevent one primary event over 2 years was 121, the report states.
The corresponding HR for MI was 0.77 (95% CI, 0.66-0.90; P < .001), for an NNT benefit of 136. For net adverse clinical events, the HR was 0.89 (95% CI, 0.81-0.98; P = .020), for an NNT benefit of 121.
Risk for major bleeding was not significantly different (HR, 0.87; 95% CI, 0.70-1.09; P = .23), nor were risks for stroke (HR, 0.84; 95% CI, 0.70-1.02; P = .076) or cardiovascular death (HR, 1.02; 95% CI, 0.86-1.20; P = .82).
Still, the P2Y12 inhibitor group showed significant risk reductions for the following:
- GI bleeding: HR, 0.75 (95% CI, 0.57-0.97; P = .027)
- Definite stent thrombosis: HR, 0.42 (95% CI, 0.19-0.97; P = .028)
- Hemorrhagic stroke: HR, 0.43 (95% CI, 0.23-0.83; P = .012)
The current findings are “hypothesis-generating but not definitive,” Dharam Kumbhani, MD, University of Texas Southwestern, Dallas, said in an interview.
It remains unclear “whether aspirin or P2Y12 inhibitor monotherapy is better for long-term maintenance use among patients with established CAD. Aspirin has historically been the agent of choice for this indication,” said Dr. Kumbhani, who with James A. de Lemos, MD, of the same institution, wrote an editorial accompanying the PANTHER report.
“It certainly would be appropriate to consider P2Y12 monotherapy preferentially for patients with prior or currently at high risk for GI or intracranial bleeding, for instance,” Dr. Kumbhani said. For the remainder, aspirin and P2Y12 inhibitors are both “reasonable alternatives.”
In their editorial, Dr. Kumbhani and Dr. de Lemos call the PANTHER meta-analysis “a well-done study with potentially important clinical implications.” The findings “make biological sense: P2Y12 inhibitors are more potent antiplatelet agents than aspirin and have less effect on gastrointestinal mucosal integrity.”
But for now, they wrote, “both aspirin and P2Y12 inhibitors remain viable alternatives for prevention of atherothrombotic events among patients with established CAD.”
Dr. Gragnano had no disclosures; potential conflicts for the other authors are in the report. Dr. Kumbhani reports no relevant relationships; Dr. de Lemos has received honoraria for participation in data safety monitoring boards from Eli Lilly, Novo Nordisk, AstraZeneca, and Janssen.
A version of this article first appeared on Medscape.com.
FROM JACC
Expanded coverage of carotid stenting in CMS draft proposal
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS “to standard surgical risk patients by removing the limitation of coverage to only high surgical risk patients.” It would limit it to patients for whom CAS is considered “reasonable and necessary” and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to “engage in a formal shared decision-making interaction with the beneficiary” that involves use of a “validated decision-making tool.” The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as “incorporate the patient’s personal preferences and priorities.”
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the Jan. 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology and the American Heart Association.
Carotid stenting, commented the ACC/AHA, “was first introduced in 1994, and the field has matured in the last 3 decades.” The procedure “is a well-established treatment option.” The groups declared support for “removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice.”
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of “large, prospective registry-based studies” since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence “suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective” with respect to the clinical primary endpoints of recent trials “in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%.”
A version of this article appeared on Medscape.com.
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS “to standard surgical risk patients by removing the limitation of coverage to only high surgical risk patients.” It would limit it to patients for whom CAS is considered “reasonable and necessary” and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to “engage in a formal shared decision-making interaction with the beneficiary” that involves use of a “validated decision-making tool.” The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as “incorporate the patient’s personal preferences and priorities.”
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the Jan. 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology and the American Heart Association.
Carotid stenting, commented the ACC/AHA, “was first introduced in 1994, and the field has matured in the last 3 decades.” The procedure “is a well-established treatment option.” The groups declared support for “removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice.”
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of “large, prospective registry-based studies” since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence “suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective” with respect to the clinical primary endpoints of recent trials “in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%.”
A version of this article appeared on Medscape.com.
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS “to standard surgical risk patients by removing the limitation of coverage to only high surgical risk patients.” It would limit it to patients for whom CAS is considered “reasonable and necessary” and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to “engage in a formal shared decision-making interaction with the beneficiary” that involves use of a “validated decision-making tool.” The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as “incorporate the patient’s personal preferences and priorities.”
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the Jan. 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology and the American Heart Association.
Carotid stenting, commented the ACC/AHA, “was first introduced in 1994, and the field has matured in the last 3 decades.” The procedure “is a well-established treatment option.” The groups declared support for “removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice.”
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of “large, prospective registry-based studies” since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence “suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective” with respect to the clinical primary endpoints of recent trials “in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%.”
A version of this article appeared on Medscape.com.
Mixed bag: New performance data on femoral-popliteal artery revascularization
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JACC: CARDIOVASCULAR INTERVENTIONS
FDA: No excess mortality risk from paclitaxel stents, balloons for peripheral intervention
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
New AHA statement on ischemia after cardiac surgery
The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.
Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.
The new statement was published online in Circulation.
Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.
Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.
Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.
Prompt diagnosis and treatment important
Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.
because timely diagnosis and treatment are key to a good clinical outcome,” they write.
Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.
Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.
Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.
The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.
The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.
The research had no commercial funding. Disclosures for the writing group are listed with the original article.
A version of this article originally appeared on Medscape.com.
The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.
Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.
The new statement was published online in Circulation.
Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.
Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.
Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.
Prompt diagnosis and treatment important
Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.
because timely diagnosis and treatment are key to a good clinical outcome,” they write.
Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.
Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.
Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.
The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.
The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.
The research had no commercial funding. Disclosures for the writing group are listed with the original article.
A version of this article originally appeared on Medscape.com.
The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.
Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.
The new statement was published online in Circulation.
Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.
Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.
Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.
Prompt diagnosis and treatment important
Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.
because timely diagnosis and treatment are key to a good clinical outcome,” they write.
Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.
Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.
Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.
The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.
The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.
The research had no commercial funding. Disclosures for the writing group are listed with the original article.
A version of this article originally appeared on Medscape.com.
FROM CIRCULATION
TAVI turmoil: Did an ANP perform transcatheter aortic valve replacement in the U.K.?
In the United Kingdom, John Steele, an advanced nurse practitioner (ANP) at Glenfield Hospital, part of the University Hospitals of Leicester NHS Trust (UHL), was congratulated on Twitter as “the first nurse-ANP who has performed the whole TAVI procedure as the first operator – true transformation addressing NHS needs.”
The now-deleted tweet from @GHCardiology is still visible in the Twitter thread of Mamas A. Mamas, a professor of interventional cardiology at Keele University, England. “This is so inappropriate on so many levels,” Dr. Mamas tweeted. “This is not safe for patients particularly given that there are numerous TAVI trained medically qualified operators in UK. You have also taken away training opportunities for medical / surgical trainees.”
Other followers also responded, largely negatively.
“This is crazy. Is this @TheOnion???” tweeted Martha Gulati, MD, director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, Calif., in response to Dr. Mamas, referring to the popular satirical news outlet. “Seriously I can’t see this as an actuality given the potential for so many other issues they wouldn’t know how to deal with.”
Could it happen in the U.S.?
Could a U.S.-based nurse practitioner perform TAVR? Possibly. Should they? No, says Andrew M. Goldsweig, MD, chair of the U.S. Society for Cardiovascular Angiography and Interventions Structural Heart Council. “Experienced nurse practitioners who have participated as secondary operators in many TAVR procedures and have observed the primary physician operators likely know the technical steps involved in an uncomplicated transfemoral TAVR procedure,” he told this news organization.
“However, a physician’s depth and breadth of training are absolutely required both to recognize and to address any periprocedural issues,” said Dr. Goldsweig, who is also director of the cardiac catheterization laboratory and director of cardiovascular clinical research at Baystate Medical Center in Springfield, Mass.
What it takes to do TAVR
Transcatheter aortic valves were first approved by the FDA in 2011 for use in patients with severe, inoperable, aortic stenosis. The procedure is now increasingly used as an alternative to surgical AVR in intermediate- and low-risk patients and has a longer history in Europe.
Dr. Goldsweig notes that “TAVR is a complex procedure with many potential challenges. Physicians are trained to diagnose and manage vascular access complications, heart failure and respiratory complications, rhythm disturbances, stroke, paravalvular leak, valve malpositioning/embolization, cardiogenic shock, and any other issues that may arise in the peri-TAVR period.
“Physicians can perform vascular imaging and interventions, transition to alternative access, manage intubation and ventilation, facilitate embolectomy, place a pacemaker, close a paravalvular leak, capture a misplaced valve, deploy mechanical circulatory support, and perform other diagnostic and interventional procedures as necessary that are required for TAVR operators and vastly exceed the training and scope of a nurse practitioner.”
The 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology defines select competencies for interventional cardiologists who choose to focus their career on peripheral, vascular, or structural heart interventions.
In a recent article in Structural Heart, Dr. Goldsweig and colleagues write, “Training in SHD [structural heart disease] has historically been fragmented and informal. Current modes of SHD training include unaccredited fellowship training, industry-sponsored forums and device-specific training, and training through on-site proctorship.”
Such programs have grown “exponentially,” they write, “despite the conspicuous absence of formalized training requirements.”
In response to the John Steele uproar, the British Cardiovascular Intervention Society posted a statement on its website, noting, “As medicine has changed so there has increasingly been a role for allied health practitioners with advanced skills to take on responsibilities that were previously considered to be the domain of doctors ...
“TAVI procedures however carry a mortality risk, and the responsibility for undertaking a successful TAVI procedure will always lie with a Cardiologist who has had the breadth of training to manage the various complications that may occur during or after a procedure. This requires years of training, and there is no short-cut, or substitute.”
The BCIS promises a statement “later in the year [on] the expected training route for undertaking TAVI and other structural heart procedures.”
Why it matters: Scope creep
Despite the current upheaval, it’s not the first time that a nurse in the United Kingdom has performed a procedure normally performed by a medical doctor. A 3-year-old Reddit post on r/JuniorDoctorsUK points to a 2017 Guardian article titled, “Meet the nurse who will soon perform surgery on patients alone.” Although the “surgical care practitioner” seems to be performing within the scope of her practice, people responding to the post say it’s an example of “mid-level [scope] creep.”
More recently, a Reddit post in the same group points to a congratulatory post for a “nurse-led radial access.” One person commented, “Today they do the access. Tomorrow they do the full diagnostic. Day after they do the pressure wire. Next week they do the PCI [percutaneous coronary intervention].”
Broadly, “scope creep” refers to scope-of-practice expansions, but not turf wars, according to Rebekah Bernard, MD, a family physician in Fort Myers, Fla., who cowrote, “Patients at Risk: The Rise of the Nurse Practitioner and Physician Assistant in Healthcare,” with Niran Al-Agba, MD, a pediatrician in Silverdale, Wash.
The reasons behind U.K. scope creep aren’t clear. Some believe it’s money. Some say the system is broken and that doctors are being exploited.
In relation to the NP-TAVI case, the British Junior Cardiologist Association commented that it reflects a lack of support and advocacy for medical/surgical trainees who need the training opportunities that are going instead to allied health professionals.
In the United States, scope creep is being taken seriously (some may say too seriously) by the American Medical Association. The AMA is lobbying to stop “inappropriate scope expansions,” bolstered by its AMA Scope of Practice Partnership.
Pointing to a scope creep video produced by the AMA, one JuniorDoctorsUK Reddit post asks, “why isn’t the BMA doing anything similar?”
Time for a rethink?
Back to Glenfield Hospital. Not only has Cardiology Glenfield deleted the controversial tweet; it is now is backtracking on its congratulations to ANP Steele, tweeting, “We want to make clear that the lead operator for the procedure was a consultant structural interventionist. However, we are looking into the circumstances, including a review of clinical governance.” From the responses, few clinicians are buying that explanation.
In response to a request for a comment from Glenfield, Andrew Furlong, UHL medical director, reiterated to this news organization through communications manager Gareth Duggan, “We are investigating the circumstances of the procedure with our cardiology team and reviewing our governance processes.”
Dr. Goldsweig participated in a past speaking engagement for Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
In the United Kingdom, John Steele, an advanced nurse practitioner (ANP) at Glenfield Hospital, part of the University Hospitals of Leicester NHS Trust (UHL), was congratulated on Twitter as “the first nurse-ANP who has performed the whole TAVI procedure as the first operator – true transformation addressing NHS needs.”
The now-deleted tweet from @GHCardiology is still visible in the Twitter thread of Mamas A. Mamas, a professor of interventional cardiology at Keele University, England. “This is so inappropriate on so many levels,” Dr. Mamas tweeted. “This is not safe for patients particularly given that there are numerous TAVI trained medically qualified operators in UK. You have also taken away training opportunities for medical / surgical trainees.”
Other followers also responded, largely negatively.
“This is crazy. Is this @TheOnion???” tweeted Martha Gulati, MD, director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, Calif., in response to Dr. Mamas, referring to the popular satirical news outlet. “Seriously I can’t see this as an actuality given the potential for so many other issues they wouldn’t know how to deal with.”
Could it happen in the U.S.?
Could a U.S.-based nurse practitioner perform TAVR? Possibly. Should they? No, says Andrew M. Goldsweig, MD, chair of the U.S. Society for Cardiovascular Angiography and Interventions Structural Heart Council. “Experienced nurse practitioners who have participated as secondary operators in many TAVR procedures and have observed the primary physician operators likely know the technical steps involved in an uncomplicated transfemoral TAVR procedure,” he told this news organization.
“However, a physician’s depth and breadth of training are absolutely required both to recognize and to address any periprocedural issues,” said Dr. Goldsweig, who is also director of the cardiac catheterization laboratory and director of cardiovascular clinical research at Baystate Medical Center in Springfield, Mass.
What it takes to do TAVR
Transcatheter aortic valves were first approved by the FDA in 2011 for use in patients with severe, inoperable, aortic stenosis. The procedure is now increasingly used as an alternative to surgical AVR in intermediate- and low-risk patients and has a longer history in Europe.
Dr. Goldsweig notes that “TAVR is a complex procedure with many potential challenges. Physicians are trained to diagnose and manage vascular access complications, heart failure and respiratory complications, rhythm disturbances, stroke, paravalvular leak, valve malpositioning/embolization, cardiogenic shock, and any other issues that may arise in the peri-TAVR period.
“Physicians can perform vascular imaging and interventions, transition to alternative access, manage intubation and ventilation, facilitate embolectomy, place a pacemaker, close a paravalvular leak, capture a misplaced valve, deploy mechanical circulatory support, and perform other diagnostic and interventional procedures as necessary that are required for TAVR operators and vastly exceed the training and scope of a nurse practitioner.”
The 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology defines select competencies for interventional cardiologists who choose to focus their career on peripheral, vascular, or structural heart interventions.
In a recent article in Structural Heart, Dr. Goldsweig and colleagues write, “Training in SHD [structural heart disease] has historically been fragmented and informal. Current modes of SHD training include unaccredited fellowship training, industry-sponsored forums and device-specific training, and training through on-site proctorship.”
Such programs have grown “exponentially,” they write, “despite the conspicuous absence of formalized training requirements.”
In response to the John Steele uproar, the British Cardiovascular Intervention Society posted a statement on its website, noting, “As medicine has changed so there has increasingly been a role for allied health practitioners with advanced skills to take on responsibilities that were previously considered to be the domain of doctors ...
“TAVI procedures however carry a mortality risk, and the responsibility for undertaking a successful TAVI procedure will always lie with a Cardiologist who has had the breadth of training to manage the various complications that may occur during or after a procedure. This requires years of training, and there is no short-cut, or substitute.”
The BCIS promises a statement “later in the year [on] the expected training route for undertaking TAVI and other structural heart procedures.”
Why it matters: Scope creep
Despite the current upheaval, it’s not the first time that a nurse in the United Kingdom has performed a procedure normally performed by a medical doctor. A 3-year-old Reddit post on r/JuniorDoctorsUK points to a 2017 Guardian article titled, “Meet the nurse who will soon perform surgery on patients alone.” Although the “surgical care practitioner” seems to be performing within the scope of her practice, people responding to the post say it’s an example of “mid-level [scope] creep.”
More recently, a Reddit post in the same group points to a congratulatory post for a “nurse-led radial access.” One person commented, “Today they do the access. Tomorrow they do the full diagnostic. Day after they do the pressure wire. Next week they do the PCI [percutaneous coronary intervention].”
Broadly, “scope creep” refers to scope-of-practice expansions, but not turf wars, according to Rebekah Bernard, MD, a family physician in Fort Myers, Fla., who cowrote, “Patients at Risk: The Rise of the Nurse Practitioner and Physician Assistant in Healthcare,” with Niran Al-Agba, MD, a pediatrician in Silverdale, Wash.
The reasons behind U.K. scope creep aren’t clear. Some believe it’s money. Some say the system is broken and that doctors are being exploited.
In relation to the NP-TAVI case, the British Junior Cardiologist Association commented that it reflects a lack of support and advocacy for medical/surgical trainees who need the training opportunities that are going instead to allied health professionals.
In the United States, scope creep is being taken seriously (some may say too seriously) by the American Medical Association. The AMA is lobbying to stop “inappropriate scope expansions,” bolstered by its AMA Scope of Practice Partnership.
Pointing to a scope creep video produced by the AMA, one JuniorDoctorsUK Reddit post asks, “why isn’t the BMA doing anything similar?”
Time for a rethink?
Back to Glenfield Hospital. Not only has Cardiology Glenfield deleted the controversial tweet; it is now is backtracking on its congratulations to ANP Steele, tweeting, “We want to make clear that the lead operator for the procedure was a consultant structural interventionist. However, we are looking into the circumstances, including a review of clinical governance.” From the responses, few clinicians are buying that explanation.
In response to a request for a comment from Glenfield, Andrew Furlong, UHL medical director, reiterated to this news organization through communications manager Gareth Duggan, “We are investigating the circumstances of the procedure with our cardiology team and reviewing our governance processes.”
Dr. Goldsweig participated in a past speaking engagement for Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
In the United Kingdom, John Steele, an advanced nurse practitioner (ANP) at Glenfield Hospital, part of the University Hospitals of Leicester NHS Trust (UHL), was congratulated on Twitter as “the first nurse-ANP who has performed the whole TAVI procedure as the first operator – true transformation addressing NHS needs.”
The now-deleted tweet from @GHCardiology is still visible in the Twitter thread of Mamas A. Mamas, a professor of interventional cardiology at Keele University, England. “This is so inappropriate on so many levels,” Dr. Mamas tweeted. “This is not safe for patients particularly given that there are numerous TAVI trained medically qualified operators in UK. You have also taken away training opportunities for medical / surgical trainees.”
Other followers also responded, largely negatively.
“This is crazy. Is this @TheOnion???” tweeted Martha Gulati, MD, director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, Calif., in response to Dr. Mamas, referring to the popular satirical news outlet. “Seriously I can’t see this as an actuality given the potential for so many other issues they wouldn’t know how to deal with.”
Could it happen in the U.S.?
Could a U.S.-based nurse practitioner perform TAVR? Possibly. Should they? No, says Andrew M. Goldsweig, MD, chair of the U.S. Society for Cardiovascular Angiography and Interventions Structural Heart Council. “Experienced nurse practitioners who have participated as secondary operators in many TAVR procedures and have observed the primary physician operators likely know the technical steps involved in an uncomplicated transfemoral TAVR procedure,” he told this news organization.
“However, a physician’s depth and breadth of training are absolutely required both to recognize and to address any periprocedural issues,” said Dr. Goldsweig, who is also director of the cardiac catheterization laboratory and director of cardiovascular clinical research at Baystate Medical Center in Springfield, Mass.
What it takes to do TAVR
Transcatheter aortic valves were first approved by the FDA in 2011 for use in patients with severe, inoperable, aortic stenosis. The procedure is now increasingly used as an alternative to surgical AVR in intermediate- and low-risk patients and has a longer history in Europe.
Dr. Goldsweig notes that “TAVR is a complex procedure with many potential challenges. Physicians are trained to diagnose and manage vascular access complications, heart failure and respiratory complications, rhythm disturbances, stroke, paravalvular leak, valve malpositioning/embolization, cardiogenic shock, and any other issues that may arise in the peri-TAVR period.
“Physicians can perform vascular imaging and interventions, transition to alternative access, manage intubation and ventilation, facilitate embolectomy, place a pacemaker, close a paravalvular leak, capture a misplaced valve, deploy mechanical circulatory support, and perform other diagnostic and interventional procedures as necessary that are required for TAVR operators and vastly exceed the training and scope of a nurse practitioner.”
The 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology defines select competencies for interventional cardiologists who choose to focus their career on peripheral, vascular, or structural heart interventions.
In a recent article in Structural Heart, Dr. Goldsweig and colleagues write, “Training in SHD [structural heart disease] has historically been fragmented and informal. Current modes of SHD training include unaccredited fellowship training, industry-sponsored forums and device-specific training, and training through on-site proctorship.”
Such programs have grown “exponentially,” they write, “despite the conspicuous absence of formalized training requirements.”
In response to the John Steele uproar, the British Cardiovascular Intervention Society posted a statement on its website, noting, “As medicine has changed so there has increasingly been a role for allied health practitioners with advanced skills to take on responsibilities that were previously considered to be the domain of doctors ...
“TAVI procedures however carry a mortality risk, and the responsibility for undertaking a successful TAVI procedure will always lie with a Cardiologist who has had the breadth of training to manage the various complications that may occur during or after a procedure. This requires years of training, and there is no short-cut, or substitute.”
The BCIS promises a statement “later in the year [on] the expected training route for undertaking TAVI and other structural heart procedures.”
Why it matters: Scope creep
Despite the current upheaval, it’s not the first time that a nurse in the United Kingdom has performed a procedure normally performed by a medical doctor. A 3-year-old Reddit post on r/JuniorDoctorsUK points to a 2017 Guardian article titled, “Meet the nurse who will soon perform surgery on patients alone.” Although the “surgical care practitioner” seems to be performing within the scope of her practice, people responding to the post say it’s an example of “mid-level [scope] creep.”
More recently, a Reddit post in the same group points to a congratulatory post for a “nurse-led radial access.” One person commented, “Today they do the access. Tomorrow they do the full diagnostic. Day after they do the pressure wire. Next week they do the PCI [percutaneous coronary intervention].”
Broadly, “scope creep” refers to scope-of-practice expansions, but not turf wars, according to Rebekah Bernard, MD, a family physician in Fort Myers, Fla., who cowrote, “Patients at Risk: The Rise of the Nurse Practitioner and Physician Assistant in Healthcare,” with Niran Al-Agba, MD, a pediatrician in Silverdale, Wash.
The reasons behind U.K. scope creep aren’t clear. Some believe it’s money. Some say the system is broken and that doctors are being exploited.
In relation to the NP-TAVI case, the British Junior Cardiologist Association commented that it reflects a lack of support and advocacy for medical/surgical trainees who need the training opportunities that are going instead to allied health professionals.
In the United States, scope creep is being taken seriously (some may say too seriously) by the American Medical Association. The AMA is lobbying to stop “inappropriate scope expansions,” bolstered by its AMA Scope of Practice Partnership.
Pointing to a scope creep video produced by the AMA, one JuniorDoctorsUK Reddit post asks, “why isn’t the BMA doing anything similar?”
Time for a rethink?
Back to Glenfield Hospital. Not only has Cardiology Glenfield deleted the controversial tweet; it is now is backtracking on its congratulations to ANP Steele, tweeting, “We want to make clear that the lead operator for the procedure was a consultant structural interventionist. However, we are looking into the circumstances, including a review of clinical governance.” From the responses, few clinicians are buying that explanation.
In response to a request for a comment from Glenfield, Andrew Furlong, UHL medical director, reiterated to this news organization through communications manager Gareth Duggan, “We are investigating the circumstances of the procedure with our cardiology team and reviewing our governance processes.”
Dr. Goldsweig participated in a past speaking engagement for Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
Interventional cardiologists worldwide burned out: Survey
“What surprised me was the magnitude of the findings,” Emmanouil S. Brilakis, MD, PhD of the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, said in an interview.
“I was expecting that some interventionalists would feel burned out, but not that 78% would feel they are working too hard, 64% are emotionally exhausted, and 41% considered quitting their job during the past year.
The survey, conducted in January, also showed that while 69% of respondents were affected by burnout, many were either not seeking mental health support or not willing to share whether they were under treatment.
Overall, 28% of interventional cardiologists were not happy with their lives, similar to the 29% reported in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2022.
“Many institutions have formed task forces to better understand burnout and recommend solutions, but progress has been slow,” Dr. Brilakis said. “Barriers include financial constraints, understaffing, lack of understanding of the root causes of burnout in each practice, and perhaps underappreciation of the consequences of burnout.”
The study was published online in JACC: Cardiovascular Interventions.
Too much paperwork
The investigators conducted an international, online survey of IC attending physicians and fellows to assess their psychological well-being. The 78 survey questions prepared by the coauthors were shown to perform similarly to the validated Maslach Burnout Inventory.
A total of 1,159 attendings and 192 fellows completed the survey, representing 12% of U.S. IC attendings and 19% of U.S. IC fellows.
Half of attending physicians were from the United States, followed by the European Union (16%). Overall, 37% were from academic institutions; the median age was 41-45 years; 91% were men; and mean clinical work hours per week were 63.
Most (86%) had a partner with whom they lived. Yet most (84%) also felt lonely; 41% considered leaving their jobs during the past year; and 32% said they were currently considering leaving.
Compared with the previous year, 12% had increased enthusiasm and 44% had decreased enthusiasm toward work. One-third (33%) felt overwhelmed and 20% doubted the significance of their work three or more times a week.
As noted, most (78%) felt they were “working too hard,” were emotionally exhausted (64%), and frustrated by work (58%). Almost one-third (30%) considered themselves physically unhealthy.
Unhappiness was highest (33%) among 51- to 60-year-olds, followed by 31- to 40-year-olds (31%); it was lowest (21%) among those over age 60.
Unhappiness was similar between men and women (27% vs. 30%) and was highest in North America (30%) and lower in Asia (26%).
Most (69%) respondents said that burnout impacted their life, with very little difference between men and women (68% vs. 73%).
Two-thirds (67%) said they had somebody they could share their mental health concerns with, yet only 37% reported having access to mental health support if needed through their hospital/practice.
For fellows, the median age was 31-35 years; 88% were men; 42% were from the United States and 22% from the European Union. Two-thirds were from academic institutions (67%) and the mean clinical work hours were 67 per week.
Two-thirds (67%) lived with a partner; half (48%) felt lonely, 29% considered leaving their jobs in the past year, and 15% were currently considering leaving.
Compared with the previous year, 27% had increased enthusiasm, and 32% had decreased enthusiasm toward work. More than one-quarter (29%) felt overwhelmed and 26% doubted the significance of their work three or more times per week.
Attendings rated excessive paperwork requirements, bureaucratic tasks, challenges in equipment acquisition, and excessive government regulations higher (in contributing to burnout) compared with fellows.
Non-U.S. attendings reported insufficient income and challenges with equipment acquisition as significant contributors to their burnout more than did their United States counterparts.
Fellows rated insufficient income as the most significant contributor to burnout.
Their main coping mechanisms were talking with family/friends (at 6.8 rated on a scale of 0-10), watching movies (6.4), and listening/playing music (6.0).
Attendings were more likely to use exercise as a coping skill, and fellows were more likely to cope by watching movies/series, sleeping, and eating junk food.
Asked what hospitals and practices can do to reduce burnout and improve well-being, attendings suggested removing rules/regulations that do not contribute to patient care, such as reforming prior authorization (mean rating, 8.1), better administrative support (8.0), and professional growth opportunities (7.9).
Non-U.S. attendings more often requested growth opportunities, increased compensation, availability of better hospital food, better hospital infrastructure, streamlined access to equipment, better on-call rooms, and access to mental health professionals to improve their well-being.
Overall, fellows were more likely than were attendings to request professional growth opportunities and were more likely to ask for availability of better food in the hospital, and better on-call rooms.
Reforms needed
Laxmi Mehta, MD, chief well-being leader, faculty director of the Gabbe Health and Well-Being Program, professor of medicine at The Ohio State University Wexner Medical Center in Columbus, and spokesperson for the American Heart Association, noted, “The burnout rates are much higher than our previously reported American College of Cardiology data, which found burnout rates at about 27%; however, that survey was conducted prepandemic,” she said. Dr. Mehta was the lead author of that 2019 report.
She said in an interview that she would have liked to see more breakdowns by gender, and whether there was an association between burnout and the number of procedures performed.
“Nevertheless,” she said, “the rates are very high for burnout, stress, and dissatisfaction, as well as mental health issues. Almost one half of the IC attendings considered leaving their job, which is also seen in other surveys, and is concerning given the projected shortages in the workforce.”
Changes need to be made in the profession of medicine as a whole, she said, though that is unlikely to happen any time soon. “Optimizing workflows and improving the work culture requires not only time, but also collaboration between administration and clinicians, along with an intent and strategic plan focused on well-being of the organization.”
With regard to prior authorization, she said, “medical organizations are advocating for reform at the state and national level. If meaningful reforms can occur, that can reduce some of the bureaucracy. However, there is much more [bureaucracy] in medicine.”
With respect to mental health, she added, “there is a lot that needs to be done to reduce the stigma of seeking help. Many physicians don’t seek help due to the shame, lack of time, and potential impact it can have on hospital credentialing and state medical licensing. Medical organizations and individuals are advocating for reforms in this space, as well, to normalize mental health.”
The Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr. Brilakis, study coauthors, and Dr. Mehta report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
“What surprised me was the magnitude of the findings,” Emmanouil S. Brilakis, MD, PhD of the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, said in an interview.
“I was expecting that some interventionalists would feel burned out, but not that 78% would feel they are working too hard, 64% are emotionally exhausted, and 41% considered quitting their job during the past year.
The survey, conducted in January, also showed that while 69% of respondents were affected by burnout, many were either not seeking mental health support or not willing to share whether they were under treatment.
Overall, 28% of interventional cardiologists were not happy with their lives, similar to the 29% reported in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2022.
“Many institutions have formed task forces to better understand burnout and recommend solutions, but progress has been slow,” Dr. Brilakis said. “Barriers include financial constraints, understaffing, lack of understanding of the root causes of burnout in each practice, and perhaps underappreciation of the consequences of burnout.”
The study was published online in JACC: Cardiovascular Interventions.
Too much paperwork
The investigators conducted an international, online survey of IC attending physicians and fellows to assess their psychological well-being. The 78 survey questions prepared by the coauthors were shown to perform similarly to the validated Maslach Burnout Inventory.
A total of 1,159 attendings and 192 fellows completed the survey, representing 12% of U.S. IC attendings and 19% of U.S. IC fellows.
Half of attending physicians were from the United States, followed by the European Union (16%). Overall, 37% were from academic institutions; the median age was 41-45 years; 91% were men; and mean clinical work hours per week were 63.
Most (86%) had a partner with whom they lived. Yet most (84%) also felt lonely; 41% considered leaving their jobs during the past year; and 32% said they were currently considering leaving.
Compared with the previous year, 12% had increased enthusiasm and 44% had decreased enthusiasm toward work. One-third (33%) felt overwhelmed and 20% doubted the significance of their work three or more times a week.
As noted, most (78%) felt they were “working too hard,” were emotionally exhausted (64%), and frustrated by work (58%). Almost one-third (30%) considered themselves physically unhealthy.
Unhappiness was highest (33%) among 51- to 60-year-olds, followed by 31- to 40-year-olds (31%); it was lowest (21%) among those over age 60.
Unhappiness was similar between men and women (27% vs. 30%) and was highest in North America (30%) and lower in Asia (26%).
Most (69%) respondents said that burnout impacted their life, with very little difference between men and women (68% vs. 73%).
Two-thirds (67%) said they had somebody they could share their mental health concerns with, yet only 37% reported having access to mental health support if needed through their hospital/practice.
For fellows, the median age was 31-35 years; 88% were men; 42% were from the United States and 22% from the European Union. Two-thirds were from academic institutions (67%) and the mean clinical work hours were 67 per week.
Two-thirds (67%) lived with a partner; half (48%) felt lonely, 29% considered leaving their jobs in the past year, and 15% were currently considering leaving.
Compared with the previous year, 27% had increased enthusiasm, and 32% had decreased enthusiasm toward work. More than one-quarter (29%) felt overwhelmed and 26% doubted the significance of their work three or more times per week.
Attendings rated excessive paperwork requirements, bureaucratic tasks, challenges in equipment acquisition, and excessive government regulations higher (in contributing to burnout) compared with fellows.
Non-U.S. attendings reported insufficient income and challenges with equipment acquisition as significant contributors to their burnout more than did their United States counterparts.
Fellows rated insufficient income as the most significant contributor to burnout.
Their main coping mechanisms were talking with family/friends (at 6.8 rated on a scale of 0-10), watching movies (6.4), and listening/playing music (6.0).
Attendings were more likely to use exercise as a coping skill, and fellows were more likely to cope by watching movies/series, sleeping, and eating junk food.
Asked what hospitals and practices can do to reduce burnout and improve well-being, attendings suggested removing rules/regulations that do not contribute to patient care, such as reforming prior authorization (mean rating, 8.1), better administrative support (8.0), and professional growth opportunities (7.9).
Non-U.S. attendings more often requested growth opportunities, increased compensation, availability of better hospital food, better hospital infrastructure, streamlined access to equipment, better on-call rooms, and access to mental health professionals to improve their well-being.
Overall, fellows were more likely than were attendings to request professional growth opportunities and were more likely to ask for availability of better food in the hospital, and better on-call rooms.
Reforms needed
Laxmi Mehta, MD, chief well-being leader, faculty director of the Gabbe Health and Well-Being Program, professor of medicine at The Ohio State University Wexner Medical Center in Columbus, and spokesperson for the American Heart Association, noted, “The burnout rates are much higher than our previously reported American College of Cardiology data, which found burnout rates at about 27%; however, that survey was conducted prepandemic,” she said. Dr. Mehta was the lead author of that 2019 report.
She said in an interview that she would have liked to see more breakdowns by gender, and whether there was an association between burnout and the number of procedures performed.
“Nevertheless,” she said, “the rates are very high for burnout, stress, and dissatisfaction, as well as mental health issues. Almost one half of the IC attendings considered leaving their job, which is also seen in other surveys, and is concerning given the projected shortages in the workforce.”
Changes need to be made in the profession of medicine as a whole, she said, though that is unlikely to happen any time soon. “Optimizing workflows and improving the work culture requires not only time, but also collaboration between administration and clinicians, along with an intent and strategic plan focused on well-being of the organization.”
With regard to prior authorization, she said, “medical organizations are advocating for reform at the state and national level. If meaningful reforms can occur, that can reduce some of the bureaucracy. However, there is much more [bureaucracy] in medicine.”
With respect to mental health, she added, “there is a lot that needs to be done to reduce the stigma of seeking help. Many physicians don’t seek help due to the shame, lack of time, and potential impact it can have on hospital credentialing and state medical licensing. Medical organizations and individuals are advocating for reforms in this space, as well, to normalize mental health.”
The Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr. Brilakis, study coauthors, and Dr. Mehta report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
“What surprised me was the magnitude of the findings,” Emmanouil S. Brilakis, MD, PhD of the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, said in an interview.
“I was expecting that some interventionalists would feel burned out, but not that 78% would feel they are working too hard, 64% are emotionally exhausted, and 41% considered quitting their job during the past year.
The survey, conducted in January, also showed that while 69% of respondents were affected by burnout, many were either not seeking mental health support or not willing to share whether they were under treatment.
Overall, 28% of interventional cardiologists were not happy with their lives, similar to the 29% reported in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2022.
“Many institutions have formed task forces to better understand burnout and recommend solutions, but progress has been slow,” Dr. Brilakis said. “Barriers include financial constraints, understaffing, lack of understanding of the root causes of burnout in each practice, and perhaps underappreciation of the consequences of burnout.”
The study was published online in JACC: Cardiovascular Interventions.
Too much paperwork
The investigators conducted an international, online survey of IC attending physicians and fellows to assess their psychological well-being. The 78 survey questions prepared by the coauthors were shown to perform similarly to the validated Maslach Burnout Inventory.
A total of 1,159 attendings and 192 fellows completed the survey, representing 12% of U.S. IC attendings and 19% of U.S. IC fellows.
Half of attending physicians were from the United States, followed by the European Union (16%). Overall, 37% were from academic institutions; the median age was 41-45 years; 91% were men; and mean clinical work hours per week were 63.
Most (86%) had a partner with whom they lived. Yet most (84%) also felt lonely; 41% considered leaving their jobs during the past year; and 32% said they were currently considering leaving.
Compared with the previous year, 12% had increased enthusiasm and 44% had decreased enthusiasm toward work. One-third (33%) felt overwhelmed and 20% doubted the significance of their work three or more times a week.
As noted, most (78%) felt they were “working too hard,” were emotionally exhausted (64%), and frustrated by work (58%). Almost one-third (30%) considered themselves physically unhealthy.
Unhappiness was highest (33%) among 51- to 60-year-olds, followed by 31- to 40-year-olds (31%); it was lowest (21%) among those over age 60.
Unhappiness was similar between men and women (27% vs. 30%) and was highest in North America (30%) and lower in Asia (26%).
Most (69%) respondents said that burnout impacted their life, with very little difference between men and women (68% vs. 73%).
Two-thirds (67%) said they had somebody they could share their mental health concerns with, yet only 37% reported having access to mental health support if needed through their hospital/practice.
For fellows, the median age was 31-35 years; 88% were men; 42% were from the United States and 22% from the European Union. Two-thirds were from academic institutions (67%) and the mean clinical work hours were 67 per week.
Two-thirds (67%) lived with a partner; half (48%) felt lonely, 29% considered leaving their jobs in the past year, and 15% were currently considering leaving.
Compared with the previous year, 27% had increased enthusiasm, and 32% had decreased enthusiasm toward work. More than one-quarter (29%) felt overwhelmed and 26% doubted the significance of their work three or more times per week.
Attendings rated excessive paperwork requirements, bureaucratic tasks, challenges in equipment acquisition, and excessive government regulations higher (in contributing to burnout) compared with fellows.
Non-U.S. attendings reported insufficient income and challenges with equipment acquisition as significant contributors to their burnout more than did their United States counterparts.
Fellows rated insufficient income as the most significant contributor to burnout.
Their main coping mechanisms were talking with family/friends (at 6.8 rated on a scale of 0-10), watching movies (6.4), and listening/playing music (6.0).
Attendings were more likely to use exercise as a coping skill, and fellows were more likely to cope by watching movies/series, sleeping, and eating junk food.
Asked what hospitals and practices can do to reduce burnout and improve well-being, attendings suggested removing rules/regulations that do not contribute to patient care, such as reforming prior authorization (mean rating, 8.1), better administrative support (8.0), and professional growth opportunities (7.9).
Non-U.S. attendings more often requested growth opportunities, increased compensation, availability of better hospital food, better hospital infrastructure, streamlined access to equipment, better on-call rooms, and access to mental health professionals to improve their well-being.
Overall, fellows were more likely than were attendings to request professional growth opportunities and were more likely to ask for availability of better food in the hospital, and better on-call rooms.
Reforms needed
Laxmi Mehta, MD, chief well-being leader, faculty director of the Gabbe Health and Well-Being Program, professor of medicine at The Ohio State University Wexner Medical Center in Columbus, and spokesperson for the American Heart Association, noted, “The burnout rates are much higher than our previously reported American College of Cardiology data, which found burnout rates at about 27%; however, that survey was conducted prepandemic,” she said. Dr. Mehta was the lead author of that 2019 report.
She said in an interview that she would have liked to see more breakdowns by gender, and whether there was an association between burnout and the number of procedures performed.
“Nevertheless,” she said, “the rates are very high for burnout, stress, and dissatisfaction, as well as mental health issues. Almost one half of the IC attendings considered leaving their job, which is also seen in other surveys, and is concerning given the projected shortages in the workforce.”
Changes need to be made in the profession of medicine as a whole, she said, though that is unlikely to happen any time soon. “Optimizing workflows and improving the work culture requires not only time, but also collaboration between administration and clinicians, along with an intent and strategic plan focused on well-being of the organization.”
With regard to prior authorization, she said, “medical organizations are advocating for reform at the state and national level. If meaningful reforms can occur, that can reduce some of the bureaucracy. However, there is much more [bureaucracy] in medicine.”
With respect to mental health, she added, “there is a lot that needs to be done to reduce the stigma of seeking help. Many physicians don’t seek help due to the shame, lack of time, and potential impact it can have on hospital credentialing and state medical licensing. Medical organizations and individuals are advocating for reforms in this space, as well, to normalize mental health.”
The Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr. Brilakis, study coauthors, and Dr. Mehta report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM JACC: CARDIOVASCULAR INTERVENTIONS