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Cardiac issues twice as likely with COVID plus high troponin
Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.
The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.
“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”
“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”
The study, published online in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
Injury patterns different
Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.
Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.
Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).
Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).
The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).
Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).
The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).
However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).
The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.
During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).
Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).
“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.
Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
‘Tour de force’
James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”
Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”
Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.
“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.
No commercial funding or relevant financial relationships were reported.
A version of this article originally appeared on Medscape.com.
Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.
The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.
“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”
“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”
The study, published online in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
Injury patterns different
Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.
Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.
Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).
Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).
The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).
Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).
The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).
However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).
The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.
During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).
Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).
“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.
Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
‘Tour de force’
James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”
Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”
Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.
“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.
No commercial funding or relevant financial relationships were reported.
A version of this article originally appeared on Medscape.com.
Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.
The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.
“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”
“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”
The study, published online in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
Injury patterns different
Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.
Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.
Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).
Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).
The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).
Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).
The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).
However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).
The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.
During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).
Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).
“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.
Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
‘Tour de force’
James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”
Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”
Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.
“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.
No commercial funding or relevant financial relationships were reported.
A version of this article originally appeared on Medscape.com.
Dapagliflozin gets expanded heart failure indication in Europe
The European Commission has expanded the indication for dapagliflozin (Forxiga) to include heart failure across the full spectrum of left ventricular ejection fraction – including HF with mildly reduced and preserved ejection fraction, AstraZeneca has announced.
The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.
The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.
The study was published in the New England Journal of Medicine and presented at the European Society of Cardiology’s annual congress.
The data support the use of SGLT2 inhibitors as “foundational agents for virtually all patients with heart failure” regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
The Food and Drug Administration is currently reviewing AstraZeneca’s application to expand the HF indication for dapagliflozin in the United States.
A version of this article first appeared on Medscape.com.
The European Commission has expanded the indication for dapagliflozin (Forxiga) to include heart failure across the full spectrum of left ventricular ejection fraction – including HF with mildly reduced and preserved ejection fraction, AstraZeneca has announced.
The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.
The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.
The study was published in the New England Journal of Medicine and presented at the European Society of Cardiology’s annual congress.
The data support the use of SGLT2 inhibitors as “foundational agents for virtually all patients with heart failure” regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
The Food and Drug Administration is currently reviewing AstraZeneca’s application to expand the HF indication for dapagliflozin in the United States.
A version of this article first appeared on Medscape.com.
The European Commission has expanded the indication for dapagliflozin (Forxiga) to include heart failure across the full spectrum of left ventricular ejection fraction – including HF with mildly reduced and preserved ejection fraction, AstraZeneca has announced.
The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.
The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.
The study was published in the New England Journal of Medicine and presented at the European Society of Cardiology’s annual congress.
The data support the use of SGLT2 inhibitors as “foundational agents for virtually all patients with heart failure” regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
The Food and Drug Administration is currently reviewing AstraZeneca’s application to expand the HF indication for dapagliflozin in the United States.
A version of this article first appeared on Medscape.com.
Cardiac monitoring company settles DOJ false claims allegations
Beyond Reps (dba IronRod Health and Cardiac Monitoring Services) has agreed to pay $673,200 to resolve allegations that it submitted false claims to federal health care programs relating to remote cardiac monitoring services.
The U.S. Department of Justice alleges that between Jan. 1, 2018, and April 30, 2021, IronRod, with headquarters in Phoenix, used technicians who lacked required credentials to conduct remote cardiac monitoring readings.
The government further alleges that between June 1, 2018, and Aug. 20, 2018, the company misrepresented that it performed services in New York state in order to get higher reimbursements from Medicare for remote cardiac monitoring services.
“Providers that seek payment from federal health programs are required to follow laws meant to protect beneficiaries, as well as to protect the integrity of those programs,” U.S. Attorney Trini E. Ross said in a statement.
“Our office is committed to pursuing cases against any provider that cuts corners or seeks to obtain payments for which they are not entitled,” Ms. Ross said.
A request to Beyond Reps for comment was not returned.
The civil settlement resolves claims brought under the qui tam (whistleblower) provisions of the False Claims Act by Coleen DeGroat.
Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Ms. DeGroat will receive a share of the settlement.
A version of this article first appeared on Medscape.com.
Beyond Reps (dba IronRod Health and Cardiac Monitoring Services) has agreed to pay $673,200 to resolve allegations that it submitted false claims to federal health care programs relating to remote cardiac monitoring services.
The U.S. Department of Justice alleges that between Jan. 1, 2018, and April 30, 2021, IronRod, with headquarters in Phoenix, used technicians who lacked required credentials to conduct remote cardiac monitoring readings.
The government further alleges that between June 1, 2018, and Aug. 20, 2018, the company misrepresented that it performed services in New York state in order to get higher reimbursements from Medicare for remote cardiac monitoring services.
“Providers that seek payment from federal health programs are required to follow laws meant to protect beneficiaries, as well as to protect the integrity of those programs,” U.S. Attorney Trini E. Ross said in a statement.
“Our office is committed to pursuing cases against any provider that cuts corners or seeks to obtain payments for which they are not entitled,” Ms. Ross said.
A request to Beyond Reps for comment was not returned.
The civil settlement resolves claims brought under the qui tam (whistleblower) provisions of the False Claims Act by Coleen DeGroat.
Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Ms. DeGroat will receive a share of the settlement.
A version of this article first appeared on Medscape.com.
Beyond Reps (dba IronRod Health and Cardiac Monitoring Services) has agreed to pay $673,200 to resolve allegations that it submitted false claims to federal health care programs relating to remote cardiac monitoring services.
The U.S. Department of Justice alleges that between Jan. 1, 2018, and April 30, 2021, IronRod, with headquarters in Phoenix, used technicians who lacked required credentials to conduct remote cardiac monitoring readings.
The government further alleges that between June 1, 2018, and Aug. 20, 2018, the company misrepresented that it performed services in New York state in order to get higher reimbursements from Medicare for remote cardiac monitoring services.
“Providers that seek payment from federal health programs are required to follow laws meant to protect beneficiaries, as well as to protect the integrity of those programs,” U.S. Attorney Trini E. Ross said in a statement.
“Our office is committed to pursuing cases against any provider that cuts corners or seeks to obtain payments for which they are not entitled,” Ms. Ross said.
A request to Beyond Reps for comment was not returned.
The civil settlement resolves claims brought under the qui tam (whistleblower) provisions of the False Claims Act by Coleen DeGroat.
Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Ms. DeGroat will receive a share of the settlement.
A version of this article first appeared on Medscape.com.
What happened to surgical mitral valve repair in the MitraClip era?
The overall case volume for surgical mitral valve (MV) repair of degenerative mitral regurgitation (DMR) hasn’t changed much nearly a decade into the age of transcatheter edge-to-edge repair (TEER). But, over the same period, there’s been a shift in the surgical–MV repair case mix at centers that have offered both the surgical option and TEER, a new study suggests.
Once TEER was introduced, those centers over time used the operative approach less in higher– and intermediate–surgical risk patients and more often in those deemed low risk for surgery. And that trend – at centers offering both approaches – paralleled improved risk-adjusted surgical repair short-term complications and 30-day and 5-year mortality.
The findings come from an analysis based on Society of Thoracic Surgeons and Medicare claims data collected from 2011 through 2018 at surgical–MV repair centers that also offered TEER for DMR after its 2013 approval. The transcatheter procedure, until only recently the exclusive domain of Abbott’s MitraClip in various incarnations, is officially indicated for patients judged too high risk for surgical MV repair.
A shift in surgical MV repair to predominantly lower-risk patients would be expected to improve outcomes. But the improvements seen in the current study seem to have a more complex explanation, Sreekanth Vemulapalli, MD, told this news organization.
The data seem to show TEER indication creep from higher-risk cases, for which there is clinical trial support, to intermediate-risk patients, that lack such evidence in favor of TEER. That seemed to push surgical repair toward even lower-risk cases. “I think that’s exactly right,” said Dr. Vemulapalli, Duke Clinical Research Institute, Durham, N.C.
Still, he observed, the analysis was adjusted for surgical risk, and “Even after that adjustment, it looked like surgical outcomes were getting better after the availability of transcatheter mitral repair techniques.”
That observation may be explained by an increasingly sharp, “more careful” process for selecting patients for surgical repair vs. TEER, said Dr. Vemulapalli, who is senior author of the study published in the Journal of the American College of Cardiology. Angela M. Lowenstern, MD, Vanderbilt University, Nashville, and Andrew M. Vekstein, MD, Duke Clinical Research Institute, were the lead authors.
Indeed, the report states, the analysis supports the view that “a systematic evaluation by a heart team able to direct patients towards either surgical or transcatheter approaches enhances both short-term and long-term surgical outcomes.”
“In a world where both surgical and transcatheter techniques are going to be available,” Dr. Vemulapalli said, “patient selection becomes very, very important.”
An accompanying editorial acknowledges the heart-team approach’s potential for improving the selection of patients for surgery and perhaps therefore outcomes. But it also cites issues with that interpretation of the data.
For example, the heart-team approach is not used in consistent ways across the United States. And “although the heart team is recommended in multiple guidelines for valvular heart therapies, there is little evidence for its efficacy, specifically regarding improving clinical outcomes,” write Matthew W. Sherwood, MD, MHS, and Wayne B. Batchelor, MD, MHS, Inova Heart and Vascular Institute, Falls Church, Va.
The editorialists highlight the study’s “significant downtrend in both high-risk and intermediate-risk surgical cases, with a concomitant increase in low-risk cases,” after introduction of TEER. That shift in case mix, they write, “would seem to be a more likely explanation for the modest improvement in outcomes for surgical MV repair.”
Also, importantly, the analysis didn’t include data on TEER procedures, only indirect evidence for TEER’s effect on surgical MV repair, the editorialists observe, and study authors acknowledge.
Still, the analysis looked at nearly 14,000 patients at 278 U.S. sites with surgical MV repair that launched TEER programs during the study period. They accounted for 6,806 surgical cases before and 7,153 surgical cases after the advent of TEER.
Their median annualized institutional surgical MV repair volume was 32 before and 29 after TEER availability (P = .06).
The risk-adjusted odds ratio for 30-day mortality after vs. before TEER became an option was 0.73 (95% confidence interval, 0.54-0.99). The corresponding hazard ratio for mortality at 5 years was 0.75 (95% CI, 0.66-0.86).
Other risk-adjusted surgical outcomes improved once TEER became available, including MV adverse outcomes (OR, 0.71; 95% CI, 0.58-0.86; P < .001), operative mortality (OR, 0.73; 95% CI, 0.54-0.99; P = .041), and major morbidity (OR, 0.85; 95% CI, 0.73-0.98; P = .026)
Despite the data’s suggestion of TEER indication creep from solely high–surgical risk patients to those at intermediate risk, Dr. Vemulapalli said, “I don’t think that people should be doing transcatheter mitral repair in intermediate- or low-risk patients as a general rule.” Although, he added, “there will always be certain exceptions, depending on the patient’s specific situation.”
Dr. Vemulapalli pointed to several ongoing trials comparing TEER vs. surgical MR repair in patients with DMR at intermediate surgical risk, including REPAIR MR and PRIMARY.
The study was supported by the National Institutes of Health and Abbott. Dr. Vemulapalli discloses receiving grants or contracts from the American College of Cardiology, the Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, the National Institutes of Health, and Boston Scientific; and consulting or serving on an advisory board for Janssen, the American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr. Sherwood discloses receiving honoraria or consulting fees from Medtronic and Boston Scientific. Dr. Batchelor discloses receiving consulting fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott.
A version of this article first appeared on Medscape.com.
The overall case volume for surgical mitral valve (MV) repair of degenerative mitral regurgitation (DMR) hasn’t changed much nearly a decade into the age of transcatheter edge-to-edge repair (TEER). But, over the same period, there’s been a shift in the surgical–MV repair case mix at centers that have offered both the surgical option and TEER, a new study suggests.
Once TEER was introduced, those centers over time used the operative approach less in higher– and intermediate–surgical risk patients and more often in those deemed low risk for surgery. And that trend – at centers offering both approaches – paralleled improved risk-adjusted surgical repair short-term complications and 30-day and 5-year mortality.
The findings come from an analysis based on Society of Thoracic Surgeons and Medicare claims data collected from 2011 through 2018 at surgical–MV repair centers that also offered TEER for DMR after its 2013 approval. The transcatheter procedure, until only recently the exclusive domain of Abbott’s MitraClip in various incarnations, is officially indicated for patients judged too high risk for surgical MV repair.
A shift in surgical MV repair to predominantly lower-risk patients would be expected to improve outcomes. But the improvements seen in the current study seem to have a more complex explanation, Sreekanth Vemulapalli, MD, told this news organization.
The data seem to show TEER indication creep from higher-risk cases, for which there is clinical trial support, to intermediate-risk patients, that lack such evidence in favor of TEER. That seemed to push surgical repair toward even lower-risk cases. “I think that’s exactly right,” said Dr. Vemulapalli, Duke Clinical Research Institute, Durham, N.C.
Still, he observed, the analysis was adjusted for surgical risk, and “Even after that adjustment, it looked like surgical outcomes were getting better after the availability of transcatheter mitral repair techniques.”
That observation may be explained by an increasingly sharp, “more careful” process for selecting patients for surgical repair vs. TEER, said Dr. Vemulapalli, who is senior author of the study published in the Journal of the American College of Cardiology. Angela M. Lowenstern, MD, Vanderbilt University, Nashville, and Andrew M. Vekstein, MD, Duke Clinical Research Institute, were the lead authors.
Indeed, the report states, the analysis supports the view that “a systematic evaluation by a heart team able to direct patients towards either surgical or transcatheter approaches enhances both short-term and long-term surgical outcomes.”
“In a world where both surgical and transcatheter techniques are going to be available,” Dr. Vemulapalli said, “patient selection becomes very, very important.”
An accompanying editorial acknowledges the heart-team approach’s potential for improving the selection of patients for surgery and perhaps therefore outcomes. But it also cites issues with that interpretation of the data.
For example, the heart-team approach is not used in consistent ways across the United States. And “although the heart team is recommended in multiple guidelines for valvular heart therapies, there is little evidence for its efficacy, specifically regarding improving clinical outcomes,” write Matthew W. Sherwood, MD, MHS, and Wayne B. Batchelor, MD, MHS, Inova Heart and Vascular Institute, Falls Church, Va.
The editorialists highlight the study’s “significant downtrend in both high-risk and intermediate-risk surgical cases, with a concomitant increase in low-risk cases,” after introduction of TEER. That shift in case mix, they write, “would seem to be a more likely explanation for the modest improvement in outcomes for surgical MV repair.”
Also, importantly, the analysis didn’t include data on TEER procedures, only indirect evidence for TEER’s effect on surgical MV repair, the editorialists observe, and study authors acknowledge.
Still, the analysis looked at nearly 14,000 patients at 278 U.S. sites with surgical MV repair that launched TEER programs during the study period. They accounted for 6,806 surgical cases before and 7,153 surgical cases after the advent of TEER.
Their median annualized institutional surgical MV repair volume was 32 before and 29 after TEER availability (P = .06).
The risk-adjusted odds ratio for 30-day mortality after vs. before TEER became an option was 0.73 (95% confidence interval, 0.54-0.99). The corresponding hazard ratio for mortality at 5 years was 0.75 (95% CI, 0.66-0.86).
Other risk-adjusted surgical outcomes improved once TEER became available, including MV adverse outcomes (OR, 0.71; 95% CI, 0.58-0.86; P < .001), operative mortality (OR, 0.73; 95% CI, 0.54-0.99; P = .041), and major morbidity (OR, 0.85; 95% CI, 0.73-0.98; P = .026)
Despite the data’s suggestion of TEER indication creep from solely high–surgical risk patients to those at intermediate risk, Dr. Vemulapalli said, “I don’t think that people should be doing transcatheter mitral repair in intermediate- or low-risk patients as a general rule.” Although, he added, “there will always be certain exceptions, depending on the patient’s specific situation.”
Dr. Vemulapalli pointed to several ongoing trials comparing TEER vs. surgical MR repair in patients with DMR at intermediate surgical risk, including REPAIR MR and PRIMARY.
The study was supported by the National Institutes of Health and Abbott. Dr. Vemulapalli discloses receiving grants or contracts from the American College of Cardiology, the Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, the National Institutes of Health, and Boston Scientific; and consulting or serving on an advisory board for Janssen, the American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr. Sherwood discloses receiving honoraria or consulting fees from Medtronic and Boston Scientific. Dr. Batchelor discloses receiving consulting fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott.
A version of this article first appeared on Medscape.com.
The overall case volume for surgical mitral valve (MV) repair of degenerative mitral regurgitation (DMR) hasn’t changed much nearly a decade into the age of transcatheter edge-to-edge repair (TEER). But, over the same period, there’s been a shift in the surgical–MV repair case mix at centers that have offered both the surgical option and TEER, a new study suggests.
Once TEER was introduced, those centers over time used the operative approach less in higher– and intermediate–surgical risk patients and more often in those deemed low risk for surgery. And that trend – at centers offering both approaches – paralleled improved risk-adjusted surgical repair short-term complications and 30-day and 5-year mortality.
The findings come from an analysis based on Society of Thoracic Surgeons and Medicare claims data collected from 2011 through 2018 at surgical–MV repair centers that also offered TEER for DMR after its 2013 approval. The transcatheter procedure, until only recently the exclusive domain of Abbott’s MitraClip in various incarnations, is officially indicated for patients judged too high risk for surgical MV repair.
A shift in surgical MV repair to predominantly lower-risk patients would be expected to improve outcomes. But the improvements seen in the current study seem to have a more complex explanation, Sreekanth Vemulapalli, MD, told this news organization.
The data seem to show TEER indication creep from higher-risk cases, for which there is clinical trial support, to intermediate-risk patients, that lack such evidence in favor of TEER. That seemed to push surgical repair toward even lower-risk cases. “I think that’s exactly right,” said Dr. Vemulapalli, Duke Clinical Research Institute, Durham, N.C.
Still, he observed, the analysis was adjusted for surgical risk, and “Even after that adjustment, it looked like surgical outcomes were getting better after the availability of transcatheter mitral repair techniques.”
That observation may be explained by an increasingly sharp, “more careful” process for selecting patients for surgical repair vs. TEER, said Dr. Vemulapalli, who is senior author of the study published in the Journal of the American College of Cardiology. Angela M. Lowenstern, MD, Vanderbilt University, Nashville, and Andrew M. Vekstein, MD, Duke Clinical Research Institute, were the lead authors.
Indeed, the report states, the analysis supports the view that “a systematic evaluation by a heart team able to direct patients towards either surgical or transcatheter approaches enhances both short-term and long-term surgical outcomes.”
“In a world where both surgical and transcatheter techniques are going to be available,” Dr. Vemulapalli said, “patient selection becomes very, very important.”
An accompanying editorial acknowledges the heart-team approach’s potential for improving the selection of patients for surgery and perhaps therefore outcomes. But it also cites issues with that interpretation of the data.
For example, the heart-team approach is not used in consistent ways across the United States. And “although the heart team is recommended in multiple guidelines for valvular heart therapies, there is little evidence for its efficacy, specifically regarding improving clinical outcomes,” write Matthew W. Sherwood, MD, MHS, and Wayne B. Batchelor, MD, MHS, Inova Heart and Vascular Institute, Falls Church, Va.
The editorialists highlight the study’s “significant downtrend in both high-risk and intermediate-risk surgical cases, with a concomitant increase in low-risk cases,” after introduction of TEER. That shift in case mix, they write, “would seem to be a more likely explanation for the modest improvement in outcomes for surgical MV repair.”
Also, importantly, the analysis didn’t include data on TEER procedures, only indirect evidence for TEER’s effect on surgical MV repair, the editorialists observe, and study authors acknowledge.
Still, the analysis looked at nearly 14,000 patients at 278 U.S. sites with surgical MV repair that launched TEER programs during the study period. They accounted for 6,806 surgical cases before and 7,153 surgical cases after the advent of TEER.
Their median annualized institutional surgical MV repair volume was 32 before and 29 after TEER availability (P = .06).
The risk-adjusted odds ratio for 30-day mortality after vs. before TEER became an option was 0.73 (95% confidence interval, 0.54-0.99). The corresponding hazard ratio for mortality at 5 years was 0.75 (95% CI, 0.66-0.86).
Other risk-adjusted surgical outcomes improved once TEER became available, including MV adverse outcomes (OR, 0.71; 95% CI, 0.58-0.86; P < .001), operative mortality (OR, 0.73; 95% CI, 0.54-0.99; P = .041), and major morbidity (OR, 0.85; 95% CI, 0.73-0.98; P = .026)
Despite the data’s suggestion of TEER indication creep from solely high–surgical risk patients to those at intermediate risk, Dr. Vemulapalli said, “I don’t think that people should be doing transcatheter mitral repair in intermediate- or low-risk patients as a general rule.” Although, he added, “there will always be certain exceptions, depending on the patient’s specific situation.”
Dr. Vemulapalli pointed to several ongoing trials comparing TEER vs. surgical MR repair in patients with DMR at intermediate surgical risk, including REPAIR MR and PRIMARY.
The study was supported by the National Institutes of Health and Abbott. Dr. Vemulapalli discloses receiving grants or contracts from the American College of Cardiology, the Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, the National Institutes of Health, and Boston Scientific; and consulting or serving on an advisory board for Janssen, the American College of Physicians, HeartFlow, and Edwards LifeSciences. Dr. Sherwood discloses receiving honoraria or consulting fees from Medtronic and Boston Scientific. Dr. Batchelor discloses receiving consulting fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Acute cardiac events common during COVID hospitalization
particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.
“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.
Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”
However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”
The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”
The study was published online in the Journal of the American College of Cardiology.
Underlying cardiac disease key
Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.
Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.
As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).
Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.
Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.
In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).
Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.
“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.
The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
Contemporary data needed
James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.
“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.
“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.
In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”
“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”
No commercial funding or relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.
“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.
Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”
However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”
The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”
The study was published online in the Journal of the American College of Cardiology.
Underlying cardiac disease key
Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.
Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.
As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).
Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.
Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.
In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).
Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.
“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.
The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
Contemporary data needed
James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.
“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.
“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.
In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”
“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”
No commercial funding or relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.
“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.
Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”
However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”
The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”
The study was published online in the Journal of the American College of Cardiology.
Underlying cardiac disease key
Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.
Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.
As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).
Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.
Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.
In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).
Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.
“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.
The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
Contemporary data needed
James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.
“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.
“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.
In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”
“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”
No commercial funding or relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
What is the psychological cost of performing CPR?
One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.
Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.
“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”
We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.
In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.
“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
Doing one’s duty
There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.
“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”
Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”
Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.
Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.
In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:
- The lay rescuers possessed helping traits and high motivation.
- The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
- The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event. “Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.
Potential trauma
In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”
Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.
Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.
“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.
“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.
“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.
For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.
In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.
But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
Other obstacles
Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.
Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”
Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.
“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.
“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”
Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.
“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.
It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”
Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com. This article was translated from Medscape Spanish.
One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.
Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.
“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”
We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.
In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.
“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
Doing one’s duty
There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.
“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”
Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”
Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.
Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.
In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:
- The lay rescuers possessed helping traits and high motivation.
- The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
- The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event. “Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.
Potential trauma
In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”
Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.
Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.
“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.
“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.
“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.
For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.
In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.
But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
Other obstacles
Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.
Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”
Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.
“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.
“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”
Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.
“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.
It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”
Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com. This article was translated from Medscape Spanish.
One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.
Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.
“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”
We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.
In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.
“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
Doing one’s duty
There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.
“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”
Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”
Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.
Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.
In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:
- The lay rescuers possessed helping traits and high motivation.
- The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
- The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event. “Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.
Potential trauma
In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”
Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.
Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.
“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.
“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.
“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.
For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.
In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.
But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
Other obstacles
Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.
Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”
Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.
“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.
“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”
Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.
“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.
It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”
Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com. This article was translated from Medscape Spanish.
Persistent gaps in drug use by patients with type 2 diabetes
Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.
A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.
A new group of participants was enrolled for each successive 2-year survey.
“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.
Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.
The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.
Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.
“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”
“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.
“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.
“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”
The study was published online in JAMA Network Open.
Investigating trends in medication adherence
Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.
After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.
Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.
However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.
Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.
The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.
About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).
Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.
“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.
They are preparing another paper that explores changes in medication regimens.
The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.
It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.
Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.
“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.
“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.
This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.
Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).
The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.
A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.
A new group of participants was enrolled for each successive 2-year survey.
“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.
Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.
The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.
Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.
“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”
“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.
“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.
“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”
The study was published online in JAMA Network Open.
Investigating trends in medication adherence
Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.
After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.
Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.
However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.
Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.
The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.
About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).
Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.
“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.
They are preparing another paper that explores changes in medication regimens.
The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.
It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.
Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.
“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.
“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.
This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.
Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).
The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.
A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.
A new group of participants was enrolled for each successive 2-year survey.
“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.
Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.
The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.
Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.
“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”
“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.
“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.
“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”
The study was published online in JAMA Network Open.
Investigating trends in medication adherence
Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.
After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.
Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.
However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.
Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.
The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.
About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).
Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.
“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.
They are preparing another paper that explores changes in medication regimens.
The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.
It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.
Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.
“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.
“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.
This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.
Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).
The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Accelerated pacing a possible strategy for HFpEF?
Evidence supporting medications that slow the heart rate (HR), notably beta-blockers, is overwhelming in heart failure (HF) with reduced ejection fraction. Underwhelming, however, is clinical trial support for such agents in patients with HF with preserved ejection fraction (HFpEF).
Indeed, at least for some such patients, a treatment that modestly accelerates resting HR may be a more promising strategy, suggests an early line of research that challenges prevalent thinking about HFpEF therapy.
In a small, randomized test of the idea, patients with HFpEF and standard pacemakers set to a backup resting HR a bit higher than a standard of care 60 bpm, usually to about 75 bpm, reaped important quality of life benefits.
More strikingly, their natriuretic peptide levels and burden of atrial fibrillation (AFib) fell significantly, the latter by 27% over 1 year.
The trial enrolled only HFpEF patients with pacemakers previously implanted for sick sinus syndrome or atrioventricular block. But researchers say their 107-patient study called myPACE – if confirmed in larger, multicenter trials – lays the groundwork for a device therapy that is broadly useful, potentially, in patients with “preclinical or overt” HFpEF.
Indeed, some of the intervention’s “quite substantial” benefits rivaled or surpassed what his group has observed with available HFpEF drug therapies, including the sodium-glucose cotransporter 2 inhibitors, observed Markus Meyer, MD, PhD, University of Minnesota, Minneapolis.
Moreover, the study may be “the first to show that, with this approach, we can actually also reduce atrial fibrillation,” he said in an interview.
Dr. Meyer said his group is “confident” that the HR-modulation strategy will be successful in appropriate clinical trials and that “pacemakers, in the end, will become a treatment modality for HFpEF.”
Meyer is senior author on the trial’s publication in JAMA Cardiology in JAMA Cardiology (2023 Feb 1. doi: 10.1001/jamacardio.2022.5320), with lead author Margaret Infeld, MD, University of Vermont, Burlington.
The trial entered pacemaker patients with HFpEF of stage B or C – that is, either asymptomatic with structural disease or fully symptomatic. But, Dr. Meyer said, “we saw that the treatment effect was much more pronounced in the patients who had overt heart failure with preserved ejection fraction.”
Challenging beta-blocker dogma
The study, the report states, “contradicts canonical thinking” by suggesting HFpEF patients may benefit from a higher resting heart rate, which would presumably shorten diastolic filling time. It also “may help reduce the overprescription of beta-blockers to allow higher heart rates in this population.”
Indeed, Dr. Meyer observed, no one really knows whether beta-blockers work in HFpEF, “because they really have never been studied in a sufficiently powered randomized controlled trial.”
The current study “basically rewrites what we know about the pathophysiology of this form of clinical heart failure,” said Michael R. Zile, MD, Medical University of South Carolina and Veterans Affairs Medical Center, both in Charleston, who was not part of the trial or report.
Previously in HFpEF, Dr. Zile said in an interview, “everybody thought you needed to make diastole longer to give the ventricle a longer time to fill. And none of that really made any sense. It was just sort of accepted as dogma.”
The idea led to widespread use of beta-blockers in HFpEF but “turned out just not to be true.” Indeed, European and North American guidelines, Dr. Zile observed, “have all taken beta-blockers out of the equation for HFpEF” except for treating comorbidities that can be associated with HFpEF, like hypertension or AFib.
Many patients with HFpEF and chronotropic incompetence could be provided with standard pacemakers with primarily conduction-system pacing but are not getting them, he observed.
The current study might help change that. No one is suggesting, based on the current study, “that we start putting pacemakers in every single patient with HFpEF,” Dr. Zile said. Still, for HFpEF patients already with a pacemaker, the study provides “reasonable assurance” that its criteria for elevated resting HR may well improve symptoms.
Moreover, it suggests such pacemakers, programmed as in the study, might potentially give a boost to HFpEF patients without chronotropic incompetence but with persisting symptoms despite guideline-directed drug therapy. That’s certainly worth exploring in further trials, Dr. Zile said.
How the study worked
The single-center trial entered 107 participants with HFpEF and pacemakers set, at baseline, to a backup resting HR of 60 bpm; their age averaged 75 and 48% were women. Only patients with devices for atrial pacing, conduction-system pacing, or biventricular pacing – which are unlikely to promote ventricular dyssynchrony – were included.
They were randomly assigned, double-blind, to have their devices set to an accelerated backup rate or to be continued at 60 bpm. The backup resting rate set for the intervention group’s 50 patients was individualized based on height and other factors; the median was 75 bpm.
Scores on the Minnesota Living with Heart Failure Questionnaire, the primary endpoint, improved in the intervention group, compared with baseline, by about 11 points after 1 month and by 15 points after 1 year (P < .001).
The scores in the usual-care group deteriorated by half a point and by 3.5 points at 1 month and 1 year (P = .03), respectively.
Consistent advantages for the accelerated-HR strategy were evident throughout the major secondary endpoints. For example, levels of N-terminal pro-B-type natriuretic peptide fell an average 109 pg/dL after 1 month in the accelerated-HR group and rose a mean of 128 pg/dL in the usual-care group (P = .02).
Mean daily pacemaker-monitored activity level rose by 47 minutes by 1 year in the accelerated-HR group, compared with a drop of 22 minutes for those assigned to the standard-care rate (P < .001).
AFib was detected in 18% of intervention patients at the 1-year follow-up, down from 31% at baseline. Their risk ratio for AFib at 1 year was 0.73 (95% confidence interval, 0.55-0.99, P = .04), compared with the control group.
In other patients with HFpEF “we have done pacing studies where we just ramped up the pacing rate, and we see that these pressures in the left atrium actually drop immediately,” Dr. Meyer said. It’s that “unburdening of the atria,” he added, that probably leads to the reduction in AFib.
Dr. Meyer reported holding a patent for pacemakers for HFpEF licensed to Medtronic. Dr. Zile said he consults for Medtronic and has no other relevant financial relationships.
A version of this article first appeared on Medscape.com.
Evidence supporting medications that slow the heart rate (HR), notably beta-blockers, is overwhelming in heart failure (HF) with reduced ejection fraction. Underwhelming, however, is clinical trial support for such agents in patients with HF with preserved ejection fraction (HFpEF).
Indeed, at least for some such patients, a treatment that modestly accelerates resting HR may be a more promising strategy, suggests an early line of research that challenges prevalent thinking about HFpEF therapy.
In a small, randomized test of the idea, patients with HFpEF and standard pacemakers set to a backup resting HR a bit higher than a standard of care 60 bpm, usually to about 75 bpm, reaped important quality of life benefits.
More strikingly, their natriuretic peptide levels and burden of atrial fibrillation (AFib) fell significantly, the latter by 27% over 1 year.
The trial enrolled only HFpEF patients with pacemakers previously implanted for sick sinus syndrome or atrioventricular block. But researchers say their 107-patient study called myPACE – if confirmed in larger, multicenter trials – lays the groundwork for a device therapy that is broadly useful, potentially, in patients with “preclinical or overt” HFpEF.
Indeed, some of the intervention’s “quite substantial” benefits rivaled or surpassed what his group has observed with available HFpEF drug therapies, including the sodium-glucose cotransporter 2 inhibitors, observed Markus Meyer, MD, PhD, University of Minnesota, Minneapolis.
Moreover, the study may be “the first to show that, with this approach, we can actually also reduce atrial fibrillation,” he said in an interview.
Dr. Meyer said his group is “confident” that the HR-modulation strategy will be successful in appropriate clinical trials and that “pacemakers, in the end, will become a treatment modality for HFpEF.”
Meyer is senior author on the trial’s publication in JAMA Cardiology in JAMA Cardiology (2023 Feb 1. doi: 10.1001/jamacardio.2022.5320), with lead author Margaret Infeld, MD, University of Vermont, Burlington.
The trial entered pacemaker patients with HFpEF of stage B or C – that is, either asymptomatic with structural disease or fully symptomatic. But, Dr. Meyer said, “we saw that the treatment effect was much more pronounced in the patients who had overt heart failure with preserved ejection fraction.”
Challenging beta-blocker dogma
The study, the report states, “contradicts canonical thinking” by suggesting HFpEF patients may benefit from a higher resting heart rate, which would presumably shorten diastolic filling time. It also “may help reduce the overprescription of beta-blockers to allow higher heart rates in this population.”
Indeed, Dr. Meyer observed, no one really knows whether beta-blockers work in HFpEF, “because they really have never been studied in a sufficiently powered randomized controlled trial.”
The current study “basically rewrites what we know about the pathophysiology of this form of clinical heart failure,” said Michael R. Zile, MD, Medical University of South Carolina and Veterans Affairs Medical Center, both in Charleston, who was not part of the trial or report.
Previously in HFpEF, Dr. Zile said in an interview, “everybody thought you needed to make diastole longer to give the ventricle a longer time to fill. And none of that really made any sense. It was just sort of accepted as dogma.”
The idea led to widespread use of beta-blockers in HFpEF but “turned out just not to be true.” Indeed, European and North American guidelines, Dr. Zile observed, “have all taken beta-blockers out of the equation for HFpEF” except for treating comorbidities that can be associated with HFpEF, like hypertension or AFib.
Many patients with HFpEF and chronotropic incompetence could be provided with standard pacemakers with primarily conduction-system pacing but are not getting them, he observed.
The current study might help change that. No one is suggesting, based on the current study, “that we start putting pacemakers in every single patient with HFpEF,” Dr. Zile said. Still, for HFpEF patients already with a pacemaker, the study provides “reasonable assurance” that its criteria for elevated resting HR may well improve symptoms.
Moreover, it suggests such pacemakers, programmed as in the study, might potentially give a boost to HFpEF patients without chronotropic incompetence but with persisting symptoms despite guideline-directed drug therapy. That’s certainly worth exploring in further trials, Dr. Zile said.
How the study worked
The single-center trial entered 107 participants with HFpEF and pacemakers set, at baseline, to a backup resting HR of 60 bpm; their age averaged 75 and 48% were women. Only patients with devices for atrial pacing, conduction-system pacing, or biventricular pacing – which are unlikely to promote ventricular dyssynchrony – were included.
They were randomly assigned, double-blind, to have their devices set to an accelerated backup rate or to be continued at 60 bpm. The backup resting rate set for the intervention group’s 50 patients was individualized based on height and other factors; the median was 75 bpm.
Scores on the Minnesota Living with Heart Failure Questionnaire, the primary endpoint, improved in the intervention group, compared with baseline, by about 11 points after 1 month and by 15 points after 1 year (P < .001).
The scores in the usual-care group deteriorated by half a point and by 3.5 points at 1 month and 1 year (P = .03), respectively.
Consistent advantages for the accelerated-HR strategy were evident throughout the major secondary endpoints. For example, levels of N-terminal pro-B-type natriuretic peptide fell an average 109 pg/dL after 1 month in the accelerated-HR group and rose a mean of 128 pg/dL in the usual-care group (P = .02).
Mean daily pacemaker-monitored activity level rose by 47 minutes by 1 year in the accelerated-HR group, compared with a drop of 22 minutes for those assigned to the standard-care rate (P < .001).
AFib was detected in 18% of intervention patients at the 1-year follow-up, down from 31% at baseline. Their risk ratio for AFib at 1 year was 0.73 (95% confidence interval, 0.55-0.99, P = .04), compared with the control group.
In other patients with HFpEF “we have done pacing studies where we just ramped up the pacing rate, and we see that these pressures in the left atrium actually drop immediately,” Dr. Meyer said. It’s that “unburdening of the atria,” he added, that probably leads to the reduction in AFib.
Dr. Meyer reported holding a patent for pacemakers for HFpEF licensed to Medtronic. Dr. Zile said he consults for Medtronic and has no other relevant financial relationships.
A version of this article first appeared on Medscape.com.
Evidence supporting medications that slow the heart rate (HR), notably beta-blockers, is overwhelming in heart failure (HF) with reduced ejection fraction. Underwhelming, however, is clinical trial support for such agents in patients with HF with preserved ejection fraction (HFpEF).
Indeed, at least for some such patients, a treatment that modestly accelerates resting HR may be a more promising strategy, suggests an early line of research that challenges prevalent thinking about HFpEF therapy.
In a small, randomized test of the idea, patients with HFpEF and standard pacemakers set to a backup resting HR a bit higher than a standard of care 60 bpm, usually to about 75 bpm, reaped important quality of life benefits.
More strikingly, their natriuretic peptide levels and burden of atrial fibrillation (AFib) fell significantly, the latter by 27% over 1 year.
The trial enrolled only HFpEF patients with pacemakers previously implanted for sick sinus syndrome or atrioventricular block. But researchers say their 107-patient study called myPACE – if confirmed in larger, multicenter trials – lays the groundwork for a device therapy that is broadly useful, potentially, in patients with “preclinical or overt” HFpEF.
Indeed, some of the intervention’s “quite substantial” benefits rivaled or surpassed what his group has observed with available HFpEF drug therapies, including the sodium-glucose cotransporter 2 inhibitors, observed Markus Meyer, MD, PhD, University of Minnesota, Minneapolis.
Moreover, the study may be “the first to show that, with this approach, we can actually also reduce atrial fibrillation,” he said in an interview.
Dr. Meyer said his group is “confident” that the HR-modulation strategy will be successful in appropriate clinical trials and that “pacemakers, in the end, will become a treatment modality for HFpEF.”
Meyer is senior author on the trial’s publication in JAMA Cardiology in JAMA Cardiology (2023 Feb 1. doi: 10.1001/jamacardio.2022.5320), with lead author Margaret Infeld, MD, University of Vermont, Burlington.
The trial entered pacemaker patients with HFpEF of stage B or C – that is, either asymptomatic with structural disease or fully symptomatic. But, Dr. Meyer said, “we saw that the treatment effect was much more pronounced in the patients who had overt heart failure with preserved ejection fraction.”
Challenging beta-blocker dogma
The study, the report states, “contradicts canonical thinking” by suggesting HFpEF patients may benefit from a higher resting heart rate, which would presumably shorten diastolic filling time. It also “may help reduce the overprescription of beta-blockers to allow higher heart rates in this population.”
Indeed, Dr. Meyer observed, no one really knows whether beta-blockers work in HFpEF, “because they really have never been studied in a sufficiently powered randomized controlled trial.”
The current study “basically rewrites what we know about the pathophysiology of this form of clinical heart failure,” said Michael R. Zile, MD, Medical University of South Carolina and Veterans Affairs Medical Center, both in Charleston, who was not part of the trial or report.
Previously in HFpEF, Dr. Zile said in an interview, “everybody thought you needed to make diastole longer to give the ventricle a longer time to fill. And none of that really made any sense. It was just sort of accepted as dogma.”
The idea led to widespread use of beta-blockers in HFpEF but “turned out just not to be true.” Indeed, European and North American guidelines, Dr. Zile observed, “have all taken beta-blockers out of the equation for HFpEF” except for treating comorbidities that can be associated with HFpEF, like hypertension or AFib.
Many patients with HFpEF and chronotropic incompetence could be provided with standard pacemakers with primarily conduction-system pacing but are not getting them, he observed.
The current study might help change that. No one is suggesting, based on the current study, “that we start putting pacemakers in every single patient with HFpEF,” Dr. Zile said. Still, for HFpEF patients already with a pacemaker, the study provides “reasonable assurance” that its criteria for elevated resting HR may well improve symptoms.
Moreover, it suggests such pacemakers, programmed as in the study, might potentially give a boost to HFpEF patients without chronotropic incompetence but with persisting symptoms despite guideline-directed drug therapy. That’s certainly worth exploring in further trials, Dr. Zile said.
How the study worked
The single-center trial entered 107 participants with HFpEF and pacemakers set, at baseline, to a backup resting HR of 60 bpm; their age averaged 75 and 48% were women. Only patients with devices for atrial pacing, conduction-system pacing, or biventricular pacing – which are unlikely to promote ventricular dyssynchrony – were included.
They were randomly assigned, double-blind, to have their devices set to an accelerated backup rate or to be continued at 60 bpm. The backup resting rate set for the intervention group’s 50 patients was individualized based on height and other factors; the median was 75 bpm.
Scores on the Minnesota Living with Heart Failure Questionnaire, the primary endpoint, improved in the intervention group, compared with baseline, by about 11 points after 1 month and by 15 points after 1 year (P < .001).
The scores in the usual-care group deteriorated by half a point and by 3.5 points at 1 month and 1 year (P = .03), respectively.
Consistent advantages for the accelerated-HR strategy were evident throughout the major secondary endpoints. For example, levels of N-terminal pro-B-type natriuretic peptide fell an average 109 pg/dL after 1 month in the accelerated-HR group and rose a mean of 128 pg/dL in the usual-care group (P = .02).
Mean daily pacemaker-monitored activity level rose by 47 minutes by 1 year in the accelerated-HR group, compared with a drop of 22 minutes for those assigned to the standard-care rate (P < .001).
AFib was detected in 18% of intervention patients at the 1-year follow-up, down from 31% at baseline. Their risk ratio for AFib at 1 year was 0.73 (95% confidence interval, 0.55-0.99, P = .04), compared with the control group.
In other patients with HFpEF “we have done pacing studies where we just ramped up the pacing rate, and we see that these pressures in the left atrium actually drop immediately,” Dr. Meyer said. It’s that “unburdening of the atria,” he added, that probably leads to the reduction in AFib.
Dr. Meyer reported holding a patent for pacemakers for HFpEF licensed to Medtronic. Dr. Zile said he consults for Medtronic and has no other relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
Longer diabetes duration links with increased heart failure
The longer people had diabetes, the greater their rate of incident heart failure, suggests a recently published review of prospectively collected observational data from nearly 24,000 people with diabetes in the UK Biobank.
The findings “add to the growing body of evidence suggesting that duration of diabetes is an important and independent determinant of heart failure among patients with diabetes,” comments Justin B. Echouffo-Tcheugui, MD, PhD, in an accompanying editorial.
Collectively, the new UK Biobank results and prior findings, “provide additional persuasive evidence that the link between duration of diabetes and heart failure is real,” although the physiological mechanisms behind the relationship remain incompletely understood, wrote Dr. Echouffo-Tcheugui, an endocrinologist at Johns Hopkins Medicine, Baltimore.
“The duration of diabetes may reflect cumulative effects of various adverse processes in the setting of diabetes” that result in “intrinsic myocardial lesions,” he suggested. These adverse processes might include not only hyperglycemia, but also glucotoxicity, lipotoxicity, hyperinsulinemia, advanced glycosylation end products, oxidative stress, mitochondrial dysfunction, cardiac autonomic neuropathy, and coronary microvascular dysfunction. Long-duration diabetes may also contribute to declining kidney function, which can further worsen heart failure risk.
The upshot is that clinicians may need to consider more systematically the duration of diabetes when assessing people with diabetes for heart failure.
Existing risk-assessment tools for predicting heart failure in people with diabetes “have not always accounted for diabetes duration,” Dr. Echouffo-Tcheugui noted.
Intensify heart failure detection with longer diabetes duration
“Active heart failure detection should perhaps be intensified with increased diabetes duration,” Dr. Echouffo-Tcheugui suggested in his editorial. He noted that a 2022 consensus report by the American Diabetes Association recommends clinicians measure natriuretic peptide or high-sensitivity cardiac troponin in all people with diabetes “on at least a yearly basis to identify the earliest heart failure stages and implement strategies to prevent transition to symptomatic heart failure.”
The UK Biobank study was run by investigators primarily based in China and included data from 23,754 people with type 1 or type 2 diabetes and no heart failure at baseline. The prospectively collected data allowed for a median follow-up of 11.7 years, during which time 2,081 people developed incident heart failure.
In an analysis that divided participants into four categories of diabetes duration (< 5 years, 5-9 years, 10-14 years, and ≥ 15 years) and adjusted for potential confounders, heart failure incidence showed a significant 32% increased incidence among those with diabetes for at least 15 years, compared with those with diabetes for less than 5 years. People with a diabetes duration of 5-14 years showed a trend toward having more incident heart failure, compared with those with diabetes for less than 5 years, but the difference was not significant.
An adjusted analysis also showed poor glycemic control at baseline (hemoglobin A1c ≥ 8.0%) significantly linked with a 46% increased incidence of heart failure, compared with those with baseline A1c less than 7.0%.
Additive effect?
When the authors analyzed the effect of both these variables, they saw a roughly additive effect.
Patients with diabetes for at least 15 years and a baseline A1c of at least 8.0% had a 98% increased incidence of heart failure, compared with those who had diabetes for less than 5 years and a baseline A1c less than 7.0%, after adjustment. This association was independent of age, sex, and race.
These findings “highlight the paramount role of the duration of diabetes and its interaction with glycemic control in the development of heart failure,” the authors concluded. “Long duration of diabetes and poor glycemic control may result in structural and functional changes in the myocardium, which is likely to underlie the pathogenesis of heart failure among individuals with diabetes.”
In his editorial, Dr. Echouffo-Tcheugui lauded the report for its “robust” analyses that included a large sample and accounted for key confounders, such as glycemic control. However, he also cited eight “shortcomings” of the study, including its sole reliance on A1c levels to identify diabetes, a likely underestimation of diabetes duration, the lumping together of people with type 1 and type 2 diabetes, and lack of a subanalysis of incident heart failure in those with preserved or reduced left ventricular ejection fraction.
Among prior reports of evidence also suggesting an effect of diabetes duration on incident heart failure, Dr. Echouffo-Tcheugui cited a study he led, published in 2021, that analyzed prospective, longitudinal, observational data from 9,734 adults enrolled in the Atherosclerosis Risk in Communities study. The results showed that, compared with those without diabetes, the incidence of heart failure rose with longer diabetes duration, with the highest risk among those with diabetes for at least 15 years, who had a 2.8-fold increase in heart failure versus the reference group. Each 5-year increase in diabetes duration was associated with a significant 17% relative increase in heart failure incidence.
The study received no commercial funding. The authors and editorialist reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The longer people had diabetes, the greater their rate of incident heart failure, suggests a recently published review of prospectively collected observational data from nearly 24,000 people with diabetes in the UK Biobank.
The findings “add to the growing body of evidence suggesting that duration of diabetes is an important and independent determinant of heart failure among patients with diabetes,” comments Justin B. Echouffo-Tcheugui, MD, PhD, in an accompanying editorial.
Collectively, the new UK Biobank results and prior findings, “provide additional persuasive evidence that the link between duration of diabetes and heart failure is real,” although the physiological mechanisms behind the relationship remain incompletely understood, wrote Dr. Echouffo-Tcheugui, an endocrinologist at Johns Hopkins Medicine, Baltimore.
“The duration of diabetes may reflect cumulative effects of various adverse processes in the setting of diabetes” that result in “intrinsic myocardial lesions,” he suggested. These adverse processes might include not only hyperglycemia, but also glucotoxicity, lipotoxicity, hyperinsulinemia, advanced glycosylation end products, oxidative stress, mitochondrial dysfunction, cardiac autonomic neuropathy, and coronary microvascular dysfunction. Long-duration diabetes may also contribute to declining kidney function, which can further worsen heart failure risk.
The upshot is that clinicians may need to consider more systematically the duration of diabetes when assessing people with diabetes for heart failure.
Existing risk-assessment tools for predicting heart failure in people with diabetes “have not always accounted for diabetes duration,” Dr. Echouffo-Tcheugui noted.
Intensify heart failure detection with longer diabetes duration
“Active heart failure detection should perhaps be intensified with increased diabetes duration,” Dr. Echouffo-Tcheugui suggested in his editorial. He noted that a 2022 consensus report by the American Diabetes Association recommends clinicians measure natriuretic peptide or high-sensitivity cardiac troponin in all people with diabetes “on at least a yearly basis to identify the earliest heart failure stages and implement strategies to prevent transition to symptomatic heart failure.”
The UK Biobank study was run by investigators primarily based in China and included data from 23,754 people with type 1 or type 2 diabetes and no heart failure at baseline. The prospectively collected data allowed for a median follow-up of 11.7 years, during which time 2,081 people developed incident heart failure.
In an analysis that divided participants into four categories of diabetes duration (< 5 years, 5-9 years, 10-14 years, and ≥ 15 years) and adjusted for potential confounders, heart failure incidence showed a significant 32% increased incidence among those with diabetes for at least 15 years, compared with those with diabetes for less than 5 years. People with a diabetes duration of 5-14 years showed a trend toward having more incident heart failure, compared with those with diabetes for less than 5 years, but the difference was not significant.
An adjusted analysis also showed poor glycemic control at baseline (hemoglobin A1c ≥ 8.0%) significantly linked with a 46% increased incidence of heart failure, compared with those with baseline A1c less than 7.0%.
Additive effect?
When the authors analyzed the effect of both these variables, they saw a roughly additive effect.
Patients with diabetes for at least 15 years and a baseline A1c of at least 8.0% had a 98% increased incidence of heart failure, compared with those who had diabetes for less than 5 years and a baseline A1c less than 7.0%, after adjustment. This association was independent of age, sex, and race.
These findings “highlight the paramount role of the duration of diabetes and its interaction with glycemic control in the development of heart failure,” the authors concluded. “Long duration of diabetes and poor glycemic control may result in structural and functional changes in the myocardium, which is likely to underlie the pathogenesis of heart failure among individuals with diabetes.”
In his editorial, Dr. Echouffo-Tcheugui lauded the report for its “robust” analyses that included a large sample and accounted for key confounders, such as glycemic control. However, he also cited eight “shortcomings” of the study, including its sole reliance on A1c levels to identify diabetes, a likely underestimation of diabetes duration, the lumping together of people with type 1 and type 2 diabetes, and lack of a subanalysis of incident heart failure in those with preserved or reduced left ventricular ejection fraction.
Among prior reports of evidence also suggesting an effect of diabetes duration on incident heart failure, Dr. Echouffo-Tcheugui cited a study he led, published in 2021, that analyzed prospective, longitudinal, observational data from 9,734 adults enrolled in the Atherosclerosis Risk in Communities study. The results showed that, compared with those without diabetes, the incidence of heart failure rose with longer diabetes duration, with the highest risk among those with diabetes for at least 15 years, who had a 2.8-fold increase in heart failure versus the reference group. Each 5-year increase in diabetes duration was associated with a significant 17% relative increase in heart failure incidence.
The study received no commercial funding. The authors and editorialist reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The longer people had diabetes, the greater their rate of incident heart failure, suggests a recently published review of prospectively collected observational data from nearly 24,000 people with diabetes in the UK Biobank.
The findings “add to the growing body of evidence suggesting that duration of diabetes is an important and independent determinant of heart failure among patients with diabetes,” comments Justin B. Echouffo-Tcheugui, MD, PhD, in an accompanying editorial.
Collectively, the new UK Biobank results and prior findings, “provide additional persuasive evidence that the link between duration of diabetes and heart failure is real,” although the physiological mechanisms behind the relationship remain incompletely understood, wrote Dr. Echouffo-Tcheugui, an endocrinologist at Johns Hopkins Medicine, Baltimore.
“The duration of diabetes may reflect cumulative effects of various adverse processes in the setting of diabetes” that result in “intrinsic myocardial lesions,” he suggested. These adverse processes might include not only hyperglycemia, but also glucotoxicity, lipotoxicity, hyperinsulinemia, advanced glycosylation end products, oxidative stress, mitochondrial dysfunction, cardiac autonomic neuropathy, and coronary microvascular dysfunction. Long-duration diabetes may also contribute to declining kidney function, which can further worsen heart failure risk.
The upshot is that clinicians may need to consider more systematically the duration of diabetes when assessing people with diabetes for heart failure.
Existing risk-assessment tools for predicting heart failure in people with diabetes “have not always accounted for diabetes duration,” Dr. Echouffo-Tcheugui noted.
Intensify heart failure detection with longer diabetes duration
“Active heart failure detection should perhaps be intensified with increased diabetes duration,” Dr. Echouffo-Tcheugui suggested in his editorial. He noted that a 2022 consensus report by the American Diabetes Association recommends clinicians measure natriuretic peptide or high-sensitivity cardiac troponin in all people with diabetes “on at least a yearly basis to identify the earliest heart failure stages and implement strategies to prevent transition to symptomatic heart failure.”
The UK Biobank study was run by investigators primarily based in China and included data from 23,754 people with type 1 or type 2 diabetes and no heart failure at baseline. The prospectively collected data allowed for a median follow-up of 11.7 years, during which time 2,081 people developed incident heart failure.
In an analysis that divided participants into four categories of diabetes duration (< 5 years, 5-9 years, 10-14 years, and ≥ 15 years) and adjusted for potential confounders, heart failure incidence showed a significant 32% increased incidence among those with diabetes for at least 15 years, compared with those with diabetes for less than 5 years. People with a diabetes duration of 5-14 years showed a trend toward having more incident heart failure, compared with those with diabetes for less than 5 years, but the difference was not significant.
An adjusted analysis also showed poor glycemic control at baseline (hemoglobin A1c ≥ 8.0%) significantly linked with a 46% increased incidence of heart failure, compared with those with baseline A1c less than 7.0%.
Additive effect?
When the authors analyzed the effect of both these variables, they saw a roughly additive effect.
Patients with diabetes for at least 15 years and a baseline A1c of at least 8.0% had a 98% increased incidence of heart failure, compared with those who had diabetes for less than 5 years and a baseline A1c less than 7.0%, after adjustment. This association was independent of age, sex, and race.
These findings “highlight the paramount role of the duration of diabetes and its interaction with glycemic control in the development of heart failure,” the authors concluded. “Long duration of diabetes and poor glycemic control may result in structural and functional changes in the myocardium, which is likely to underlie the pathogenesis of heart failure among individuals with diabetes.”
In his editorial, Dr. Echouffo-Tcheugui lauded the report for its “robust” analyses that included a large sample and accounted for key confounders, such as glycemic control. However, he also cited eight “shortcomings” of the study, including its sole reliance on A1c levels to identify diabetes, a likely underestimation of diabetes duration, the lumping together of people with type 1 and type 2 diabetes, and lack of a subanalysis of incident heart failure in those with preserved or reduced left ventricular ejection fraction.
Among prior reports of evidence also suggesting an effect of diabetes duration on incident heart failure, Dr. Echouffo-Tcheugui cited a study he led, published in 2021, that analyzed prospective, longitudinal, observational data from 9,734 adults enrolled in the Atherosclerosis Risk in Communities study. The results showed that, compared with those without diabetes, the incidence of heart failure rose with longer diabetes duration, with the highest risk among those with diabetes for at least 15 years, who had a 2.8-fold increase in heart failure versus the reference group. Each 5-year increase in diabetes duration was associated with a significant 17% relative increase in heart failure incidence.
The study received no commercial funding. The authors and editorialist reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Legacy ICDs exposed to MRI still shock, pace as needed
Functions like sensing and pacing in implantable cardioverter defibrillators (ICDs) tend to resist interference from the energy fields generated by MRI, as long as device programming is properly adjusted before the scan.
That applies even to patients with older “legacy” devices implanted before the 2015 advent of MRI-conditional ICDs despite, in practice, prevalent but misguided resistance to obtaining MRI scans in such cases.
Less is known whether such non–MRI-conditional devices, once exposed to MRI, will then reliably deliver antiarrhythmic shocks or antitachycardia pacing (ATP) when needed.
A new cohort study has tried to fill in some of that knowledge gap. It showed no evidence of an excess risk for death or ICD failure to deliver therapy within about 2 years of clinically indicated MRI scans in 629 patients with non–MRI-conditional devices.
The findings, published online in the Annals of Internal Medicine, come with caveats. For example, they’re based on the experience of one, albeit major, center and on MRIs that were for varied indications using 1.5-tesla equipment only.
Despite such safety evidence for appropriately adjusted non–MRI-conditional ICDs, many patients with the devices don›t receive clinically indicated MRI scans due to “perceived risk” that the ICDs won’t then reliably deliver appropriate therapy, observe the authors, led by Joshua Ra, MD, University of California, San Francisco.
Any such risks are “largely theoretical,” but may still explain “why some institutions are shying away from offering MRI exams” to patients with non–MRI-conditional ICDs, Dr. Ra told this news organization.
Many such hospitals refer such patients to more experienced centers, creating “significant logistical barriers in terms of patient access to these MRIs,” he said. “That seems to still be prevalent, unfortunately.”
The current findings “provide another layer of reassurance” that MRI scans in patients with non–MRI-conditional ICDs don’t impair a device’s ability to deliver shocks or ATP, Dr. Ra said.
The cohort consisted of 629 patients with non–MRI-conditional ICDs who underwent 813 clinically indicated MRI exams from 2003 to early 2015 at Johns Hopkins University, Baltimore.
Scans performed within 4 weeks of device implantation were excluded because, the report notes, that’s when spontaneous lead dislodgements or changes to device parameters are most likely to occur. Also excluded were patients with permanent epicardial leads, abandoned leads, or subcutaneous ICD lead systems, the report states.
Still, Dr. Ra said, the cohort is fairly representative of “the modern patient population” of non–MRI-conditional ICD recipients.
A total of 4,177 arrhythmia episodes were documented during a median 2.2 years between scans and last device interrogation prior to pulse-generator change-out or lead exchange.
Of note, Dr. Ra observed, the arrhythmias were confirmed in only 85% of the cohort. Most of the remainder were referral patients who were lost to follow-up whose devices were unavailable for interrogation.
Device therapy terminated “nearly all” documented spontaneous arrhythmias in that 85% of patients, the report states. They included 757 episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), including 130 that were shocked and the remainder that were managed with ATP. There were also 105 supraventricular tachycardias, all successfully terminated with shocks.
There were no cases of VT or VF detection delay from undersensing or instances of syncope because of “abnormalities” in device detection of arrhythmias, the report states.
Of the 210 known deaths, which occurred a median 1.7 years after the scan, about half were noncardiac and more than a third were cardiac but nonarrhythmic.
Ten patients died from arrhythmia-related cardiac causes, representing 5% of deaths; but 7% of deaths were of undetermined cause.
“No direct relationship of deaths attributable to prior MRI exposure was found or reported,” the report states.
The researchers informally compared outcomes between older and more recently implanted non–MRI-conditional ICDs, the latter presumably with more modern design features. Their data, based on device interrogations, Dr. Ra said, “seem to suggest there were no differences.”
The study was supported by Johns Hopkins University and the National Institutes of Health. Author disclosures are available at apconline.org.
A version of this article first appeared on Medscape.com.
Functions like sensing and pacing in implantable cardioverter defibrillators (ICDs) tend to resist interference from the energy fields generated by MRI, as long as device programming is properly adjusted before the scan.
That applies even to patients with older “legacy” devices implanted before the 2015 advent of MRI-conditional ICDs despite, in practice, prevalent but misguided resistance to obtaining MRI scans in such cases.
Less is known whether such non–MRI-conditional devices, once exposed to MRI, will then reliably deliver antiarrhythmic shocks or antitachycardia pacing (ATP) when needed.
A new cohort study has tried to fill in some of that knowledge gap. It showed no evidence of an excess risk for death or ICD failure to deliver therapy within about 2 years of clinically indicated MRI scans in 629 patients with non–MRI-conditional devices.
The findings, published online in the Annals of Internal Medicine, come with caveats. For example, they’re based on the experience of one, albeit major, center and on MRIs that were for varied indications using 1.5-tesla equipment only.
Despite such safety evidence for appropriately adjusted non–MRI-conditional ICDs, many patients with the devices don›t receive clinically indicated MRI scans due to “perceived risk” that the ICDs won’t then reliably deliver appropriate therapy, observe the authors, led by Joshua Ra, MD, University of California, San Francisco.
Any such risks are “largely theoretical,” but may still explain “why some institutions are shying away from offering MRI exams” to patients with non–MRI-conditional ICDs, Dr. Ra told this news organization.
Many such hospitals refer such patients to more experienced centers, creating “significant logistical barriers in terms of patient access to these MRIs,” he said. “That seems to still be prevalent, unfortunately.”
The current findings “provide another layer of reassurance” that MRI scans in patients with non–MRI-conditional ICDs don’t impair a device’s ability to deliver shocks or ATP, Dr. Ra said.
The cohort consisted of 629 patients with non–MRI-conditional ICDs who underwent 813 clinically indicated MRI exams from 2003 to early 2015 at Johns Hopkins University, Baltimore.
Scans performed within 4 weeks of device implantation were excluded because, the report notes, that’s when spontaneous lead dislodgements or changes to device parameters are most likely to occur. Also excluded were patients with permanent epicardial leads, abandoned leads, or subcutaneous ICD lead systems, the report states.
Still, Dr. Ra said, the cohort is fairly representative of “the modern patient population” of non–MRI-conditional ICD recipients.
A total of 4,177 arrhythmia episodes were documented during a median 2.2 years between scans and last device interrogation prior to pulse-generator change-out or lead exchange.
Of note, Dr. Ra observed, the arrhythmias were confirmed in only 85% of the cohort. Most of the remainder were referral patients who were lost to follow-up whose devices were unavailable for interrogation.
Device therapy terminated “nearly all” documented spontaneous arrhythmias in that 85% of patients, the report states. They included 757 episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), including 130 that were shocked and the remainder that were managed with ATP. There were also 105 supraventricular tachycardias, all successfully terminated with shocks.
There were no cases of VT or VF detection delay from undersensing or instances of syncope because of “abnormalities” in device detection of arrhythmias, the report states.
Of the 210 known deaths, which occurred a median 1.7 years after the scan, about half were noncardiac and more than a third were cardiac but nonarrhythmic.
Ten patients died from arrhythmia-related cardiac causes, representing 5% of deaths; but 7% of deaths were of undetermined cause.
“No direct relationship of deaths attributable to prior MRI exposure was found or reported,” the report states.
The researchers informally compared outcomes between older and more recently implanted non–MRI-conditional ICDs, the latter presumably with more modern design features. Their data, based on device interrogations, Dr. Ra said, “seem to suggest there were no differences.”
The study was supported by Johns Hopkins University and the National Institutes of Health. Author disclosures are available at apconline.org.
A version of this article first appeared on Medscape.com.
Functions like sensing and pacing in implantable cardioverter defibrillators (ICDs) tend to resist interference from the energy fields generated by MRI, as long as device programming is properly adjusted before the scan.
That applies even to patients with older “legacy” devices implanted before the 2015 advent of MRI-conditional ICDs despite, in practice, prevalent but misguided resistance to obtaining MRI scans in such cases.
Less is known whether such non–MRI-conditional devices, once exposed to MRI, will then reliably deliver antiarrhythmic shocks or antitachycardia pacing (ATP) when needed.
A new cohort study has tried to fill in some of that knowledge gap. It showed no evidence of an excess risk for death or ICD failure to deliver therapy within about 2 years of clinically indicated MRI scans in 629 patients with non–MRI-conditional devices.
The findings, published online in the Annals of Internal Medicine, come with caveats. For example, they’re based on the experience of one, albeit major, center and on MRIs that were for varied indications using 1.5-tesla equipment only.
Despite such safety evidence for appropriately adjusted non–MRI-conditional ICDs, many patients with the devices don›t receive clinically indicated MRI scans due to “perceived risk” that the ICDs won’t then reliably deliver appropriate therapy, observe the authors, led by Joshua Ra, MD, University of California, San Francisco.
Any such risks are “largely theoretical,” but may still explain “why some institutions are shying away from offering MRI exams” to patients with non–MRI-conditional ICDs, Dr. Ra told this news organization.
Many such hospitals refer such patients to more experienced centers, creating “significant logistical barriers in terms of patient access to these MRIs,” he said. “That seems to still be prevalent, unfortunately.”
The current findings “provide another layer of reassurance” that MRI scans in patients with non–MRI-conditional ICDs don’t impair a device’s ability to deliver shocks or ATP, Dr. Ra said.
The cohort consisted of 629 patients with non–MRI-conditional ICDs who underwent 813 clinically indicated MRI exams from 2003 to early 2015 at Johns Hopkins University, Baltimore.
Scans performed within 4 weeks of device implantation were excluded because, the report notes, that’s when spontaneous lead dislodgements or changes to device parameters are most likely to occur. Also excluded were patients with permanent epicardial leads, abandoned leads, or subcutaneous ICD lead systems, the report states.
Still, Dr. Ra said, the cohort is fairly representative of “the modern patient population” of non–MRI-conditional ICD recipients.
A total of 4,177 arrhythmia episodes were documented during a median 2.2 years between scans and last device interrogation prior to pulse-generator change-out or lead exchange.
Of note, Dr. Ra observed, the arrhythmias were confirmed in only 85% of the cohort. Most of the remainder were referral patients who were lost to follow-up whose devices were unavailable for interrogation.
Device therapy terminated “nearly all” documented spontaneous arrhythmias in that 85% of patients, the report states. They included 757 episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), including 130 that were shocked and the remainder that were managed with ATP. There were also 105 supraventricular tachycardias, all successfully terminated with shocks.
There were no cases of VT or VF detection delay from undersensing or instances of syncope because of “abnormalities” in device detection of arrhythmias, the report states.
Of the 210 known deaths, which occurred a median 1.7 years after the scan, about half were noncardiac and more than a third were cardiac but nonarrhythmic.
Ten patients died from arrhythmia-related cardiac causes, representing 5% of deaths; but 7% of deaths were of undetermined cause.
“No direct relationship of deaths attributable to prior MRI exposure was found or reported,” the report states.
The researchers informally compared outcomes between older and more recently implanted non–MRI-conditional ICDs, the latter presumably with more modern design features. Their data, based on device interrogations, Dr. Ra said, “seem to suggest there were no differences.”
The study was supported by Johns Hopkins University and the National Institutes of Health. Author disclosures are available at apconline.org.
A version of this article first appeared on Medscape.com.