Coverage of the annual AHA Scientific Sessions

American Heart Association Scientific Sessions 2021

Cardiology Month in Review: November 2021

Articles

November's cardiology month in review features stories from the AHA's late-breaking sessions and Kidney Week 2021. 

Patrick Campbell is the senior editor of Practical Cardiology, as well as its sister publication Endocrinology Network. Prior to joining these brands, he led coverage of cardiology and diabetes with HCPLive. Before joining parent company MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a freelance multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Results of a recent trial suggest patients who are undergoing mitral valve surgery for degenerative mitral regurgitation may also benefit from undergoing tricuspid annuloplasty (TA).

The trial, which assessed mitral valve surgery with or without TA, randomized 401 patients and suggests those who received TA had a lower incidence of primary endpoint events than those who underwent mitral valve surgery alone at 2 years, with this reduction primarily driven by less frequent progression to severe tricuspid regurgitation.

“There’s a general agreement among surgeons that if there is severe leakage of the tricuspid valve, then we should fix it,” said lead investigator James Gammie, MD, surgical leader and co-director of the Heart and Vascular Institute at the Johns Hopkins University School of Medicine, 

. “However, there has been considerable uncertainty as to whether the tricuspid valve needs repair at the time of mitral valve surgery when the leakage is only moderate or less.”

Although tricuspid regurgitation is common among patients with severe degenerative mitral, contemporary evidence fails to provide clear determination whether to perform tricuspid valve repair during mitral valve surgery in patients with moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation. With this in mind, the current trial was conducted across 39 sites in the United States, Canada, and Germany and designed to assess a composite primary end point of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death at 2 years.

All patients enrolled in the study were scheduled for mitral valve surgery and those with either moderate tricuspid regurgitation or less-than-moderate regurgitation were randomized in a 1:1 ratio to undergo surgery with or without TA. From 2016-2018, investigators screened more than 5200 patients and 885 patients from this group were considered eligible to participate. Of these, 401 underwent randomization, with 203 randomized to surgery alone and 198 randomized to surgery plus TA.

Among the 401 patients who underwent randomization, mitral valve repair was performed among 89.8% (n=360) and mitral valve replacement was performed in 10.2% (n=41). Among those who underwent TA, the mean annuloplasty ring size was 29.0±1.9 mm among men and 27.8±1.6 mm among women. Investigators noted the mean cardiopulmonary bypass time was 33.5 (95% CI, 20.9-46.1) minutes longer among the TA group than among the surgery-only group (166.1±69.3 vs 132.6±58.8). Additionally, 4 patients crossed over to undergo the other procedure in the operating room and more than half of the patients included in the study underwent concomitant procedures, including CABG, ablation, LAA closure, and oversewing of a PFO.

Secondary outcomes of interest for the study included death, MACCE, pacemaker implantation, length of hospital stay, residual tricuspid regurgitation, and more.

Upon analysis, results indicated those who underwent surgery plus TA experienced fewer primary end point events than their counterparts who underwent surgery alone (3.9% vs 10.2%; relative risk, 0.37 [95% CI, 0.16-0.86]; 

=.02). When assessing mortality at 2 years, the observed incidence of mortality was 3.2% among the surgery plus TA group compared to 4.5% for the surgery alone group (RR, 0.69 [95% CI, 0.25-1.88). Further analysis suggested the 2-year prevalence of progression of tricuspid regurgitation was lower among those who received surgery plus TA compared to those receiving surgery alone (0.6% vs 6.1%; RR, 0.09 [95% CI, 0.01-0.69]).

When assessing the frequency of MACCE, functional status, and quality of life, results indicated frequency were similar between the groups at 2 years, but the incidence of permanent pacemaker implantation was greater among the surgery plus TA group than the surgery alone group (14.1% vs 2.5%; rate ratio, 5.75 [95% CI, 2.27-14.60]).

“We clearly need to better understand the risk factors for needing a permanent pacemaker implanted after tricuspid valve repair and how to best mitigate the risk with technique modifications or different postoperative management strategies,” Gammie added. “But for the first time, we have high-level evidence to help us understand what to do in the operating room when it comes to tricuspid valve repair in those with less than severe regurgitation.”

Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation

A recent trial found concomitant tricuspid annuloplasty could lower the risk of mortality and progression to severe tricuspid regurgitation among patients with degenerative mitral valve regurgitation.

Concomitant Tricuspid Repair Could Lower Mortality Risk in Patients with Degenerative Mitral Regurgitation

It has been nearly 2 years since the first cases of clinical COVID-19 were identified. Since then, the novel coronavirus has infected tens of millions of people worldwide and led to unprecedented mortality and morbidity. Through it all colleges and societies of cardiologists have raced to keep up with the cardiovascular implications of exposure and infection with COVID-19. The European Society of Cardiology (ESC) has kept pace studying the data and issuing recommendations for the diagnosis and treatment of CVD during the pandemic.

Most recently the ESC has issued guidance with regards to care pathways, treatment, and follow-up for patients presenting with cardiovascular conditions during the COVID-19 pandemic. This latest guide produced by The Task Force for the Management of COVID-19 of the European Society of Cardiology represents the second part of a two-part series addressing care of the cardiovascular patient during the pandemic. In this part they specifically address care pathways, treatment plans, and following up after discharge.

Diagnosis and Treatment of Patients with Suspected Acute Coronary Syndromes:

The management of cardiogenic shock and out-of-hospital cardiac arrest are critically time-dependent conditions requiring prompt standardized care with multidisciplinary expertise.

Established, standardized protocols including selection for mechanical circulatory support (MCS) should continue to be employed.

Invasive coronary angiography (ICA) remains the mainstay of treatment. However, special considerations need to be considered to minimize the risk of widespread nosocomial infections.

If patients have COVID-19, escalation to MCS, should be weighed against possible coagulopathy and need for prone positioning.

Extracorporeal Membrane Oxygenation (ECMO) should be the preferred temporary MCS due to oxygenation capabilities.

Continuous renal replacement therapy (CRRT) should be used restrictively for acute renal failure.

Daily organ failure assessments should be made to determine which patients are most critical.

Promoting the safety of health care providers is of predominant importance.

COVID-19 infection should be excluded through two negative tests.

Prone patients may receive CPR in the prone position if technically challenging to place supine.

ST-Segment Elevation Myocardial Infarction:

The maximum delay from STEMI diagnosis to reperfusion should remain 120 minutes.

If COVID-19 test results are not available immediately, the patient should be considered infected.

All STEMI patients should undergo COVID-19 testing as soon as possible.

Consider immediate complete revascularization if indicated to avoid staged procedures.

Physicians should be familiar with fibrinolysis protocols.

Generally low risk for CV events, may defer diagnostic and or interventional procedures, in most cases.

Utilize remote clinical follow-up when possible.

Acute HF may complicate the course of COVID-19.

HF may arise from many root causes including acute myocarditis from COVID-19.

COVID-19 pneumonia may worsen hemodynamic status.

Symptoms of COVID-19 and worsening HF are similar. Consider point of care echocardiography.

Treatment of HF in COVID-19 patients should be the same as in non-COVID-19 patients.

Myocarditis is rare but seen in some COVID-19 patients.

Myocarditis may be present in COVID-19 patients without respiratory symptoms.

It should be suspected in patients with acute onset chest pain or other cardiac symptoms/signs.

Myocardial biopsy is not recommended in COVID-19 patients routinely.

Both conditions should be managed conservatively unless symptomatic and urgent intervention is needed.

Non-urgent procedures should be deferred.

Should be treated with existing recommendations with no change.

Prompt anticoagulation should not be delayed. Use existing guidelines.

Arrhythmias may complicate COVID-19 infection and are a poor prognostic sign.

They should be treated with existing guidelines keeping in mind drug interactions with therapies used for COVID-19.

Amiodarone is the drug of choice for hemodynamically unstable tachy-arrhythmias.

For the most part arrhythmias should be treated according to established guidelines.

The evidence regarding the efficacy and risk of different treatment strategies in patients with COVID-19 is extensive and continuously evolving; the current and regularly updated version of the World Health Organization (WHO) ‘living guidelines’ is online available.

Recent randomized clinical trials suggest that, with the exception of glucocorticoids (especially dexamethasone) in hospitalized patients with severe and critical COVID-19, the majority of the initially used antiviral, anti-inflammatory, or immunomodulatory experimental drugs have no or limited effect on the natural history of COVID-19.

In all patients undergoing antiviral treatment, it is of major importance to correct modifiable predisposing factors to QTc prolongation: electrolyte imbalances, concomitant drugs, and bradycardia.

Transparent patient centered information is essential to support patients and reduce transmission risk.

Pre-existing CVD has a direct impact on COVID-19 disease and survival.

Patients should be counseled to avoid sick people, practice social distancing, proper hand washing techniques and frequency, covering their mouth and nose when coughing, avoidance of touching their faces, and surface decontamination techniques.

Patients should be told to self-isolate in case of symptoms but when healthy they should engage in physical activity and maintain well-being.

Finally, patients with CVD should continue to practice healthy lifestyle behaviors. They should not smoke, they should avoid inactivity, and they should attend any clinical appointments with an emphasis on telehealth visits when feasible. As clinicians we should encourage our patients to keep up with their medication regimen and unless contraindicated, get vaccinated for COVID-19.

While the most salient points contained within the ESC recommendations have been relayed here the sheer volume of information was beyond the brevity and scope of this review. The entirety of the recommendations can be found 

ESC guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic: part 2—care pathways, treatment, and follow-up. 

Dr. Gregory Weiss offers a breakdown of the recent ESC guidelines for management of cardiovascular disease during the ongoing COVID-19 pandemic, including specific insight into care pathways, treatment, and follow-up.

ESC Releases New Guidance on Cardiovascular Disease Management During COVID-19 Pandemic

This article was originally published on 

A recent analysis of data from the SWISS-AF study suggests patients with diabetes were less likely to perceive symptoms of atrial fibrillation than their counterparts without diabetes. 

Results of the analysis, which included data from more than 2400 patients, provide clinicians with insight into the lower likelihood of reporting arrhythmias as well as the prevalence of cardiovascular and neurologic comorbidities among these patients.

“Since diabetes is one of the major risk factors for AFib, our team investigated whether patients with and without diabetes differ in terms of atrial fibrillation symptoms and complications,” said study author Tobias Reichlin, MD, professor of cardiology at Bern University Hospital at the University of Bern in Switzerland, in a statement. “This research can provide insights on improving the management of atrial fibrillation and prevention of its complications.”

The current study was designed by Reichlin and a team of colleagues with an interest in assessing potential associations of diabetes with parameters of AF phenotype, including AF type, AF symptoms, and quality of life. Using the ongoing SWISS-AF study, investigators obtained information related to 2415 patients, of which 2411 had complete data on history of diabetes and AF phenotype. Of the 2411 included in the investigators’ analyses, 420 had known diabetes, the mean age at baseline was 73.2 years, and 27.4% were women.

Compared to those without diabetes, patients with diabetes were more likely to be older, men, smokers, and have a higher body mass index. Additionally, patients with diabetes had a greater stroke risk, which was assessed according to median CHA2DS2-VASC. 

The primary outcomes of interest for the study were parameters of AF phenotype, AF symptoms, and quality of life. Secondary outcomes of interest for the study included cardiac and neurological comorbidities. For the purpose of analysis, neurological morbidities included history of stroke and cognitive impairment while cardiac comorbidities included hypertension, myocardial infarction, and heart failure. Quality

Investigators planned to assess cross-sectional associations of diabetes with the aforementioned outcomes using logistic and linear regression, adjusted for age, sex, and cardiovascular risk factors.

Results of the investigators’ analyses indicated diabetes was not associated with increased likelihood of nonparoxysmal (OR, 1.01; 95% CI, 0.81-1.27). Further analysis suggested patients with diabetes were less likely to perceive AF symptoms (OR, 0.74; 95% CI, 0.59-0.92) and had a lower quality of life (β=−4.54; 95% CI, −6.40 to −2.68) than their counterparts without diabetes.

When assessing presence of comorbidities, patients with diabetes were more likely to have hypertension (OR, 3.04; 95% CI, 2.19-4.22), myocardial infarction (OR, 1.55; 95% CI, 1.18-2.03), and heart failure (OR, 1.99; 95% CI, 1.57-2.51) than those without diabetes. Additionally, patients with diabetes were also more likely to report neurological comorbidities, with increased likelihood observed for both stroke (OR, 1.39; 95% CI, 1.03-1.87) and cognitive impairment (OR, 1.75; 95% CI, 1.39-2.21)

”These important new findings from the large Swiss AF study show compared to AFib patients without diabetes, those with diabetes were less likely to experience any symptom related to atrial fibrillation,” said Prakash Deedwania, MD, a member of the scientific advisory board for Know Diabetes By Heart (KDBH), a joint initiative of the American Heart Association and the American Diabetes Association and a professor of medicine at the University of California, San Francisco School of Medicine. “These results were seen even though people with diabetes and AFib had more coexisting health conditions such as high blood pressure, as well as a history of heart attack and heart failure. Keeping these new observations in mind, along with the serious consequences of failing to recognize AFib in time, it seems prudent to consider screening older patients with diabetes for AFib so that treatment may be initiated when appropriate."

Association of Diabetes With Atrial Fibrillation Phenotype and Cardiac and Neurological Comorbidities: Insights From the Swiss‐AF Study

Journal of the American Heart Association.

A recent analysis found patients with diabetes were about 26% less likely to notice symptoms of atrial fibrillation and more likely to experience more comorbidities than their counterparts without diabetes.

Symptoms of Atrial Fibrillation More Likely to Go Unreported, Unrecognized in Diabetes

Data from a new study provides evidence detailing the apparent reduction in risks of major adverse liver and cardiovascular outcomes associated with undergoing bariatric surgery among patients with biopsy-proven nonalcoholic steatohepatitis (NASH).

Performed by investigators from the Cleveland Clinic, results of the retrospective cohort study indicate undergoing bariatric surgery was associated with an 88% reduction in risk of progression of fatty liver to cirrhosis, liver cancer, or liver-related death and a 70% reduction in risk of major adverse cardiovascular events (MACE).

“The SPLENDOR study shows that in patients with obesity and NASH, substantial and sustained weight loss achieved with bariatric surgery can simultaneously protect the heart and decrease the risk of progression to end-stage liver disease,” said the study’s senior investigator, Steven Nissen, MD, chief academic officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic, 

. “This is the first study in the medical field reporting a treatment modality that is associated with decreased risk of major adverse events in patients with biopsy-proven NASH.”

With an interest in assessing the effects of bariatric surgery compared with nonsurgical management of obesity in patients with NASH, a team of Cleveland Clinic investigators designed the current study as an analysis of data from the Surgical Procedures and Long-term Effectiveness in NASH Disease and Obesity Risk (SPLENDOR) study. SPLENDOR, which was designed to assess the long-term associations between bariatric surgery and future risk of progression to cirrhosis and MACE, collected data from more than 25,828 patients who had a liver biopsy from 2004-2016 and were followed through March 2021.

From the 25,828 who had a liver biopsy, investigators identified a cohort of 1158 patients with NASH and obesity. This cohort was 63.9% women, had a median age of 49.8 (IQR, 40.9-57.9) years, a median BMI of 44.1 (IQR, 39.4-51.4) kg/m2, and a median follow-up of 7 (IQR, 4-10) years. The cohort included 650 patients who underwent bariatric surgery and 508 who underwent nonsurgical management.

The primary outcomes of interest for the analysis were the incidence of major adverse liver outcomes and MACE. Major adverse liver outcomes included progression to clinical or histological cirrhosis, development of hepatocellular carcinoma, liver transplantation, or liver-related mortality. MACE was defined as a composite of coronary artery events, cerebrovascular events, heart failure, or cardiovascular death. Associations with bariatric surgery were estimated using the Firth penalized method in a multivariable-adjusted Cox regression analysis framework.

At the end of the follow-up period, in the unsighted data set, major adverse liver outcomes occurred among 5 patients who underwent Bariatric Surgery and 40 in the nonsurgical group. In regard to MACE among the same at a set, a MACE outcome occurred among 39 patients in the bariatric surgery group and 60 in the nonsurgical group.

In analyses with overlap weighting methods, results indicated the cumulative incidence of major adverse liver outcomes at 10 years was 2.3% (95% CI, 0-4.6) in the bariatric surgery group and 9.6% (95% CI, 6.1-12.9) in the nonsurgical group (adjusted absolute risk difference, 12.4% [95% CI, 5.7-19.7]; aHR, 0.12 [95% CI, 0.02-0.63]; 

=.01). When assessing incidence of MACE at 10 years, results indicated the cumulative incidence was 8.5% (95% CI, 5.5%-11.4%) in the bariatric surgery group and 15.7% (95% CI, 11.3-19.8) in the nonsurgical group (adjusted ARD, 13.9% [95% CI, 5.9-21.9]; aHR, 0.30 [95% CI, 0.12-0.72]; 

=.007). Investigators noted 4 patients (0.6%) died from surgical complications, including 2 with gastrointestinal leak and 2 with respiratory failure, within the first year of bariatric surgery.

“No treatment other than bariatric surgery has been shown to have such a significant effect in reducing the risk of severe outcomes or death in patients with NASH,” said Shanu N. Kothari, MD, president of the American Society for Metabolic and Bariatric Surgery, 

 “Bariatric surgery should be considered a first-line treatment for these patients.”

Association of Bariatric Surgery With Major Adverse Liver and Cardiovascular Outcomes in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis

An analysis of data from the SPLENDOR study suggests 88% reduction in risk of progression of fatty liver to cirrhosis, liver cancer, or liver-related death and a 70% reduction in risk of major adverse cardiovascular events in patients with NASH and obesity.

Bariatric Surgery Could Cut Risk of Adverse Liver, Cardiovascular Outcomes in NASH

A study presented at the American Heart Association 2021 Scientific Sessions suggests investigators have identified a number of predictors for ischemic events or death for patients with stable coronary artery disease (SCAD).

A team, led by Alvaro Acena, MAdrid, assessed the influence of estimated glomerular filtration rate (eGFR) on predicting Parathormone (PTH) and other Mineral Metabolism (MM) markers in patients with SCAD.

Parathormone, part of the Mineral Metabolism system, has recently shown value in forecasting stable coronary artery disease and average renal function. However, it is uncertain what the influence of renal function on forecasting PTH on patients with SCAD might be. In the study, the investigators analyzed the prognostic value of different markers, including PTH, klotho, phosphate, calcidiol (25-hydroxyvitamin D3), and fibroblast growth factor-23 [FGF-23].

The study included 964 patients with SCAD and an eGFR <60 ml/min/1.73 m2 (LGFR), which were compared to patients with eGFR≥60 ml/min/1.73 m2 (HGFR) at 5 hospitals in Spain.

The investigators sought main outcomes of the combination of death with ischemic events based on any acute coronary syndrome, ischemic stroke, or transient ischemic attack. They calculated eGFR using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI).

Overall, 790 patients had HGFR and 174 participants had LGFR.

The predictors of ischemic events or death were plasma levels of calcidol [HR, 0.023; 95% CI, 0.94-0.99; 

= 0.023], FGF23 [HR, 1.00; 95% CI, 1.00-1.003; 

= 0.036], non-HDL cholesterol [HR, 1.01; 95% CI, 1.00-1.01; 

= 0.026], and high sensitivity troponin [HR, 5.12; 95% CI, 1.67-15.59; 

= 0.004 in the HGFR group]. Age was also a predictor (HR, 1.03; 95% CI, 1.01-1.05; 

Other predictors also included treatment with statins [HR, 0.36; 95% CI, 0.19-0.68; 

= 0.002], nitrates [HR, 1.13; 95% CI, 1.07-2.79; 

= 0.027], dihydropyridines [HR, 1.71; 95% CI, 1.05-2.77; 

= 0.032], verapamil [HR, 5.71; 95% CI, 1.35-24.1; 

= 0.018], and proton-pump inhibitors [HR, 2.23; 95% CI, 1.36-3.68; 

There were some similarities in the LGFR cohort. Predictors of death or ischemic events in this group were PTH plasma levels, [HR, 1.01; 95% CI, 1.00-1.01; 

= 0.005], the eGFR [HR, 0.96; 95% CI, 0.94-0.99; 

= 0.004], age [HR, 1.06; 95% CI, 1.02-1.10; 

= 0.003], Caucasian race [HR, 0.04; 95% CI, 0.004-0.380; 

= 0.005], and treatment with insulin [HR, 2.6; 95% CI, 1.20-5.63; 

“In [patients] with SCAD, PTH is an independent predictor of poor outcomes only in those with eGFR<60 ml/min/1.73 m2 , while in [patients] with eGFR≥60 ml/min/1.73 m2 calcidiol and FGF-23 become the only components of MM that may predict prognosis,” the authors wrote. “Then, renal function influences the predictive power of MM markers in [patients] with SCAD.”

Mineral Metabolism Predictors of Poor Outcomes in Stable Coronary Artery Disease With and Without Impaired Renal Function

An analysis of nearly 1000 patients from Spain is providing clinicians with insight into factors that could help predict negative outcomes among patients with stable coronary artery disease.

AHA Study Evaluates Predictors of Negative Outcomes in Stable CAD

Data from a digital care program conducted out of Mss General Brigham is providing data underlining the potential impact of digital monitoring programs on achieving 

Presented as a late-breaker at the American Heart Association 2021 Scientific Sessions, results of the study demonstrate use of a remotely delivered, navigator and pharmacist-led hypertension and lipid program played a significant role in helping patients achieve target goals in a population of more than 10,000 patients.

“Our results in over 10,000 patients demonstrate that a remote program can effectively optimize guideline-directed therapy at scale, reduce cardiovascular risk, and minimize the need for in-person visits,” said Alexander Blood, MD, cardiovascular medicine and critical care fellow at Brigham and Women’s Hospital, 

. “These results highlight that traditionally underserved and undertreated populations can be managed effectively with digitally enabled remote care programs.”

Using electronic medical record data, investigators identified a cohort of 37,452 who were not at treatment goals. Ultimately, 2025 patients with hypertension, 5719 patients with hyperlipidemia, and 3015 with both, were enrolled in the digital care program, which implemented an “end-to-end” management system consisting of guidance from non-licensed navigators and supervision from a care team consisting of pharmacists, nurse practitioners, and physicians.

In the results presented at AHA 2021, 92% of patients who completed the program had reached their blood pressure goals and 94% of patients who completed the lipids program achieved their LDL-C goals.Among those who completed the blood pressure program, the mean blood pressure was 124/74 mmHg and the mean LDL-C reduction was 55 mg/dL.

For more insight into the study, the applicability of results to smaller institutions, and other key points from the results, 

reached out to Blood and that conversation is the subject of the following AHA 2021 House Call.

This study, “A Remotely Delivered Hypertension And Lipid Program In 10,000 Patients Across A Diverse Health Care Network,” was presented at AHA 2021.

Videos

The latest data from the digital care transformation program provides insight into effects of digital monitoring programs on helping patients achieve blood pressure and cholesterol goals. 

Digital Monitoring Programs Can Aid in Reaching Blood Pressure, Cholesterol Goals

Every year, AHA Scientific Sessions provides clinicians and researchers with a glimpse into the latest data from clinical trials. Our editorial staff's top picks for late-breaking data from 

 include AVATAR, RAPID CABG, REVERSE-IT, ASCEND, and CRAVE. 

Editor's note: clicking in the center of a slide will redirect you to a related article or video. 

Top New Data from AHA 2021 Scientific Sessions

Every year, AHA Scientific Sessions provides clinicians and researchers with a glimpse into the latest data from clinical trials. Our editorial staff's top picks for late-breaking data from AHA 2021 Scientific Sessions includes AVATAR, RAPID CABG, REVERSE-IT, and more.

AHA 2021: Top Data Slideshow

Data from the ASCEND trial demonstrates long-term use of low-dose aspirin did not increase risk of dementia among patients with type 2 diabetes and shed light on the risk associated with vascular or major bleeding events in these patients. 

American Heart Association 2021 Scientific Sessions

, data from the study indicate use of low-dose aspirin was not associated with an increased risk of dementia among patients aged 40 years and older with type 2 diabetes and no history of cardiovascular disease, but investigators cautioned further research is needed.

“The results show no clear effect of daily low-dose aspirin on the risk of dementia, with a non-significant 9% proportional reduction in risk. However, the uncertainty around this 9% benefit ranged from a 19% reduction in dementia risk to a 2% increase. This is reassuring that an increase in the risk of dementia is unlikely for the millions of people worldwide who regularly take aspirin to protect against the risk of heart attack and stroke,” said study author, Jane Armitage, FRCP, a professor of clinical trials and epidemiology at the Nuffield Department of Population Health at the University of Oxford in the UK, 

. “The results mean a modest benefit of daily low-dose aspirin on risk of dementia is possible, however, we need studies with more people developing dementia to be sure.”

Funded by Alzheimer’s Research UK, Bayer, the British Heart Foundation and the UK Medical Research Council, the ASCEND trial randomized 15,427 patients in the UK with diabetes and without cardiovascular disease or recorded dementia who were followed for a mean of 7.4 years. With results related to primary prevention of cardiovascular disease published in 

 in 2018, the AHA 2021 analysis was a prespecified secondary analysis of the trial, which examined end points included incidence of broad dementia as well as incidence of vascular and major bleeding events.

The analysis included multiple key outcomes of interest. These included a broad dementia outcome, narrow dementia outcome, and cognitive function z-score at final follow-up. The broad dementia outcome was defined as dementia, cognitive impairment, confusion, use of dementia mediations, and referral to memory clinic or geriatric psychiatry. The narrow dementia outcome only included dementia. Investigators pointed out dementia outcomes were identified via events reported by participants during the trial, use of ICD-10 codes, and other indications of cognitive impairment in follow-up and electronic records.

Among the 15,427 patients included in the study, 1146 participants experienced the broad dementia outcome, including 548 randomized to aspirin and 598 randomized to placebo (RR, 0.91 [95% CI, 0.81-1.02]). The narrow dementia outcome occurred among 537 patients, including 254 randomized to aspirin and 283 randomized to placebo (RR, 0.89 [95% CI, 0.75-1.06]).

In observational analyses, results suggested having a nonfatal vascular event was associated with a more than doubling in risk of experiencing the broad dementia outcome (RR, 2.39 [95% CI, 1.96-2.92]). Additionally, experiencing a major bleeding event was associated with increased risk of experiencing the broad dementia outcome (RR, 1.99 [95% CI, 1.52-2.60]).

“The overall effect of aspirin on dementia and cognitive impairment was uncertain,” Armitage added. “Aspirin may be protective for dementia by preventing some strokes due to blockages, or it may increase the risk because of bleeding into the brain.”

This study, “Effects of Aspirin on Dementia and Cognitive Impairment in the ASCEND Trial,” was presented at AHA 2021.

The ASCEND trial indicates low-dose aspirin use was associated with a nonsignificant reduction in risk of dementia among patients with diabetes and no history of cardiovascular disease.

Low-Dose Aspirin Not Linked to Increased Dementia Risk in Patients with Diabetes

The latest installment in the TRANSLATE-HF program provides insight into the potential impact of in-hospital initiation on post-discharge mortality and readmission among Medicare beneficiaries with heart failure.

A series of analyses examining data from the Get With the Guidelines-Heart Failure (GWTG-HF) registry, the latest data from the TRANSLATE-HF program suggest that, despite being included in contemporary guidelines and demonstrating efficacy in multiple phase 3 clinical trials, early adoption of SGLT2 inhibitors remains low prior to hospitalization and within the immediate post-discharge, which investigators purport represents an addressable gap in care.

“Medicare beneficiaries eligible for dapagliflozin after HF hospitalization, including those well-treated with other therapies, face high risks of mortality and HF readmission,” said Muthiah Vaduganathan, MD, lead investigator and cardiologist at Brigham and Women’s Hospital, 

. “If risk reductions in clinical trials can be fully realized, absolute benefits of SGLT-2 inhibitors among eligible candidates are anticipated to be substantial in the high-risk post-discharge setting.”

An industry-education collaboration, TRANSLATE-HF was designed as a series to include 6 studies to identify knowledge gaps and treatment barriers related to SGLT2 inhibitor use in heart failure management. With previous TRANSLATE-HF analyses presented at AHA 2020 and ACC 2021, the program has outlined the 

optimal patient population for dapagliflozin based on the FDA label

lack of prescribing among patients with comorbid chronic kidney disease

The most recent analysis from the program, which was presented at the 

American Heart Association (AHA) 2021 Scientific Sessions

, assessed prescribing data among Medicare Beneficiaries with heart failure with reduced ejection fraction hospitalized in 2016 at a hospital in the GWTG-HF Registry with linked claims data for a least 1 year following discharge. The primary aim of the analysis was to identify patients considered eligible for an SGLT2 inhibitor prescription under the FDA label for dapagliflozin overall and among multiple subgroups defined by age, sex, race, location, eGFR, diabetes status, and presence of triple therapy.

Investigators identified a cohort of 7767 patients hospitalized for HFrEF. Of these, 6218 would have been considered eligible for an SGLT2 inhibitor prescription. This cohort of eligible patients had a mean age of 79±8 years, 38% were women, 12% were Black. Investigators pointed out an assessment of prescription data from these patients indicated use of beta-blockers, ACE inhibitors or ARBs, MRA, ARNI, and triple therapy was recorded in 88%, 64%, 29%, 3%, and 20%, respectively.

Among patients considered eligible for dapagliflozin, the 10-year incidence of mortality was 37% (95% CI, 36-38) and the rate of heart failure readmission was 33% (95% CI, 32-34). Additionally, investigators pointed out the 1-year incidence of mortality and rate of heart failure readmission exceed 25% in all subgroups. In an analysis of patients already on triple therapy, the 1-year incidence of mortality was 26% (95% CI, 24-29) and the rate of readmission was 30% (95% CI, 27-32).

After application of relative risk reductions observed in the DAPA-HF trial, estimated absolute risk reductions with optimal implementation of dapagliflozin were projected to be 5% (95% CI, 1-9) for 1-year incidence of mortality and 9% (95% CI, 5-12) for rate of heart failure readmission. When assessing the projected number needed to treat (NNT) to prevent a single death at 1 year was 19 (11-114) and the NNT to prevent a single heart failure readmission was 12 (8-21).

Investigators cautioned clinicians to consider limitations within their analysis when interpreting results. These included being restricted to Medicare Fee-for-Service beneficiaries, being restricted to hospitalizations occurring within 2016, and reliance on the DAPA-HF effect sizes.

Projected Clinical Benefits of Implementation of SGLT-2 Inhibitors among Medicare Beneficiaries Hospitalized for Heart Failure

,” was presented at AHA 2021 and simultaneously published in the 

The most recent analysis from TRANSLATE-HF suggests optimal prescription of dapagliflozin, based on the FDA label, could reduce the risk of mortality and readmission among patients hospitalized for HFrEF. 

Optimal Prescription of SGLT2 Inhibitors in Hospitalized HFrEF Patients Could Provide Substantial Benefit

At the American Heart Association (AHA) 2020 Scientific Sessions, much of the discussion related to COVID-19 among cardiologists concerned the apparent risk of blood clots associated with contracting SARS-CoV-2. Fast forward to 

 and the conversation related to COVID-19 among cardiologists has shifted to discussions around the potential risk of myocarditis and pericarditis associated with the COVID-19 vaccines.

Results of a study from the Intermountain Heart Institute, which assessed rates of pericarditis or myocarditis per 10 million patient-days for vaccinated patients compared to unvaccinated patients, indicate the rate of acute pericarditis was 4.49 times greater in vaccinated patients than unvaccinated patients, but investigators noted this risk was lower than risk inferred by contracting COVID-19.

With an interest in describing the risk of pericarditis among patients who have received the COVID-19 vaccine, investigators designed their study to compare rates among vaccinated and unvaccinated patients from December 15, 2020, to June 15, 2021. A total of 1.7 million Intermountain Healthcare patients were considered eligible for inclusion in the investigators’ analyses, which included 914,611 vaccinated patients and 780,878 unvaccinated patients.

From these patient groups, investigators identified 67 instances of inflammatory heart disease, including 21 among vaccinated patients and 46 among unvaccinated patients. The cases of inflammatory heart disease among vaccinated patients included 10 cases of pericarditis, 21 of myocarditis, and 9 of myopericarditis. The cases of inflammatory heart disease included 18 cases of pericarditis, 16 cases of myocarditis, and 12 cases of myopericarditis.

For the purpose of analysis, pericarditis was defined by at least 2 of the following criteria: chest pain, EKG changes, pericardial effusion, and pericardial rub. The investigators designed analysis to assess rates of pericarditis per 10 million patient days and also designed a case-crossover analysis with 4 control dates for each pericarditis case.

When assessing the rate of acute pericarditis, myocardial injury, or myocarditis per 10 million patient-days was 3.11 for vaccinated patients and 1.91 per 10 million patient-days among unvaccinated patients. Upon analysis, investigators determined the rate of acute pericarditis, myocardial injury, or myocarditis in vaccinated patients was 1.64 times higher compared to unvaccinated patients (95% CI, 0.95-2.71; 

=.07). When restricting this to a 30-day post-vaccination window, this rate increased to 2.05 (95% CI, 1.17-3.48; 

=.01). In case-crossover analyses, results indicated the odds of experiencing post-vaccine inflammatory heart disease was significantly higher than the unvaccinated interval for both the 30- and 60-day windows (60-day OR, 4.36; 30-day OR, 4.18; [

For more on the results of this study and the topic, 

reached out to study investigator Viet Le, PA-C, a physician assistant at Intermountain Healthcare, and that conversation is the subject of the following AHA 2021 House Call.

This study, “A Small but Significant Increased Incidence of Acute Pericarditis Identified After Vaccination for SARS-CoV-2,” was presented at AHA 2021.

A study from the Intermountain Heart Institute details the risk of pericarditis and myocarditis associated with COVID-19 vaccines among patients from within their institution's health system.

AHA Study Assesses Risk of Pericarditis and Myocarditis Associated with COVID-19 Vaccines

Two years after the Apple Heart Study made waves at AHA 2019, results of the Fitbit Heart study demonstrate the potential of the Fitbit and other wearable devices for the detection of undiagnosed atrial fibrillation.

, results of the study suggest a novel software algorithm compatible with an array of smartwatches and wearable fitness trackers has the potential to identify cases of atrial fibrillation with a positive predictive value of 98% in a population of more than 450,000.

“These results show that wearables have the ability to identify undiagnosed atrial fibrillation with high reliability,” said Steven A. Lubitz, MD, MPH, associate professor of medicine at Harvard Medical School and cardiologist at the Massachusetts General Hospital, 

. “Since so many consumers use wearables, it is possible that algorithms such as the one we studied could be applied widely to help identify undiagnosed atrial fibrillation, allowing patients to obtain care before devastating complications such as a disabling stroke may occur.”

As the popularity of wearable devices has ballooned and technology continues to evolve, these devices offer a unique opportunity to assess patients for atrial fibrillation on a large scale. With this in mind, Fitbit sponsored the current study to assess whether a novel software algorithm with frequent overlapping photoplethysmography (PPG) pulse tachogram sampling reliably detect atrial fibrillation and flutter.

A prospective single-arm remote clinical trial enrolling US adults aged 22 years and older, the primary end point of interest was the positive predictive value (PPV) of the first irregular heart rhythm detection during ECG monitoring, which was defined as the portion of subjects with an irregular heart rhythm detection and 30 seconds or more of concurrent atrial fibrillation confirmed on the ECG. The secondary end point of interest was the proportion of 5-minute pulse tachograms within the first irregular heart rhythm detection during the ECG that corresponded with 30 seconds or more of atrial fibrillation confirmed on the ECG.

With patients recruited via email, Fitbit app notifications, social media, and other channels, investigators enrolled a population of 455,000 adult smartwatch or fitness tracker users in the US for inclusion in the trial. The mean age of participants was 47 years, 71% were female, 73% were white, and irregular heart rhythms were detected among 4728 (1%). Investigators noted 2070 of these events occurred among patients aged 65 years or older.

Of the 4728 irregular heart rhythm detections to occur in the trial, 1057 individuals underwent subsequent ECG monitoring. Of the 1057 who underwent ECG patch monitoring, atrial fibrillation was detached in 32.2% (n=340). Additionally, an irregular heart rhythm detection occurred during ECG monitoring in 225 individuals, including 221 with had concurrent atrial fibrillation on the ECG, which corresponded to a positive predictive value of 98.2% (95%CI, 95.5-99.5).

Further analysis of patients aged 65 and older indicated the positive predictive value was 97.0% (95% CI, 91.4-99.4). Investigators also pointed out 98.1% of the 5-minute pulse tachograms corresponded to atrial fibrillation on the ECG during the first irregular heart rhythm detection during the ECG monitoring period.

“Most of the episodes of undiagnosed atrial fibrillation detected occurred during sleep, and we suspect that these episodes were asymptomatic. Since the algorithm is most active when wearers are physically inactive, the wearable should be worn during sleep for the greatest benefits,” Lubitz added.

Data from the Fitbit Heart study presented at AHA 2021 suggest a novel algorithm for detecting irregular heart rhythms had a positive predictive value of 98% for detecting atrial fibrillation in patients with undiagnosed atrial fibrillation.