Patrick Campbell

Patrick Campbell is the assistant managing editor of Endocrinology Network, as well as its sister publication Practical Cardiology. 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 the ATLAS trial demonstrate use of subcutaneous implantable cardioverter-defibrillator (S-ICD) was associated with a more than 90% reduction in major lead complications compared against transvenous implantable cardioverter-defibrillator (TV-ICD) in ICD-eligible patients

A randomized trial comparing use of S-ICD versus TV-ICD in a cohort of more than 500 ICD-eligible patients with cardiogenetic syndrome or considered to be at high risk for lead-related complications, results of the trial indicate use of the S-ICD, which is implanted under the skin just below the patient’s armpit, was associated with lower odds of the study’s primary outcome of major lead complications at 6 months, with no instances of pneumothorax, lead dislodgement, subclavian venous thrombosis, or significant tricuspid insufficiency occurring among those receiving S-ICD in the trial.

“The S-ICD greatly reduces perioperative, lead-related complications without significantly compromising ICD performance,” says Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI) at McMaster University and Hamilton Health Sciences, 

. “The S-ICD is now an attractive alternative to the TV-ICD, particularly in patients at increased risk for lead-related complications.”

Led by Healey and colleagues at the PHRI, the Boston Scientific-funded Avoid Transvenous Leads in Appropriate Subjects (ATLAS) trial was designed as a multicenter, randomized, open-label, parallel-group trial with the intent of comparing use of a standard, single chamber TV-ICD against S-ICD for risk of preoperative and long-term complications. With this in mind, investigators enrolled patients aged 18-60 years of age with a primary or secondary indication for an ICD and randomized them to either TV-ICD or S-ICD, these patients were then followed for 12-48 months to assess outcome measures.

The primary outcome of interest was a composite of major lead-related preoperative complications at 6 months, which consisted of hemothorax or pneumothorax, cardiac perforation, tamponade, pericardial effusion, or pericarditis, lead dislodgement or loss of pacing/sensing requiring revision, new moderate-severe or severe tricuspid insufficiency, or ipsilateral upper-extremity deep venous thrombosis. The secondary outcome of interest for the trial was a safety composite that included all the primary outcome events and device-related infection requiring surgical revision, significant wound hematoma, myocardial infarction, stroke, and mortality.

Ultimately, 503 patients underwent randomization in the trial, with 251 randomized to S-ICD and 252 randomized to TV-ICD. This cohort had a mean age of 49 (SD, 11.5) years, 74.2% were men, 22.5% had a history of cardiac arrest, 78.5% reported beta-blocker use at baseline, and the mean follow-up time was 2.5 (SD, 1.1) years. Of the 251 in the S-ICD group, 247 underwent implantation. Of the 252 in the TV-ICD group, 246 underwent implantation.

Upon analysis, results indicated the risk of a primary outcome event was significantly reduced with S-ICD compared to TV-ICD (OR, 0.08 [95% CI, 0.00-0.55]; 

.003). Investigators pointed out just a single patient in the S-ICD arm of the trial experienced a patient had cardiac perforation, tamponade, pericardial effusion, or pericarditis, while a total of 12 primary outcome events occurred among patients in the TV-ICD arm. Further analysis indicated there were no statistically significant difference in the rate of secondary outcome events (4.4% vs 5.6%; OR 0.78; 95% CI 0.35-1.75), but Healey pointed out in his presentation that a numerically greater number of these events occurred when assessing any inappropriate shock among patients in the S-ICD arm compared against the TV-ICD arm.

“The S-ICD produces the first demonstration that there is a clear reduction in major lead-related complications of 92%. There is no significant loss in ICD performance; specifically, no reduction in shock efficacy and inappropriate shocks. Although numerically higher, it did not reach statistical significance and will be the subject of additional analyses,” Healey added during his presentation.

This study, “Subcutaneous Versus Transvenous Defibrillators: The Atlas Trial,” was presented at HRS 2022.

Articles

Data from the ATLAS trial suggests receiving an S-ICD was associated with a 92% lower risk of major lead-related complications compared to receiving a TV-ICD. 

Subcutaneous ICDs Could Reduce Risk of Lead-Related Complications

A history of infertility could increase a woman’s risk of developing 

 by 16%, according to a new analysis of more than 35,000 postmenopausal women.

Using data from the Women’s Health Initiative, a team from Massachusetts General Hospital assessed risk of heart failure in a cohort of 38,528 postmenopausal women based on history of infertility and found a history of infertility was independently associated with a 16% increase in risk of future heart failure overall and a 27% greater risk of heart failure with preserved ejection fraction (HFpEF).

“We as scientists and doctors are beginning to recognize how important a woman's reproductive history is for their future risk of heart disease. Infertility is one of many cardiovascular risk factors, such as hypertension and high blood pressure, but reproductive history is not routinely considered as part of the cardiovascular risk assessment,” said lead investigator Emily Lau, MD, MPH, cardiologist and director of the Menopause, Hormones and Cardiovascular Clinic at Massachusetts General Hospital, 

 “We cannot change a woman’s history of infertility, but if we know a woman has had a history of infertility, we can be more aggressive about counseling her about other modifiable risk factors including high blood pressure, high cholesterol, smoking, and beyond.”

With support from the National Institutes of Health and the American Heart Association, the current study was conducted by Lau and a team of colleagues at Massachusetts General Hospital with an interest in furthering the knowledge base surrounding risk factors for heart failure among aging women. To do so, investigators designed their study as an analysis of data from the Women’s Health Initiative.

From the prospective study, investigators obtained data related to a cohort of 38,528 postmenopausal women for inclusion in their analyses. This cohort had a mean age of 63±7 years at baseline, 4399 (14%) reported a history of infertility, and, over a median follow-up of 15 years, 2373 developed incident heart failure, including 807 with heart failure with reduced ejection fraction (HFrEF) and 1133 with HFpEF.

For the purpose of analysis, investigators used multivariable cause-specific Cox models to assess associations of infertility with incident overall heart failures and heart failure subtypes. Investigators defined HFrEF as a left ventricular ejection fraction (LVEF) less than 50% and HFpEF as an LVEF of 50% or greater.

In adjusted analysis, results indicated infertility was independently associated with future risk of overall heart failure (HR, 1.16 [95% CI, 1.04-1.30]; 

=.006). When assessing risk according to heart failure subtypes, infertility was associated with an increased risk of future HFpEF (HR, 1.27 [95% CI, 1.09-1.48]; 

=.002), but this increase in risk was not observed for HFrEF (HR, 0.97 [95% CI, 0.80-1.18]).

Investigators pointed out additional analyses were performed to assess if the apparent increase in risk would be mediated by other infertility-related risk factors, such as irregular menses, thyroid disease, and waist circumference, and these analyses indicated these risk factors were associated with infertility, but not associated with incident heart failure risk.

, Ersilia M. DeFilippis, MD, of Brigham and Women’s Hospital, commended both the study’s investigators for their efforts in furthering research and the participants of the Women’s Health Initiative for their contributions to science.

“One of the best ways to honor these research participants is to improve our history taking, early evaluation, and risk assessment of young women of reproductive age, both in clinical practice and as part of clinical trials. This should include an assessment of traditional cardiovascular risk factors but also inquire about age of menarche, difficulty conceiving, number of pregnancies and any adverse pregnancy outcomes, breastfeeding, and timing of menopause,” DeFilippis wrote.

Infertility and Risk of Heart Failure in the Women’s Health Initiative

Journal of the American College of Cardiology.

An analysis of data from more than 35,000 women in the Women's Health Initiative indicates a history of infertility was independently associated with a 16% increase in risk of incident heart failure, with a 27% increase in risk of HFpEF, in postmenopausal women. 

History of Infertility Linked to Increased Risk of Heart Failure in Women

The American Heart Association is hoping to draw attention to an overlooked issue impacting the cardiovascular health of millions worldwide with their latest scientific statement: nonalcoholic fatty liver disease (NAFLD).

With previous data suggesting NAFLD could be affecting 25% of adults worldwide, the AHA’s scientific statement is aimed at increasing awareness around NAFLD as well as facilitate improved diagnosis and early treatment effort to help reduce the impact NAFLD can have on cardiovascular disease risk on a societal level.

“Nonalcoholic fatty liver disease is a common condition that is often hidden or missed in routine medical care. It is important to know about the condition and treat it early because it is a risk factor for chronic liver damage and cardiovascular disease,” said P. Barton Duell, MD, FAHA, chair of the statement writing committee and professor of medicine in the Knight Cardiovascular Institute and Division of Endocrinology, Diabetes and Clinical Nutrition at Oregon Health & Science University, in 

Published on April 14 and citing more than 160 reference documents, the statement composed by Duell and colleagues was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Atherosclerosis, Thrombosis and Vascular Biology, the Council on Hypertension, the Council on the Kidney in Cardiovascular Disease, the Council on Lifestyle and Cardiometabolic Health, and the Council on Peripheral Vascular Disease. At 18 pages in length, the document dedicates 10 subsections to outlining terminology, risk factors for NAFLD, Pathogenesis of NAFLD, predisposing genetic risk factors, NAFLD and atherosclerotic cardiovascular disease risk, NAFLD in patients undergoing PCI and CABG, hypobetalipoproteinemia and NAFLD, Safety of statins in NAFLD, strategies for screening of NAFLD and NASH, and potential interventions for NAFLD.

A large portion of the statement was dedicated to interventions for NAFLD, both from a pharmacological perspective and also addressing modifiable risk factors. In addition to dietary and lifestyle modification, authors underlined the importance of using proven agents, such as GLP-1 RAs, metformin, and lipid-lowering therapies, among patients with NAFLD or NASH. In addition to providing information on established therapies, the writing committee also offered insight into the potential for experimental agents from contemporary data.

“Part of the good news about managing NAFLD is that healthy eating, regular exercise and weight loss or avoiding weight gain are all valuable interventions to improve health in most of us, regardless of whether we have NAFLD,” said Duell.

In their conclusion, authors provided clinicians with their top take-home messages from the statement, which are summarized in the graphic below.

Summary of the top take-home messages from the AHA's scientific statement on NAFLD's role in cardiovascular disease risk. 

Nonalcoholic Fatty Liver Disease and Cardiovascular Risk: A Scientific Statement From the American Heart Association

Arteriosclerosis, Thrombosis, and Vascular Biology.

The latest scientific statement from the American Heart Association is aimed at improving the awareness of NAFLD and its associated cardiovascular risk among clinicians as well as optimizing diagnosis and early treatment strategies for patients with NAFLD. 

AHA Calls Attention to Growing Impact of NAFLD on Cardiovascular Disease Risk

This article was originally published on 

Finerenone (Kerendia) provides a consistent effect for reducing the risk of adverse cardiovascular and kidney events was consistent regardless of whether or not patients had a history of atherosclerotic cardiovascular disease (ASCVD), according to a recent FIDELITY analysis.

With ASCVD placing patients with diabetes at a greater risk of adverse outcomes, results of the respecified analysis provide clinically applicable insight into the magnitude of effect seen with finerenone based on presence of ASCVD among patients with type 2 diabetes and chronic kidney disease.

“In patients with chronic kidney disease associated with type 2 diabetes, cardiovascular complications are among the most frequent causes of death. However, there is limited data on how the risk of cardiovascular events could be reduced in these patients,” said Javed Butler, MD, MPH, MBA, president of the Baylor Scott & White Research Institute and senior vice president for Baylor Scott & White Health, and distinguished professor of medicine at the University of Mississippi, in a 

Combining data from the FIGARO-DKD and FIDELIO-DKD analyses, FIDELITY represents efforts to pool data from both studies to learn more about the effects of finerenone, including the consistency of benefit across different subgroups of patients. At ACC.22, Gerasimos Filippatos, MD, presented data from a FIDELITY analysis assessing impact of baseline ASCVD on cardiorenal outcomes among patients within both trials using finerenone. Primary analyses of FIDELITY indicated use of finerenone reduced risk of a composite cardiovascular outcome, which included cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, by 14% and risk of chronic kidney disease progression by 23% (HR, 0.77 [95% CI, 0.67-0.88]) when compared against placebo therapy.

Of the more than 13,000 patients enrolled in FIDELIO-DKD and FIGARO-DKD, 5935 had a history of ASCVD and 7091 had no history of ASCVD. When comparing baseline characteristics of these patient subgroups, investigators pointed out patients with ASCVD had a lower eGFR and UACR than those without, but blood pressure and HbA1c were well-controlled in both groups. Investigators also pointed out patients with ASCVD were more likely to be prescribed beta-blockers, statins, and insulin than their counterparts without ASCVD.

Upon analysis, results indicated patients with a history of ASCVD were at a 2-fold increase in risk of a composite cardiovascular outcome that included time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalizations for heart failure compared to those without a history of ASCVD (HR, 2.09 [95% CI, 1.89-2.30]). When assessing the effects of finerenone, use was associated with a 17% (HR, 0.83 [95% CI, 0.74-0.94]) reduction in risk of the composite cardiovascular outcome among those with a history of ASCVD and a 9% (HR, 0.91 [95% CI, 0.78-1.06]) reduction in risk among those without a history of ASCVD when compared against placebo therapy. Analysis of treatment-emergent adverse events indicated the safety profile of finerenone was similar between patients with and without a history of ASCVD.

“In general, overall, the data presented today indicate that finerenone may be used for both primary and secondary cardiovascular disease prevention in these groups of patients with type 2 diabetes and chronic kidney disease as well as protection from worsening kidney disease,” Filippatos said, at the conclusion of his presentation.

This study, “Finerenone and Cardiorenal Outcomes by History of Cardiovascular Disease in Patients with Type 2 Diabetes and Chronic Kidney Disease: Fidelity Analyses,” was presented at ACC.22.

A prespecified analysis of FIDELITY presented at ACC.22 details the effects of finerenone on reducing cardiovascular risk based on whether or not patients had a history of atherosclerotic cardiovascular disease at baseline. 

Finerenone Provides Consistent Benefit for Reducing CV Risk, Regardless of CVD History

Data from a phase 2b trial presented at the 

American College of Cardiology’s 71st Annual Scientific Sessions

 detail the ability of bentracimab to provide immediate and durable reversal of the antiplatelet effects of ticagrelor.

Presented by Deepak Bhatt, MD, MPH, the analysis comes less than a year after results of an interim analysis of the REVERSE-IT trial were presented at AHA 2021 and provides insight into the effects of bentracimab as a reversal agent for ticagrelor in older patients in a double-blind, placebo-controlled trial.

“Compared with placebo, bentracimab significantly restored platelet function as measured by multiple assays by binding and eliminating free ticagrelor and ticagrelor active metabolite,” said Bhatt, who serves as the executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, during his presentation.

A multicenter, open-label, prospective, single-arm trial, REVERSE-IT was designed with the intent of assessing the ability of bentracimab, a monoclonal antibody from PhaseBio, for reversal of the antiplatelet effects of ticagrelor. An interim analysis off the first 140 enrolled patients, results of the interim analysis demonstrated use of bentracimab results in rates of effective hemostasis that were adjudicated as good or excellent in more than 90% of cases, with no drug-related serious adverse events, or allergic or infusion-related reactions.

The phase 2b study was a randomized, double-blind, placebo-controlled trial that randomized patients in a 3:1 ratio to bentracimab or placebo therapy. In this trial, all participants were aged 50-80 years of age and pretreated with ticagrelor and aspirin for 48 prior to receiving bentracimab. The primary outcome of interest for the trial was the inhibition of platelet reality unit (PRU).

In total, the trial enrolled 205 patients, with 154 randomized to bentracimab and 51 randomized to placebo. The overall study population had a mean age of 61.2 (SD, 6.85) years, 50.2% were male, and 80% were White.

Upon analysis, results of the trial suggested bentracimab achieved immediate and sustained reversal of antiplatelet effects among adults aged 50-80 years old who had been pretreated with dual antiplatelet therapy in both VerifyNow PRU and VASP PRI Assay analyses. In his presentation, Bhatt highlighted the effects of bentracimab on the primary endpoint were statistically significant within 4 hours and were consistent across various subgroups, including those defined by sex, age, and race.

In safety analyses, results indicated there were no drug-related serious adverse events or thrombotic events among those in the bentracimab arm. Those most common treatment-related adverse event observed in the trial were headache, ecchymosis, and contusion, but investigators highlighted there were no significant differences observed between bentracimab and placebo for any treatment-emergent adverse events in the trial.

“Based on these data, bentracimab appears to be a very promising option for ticagrelor reversal. Assessments of bentracimab’s clinical effect on patients with bleeding awaits completion of the REVERSE-IT study,” added Bhatt, in the latter portion of his presentation.

This study, “Bentracimab Immediately And Significantly Reverses The Antiplatelet Effects Of Ticagrelor In Older People,” was presented at ACC.22.

Data from a phase 2b trial of bentracimab presented by Deepak Bhatt, MD, MPH, at ACC.22 demonstrates it the ability for reversing antiplatelet effects in an older population.

Phase 2b Trial of Bentracimab Supports Use in Older Patients

 is shedding light on the relationship between alcohol consumption and event risk based on whether or not a patient has been exposed to 

An analysis of electronic medical record information from patients at Intermountain Healthcare assessing the effects of prescription history of statin use or non-use and a self-report of alcohol use or non-use, results of the analysis suggest alcohol consumption could provide benefit for reducing risk of major adverse cardiovascular events in patients without exposure to statins, but demonstrated no benefit when added to statins for primary prevention and no benefit with or without statin use for secondary prevention.

Consumption of alcohol and its benefit or harm on cardiovascular health has long been a subject of debate, but no randomized trials have been able to draw an evidence-based conclusion on the topic. With this in mind, a team from Intermountain Healthcare and the University of Utah School of Medicine designed the current study as an analysis of laboratory electronic medical record data from Intermountain Healthcare patients to assess associations of alcohol consumption with long-term MACE risk based on whether or not a patient had exposure to statin therapy and if it were in a primary or secondary prevention setting.

From the electronic medical record database, investigators identified 416 not using statins and 164 on statins with reported alcohol consumption for inclusion. In contrast, 808 patients not on statins and 313 patients on statins with no reported alcohol consumption were identified for inclusion.

During the follow-up period, which lasted a mean of 4.0 (SD, 3.2) years, MACE rates were 6.5% and 14.2% for primary prevention alcohol users and non-users (HR, 0.50 [95% CI, 0.33-0.78]; 

=.002), respectively, for those not on statins in primary prevention analyses. Among statin users, MACE rates were 19.5% and 22.7%, among alcohol users and nonusers (HR, 0.84 [95% CI, 0.54-1.32]; 

=.45), respectively, in the primary prevention analyses. For secondary prevention, MACE rates for alcohol users and non-alcohol users were 18.2% and 19.9%, respectively, for those without exposure to statin therapy (

=.70) and 19.9% and 22.7%, respectively, for those on statins (

For more on this study, we reached out to study investigator Viet Le, PA-C, associate professor of research at Intermountain Healthcare and president of the

 Association of Physician Associates in Cardiology (APAC

), for more insight into the design and results of the investigation.

This study, “Is Alcohol Consumption Associated with a Lower Risk of Cardiovascular Events in Patients Treated with Statins? An Observational Real-World Experience,” was presented at ACC.22.

Viet Le, PA-C, provides perspective on an ACC.22 study examining long-term risk of MACE based on alcohol consumption and whether or not the patient had a history of statin use. 