Key Points

-The RAPID study achieved its primary efficacy endpoint of terminating PSVT with self-administered Etripamil using a symptom-based optimal repeat dosing.

-Pooled analysis with the NODE-301 study showed that self-administered etripamil showed a significant reduction in emergency department utilization and medical intervention.

-This Phase III trial showed a favorable safety and tolerability profile of etripamil consistent with prior etripamil trials.

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Key Points:

-In a Phase II, dose-ranging trial of epicardial fat pad injection of botulinum toxin type A (AGN-151607) there was no significant differences in the rates of post-operative atrial fibrillation (POAF).

-Subgroup analyses suggest a lower rate of POAF and rehospitalization in patients >65 years of age who received the 125 U dose of AGN-151607, and those undergoing isolated CABG.

-The mechanism of POAF within the first 30 days may be related to both direct autonomic influences and decreased inflammation.

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KEY POINTS:

• Implantable Cardioverter Defibrillators (ICDs) are indicated for post-myocardial infarction patients with severely reduced left ventricular systolic function, however, less is known about patients with moderately reduced LVEF.
• SMART-MI randomized post-myocardial infarction (MI) patients with moderate reduction in LVEF to receive an implantable cardiac monitor or continue with standard of care.
• In the Implantable Cardiac Monitor (ICM) group, arrhythmias were detected three times as often, and led to a higher number of therapies delivered to terminate such arrhythmias.

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The WATCHMAN left atrial appendage occluder device has been widely accepted as an alternative to oral anticoagulation for stroke prevention in patients with underlying atrial fibrillation. However, the indications for WATCHMAN implantation laid forth by the Centers for Medicare & Medicaid Services in the United States differ from the original trials supporting its use. Real-world practice, therefore, highlights significant differences in the characteristics of patients receiving the therapy from those originally studied.  In a Focused Clinical Research Session at the 2021 American College of Cardiology meeting, Dr. Matthew Price, Director of the Cardiac Cath Lab at Scripps Green Hospital and Assistant Professor at the Scripps Translational Science Institute, La Jolla, California, presented the results of his study from the NCDR LAAO Registry (NCT02699957), assessing one- year real-world outcomes for patients undergoing WATCHMAN implantation.

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A recent trial by Dr. Oussama M. Wazni, published in the New England Journal of Medicine, indicated that in patients with paroxysmal atrial fibrillation, cryoballoon ablation therapy is superior as compared with antiarrhythmic drug therapy, in the prevention of atrial fibrillation recurrence. The study also showed the non-inferiority of this procedure over the drug therapy approach in terms of safety.

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A recent study by Dr. Jason G. Andrade, published in New England Journal of Medicine, found that the use of catheter cryoablation as first-line therapy for patients with newly diagnosed, symptomatic, paroxysmal atrial fibrillation is associated with lower recurrence of arrhythmia and a better quality of life when compared to an antiarrhythmic treatment approach. Continue reading →

Results of the DAPA trial, published in Circulation: Arrhythmia and Electrophysiology, demonstrated that the use of early prophylactic implantable cardioverter defibrillator (ICD) in high-risk post-primary percutaneous coronary intervention (PCI) patients was associated with lower all-cause and cardiac mortality rates. However, the results of this trial should be interpreted with caution, since the trial was stopped prematurely.

The optimal timing of ICD implantation in STEMI patients treated with primary angioplasty is not identified yet. Previous clinical trials have failed to show the benefit of early ICD implantation (4-60 days) in post-MI patients with a low left ventricular ejection fraction (≤35-40%). The risk of sudden cardiac death (SCD) is high within the post STEMI period.  However, ICD implantation after 40 days may not be indicated due to left ventricular remodeling and a potential increase in LVEF post-primary PCI. The Defibrillator After Primary Angioplasty (DAPA) trial evaluated all-cause and cardiac mortality of patients undergoing early prophylactic ICD implantation after PCI for STEMI. Following a recommendation from the data safety board, the trial was terminated early after just 38% of the planned sample size was enrolled due to slow enrollment.

This multicenter, randomized, controlled trial included patients with STEMI who had undergone primary PCI and met at least one of the following criteria: LVEF<30% within 4 days after admission, primary ventricular fibrillation (VF) within 24 hours (during PCI excluded), signs of heart failure on admission (Killip class ≥ 2), and/or thrombolysis in myocardial infarction (TIMI) flow post PCI < 3. The participants were randomized in a 1:1 ratio to receive either ICD implantation or conventional therapy within 30 to 60 days of the STEMI event. The primary endpoint was all-cause mortality at 3 and 9-years. The secondary endpoints of the study included the incidence of sudden cardiac death (SCD) and hospital admission for sustained ventricular tachyarrhythmias or appropriate ICD therapy.

A total of 266 patients with primary PCI for STEMI were included in the study with 131 patients allocated to the ICD arm and 135 patients assigned to the conventional therapy arm. After 3-years of follow-up, the primary outcome of interest was significantly lower among patients who received ICD implantation (5%) compared to the conventional therapy group (13%) (Hazard ratio (HR):0.37; [95% CI: 0.15-0.95]; p=0.04). This result remained similar at a median of 9-years follow-up (HR: 0.58; [95% CI: 0.37-0.91]; p=0.02). In terms of cardiac mortality, ICD implantation was associated with fewer deaths (11%) compared to the control group (22%) (HR: 0.52; [95% CI: 0.28-0.99]; p=0.04). Although not statistically significant, the incidence of SCD was also lower in the ICD group (3.1%) compared to the control group (5.9%) (HR 0.45; [95% CI 0.14–1.50]; p=0.19).

The results of this study should be interpreted with consideration of the following limitations. First, the premature termination of the study makes it underpowered for analysis. Second, the study used more than one inclusion criteria, so results should be interpreted with consideration of the patient characteristics. The high treatment crossovers (10.2%) within the first 3 years of the study and the lack of information on treatment crossovers between 3 and 9 years are additional limitations of the trial.  Furthermore, while pharmacotherapy of the participants was similar at baseline, there is a lack of data regarding the follow-up medical therapy which may have impacted the mortality rates.

In conclusion, this prematurely terminated trial suggests that early prophylactic ICD implantation may be associated with a better survival rate in patients at high risk of death after primary PCI for STEMI. The results of this trial should be confirmed in future studies.

A recent study by Dr. Khan and his colleagues, published in the American Heart Journal, has shown that the application of post-resuscitation targeted temperature management (TTM) or hypothermia protocol was associated with increased mortality in patients with non-shockable associated sudden cardiac arrest (SCA). Additionally, TTM utilization was recognized as an independent predictor of mortality in this specific group after multivariate regression analysis. Continue reading →

In a recent Dutch study, published in European Heart Journal, integrated care for elderly atrial fibrillation (AF) patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.

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In an original study conducted by Dr. Aleksandr Voskoboinik et al. recently published in The New England Journal of Medicine, it was found that alcohol consumption is a modifiable risk factor for Atrial Fibrillation (AFib) and abstinence from alcohol in people with AFib causes a reduction in burden and recurrence rates of AFib. Continue reading →

Hypertrophic cardiomyopathy (HCM) is the most common inherited genetic disorder of the myocardium, and the number one culprit of sudden cardiac death in athletes, particularly African Americans.

“Is race associated with differential disease expression, inequitable care provision, or disparate clinical outcomes among patients with hypertrophic cardiomyopathy?”

In order to answer the above question, Lauren A. Eberly, et al. studied 2,467 patients with hypertrophic cardiomyopathy. In a retrospective cohort study, black and white patients with hypertrophic cardiomyopathy from the US-based sites of the Sarcomeric Human Cardiomyopathy Registry from 1989 through 2018 compared in terms of baseline characteristics; genetic architecture; adverse outcomes such as cardiac arrest, cardiac transplantation or left ventricular assist device implantation, cardioverter-defibrillator implantation, all-cause mortality, atrial fibrillation, stroke,  prevalence and likelihood of developing heart failure; and receiving septal reduction therapies.

According to the results of this study (8.3 percent black; 91.7 percent white), published in the JAMA CARDIOLOGY (December 2019), compared with white patients, black patients with HCM were younger (mean age, 36.5 versus 41.9 years), were less likely to have sarcomere mutations (26.1 versus 40.5 percent), had a higher prevalence of New York Heart Association (NYHA) class III or IV heart failure at presentation (22.6 versus 15.8 percent) and were more prone to developing heart failure (hazard ratio, 1.45). Lower rates of genetic testing (26.1 versus 40.5 percent) have been observed in black patients. Although there were no racial differences in implantation of implantable cardioverter-defibrillators, the invasive septal reduction was less common among African Americans (14.6 versus 23 percent). Nevertheless, Black patients had fewer incidents of atrial fibrillation (35 [17.1 percent] versus 608 [26.9 percent].

The results of this study were in accordance with the previous studies that mentioned a higher prevalence of complicated hypertrophic cardiomyopathy in African Americans in contrast to the lower prevalence of HCM in this community.  Eberly, et al. believe that racial differences in disease expression and adverse clinical outcomes are not only because of different characteristics of the disease in African Americans but also inequities in clinical care provision might be responsible for these observed differences.

The sympathetic drive leading to the release of arrhythmogenic agents after myocardial infarction (MI) is the target of pharmacologic treatment to reduce the mortality associated with post-MI arrhythmias. Beta-blockers, so far, are the only primary prevention antiarrhythmic drugs that decrease the mortality following MI.  However, ventricular arrhythmias still complicate up to 10% of the cases despite sufficient beta-blockade. Additionally, MI has been associated with the release of non-catecholaminergic co-transmitters such as neuropeptide Y (NPY). This cardiac sympathetic co-transmitter can affect calcium electrophysiology of the cardiomyocytes and trigger arrhythmic events.

The new study by Dr. Kalla and his colleagues hypothesized that NPY is the pro-arrhythmic agent after an MI. To evaluate their hypothesis, they monitored 78 patients with ST-elevation MI  treated with primary percutaneous coronary intervention (PPCI) for the development of ventricular arrhythmias. Peripheral venous blood sampling was done at the time of intervention to assess the NPY level. To compare, they also measured the NPY level of peripheral venous blood in 12 candidates of elective angiography of similar age and gender, who had normal coronary arteries.

Ventricular arrhythmias occurred in 7% of the STEMI patients within 48 hours. Their venous NPY level has observed to be significantly (P < 0.05) higher compared to control patients. The author also suggested that an NPY level of 27.3 pg/mL has a sensitivity of 0.83 and a specificity of 0.71 for ventricular arrhythmias threshold. To further evaluate their hypothesis regarding the arrhythmogenic effect of sympathetic-induced NPY release, they experimented with an animal model. Through their rat model experiment, Dr. Kalla demonstrated that despite maximal beta-blockade with metoprolol, prolonged stimulation of the sympathetic system caused an enormous increase in NPY level and subsequent decrease in ventricular arrhythmias threshold. Interestingly, NPY, antagonized by Y1 receptor antagonist BIBO3304, prevented these effects.

The authors added, ” In patients presenting with STEMI treated with PPCI, NPY levels are associated with an increased incidence of ventricular arrhythmia in the immediate postinfarct period, independent of classical risk factors, such as late presentation, larger infarct size, and prior beta-blocker usage.” The author concluded that sympathetic-induced release of NPY is associated with post-MI arrhythmia and drugs reversing its effect work along with beta-blockers as a new anti-arrhythmic therapy.

In an original article written by Leroy C. Joseph et al, it was found the molecular mechanisms of cardiac metabolism to arrhythmia and NAPDH Oxidase2(NOX2) deletion or pharmacological inhibition can prevent arrhythmia caused due to the ingestion of a high saturated fat diet. The results of the study were published in Circulation: Arrhythmia and Electrophysiology. Continue reading →

A study led by Dr. Wulfran Bougouin published in the European Heart Journal analyzed out of hospital cardiac arrests (OHCA) and compared outcomes in patients who received and did not receive extracorporeal cardiopulmonary resuscitation (CPR). Dr. Bougouin and his team found that 4% of OHCAs were treated with extracorporeal-CPR and this was not associated with an increased hospital survival rate.

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According to the results of Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Treated with Left Atrial Appendage Closure (ADRIFT) trial, recently presented at the European Society of Cardiology (ESC) Congress 2019 by Prof. Dr. Montalescot, from Pitié-Salpêtrière Hospital, Paris, low dose rivaroxaban is superior to dual antiplatelet therapy (DAPT) in controlling thrombin generation in patients undergoing Left Atrial Appendage Closure (LAAC).

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A randomized trial led by Dr. Francisco Javier Garcia-Fernandez, published in the European Heart Journal, demonstrated that a simplified protocol of remote monitoring and for monitoring patients with implantable cardiac defibrillators or pacemakers was as safe and efficient as a protocol involving in-patient follow up.

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The design of the HEARTLINE randomized trial of up to 180,000 pts for assessing the efficacy of the Apple Watch & educational initiatives to reduce a composite outcome of death, MI and stroke was presented by Dr. C. Michael Gibson, PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston, Massachusetts, at ACC 2019, in New Orleans,  LA earlier today. The HEARTLINE Study brings together Johnson & Johnson’s health and behavioral science expertise and long heritage in treating cardiovascular disease with Apple’s technology expertise. Emerging technology holds great potential to help identify people at risk for future disease and develop interventions to prevent disease before it occurs. Leveraging a new heart health app from Johnson & Johnson in combination with Apple Watch’s irregular rhythm notifications and ECG app, the HEARTLINE Study will seek to investigate whether this technology can accelerate the diagnosis of AFib and improve outcomes including the prevention of stroke, as well as assess the impact of a medication adherence program. The study will be conducted in the U.S. only and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older. Continue reading →

COAPT trial

This prospective, multicenter, open-label, randomized trial aimed to assess the use of transcatheter mitral valve repair in heart failure (HF) patients with mitral regurgitation due to left ventricular dysfunction. A total of 614 patients were randomized to either receiving guideline-directed medical therapy (GDMT) alone or GDMT in addition to transcatheter mitral-valve repair. The primary efficacy endpoint was all hospitalizations due to heart failure at 24 months of follow-up, while the primary safety endpoint was freedom from device-related complications at 12 months of follow-up. The study showed that the device group had a lower risk of hospitalization for HF (HR 0.53, 95% CI 0.4-0.7) and all-cause mortality (HR 0.62, 95% CI 0.46-0.82) at 24 months. Moreover, the rate of freedom from device complications at 12 months was 96.6% which exceeded the prespecified safety threshold. Continue reading →

A new study by Neal et al. demonstrated that although patients with atrial fibrillation (AF) and cancer were less likely to see a cardiologist or fill anticoagulant prescriptions, cardiology involvement was associated with increased anticoagulant prescription fills and favorable AF-related outcomes. The results of the study were published online in JACC. Continue reading →

In patients with acute myocardial infarction (MI) and a left ventricular ejection fraction (LVEF) equal or less than 35%, the use of wearable cardioverter defibrillator early after the MI did not lead to significant lowering of death from arrhythmia or from any cause, according to a new study published in the New England Journal of Medicine. Continue reading →