NOVA – No significant difference in rate of post-op AF with botulinum toxin vs placebo

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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Amulet IDE: Continued safety and effectiveness of the Amulet LAA occluder device at three years in patients with nonvalvular atrial fibrillation

Key Points:

  • In 2021, the Amulet IDE study demonstrated that the novel Amulet left atrial appendage occluder device was noninferior to the standard Watchman device for stroke prevention in patients with nonvalvular atrial fibrillation. The study investigators have now pursued an analysis of the three year outcomes.
  • The Amulet device continued to demonstrate safety and effectiveness through 3 years of follow up.

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ILR use led to increased diagnosis of Atrial Fibrillation, but no reduction in stroke or arterial embolism noted: Results from LOOP

Key Points:

• In the LOOP trial, patients at high risk of stroke were randomized to either implantable loop recorder (ILR) versus usual care.
• The primary endpoint was time to stroke or arterial embolism, and secondary outcomes included a) combined ischemic stroke, systemic arterial embolism, and TIA, b) combined stroke, systemic arterial embolism, and CV death, and c) all-cause mortality. Other outcomes of interest included atrial fibrillation (AF) diagnosis and oral anticoagulant use.

• The use of ILR resulted in a three-fold increase in AF detection and initiation of anticoagulation, but there was no observed reduction in the primary endpoint of stroke or systemic arterial embolism.
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Acute alcohol consumption elevates risk of AF event

Presented as a Late Breaking Clinical Trial at the American College of Cardiology 2021 Scientific Sessions by Gregory M. Marcus MD, Professor of Medicine, UCSF, demonstrated that acute alcohol consumption was associated with an elevated risk of discrete atrial fibrillation (AF) event. This event may appear within several hours of the drink and even one drink may increase the risk of such events.
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STOP AF First Trial: Cryoballoon Ablation Is Superior to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrhythmia Recurrence in Patients With Paroxysmal Atrial Fibrillation

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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ADRIFT Study: Reduced Rivaroxaban Doses Are Associated With Lower Thrombin Generation Following Percutaneous Left Atrial Appendage Closure Compared to Dual Antiplatelet Therapy

A recent study by Dr. Duthoit, MD, published in Circulation: Cardiovascular Interventions, showed that compared to dual antiplatelet therapy, nonvitamin k antagonist monotherapy using a reduced dose of rivaroxaban (10 and 15 mg) in patients undergone left atrial appendage closure was associated with lower thrombin generation. This data supported that reduced rivaroxaban doses could be a substitute for the antithrombotic medications currently used after this procedure. Continue reading

Integrated Management of Atrial Fibrillation in Primary Care Demonstrates 45% Reduction in All-Cause Mortality Compared to Usual Care in Elderly Patients

In a recent Dutch study, published in European Heart Journalintegrated 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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Trial Shows Abstinence From Alcohol Can Reduce Recurrence of Atrial Fibrillation In Patients With Paroxysmal Atrial Fibrillation Who Regularly Consume Alcohol

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

The Sarcomeric Human Cardiomyopathy Registry: Race Associated with Disease Expression and Clinical Outcomes Among Patients with Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy and race: differences in disease expression, inequitable care provision, and disparate clinical outcomes

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.

New-Onset AF After TAVR linked To Worse Long-Term Outcomes Compared With Patients With Pre-Existing AF and No AF New-onset AF associated with a higher rate of death, stroke, bleeding and heart failure hospitalizations after TAVR

A registry-based cohort study including 72,660 Medicare patients with and without atrial fibrillation (AF) who underwent non-apical transcatheter aortic valve replacement (TAVR) from 2014 to 2016, has shown that, TAVR patients with new-onset AF have the highest rate of all-cause mortality (32%) compared to patients with pre-existing or no AF (23.3% and 12.8%, respectively). New-onset AF was also associated with an increased risk of bleeding, stroke and heart failure (HF) hospitalizations.

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ADRIFT Trial: Low-Dose Rivaroxaban is Superior to Dual Antiplatelet Therapy for Controlling Thrombin Generation after Left Atrial Appendage Closure in Atrial Fibrillation Patients Results of ADRIFT trial presented at the ESC Congress 2019

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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Dual Anti-thrombotic Therapy Safe For Patients with Atrial Fibrillation and Recent PCI:ENTRUST-AF PCI Results of the ENTRUST-AF PCI trial presented at the ESC Congress 2019

Results from a phase-IIIb, open-label, multi-center, randomized clinical trial comparing the safety of dual anti-thrombotic therapy (DAT) with triple anti-thrombotic therapy (TAT) for patients with atrial fibrillation who have undergone recent (4 hours – 5 days) percutaneous coronary intervention (PCI), have shown that the DAT regimen (Edoxaban plus a P2Y12 inhibitor) is non-inferior to Vitamin K antagonist(VKA) plus a P2Y12 inhibitor and aspirin or TAT regimen.

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Population Based Cohort Study: With or Without AFib, CHA₂DS₂-VASc Score is a Sensitive Predictor and Stratifies the Risk of MACCE 22,000 Patient Study Showed Increased Risk of Ischemic Stroke and New-Onset Atrial Fibrillation in Patients Without Atrial Fibrillation

Giulia Renda et al. recently published in the European Journal of Preventive Cardiology that the CHA2DS2-VASc score is a sensitive measure of predicting new-onset atrial fibrillation (AF) and adverse outcomes in patients with and without atrial fibrillation in the middle-aged patient population. Continue reading

ORBIT-AF Registry: INR Metrics Associated with Bleeding but Not Ischemia

Among patients with atrial fibrillation (AF) treated with warfarin, clinical risk scores for major bleeding and thrombotic events were more strongly associated with future clinical events than any International Normalized Ratio (INR) metrics for warfarin control. A post hoc analysis of ORBIT-AF study by Dr. Pokorney et al, published in JAMA Cardiology, revealed. Continue reading

New Study Demonstrates Significant Burden of New Onset Atrial Fibrillation in Patients Undergoing Aortic Valve Replacement

A study led by Dr. Rajat Kalra published in JAMA Internal Medicine showed that new-onset atrial fibrillation is a significant burden on patients after aortic valve replacement either through trans-jugular aortic valve implantation (TAVI) or aortic valve replacement (AVR). Additionally, the investigators demonstrated that atrial fibrillation (AF) was higher after AVR than after TAVI.

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AUGUSTUS: Less Bleeding and Fewer Hospitalizations Without Significant Differences in Ischemic Events With Apixaban and No Aspirin in Patients With AFib and ACS ACC 2019: Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation

ACC 2019: In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without signifi­cant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both, according to results of the AUGUSTUS trial presented at ACC.19 in New Orleans. The results were also published simultaneously in the New England Journal of Medicine. Continue reading

HEARTLINE: A 180,000 Patient-Strong, Pragmatic, Real World Randomized Trial Assesses the Prowess of Apple Technology in Afib Diagnosis and Improvement of Hard Outcomes Presented at the ACC 2019, New Orleans, LA.

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

Nationwide Comparison of Oral Anticoagulants in Nonvalvular Atrial Fibrillation Patients of Low Body Weight

The first nationwide comparison of the effectiveness and safety of warfarin and direct oral anticoagulants (DOACs) in a large atrial fibrillation (AF) cohort with data on low body weight (LBW) was conducted.  The findings, published in JACC, showed that DOACs are associated with a reduced risk of ischemic stroke, intracranial hemorrhage, hospitalization for gastrointestinal or major bleeds, all-cause death or the composite outcome in patients with LBW (<60kg).  A consistent trend was observed in patients with extremely LBW (<50kg), with the exception of hospitalization for gastrointestinal bleeding. Continue reading

Major Bleeding Rates With Antithrombotic Therapy in Atrial Fibrillation  Results from a Nationwide Danish Cohort Study

The results of a study conducted by Rein et al. have shown that patients with atrial fibrillation on triple therapy experienced high rates of major bleeding compared with patients on dual therapy or monotherapy. The high bleeding rates observed in patients on triple therapy over the age of 90 years or with a CHA2DS2-VASc score over 6 or with a history of a major bleeding warranted careful consideration of such therapy in these patients. The results were published online ahead of print in Circulation. Continue reading

Does Race/Ethnicity Affect Oral Anticoagulant Use in Patients With Atrial Fibrillation? Findings From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II

A study by Essien and his colleagues published in JAMA aimed to determine if there were racial/ethnic differences in the use of oral anticoagulants, particularly direct-acting oral anticoagulants (DOACs), in patients with atrial fibrillation. The findings showcased the fact that after controlling for clinical and socioeconomic factors, black individuals were less likely than white individuals to receive DOACs for atrial fibrillation, with no difference between white and Hispanic groups. Continue reading