Atrial Fibrillation - Atrial Fibrillation - 624 · atrial-fibrillation

Dr. Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI is a Professor of Medicine and the Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine. In this podcast Dr. Mehran discusses Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT).


Link to Abstract-
https://clinicaltrials.gov/ct2/show/study/NCT02270242?recrs=e&cond=Cardiology&phase=23&lupd_s=01%2F01%2F2019&lupd_e=01%2F06%2F2022&draw=2&rank=1

Abstract-
The goal of this study is to see how ticagrelor alone compares to ticagrelor and aspirin together. Both ticagrelor and aspirin prevent platelets from adhering to one another and forming a blood clot, which might cut off blood flow to the heart. This trial will assess the efficacy and safety of ticagrelor alone with ticagrelor + aspirin in reducing clinically meaningful bleeding and ischemic adverse events in high-risk patients who have had at least one drug-eluting stent percutaneous intervention. If a patient meets particular clinical and/or anatomic criteria, they are deemed high-risk.


At the time of their index PCI, up to 9000 participants will be registered. At 3 months after enrolment, subjects who meet the randomization criteria will be randomized to ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Following enrollment, clinic visits will be scheduled at 3 months, 9 months, and 15 months.

Description in detail:

This is a multicenter, blinded, prospective dual-arm research. Up to 9000 high-risk patients discharged on DAPT with aspirin and ticagrelor for at least 3 months from sites in the United States, Canada, Europe, and Asia who have undergone successful PCI with at least one locally approved drug eluting stent. The primary goal of this trial is to compare the effectiveness of antiplatelet monotherapy with ticagrelor alone against DAPT with ticagrelor plus aspirin for 12 months in preventing clinically meaningful bleeding in high-risk PCI patients who have completed a 3-month course of aspirin plus ticagrelor. The study's secondary goal is to see how effective antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months is in reducing major ischemic adverse events (safety) in high-risk PCI patients who have completed a 3-month course of aspirin plus ticagrelor.

Assessing the comparative safety and efficacy of the various DAPT regimens for particular components of the primary efficacy and secondary safety objectives is one of the exploratory objectives.

The London School of Hygiene and Tropical Medicine will conduct the primary analysis for TWILIGHT on its own.

Dr. Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI is a Professor of Medicine and the Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine. In this video Dr. Mehran discusses Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT).


Link to Abstract-
https://clinicaltrials.gov/ct2/show/study/NCT02270242?recrs=e&cond=Cardiology&phase=23&lupd_s=01%2F01%2F2019&lupd_e=01%2F06%2F2022&draw=2&rank=1

Abstract-
The goal of this study is to see how ticagrelor alone compares to ticagrelor and aspirin together. Both ticagrelor and aspirin prevent platelets from adhering to one another and forming a blood clot, which might cut off blood flow to the heart. This trial will assess the efficacy and safety of ticagrelor alone with ticagrelor + aspirin in reducing clinically meaningful bleeding and ischemic adverse events in high-risk patients who have had at least one drug-eluting stent percutaneous intervention. If a patient meets particular clinical and/or anatomic criteria, they are deemed high-risk.


At the time of their index PCI, up to 9000 participants will be registered. At 3 months after enrolment, subjects who meet the randomization criteria will be randomized to ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Following enrollment, clinic visits will be scheduled at 3 months, 9 months, and 15 months.

Description in detail:

This is a multicenter, blinded, prospective dual-arm research. Up to 9000 high-risk patients discharged on DAPT with aspirin and ticagrelor for at least 3 months from sites in the United States, Canada, Europe, and Asia who have undergone successful PCI with at least one locally approved drug eluting stent. The primary goal of this trial is to compare the effectiveness of antiplatelet monotherapy with ticagrelor alone against DAPT with ticagrelor plus aspirin for 12 months in preventing clinically meaningful bleeding in high-risk PCI patients who have completed a 3-month course of aspirin plus ticagrelor. The study's secondary goal is to see how effective antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months is in reducing major ischemic adverse events (safety) in high-risk PCI patients who have completed a 3-month course of aspirin plus ticagrelor.

Assessing the comparative safety and efficacy of the various DAPT regimens for particular components of the primary efficacy and secondary safety objectives is one of the exploratory objectives.

The London School of Hygiene and Tropical Medicine will conduct the primary analysis for TWILIGHT on its own.

Dr. David Z. Rose is an Associate Professor in the Department of Neurology at USF Health, the Neurology Medical Director, a Neuro-Icu Member, and part of the Critical Care Steering Committee. In this podcast Dr. Rose discusses the AREST trial known as Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation.

Link to Abstract-
https://clinicaltrials.gov/ct2/show/NCT02283294

Abstract-
The goal of this study is to see if starting Apixaban earlier than standard of treatment reduces the risk of second stroke in adults with atrial fibrillation.

This is an open label, randomized, active control, parallel-group pilot trial to see if starting APIXABAN at days 0-3 (TIA), days 3-5 (small stroke), and days 7-9 (medium stroke) reduces fatal and/or recurrent stroke/TIA in 120 people who have had a recent (within 48 hours of symptoms) TIA or small to medium ischemic stroke. The subjects will be randomly assigned to one of two treatment arms in a 1:1 ratio (apixaban or warfarin). From screening to monthly follow-up visits, subjects will be observed for a total of 180 days.

The following are the primary outcome measures:

Number of people who had a fatal stroke, recurrent ischaemic stroke, or TIA as a composite endpoint [180-day time frame]

Measures of Secondary Outcomes:

The number of people who had an intracranial hemorrhage as determined by MRI/CT [duration: 180 days]

Dr. David Z. Rose is an Associate Professor in the Department of Neurology at USF Health, the Neurology Medical Director, a Neuro-Icu Member, and part of the Critical Care Steering Committee. In this video Dr. Rose discusses the AREST trial known as Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation.

Link to Abstract-
https://clinicaltrials.gov/ct2/show/NCT02283294

Abstract-
The goal of this study is to see if starting Apixaban earlier than standard of treatment reduces the risk of second stroke in adults with atrial fibrillation.

This is an open label, randomized, active control, parallel-group pilot trial to see if starting APIXABAN at days 0-3 (TIA), days 3-5 (small stroke), and days 7-9 (medium stroke) reduces fatal and/or recurrent stroke/TIA in 120 people who have had a recent (within 48 hours of symptoms) TIA or small to medium ischemic stroke. The subjects will be randomly assigned to one of two treatment arms in a 1:1 ratio (apixaban or warfarin). From screening to monthly follow-up visits, subjects will be observed for a total of 180 days.

The following are the primary outcome measures:

Number of people who had a fatal stroke, recurrent ischaemic stroke, or TIA as a composite endpoint [180-day time frame]

Measures of Secondary Outcomes:

The number of people who had an intracranial hemorrhage as determined by MRI/CT [duration: 180 days]

Dr. Pavel Osmanick works at the University Hospital Kralovske Vinohrady, Third Faculty of Medicine, along with Charles University, in Prague, Czech Republic. In this video Dr. Osmanick discusses The Efficacy and Safety of Hybrid Ablations for Atrial Fibrillation.

Link to Abstract-
https://www.jacc.org/doi/10.1016/j.jacep.2021.04.013

Abstract
Objectives
This study sought to comprehensively determine the procedural safety and midterm efficacy of hybrid ablations.
Background
Hybrid ablation of atrial fibrillation (AF) (thoracoscopic ablation followed by catheter ablation) has been used for patients with nonparoxysmal AF; however, accurate data regarding efficacy and safety are still limited.
Methods
Patients with nonparoxysmal AF underwent thoracoscopic, off-pump ablation using the COBRA Fusion radiofrequency system (Estech) followed by a catheter ablation 3 months afterward. The safety of the procedure was assessed using sequential brain magnetic resonance and neuropsychological examinations at baseline (1 day before), postoperatively (2-4 days for brain magnetic resonance imaging or 1 month for neuropsychological examination), and at 9 months after the surgical procedure. Implantable loop recorders were used to detect arrhythmia recurrence. Arrhythmia-free survival (the primary efficacy endpoint) was defined as no episodes of AF or atrial tachycardia while off antiarrhythmic drugs, redo ablations or cardioversions.
Results
Fifty-nine patients (age: 62.5 ± 10.5 years) were enrolled, 37 (62.7%) were men, and the mean follow-up was 30.3 ± 10.8 months. Thoracoscopic ablation was successfully performed in 55 (93.2%) patients. On baseline magnetic resonance imaging, chronic ischemic brain lesions were present in 60.0% of patients. New ischemic lesions on postoperative magnetic resonance imaging were present in 44.4%. Major postoperative cognitive dysfunction was present in 27.0% and 17.6% at 1 and 9 months postoperatively, respectively. The probability of arrhythmia-free survival was 54.0% (95% CI: 41.3-66.8) at 1 year and 43.8% (95% CI: 30.7–57.0) at 2 years.
Conclusions
The thoracoscopic ablation is associated with a high risk of silent cerebral ischemia. The midterm efficacy of hybrid ablations is moderate.

Dr. Pavel Osmanick works at the University Hospital Kralovske Vinohrady, Third Faculty of Medicine, along with Charles University, in Prague, Czech Republic. In this video Dr. Osmanick discusses The Efficacy and Safety of Hybrid Ablations for Atrial Fibrillation.

Link to Abstract-
https://www.jacc.org/doi/10.1016/j.jacep.2021.04.013

Abstract
Objectives
This study sought to comprehensively determine the procedural safety and midterm efficacy of hybrid ablations.
Background
Hybrid ablation of atrial fibrillation (AF) (thoracoscopic ablation followed by catheter ablation) has been used for patients with nonparoxysmal AF; however, accurate data regarding efficacy and safety are still limited.
Methods
Patients with nonparoxysmal AF underwent thoracoscopic, off-pump ablation using the COBRA Fusion radiofrequency system (Estech) followed by a catheter ablation 3 months afterward. The safety of the procedure was assessed using sequential brain magnetic resonance and neuropsychological examinations at baseline (1 day before), postoperatively (2-4 days for brain magnetic resonance imaging or 1 month for neuropsychological examination), and at 9 months after the surgical procedure. Implantable loop recorders were used to detect arrhythmia recurrence. Arrhythmia-free survival (the primary efficacy endpoint) was defined as no episodes of AF or atrial tachycardia while off antiarrhythmic drugs, redo ablations or cardioversions.
Results
Fifty-nine patients (age: 62.5 ± 10.5 years) were enrolled, 37 (62.7%) were men, and the mean follow-up was 30.3 ± 10.8 months. Thoracoscopic ablation was successfully performed in 55 (93.2%) patients. On baseline magnetic resonance imaging, chronic ischemic brain lesions were present in 60.0% of patients. New ischemic lesions on postoperative magnetic resonance imaging were present in 44.4%. Major postoperative cognitive dysfunction was present in 27.0% and 17.6% at 1 and 9 months postoperatively, respectively. The probability of arrhythmia-free survival was 54.0% (95% CI: 41.3-66.8) at 1 year and 43.8% (95% CI: 30.7–57.0) at 2 years.
Conclusions
The thoracoscopic ablation is associated with a high risk of silent cerebral ischemia. The midterm efficacy of hybrid ablations is moderate.

Chris is a cardiologist who works in both clinical and academic settings. His research interests include cardiovascular medicine, cardiac rhythm disorders, and public health. He received a full scholarship to Pembroke School and graduated as Dux with the highest tertiary entry rating. He was awarded a Rhodes Scholarship after studying medicine at the University of Adelaide, where he was elected to the University Council. At the University of Oxford, he studied clinical trials, epidemiology, and population health for master's degrees before completing a PhD in cardiovascular medicine. In this video Dr. Wong discusses the Risk Thresholds for Total and Beverage-Specific Alcohol Consumption and Incident Atrial Fibrillation.

Link to Abstract-
https://www.jacc.org/doi/10.1016/j.jacep.2021.05.013

Abstract-
Objectives
This study sought to characterize associations of total and beverage-specific alcohol consumption with incident atrial fibrillation (AF).
Background
Although binge drinking and moderate to high consumption of alcohol are both established risk factors for AF, comparatively less is known about the effect of low alcohol consumption and whether associations differ by specific alcoholic beverages.
Methods
Using data from the UK Biobank, total and beverage-specific alcohol consumption was calculated as UK standard drinks (8 g alcohol) per week. Past drinkers and those with a history of AF were excluded. Incident AF events were assessed through hospitalization and death records, and dose-response associations were characterized using Cox regression models with correction for regression dilution bias.
Results
We studied 403,281 middle-aged individuals (52.4% female). Over a median follow-up time of 11.4 years (IQR: 10.7-12.3 years), a total of 21,312 incident AF events occurred. A J-shaped association of total alcohol consumption was observed, with lowest risk of AF with fewer than 7 drinks/week. Beverage-specific analyses demonstrated harmful associations of beer/cider consumption with any consumption. In contrast, consumption of red wine, white wine, and spirits up to 10, 8, and 3 drinks/week, respectively, was not associated with increased risk.
Conclusions
In this predominantly White population, low levels of alcohol consumption (<7 U.K. standard drinks [56 g alcohol]/week) were associated with lowest AF risk. Low consumption of red and white wine and very low consumption of spirits may not be associated with increased AF risk, whereas any consumption of beer/cider may be associated with harm. These findings may have important implications for the primary prevention of AF that should be explored in future studies.

Chris is a cardiologist who works in both clinical and academic settings. His research interests include cardiovascular medicine, cardiac rhythm disorders, and public health. He received a full scholarship to Pembroke School and graduated as Dux with the highest tertiary entry rating. He was awarded a Rhodes Scholarship after studying medicine at the University of Adelaide, where he was elected to the University Council. At the University of Oxford, he studied clinical trials, epidemiology, and population health for master's degrees before completing a PhD in cardiovascular medicine. In this video Dr. Wong discusses the Risk Thresholds for Total and Beverage-Specific Alcohol Consumption and Incident Atrial Fibrillation.

Link to Abstract-
https://www.jacc.org/doi/10.1016/j.jacep.2021.05.013

Abstract-
Objectives
This study sought to characterize associations of total and beverage-specific alcohol consumption with incident atrial fibrillation (AF).
Background
Although binge drinking and moderate to high consumption of alcohol are both established risk factors for AF, comparatively less is known about the effect of low alcohol consumption and whether associations differ by specific alcoholic beverages.
Methods
Using data from the UK Biobank, total and beverage-specific alcohol consumption was calculated as UK standard drinks (8 g alcohol) per week. Past drinkers and those with a history of AF were excluded. Incident AF events were assessed through hospitalization and death records, and dose-response associations were characterized using Cox regression models with correction for regression dilution bias.
Results
We studied 403,281 middle-aged individuals (52.4% female). Over a median follow-up time of 11.4 years (IQR: 10.7-12.3 years), a total of 21,312 incident AF events occurred. A J-shaped association of total alcohol consumption was observed, with lowest risk of AF with fewer than 7 drinks/week. Beverage-specific analyses demonstrated harmful associations of beer/cider consumption with any consumption. In contrast, consumption of red wine, white wine, and spirits up to 10, 8, and 3 drinks/week, respectively, was not associated with increased risk.
Conclusions
In this predominantly White population, low levels of alcohol consumption (<7 U.K. standard drinks [56 g alcohol]/week) were associated with lowest AF risk. Low consumption of red and white wine and very low consumption of spirits may not be associated with increased AF risk, whereas any consumption of beer/cider may be associated with harm. These findings may have important implications for the primary prevention of AF that should be explored in future studies.

Dawood Darbar, MBCHB, MD, FACC, FAHA, FHRS from the Division of Cardiology, Departments of Medicine, the University of Illinois at Chicago and Jesse Brown Veterans Administration speaks about Review Article - Genetics of atrial fibrillation—practical applications for clinical management: if not now, when and how?

Link to Article:
https://academic.oup.com/cardiovascres/article/117/7/1718/6274893

Abstract:

Over the next few decades, the prevalence and economic burden of atrial fibrillation (AF) are expected to more than double. Early and systematic rhythm control therapy, in addition to anticoagulation and treatment of concurrent cardiovascular diseases, lowers cardiovascular outcomes when compared to a rate control strategy, favoring the safe restoration and maintenance of sinus rhythm. Antiarrhythmic medications (AADs) and catheter ablation are two current treatments for AF rhythm management (CA). Individual patient response is very varied, with some patients maintaining AF-free for lengthy periods of time on antiarrhythmic treatment while others need repeat AF ablation within weeks. The lack of effectiveness of rhythm control treatment for AF is due in part to a lack of knowledge of the pathophysiological processes and our inability to anticipate individual patient responses. As a result, determining which patients with AF are likely to react to rhythm management approaches is a huge knowledge gap. With the discovery of uncommon mutations in cardiac ion channels, signaling molecules, and myocardial structural proteins linked with familial (early-onset) AF during the last decade, great progress has been made in characterizing the genetic architecture of AF. Genome-wide association studies, on the other hand, have revealed common variations at over 100 genetic loci, and the creation of polygenic risk scores has identified people at high risk. Although retrospective studies show that common genetic variation influences response to AADs and CA, the creation of a complete clinical and genetic risk score might allow genetic data to be translated into bedside therapy for AF patients. Given the economic implications of the AF pandemic, even minor increases in treatment effectiveness might result in significant benefits for individuals and healthcare systems.

Mads Hashiba Jensen, a Medical Student at the Department of Cardiology at Herlev og Gentofle Hospital and the University of Copenhagen a presentation on DANish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl (DANAPNO).

Link to Study:
https://www.clinicaltrials.gov/ct2/show/NCT04760002?term=04760002&draw=2&rank=1

Description of the Research -

A study to see whether NightOwl could be used to detect the prevalence of obstructive sleep apnea (OSA) in patients with atrial fibrillation (AF). The long-term goal is to use the system to test for OSA in AF patients undergoing ablation and/or AF patients undergoing cardioversion in a randomized clinical trial.

Patients with some form of AF who are referred to a nurse-run ambulatory for anticoagulation initiation will be required to participate. The ambulatory consists of four regular nurse-led tracks at Herlev-Gentofte University Hospital's Department of Cardiology. In a formal partnership, Herlev-Gentofte University Hospital's Department of Pulmonology offers work-up with cardio-respiratory monitoring investigation and clinical assessment of starting sleep apnea care in patients referred from the study. Those in attendance Participants will be recruited from the Thrombosis unit (Tromboseklinikken) at Herlev-GentofteHospital who have AF without established sleep apnea and a need for anticoagulation. As part of their routine check at the anticoagulation outpatient clinic at Herlev and Gentofte Hospital, participants will be contacted and invited to participate in the research project by a local investigator or a project nurse. Participants will be given verbal details about the research project as well as the appropriate time to discuss recruitment during the interview. The written participant information will be given to the participants before the verbal information, and it will be given to them by a researcher or a project nurse who is well-versed in the project. Before a written informed consent is received, the investigators will be given the details they need to find eligible participants. The written informed consent enables the researchers to access the participant's medical health records for the purposes of the study.


The analysis is cross-sectional in nature. A third visit will be scheduled for the first 20 participants and those with an apnea-hypopnea index (AHI)>15 who are included in the sample.

The participant borrows a NightOwl and receives system guidance during the initial visit, which includes a clinical assessment and a questionnaire about OSA symptoms.

In a home setting, NightOwlTM was used for four nights of recording.

A follow-up visit to discuss the findings of the home surveillance and the soft node questionnaire.

A fourth visit to the sleep apnea clinic will be scheduled for the first 20 patients, as well as all patients whose home test shows (AHI>15).

The research will take about 6 months from the time the first patient is enrolled until the last patient is enrolled.

Eric Y. Ding, Ms from the Division of Cardiology, Department of Medicine, University of Massachusetts Medical School speaks about the Survey of current perspectives on consumer-available digital health devices for detecting atrial fibrillation.

Link to Article:
https://www.sciencedirect.com/science/article/pii/S2666693620300049#!

Background
Patients have direct access to a variety of digital health services that can detect atrial fibrillation (AF). Heart rhythm healthcare practitioners' (HCPs) adaptation into clinical practice, on the other hand, is uncertain.


Goal
The aim of this study was to look into the perspectives of HCPs on the use of commercial technologies for AF detection and management.



Methodologies
We developed an electronic survey for HCPs to determine practice demographics and attitudes toward digital devices for AF identification and management. The survey was sent to all members of three heart rhythm professional societies via email.



Conclusions
Out of 73,563 e-mails sent, we got 1601 responses, with 43.6 percent coming from cardiologists, 12.8 percent from fellows, and 11.6 percent from advanced practice practitioners. The majority of respondents (62.3 percent) said they had advised patients to use a digital system for AF detection. Many that didn't were worried about their accuracy (29.6%), the clinical usefulness of the findings (22.8%), and incorporation into electronic health records (22.8%). (19.8 percent ). For patients at high risk of stroke, the findings of a 30-second single-lead electrocardiogram were enough for 42.7 percent of HCPs to prescribe oral anticoagulation. More data comparing the accuracy of digital devices versus traditional devices for AF monitoring was requested by respondents (64.9 percent ). A quarter of HCPs (27.3%) had no concerns about recommending digital devices for AF detection, and the majority (53.4%) required guidelines from their professional societies about how to use them properly.



Final Thoughts
Many healthcare professionals have already begun to incorporate digital technologies into their clinical practice. However, when using digital technology for AF detection, HCPs identified difficulties, and professional society guidelines are required.

Todd Chapin, PharmD, BCPS from Sanford Health speaks about Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation.

Link to Study:
https://clinicaltrials.gov/ct2/show/NCT02889562?recrs=dem&cond=Atrial+Fibrillation&cntry=US&phase=123&draw=2&rank=51

Patients who experience atrial fibrillation after isolated coronary artery bypass grafting surgery will be identified in this open-label, prospective, randomized pilot study. Patients with chronic prolonged atrial fibrillation (>2 episodes of atrial fibrillation lasting longer than 30 minutes) or persistent atrial fibrillation (>12 hours) would be qualified. Patients will be randomized to either the standard of care (warfarin per protocol) or the apixaban arms of the trial after meeting research inclusion and exclusion requirements and giving informed consent. Both groups will receive routine postoperative treatment after CABG. The anticoagulation clinic will treat anticoagulation in both classes after discharge. After surgery, patients will be monitored for 30 days.