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Performing Transcatheter Left Atrial Appendage Closure: Techniques and Challenges
The left atrial appendage (LAA) has been demonstrated to be the major source of thromboemboli in patients with atrial fibrillation (AF).1 The rationale of LAA closure is based on eliminating LAA continuity with the left atrium thereby reducing stroke risk. Indeed, left atrial appendage occlusion (LAAO) procedures play an important role in anticoagulation-intolerant patients at risk for AF-related stroke. Based on the PROTECT-AF2 and PREVAIL3 studies, the Food and Drug Administration (FDA) approved use of the Watchman (Boston Scientific, MA) device in 2015, with an updated generation of device subsequently ratified in 2020 ...
Source: Heart Rhythm - August 6, 2022 Category: Cardiology Authors: Ammar M. Killu, Mohamad A. Alkhouli Source Type: research

Adverse events associated with the AtriClip device for left atrial appendage occlusion: A Food and Drug Administration MAUDE database study
Based on autopsy studies, the left atrial appendage has been implicated as the cause of stroke in>90% of cases with nonvalvular atrial fibrillation. The AtriClip device (Atricure, West Chester, OH) is used for left atrial appendage exclusion at the time of median sternotomy or thoracoscopically (as a  stand-alone procedure or at the time of hybrid epicardial-endocardial ablation for atrial fibrillation).1–3 The real-world safety profile of AtriClip has not been evaluated, and we analyzed adverse events related to its use reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
Source: Heart Rhythm - April 28, 2022 Category: Cardiology Authors: Tahmeed Contractor, Rahul Bhardwaj, Ravi Mandapati, Kamal Kotak, Jalaj Garg Tags: Research Letter Source Type: research

Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus Watchman FLX Device: A Meta-Analysis
Left atrial appendage (LAA) occlusion provides effective protection against thromboembolic (TE) events in high-risk atrial fibrillation patients. Two percutaneous devices are currently available in the United States for stroke prophylaxis: the WatchmanTM device (Boston Scientific, USA) and the AmplatzerTM AmuletTM Left Atrial Appendage Occluder (Abbott, USA). The latter has recently received Food and Drug Administration approval as a result of the findings of the Amulet IDE randomized trial (1), which showed superiority for LAA occlusion (lower rates of leaks>5mm) based on a comparison between the second generation Amplatz...
Source: Heart Rhythm - February 11, 2022 Category: Cardiology Authors: Domenico G. Della Rocca, Michele Magnocavallo, Carola Gianni, Sanghamitra Mohanty, Veronica N. Natale, Amin Al-Ahmad, Carlo Lavalle, Rodney P. Horton, Luigi Di Biase, Andrea Natale Source Type: research

EP News: Allied Professionals
Using data on patients in the United States Renal Data System (USRDS), Siontis et  al (Circulation 2018; https://doi.org/10.1161/CIRCULATIONAHA.118.035418 [Epub ahead of print], PMID 29954737) sought to assess patterns of apixaban use and outcomes related to use of anticoagulants in patients with end-stage renal disease (ESRD) and atrial fibrillation (AF). As background, patient s with ESRD have both higher risk of bleeding and higher risk of stroke with AF. The Food and Drug Administration has approved updated labeling for the use of apixaban in patients with ESRD on the basis of a small pharmacokinetic study.
Source: Heart Rhythm - July 26, 2018 Category: Cardiology Authors: Erica S. Zado Tags: EP News Source Type: research

EWOLUTION —The next evolution in appendage closure?
Oral anticoagulation (OAC) is a class I indication for patients with nonvalvular atrial fibrillation (AF) and ≥2 risk factors for stroke.1 However, many patients with AF are ineligible for OAC because of prohibitive bleeding. Subsequently, as a result of the pivotal role of the left atrial appendage (LAA) in the formation of thrombi, an alternative strategy to OAC is occlusion of the LAA.2 The WATCHMAN de vice (Boston Scientific Corporation, Marlborough, MA) is the only US Food and Drug Administration (FDA)–approved LAA occlusion product that has been studied in randomized control trials (RCTs) (Table).
Source: Heart Rhythm - June 22, 2017 Category: Cardiology Authors: Muhammad R. Afzal, Emile G. Daoud Tags: Editorial Commentary Source Type: research