ArticleJACC. Cardiovascular interventions2022
Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.
Article in JACC. Cardiovascular interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry.Journal of the American Heart Association · 2025Article
- Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion.Circulation. Cardiovascular interventions · 2024Article
- State-of-the-Art of Transcatheter Left Atrial Appendage Occlusion.Journal of clinical medicine · 2024Review
- Watchman device migration and embolization: A report from the NCDR LAAO Registry.Journal of cardiovascular electrophysiology · 2023Article
- Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Article
- Safety and feasibility of left atrial appendage inversion in swine: A proof-of-concept study for potential therapy to prevent embolic stroke.Frontiers in bioengineering and biotechnology · 2023Article
- Left Atrial Appendage Occlusion: Current Advances and Remaining Challenges.JACC. Advances · 2022Review
- Transcatheter Left Atrial Appendage Occlusion: A Multi-Center Real Life Experience.Journal of clinical medicine · 2022Article
Corrections and comments
- Commented on by
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- Erratum issuedCorrection.2022
Authors and funding
11 authors at 8 institutions in 1 country.
Funding
Abstract
objectivesThe aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.
backgroundPatients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.
methodsPropensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.
resultsA total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.
conclusionIn clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.