Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices.

Background: Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described.
Objectives: The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.
Methods: The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX.
Results: The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001).
Conclusions: Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.
Competing Interests: Funding Support and Author Disclosures The Human Investigation Committee of the Yale University School of Medicine approved the use of a limited dataset from the NCDR for research and granted a waiver of the requirement to obtain informed consent. Boston Scientific provided partial support for this study through an investigator-initiated grant; had no role in study design, data analysis, or writing of the manuscript; and were not provided a copy of the manuscript prior to submission. This study was funded by the American College of Cardiology NCDR; National Heart, Lung, and Blood Institute grants R56HL142765 and R01HL142765; and an investigator-initiated grant from Boston Scientific. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria from W. L. Gore, Baylis Medical, Biotronik, Philips, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; has received speaker fees from ACIST Medical; and has equity interest in Indian Wells. Dr Friedman has received research grants from the American Heart Association, the NCDR, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; and has received consulting fees from Abbott, AtriCure, and Sanofi. Dr Curtis has an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR; and has equity in Medtronic. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Biosense Webster, and PaceMate; and has equity interest in PaceMate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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