Abstract 16825: Minimizing the Risk for Pericardial Effusion/Tamponade During LA Appendage Closure Using a Next-Generation Watchman LAA Closure Device (Preliminary Results of the European EVOLVE Registry)
Introduction: The PROTECT AF randomized trial compared Warfarin with left atrial appendage (LAA) closure using a filter device (Watchman) in atrial fibrillation (AF) pts with CHADS2 ≥ 1. While the primary endpoint of stroke/systemic embolism/cardiovascular death favored LAA closure (RR = 0.71, 95%CI 0.44 - 1.30), there was a significantly higher risk of safety complications of LAA closure compared to control- the most frequent being peri-procedure pericardial effusion and tamponade. Herein, we report the early experience with a next generation Watchman device designed for less traumatic LAA placement.
Methods: As compared to the current Watchman device, the distal tines of the next generation Watchman device are designed to deploy in a less traumatic fashion. Implantation with this next generation device was offered to AF patients with a CHADS2 score of ≥ 1. The device was implanted in standard fashion: IV heparinization, transseptal puncture, TEE guidance. Post-implantation, patients were discharged on 6 weeks of warfarin followed by 4.5 months clopidogrel and life-long aspirin therapy.
Results: Patients (n=51) were enrolled at 3 centers in Europe: age 70.9 ± 7.4 (56-83), 33% female, CHF in 33%, HTN in 86%, DM in 39%, prior stroke/TIA in 33%, Age ≥ 75 in 45%, CHADS2 score = 2.7 ± 1.2 (1 - 6). Implantation was successful in 49/51 patients (96%). Currently, mean follow-up is 3.8 months with 5 patients followed to one year. The atraumatic distal end of the device could be inadvertently or purposefully pushed against the LAA tissue without fear of trauma; indeed there were no instances of acute or delayed pericardial tamponade.
Conclusions: This very early experience reveals that modifications to this next generation WATCHMAN device have rendered it possible to implant without fear of pericardial tamponade.
- © 2011 by American Heart Association, Inc.