Left atrial appendage closure in patients with prohibitive anatomy: Insights from PINNACLE FLX
| Autor: | Christopher R. Ellis, Vicki M. Houle, Brad Sutton, Moussa Mansour, Jose Osorio, Gregory G. Jackson, Shephal K. Doshi, Arvindh Kanagasundram, Saibal Kar |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Pinnacle Time Factors 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Left atrial Physiology (medical) Atrial Fibrillation Occlusion Humans Medicine Atrial Appendage In patient Prospective Studies Registries 030212 general & internal medicine Cardiac Surgical Procedures Aged business.industry Atrial fibrillation Anatomy medicine.disease Stroke Ostium Future study Female Implant Cardiology and Cardiovascular Medicine business Echocardiography Transesophageal Follow-Up Studies |
| Zdroj: | Heart Rhythm. 18:1153-1161 |
| ISSN: | 1547-5271 |
| Popis: | Watchman 2.5 (Boston Scientific Inc, Marlborough, MA) implant success approaches 95% in registries, yet many patients are not attempted because of complex left atrial appendage (LAA) anatomy. Watchman FLX can expand the range of ostium width (14-31.5 mm) and depth available for LAA closure.The purpose of this study was to evaluate the safety and efficacy of Watchman FLX in patients with a failed Watchman 2.5 attempt or prohibitive LAA anatomy.The roll-in (n = 58) and primary effectiveness (n = 400) cohorts of the PINNACLE FLX trial comprised the study population. Subjects were identified who previously failed implantation of Watchman 2.5 (n = 11) or were not attempted because of prohibitive LAA anatomy (n = 88). Demographic characteristics, implant procedure details, and TEE follow-up data were compared to controls composed of enrollees not meeting these criteria (n = 359).Watchman FLX LAA closure was successfully implanted in all subjects with a prior failed Watchman 2.5 attempt (n = 11 of 11). Subjects with previously failed Watchman 2.5 were more likely to receive a 35 mm FLX device than controls (27.3% vs 7.3%; P = .047). Patients with prohibitive anatomy had smaller LAA dimensions than did controls (diameter 18.0 ± 4 mm vs 20.4 ± 3 mm; P.001 and length 23.7 ± 5 mm vs 28.9 ± 5 mm; P.001). There was no difference in age, sex, CHAWatchman FLX implantation in patients with a prior failed Watchman 2.5 attempt or prohibitive LAA anatomy remained safe and highly effective. The association of reduced overall mortality with smaller LAA dimension warrants future study. |
| Databáze: | OpenAIRE |
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