Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation.

Autor: Kapadia SR; Cleveland Clinic, Cleveland, OH (S.R.K., A.K., V.M., K.W., Q.W.)., Krishnaswamy A; Cleveland Clinic, Cleveland, OH (S.R.K., A.K., V.M., K.W., Q.W.)., Whisenant B; Intermountain Medical Center, Salt Lake City, UT (B.W.)., Potluri S; Baylor Scott and White The Heart Hospital, Plano, TX (S.P.)., Iyer V; University of Buffalo, NY (V.I.)., Aragon J; Santa Barbara Cottage Hospital, CA (J.A.)., Gideon P; Banner University Medical Center, Phoenix, AZ (P.G.)., Strote J; Medical Center of the Rockies, Loveland, CO (J.S.)., Leonardi R; Lexington Medical Heart and Vascular Center, West Columbia, SC (R.L.)., Agarwal H; CHI Health Research Center; Omaha, NE (H.A.)., Larrain G; Aspirus Research Institute, Wausau, WI (G.L.)., Sanchez C; OhioHealth Research Institute, Columbus (C.S.)., Panaich SS; University of Iowa Hospitals & Clinics, Iowa City (S.S.P.)., Harvey J; WellSpan York Hospital, York, PA (J.H.)., Vahl T; Columbia University Medical Center, New York, NY (T.V., M.B.L.)., Menon V; Cleveland Clinic, Cleveland, OH (S.R.K., A.K., V.M., K.W., Q.W.)., Wolski K; Cleveland Clinic, Cleveland, OH (S.R.K., A.K., V.M., K.W., Q.W.)., Wang Q; Cleveland Clinic, Cleveland, OH (S.R.K., A.K., V.M., K.W., Q.W.)., Leon MB; Columbia University Medical Center, New York, NY (T.V., M.B.L.).
Jazyk: angličtina
Zdroj: Circulation [Circulation] 2024 Mar 05; Vol. 149 (10), pp. 734-743. Date of Electronic Publication: 2023 Oct 24.
DOI: 10.1161/CIRCULATIONAHA.123.067312
Abstrakt: Background: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied.
Methods: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies.
Results: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA 2 DS 2 -VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; P noninferiority <0.001).
Conclusions: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.
Competing Interests: Disclosures Dr Kapadia holds stock options for Navigate and stocks for Anteris (no longer held, but within the past 12 months). Dr Whisenant consults for Boston Scientific, Edwards, and Medtronic. Dr Iyer is a member of the medical advisory board for Boston Scientific. Dr Leonardi is a speaker for Edwards Lifesciences and Medical and a physician proctor for Edwards Lifesciences. Dr Agarwal is a speaker and proctor for Medtronic, Abbott, and Boston Scientific, and a proctor for Edwards Lifesciences. The other authors report no disclosures related to this study.
Databáze: MEDLINE
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