Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial

Journal of the American Heart Association - Tập 8 Số 21 - 2019
Christopher Meduri1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Dean J. Kereiakes1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Vivek Rajagopal1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Raj Makkar1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Daniel O’Hair1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Axel Linke1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Ron Waksman1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Vasilis Babliaros1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Robert Stoler1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Gregory Mishkel1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, David G. Rizik1,2,3,4,5,6,7,8,9,10,11,18,12,13,15,16,17, Vijay Iyer1,2,3,4,5,6,7,8,9,10,12,13,14,15,16,19,17, John Schindler1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Dominic Allocco1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Ian T. Meredith1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Ted Feldman1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17, Michael J. Reardon1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17
1); The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, OH (D.J.K.);
2.); Aurora St. Luke's Medical Center, Milwaukee, WI (D.O.);
3A.L.); Washington Hospital Center, Washington, DC (R.W.);
4Baylor Heart & Vascular Hospital, Dallas, TX (R.C.S.);
5Boston Scientific Corp, Marlborough, MA
6Cedars-Sinai Heart Institute, Los Angeles, CA
7Center, Houston, TX
8Dresden University Hospital, Heart Center Dresden, Germany (
9Edwards Lifesciences, Irvine, California
10Emory University Hospital, Emory University, Atlanta, GA (V.B.);
11Gates Vascular Institute, Buffalo, NY (V.S.I.);
12NorthShore University Health System, Evanston Hospital, Evanston, Illinois
13Piedmont Heart Institute, 95 Collier Road Suite 5015, Atlanta, GA 30309.
14Scottsdale-Lincoln Health Network, Scottsdale, AZ
15St John's Hospital, Springfield, IL
16University at Buffalo
17University of Pittsburgh Medical Center, Pittsburgh, PA (J.S.);
18HonorHealth and the Scottsdale‐Lincoln Health Network Scottsdale AZ
19University at Buffalo/Gates Vascular Institute Buffalo NY

Tóm tắt

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long‐term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System—Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre‐specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier NCT 02202434.

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Journal of the American Heart Association

Tập 8 Số 21

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