@article{69b97f3a0a3d4af0854e96af182826e7,
title = "Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial",
abstract = "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 NCT02202434.",
keywords = "aortic valve stenosis, pacemaker dependency, permanent pacemaker, transcatheter aortic valve replacement",
author = "Meduri, {Christopher U.} and Kereiakes, {Dean J.} and Vivek Rajagopal and Makkar, {Raj R.} and Daniel O'Hair and Axel Linke and Ron Waksman and Vasilis Babliaros and Stoler, {Robert C.} and Mishkel, {Gregory J.} and Rizik, {David G.} and Iyer, {Vijay S.} and John Schindler and Allocco, {Dominic J.} and Meredith, {Ian T.} and Feldman, {Ted E.} and Reardon, {Michael J.}",
note = "Funding Information: Dr Meduri reports membership on the advisory boards of Boston Scientific and Mitralign, consulting fees from Medtronic, Boston Scientific, and Mitralign, and research grants from Medtronic and Edwards Life Sciences, fees for proctoring for Edwards Life Sciences, Medtronic, Boston Scientific, and Mitralign. Dr Kereiakes reports research grants from Boston Scientific and Edwards Life Sciences and membership on the Boston Scientific Advisory Board. Dr Rajagopal reports membership on the Boston Scientific Advisory Board, speaker/proctoring fees from Medtronic, Edwards Life Sciences, and Abbott. Dr O'Hair reports consultant fees from Medtronic. Dr Linke reports speaker/consultant fees from Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, Edwards Life Sciences, Symetis, Bard, and stock options from Claret Medical. Dr Waksman reports research support/consultant/honoraria from Boston Scientific, Biotronik, Biosensors, Medtronic, Abbott, Symetis, Med Alliance, LifeTech, Amgen, and Volcano/Philips. Dr Stoler reports Medtronic and Boston Scientific advisory board membership and proctor fees from Boston Scientific. Dr Mishkel reports minor honorarium/travel expenses for provision of proctoring services during the trial from Boston Scientific. Dr Schindler reports consultant fees from Boston Scientific and proctor fees from Edwards Life Sciences. Drs Allocco and Meredith are full‐time employee and stockholders at Boston Scientific. Dr Feldman reports research grants from Boston Scientific, Abbott, Edwards Life Sciences, WL Gore, and minor honorarium/travel expenses for provision of proctoring services during the trial from Boston Scientific (and from Abbott, Edwards, WL Gore, outside the submitted work); he is now an employee at Edwards Lifesciences. Dr Reardon reports consulting fees paid to his institution from Medtronic. The remaining authors have no disclosures to report. Funding Information: This work was funded by the Boston Scientific Corporation. Publisher Copyright: {\textcopyright} 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.",
year = "2019",
month = nov,
day = "5",
doi = "10.1161/JAHA.119.012594",
language = "English (US)",
volume = "8",
journal = "Journal of the American Heart Association",
issn = "2047-9980",
publisher = "Wiley",
number = "21",
}