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

Research output: Contribution to journalArticle

Christopher U. Meduri, Dean J. Kereiakes, Vivek Rajagopal, Raj R. Makkar, Daniel O'Hair, Axel Linke, Ron Waksman, Vasilis Babliaros, Robert C. Stoler, Gregory J. Mishkel, David G. Rizik, Vijay S. Iyer, John Schindler, Dominic J. Allocco, Ian T. Meredith, Ted E. Feldman, Michael J. Reardon

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.

Original languageEnglish (US)
Pages (from-to)e012594
JournalJournal of the American Heart Association
Volume8
Issue number21
DOIs
StatePublished - Nov 5 2019

PMID: 31640455

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Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. / Meduri, Christopher U.; Kereiakes, Dean J.; Rajagopal, Vivek; Makkar, Raj R.; O'Hair, Daniel; Linke, Axel; Waksman, Ron; Babliaros, Vasilis; Stoler, Robert C.; Mishkel, Gregory J.; Rizik, David G.; Iyer, Vijay S.; Schindler, John; Allocco, Dominic J.; Meredith, Ian T.; Feldman, Ted E.; Reardon, Michael J.

In: Journal of the American Heart Association, Vol. 8, No. 21, 05.11.2019, p. e012594.

Research output: Contribution to journalArticle

Harvard

Meduri, CU, Kereiakes, DJ, Rajagopal, V, Makkar, RR, O'Hair, D, Linke, A, Waksman, R, Babliaros, V, Stoler, RC, Mishkel, GJ, Rizik, DG, Iyer, VS, Schindler, J, Allocco, DJ, Meredith, IT, Feldman, TE & Reardon, MJ 2019, 'Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial' Journal of the American Heart Association, vol. 8, no. 21, pp. e012594. https://doi.org/10.1161/JAHA.119.012594

APA

Meduri, C. U., Kereiakes, D. J., Rajagopal, V., Makkar, R. R., O'Hair, D., Linke, A., ... Reardon, M. J. (2019). Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. Journal of the American Heart Association, 8(21), e012594. https://doi.org/10.1161/JAHA.119.012594

Vancouver

Meduri CU, Kereiakes DJ, Rajagopal V, Makkar RR, O'Hair D, Linke A et al. Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. Journal of the American Heart Association. 2019 Nov 5;8(21):e012594. https://doi.org/10.1161/JAHA.119.012594

Author

Meduri, Christopher U. ; Kereiakes, Dean J. ; Rajagopal, Vivek ; Makkar, Raj R. ; O'Hair, Daniel ; Linke, Axel ; Waksman, Ron ; Babliaros, Vasilis ; Stoler, Robert C. ; Mishkel, Gregory J. ; Rizik, David G. ; Iyer, Vijay S. ; Schindler, John ; Allocco, Dominic J. ; Meredith, Ian T. ; Feldman, Ted E. ; Reardon, Michael J. / Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. In: Journal of the American Heart Association. 2019 ; Vol. 8, No. 21. pp. e012594.

BibTeX

@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.}",
year = "2019",
month = "11",
day = "5",
doi = "10.1161/JAHA.119.012594",
language = "English (US)",
volume = "8",
pages = "e012594",
journal = "Journal of the American Heart Association",
issn = "2047-9980",
publisher = "Wiley",
number = "21",

}

RIS

TY - JOUR

T1 - Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial

AU - Meduri, Christopher U.

AU - Kereiakes, Dean J.

AU - Rajagopal, Vivek

AU - Makkar, Raj R.

AU - O'Hair, Daniel

AU - Linke, Axel

AU - Waksman, Ron

AU - Babliaros, Vasilis

AU - Stoler, Robert C.

AU - Mishkel, Gregory J.

AU - Rizik, David G.

AU - Iyer, Vijay S.

AU - Schindler, John

AU - Allocco, Dominic J.

AU - Meredith, Ian T.

AU - Feldman, Ted E.

AU - Reardon, Michael J.

PY - 2019/11/5

Y1 - 2019/11/5

N2 - 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.

AB - 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.

KW - aortic valve stenosis

KW - pacemaker dependency

KW - permanent pacemaker

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85073711854&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073711854&partnerID=8YFLogxK

U2 - 10.1161/JAHA.119.012594

DO - 10.1161/JAHA.119.012594

M3 - Article

VL - 8

SP - e012594

JO - Journal of the American Heart Association

T2 - Journal of the American Heart Association

JF - Journal of the American Heart Association

SN - 2047-9980

IS - 21

ER -

ID: 54736870