Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial
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 r...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-11-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.119.012594 |
| _version_ | 1811333989516967936 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Christopher U. Meduri |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T17:01:06Z |
| format | Article |
| id | doaj.art-1b1acb8a5e0c424b90714157e4ebc6c9 |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-13T17:01:06Z |
| publishDate | 2019-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-1b1acb8a5e0c424b90714157e4ebc6c92022-12-22T02:38:39ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802019-11-0182110.1161/JAHA.119.012594Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III TrialChristopher U. Meduri0Dean J. Kereiakes1Vivek Rajagopal2Raj R. Makkar3Daniel O'Hair4Axel Linke5Ron Waksman6Vasilis Babliaros7Robert C. Stoler8Gregory J. Mishkel9David G. Rizik10Vijay S. Iyer11John Schindler12Dominic J. Allocco13Ian T. Meredith14Ted E. Feldman15Michael J. Reardon16Piedmont Heart Institute Atlanta GAThe Christ Hospital Heart and Vascular Center The Lindner Research Center Cincinnati OHPiedmont Heart Institute Atlanta GACedars—Sinai Heart Institute Los Angeles CAAurora St. Luke's Medical Center Milwaukee WIDresden University Hospital, Heart Center Dresden GermanyWashington Hospital Center Washington DCEmory University Hospital Emory University Atlanta GABaylor Heart & Vascular Hospital Dallas TXSt. John's Hospital Springfield ILHonorHealth and the Scottsdale‐Lincoln Health Network Scottsdale AZUniversity at Buffalo/Gates Vascular Institute Buffalo NYUniversity of Pittsburgh Medical Center Pittsburgh PABoston Scientific Corp Marlborough MABoston Scientific Corp Marlborough MAEdwards Lifesciences Irvine CaliforniaHouston Methodist DeBakey Heart and Vascular Center Houston TXBackground 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.https://www.ahajournals.org/doi/10.1161/JAHA.119.012594aortic valve stenosispacemaker dependencypermanent pacemakertranscatheter aortic valve replacement |
| spellingShingle | 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 Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease aortic valve stenosis pacemaker dependency permanent pacemaker transcatheter aortic valve replacement |
| title | Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial |
| title_full | Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial |
| title_fullStr | Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial |
| title_full_unstemmed | Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial |
| title_short | Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial |
| title_sort | pacemaker implantation and dependency after transcatheter aortic valve replacement in the reprise iii trial |
| topic | aortic valve stenosis pacemaker dependency permanent pacemaker transcatheter aortic valve replacement |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.119.012594 |
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