Evidence map›Paper›PMID 31640455›Full record

Trial reportJournal of the American Heart Association2019

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

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 and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02202434 (REPRISE III), which is not on this map. Cited by 33 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 6 pooled it
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02202434 naterminatednot on this map

REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

TypeinterventionalSponsorBoston Scientific CorporationRan2014 to 2021Enrolled1,425ConditionsAortic StenosisArmsLotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 6 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2022
    Pooled it
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  7. Trial
  8. Review
  9. Conduction Disorders: The Achilles' Heel of TAVR?Journal of clinical medicine · 2026
    Review
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  15. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 14 institutions in 2 countries.

Christopher U MeduriPiedmont Heart Institute Atlanta GA.
Dean J KereiakesThe Christ Hospital Heart and Vascular Center The Lindner Research Center Cincinnati OH.
Vivek RajagopalPiedmont Heart Institute Atlanta GA.
Raj R MakkarCedars-Sinai Heart Institute Los Angeles CA.
Daniel O'HairAurora St. Luke's Medical Center Milwaukee WI.
Axel LinkeDresden University Hospital, Heart Center Dresden Germany.
Ron WaksmanWashington Hospital Center Washington DC.
Vasilis BabliarosEmory University Hospital Emory University Atlanta GA.
Robert C StolerBaylor Heart & Vascular Hospital Dallas TX.
Gregory J MishkelSt. John's Hospital Springfield IL.
David G RizikHonorHealth and the Scottsdale-Lincoln Health Network Scottsdale AZ.
Vijay S IyerUniversity at Buffalo/Gates Vascular Institute Buffalo NY.
John SchindlerUniversity of Pittsburgh Medical Center Pittsburgh PA.
Dominic J AlloccoBoston Scientific Corp Marlborough MA.
Ian T MeredithBoston Scientific Corp Marlborough MA.
Ted E FeldmanEdwards Lifesciences Irvine California.
Michael J ReardonHouston Methodist DeBakey Heart and Vascular Center Houston TX.
Boston Scientific (United States) · USPiedmont Atlanta Hospital · USAurora St. Luke's Medical Center · USBaylor Jack and Jane Hamilton Heart and Vascular Hospital · USBuffalo VA Medical Center · USChrist Hospital · USEmory University Hospital · USEvanston Hospital · USHonorHealth · USHouston Methodist · USMedStar Washington Hospital Center · USSt. John's Hospital · USUniversity Hospital Carl Gustav Carus · DEUniversity of Pittsburgh Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Pacemaker, ArtificialTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAortic Valve StenosisBundle-Branch BlockFemaleHumansMalePostoperative Complicationsaortic valve stenosispacemaker dependencypermanent pacemakertranscatheter aortic valve replacement

Identifiers

PMID31640455
PMCPMC6898843
OpenAlexW2981414804

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.