Evidence map›Paper›PMID 28283746›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2017

Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve.

Birgid Gonska, Julia Seeger, Mirjam Keßler, Alexander von Keil, Wolfgang Rottbauer, Jochen Wöhrle

2 registry-linked trialsAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
5.5field-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.

NCT02162069 nacompletednot on this map

Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

TypeinterventionalSponsorUniversity of UlmRan2014 to 2018Enrolled843ConditionsAortic Valve StenosisArmsCE certified transcatheter ( aortic valve replacement)
NCT03715894 completednot on this mapstarted 2018, after this paper: background citation

Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve

TypeobservationalSponsorInstitut für Pharmakologie und Präventive MedizinRan2018 to 2023Enrolled300ConditionsAortic Valve Stenosis, AV Block, Bundle-Branch BlockArmstranscatheter valve implantation
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. [Left bundle branch pacing in a patient with decreased cardiac function after transcatheter aortic valve replacement].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2025
    Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.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
    Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Transvascular transcatheter aortic valve implantation in 2017.Clinical research in cardiology : official journal of the German Cardiac Society · 2020
    Article
  19. Article
  20. One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.Clinical research in cardiology : official journal of the German Cardiac Society · 2019
    Article
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

6 authors at 1 institution in 1 country.

Birgid GonskaDepartment of Internal Medicine II-Cardiology, University of Ulm, Ulm, Germany.
Julia SeegerDepartment of Internal Medicine II-Cardiology, University of Ulm, Ulm, Germany.
Mirjam KeßlerDepartment of Internal Medicine II-Cardiology, University of Ulm, Ulm, Germany.
Alexander von KeilDepartment of Internal Medicine II-Cardiology, University of Ulm, Ulm, Germany.
Wolfgang RottbauerDepartment of Internal Medicine II-Cardiology, University of Ulm, Ulm, Germany.
Jochen WöhrleDepartment of Internal Medicine II-Cardiology, University of Ulm, Ulm, Germany. jochen.woehrle@uniklinik-ulm.de.
Universität Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPredictors for the need of permanent pacemaker implantation (PPMI) in the context of transcatheter aortic valve implantation (TAVI) are not well defined yet. We evaluated the impact of conduction disturbances, calcium volume of the device landing zone, oversizing and implantation depth on PPMI after TAVI with the balloon-expandable Edwards Sapien 3 (ES3). METHODS AND

results335 consecutive patients undergoing transfemoral TAVI with the ES3 for the treatment of symptomatic severe aortic stenosis were included (clinicaltrials NCT02162069). Rate of PPMI after TAVI was 18.4%, excluding patients with permanent pacemakers prior to TAVI or valve-in-valve implantations. Patients requiring PPMI more often had first degree atrioventricular block (AVB) at baseline (48.7 vs. 16.5%, p < 0.01), preprocedural complete right bundle branch block (RBBB; 25.0 vs. 3.9%, p < 0.01) and higher calcium volume of the aortic valve (258.5 ± 317.3 vs. 163.6 ± 178.8 mm³, p < 0.01). There was a trend towards higher rate of PPMI in patients with new-onset left bundle branch block after TAVI (32.7 vs. 20.7%, p = 0.06). Multivariate logistic regression analysis showed that baseline first degree AVB (odds ratio 3.9, 95% confidence interval 1.73-9.10, p < 0.01) and preprocedural complete RBBB (odds ratio 4.5, 95% confidence interval 1.50-13.21, p < 0.01) were independent predictors of PPMI. Of note, neither oversizing nor implantation depth were independent predictors for need of PPMI with the ES3.

conclusionsIn patients treated with the ES3 for symptomatic severe aortic stenosis first degree AVB and complete RBBB at baseline were independently associated with higher rates of postprocedural PPMI, whereas implantation depth and oversizing did not have an impact on PPMI.

Indexed as

Heart Valve ProsthesisAgedAged, 80 and overAortic ValveAortic Valve StenosisAtrioventricular BlockFemoral ArteryHumansPacemaker, ArtificialPrognosisProsthesis DesignTranscatheter Aortic Valve ReplacementEdwards Sapien 3Permanent pacemaker implantationTranscatheter aortic valve implantation

Identifiers

PMID28283746
OpenAlexW2594830607

What OpenQuestion holds

Textmetadata
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.