Evidence map›Paper›PMID 32591894›Full record

ArticleHeart and vessels2020

Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis.

Michal Droppa, Tanja K Rudolph, Jan Baan, Niels-Erik Nielsen, Helmut Baumgartner, Jeroen Vendrik, Maren Froehlich, Oliver Borst, Jochen Wöhrle, Meinrad Gawaz and 9 more

Registry-linked trialOpen access · greenAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Heart and vessels, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03497611 (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), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 33% 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.

NCT03497611 completednot on this map

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 2019Enrolled1,000ConditionsAortic Valve Stenosis, AV Block, Bundle-Branch BlockArmstranscatheter valve implantation
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
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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

19 authors at 9 institutions in 4 countries.

Michal DroppaDepartment of Cardiology and Angiology, University Hospital of Tübingen, Tübingen, Germany.
Tanja K RudolphDepartment of Cardiology, Heart Center, Cologne University, Cologne, Germany.
Jan BaanHeart Center, Academic Medical Center, Amsterdam University, Amsterdam, Netherlands.
Niels-Erik NielsenDepartment of Cardiology, Linköping University Hospital, Linköping, Sweden.
Helmut BaumgartnerDepartment of Cardiology III: Adult Congenital and Valvular Heart Disease, University Hospital Münster, Münster, Germany.
Jeroen VendrikHeart Center, Academic Medical Center, Amsterdam University, Amsterdam, Netherlands.
Maren FroehlichInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Oliver BorstDepartment of Cardiology and Angiology, University Hospital of Tübingen, Tübingen, Germany.
Jochen WöhrleDepartment of Internal Medicine II, Cardiology, Angiology, Pulmonology, Intensive Care Medicine, University of Ulm, Ulm, Germany.
Meinrad GawazDepartment of Cardiology and Angiology, University Hospital of Tübingen, Tübingen, Germany.
Paul PotratzDepartment of Cardiology and Angiology, University Hospital of Tübingen, Tübingen, Germany.
Luis P HackDepartment of Cardiology and Angiology, University Hospital of Tübingen, Tübingen, Germany.
Victor MauriDepartment of Cardiology, Heart Center, Cologne University, Cologne, Germany.
Jacek BaranowskiDepartment of Cardiology, Linköping University Hospital, Linköping, Sweden.
Peter BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.ORCID http://orcid.org/0000-0003-4970-2110
Jana KurucovaEdwards Lifesciences, Prague, Czech Republic.
Martin ThoenesEdwards Lifesciences, Nyon, Switzerland.
Wolfgang RottbauerDepartment of Internal Medicine II, Cardiology, Angiology, Pulmonology, Intensive Care Medicine, University of Ulm, Ulm, Germany.
Tobias GeislerDepartment of Cardiology and Angiology, University Hospital of Tübingen, Tübingen, Germany. tobias.geisler@med.uni-tuebingen.de.
University Children's Hospital Tübingen · DEAmsterdam UMC Location University of Amsterdam · NLIPPMed (Germany) · DELinköping University Hospital · SEUniversität Ulm · DEEdwards Lifesciences (Switzerland) · CHHeart and Diabetes Center North Rhine-Westphalia · DEUniversity Hospital Cologne · DEUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Permanent pacemaker implantation (PPI) is a widely recognized complication associated with TAVI (incidence up to 20%). Smaller registries have identified several variables associated with PPI. The objective was to validate patient- and transcatheter aortic valve implantation (TAVI)-related procedural variables associated with PPI. We performed a retrospective analysis of patients from six European centers undergoing TAVI with the Edwards SAPIEN 3 prosthesis. Baseline variables and pre-procedural ECG characteristics and CT-scans were taken into account. Data for 1745 patients were collected; 191 (10.9%) required PPI after TAVI. The baseline variables pulmonary hypertension (OR 1.64; 95% CI 1.01-2.59), QRS duration > 117 ms (OR 2.58; 95% CI 1.73-3.84), right bundle branch block (RBBB; OR 5.14; 95% CI 3.39-7.72), left anterior hemi block (OR 1.92; 95% CI 1.19-3.02) and first-degree atrioventricular block (AVB, OR 1.63; 95%CI 1.05-2.46) were significantly associated with PPI. RBBB (OR 8.11; 95% CI 3.19-21.86) and first-degree AVB (OR 2.39; 95% CI 1.18-4.66) remained significantly associated in a multivariate analysis. Procedure-related variables included access site (TF; OR 1.97; 95% CI 1.07-4.05), implanted valve size (29 mm; OR 1.88; 95% CI 1.35-2.59), mean TAVI valve implantation depth below the annulus > 30% (OR 3.75; 95% CI 2.01-6.98). Patients receiving PPI had longer ICU stays and later discharges. Acute kidney injury stage 2/3 was more common in patients with PPI until discharge (15.2 vs. 3.1%; p = 0.007), but was not statistically significant thereafter. Further differences in outcomes at 30 days did not reach significance. The data will aid pre- and post-procedural patient management and prevent adverse long-term outcomes.Clinical Trial: NCT03497611.

Indexed as

Cardiac Pacing, ArtificialHeart RateHeart Valve ProsthesisPacemaker, ArtificialAgedAged, 80 and overAortic ValveAortic Valve StenosisBalloon ValvuloplastyEuropeFemaleHeart BlockHumansMaleRegistriesRetrospective StudiesAortic stenosisPacemakerTranscatheter aortic valve implantation

Identifiers

PMID32591894
OpenAlexW3037812789

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.