Trial reportOpen heart2023
Modifiable risk factors for permanent pacemaker after transcatheter aortic valve implantation: CONDUCT registry.
Trial report in Open heart, 2023. 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 6 papers.
What it found
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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.
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.
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
Who cites it
6 citing papers in PubMed, 11 citations in OpenAlex.
- Feasibility of large-scale in silico transcatheter aortic valve implantation trials using a fast-to-evaluate model.Biomechanics and modeling in mechanobiology · 2026Article
- One-year Outcomes of Permanent Pacemaker Implantation after Transcatheter Aortic Valve Replacement: CONDUCT Registry: A Propensity Score-Matched Comparison.Arrhythmia & electrophysiology review · 2025Article
- Patient-specific Factors Influencing Choice of Transcatheter Aortic Valve Prosthesis.Interventional cardiology (London, England) · 2025Review
- Right transaxillary transcatheter aortic valve replacement is comparable to left despite challenges.General thoracic and cardiovascular surgery · 2024Article
- Impact of cancer in patients with aortic stenosis undergoing transcatheter aortic valve replacement: A systematic review and meta-analysis.International journal of cardiology. Heart & vasculature · 2024Article
- Risk of permanent pacemaker implantation following transcatheter aortic valve replacement: Which factors are most relevant?World journal of cardiology · 2024Article
Corrections and comments
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Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe onset of new conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is still a relevant adverse event. The main objective of this registry was to identify modifiable procedural risk factors for an improved outcome (lower rate of PPI) after TAVI in patients at high risk of PPI.
methodsPatients from four European centres receiving a balloon-expandable TAVI (Edwards SAPIEN 3/3 Ultra) and considered at high risk of PPI (pre-existing conduction disturbance, heavily calcified left ventricular outflow tract or short membranous septum) were prospectively enrolled into registry.
resultsA total of 300 patients were included: 42 (14.0%) required PPI after TAVI and 258 (86.0%) did not. Patients with PPI had a longer intensive care unit plus intermediate care stay (65.7 vs 16.3 hours, p<0.001), general ward care stay (6.9 vs 5.3 days, p=0.004) and later discharge (8.6 vs 5.0 days, p<0.001). Of the baseline variables, only pre-existing right bundle branch block at baseline (OR 6.8, 95% CI 2.5 to 18.1) was significantly associated with PPI in the multivariable analysis. Among procedure-related variables, oversizing had the highest impact on the rate of PPI: higher than manufacturer-recommended sizing, mean area oversizing as well as the use of the 29 mm valve (OR 3.4, 95% CI 1.4 to 8.5, p=0.008) all were significantly associated with PPI. Rates were higher with the SAPIEN 3 (16.1%) vs SAPIEN 3 Ultra (8.5%), although not statistically significant but potentially associated with valve sizing. Implantation depth and postdelivery balloon dilatation also tended to affect PPI rates but without a statistical significance.
conclusionValve oversizing is a strong procedure-related risk factor for PPI following TAVI. The clinical impact of the valve type (SAPIEN 3), implantation depth, and postdelivery balloon dilatation did not reach significance and may reflect already refined procedures in the participating centres, giving attention to these avoidable risk factors. TRIAL REGISTRATION NUMBER: NCT03497611.
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