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Pacemaker Implantation After Balloon- or Self-Expandable Transcatheter Aortic Valve Replacement in Patients With
Arnaud Bisson1, Alexandre Bodin1, Julien Herbert1,2
1Service de Cardiologie Centre Hospitalier Universitaire Trousseau et Faculté de Médecine EA7505 Université de Tours France.
Insights
Permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) is more common than previously thought. Balloon-expandable TAVR valves are associated with lower PPI rates compared to self-expanding valves.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials and Medical Devices
Background:
- The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) following transcatheter aortic valve replacement (TAVR) is a subject of ongoing debate, particularly concerning early versus later generation prostheses.
- Understanding the factors influencing PPI rates is crucial for optimizing TAVR procedures and patient outcomes.
Purpose of the Study:
- To compare the incidence of PPI after TAVR based on the type (balloon-expandable vs. self-expanding) and generation of the implanted valve.
- To analyze PPI rates in a large, nationwide cohort of patients undergoing TAVR for aortic stenosis.
Main Methods:
- A retrospective analysis of administrative hospital-discharge data from France (2010-2019) was conducted.
- Data included 49,201 patients with aortic stenosis treated with TAVR using either balloon-expandable (BE) Edwards SAPIEN valves or self-expanding (SE) Medtronic CoreValve prostheses.
- Multivariable analysis was used to compare PPI rates between different valve types and generations, adjusting for potential confounders.
Main Results:
- The overall incidence of PPI was higher than previously reported, with 22.4% of patients requiring implantation within 30 days.
- Compared to early balloon-expandable (BE) TAVR, latest BE TAVR showed a lower adjusted odds ratio for early PPI (0.88).
- Self-expanding (SE) TAVR, both early (1.40) and latest (1.17), demonstrated higher adjusted odds ratios for early PPI compared to early BE TAVR.
- During the entire follow-up, latest BE TAVR showed similar PPI rates to early BE TAVR (HR 1.01), while early SE TAVR (1.30) and latest SE TAVR (1.25) had higher rates.
Conclusions:
- Balloon-expandable TAVR technology is independently associated with lower rates of permanent pacemaker implantation in both acute and chronic phases compared to self-expanding technology.
- Recent generations of TAVR devices did not show independent associations with significantly different PPI rates compared to early generations over the entire follow-up period.
- The findings highlight the importance of valve type selection in mitigating the risk of conduction abnormalities after TAVR.
Abstract:
Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with early and later generation prostheses remains debated. Methods and Results Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. A total of 49 201 patients with aortic stenosis treated with TAVR using the balloon-expandable (BE) Edwards SAPIEN valve (early Sapien XT and latest Sapien 3) or the self-expanding (SE) Medtronic CoreValve (early CoreValve and latest Evolut R) were found in the database. Mean (SD) follow-up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1-2.0] years). PPI after the procedure was reported in 13 289 patients, among whom 11 010 (22.4%) had implantation during the first 30 days. In multivariable analysis, using early BE TAVR as reference, adjusted odds ratio (95% CI) for PPI during the first 30 days was 0.88 (0.81-0.95) for latest BE TAVR, 1.40 (1.27-1.55) for early SE TAVR, and 1.17 (1.07-1.27) for latest SE TAVR. Compared with early BE TAVR, the adjusted hazard ratio for PPI during the whole follow-up was 1.01 (0.95-1.08) for latest BE TAVR, 1.30 (1.21-1.40) for early SE TAVR, and 1.25 (1.18-1.34) for latest SE TAVR. Conclusions In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow-up.
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