Key result
Self-expanding TAVR is linked to ~25% higher pacemaker implantation rates than balloon-expandable valves.
Why the study?
The incidence of conduction abnormalities requiring permanent pacemaker implantation after TAVR with early and later generation prostheses remains debated.
Cohort (n=49,201)
Yes
Answers are grounded in this paper and cite their sources.
Should not yet alter TAVR valve selection; leaves open whether randomized data confirm excess pacemaker risk with self-expanding devices.
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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Bisson et al. (2020) conducted a cohort in Aortic stenosis treated with transcatheter aortic valve replacement (TAVR) (n=49,201). Latest self-expanding TAVR (Medtronic Evolut R) vs. Early balloon-expandable TAVR (Edwards Sapien XT) was evaluated on Permanent pacemaker implantation during the whole follow-up (HR 1.25, 95% CI 1.18-1.34, p=<0.0001). Self-expanding TAVR had higher pacemaker implantation rates than early balloon-expandable TAVR over follow-up (adjusted HR 1.30 for early SE, HR 1.25 for latest SE; P<0.0001).
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