ClinicalOutcomes associated with pacemaker implantation following transcatheter aortic valve replacement: A nationwide cohort study
Graphical abstract
Introduction
Transcatheter aortic valve replacement (TAVR) has become an indispensable treatment in selected symptomatic patients presenting with aortic stenosis.1 Conduction abnormalities following TAVR are commonly reported and often may require permanent pacemaker implantation (PPM), but little is known about its potential consequences on outcomes in this population.2 Cardiac pacing is likely to reduce the risk of cardiac death related to severe bradycardia but may have deleterious effects on hemodynamic status and may increase the risk of atrial fibrillation on mid-term follow-up. We sought to evaluate outcomes associated with PPM after a TAVR procedure in a systematic analysis of a large-scale population of such patients seen at a nationwide level.
Section snippets
Data collection
All patients admitted with aortic stenosis in France from January 2010 to June 2019 were screened using the national administrative Programme de Médicalisation des Systèmes d'Information database, through The French Data Protection Authority, covering hospital care from the entire French population, as previously described.3,4 The study was conducted retrospectively, with no impact on patient care. Data collection and management were approved by the Commission Nationale de l'Informatique et des
Population
Among 49,201 patients, PPM at the time of or after the procedure was reported in 13,218 patients (26.9%) (Supplemental Table 1).
A total of 29,422 patients had follow-up ≥6 months or died earlier. This population included 6362 patients (21.6%) who already had a pacemaker at baseline, and 6549 (22.3%) who underwent PPM within the first 30 days post-TAVR procedure (Table 1). The latter patients were older, more likely to be male, had overall more comorbidities, and were more likely to be implanted
Main results
Our study shows for the first time at a nationwide scale that (1) PPM before or after TAVR procedure is associated with a higher rate of rehospitalization for HF; (2) PPM in the postoperative period following TAVR procedure independently predicts a higher risk of death of any cause; and (3) PPM in TAVR patients is independently associated with a higher risk of major complications, especially infective endocarditis.
We report a rather high rate of PPM of 22% in the postoperative period following
Conclusion
In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found high rates of PPM. PPM both at baseline and during the first 30 days post-TAVR was associated with higher risk of death and rehospitalization for HF. Further studies are needed to determine whether a strategy aimed at reducing the rate of PPM can improve outcomes in patients treated with TAVR.
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Funding sources: The authors have no funding sources to disclose.
Disclosures: Dr Pierre reports personal fees from Abbott, Biotronik, Boston Scientific, and Microport. Dr Saint Etienne reports honoraria from Abbott and Biotronik. Dr Fauchier reports consultant or speaker activities for Bayer, BMS/Pfizer, Boehringer Ingelheim, Medtronic, and Novartis. Dr Clementy reports consultant activities for Medtronic and Boston Scientific. Dr Bisson reports speaker activities for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.