Elsevier

Heart Rhythm

Volume 18, Issue 12, December 2021, Pages 2027-2032
Heart Rhythm

Clinical
Outcomes associated with pacemaker implantation following transcatheter aortic valve replacement: A nationwide cohort study

https://doi.org/10.1016/j.hrthm.2021.06.1175Get rights and content

Background

Conduction abnormalities following transcatheter aortic valve replacement (TAVR) often may require permanent pacemaker implantation (PPM).

Objective

The purpose of this study was to evaluate outcomes associated with PPM after a TAVR procedure in a large, nationwide-level population.

Methods

Based on the administrative hospital discharge database, the incidence of all-cause death, cardiovascular death, and hospitalization for heart failure (HF) were retrospectively collected, based on the presence or absence of PPM, in the first 30 days following all TAVRs in France from 2010 to 2019.

Results

Among 520,662 patients hospitalized for aortic stenosis, 49,201 were treated with TAVR. A total of 29,422 patients had follow-up ≥6 months (median 1.7 years), 22% already had PPM at baseline, and 22% underwent PPM within the first 30 days post-TAVR. Adjusted hazard ratios for the combined risk of all-cause death and hospitalization for HF, during the whole follow-up, were higher in both patients with a previous PPM and in those implanted within 30 days (hazard ratio [95% confidence interval] 1.12 [1.07–1.17] and 1.11 [1.06–1.16], respectively).

Conclusion

PPM at baseline and within 30 days post-TAVR are independently associated with higher mortality and HF hospitalization during follow-up.

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.

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