Outcomes of permanent pacemaker insertion after TAVR: a systematic review and meta-analysis
Authors: Mahajan P , Mahajan S , Gupta R , Aedma S , Samala V , Malik A , Mehta S 
Published: October 2021

Abstract

Background/Introduction
Conduction abnormalities are frequently encountered after transcatheter aortic valve replacement (TAVR) performed for severe aortic stenosis, leading to post-procedure permanent pacemaker (PPM) insertion. Although the predictors of- and factors leading to post-TAVR PPM have been studied extensively, its short-term and long-term outcomes have not been established.

Purpose
PPM placement can lead to significant changes in outcomes in post-TAVR patients, which remain unclear. With this analysis, we aim to evaluate the differences between outcomes of patients requiring PPM and those not requiring PPM post-TAVR.

Methods
A comprehensive literature search was performed in PubMed, EMBASE, and Cochrane to identify relevant trials. Outcomes were compared between the two groups of patients- those requiring post-TAVR PPM and those not requiring post-TAVR PPM. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio (OD) with 95% confidence intervals (CI) for all the clinical endpoints.

Results
34 studies, including observational and prospective studies, met our inclusion criteria, with a total of 76,402 patients undergoing TAVR and 10,381 requiring post-TAVR PPM. There were no significant differences between 30-days (OR 1.04; 95% CI 0.96–1.13) and 1-year (OR 1.09; 95% CI 0.72–1.03) all-cause mortality rates, and 30-days (OR 0.86; 95% CI 0.72–1.03) and 1-year (OR 0.85; 95% CI 0.70–1.04) cardiovascular deaths among the two groups. Incidence of heart failure was higher in the post-TAVR PPM group at 30 days (OR 1.26; 95% CI 1.05–1.51) but not at 1 year (OR 1.21; 95% CI 0.93–1.57). No significant difference was noted between the two groups in 30-days or 1-year stroke, 30-days or 1-year myocardial infarction, 30-days or 1-year atrial fibrillation, 30-days or 1-year major bleeding, or 30-days and 1-year readmission rate. Other outcomes, including post-procedure aortic regurgitation, major vascular complications, minor bleeding, valve migration, and device success, also did not have any statistically significant difference in the two patient groups (Figure 1). Of all the patients who received post-TAVR PPM, an average of 46.4% and 58.5% patients had &gt;40% ventricular pacing, and 48.9% and 41.4% had &lt;40% ventricular pacing at 1-month, and 1-year follow up respectively.

Conclusions
Although there were no differences in the outcomes between the two groups at 30-days and 1-year follow-ups (except the higher incidence of heart failure at 30 days in the post-TAVR PPM group), long-term follow-up studies would be needed to identify any possible adverse events after one year. Also, a significant number of patients requiring post-TAVR PPM had &lt;40% ventricular pacing at 1-month and even at 1-year intervals, which might suggest adopting an alternate approach of closely monitoring any conduction disturbances and avoiding early PPM implantation in post-TAVR patients, if possible.

Funding Acknowledgement
Type of funding sources: None. Forest plot of differences in outcomes