Risk of adverse events in patients requiring pacemaker implantation after transcatheter aortic valve replacement: observations from a global federated network

Background

Pacemaker (PM) implantation is a frequent complication following transcatheter aortic valve replacement (TAVR), mainly driven by new-onset conduction disturbances induced by valve deployment. As TAVR is increasingly offered to younger and lower-risk patients, the long-term prognostic impact of early PM implantation remains uncertain.

Purpose

To evaluate the risk of adverse clinical events in patients undergoing pacemaker implantation within 30 days after TAVR compared with those who do not.

Methods

A retrospective cohort study was conducted using the TriNetX Global Research Network, a multinational electronic health record platform. Adult patients (≥18 years) who underwent TAVR between 2002 and 2024 and had no pre-existing conduction disorders at the time of the procedure were included. Patients were stratified according to early pacemaker implantation. The PM group consisted of patients who survived the index procedure and received a permanent pacemaker (ICD-10-CM Z95.0) within 30 days, while the No-PM group included survivors without early PM implantation. The primary outcome was a composite of all-cause mortality and acute decompensated heart failure (ADHF), defined using ICD-10 codes for acute or acute-on-chronic heart failure (I50.21, I50.23, I50.31, I50.33). Secondary outcomes were the individual components of the composite. Exploratory outcomes included acute myocardial infarction, stroke, ventricular arrhythmias, and atrial fibrillation. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox regression after 1:1 propensity score matching (PSM).

Results

A total of 2,220 TAVI patients with early pacemaker implantation and 33,237 without were identified. Before PSM, PM recipients were older (80.7 ± 7.6 vs. 77.7 ± 9.1 years), more commonly male (60.4% vs. 55.4%), and had a higher burden of cardiovascular comorbidities compared with the No-PM group. After PSM, 2,220 matched pairs were analyzed.

Early PM implantation was associated with a higher risk of the primary composite outcome (HR 1.23, 95% CI 1.07–1.41) (Figure 1), all-cause mortality (HR 1.29, 95% CI 1.06–1.57), and ADHF (HR 1.30, 95% CI 1.09–1.54) (Figure 2). Among the exploratory outcomes, a significantly increased risk of atrial fibrillation was observed in PM patients (HR 1.60, 95% CI 1.46–1.76), whereas no significant differences were found for the other endpoints (Figure 2).

Conclusion

Early pacemaker implantation after TAVR is associated with an increased risk of adverse events, particularly higher all-cause mortality and acute heart failure decompensation. Appropriate identification and selection of patients at increased risk for post-procedural conduction disturbances is critical to optimize clinical decision-making, refine pacing strategies, and ultimately improve long-term outcomes after TAVR.