Prospective validation of a prespecified algorithm for the management of conduction disturbances after transcatheter aortic valve replacement: The PROMOTE study

Heart Rhythm. 2024 Dec 16:S1547-5271(24)03692-0. doi: 10.1016/j.hrthm.2024.12.019. Online ahead of print.

Abstract

Background: There is a large variability in the management of conduction disturbances (CDs) after transcatheter aortic valve replacement (TAVR).

Objective: This study aimed to validate a prespecified algorithm for managing CDs in patients undergoing TAVR.

Methods: This was a prospective multicenter study including consecutive patients without prior pacemaker undergoing TAVR. Patients were stratified in different groups according to the presence of prior right bundle branch block (RBBB) and the occurrence of CDs during the procedure: no prior RBBB and no CDs (group NCD), prior RBBB and no CDs (group RBBB-NCD), and occurrence of CDs (group CD). A management algorithm was prespecified for each group. Permanent pacemaker (PPM) and mortality (overall, sudden cardiac death) at 30 days were the primary end points.

Results: A total of 2110 TAVR recipients were included. Patients were distributed in NCD (32.0%), RBBB-NCD (5.1%), and CD (62.9%) groups. A total of 329 patients (15.6%) received a PPM at 30 days, with a PPM rate of 5.5%, 15.9%, and 20.7% in the NCD, RBBB-NCD, and CD groups, respectively (P < .001). The PPM rate was 17.4% and 57.2% in patients with procedural new-onset left bundle branch block and high-degree atrioventricular block/complete heart block, respectively. There were no differences in 30-day all-cause mortality and sudden cardiac death between groups (NCD group, 1.2% and 0.2%; RBBB-NCD group, 0% and 0%; CD group, 0.7% and 0.1%; P = .45 and P = .99 for all-cause mortality and sudden cardiac death, respectively).

Conclusion: A prespecified strategy for the management of CDs in contemporary TAVR recipients was feasible and safe, with no increased mortality and an extremely low rate of sudden cardiac death in patients with CDs. However, PPM rates remained high, and continued efforts for preventing the occurrence of CDs are warranted.

Keywords: Conduction disturbances; Left bundle branch block; Permanent pacemaker; Sudden cardiac death; Transcatheter aortic valve implantation.