Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study.

Abstract

Background: There is a large variability regarding the management of conduction disturbances (CDs) after TAVR.

Objectives: To validate a pre-specified algorithm for managing CDs in patients undergoing TAVR.

Methods: 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 pre-specified for each group. Permanent pacemaker (PPM) and mortality (overall, sudden cardiac death) at 30 days were the primary endpoints.

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%, 20.7%, in NCD, RBBB-NCD, and CD groups, respectively (p<0.001). The PPM rate was 17.4% and 57.2% in patients with procedural new-onset LBBB and HAVB/CHB, respectively. There were no differences in 30-day all-cause mortality and sudden cardiac death between groups (NCD: 1.2/0.2%, RBBB-NCD: 0/0%, CDs 0.7/0.1%; p=0.45/0.99 for all-cause mortality and sudden cardiac death, respectively).

Conclusions: A pre-specified 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 among patients with CDs. However, PPM rates remained high, and continued efforts for preventing the occurrence of CDs are warranted.