Clinical and health status after permanent pacemaker implantation in patients undergoing transcatheter aortic valve replacement: Insights from the SCOPE I randomized trial.

Background: The impact of new permanent pacemaker (PPM) implantation on prognosis after transcatheter aortic valve replacement (TAVR) is controversial.

Objectives: To investigate the impact of new PPM implantation on combined outcomes of vital and patient-reported health status after TAVR.

Methods: Patients in the SCOPE (Safety and Efficacy of the ACURATE Neo/TF Compared to the SAPIEN 3 Bioprosthesis) trial were stratified according to new PPM implantation within 30 days of TAVR. In this trial, clinical endpoints were adjudicated according to the Valve Academic Research Consortium (VARC)-2 definition. The combined outcomes, including general outcomes and clinical efficacy, were retrospectively adjudicated according to the VARC-3 definition at 1 and 3 years of follow-up.

Results: Among 640 patients without a PPM at baseline (mean age 82.8 ± 4.1 years, 58.1 % females, mean Society of Thoracic Surgeons predicted risk of mortality 4.2 ± 2.5), 69 (10.8 %) required PPM implantation within 30 days of TAVR. Patients requiring a PPM had higher rates of right ventricular dysfunction (33 % versus 15 %, P = 0.038) at 1 year. Improvement in patient-health status measures was similar between groups throughout the study period. Patients requiring a new PPM had similar rates of unfavorable clinical outcomes (Risk ratio [RR] 0.89 [95 % CI 0.68-1.16]) and clinical efficacy (RR 0.96 [95 % CI 0.76-1.22]) compared to those who did not require new PPM implantation.

Conclusions: In the SCOPE I trial, new PPM implantation complicating TAVR had no impact on an integrated endpoint of vital and disease-specific health status throughout 3 years of follow-up.