Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial

Abstract

BackgroundAs transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long‐term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve.Methods and ResultsA total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System—Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre‐specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent.ConclusionsPacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.

Clinical Impact of Preexisting Right Bundle Branch Block after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

“…The nine remaining studies identified risk factors for 30-day PPI as summarized in Table 2 [ 12 – 20 ]. Meduri et al identified preexisting RBBB, female sex, and depth of implantation to be a risk factors for 30-day PPI in their retrospective review of the REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial [ 12 ].…”

“…The nine remaining studies identified risk factors for 30-day PPI as summarized in Table 2 [ 12 – 20 ]. Meduri et al identified preexisting RBBB, female sex, and depth of implantation to be a risk factors for 30-day PPI in their retrospective review of the REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial [ 12 ]. Nazif et al identified preexisting RBBB, prosthesis to left ventricular outflow tract diameter ratio, and left ventricular end-diastolic diameter as risk factors for 30-day PPI in their retrospective review of the PARTNER (Placement of AoRtic TraNscathetER Valves) trial [ 15 ].…”

“…e results from Watanabe et al are limited by the relatively small size of the cohort (n � 749) and the relatively short median follow-up of 16 months [10]. e retrospective studies of existing data are subject to all of the limitations inherent to this study design [12][13][14][15][16][17][18][19][20]. Availability of specific data points, such as medication that could influence cardiac conduction, is a common limitation for retrospective studies.…”

Intraventricular Conduction Disturbances After Transcatheter Aortic Valve Implantation

“…A previous study suggested that periodic examination and adjustment of pacemaker settings minimised the risk of long-term pacing in patients requiring PMI after TAVI. 75 Prior studies also showed pacemaker dependency after TAVI was not so high. 28,59 Thus, leadless pacemakers may contribute to less morbidity in these patients.…”

Transcatheter management of severe aortic stenosis during the COVID-19 pandemic

“…Permanent pacemaker rates have also been higher in TAVI patients, particularly with the self-expanding valves. 38 While pacing rates seem to be lower in younger patients (with healthier cardiac conducting systems) as demonstrated in the PARTNER 3 study, there is concern that pacing will have a greater impact in the treatment of younger patients who may need multiple generator changes throughout their lifetimes and be subject to longer term right ventricular pacing.…”