Real-world evidence of implanting leadless pacemakers after transcatheter aortic valve implantation procedures

Abstract Background Conduction disturbances can be a complication of Transcatheter Aortic Valve Implantation (TAVI) procedures, for which transvenous pacemakers (TVPs) are recommended. Leadless pacemakers (LPs) are a safe alternative to TVPs in a pacemaker-indicated population, but little is known about their use for TAVI-related conduction disturbances. Purpose To examine rates of pacemaker implantation post-TAVI, compare complications, all-cause mortality, and ventricular pacing rates in LP vs. TVP patients, and assess pacemaker deactivations/upgrades in LP patients. Methods Data from Optum’s de-identified Clinformatics Data Mart Database linked to a device registry between 2016 and 2021 were used to identify patients with TAVI procedures that are subsequently implanted with an LP or a TVP. Claims data were used to assess complications and all-cause mortality; device-reported parameters were used to calculate VP rates and deactivations. Complication rates, all-cause mortality, ventricular pacing rates, and device deactivations were calculated for patients with a pacemaker implant between 7 days before and 90 days after TAVI. Chronic complication rates, defined as complications with the potential to occur outside the acute peri- or post-procedural period, were assessed at 1 year. Regressions were used to compare complications and all-cause mortality, adjusting for patient characteristics. Results In a cohort of 18,073 patients with a TAVI procedure, 11.7% were implanted with a pacemaker at 1 year post-TAVI; 76.7% of implants occurred within 7 days. LPs comprised 7.2% of the total pacemaker implants observed. Of those LPs in the registry, around 25% have VDD capability. LP patients were older (avg. 84 LP, 82 TVP, p=0.02) and were more likely to have atrial fibrillation, end-stage or chronic kidney disease, and ventricular arrhythmias. Of patients implanted with a pacemaker within 90 days post-TAVI (LP N=122, TVP N=1,779), there were no differences in 30-day complication rates (12.3% LP, 15.6% TVP, unadj. p=0.33, adj. p=0.27). LP had fewer chronic complications than TVP (0.8% LP, 9.4% TVP, unadj. p=0.02, adj p=0.02) though the sample size was small. LP patients had higher unadjusted 30-day all-cause mortality (4.1% LP, 1.0% TVP, unadj. p=0.01, adj. p=0.06), reflecting the higher acuity of LP patients. At both 30 days and 1 year post-implant, most patients (85.3% LP, 72.7% TVP) continued to receive pacing support (ventricular pacing >10%). TVP patients were more likely than LP patients to be pacing dependent (ventricular pacing ≥90%) at both 30 days (53.8% vs. 29.4%) and 1 year (44.7% vs. 35.7%) post-implant. There were no observed deactivations/upgrades in LP patients at 1 year. Conclusion LPs, when used concomitantly with TAVI procedures, show similar acute and lower chronic complication rates compared to patients treated with TVPs implanted with TAVI. Most patients who received a pacemaker post-TAVI continue to receive pacing support.Acute and Chronic complicationsVentricular pacing