Patients implanted with a leadless pacemaker after transcatheter aortic valve implantation: Results from the MITAVI prospective study

BACKGROUND: Transcatheter aortic valve implantation is a well-established clinical procedure for treating severe aortic stenosis. High-grade atrioventricular block has been reported in 10-30% of patients following transcatheter aortic valve implantation. Traditional transvenous pacemakers are associated with several potential complications, including endocarditis, lead dislodgement or fracture, pocket haematoma and tricuspid regurgitation. These risks may be mitigated with the use of leadless pacemakers. AIM: We proposed to evaluate the 1-year clinical and electrical outcomes of patients implanted with a leadless pacemaker following transcatheter aortic valve implantation. METHODS: From July 2019 to December 2022, 102 patients from four French centres who underwent transcatheter aortic valve implantation and subsequently required pacemaker implantation with a leadless pacemaker (Micra; Medtronic, Dublin, Ireland) were evaluated prospectively. RESULTS: The mean patient age was 82±9 years, and the mean baseline left ventricular ejection fraction was 58.4±10.6%. Major complications included one case of cardiac tamponade and one case of device migration. During 12-month follow-up, one patient required transvenous cardiac resynchronization therapy pacing because of severe heart failure. The all-cause death rate was 12%, and the heart failure hospitalization rate was also 12%. Compared with baseline, leadless pacemaker electrical variables improved at 1 year. Additionally, complete atrioventricular conduction restoration was observed in 38% of the cohort. CONCLUSIONS: Leadless pacemakers can be implanted in patients following transcatheter aortic valve implantation, with low complication rates and excellent electrical variables at 1-year follow-up. The need for an upgrade to a transvenous pacemaker was low (< 1%).