6 Year Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valves: A Propensity-Matched Analysis.

Abstract

Prior reports comparing long-term outcomes of balloon-expandable (BE) versus self-expanding (SE) transcatheter aortic valve implantation (TAVI) have been limited. We compared in-hospital, 1-year, and 6-year outcomes in 1,685 BE (S3, Ultra) versus 776 SE (Evolut R, PRO, PRO+) patients undergoing transfemoral TAVI at a single center. Valve-in-valve and non-transfemoral access cases were excluded. Propensity-score matched BE (n=683) and SE (n=680) cohorts did not differ with respect to age (82.2±8.0 vs 82.1±7.8 years, p=0.407), baseline demographics and comorbidities, pre-TAVI echo and cardiac catheterization results, and STS Risk Score (7.9±5.9 vs 7.9±5.5%, p=0.481). BE vs SE patients had similar in-hospital mortality (0.9 vs 0.6%, p=0.0.072), stroke (1.3 vs 1.8%, p=0.503), major vascular complications (2.8 vs 2.2%, p=0.495) and composite bleeding (4.7 vs 3.4%, p=0.178), although the BE cohort required fewer permanent pacemakers (8.3 vs 13.3%, p=0.003). At 1-year, BE and SE patients had similar all-cause mortality (10.8 vs 11.2%, p=0.825), hospital readmission (22.5 vs 19.6%, p=0.192), and KCCQ12 scores (83.7±25.5 vs 83.0±24.6, p=0.606). At a median follow-up of 77.0 (72.6-81.5) months, Kaplan-Meier survival analysis demonstrated no difference in BE vs SE all-cause mortality (33.2 vs 40.4%, p=0.586), with no differences in late valve-related outcomes including myocardial infarction, stroke, AV endocarditis, and AV re-intervention (balloon aortic valvuloplasty, percutaneous paravalvular leak closure, repeat TAVI, surgical AV replacement). However, BE patients more commonly required treatment for subclinical leaflet thrombosis, while SE patients had a higher incidence of transient ischemic attack during follow-up. In conclusion, BE and SE TAVI patients have similar in-hospital, 1-year and median 6-year adverse outcomes, other than higher subclinical leaflet thrombosis in BE patients and an increased transient ischemic attack rate in SE patients.