Ten-Year Clinical Outcomes and Valve Durability after Transcatheter Aortic Valve Implantation with Balloon-Expandable Valves

BACKGROUND:Transcatheter aortic valve implantation (TAVI) is a well-established treatment for patients with severe aortic stenosis. However, long-term data exceeding 10 years remain scarce. OBJECTIVES:This study aimed to evaluate long-term clinical outcomes and transcatheter heart valve durability in patients who underwent TAVI and completed a 10-year follow-up. METHODS:Using data from the multicenter registry in Japan, we analyzed outcomes of 297 patients who received the SAPIEN XT valve (Edwards Lifesciences) from June 2010 to June 2014. All-cause mortality was the primary endpoint. Valve-related outcomes, including bioprosthetic valve failure, were defined according to the Valve Academic Research Consortium 3 criteria. RESULTS:The mean age of the participants was 83.8 ± 6.0 years, and the mean Society of Thoracic Surgeons risk score was 7.5 ± 4.0. Freedom from all-cause mortality at 10 years was 13.2%. Severe structural valve deterioration and bioprosthetic valve failure gradually increased up to 10 years, reaching 3.0% and 10.8%, respectively. Reintervention was performed in 4.5% of patients. Valve-related deaths accounted for 1.3% of all deaths. Most deaths were due to non-valve-related causes. Multivariate analysis revealed that high Society of Thoracic Surgeons score, high clinically frailty scale, renal dysfunction, and low serum albumin levels were independent predictors of mortality. CONCLUSIONS:Few older adult high-risk patients survived beyond 10 years following TAVI. In contrast, transcatheter heart valve demonstrated acceptable durability, and long-term outcomes were primarily determined by baseline comorbidities rather than valve dysfunction. These results support the role of TAVI as a feasible therapeutic approach in this population.