Ten-Year Clinical Outcomes and Valve Durability After Transcatheter Aortic Valve Implantation With Balloon-Expandable...

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.

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.

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.

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.

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.