Five-year haemodynamic outcomes of the first-generation SAPIEN balloon-expandable transcatheter heart valve.

Aims: Transcatheter aortic valve implantation (TAVI) has gained rapid acceptance for patients with severe aortic stenosis (AS) at high surgical risk for conventional valve replacement. Although TAVI is now a relatively mature technique, limited data about long-term valvular function are available. Our aim was to report the five-year echocardiographic data evaluating valve performance from three early European feasibility studies designed to assess the safety and effectiveness of the first-generation balloon-expandable transcatheter heart valve (SAPIEN THV).

Methods And Results: A total of 410 patients were enrolled in the following single-arm, non-randomised, prospective multicentre clinical studies: REVIVE II, TRAVERCE and PARTNER EU. Five-year follow-up was completed in 114 surviving patients. Mean patient age was 82.3±5.6 years; 63.4% were female. The mean logistic EuroSCORE was 28.4±13.3%. NYHA Class III/IV was reported in 92.5%. At five years, the mean effective orifice area (EOA) was 1.6±0.6 cm² (n=34) and the mean gradient was 11.7±5.4 mmHg (n=39). In paired patient data, the difference between discharge and five-year EOA was 0.1±0.7 cm² (p=0.3956) and mean gradient was 2.2±5.7 mmHg (p=0.0900). At discharge and five years, respectively, aortic regurgitation (AR) was evaluated as none/trace in 66.6% (n=162/243) and 55.3% (n=19/38), mild in 28.4% (n=69/243) and 39.5% (n=15/38), and moderate in 4.9% (n=12/243) and 5.3% (n=2/38). No severe AR was reported at follow-up. Valve thrombosis was observed in three patients and occurred within one year. No valve-related explants and no case of structural valve deterioration have been reported.

Conclusions: Long-term echocardiographic outcomes in high-risk patients with severe AS suggest stable haemodynamic function of first-generation balloon-expandable SAPIEN THVs at five years, with no worsening of AR severity over time.