Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial.

BACKGROUND: Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR versus BAV pre TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519).

METHODS: Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n=228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation).

RESULTS: Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ±6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, p=0.6). Prevalence of predicted prothesis-patient mismatch was low (n=13 [11.4%] in the direct TAVR group versus n=15 [13.2%] in BAV group) and similar between both groups (p=0.7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (p=0.4, p=0.7, p=0.3 and p=0.3 respectively).

CONCLUSION: Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible.

CLINICAL TRIALS REGISTRATION NUMBER: NCT05140317.