Transcatheter aortic valve implantation (TAVI) has now a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation (AR).

We sought to evaluate the results of TAVI using the balloon-expandable SAPIEN 3 transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, CA) in patients with pure AR on native, non-calcified valves.

We conducted a retrospective and prospective French, multicentre, observational study. We included all the patients with symptomatic, severe, pure AR on native, non-calcified valves, contraindicated to, or at high-risk for surgical valve replacement, who underwent TAVI using the SAPIEN 3 THV.

A total of 37 patients (male gender: 73%, median age: 81 years, interquartile 25–75 [IQR]: 69–85 years) were screened using transthoracic echocardiography and computed tomography, and included in 8 French centres. At baseline, 83.8% of patients (n=31) had dyspnoea New York Heart Association (NYHA) ≥III. The device success rate was 95% (n=35). At 30 days, all-cause mortality rate was 8% (n=3) and valve migration occurred in 11% of cases (n=4). Eighty-six percent of patients (n=32) had dyspnoea NYHA class ≤II and all survivors had AR grade ≤1. At 1-year follow-up, all-cause mortality was 16.2% (n=6), 89.7% (n=26/29) of survivors were in NYHA class ≤II and all had AR grade ≤2.

TAVI using SAPIEN 3 THV seems technically feasible in carefully selected, high-risk patients with pure AR on native and non-calcified valves, who are contraindicated for surgery. It remains an off-label and compassionate use with no mention in current international guidelines. The procedure is more challenging than TAVI for AS and needs some technical precautions (Fig. 1).