Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study

Background: Transcatheter aortic valve implantation now has 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.Aims: We sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves.Methods: We conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve.Results: A total of 37 patients (male sex, 73%) with a median age of 81 years (interquartile range 69-85 years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n = 31) had dyspnoea New York Heart Association class > III. The device success rate was 94.6% (n = 35). At 30 days, the all-cause mortality rate was 8.1% (n = 3) and valve migration occurred in 10.8% of cases (n = 4). Dyspnoea New York Heart Associ-ation class <= II was seen in 86.5% of patients (n = 32), and all survivors had aortic regurgitation grade <= 1. At 1-year follow-up, all-cause mortality was 16.2% (n = 6), 89.7% (n = 26/29) of survivors were in New York Heart Association class <= II and all had aortic regurgitation grade <= 2.Conclusion: Transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.(c) 2023 Elsevier Masson SAS. All rights reserved.

Automated summary

This study evaluated the effectiveness of transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve in patients with pure aortic regurgitation. The results showed a device success rate of 94.6%, a 30-day all-cause mortality rate of 8.1%, and a one-year all-cause mortality rate of 16.2%. This method appears promising for treating high-risk patients with pure aortic regurgitation, but further research is needed.