Performance of the Edwards Sapien 3 Ultra Transcatheter Aortic Valve System in Patients With Aortic Stenosis and Annulus Diameter in Proximity to Valve Size.

OBJECTIVES

The new Sapien 3 Ultra (S3U) transcatheter heart valve (Edwards Lifesciences) was designed with the intention to improve paravalvular sealing. In patients with an annulus size in proximity to the prosthesis size, little or no oversizing of the transcatheter aortic valve implantation (TAVI) prosthesis may lead to paravalvular regurgitation. Thus, this study was designed to assess valve performance in such patients.

METHODS

We retrospectively enrolled 30 consecutive patients with symptomatic high-grade aortic stenosis scheduled for transfemoral TAVI between October 2019 and May 2020. Comprehensive computed tomography angiography for TAVI planning included standard measurements and quantification of calcification of the aortic valve. All patients had an aortic annular size in proximity to the valve size (maximum <15%) and received an S3U valve. Before discharge, paravalvular leakage was assessed via transthoracic echocardiography with an operator blinded to the TAVI results. In addition, 30-day outcome was assessed.

RESULTS

The S3U was implanted in all patients without any procedural complications. One patient received a 20 mm S3U valve, 18 received 23 mm S3U valves, and 11 received 26 mm S3U valves; the annular sizes were 19.7 mm, 22.9 ± 0.2 mm, and 25.8 ± 0.2 mm, respectively. Quantification of calcification of the aortic valve revealed significant calcifications with a median Agatston score of 2571 AU (interquartile range, 1685-3467 AU). Postprocedural transthoracic echocardiography showed an excellent result in all but 2 patients. In the latter, aortic insufficiency grade I was seen. Thirty-day survival was 96.7%.

CONCLUSIONS

The new S3U valve shows excellent performance in patients with high-grade aortic stenosis and annular size in proximity to the valve size, even in presence of significant valvular calcification.