Comparison of Hemodynamic Performance of the Balloon-Expandable SAPIEN 3 Versus SAPIEN XT Transcatheter Valve

• Despite major improvements in aortic annulus measurements and valve sizing, the occurrence of paravalvular leaks remains one of the most important challenges of transcatheter aortic valve implantation (TAVI).
• The present case-matched study with central echo core laboratory analysis showed a major reduction in the occurrence and severity of residual aortic regurgitation after TAVI with a new-generation balloon-expandable valve with enhanced anti-paravalvular leak properties (SAPIEN 3) compared with an earlier generation transcatheter valve (SAPIEN XT). Also, the SAPIEN 3 valve was associated with a significant reduction in the need for balloon postdilation after TAVI.

The SAPIEN 3 valve (S3V) is a new-generation transcatheter valve with enhanced anti-paravalvular leak properties, but no data comparing with earlier transcatheter valve systems are available. We aimed to compare the hemodynamic performance of the S3V and the SAPIEN XT valve (SXTV) in a case-matched study with echo core laboratory analysis. A total of 27 patients who underwent transcatheter aortic valve replacement (TAVR) with the S3V were matched for prosthesis size (26 mm), aortic annulus area, and mean diameter measured by computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 50 patients treated with the SXTV. The prosthesis size was determined by oversizing of 1% to 15% of annulus area. Doppler echocardiographic images collected at baseline and 1-month follow-up were analyzed in a central echocardiography core laboratory. The need for postdilation was higher in the SXTV group (20% vs 4%, p = 0.047), and mean residual gradient and effective orifice area were similar in both groups (p >0.05). The incidence of paravalvular aortic regurgitation was greater with the SXTV (≥mild: 42%, moderate: 8%) than with the S3V (≥mild: 7%, moderate: 0%; p = 0.002 for ≥mild vs SXTV). The implantation of an S3V was the only factor associated with trace or no paravalvular leak after TAVR (p = 0.007). In conclusion, TAVR with the S3V was associated with a very low rate of paravalvular leaks and need for balloon postdilation, much lower than that observed with the earlier generation of balloon-expandable valve (SXTV). The confirmation of these results in a larger cohort of patients will represent a major step forward in using transcatheter valves for the treatment of aortic stenosis.