Comparison of Hemodynamic Performance of Two Current Generation Transcatheter Heart Valve Prostheses

Objectives: Prosthesis-patient mismatch (PPM) and paravalvular leakage (PVL) play a major role in transcatheter aortic valve implantation (TAVI) outcome. We sought to compare the Sapien 3 (S3) and Evolut Pro (EPro) transcatheter heart valve regarding hemodynamic parameters following implantation.

Methods: A total of 365 patients who underwent TAVI in our institution (S3 = 251; EPro = 114) were retrospectively enrolled in this analysis. The mean age was 81.6 ± 7.2 years in the S3 and 84 ± 4.5 years in the EPro group (p = 0.052). Transvalvular gradients, effective orifice area (EOA), and EOA indexed to the body surface area (EOAi) were assessed by transthoracic echo before discharge. PPM was classified into clinically nonsignificant (EOAi > 0.85 cm²/m²), moderate (0.66–0.85 cm²/m²), or severe (<0.65 cm²/m²). PVL was assessed via angiography after TAVI.

Results: Mean aortic valve area was 0.71 ± 0.16 cm², 0.71 ± 0.16 cm² in the S3 and 0.7 ± 0.17 cm² in the EPro group (p = 0.57). Mean aortic valve pressure following implantation was 9.7 ± 4.3 mm Hg; 10.6 ± 4.1 mm Hg in the S3 and 7.8 ± 4.2 mm Hg in the EPro group (p ≤ 0.001). EOAi was 0.9 ± 0.18 cm²/m² in the S3 and 1.06 ± 0.26 in the EPro group (p ≤ 0.001). Comparing S3 vs. EPro, moderate PPM was found in 97 (38.7%) vs. 16 (14%; < p ≤ 0.001) and severe PPM in 18 (7.2%) vs. 1 (0.9%) (p ≤ 0.001). No/trace PVL was found in 72.9%, mild PVL in 25.2%, and moderate PVL in 1.9% of the patients. No/trace PVL was observed more frequently in the S3 group (74.9 vs. 64.9%; p = 0.02), whereas mild PVL occurred more often in the EPro group (15.5 vs. 46.5%; p = 0.007). There was no difference in moderate PVL between the two groups; severe PVL did not occur in any patient.

Conclusion: Mild PVL was less frequent in the balloon-expanding S3, while mean aortic valve pressure was lower in the self-expanding EPro group. However, patient prosthesis mismatch—moderate as well as severe—was observed more often in the S3 group which might be due to the intravalvular design. Whether these findings impact on long-term outcome needs to be elucidated.