Comparison of Two Contemporary Balloon-Expandable Transcatheter Heart Valves: Sapien 3 versus Sapien 3 Ultra

Objectives: Transcatheter aortic valve implantation (TAVI) is an established therapy for severe aortic valve stenosis in patients at high or intermediate risk. Balloon-expandable (BE) transcatheter heart valves (THV) from the Sapien family (Edwards Lifesciences Inc., Irvine, California, USA) are among the most frequently used TAVI systems. We herein aimed to compare outcomes of patients receiving with Sapien 3 (S3) with S3 Ultra (S3U) at our center.

Methods: Between 05/2018 and 05/2020, a total of 100 consecutive patients (41% female, 80.2 ± 6.7 years, logEuroSCORE I 15.7 ± 14.2%) received transfemoral TAVI using the S3 device and 100 consecutive patients (32% female, 79.8 ± 6.4 years, logEuroSCORE I 11.7 ± 10.3%) received S3U THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium (VARC-2) definitions.

Result: Patients receiving a S3 THV were at significantly increased preoperative risk compared with the S3U cohort (logEuroSCORE I: S3 15.7 ± 14.2 vs. S3U 11.7 ± 10.3, p = 0.02). Device success (98 vs. 97%, p = 1.0), early safety (87 vs. 92%, p = 0.36), 30-day mortality (4 vs. 2%, p = 0.36), periprocedural stroke (2 vs. 2%, p = 1.0), myocardial Infarction (1 vs. 0%, p = 1.0), access site complications (5 vs. 3%, p = 0.72), acute kidney injury (6 vs. 1%, p = 0.12), postprocedural permanent pacemaker implantation (10 vs. 11%, p = 1.0) and postprocedural transvalvular pressure gradients (peak gradient: 20.9 ± 10.7 vs. 19.6 ± 8.3, p = 0.37; mean gradient: 10.5 ± 5.6 vs. 10.1 ± 4.7, p = 0.59) showed no significant differences between the two THV cohorts. Although rates of paravalvular leakage (PVL) ≥ moderate were not different at 30-day follow-up (1 vs. 0%, p = 1.0), incidence of mild PVL was observed more frequently in S3 patients (36 vs. 22%, p = 0.04).

Conclusion: Both herein investigated THV demonstrated adequate 30-day outcomes and hemodynamic results. Comparison of the two systems revealed similar clinical results, despite a significantly higher preoperative risk profile in the S3 cohort. Incidence of mild PVL was significantly lower in the S3U cohort, which may be of particular importance for future indication of TAVI in younger patients with lower risk profiles. These results have to be confirmed in larger patient cohorts.

Publication History

Article published online:
19 February 2021