OBJECTIVES: The aim of this multicenter study was to investigate the hemodynamic and clinical performance of the new SAPIEN 3 Ultra prosthesis in comparison to its precursor, the SAPIEN 3 within the multicenter Rhineland cohort.

METHODS: The study cohort consisted of 697 consecutive patients who underwent transcatheter aortic valve replacement (TAVR) between May 2018 and October 2020 in three German high-volume TAVR centres. Patients receiving either the preceding S3 prosthesis (n=383) or the new S3 Ultra (n=314) were compared regarding pre-, peri- and postprocedural outcome with special focus on hemodynamic performance.

RESULTS: Both groups represent patients of intermediate risk (EuroScore II S3 versus S3 Ultra: 4.8 ± 4.5 % versus 4.8 ± 5.0 %; p =0.96). The procedure was performed successfully in both groups in regard of safety and efficacy. Mean aortic gradient (MPG) and maximum velocity (Vmax) significantly reduced after TAVR in both groups. However, patients receiving the S3 Ultra prosthesis showed significantly higher post procedural mean transprosthetic gradients (S3 versus S3U: 10.2 ± 6.48 mmHg vs. 15.1 ±11.09 mmHg; p < 0.0001) and Vmax (S3 versus S3U: 2.32 ± 0,.44 m/sec vs. 2.46 ± 0.47; p < 0.0001) compared with patients receiving the S3 prosthesis at discharge. Moderate paravalvular leakage or more was observed in 2.2% of the S3 Ultra group and in 13.6 % of the S3 group (p < 0.0001), respectively.

CONCLUSION: Despite of a successful device implantation, post procedural echocardiographic assessment demonstrated significantly higher transprosthetic gradients and Vmax in patients receiving the new S3 Ultra valve prosthesis. These echocardiographic findings could be an indication towards valve degeneration processes and should be further evaluated in long-term studies.