Sapien 3 is Superior to Sapien XT: A Single-Center Analysis of Implanted Balloon Expandable Transcatheter Heart Valves

Objectives: Transcatheter Aortic Valve Implantation (TAVI) is a well-established treatment option for patients with severe aortic stenosis, who are at high risk for surgical aortic valve replacement. In this analysis we directly compared safety and efficacy of transfemoral implanted Edwards Sapien XT (XT) and Sapien 3 (S3) balloon-expandable transcatheter heart valves (THV) in all-comers.

Methods and Results: In a retrospective analysis we included 347 consecutive patients receiving a transfemoral implanted balloon-expandable THV (XT: n = 251; S3: n = 96) between September 2012 and October 2014 at our center. All clinical endpoints were defined according to VARC2 criteria. Calculated risk (XT versus S3: logistic EuroSCORE I 17.4 ± 12% versus 15.8 ± 11.9%, p = 0.26; STS PROM 6.8 ± 4.6% versus 6.3 ± 4.6%, p = 0.35), mean age (XT versus S3: 81.6 ± 6.7 years versus 81.7 ± 6.3 years) and mean annulus size by MSCT perimeter (XT versus S3: 24.5 ± 1.6 mm versus 24.6 ± 1.8 mm, p = 0,2) did not differ between groups. Successful deployment of the THV was achieved in all patients. Despite similar annular dimensions smaller THV were more frequently used in the S3 group (mean oversizing index XT versus S3: 11.5 versus 4.7; p< 0.001). Device success was superior in the S3 compared with the XT group (XT versus S3: 87.2% versus 97.9%; p = 0.001) whereas the transvalvular gradient at discharge by transthoracic echocardiography was higher in S3 than in XT (XT versus S3: 9.25 ± 3.7 mm Hg versus 11.2 ± 3.7 mm Hg, p< 0.001). More patients in the S3-group had AR ≤ trace compared with the XT-group (XT versus S3: 48.1% versus 69.15%, p< 0.001). Intra procedural mortality was similar in both groups (0.6%), whereas in-hospital mortality was higher in the XT-group (9.2% versus 2.08%, p = 0.02). Rate of major stroke post implantation did not significantly differ between groups (XT versus S3: 3.72% versus 2.1%, p = 0.73). Also, prevalence of post procedural pacemaker implantation due to grade 3 atrioventricular block did not differ between groups (XT versus S3: 7.6% versus 11.2%, p = 0.37). The combined safety endpoint occurred more often in the XT-group (23.9% versus 13.5%, p = 0.039).

Conclusion: In this single center study the balloon-expandable Sapien 3 THV was found to be superior to the Sapien XT THV by means of device success, in-hospital mortality, combined safety and paravalvular leakage. Only the transvalvular gradient after implantation was significantly higher in patients treated with S3, an observation that is most likely related to a lower necessity of oversizing with the S3 THV.