SAPIEN3 Ultra RESILIA versus NAVITOR valve system in patients with a small aortic annulus: Insights from the OCEAN-TAVI Registry.

BACKGROUND

No studies have compared the outcomes of using the SAPIEN3 Ultra RESILIA (S3UR) balloon-expandable valve or the Navitor self-expandable valve for transcatheter aortic valve replacement (TAVR) in patients with a small annulus.

OBJECTIVE

This study aimed to compare in-hospital outcomes and hemodynamic performance of S3UR and Navitor TAVR in patients with an annulus area ≤ 430 mm2.

METHODS

We retrospectively analyzed the Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation registry data. The endpoints included technical success, device success (per Valve Academic Research Consortium 3 criteria), and post-TAVR echocardiographic function (severe prosthesis-patient mismatch [PPM], aortic-valve mean pressure gradient [mAVPG] ≥ 20 mmHg, and para-valvular leakage [PVL] ≥ mild). We adjusted for differences in baseline characteristics using multivariate logistic regression and propensity score analyses.

RESULTS

Of 1224 patients, 706 (57.7 %) underwent TAVR using S3UR. The Navitor TAVR group had higher rates of mild or severe PVL (13.3 % vs. 36.4 %), postoperative pacemaker implantation (5.2 % vs. 13.1 %), and ischemic stroke (0.7 % vs. 2.5 %), compared with the S3UR TAVR group. Both groups had similar moderate or severe PPM rates; however, fewer patients in the Navitor TAVR group had a mAVPG >20 mmHg compared with those in the S3UR TAVR group.

CONCLUSIONS

TAVR using S3UR resulted in lower rates of ischemic stroke, pacemaker implantation, and PVL compared with that using Navitor. The incidence of moderate or severe PPM was similar in both groups; however, the Navitor TAVR group showed superior hemodynamic valve performance, compared with S3UR TAVR group.