Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve

Abstract

Background: Despite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach.

Methods: Patients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria.

Results: Two hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume-more than double that of the systematic group (445 ± 306 mm³ vs 970 ± 578 mm³, respectively; P < 0.0001). There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts.

Conclusions: In patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles.