Oversized Versus Not Oversized: 3-Year Outcomes after Transapical Transcatheter Aortic Valve Implantation with Sapien 3 Valve

Aim: A certain degree of prosthesis oversizing is recommended for the Sapien 3 to achieve device success. We aimed to investigate 3-year outcomes of patients who received oversized (OS) Sapien 3 valve during transapical transcatheter aortic valve implantation (TA-TAVI).

Methods: From a total of 122 patients with severe aortic stenosis who underwent TA-TAVI utilizing Sapien 3 valve at our institution, 42 patients received oversized prosthesis. We employed computed tomography-derived area and effective diameter for annulus sizing and to access oversizing, respectively. We defined oversizing if the implanted prosthesis exceeded diameter of the native annulus with ≥ 2 mm. We found 41 patients out who received the same prosthesis size as their annulus size (not oversized [nOS]). The rest of the patients was excluded. We conducted 3-year follow-up. All end-point-related outcomes were adjudicated according to VARC-2 definitions.

Results: The study groups showed similar risk score and age: [STS-PROM 5.5 ± 2.2 in OS vs. 5.4 ± 3.7 in nOS] and [80.7 ± 6.7 years in OS vs. 80.7 ± 4.3 years in nOS]. Thirty-day mortality was 7.1% in OS versus 2.4% in nOS. Thirty-day all-stroke was 2.4% in OS versus 0% in nOS. No coronary obstruction occurred in both groups. Median follow-up time was 20 months. 1-year and 3-year all-cause mortality rates were 23 and 21.8% in OS vs. 22.5 and 11.1% in nOS, respectively. Three-year cardiocerebral adverse events occurred with similar frequency in both groups: 4% in OS vs. 5.1% in nOS. Postoperative moderate/severe paravalvular leakage ≥ 2 occurred in 0% in OS vs. 5.4% in nOS. The rate of new pacemakers was 15.7% in OS vs. 9.3% in nOS. Intraprocedural postdilation was 7.1% in OS vs. 15.3% in nOS, necessary.

Conclusions: Oversizing reduces the risk for device failure and intra-procedural postdilation but increases the risk for new pacemaker implantation rates. We observed considerably higher early and late mortality rates in OS group.