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DOI: 10.1055/s-0039-1678994
Oversized Versus Not Oversized: 3-Year Outcomes after Transapical Transcatheter Aortic Valve Implantation with Sapien 3 Valve
Publication History
Publication Date:
28 January 2019 (online)
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.
No conflict of interest has been declared by the author(s).