@article{JTD35173,
author = {Mirosław Gozdek and Jakub Ratajczak and Adam Arndt and Kamil Zieliński and Michał Pasierski and Matteo Matteucci and Dario Fina and Federica Jiritano and Paolo Meani and Giuseppe Maria Raffa and Pietro Giorgio Malvindi and Michele Pilato and Domenico Paparella and Artur Słomka and Uri Landes and Ran Kornowski and Jacek Kubica and Roberto Lorusso and Piotr Suwalski and Mariusz Kowalewski and on behalf of Thoracic Research Centre},
title = {Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves: a systematic review and meta-analysis},
journal = {Journal of Thoracic Disease},
volume = {12},
number = {3},
year = {2020},
keywords = {},
abstract = {Background: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements. Current systematic review and meta-analysis sought to compare outcomes of TAVR for severe native valve stenosis with next-generation devices: Lotus and Sapien 3.
Methods: Electronic databases were screened for studies comparing outcomes of TAVR with Lotus and Sapien 3. In a random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed.
Results: Eleven observational studies including 2,836 patients (Lotus N=862 vs. Sapien 3 N=1,974) met inclusion criteria. No differences were observed regarding composite endpoints—device success and early safety. Similarly, 30-day mortality, major vascular complications, acute kidney injury and serious bleeding events were similar with both devices. Lotus valve demonstrated 35% reduction of the risk for mild PVL: risk ratio (RR) 0.65, 95% confidence interval (CI): 0.49–0.85, P=0.002; but there were no statistical differences with regard to moderate/severe PVL (RR 0.56, 95% CI: 0.18–1.77, P=0.320). Lotus valves produced significantly higher mean transaortic gradients: mean difference (MD) 0.88 mmHg, 95% CI, 0.24–1.53 mmHg, P=0.007; however, without translation into higher rate of prosthesis-patient mismatch (RR 1.10, 95% CI: 0.82–1.47, P=0.540). As compared to Sapien 3, Lotus device placement was associated with significantly higher rate of permanent pacemaker implantation (RR 2.30, 95% CI: 1.95–2.71, P},
issn = {2077-6624}, url = {https://jtd.amegroups.org/article/view/35173}
}