TY - JOUR AU - Gozdek, Mirosław AU - Ratajczak, Jakub AU - Arndt, Adam AU - Zieliński, Kamil AU - Pasierski, Michał AU - Matteucci, Matteo AU - Fina, Dario AU - Jiritano, Federica AU - Meani, Paolo AU - Raffa, Giuseppe Maria AU - Malvindi, Pietro Giorgio AU - Pilato, Michele AU - Paparella, Domenico AU - Słomka, Artur AU - Landes, Uri AU - Kornowski, Ran AU - Kubica, Jacek AU - Lorusso, Roberto AU - Suwalski, Piotr AU - Kowalewski, Mariusz AU - Thoracic Research Centre, on behalf of PY - 2020 TI - Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves: a systematic review and meta-analysis JF - Journal of Thoracic Disease; Vol 12, No 3 (March 23, 2020): Journal of Thoracic Disease Y2 - 2020 KW - N2 - 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 Conclusions: Lotus valve, as compared with Sapien 3, was associated with lower risk for PVL but higher risk for permanent pacemaker implantation and cerebrovascular events. UR - https://jtd.amegroups.org/article/view/35173