Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves: a systematic review and meta-analysis

• Published in: Journal of thoracic disease 2020-03, Vol.12 (3), p.893-906
• Main Authors: Gozdek, Mirosław, Ratajczak, Jakub, Arndt, Adam, Zieliński, Kamil, Pasierski, Michał, Matteucci, Matteo, Fina, Dario, Jiritano, Federica, Meani, Paolo, Raffa, Giuseppe Maria, Malvindi, Pietro Giorgio, Pilato, Michele, Paparella, Domenico, Słomka, Artur, Landes, Uri, Kornowski, Ran, Kubica, Jacek, Lorusso, Roberto, Suwalski, Piotr, Kowalewski, Mariusz
• Format: Article
• Language: English
• Subjects: Original
• ISSN: 2072-1439; 2077-6624
• DOI: 10.21037/jtd.2019.12.107

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. 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. Eleven observational studies including 2,836 patients (Lotus N=862 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