TY - JOUR
T1 - Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves
T2 - a systematic review and meta-analysis
AU - Gozdek, Miroslaw
AU - Ratajczak, Jakub
AU - Arndt, Adam
AU - Zielinski, Kamil
AU - Pasierski, Michal
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 - Slomka, Artur
AU - Landes, Uri
AU - Kornowski, Ran
AU - Kubica, Jacek
AU - Lorusso, Roberto
AU - Suwalski, Piotr
AU - Kowalewski, Mariusz
AU - Thoracic Research Centre
N1 - Publisher Copyright:
© Journal of Thoracic Disease. All rights reserved.
PY - 2020/3
Y1 - 2020/3
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, PConclusions: Lotus valve, as compared with Sapien 3, was associated with lower risk for PVL but higher risk for permanent pacemaker implantation and cerebrovascular events.
AB - 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, PConclusions: Lotus valve, as compared with Sapien 3, was associated with lower risk for PVL but higher risk for permanent pacemaker implantation and cerebrovascular events.
KW - Meta-analysis
KW - Lotus
KW - Sapien 3
KW - transcatheter aortic valve replacement (TAVR)
KW - PERMANENT PACEMAKER IMPLANTATION
KW - INTERMEDIATE-RISK PATIENTS
KW - PARAVALVULAR REGURGITATION
KW - CLINICAL-OUTCOMES
KW - HEART-VALVES
KW - PREDICTORS
KW - IMPACT
KW - STENOSIS
KW - MORTALITY
KW - CALCIFICATION
U2 - 10.21037/jtd.2019.12.107
DO - 10.21037/jtd.2019.12.107
M3 - (Systematic) Review article
C2 - 32274157
SN - 2072-1439
VL - 12
SP - 893
EP - 906
JO - Journal of Thoracic Disease
JF - Journal of Thoracic Disease
IS - 3
ER -