Among new-generation TAVI devices, Sapien 3 ranked highest for lower mortality (SUCRA 16.8%) and stroke (25.5%), while Lotus ranked highest for lower paravalvular leak (SUCRA 0.3%).
Meta-Analysis
Do different new-generation TAVI devices differ in efficacy and safety outcomes in patients with severe aortic stenosis?
Different new-generation TAVI devices have distinct efficacy and safety profiles, with Sapien 3 showing the best profile for reducing mortality and stroke, while others excel in specific safety or hemodynamic metrics.
BACKGROUND: Whether there are differences among the new-generation transcatheter aortic valve implantation (TAVI) devices for patients with aortic stenosis remains unclear. The aim of the study was to compare the efficiency and safety of different new-generation TAVI devices for patients with aortic stenosis. MATERIALS AND METHODS: A comprehensive search of PubMed, Embase and Web of Science from their inception to 1 February 2022. Randomized clinical trials and observational studies that compared two or more different TAVI devices were enroled. Pairwise meta-analysis and frequentist network meta-analysis were conducted to pool the outcome estimates of interest. RESULTS: A total of 79 studies were finally included. According to the surface under the cumulative ranking, the top two ranked valves for lower rates of events were as follows: direct flow medical (DFM) (4.6%) and Lotus (48.8%) for lower rate of device success; Sapien 3 (16.8%) and DFM (19.7%) for lower mortality; DFM (8.6%) and Sapien 3 (25.5%) for lower rates of stroke; Evolut (27.6%) and DFM (35.8%) for lower rates of major and life-threatening bleeding; Portico (22.6%) and Sapien 3 (41.9%) for lower rates of acute kidney injury; Acurate (8.6%) and DFM (13.2%) for lower rates of permanent pacemaker implantation; Lotus (0.3%) and Sapien 3 (22.7%) for lower rates of paravalvular leak; Evolut (1.4%) and Portico (29.1%) for lower rates of mean aortic valve gradients. CONCLUSIONS: The findings of the present study suggested that the device success rates were comparable among these new-generation valves except for DFM. After excluding DFM, Sapien 3 might be the best effective for decreased mortality and stroke; Lotus might be the best effective for decreased paravalvular leak; Evolut might be the best effective for decreased major and life-threatening bleeding and mean aortic valve gradients; Acurate and Portico might be the best effective for decreased permanent pacemaker implantation and acute kidney injury, respectively.
Yang et al. (Wed,) conducted a meta-analysis in severe aortic stenosis. New-generation TAVI devices vs. Different TAVI devices was evaluated on Efficiency and safety (device success, mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, paravalvular leak, mean aortic valve gradients). Among new-generation TAVI devices, Sapien 3 ranked highest for lower mortality (SUCRA 16.8%) and stroke (25.5%), while Lotus ranked highest for lower paravalvular leak (SUCRA 0.3%).