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Aims: To compare intermediate performance and mortality rates in patients, who underwent transcatheter aortic valve implantation (TAVI) with two different types of prostheses: Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM).
Methods and Results: 42 consecutive patients implanted with a DFM prosthesis for severe aortic stenosis were matched 1:1...
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Objective
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Citations
Background:
Whether there are differences among the new-generation transcatheter aortic valve implantation (TAVI) devices for patients with aortic stenosis (AS) remains unclear. The aim of the study was to compare the efficiency and safety of different new-generation TAVI devices for patients with AS.
Materials and methods:
A comprehensive search of PubMed, Embase and Web of Science from their inception to February 1, 2022. Randomized clinical trials (RCT) and observational studies that compared two or more different TAVI devices were enrolled. 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: 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 (MLTB); Portico (22.6%) and Sapien 3 (41.9%) for lower rates of acute kidney injury (AKI); Acurate (8.6%) and DFM (13.2%) for lower rates of permanent pacemaker implantation (PPI); Lotus (0.3%) and Sapien 3 (22.7%) for lower rates of paravalvular leak (PVL); Evolut (1.4%) and Portico (29.1%) for lower rates of mean aortic valve gradients (MAVG).
Conclusion:
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 PVL; Evolut might be the best effective for decreased MLTB and MAVG; Acurate and Portico might be the best effective for decreased PPI and AKI respectively.
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis. We aimed at appraising effectiveness of a new self-expandable TAVI device.
METHODS: We retrospectively analyzed our institutional experience with Allegra (Biosensors, Morges, Switzerland) for TAVI, focusing on procedural outcomes and 1-month adverse events. We explored the impact of operator experience with this device, dividing patients according to their time of intervention.
RESULTS: Between 2018 and 2021, a total of 50 patients underwent TAVI with Allegra, with average age of 81 years, 80% women, and 50% at low or intermediate surgical risk. No major significant difference in baseline patient features were found when comparing the Phase 1 and Phase 2, except for baseline left ventricular ejection fraction and New York Heart Association, which were worse in Phase 1. All procedures were performed transfemorally and percutaneously, with predilation in 94% and postdilation in 36%, yielding device success in 98%, and procedural success in 96%. No significant differences in procedural features were found when comparing Phase 1 vs. Phase 2 (all P>0.05). One-month follow-up was also favorable, with no significant difference in adverse outcomes according to phase, and a total of 1 (4%) death, 1 (4%) myocardial infarction, 1 (4%) minor vascular complication, and 4 (8%) permanent pacemaker implantations. Consistent findings were obtained at 6-month follow-up.
CONCLUSIONS: The Allegra TAVI device is associated with favorable short-to-midterm outcomes in experienced hands. Operators already proficient with other devices can achieve satisfactory results even in the early phase of adoption of Allegra.
