International journal of environmental research and public health · 2023
Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic's Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies.
МетаанализСистематический обзорСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Gozdek Mirosław, Kuźma Łukasz, Dąbrowski Emil Julian, Janiak Michał, Pietrzak Martyna, Skonieczna Karolina, Woźnica Mikołaj, Wydeheft Lidia, Makhoul Maged, Matteucci Matteo, Litwinowicz Radosław, Kowalówka Adam, Wańha Wojciech, Pasierski Michał, Ronco Daniele, Massimi Giulio, Jiritano Federica, Fina Dario, Martucci Gennaro, Raffa Giuseppe Maria, Suwalski Piotr, Lorusso Roberto, Meani Paolo, Kowalewski Mariusz, Thoracic Research Centre
Аннотация
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes.
METHODS: A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed.
RESULTS: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age (p < 0.001), sex (p < 0.001) and STS-PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] p = 0.002; I2 = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; p = 0.03; I2 = 39%), without differences in major vascular complications.
CONCLUSIONS: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.
METHODS: A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed.
RESULTS: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age (p < 0.001), sex (p < 0.001) and STS-PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] p = 0.002; I2 = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; p = 0.03; I2 = 39%), without differences in major vascular complications.
CONCLUSIONS: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.