医学
狭窄
内科学
冲程(发动机)
心脏病学
血流动力学
主动脉瓣
主动脉瓣狭窄
外科
机械工程
工程类
作者
Won-Keun Kim,Helge Möllmann,Matteo Montorfano,Julia Ellert‐Gregersen,Tanja K. Rudolph,Nicolás M. Van Mieghem,Michael Hilker,Ignacio J. Amat‐Santos,Christian Juhl Terkelsen,Anna Sonia Petronio,Pieter R. Stella,Matthias Götberg,Andreas Rück,Albert Markus Kasel,Ramiro Trillo,Clare Appleby,Marco Barbanti,Philipp Blanke,Federico M. Asch,Rodrigo Modolo,Dominic J. Allocco,Corrado Tamburino
出处
期刊:Eurointervention
[Europa Digital and Publishing]
日期:2024-01-01
卷期号:20 (1): 85-94
被引量:2
标识
DOI:10.4244/eij-d-23-00823
摘要
Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation.We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting.Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography).The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL).The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).
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