Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
San Raffaele Hospital, Milan, Italy.
JACC Cardiovasc Interv. 2016 Jan 11;9(1):68-75. doi: 10.1016/j.jcin.2015.09.027.
The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery.
The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation.
A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria.
Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2).
At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.
本研究旨在评估经导管主动脉瓣置换术（TAVR）治疗有手术禁忌或高危因素的严重症状性主动脉瓣狭窄患者的 DirectFlowMedical（DFM）瓣膜的 1 年结果。
DFM 经导管心脏瓣膜是一种新型的非金属主动脉瓣，具有加压支撑结构和顺应性双环环形密封，通过 18-F 鞘输送。该装置允许在永久性植入前重新定位、取回和评估瓣膜性能。
建立了一项前瞻性多中心欧洲注册研究，以确定 100 例连续患者（10 个中心）中瓣膜的安全性和性能。由独立核心实验室评估超声心动图和血管造影数据，并使用 ValveAcademicResearchConsortium 标准由临床事件委员会裁决不良事件。
患者年龄为 83.1±5.9 岁，逻辑 EuroSCORE 为 22.5±11.3%，胸外科医生协会评分 9.7±8.7%。99%的病例获得了正确的瓣膜定位，30 天的综合安全性终点为 10%，包括 5.0%的主要卒中、2.0%的主要血管并发症和 1%的死亡。12 个月时，95%的患者心功能处于纽约心脏协会 I 或 II 级。无任何死亡的生存率为 90%，无任何死亡或主要卒中的生存率为 85%。超声心动图显示 100%的患者无/微量至轻度主动脉瓣反流，平均主动脉梯度为 12.2±6.6mmHg，有效瓣口面积为 1.6±0.4cm2。
在 1 年时，DFM 经导管心脏瓣膜具有持久的血流动力学。本研究表明，早期并发症发生率低，严重主动脉瓣反流风险低，转化为中期临床获益。
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