Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Canada (J.R.-C., J.-M.P.).
NYU Langone Medical Center, New York, NY (M.R.W., C.S., M.S.).
Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31.
While most self-expanding transcatheter valves are repositionable, only one fully retrievable valve is currently available. The Meridian valve is a new self-expanding valve with full retrievability properties. The objective of our study was to evaluate the early feasibility, preliminary safety, and efficacy of transcatheter aortic valve replacement with the HLT Meridian valve (HLT, Inc).
This was a multicenter early feasibility study including patients with severe aortic stenosis at high surgical risk undergoing transfemoral transcatheter aortic valve replacement with the 25-mm Meridian valve. All serious adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiography data were assessed by an independent echocardiography core laboratory.
A total of 25 patients (mean age, 85±6 years; 80% of men) were included. The valve was successfully implanted in 22 (88%) patients (annulus too large and extreme horizontal aorta in 2 and 1 unsuccessful cases, respectively). Valve retrieval because of an initial nonadequate positioning was attempted and successfully performed in 10 (40%) patients. Echocardiography post-transcatheter aortic valve replacement showed a low mean residual gradient (10±4 mm Hg) and the absence of moderate-severe aortic regurgitation (none-trace and mild aortic regurgitation in 76% and 24% of patients, respectively). Mortality at 30 days was 8%, with no cases of disabling stroke, valve embolization, or major/life-threatening bleeding complications. At 6-month follow-up, the cumulative mortality rate was 12%, with no changes in echocardiographic parameters and no cases of valve dysfunction. The majority of patients (89%) were in New York Heart Association class I-II at 6 months.
Transcatheter aortic valve replacement with the Meridian valve was feasible and associated with acceptable early and 6-month clinical results. Valve retrieval after full valve deployment was successfully performed in all attempted cases, and valve performance was excellent, with low residual gradients, no cases of moderate-severe aortic regurgitation, and none-trace residual aortic regurgitation in the majority of patients.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02838680 (RADIANT-Canada); NCT02799823 (RADIANT-US).
虽然大多数自膨式经导管瓣膜可重新定位，但目前只有一种完全可回收瓣膜可用。HLT Meridian 瓣膜是一种新型自膨式瓣膜，具有完全可回收性能。我们的研究目的是评估经股动脉途径使用 HLT Meridian 瓣膜（HLT，Inc.）行经导管主动脉瓣置换术的早期可行性、初步安全性和疗效。
这是一项多中心早期可行性研究，纳入了接受 25 毫米 Meridian 瓣膜经股动脉途径行经导管主动脉瓣置换术的高危外科手术严重主动脉瓣狭窄患者。根据 Valve Academic Research Consortium-2 标准，所有严重不良事件均由独立临床事件委员会进行裁决。超声心动图数据由独立的超声心动图核心实验室评估。
共纳入 25 例患者（平均年龄 85±6 岁，80%为男性）。22 例（88%）患者成功植入瓣膜（因瓣环过大和极度水平主动脉，各有 1 例手术失败）。10 例（40%）患者因初始定位不理想尝试行瓣膜回收，均成功完成。经导管主动脉瓣置换术后超声心动图显示平均残余梯度较低（10±4mmHg），无中重度主动脉瓣反流（76%和 24%的患者分别为无反流-微量反流和轻度主动脉瓣反流）。30 天死亡率为 8%，无致残性卒中、瓣膜栓塞或重大/危及生命的出血并发症。6 个月随访时，累积死亡率为 12%，超声心动图参数无变化，无瓣膜功能障碍。89%的患者在 6 个月时心功能处于纽约心脏协会Ⅰ-Ⅱ级。
使用 Meridian 瓣膜行经导管主动脉瓣置换术是可行的，早期和 6 个月的临床结果可接受。在所有尝试的病例中均成功完成了完全瓣膜展开后的瓣膜回收，瓣膜功能良好，残余梯度低，无中重度主动脉瓣反流，大多数患者无反流-微量反流。
网址：https://www.clinicaltrials.gov。唯一识别码：NCT02838680（RADIANT-Canada）；NCT02799823（RADIANT-US）。
