Background: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).Methods: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.Results: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.Conclusions: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.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02838680 (RADIANT-Canada); NCT02799823 (RADIANT-US).

中文翻译：

---

经导管主动脉瓣置换为HLT经络瓣膜。

背景：虽然大多数自扩张式经导管瓣膜都是可重定位的，但目前仅提供一个完全可收回的瓣膜。经络阀是一种具有完全可回收特性的新型自膨胀阀。我们的研究目的是评估HLT经络瓣膜置换术（HLT，Inc）的早期可行性，初步安全性和有效性。方法：这是一项多中心早期可行性研究，包括高度严重主动脉瓣狭窄的患者进行经股动脉经导管主动脉瓣置换术（25毫米经络瓣膜）的手术风险。所有严重不良事件均由独立的临床事件委员会根据Valve Academic Research Consortium-2标准进行裁决。超声心动图数据由独立的超声心动图核心实验室评估。结果：总共25例患者（平均年龄为85±6岁；男性为80％）。该瓣膜已成功植入22例（88％）患者中（瓣环过大和2例和1例不成功的极端水平主动脉）。由于最初的定位不当，尝试进行瓣膜取回并成功地在10例（40％）患者中进行了手术。经导管主动脉瓣置换后的超声心动图显示平均残留梯度低（10±4 mm Hg），并且不存在中度至重度主动脉反流（分别有76％和24％的患者无痕迹和轻度主动脉反流）。30天死亡率为8％，无中风，瓣膜栓塞或严重/危及生命的出血并发症发生。经过6个月的随访，累积死亡率为12％，超声心动图参数无变化，无瓣膜功能异常。大多数患者（89％）在6个月时进入纽约心脏协会I-II级。结论：经络主动脉瓣置换为经导管主动脉瓣是可行的，并且与可接受的早期和6个月临床结果相关。在所有尝试的病例中，均成功完成了瓣膜完全展开后的瓣膜修复，并且瓣膜性能优异，残留梯度低，大多数患者中无中度至重度主动脉瓣关闭不全以及无痕量残余主动脉瓣关闭不全的情况。网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02838680（加拿大RADIANT）；NCT02799823（美国RADIANT）。大多数患者（89％）在6个月时进入纽约心脏协会I-II级。结论：经络主动脉瓣置换为经导管主动脉瓣是可行的，并且与可接受的早期和6个月临床结果相关。在所有尝试的病例中，均成功完成了瓣膜完全展开后的瓣膜修复，并且瓣膜性能优异，残留梯度低，大多数患者中无中度至重度主动脉瓣关闭不全以及无痕量残余主动脉瓣关闭不全的情况。网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02838680（加拿大RADIANT）；NCT02799823（美国RADIANT）。大多数患者（89％）在6个月时进入纽约心脏协会I-II级。结论：经络主动脉瓣置换为经导管主动脉瓣是可行的，并且与可接受的早期和6个月临床结果相关。在所有尝试的病例中，均成功完成了瓣膜完全展开后的瓣膜修复，并且瓣膜性能优异，残留梯度低，大多数患者中无中度至重度主动脉瓣关闭不全以及无痕量残余主动脉瓣关闭不全的情况。网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02838680（加拿大RADIANT）；NCT02799823（美国RADIANT）。在所有尝试过的病例中，均成功完成了瓣膜全开后的瓣膜取出术，并且瓣膜性能优异，残留梯度低，大多数患者中无中度至重度主动脉瓣反流，无痕量残余主动脉瓣反流。网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02838680（加拿大RADIANT）；NCT02799823（美国RADIANT）。在所有尝试的病例中，均成功完成了瓣膜完全展开后的瓣膜修复，并且瓣膜性能优异，残留梯度低，大多数患者中无中度至重度主动脉瓣关闭不全以及无痕量残余主动脉瓣关闭不全的情况。网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02838680（加拿大RADIANT）；NCT02799823（美国RADIANT）。