Oregon Health and Science University, Portland, Oregon, USA.
Oregon Health and Science University, Portland, Oregon, USA.
JACC Cardiovasc Interv. 2022 Jan 10;15(1):80-89. doi: 10.1016/j.jcin.2021.10.018. Epub 2021 Nov 6.
The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.
Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.
This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.
Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg).
Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid™ TMVR Transseptal System]; NCT02322840).
本研究旨在评估经股静脉入路行经导管二尖瓣置换术（TMVR）在手术高危患者中的疗效。
在某些患者中，手术高危可能会使二尖瓣置换手术无法进行。先前已经通过经心尖入路评估了探索性的 IntrepidTMVR 系统输送自膨式生物假体瓣膜的效果。
本前瞻性、多中心、非随机早期可行性研究评估了经股静脉入路经房间隔输送、适用于手术高危、中重度或重度有症状二尖瓣反流的 Intrepid 瓣膜的安全性和性能。心脏团队确定患者是否符合入组标准，中心筛选委员会批准后患者方能入组。由独立核心实验室进行超声心动图数据评估。临床事件由临床事件委员会裁定。
2020 年 2 月至 2021 年 5 月，在 6 个中心共入组 15 例患者。患者中位年龄为 80 岁，中位胸外科医生协会预测死亡率为 4.7%；87%的患者为男性，53%曾行胸骨切开术。14 例植入成功。1 例患者在指数手术期间转为手术治疗。患者中位术后住院时间为 5 天。有 6 例（40%）发生经皮穿刺部位出血，11 例（73%）发生医源性房间隔缺损闭合。30 天时无死亡、卒中和再介入。所有接受植入术的患者均存在微量或无瓣叶或瓣周二尖瓣反流，平均跨瓣压差为 4.7mmHg（IQR：3.0-6.7mmHg）。
Intrepid 经股静脉 TMVR 早期可行性研究的 30 天结果显示瓣膜功能良好，无死亡或卒中等不良事件。需要更多患者和更长时间的随访来证实这些结果。
