BACKGROUND Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy or thoracotomy, and cardioplegic cardiac arrest, and are associated with significant perioperative disability, and risks of morbidity and mortality. OBJECTIVES This study evaluated safety and performance of a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart. METHODS In a prospective multicenter study, 30 consecutive patients with severe degenerative mitral regurgitation (MR) were treated with a mitral valve repair system (MVRS) via small left thoracotomy. The primary (30-day) endpoint was successful implantation of cords with MR reduction to moderate or less. RESULTS The primary endpoint was met in 27 of 30 patients (90%). Three patients required conversion to open mitral surgery. There were no deaths, strokes, or permanent pacemaker implantations. At 1 month, MR was mild or less in 89% (24 of 27) and was moderate in 11% (3 of 27). At 6 months, MR was mild or less in 85 % (22 of 26), moderate in 8% (2 of 26), and severe in 8% (2 of 26). Favorable cardiac remodeling at 6 months included decreases in end-diastolic (161 ± 36 ml to 122 ± 30 ml; p < 0.001) and left atrial volumes (106 ± 36 ml to 69 ± 24 ml; p < 0.001). The anterior-posterior mitral annular dimension decreased from 34.7 ± 5.8 mm to 28.2 ± 5.1 mm; p < 0.001 as did the mitral annular area (10.0 ± 2.7 cm2 vs. 6.9 ± 2.0 cm2; p < 0.0001). CONCLUSIONS MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device's safety profile is promising and prospective trials comparing the outcomes of the MVRS to conventional MV repair surgery are warranted. (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870).

中文翻译：

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使用新型 ePTFE Cordal 植入装置修复心跳二尖瓣：前瞻性试验

背景 传统的二尖瓣 (MV) 手术允许对停搏心脏进行直接解剖评估和修复，但需要体外循环、主动脉夹闭、胸骨切开术或开胸术和心脏停搏器心脏停搏，并且与严重的围手术期残疾和发病风险相关和死亡率。目的 本研究评估了经食道超声心动图引导装置的安全性和性能，该装置设计用于在跳动的心脏二尖瓣瓣叶上植入人工膨体聚四氟乙烯 (ePTFE) 线。方法 在一项前瞻性多中心研究中，连续 30 名患有严重退行性二尖瓣关闭不全 (MR) 的患者通过左小开胸术接受二尖瓣修复系统 (MVRS) 治疗。主要（30 天）终点是成功植入脐带，MR 降低至中等或更低。结果 30 名患者中有 27 名 (90%) 达到了主要终点。三名患者需要中转开放二尖瓣手术。没有死亡、中风或永久起搏器植入。在 1 个月时，89%（27 人中的 24 人）的 MR 为轻度或更低，11％（27 人中的 3 人）为中度 MR。在 6 个月时，85%（26 个中的 22 个）的 MR 为轻度或更低，8%（26 个中的 2 个）为中度，8%（26 个中的 2 个）为重度。6 个月时良好的心脏重构包括舒张末期（161 ± 36 ml 至 122 ± 30 ml；p < 0.001）和左心房容积（106 ± 36 ml 至 69 ± 24 ml；p < 0.001）的减少。前后二尖瓣环尺寸从 34.7 ± 5.8 mm 减小到 28.2 ± 5.1 mm；p < 0.001，二尖瓣环面积也是如此（10.0 ± 2.7 cm2 vs. 6.9 ± 2.0 cm2；p < 0.0001）。结论 MVRS ePTFE 脐带植入可以降低传统 MV 手术的侵入性和发病率。该设备的安全性是有希望的，并且有必要对 MVRS 与传统 MV 修复手术的结果进行比较的前瞻性试验。（鱼叉医疗器械的 CE 标志研究 [TRACER]；NCT02768870）。