使用新型 ePTFE 腱索植入装置行不停跳二尖瓣修复术：前瞻性试验。
Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial.
机构信息
Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, Maryland.
Jagiellonian University John Paul II Hospital, Krakow Poland.
出版信息
J Am Coll Cardiol. 2018 Jan 2;71(1):25-36. doi: 10.1016/j.jacc.2017.10.062. Epub 2017 Nov 1.
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 cm vs. 6.9 ± 2.0 cm; 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).
背景
传统的二尖瓣（MV）手术允许在心脏停搏的情况下直接进行解剖评估和修复，但需要体外循环、主动脉阻断、胸骨切开术或开胸术以及心脏停搏，并且与显著的围手术期残疾以及发病率和死亡率风险相关。
目的
本研究评估了一种经食管超声心动图引导的设备在跳动的心脏上植入人造膨体聚四氟乙烯（ePTFE）缝线的安全性和性能，该设备旨在植入二尖瓣瓣叶。
方法
在一项前瞻性多中心研究中，30 例连续的严重退行性二尖瓣反流（MR）患者通过小左胸切开术接受了二尖瓣修复系统（MVRS）治疗。主要（30 天）终点是成功植入缝线并将 MR 减少到中度或更低。
结果
30 例患者中的 27 例（90%）达到了主要终点。3 例患者需要转换为开放式二尖瓣手术。无死亡、中风或永久性起搏器植入。1 个月时，27 例中的 24 例（89%）MR 为轻度或以下，27 例中的 3 例（11%）为中度。6 个月时，26 例中的 22 例（85%）MR 为轻度或以下，26 例中的 2 例（8%）为中度，26 例中的 2 例（8%）为重度。6 个月时心脏重塑有利，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）减少。前-后二尖瓣环径从 34.7 ± 5.8 mm 减小至 28.2 ± 5.1 mm；p < 0.001，二尖瓣环面积也从 10.0 ± 2.7 cm 减小至 6.9 ± 2.0 cm；p < 0.0001。
结论
MVRS ePTFE 缝线植入可以降低传统 MV 手术的侵袭性和发病率。该设备的安全性前景很有希望，有必要进行比较 MVRS 与传统 MV 修复手术结果的前瞻性试验。（CE 标志研究 Harpoon Medical Device [TRACER]；NCT02768870）。
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