Colli Andrea, Manzan Erica, Rucinskas Kestutis, Janusauskas Vilius, Zucchetta Fabio, Zakarkaitė Diana, Aidietis Audrius, Gerosa Gino
Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Padova, Italy
Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Padova, Italy.
Interact Cardiovasc Thorac Surg. 2015 May;20(5):575-80; discussion 580-1. doi: 10.1093/icvts/ivv014. Epub 2015 Feb 16.
Transapical off-pump mitral valve repair using the NeoChord device has been proposed to treat degenerative mitral valve regurgitation. This prospective study sought to evaluate acute safety and efficacy of this innovative, minimally invasive, transcatheter mitral valve repair approach.
Symptomatic patients with severe mitral regurgitation (MR) were selected if they presented a favourable valve anatomy (the presence of leaflet flail/prolapse with consistent overlap of tissue). Early device success was defined as placement of at least two neochordae with residual mitral regurgitation ≤ 2+ after the procedure. The primary acute safety and efficacy end points were evaluated at 30 days.
Between February 2013 and June 2014, in Padua and Vilnius University Hospitals, a total of 62 patients were treated, with a median age of 66 years (IQR 52-76) and a median EuroSCORE I of 1.9% (IQR 0.9-6). Fifty-six patients (88.9%) presented with a posterior leaflet prolapse, 4 (6%) with an anterior leaflet prolapse and 3 (5%) with a combined disease. Early procedural success was achieved in all patients. Two neochordae were implanted in 2 patients (3%), 3 in 20 (32%), 4 in 28 (44%), 5 in 10 (16%), 6 in 2 (3%) and 7 in 1 (2%). At 30 days, major adverse events included only 1 acute myocardial infarction (2%) successfully treated percutaneously and 2 cases of sepsis (3%). Mitral regurgitation at 30 days was absent in 29 patients (46%), Grade 1+ in 16 (25%), Grade 2+ in 10 (16%), Grade 3+ in 7 (11%) and Grade 4+ in 1 (2%). All 8 patients with MR >2+ were successfully reoperated with conventional surgery or NeoChord reintervention.
Initial results with the NeoChord procedure in a small number of patients indicate that transapical off-pump mitral valve repair is feasible and safe. Efficacy is maintained up to the 30-day follow-up with significant clinical benefit for patients.
已提出使用NeoChord装置经心尖非体外循环二尖瓣修复术来治疗退行性二尖瓣反流。这项前瞻性研究旨在评估这种创新的、微创的经导管二尖瓣修复方法的急性安全性和有效性。
入选有症状的严重二尖瓣反流（MR）患者，条件是其瓣膜解剖结构良好（存在瓣叶连枷/脱垂且组织有持续重叠）。早期手术成功定义为术后植入至少两根新腱索且残余二尖瓣反流≤2+。主要急性安全性和有效性终点在30天时进行评估。
2013年2月至2014年6月期间，在帕多瓦和维尔纽斯大学医院，共治疗了62例患者，中位年龄66岁（四分位间距52 - 76岁），中位欧洲心脏手术风险评估系统I评分为1.9%（四分位间距0.9 - 6%）。56例患者（88.9%）表现为后叶脱垂，4例（6%）为前叶脱垂，3例（5%）为合并病变。所有患者均取得早期手术成功。2例患者（3%）植入2根新腱索，20例（32%）植入3根，28例（'44%）植入4根，10例（16%）植入5根，2例（3%）植入6根，1例（2%）植入7根。30天时，主要不良事件仅包括1例经皮成功治疗的急性心肌梗死（2%）和2例脓毒症（3%）。30天时，29例患者（46%）无二尖瓣反流，16例（25%）为1+级，10例（16%）为2+级，7例（11%）为3+级，1例（2%）为4+级。所有8例二尖瓣反流>2+级的患者均成功接受了传统手术或NeoChord再次干预。
少数患者采用NeoChord手术的初步结果表明，经心尖非体外循环二尖瓣修复术是可行且安全的。在30天随访期内疗效得以维持，对患者有显著临床益处。
