Andreas Martin, Doll Nicolas, Livesey Steve, Castella Manuel, Kocher Alfred, Casselman Filip, Voth Vladimir, Bannister Christina, Encalada Palacios Juan F, Pereda Daniel, Laufer Guenther, Czesla Markus
Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
Sana Herzchirurgie Stuttgart GmbH, Stuttgart, Germany.
Eur J Cardiothorac Surg. 2016 Jan;49(1):249-54. doi: 10.1093/ejcts/ezv015. Epub 2015 Feb 17.
Recurrent mitral regurgitation is a significant problem after mitral valve repair in patients with functional valve disease. We report the safety and feasibility of a novel adjustable mitral annuloplasty device that permits downsizing of the anterior-posterior diameter late after initial surgery.
In this multicentre, non-randomized, observational register, patients with moderate or severe mitral regurgitation undergoing surgical mitral valve repair with the MiCardia EnCorSQ™ Mitral Valve Repair system were evaluated. Patient characteristics, operative specifications and results as well as postoperative follow-up were collected for all five centres.
Ninety-four patients with a median age of 71 (64-75) years (EuroSCORE II 6.7 ± 6.3; 66% male, 48% ischaemic MR, 37% dilated cardiomyopathy and 15% degenerative disease) were included. Operative mortality was 1% and the 1-year survival was 93%. Ring adjustment was attempted in 12 patients at a mean interval of 9 ± 6 months after surgery. In three of these attempts, a technical failure occurred. In 1 patient, mitral regurgitation was reduced two grades, in 2 patients mitral regurgitation was reduced one grade and in 6 patients, mitral regurgitation did not change significantly. The mean grade of mitral regurgitation changed from 2.9 ± 0.9 to 2.1 ± 0.7 (P = 0.02). Five patients were reoperated after 11 ± 9 months (Ring dehiscence: 2; failed adjustment: 3).
We conclude that this device may provide an additional treatment option in patients with functional mitral regurgitation, who are at risk for reoperation due to recurrent mitral regurgitation. Clinical results in this complex disease were ambiguous and patient selection seems to be a crucial step for this device. Further trials are required to estimate the clinical value of this therapeutic concept.
对于功能性瓣膜病患者，二尖瓣反流复发是二尖瓣修复术后的一个重要问题。我们报告一种新型可调节二尖瓣环成形术装置的安全性和可行性，该装置允许在初次手术后晚期减小前后径。
在这个多中心、非随机、观察性登记研究中，对使用MiCardia EnCorSQ™二尖瓣修复系统进行二尖瓣手术修复的中重度二尖瓣反流患者进行了评估。收集了所有五个中心的患者特征、手术规格和结果以及术后随访情况。
纳入了94例患者，中位年龄为71（64 - 75）岁（欧洲心脏手术风险评估系统II评分为6.7±6.3；男性占66%，缺血性二尖瓣反流占48%，扩张型心肌病占37%，退行性疾病占15%）。手术死亡率为1%，1年生存率为93%。12例患者在术后平均9±6个月尝试进行环调整。在这些尝试中，有3次出现技术失败。1例患者二尖瓣反流降低了两级，2例患者二尖瓣反流降低了一级，6例患者二尖瓣反流无明显变化。二尖瓣反流的平均等级从2.9±0.9变为2.1±0.7（P = 0.02）。5例患者在11±9个月后再次手术（瓣环裂开：2例；调整失败：3例）。
我们得出结论，对于因二尖瓣反流复发而有再次手术风险的功能性二尖瓣反流患者，该装置可能提供一种额外的治疗选择。这种复杂疾病的临床结果尚不明确，患者选择似乎是该装置的关键步骤。需要进一步的试验来评估这一治疗概念的临床价值。
