Hospices Civils de Lyon, Délégation à la Recherche Clinique et à l'Innovation, Cellule Innovation, quai des Célestins, 69000 Lyon, France.
Arch Cardiovasc Dis. 2013 May;106(5):287-94. doi: 10.1016/j.acvd.2013.03.059. Epub 2013 May 28.
Percutaneous mitral valve repair (MVR) using the MitraClip(®) is a new option for severe mitral regurgitation (MR).
To describe initial French experience regarding short-term and mid-term safety and efficacy.
A multicentre cohort reported experience of percutaneous MVR using the MitraClip(®) in French centres from December 2010 to September 2012. All patients were judged inoperable or at high surgical risk. Short-term and mid-term safety and efficacy results are presented.
Sixty-two patients (72.7±11.4years; 71.7% men; 81.0% New York Heart Association [NYHA] class III or IV; logistic Euroscore 18.7±13.1%; 93.3% MR≥grade 3; 73.8% secondary MR) underwent percutaneous MVR using the MitraClip(®) under general anaesthesia. Procedural success was 95.2% (83.1% of patients received one clip; 16.9% received two clips). At discharge, 88.2% of implanted patients had a residual MR≤grade 2. Transthoracic echocardiography showed a significant decrease in ejection fraction (39.9±14.8% pre vs. 36.2±14.3% post), end-diastolic diameter (63.8±10.6mm vs. 61.4±12.3mm, respectively) and systolic pulmonary pressure (52.1±13.9mmHg vs. 44.7±10.9mmHg, respectively). The in-hospital mortality rate was 3.2%. The survival rate at 6-month follow-up was estimated at 83.1%, with 90.9% of patients in NYHA class I or II and residual MR≤grade 2 in 80% of cases.
This initial French experience, despite being in its learning phase, showed promising results in patients considered ineligible for surgery, as observed in more experienced centres. Randomized studies are mandatory to confirm these preliminary data.
经皮二尖瓣修复术(MVR)使用 MitraClip(®)是严重二尖瓣反流(MR)的新选择。
描述法国在短期和中期安全性和疗效方面的初步经验。
2010 年 12 月至 2012 年 9 月,法国中心采用 MitraClip(®)进行经皮 MVR 的多中心队列报告经验。所有患者均被判定为手术禁忌或手术风险高。介绍短期和中期安全性和疗效结果。
62 例患者(72.7±11.4 岁;71.7%为男性;81.0%为纽约心脏协会[NYHA]III 或 IV 级;逻辑 Euroscore 18.7±13.1%;93.3%MR≥3 级;73.8%为继发性 MR)在全身麻醉下接受 MitraClip(®)经皮 MVR。手术成功率为 95.2%(83.1%的患者接受一个夹子;16.9%的患者接受两个夹子)。出院时,88.2%植入的患者残留 MR≤2 级。经胸超声心动图显示射血分数(术前 39.9±14.8% vs. 术后 36.2±14.3%)、舒张末期直径(63.8±10.6mm vs. 61.4±12.3mm)和收缩期肺动脉压(52.1±13.9mmHg vs. 44.7±10.9mmHg)均有显著下降。院内死亡率为 3.2%。6 个月随访时的生存率估计为 83.1%,90.9%的患者 NYHA 分级为 I 或 II 级,80%的患者残留 MR≤2 级。
尽管处于学习阶段,但这项法国初步经验表明,在被认为不适合手术的患者中,结果有希望,与经验更丰富的中心观察到的结果一致。需要随机研究来证实这些初步数据。