Pascual Isaac, Benito-González Tomás, Hernandez-Vaquero Daniel, Estévez-Loureiro Rodrigo, Lorca Rebeca, Garrote-Coloma Carmen, Avanzas Pablo, Gualis Javier, Adeba Antonio, Pérez de Prado Armando, Morís César, Fernández-Vázquez Felipe
Heart Area, Hospital Universitario Central de Asturias, Oviedo, Spain.
Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Spain.
Ann Transl Med. 2020 Aug;8(15):959. doi: 10.21037/atm.2020.02.122.
Functional mitral regurgitation (FMR) is a bad prognosis condition despite optimal medical treatment. Nowadays there is an open debate about the surgical versus percutaneous treatment. The main objective of this study is to evaluate the mid-term follow up clinical outcomes of patients with FMR treated with MitraClip system, according to their left ventricular ejection fraction (LVEF).
Data was obtained from two experienced centers in transcatheter mitral valve repair (TMVR). All consecutive cases of severe FMR undergoing TMVR in both centers with the same inclusion criteria were included prospectively in this study and followed-up. Periodical follow-ups with clinical and echocardiographic evaluation were scheduled from the baseline procedure, at 3 months and then yearly.
From October 2015 to October 2019, a total of 119 patients with FMR at 2 centers in Spain underwent TMVR with the MitraClip procedure and were included in this study. The mean age was 73.8±8.9 years old and 32 patients (26.9%) were female. A 39.5% of cases [47] had a LVEF ≤30% (group 1) and 60.5% (72 cases) had a LVEF >30% (group 2). There was a similar distribution in cardiovascular risk factors, age and other diseases. All MitraClip implantations were elective and procedural success was achieved in 110 patients (92.4%) with a similar distribution between the groups. There were no differences in procedural time and the number of implanted clips. The median follow-up was 22.6 months (IQR, 11.43-34.98 months). The primary combined endpoint occurred in the 41.6% of the global cohort, 57.5% in group 1 and 30.99% in group 2 (P=0.036). LVEF was associated to the main event in the multivariate analysis (HR 2.09, 95% CI: 1.12-3.89; P=0.02).
The MitraClip edge-to-edge technique is a safe and effective procedure for the treatment of FMR. In this study, patients with LVEF >30% treated with Mitraclip presented better clinical cardiovascular outcomes than those with a LVEF ≤30%. Regardless clinical outcomes, at the end of the follow-up, there was a sustained reduction in MR grades and an important improvement in NYHA functional class.
尽管接受了最佳药物治疗，但功能性二尖瓣反流（FMR）的预后仍较差。目前，关于手术治疗与经皮治疗存在公开辩论。本研究的主要目的是根据左心室射血分数（LVEF）评估接受MitraClip系统治疗的FMR患者的中期随访临床结果。
数据来自两个在经导管二尖瓣修复（TMVR）方面经验丰富的中心。两个中心所有符合相同纳入标准且连续接受严重FMR的TMVR病例均被前瞻性纳入本研究并进行随访。从基线程序开始，计划在3个月时进行定期随访，并进行临床和超声心动图评估，之后每年进行一次。
2015年10月至2019年10月，西班牙2个中心的119例FMR患者接受了MitraClip手术治疗并纳入本研究。平均年龄为73.8±8.9岁，32例患者（26.9%）为女性。39.5%的病例（47例）LVEF≤30%（第1组），60.5%（72例）LVEF>30%（第2组）。心血管危险因素、年龄和其他疾病的分布相似。所有MitraClip植入均为择期手术，110例患者（92.4%）手术成功，两组分布相似。手术时间和植入夹子数量无差异。中位随访时间为22.6个月（四分位间距，11.43 - 34.98个月）。主要联合终点在全球队列中的发生率为41.6%，第1组为57.5%，第2组为30.99%（P = 0.036）。多变量分析中LVEF与主要事件相关（HR 2.09，95% CI：1.12 - 3.89；P = 0.02）。
MitraClip缘对缘技术是治疗FMR的一种安全有效的方法。在本研究中，接受Mitraclip治疗的LVEF>30%的患者比LVEF≤30%的患者具有更好的临床心血管结局。无论临床结果如何，随访结束时MR分级持续降低，NYHA功能分级有重要改善。
