Lesevic Hasema, Karl Michael, Braun Daniel, Barthel Petra, Orban Martin, Pache Jürgen, Hadamitzky Martin, Mehilli Julinda, Stecher Lynne, Massberg Steffen, Ott Ilka, Schunkert Heribert, Kastrati Adnan, Sonne Carolin, Hausleiter Jörg
Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Am J Cardiol. 2017 Apr 15;119(8):1255-1261. doi: 10.1016/j.amjcard.2016.12.027. Epub 2017 Jan 25.
Numerous patients are treated with the MitraClip, although they do not fulfill the stringent inclusion criteria of the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) trials. The outcome of those patients is not well known. Therefore, we compared the long-term outcome after MitraClip treatment between patients who matched (group 1) and did not match (group 2) the EVEREST criteria. One hundred thirty-four consecutive patients were treated from September 2009 to July 2012: 59 patients (44%) in group 1 versus 75 patients (56%) in group 2. Investigated end points were acute procedural success (for group 1 vs 2: 97% vs 95%; p = 0.694), all-cause mortality (28% vs 27%; p = 0.656), reintervention (RI) rate (11% vs 37%; p = 0.010), and improvement in mitral regurgitation (MR) (-1.3 ± 1 vs -1.5 ± 1, p = 0.221) and in New York Heart Association functional class (-0.7 ± 1 vs -0.9 ± 0.8, p = 0.253) during the follow-up of 33 months (27.9 to 38.3). The morphologic extent of a flail leaflet was an independent predictor for RI. In conclusion, although the overall outcome was comparable between both groups, recurrent symptomatic MR with need for RI was higher in group 2, mainly because of complex valve pathologies: especially flail width >15 mm and gap ≥10 mm. Improvements in the interventional strategy are warranted for reducing the need for RI in patients with primary MR.
尽管许多患者不符合血管内缘对缘修复研究（EVEREST）试验严格的纳入标准，但仍接受了MitraClip治疗。这些患者的治疗结果尚不清楚。因此，我们比较了符合（第1组）和不符合（第2组）EVEREST标准的患者在接受MitraClip治疗后的长期结果。2009年9月至2012年7月期间，连续134例患者接受了治疗：第1组59例（44%），第2组75例（56%）。研究的终点包括急性手术成功率（第1组与第2组：97%对95%；p = 0.694）、全因死亡率（28%对27%；p = 0.656）、再次干预（RI）率（11%对37%；p = 0.010），以及在33个月（27.9至38.3个月）的随访期间二尖瓣反流（MR）的改善情况（-1.3±1对-1.5±1，p = 0.221）和纽约心脏协会功能分级的改善情况（-0.7±1对-0.9±0.8，p = 0.253）。连枷样瓣叶的形态学范围是RI的独立预测因素。总之，尽管两组的总体结果相当，但第2组中因复发性症状性MR而需要再次干预的比例更高，主要是由于复杂的瓣膜病变：尤其是连枷宽度>15 mm和间隙≥10 mm。有必要改进介入策略，以减少原发性MR患者再次干预的需求。
