Department of Internal Medicine III, University of Heidelberg, Heidelberg, Germany.
Department of Cardiology and Pneumology, University of Göttingen, Göttingen, Germany.
Eur J Heart Fail. 2018 Mar;20(3):598-608. doi: 10.1002/ejhf.910. Epub 2017 Aug 18.
The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function.
Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients.
In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.
本研究旨在评估经皮二尖瓣修复术（MitralClip™ 装置）治疗严重左心室收缩功能障碍（左心室射血分数 <30%）患者的安全性和疗效。
在德国二尖瓣注册中心纳入的 777 例 MitraClip™ 植入患者中，我们确定了 256 例左心室收缩功能严重降低（左心室射血分数 <30%）的患者，这些患者成功进行了经皮二尖瓣修复术。比较了各组间的手术安全性、疗效和 1 年结果，这些组包括 241 例左心室射血分数保留（>50%）患者、280 例术前左心室射血分数 30-50%的患者。所有组均达到了较高的手术成功率、较低的围手术期并发症发生率和较低的出院时残余二尖瓣反流程度。住院死亡率低且各组之间相似。1 年后，死亡率分别为 24.2%（EF <30%）、17.3%（EF 30-50%）和 18.9%（EF >50%）。主要不良心脏或心血管事件发生率分别为 29.7%（EF <30%）、24.4%（EF 30-50%）和 23.5%（EF >50%）。手术失败是 EF <30%患者死亡的主要预测因素（风险比 10.38；95%CI 3.71-29.02）。所有组中大多数患者的临床症状均有改善。因此，69.5%的 EF <30%患者的纽约心脏协会功能分级提高了一个或多个级别。与射血分数保留的患者相比，这是一个显著更大的比例（EF >50%：56.8%；P < 0.05）。此外，基线时生活质量极差的严重心力衰竭患者明显改善。
在接受 MitraClip™ 治疗的严重左心室收缩功能障碍患者中，手术安全性、疗效和 1 年后的临床改善与射血分数保留的患者相当。
