Universitätsklinikum Bonn, Sigmund-Freud-Strasse 25, 53127 Bonn, Germany.
Center for Heart- and Vascular Medicine Mediapark, Mediapark, Köln, Germany.
Cardiol J. 2021;28(2):215-222. doi: 10.5603/CJ.a2019.0071. Epub 2019 Jul 17.
The MitraClip procedure was established as a therapeutic alternative to mitral valve surgery for symptomatic patients with severe mitral regurgitation (MR) at prohibitive surgical risk. In this study, the aim was to evaluate 5-year outcomes after MitraClip.
Consecutive patients undergoing the MitraClip system were prospectively included. All patients underwent clinical follow-up and transthoracic echocardiography.
Two hundred sixty-five patients (age: 81.4 ± 8.1 years, 46.7% female, logistic EuroSCORE: 19.7 ± 16.7%) with symptomatic MR (60.5% secondary MR [sMR]). Although high procedural success of 91.3% was found, patients with primary MR (pMR) had a higher rate of procedural failure (sMR: 3.1%, pMR: 8.6%; p = 0.04). Five years after the MitraClip procedure, the majority of patients presented with reduced symptoms and improved functional capacity (functional NYHA class: p = 0.0001; 6 minutes walking test: p = 0.04). Sustained MR reduction (≤ grade 2) was found in 74% of patients, and right ventricular (RV) function was significantly increased (p = 0.03). Systolic pulmonary artery pressure (sPAP) was significantly reduced during follow-up only in sMR patients (p = 0.05, p = 0.3). Despite a pronounced clinical and echocardiographical amelioration and low interventional failure, 5-year mortality was significantly higher in patients with sMR (p = 0.05). The baseline level of creatinine (HR: 0.695), sPAP (HR: 0.96) and mean mitral valve gradient (MVG) (HR: 0.82) were found to be independent predictors for poor functional outcome and mortality.
Transcatheter mitral valve repair with the MitraClip system showed low complication rates and sustained MR reduction with improved RV function and sPAP 5 years after the procedure was found in all patients, predominantly in patients with sMR. Despite pronounced functional amelioration with low procedure failure, sMR patients had higher 5-year mortality and worse outcomes. Baseline creatinine, MVG, and sPAP were found to be independent predictors of poor functional outcomes and 5-year mortality.
对于因手术风险高而不能进行二尖瓣手术的有症状的重度二尖瓣反流（MR）患者，MitraClip 术式已被确立为一种治疗选择。本研究旨在评估 MitraClip 术后 5 年的结果。
连续入选接受 MitraClip 系统治疗的患者。所有患者均接受临床随访和经胸超声心动图检查。
265 例患者（年龄：81.4±8.1 岁，46.7%为女性，逻辑 EuroSCORE：19.7±16.7%）因有症状性 MR（60.5%为继发性 MR [sMR]）而接受了治疗。尽管手术成功率高达 91.3%，但原发性 MR（pMR）患者的手术失败率更高（sMR：3.1%，pMR：8.6%；p=0.04）。MitraClip 术后 5 年，大多数患者的症状减轻，功能能力改善（功能性纽约心脏协会分级：p=0.0001；6 分钟步行试验：p=0.04）。74%的患者持续存在 MR 减轻（≤2 级），右心室（RV）功能显著增加（p=0.03）。仅 sMR 患者的收缩期肺动脉压（sPAP）在随访期间显著降低（p=0.05，p=0.3）。尽管临床和超声心动图改善明显，介入治疗失败率低，但 sMR 患者的 5 年死亡率仍显著升高（p=0.05）。基础肌酐（HR：0.695）、sPAP（HR：0.96）和平均二尖瓣瓣口压差（MVG）（HR：0.82）是功能结局和死亡率不良的独立预测因素。
经导管二尖瓣修复术采用 MitraClip 系统治疗，所有患者术后 5 年均显示出较低的并发症发生率和持续的 MR 减轻，RV 功能改善，sPAP 降低，主要见于 sMR 患者。尽管功能明显改善，介入治疗失败率低，但 sMR 患者 5 年死亡率更高，预后更差。基础肌酐、MVG 和 sPAP 是功能结局和 5 年死亡率的独立预测因素。
