One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.
One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.
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DOI：
10.1093/eurheartj/ehv627
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发表时间：
2016-02-21
影响因子：
39.3
通讯作者：
Schillinger W
中科院分区：
文献类型：
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作者：
Puls M;Lubos E;Boekstegers P;von Bardeleben RS;Ouarrak T;Butter C;Zuern CS;Bekeredjian R;Sievert H;Nickenig G;Eggebrecht H;Senges J;Schillinger W
在德国建立了经导管二尖瓣介入治疗（TRAMI）登记研究，以评估基于导管的二尖瓣介入技术的安全性和有效性，并前瞻性入组了828例二尖瓣夹系统患者（中位年龄76岁，中位对数。EuroSCORE I 20.0%）。我们在本MitraClip队列中介绍了1年结局-这是迄今为止发表的最大的结果。749例患者（90.5%）可接受1年随访，并纳入以下分析。记录死亡率、主要不良心血管事件发生率和纽约心脏协会（NYHA）分级。采用逐步向前选择的考克斯回归模型，通过多变量分析确定1年死亡率的预测因素。1年病死率为20.3%。1年时，63.3%的TRAMI患者属于NYHA心功能I级或II级（基线时为11.0%），自评健康状况（EuroQuol视觉模拟量表）也显著改善10分。重要的是，在二尖瓣夹系统植入后，很大比例的患者恢复了完全的自我护理独立性（基线时独立性为74.0% vs. 58.6%，P = 0.005）。1年死亡率的预测因子为NYHA IV级（风险比，HR 1.62，P = 0.02），贫血（HR 2.44，P = 0.02），既往主动脉瓣介入治疗（HR 2.12，P = 0.002），血清肌酐≥1.5 mg/dL（HR 1.77，P = 0.002），外周动脉疾病（HR 2.12，P = 0.0003），左室射血分数<30%（HR 1.58，P = 0.01），重度三尖瓣返流（HR 1.84，P = 0.003）和手术失败（定义为术者报告的失败、转为手术、金属夹放置失败或术后残留重度二尖瓣返流）（HR 4.36，P < 0.0001）。12个月后，使用二尖瓣夹系统治疗严重二尖瓣返流导致高比例的TRAMI患者的临床显著改善。在TRAMI队列中，手术成功失败显示出预测1年死亡率的最高风险比。
The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort—which is the largest published to date. Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.