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经导管二尖瓣夹合术治疗后的长期结果、生存率和死亡率预测因素:德国经导管二尖瓣介入治疗(TRAMI)注册研究结果。

Long-term outcome, survival and predictors of mortality after MitraClip therapy: Results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry.

机构信息

Universitäres Herzzentrum Hamburg Eppendorf, Germany.

Universitätsmedizin Mainz, 2. Med. Klinik, Germany.

出版信息

Int J Cardiol. 2019 Feb 15;277:35-41. doi: 10.1016/j.ijcard.2018.08.023. Epub 2018 Aug 10.

Abstract

BACKGROUND

MitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce.

AIMS

The multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention.

METHODS AND RESULTS

Long-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50-70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time. Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality.

CONCLUSIONS

Long-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies.

摘要

背景

MitraClip 治疗在被认为不能手术的严重二尖瓣反流(MR)患者中越来越多地使用,但长期数据很少。

目的

多中心、独立于行业的德国经导管二尖瓣瓣膜介入治疗(TRAMI)注册研究包括接受 MitraClip 治疗的最大前瞻性入组患者队列。目前的分析重点是长期死亡率、心脏再入院和再介入。

方法和结果

TRAMI 注册研究的长期随访(中位时间 1037 天)可用于 20 个德国中心治疗的 722 名患者。纽约心脏协会(NYHA)功能分级(I/II 级长期:65%比 1 年随访:63.3%)和自我评估的健康状况(欧洲五维健康量表[EQ VAS]长期:60 [50-70]比 1 年随访:60 [50;70])随时间推移而保持改善。通过 Kaplan-Meier 方法估计的 1 年、2 年和 4 年的死亡率分别为 19.7%、31.9%和 53.1%,MR 病因无差异。多变量 Cox 回归分析确定了先前的主动脉瓣植入(风险比[HR] = 2.21;p < 0.0001)、NYHA 分级 IV(HR = 1.78;p < 0.001)、先前的心功能失代偿(HR = 1.63;p < 0.001)、肌酐 > 1.5 mg/dl(HR = 1.63;p < 0.0001)和左心室射血分数 < 30%(HR = 1.60;p < 0.001)是长期死亡率的最具预测性因素。

结论

TRAMI 注册研究的长期结果证实了持续的临床改善和低介入率。长期死亡率受心脏和非心脏合并症的强烈影响,两种 MR 病因的死亡率相似。

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