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经皮二尖瓣瓣环成形术(MitraClip)治疗的患者的发病率和院内安全结局:包括 13575 例植入物的 5 年德国全国患者样本。

Incidence and in-hospital safety outcomes of patients undergoing percutaneous mitral valve edge-to-edge repair using MitraClip: five-year German national patient sample including 13,575 implants.

机构信息

Heart Valve Center Mainz, Center of Cardiology, Cardiology I, University Medical Center, Mainz, Germany.

出版信息

EuroIntervention. 2019 Apr 20;14(17):1725-1732. doi: 10.4244/EIJ-D-18-00961.

DOI:10.4244/EIJ-D-18-00961
PMID:30666965
Abstract

AIMS

The number of percutaneous edge-to-edge mitral regurgitation valve repairs with MitraClip implantation has increased during recent years. Published studies showed promising safety outcomes in relatively small cohorts, while results from large samples are sparse. Thus, we aimed to evaluate trends and safety outcomes in the German nationwide in-patient sample.

METHODS AND RESULTS

We analysed data on patients' characteristics and in-hospital safety outcomes for all percutaneous mitral valve repairs using the MitraClip technique in Germany between 2011 and 2015. Overall, 13,575 in-patients were included. The annual number of MitraClip implantations increased from 815 in 2011 to 4,432 in 2015 (β 1.00 [95% CI: 0.96-1.03], p<0.001). The in-hospital mortality (p=0.193) and major adverse cardiac and cerebrovascular events (MACCE) (p=0.183) rate remained unchanged. Important independent predictors of in-hospital mortality were heart failure (OR 1.91 [95% CI: 1.43-2.54], p<0.001), transfusion of erythrocyte concentrates (OR 9.04 [95% CI: 7.45-10.96], p<0.001), stroke (OR 6.82 [95% CI: 4.34-10.72], p<0.001), endocarditis (OR 19.52 [95% CI: 9.04-42.14], p<0.001), pulmonary embolism (OR 7.61 [95% CI: 3.44-16.81], p<0.001), pericardial tamponade (OR 14.08 [95% CI: 7.09-27.96], p<0.001) and pericardial effusion (OR 2.59 [95% CI: 1.66-4.04], p<0.001).

CONCLUSIONS

MitraClip implantations increased markedly (5.4-fold) between 2011 and 2015, with a constant in-hospital mortality and MACCE rate. Our data indicate that edge-to-edge mitral valve repair using the MitraClip technique has acceptable in-hospital safety outcomes in a real-world scenario.

摘要

目的

近年来,经皮二尖瓣缘对缘修复术联合 MitraClip 植入术的数量不断增加。已发表的研究显示,在相对较小的队列中,该治疗方法具有良好的安全性结果,但大规模样本的结果仍较为匮乏。因此,我们旨在评估德国全国住院患者样本中的治疗趋势和安全性结果。

方法和结果

我们分析了 2011 年至 2015 年期间德国使用 MitraClip 技术进行的所有经皮二尖瓣修复术患者的特征和住院安全性结局数据。共纳入 13575 例住院患者。MitraClip 植入的年数量从 2011 年的 815 例增加到 2015 年的 4432 例(β 1.00 [95% CI:0.96-1.03],p<0.001)。住院死亡率(p=0.193)和主要不良心脏和脑血管事件(MACCE)(p=0.183)发生率保持不变。住院死亡率的重要独立预测因素包括心力衰竭(OR 1.91 [95% CI:1.43-2.54],p<0.001)、红细胞浓缩物输注(OR 9.04 [95% CI:7.45-10.96],p<0.001)、中风(OR 6.82 [95% CI:4.34-10.72],p<0.001)、心内膜炎(OR 19.52 [95% CI:9.04-42.14],p<0.001)、肺栓塞(OR 7.61 [95% CI:3.44-16.81],p<0.001)、心包填塞(OR 14.08 [95% CI:7.09-27.96],p<0.001)和心包积液(OR 2.59 [95% CI:1.66-4.04],p<0.001)。

结论

2011 年至 2015 年间,MitraClip 植入术的数量显著增加(增加了 5.4 倍),而住院死亡率和 MACCE 率保持不变。我们的数据表明,在真实世界环境中,使用 MitraClip 技术进行二尖瓣缘对缘修复术具有可接受的住院安全性结果。

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