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临床试验/NCT05714228
NCT05714228已完成不适用

Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 2,645 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,645
试验地点
1
主要终点
Euroscore II predictive power for surgery

研究概览

简要总结

The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery

  • However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair.
  • The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation.

Methods

  • Institutional database retrospective review for surgical mitral repair and MitraClip implantation.
  • Time frame: January 2012-December 2019
  • 2793 patients identified; Euroscore II 1.3% [0.6%-2%]
  • Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure.

Statistical analysis

  • Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test.
  • The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point.
  • ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undewent mitral valve repair with an open surgical approach, also in association with concomitant procedures (for example, but not limited to, aortic valve replacement, tricuspid repair, etc.)
  • Patients undergoing transcatheter mitral valve repair with MitraClip implantation
  • Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019

排除标准

  • Patients underwent mitral valve replacement with prosthesis
  • Cardiac surgery patients not eligible for mitral valve surgery
  • Patients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)

结局指标

主要结局

Euroscore II predictive power for surgery

时间窗: 30 days postop

Euroscore II overall predictive power

时间窗: 30 days postop

Euroscore II predictive power for transcatheter

时间窗: 30 days postop

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

研究点 (1)

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