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

Completed

• Conditions: Mitral Valve Regurgitation
• Interventions: Procedure: Transcatheter Mitral Valve Repair; Procedure: Surgical Mitral Valve Repair

• Registration Number: NCT05714228
• Lead Sponsor: Michele De Bonis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-10
• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2645

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcatheter repair	Transcatheter Mitral Valve Repair	-
Surgical repair	Surgical Mitral Valve Repair	-

Primary Outcome Measures

Name	Time	Method
Euroscore II predictive power for surgery	30 days postop
Euroscore II overall predictive power	30 days postop
Euroscore II predictive power for transcatheter	30 days postop

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy