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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Procedure: Surgical Mitral Valve Repair
* Procedure: Transcatheter Mitral Valve Repair


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical repair<br> | Procedure: Surgical Mitral Valve Repair<br>* Mitral valve is repaired using open surgical approach<br>|
| Transcatheter repair<br> | Procedure: Transcatheter Mitral Valve Repair<br>* Mitral valve is repaired using Mitraclip transcatheter device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euroscore II overall predictive power |  | 30 days postop | 
| Euroscore II predictive power for surgery |  | 30 days postop | 
| Euroscore II predictive power for transcatheter |  | 30 days postop |