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

Michele De Bonis

Status: Completed

Conditions: Mitral Valve Regurgitation

Treatments: Procedure: Transcatheter Mitral Valve Repair; Procedure: Surgical Mitral Valve Repair

Study type: Observational

Funder types: Other

Identifiers

NCT05714228

VEOT-MVR

Details and patient eligibility

About

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.

Enrollment: 2,645 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

2,645 participants in 2 patient groups

Surgical repair

Treatment:

Procedure: Surgical Mitral Valve Repair

Transcatheter repair

Treatment:

Procedure: Transcatheter Mitral Valve Repair