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

January 27, 2023 updated by: Michele De Bonis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2645

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgical or transcatheter mitral valve repair

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical repair
Procedure: Surgical Mitral Valve Repair
Mitral valve is repaired using open surgical approach
Transcatheter repair
Procedure: Transcatheter Mitral Valve Repair
Mitral valve is repaired using Mitraclip transcatheter device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Euroscore II overall predictive power
Time Frame: 30 days postop
30 days postop
Euroscore II predictive power for surgery
Time Frame: 30 days postop
30 days postop
Euroscore II predictive power for transcatheter
Time Frame: 30 days postop
30 days postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michele De Bonis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2020

Primary Completion (ACTUAL)

June 10, 2020

Study Completion (ACTUAL)

June 10, 2020

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEOT-MVR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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