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

NCT05714228 | Completed

• 1 other identifier: VEOT-MVR
• Study Type: observational
• Target: 2,645
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Surgical repair

Procedure: Surgical Mitral Valve Repair

Transcatheter repair

Procedure: Transcatheter Mitral Valve Repair

Interventions

Surgical Mitral Valve Repair PROCEDURE

Mitral valve is repaired using open surgical approach

Surgical repair

Transcatheter Mitral Valve Repair PROCEDURE

Mitral valve is repaired using Mitraclip transcatheter device

Transcatheter repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent surgical or transcatheter mitral valve repair

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: June 10, 2020
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)