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

Mitral Valve Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714228
• Other study ID #: VEOT-MVR
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: June 10, 2020

Study information

• Verified date: January 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2645
• Est. completion date: June 10, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Procedure:
• Surgical Mitral Valve Repair
Mitral valve is repaired using open surgical approach
• Transcatheter Mitral Valve Repair
Mitral valve is repaired using Mitraclip transcatheter device

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Euroscore II overall predictive power		30 days postop
Primary	Euroscore II predictive power for surgery		30 days postop
Primary	Euroscore II predictive power for transcatheter		30 days postop