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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05714228
Enrollment
2645
Registered
2023-02-06
Start date
2020-06-10
Completion date
2020-06-10
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

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.

Interventions

Mitral valve is repaired using open surgical approach

Mitral valve is repaired using Mitraclip transcatheter device

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frame
Euroscore II overall predictive power30 days postop
Euroscore II predictive power for surgery30 days postop
Euroscore II predictive power for transcatheter30 days postop

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026