Validation of the EuroSCORE II in Open and Trans-catheter Mi... | Clinical Trial | StuddyBuddy@endsection Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
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Completed NCT05714228

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

Conditions: Mitral Valve Regurgitation

Sex: All
Ages: 18 Years – N/A
Enrollment: 2645
Sponsor: Michele De Bonis

Location: Italy

Summary

The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgeryHowever, 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.MethodsInstitutional database retrospective review for surgical mitral repair and MitraClip implantation.Time frame: January 2012-December 20192793 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 analysisReceiver 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.

Eligibility Criteria

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 implantationPatients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019Exclusion Criteria:Patients underwent mitral valve replacement with prosthesisCardiac surgery patients not eligible for mitral valve surgeryPatients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)

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Source: ClinicalTrials.gov (NCT05714228). StuddyBuddy aggregates publicly available trial information.