Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
Study Details
Study Description
Brief Summary
The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery
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However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair.
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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
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Institutional database retrospective review for surgical mitral repair and MitraClip implantation.
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Time frame: January 2012-December 2019
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2793 patients identified; Euroscore II 1.3% [0.6%-2%]
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Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure.
Statistical analysis
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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.
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The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point.
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ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surgical repair
|
Procedure: Surgical Mitral Valve Repair
Mitral valve is repaired using open surgical approach
|
| Transcatheter repair
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Procedure: Transcatheter Mitral Valve Repair
Mitral valve is repaired using Mitraclip transcatheter device
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.)
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Patients undergoing transcatheter mitral valve repair with MitraClip implantation
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Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019
Exclusion Criteria:
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Patients underwent mitral valve replacement with prosthesis
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Cardiac surgery patients not eligible for mitral valve surgery
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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.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Ospedale San Raffaele | Milan | Italy | 20132 |
Sponsors and Collaborators
- Michele De Bonis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VEOT-MVR