Ross Operation Failure Database

Study Overview
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Brief Summary
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A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure phenomenon and feed more complex biomechanical models to be integrated with clinical imaging with the final aim to predict Ross operation's outcomes and define strategies to ameliorate its results.

Detailed Description
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On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a large multi centric registry in order to obtain data on the preoperative intraoperative management of these patients and on the postoperative long-term results of this procedure. Patients data will be entered by the investigators in an electronic database Preoperative variables will include age, comorbidities, functional status, indications for surgery, morphology of the aortic valve Additional morphological data and aortic and pulmonary measurements will be taken intraoperatively Postoperative follow-up data including both clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac events, stroke, infection) and morphological measurements by means of CT scan or echocardiography, will be inserted. Quality of life by means of SF12 and Minnesota living with heart failure questionnaire and EQ-5D score will be collected. Follow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.

Official Title
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Database on Ross Operation Failures and Outcomes

Conditions
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Ross Operation, Pulmonary Autograft, Structural Valve Degeneration

Intervention / Treatment
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* Procedure: Ross Operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergone (or undergoing) to Ross Operation Exclusion Criteria: Patients requiring combined cardiac surgical procedure in association to Ross Operation

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ross Operation<br>Patients undergone Ross Operation. Patients requiring reoperation | Procedure: Ross Operation<br>* Replacement of the aortic valve by means of pulmonary artery autograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Death from any cause | from inclusion to 20 years follow-up | 
| Cardiac Death | Mortality due to cardiac cause | from inclusion to 20 years follow-up | 
| Reoperation for Pulmonary Autograft Failure | Need for reoperation due to failure of pulmonary autograft or valve degeneration | from inclusion to 20 years follow-up | 
| Stroke | neurological stroke with impairment | from inclusion to 20 years follow-up | 
| Rehospitalization for heart failure | Readmission to hospital for heart failure | from inclusion to 20 years follow-up | 
| Quality of life-1 | Quality of life as measured with SF-12 | from inclusion to 20 years follow-up | 
| Quality of life-2 | Quality of life as measured with Minnesota living with heart failure questionnaire | from inclusion to 20 years follow-up | 
| Quality of life-3 | Quality of life as measured withEQ 5D score | from inclusion to 20 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure | postoperative period (1-30 days) |