Pulmonary Autograft, Ross Operation, Structural Valve Degeneration
Conditions
Brief summary
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
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.
Interventions
PROCEDURERoss Operation
Replacement of the aortic valve by means of pulmonary artery autograft
Sponsors
Golden Jubilee National Hospital
University of Bern
Pontifícia Universidade Católica do Paraná
Ospedale San Donato
Groupe Hospitalier Pitie-Salpetriere
Royal Children's Hospital
Centre Cardiologique du Nord
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
1 Days to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergone (or undergoing) to Ross Operation
Exclusion criteria
* Patients requiring combined cardiac surgical procedure in association to Ross Operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life-3 | from inclusion to 20 years follow-up | Quality of life as measured withEQ 5D score |
| Survival | from inclusion to 20 years follow-up | Death from any cause |
| Cardiac Death | from inclusion to 20 years follow-up | Mortality due to cardiac cause |
| Reoperation for Pulmonary Autograft Failure | from inclusion to 20 years follow-up | Need for reoperation due to failure of pulmonary autograft or valve degeneration |
| Stroke | from inclusion to 20 years follow-up | neurological stroke with impairment |
| Rehospitalization for heart failure | from inclusion to 20 years follow-up | Readmission to hospital for heart failure |
| Quality of life-1 | from inclusion to 20 years follow-up | Quality of life as measured with SF-12 |
| Quality of life-2 | from inclusion to 20 years follow-up | Quality of life as measured with Minnesota living with heart failure questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | postoperative period (1-30 days) | Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure |
Countries
France
Outcome results
None listed