Aortic Valve Disease
Conditions
Brief summary
This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
Detailed description
The optimal approach for aortic valve replacement in adults with an anticipated life expectancy greater than fifteen years remains unclear. Mechanical and bioprosthetic valves, while often used, have specific downfalls. Mechanical valves require lifelong anticoagulation usage and bioprosthetic tissue valves have a limited lifespan. The Ross procedure (pulmonary autograft replacement) is the only operation which replaces the diseased aortic valve with a living substitute. Concerns over increased surgical risk and potential long-term failure have shown decreased use of this procedure. However, recent publications from expert centers have shown, in the current era the Ross procedure can be reliably performed safely and reproducibly in selected patients. This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.
Interventions
None listed
Sponsors
Baylor Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.
Exclusion criteria
* Less than 18 years of age * Presence of active malignancy * Pregnant at the time of surgery * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of the patient | 1 year, 5 year and 10 year | The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-hospitalization | 1 year after the procedure | To identify the safety of the Ross procedure measured in percentage |
| Rate of peri operative morbidity | 1 year after the procedure | Will be measured in percentage |
| Rate of re-operation | 1 year after the procedure | Will be measured in percentage |
| Rate of re-intervention | 1 year after the procedure | will be measured in percentage |
| NYHA status | 1 year after the procedure | Will be measured as NYHA class I, II,III, IV |
| Rate of Patients with Anticoagulant Usage | 1 year after the procedure | Rate of Patients with Anticoagulant Usage 1 year after procedure. |
| Rate of Bleeding Events | 1 year after the procedure | Rate of Bleeding Events |
| Rate of Post Operative Infection | 1 year after the procedure | Rate of Post Operative Infection |
Countries
United States
Contacts
CONTACTBonnie Ostergren
Outcome results
None listed