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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival of the patient | The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals. | 1 year, 5 year and 10 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of re-hospitalization | To identify the safety of the Ross procedure measured in percentage | 1 year after the procedure |
| Rate of peri operative morbidity | Will be measured in percentage |
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Inclusion Criteria:
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Eligible patients undergoing the Ross procedure at the four institutions of the NARC will be included in this study. The primary study center will be Baylor Scott and White The Heart Hospital. The other member institutions include: The University of Pennsylvania, The University of Washington, and Northwestern University. The investigators estimate to enroll around 20 subjects per year at each institution. This will total 80 subjects per year. The investigators plan to enroll patients for 10 years during the duration of the study. The investigators plan to follow patients for their lifetime.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ostergren | Contact | 4698144181 | Bonnie.Ostergren@BSWHealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Heart Hospital | Recruiting | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33060144 | Background | Catterall F, Ames PR, Isles C. Warfarin in patients with mechanical heart valves. BMJ. 2020 Oct 15;371:m3956. doi: 10.1136/bmj.m3956. No abstract available. | |
| 35210036 | Background | El-Hamamsy I, Toyoda N, Itagaki S, Stelzer P, Varghese R, Williams EE, Erogova N, Adams DH. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815. doi: 10.1016/j.jacc.2021.11.057. |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 year after the procedure |
| Rate of re-operation | Will be measured in percentage | 1 year after the procedure |
| Rate of re-intervention | will be measured in percentage | 1 year after the procedure |
| NYHA status | Will be measured as NYHA class I, II,III, IV | 1 year after the procedure |
| Rate of Patients with Anticoagulant Usage | Rate of Patients with Anticoagulant Usage 1 year after procedure. | 1 year after the procedure |
| Rate of Bleeding Events | Rate of Bleeding Events | 1 year after the procedure |
| Rate of Post Operative Infection | Rate of Post Operative Infection | 1 year after the procedure |
| 27496856 | Background | Mazine A, David TE, Rao V, Hickey EJ, Christie S, Manlhiot C, Ouzounian M. Long-Term Outcomes of the Ross Procedure Versus Mechanical Aortic Valve Replacement: Propensity-Matched Cohort Study. Circulation. 2016 Aug 23;134(8):576-85. doi: 10.1161/CIRCULATIONAHA.116.022800. Epub 2016 Aug 5. |
| 33332150 | Background | Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available. |