Clinical trial NCT06352671: Prospective Long-Term Outcomes of a Standardized Ross Procedure
Official title: Prospective Long-Term Outcomes of a Standardized Ross Procedure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ross Procedure (Pulmonary Autograft Replacement)
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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. We estimate to enroll around 20 subjects per year at each institution. This will total 80 subjects per year. We plan to enroll patients for 10 years during the duration of the study. We will plan to follow patients for their lifetime.

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. Furthermore, an increasing body of evidence suggests the Ross procedure is associated with better long-term outcomes compared with conventional aortic valve replacement (AVR) in young and middle-aged adults (jamc 2018,72:2761-77. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival of the patient at 1-, 5- and 10-year intervals
timeFrame: 1 year, 5 year and 10 year
Secondary outcomes:
measure: Rate of re-hospitalization
timeFrame: 1 year after the procedure
measure: Rate of peri operative morbidity
timeFrame: 1 year after the procedure
measure: Rate of re-operation
timeFrame: 1 year after the procedure
measure: Rate of re-intervention
timeFrame: 1 year after the procedure
measure: NYHA status
timeFrame: 1 year after the procedure
measure: Anticoagulant usage
timeFrame: 1 year after the procedure
measure: Bleeding events
timeFrame: 1 year after the procedure
measure: Post operative infection
timeFrame: 1 year after the procedure
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott and White Heart Hospital
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.