Prospective Long-Term Outcomes of a Standardized Ross Procedure (ROSS)

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.

Study Overview

• Status: Recruiting
• Conditions: Ross Procedure (Pulmonary Autograft Replacement)

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.

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

• Study Contact: Name: Rincy Rajan; Phone Number: 4698144981; Email: Rincy.Rajan@BSWHealth.org

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Recruiting
      • Baylor Scott and White Heart Hospital
      • Contact: Sarah Hale; Phone Number: 4698144845; Email: sarah.hale@bswhealth.org
      • Principal Investigator: William Brinkman, MD
      • Contact: Rincy Rajan; Phone Number: 469-814-4981; Email: Rincy.Rajan@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the patient at 1-, 5- and 10-year intervals	To establish a standardized Ross procedure protocol to prospectively evaluate the impact patient characteristics, operative techniques and perioperative events have on long term outcomes. The primary endpoint of this study will be survival at 1-, 5-, and 10-year intervals.	1 year, 5 year and 10 year

Secondary Outcome Measures

Outcome Measure	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	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
Anticoagulant usage	will be measured as Yes/No	1 year after the procedure
Bleeding events	Measured as Yes/No	1 year after the procedure
Post operative infection	Measured as Yes/No	1 year after the procedure

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

General Publications

• 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. Erratum In: Circulation. 2021 Feb 2;143(5):e229. Circulation. 2023 Aug 22;148(8):e8. Circulation. 2023 Nov 14;148(20):e185.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 023-286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No