Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial

Abstract

IntroductionIn non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm.Methods and analysisRoss for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 18–60 years undergoing AVR, comparing the Ross procedure versus one of the alternative approaches (mechanical vs stented or stentless bioprosthesis). The feasibility objectives will be assessed after randomising 60 patients; we will then make a decision regarding whether to expand the trial with the current protocol. We will ultimately examine the impact of the Ross procedure as compared with conventional AVR in non-elderly adults on survival free of valve-related life-threatening complications (major bleeding, systemic thromboembolism, valve thrombosis and valve reoperation) over the duration of follow-up. The objectives of the pilot trial will be analysed using descriptive statistics. In the full trial, the intention-to-treat principle will guide all primary analyses. A time-to-event analysis will be performed and Kaplan-Meier survival curves with comparison between groups using a log rank test will be presented.Ethics and disseminationREVIVAL will answer whether non-elderly adults benefit from the Ross procedure over conventional valve replacement. The final results at major meetings, journals, regional seminars, hospital rounds and via the Reducing Global Perioperative Risk Multimedia Resource Centre.Trial registration numberClinicalTrials.gov Identifier: NCT03798782Protocol versionJanuary 29, 2019 (Final Version 1.0)

Formal consensus study on surgery to replace the aortic valve in adults aged 18–60 years

“…There is only one important trial of Ross and the comparison arm was another biological root replacement in the form of homograft, against which Ross was superior 20. A recent attempt to examine Ross versus conventional AVR in a multicentre prospective trial was abandoned due to the pilot study failing to recruit to target during the pandemic 14. Large retrospective studies2–5 10 12 21 22 show a clear superiority of the Ross procedure against conventional AVR in adults aged 18–60 years.…”

“…Randomised controlled trials (RCTs) on AVR are difficult to conduct because randomisation removes patient choice to a great extent and the outcome curves separate late in time. In addition, in younger patients, outcome curves separate much later 10 14. We therefore conducted a formal consensus study using RAND Corporation/University of California Los Angeles (RAND/UCLA) methodology,15 which involves using the best available evidence and expert opinion to make recommendations about what type of intervention should be offered and for whom.…”

Partial Heart Transplantation in Adult Cardiac Surgery

“…Patients who undergo this operation are free from anticoagulation therapy and its negative consequences because there is a low risk for thromboembolism, and survival rates are similar to those of the general population. 2,7,[21][22][23] Additionally, there is a lower risk of endocarditis with the Ross operation than there is with mechanical and bioprosthetic valves. 7 However, a major downfall of the Ross operation is its limited durability.…”

“…2,7,[21][22][23] Additionally, there is a lower risk of endocarditis with the Ross operation than there is with mechanical and bioprosthetic valves. 7 However, a major downfall of the Ross operation is its limited durability. 2,[21][22][23] Many Ross operation patients require reoperation at some point in their lifetime, and in many cases, this occurs within 10 years after surgery.…”

“…[2][3][4][5][6] In the United States alone, 85,000 patients undergo aortic valve replacement each year. 7 The most common treatment of irreparable aortic valve dysfunction in adults is surgical replacement using either a mechanical valve or a bioprosthetic valve. 3,5 Despite intensive research into patient outcomes after different procedures, the ideal aortic valve replacement is unknown.…”