Study protocol for an international prospective non-randomized trial evaluating the long term outcomes of Sutureless Aortic Valve Replacement Versus Stented Aortic Valve Replacement for Aortic-Valve Stenosis in Patients at Risk to Severe Valve Obstruction: The SAVI-AVR trial

Abstract Background Aortic valve (AV) stenosis (AVS) constitutes the most common major primary valvular pathology requiring surgical or transcatheter intervention in Europe and North America. This condition is increasing in prevalence at a rapid rate, consequent to the ageing population. There exists a range of mechanical interventions for the treatment of aortic valve stenosis (AVS), but there is currently a lack of robust evidence comparing the effectiveness of surgical aortic valve replacement (SAVR) with conventional stented xenograft aortic valve (St-AV) or sutureless aortic valves (Su-AV). The objective of the present study is to make a comparison between the effectiveness and clinical outcomes of SAVR using St-AV or Su-AV in patients with AVS. Methods The conception of the SAVI-AVR trial (NCT:05261204; IRB: 2022011057) is the result of a collaboration between three cardiac surgery centres across two European countries. The SAVI-AVR registry will enrol consecutive patients who have undergone surgical interventions for AVS using sutureless aortic valve implant (Su-AVI) and stented aortic valve replacement (St-AVR). The study period will span from January 2015 to December 2025, encompassing a total of patients who will be enrolled. The primary objective of the research is to assess the differences between the standard surgical approaches Su-AVI and St-AVR. The primary clinical outcome under consideration will be operative mortality and survival. That is to say, the mortality rates recorded within a given time period after the procedure has been completed at 10 years. The present study will also encompass a number of secondary endpoints, including time to explant for structural valve degeneration, occurrence of stroke, necessity for reoperation, readmission due to any cause, and emergence of new-onset atrial fibrillation within 30 days, 1 year, 5 years and 10 years. Additionally, the study will examine the length of primary hospitalization and the presence of poor treatment outcomes. Discussion The hypothesis that the nature of the trials will serve to minimise bias related to institutional volume and surgical experience is postulated. Participating centres are obliged to possess an aortic valve programme, with the capability to ensure adequate postoperative follow-up and management of late complications arising from aortic valve replacement surgeries for AVS. The data that will be collected will provide valuable insight into the comparative effectiveness of various surgical approaches, both standard and advanced, in aortic valve replacement surgery. This will be achieved using Su-AVI and St-AVR. It is further expected that this comprehensive analysis will contribute significantly to the development of robust international guidelines. Trial Registration: Clinical Trial Gov. Com. ID: NCT05261204 IRB. ID: 2022011057