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

Background Aortic valve stenosis is the primary valvular lesion that most commonly necessitates surgical or transcatheter intervention in both Europe and North America. This is due to the ageing population. There are mechanical interventions for aortic valve stenosis, but there is a lack of data on the comparative efficacy of surgical aortic valve replacement (SAVR), sutureless aortic valves (SuAVR) and transcatheter aortic valve replacement (TAVR). This study compares the effectiveness and clinical outcomes of SAVR and TAVR. Both are used to treat severe aortic stenosis, to determine the relative merits of each. Methods The SuAVR-TAVR trial is the result of a collaboration between three cardiac surgery centres across two European countries. The investigation has been designed to compare the long-term outcomes of TAVR with SuAVR for aortic stenosis in patients considered to be at risk of severe valve obstruction. Patients who have undergone mechanical intervention for aortic stenosis since January 2015 are eligible to enrol, with a deadline of the end of May 2025. The investigative team will assess the difference between replacement procedures for both the standard surgical approach and the transcatheter percutaneous approach. The primary clinical outcome will be structural valve deterioration at 10 years. The study will also assess all-cause mortality, functional status, hospitalisation, neurocognition, physiological measures (echocardiographic assessment), adverse events, and reoperation. Discussion The hypothesis is that the nature of the trials will assess the long-term outcomes of surgical procedures for aortic stenosis, using either the SuAVR or TAVR methods. The rate of structural valve deterioration in both cohorts is determined by a number of factors, including institutional volume and surgical experience. Each participating centre must have an aortic valve programme that facilitates adequate follow-up and management of late aortic events following replacement surgery for aortic stenosis. The collation of data will furnish valuable insight into the comparative effectiveness of various surgical approaches in the domain of aortic valve surgery and TAVR. This analysis will contribute to the formulation of robust international guidelines. Trial Registration: Clinical Trial Gov. Com. ID: NCT05261204 approval date March 2025; IRB. ID: 2022011057 approval date 17 March 2022