DUGi

Redefining valve choice in young adults: non-inferiority comparison of inspiris resilia and mechanical protheses in long-term reintervention

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BACKGROUND: Aortic valve replacement in patients aged 50-65 years presents a clinical dilemma regarding prosthesis selection. Current guidelines acknowledge substantial uncertainty in this age range, with both bioprosthetic and mechanical valves considered reasonable options. The INSPIRIS RESILIA bioprosthetic valve incorporates tissue preservation technology designed to enhance durability, but long-term comparative data against mechanical valves in middle-aged patients are lacking. OBJECTIVE: To determine whether the INSPIRIS RESILIA bioprosthetic valve is non-inferior to mechanical valves with respect to aortic valve reintervention at 10 years in patients aged 50-65 years undergoing surgical aortic valve replacement, with a pre-specified non-inferiority margin of 5% absolute risk difference. STUDY DESIGN AND PARTICIPANTS: This is a prospective, multicentre, longitudinal, non-inferiority cohort study conducted across six tertiary cardiac surgery centres in Catalonia, Spain. A total of 508 patients (254 per group) aged 50-65 years with severe symptomatic aortic stenosis or regurgitation requiring surgical valve replacement will be enrolled and followed for 10 years, with planned extensions to 15 and 20 years. METHODS: Patients will be assigned to receive either the INSPIRIS RESILIA bioprosthetic valve or a contemporary mechanical valve based on multidisciplinary Heart Team decision and patient preference. The primary endpoint is aortic valve reintervention at 10 years. Secondary endpoints include major adverse prosthesis-related events (composite of mortality, myocardial infarction, stroke, heart failure hospitalization, bleeding, endocarditis), patient-centred outcomes (quality of life, functional capacity, frailty), and hemodynamic performance with structural valve deterioration assessed by serial echocardiography. All endpoints will be adjudicated by an independent clinical events committee using standardized VARC-3 definitions. Statistical analysis will follow intention-as-treat principles, with propensity score methods to control for confounding

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