Inspiris Resilia Valve Classification
The Inspiris Resilia valve is a bioprosthetic (tissue) valve, not a mechanical valve. 1
Valve Composition and Structure
The Inspiris Resilia is constructed from bovine pericardial tissue that has undergone a novel sterilization and preservation process called "Resilia tissue technology." 1, 2 This bioprosthetic valve consists of:
- Tissue leaflets made from treated bovine pericardium designed to mimic native valve function 1
- An expandable stent frame that facilitates potential future valve-in-valve (ViV) procedures 1, 3
- Novel anti-calcification treatment through the Resilia tissue preservation process, which differs from traditional bioprosthetic valves 1, 2
Key Distinguishing Features from Mechanical Valves
Bioprosthetic valves like the Inspiris Resilia do not require lifelong anticoagulation with warfarin, which is mandatory for all mechanical valves. 4 This represents a fundamental clinical difference:
- Mechanical valves carry approximately 0.5% annual risk of serious thromboembolism and similar risk of major hemorrhage with warfarin therapy 4
- Bioprosthetic valves avoid these bleeding risks but have limited durability compared to mechanical valves 4
Clinical Performance Data
The Inspiris Resilia has demonstrated good early-to-intermediate outcomes:
- Five-year data show no structural valve deterioration events, with mean gradients of 14.8 ± 7.6 mmHg and effective orifice area of 1.4 ± 0.5 cm² 2
- Early mortality was 2.3% at 30 days, with late all-cause mortality of 3.2% per patient-years 2
- The valve shows superior hemodynamics compared to its predecessor (Carpentier-Edwards Magna Ease), with lower transprosthetic pressure gradients (9 mmHg vs 12 mmHg) 5
Important Clinical Caveat
The Inspiris Resilia has shown poor early durability when implanted in the native right ventricular outflow tract (pulmonary position), with only 59% freedom from valve failure at 18 months in this position. 6 This appears related to incompatibility between the valve's rigid design and the compliant pulmonary root. 6 The valve performs significantly better in the aortic position or as a conduit replacement. 6
Expandable Design for Future Interventions
A unique feature of the Inspiris Resilia is its expandable stent design that facilitates transcatheter valve-in-valve procedures when the bioprosthesis eventually degenerates. 1, 3 In documented cases, the internal diameter expanded from 22.2 mm to 24.2 mm during TAV-in-SAV procedures, allowing successful transcatheter valve deployment. 3