The MITRIS RESILIA valve
Is built for superior haemodynamic performance compared with porcine valves1,2
A primary consideration when selecting a valve for your patient is optimal haemodynamic performance for their annulus size to minimise prosthesis-patient mismatch, yet manufacturers' inconsistent label sizing makes direct comparisons challenging.3
To address this, the International Organization for Standardization (ISO) 5840-2:2021 standard for surgical valve prostheses recommends that manufacturers provide a set of universal sizing parameters to facilitate comparison. From these, the effective orifice diameter (ID-EFFECTIVE) is the only dimension that indicates haemodynamic performance and is therefore key for valve comparison.3
Find out more about how ID-EFFECTIVE is calculated
A larger ID-EFFECTIVE will allow more blood flow to pass through the valve than a valve with a smaller ID-EFFECTIVE, under identical haemodynamic conditions.3 The ID-EFFECTIVE for the MITRIS RESILIA valve is larger across all sizes compared with the Abbott EpicTM Plus porcine valve.4,5
Across two head-to-head studies, the MITRIS RESILIA valve demonstrated improved haemodynamic performance compared to porcine valves.1,2*†
Watch Prof. Pibarot discuss addressing mitral prosthesis-patient mismatch through optimal valve haemodynamics and how the specific design features of the MITRIS RESILIA valve define its performance
The MITRIS RESILIA valve had the lowest peak/mean gradients and greatest surgical valve opening area vs Abbott EpicTM and Medtronic MosaicTM porcine valves*1
In a head-to-head study of three comparable bioprostheses implanted in pigs under controlled anatomical and haemodynamic conditions, a relationship was observed between the surgical valve opening area (SOA) and mitral peak/mean pressure gradients.1
Mitral peak/mean pressure gradient (mmHg)
Due to the small sample size, only descriptive data are presented with no further statistical analysis.
The MITRIS RESILIA valve demonstrated the lowest peak/mean gradients, likely due to its non-tapered frame design and the largest SOA.1
In contrast, the porcine valves exhibited higher gradients. Abbott’s EpicTM porcine valve, with the smallest SOA, most tapered frame, and narrowest internal dimensions, had the highest gradients, while Medtronic MosaicTM porcine valve’s asymmetry and smaller SOA may have led to increased turbulence and higher gradients.1
The MITRIS RESILIA valve is built on the proven haemodynamic performance of the Carpentier-Edwards PERIMOUNT valve platform with RESILIA tissue‡§6
The COMMENCE mitral trial showed clinically stable mean pressure gradients and effective orifice areas (EOAs) through to 5-year follow-up after mitral valve replacement (MVR) with the Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve featuring RESILIA tissue.6
Adapted from Heimansohn DA, et al. 2023.6
*A head-to-head study evaluating three mitral bioprostheses of comparable measured internal diameters implanted in 12 Yorkshire pigs with similar-sized cardiac anatomy (27 mm Abbott EpicTM mitral valve [n=4]; 27 mm Medtronic MosaicTM mitral valve [n=4]; 25 mm MITRIS RESILIA valve [n=4]) via thoracotomy on cardiopulmonary bypass (CPB). After CPB, epicardial echocardiographic measurements were performed to assess haemodynamic function, followed by post-operative gated contrast CT. To ensure comparable anatomical and haemodynamic study conditions, pigs with a >6% anatomical variation were excluded from the study.1
†The 27 mm MITRIS RESILIA valve (n=3) was compared with the 29 mm Abbott EpicTM Plus (n=3) in vitro in a double activation left heart duplicator system with anatomically shaped, deformable silicone moldings of the left heart cavities and aorta. Valves were tested under standardised haemodynamic conditions (heart rate: 70 and 120 bpm, mean aortic pressure: 100 and 160 mmHg, stroke volume: 30, 70, and 100 mL). Mean transprosthetic gradient (mTPG) and EOA were measured via continuous-wave Doppler.2
‡The COMMENCE mitral trial was a prospective, multicentre, single-arm study across 17 US and Canadian centres, evaluating the Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve (Model 11000M) with RESILIA tissue. It included 82 MVR patients (with/without coronary artery bypass graft), with 54 completing 5-year follow-up. Median patient age was 70 years (IQR 13), 41.5% male, 35% NYHA II, 42% NYHA III. Valve sizes 27 or 29 mm were implanted in 65.9%. The median (IQR) follow-up time was 5.1 (1.4) years, with a total of 374.2 patient-years in aggregate.6
§Clinical data on surgical aortic valves with RESILIA tissue up to 7-year follow-up have been published, with additional follow-up to 10 years in progress.7
Abbreviations
CPB, cardiopulmonary bypass; CT, computed tomography; EOA, effective orifice area; IQR, interquartile range; ISO, International Organization for Standardisation; mTPG, mean transprosthetic gradient; MVR, mitral valve replacement; NYHA, New York Heart Association; SOA, surgical opening area; US, United States.
References
- Wang DD, et al. J Card Surg. 2021;36(12):4654-62 & supplementary materials.
- Delanoё K, et al. J Heart Valve Soc. 2025:1–13.
- Wu C, et al. Ann Cardiothorac Surg. 2024; 13: 283–90.
- Edwards Lifesciences. MITRIS RESILIA mitral valve, model 11400M, Instructions for use. 2024.
- Abbott. Epic Plus/Epic Plus Supra stented porcine tissue valves, Instructions for use. 2021.
- Heimansohn DA, et al. JTCVS Open. 2023:15:151–63.
- Beaver T, et al. J Thorac Cardiovasc Surg. 2024;168(3):781–91.
Medical device for professional use.
Medical device for professional use.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
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