Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

Jérémy Bernard; Gabriel Georges; Sébastien Hecht; Philippe Pibarot; Marie-Annick Clavel; Shervin Babaki; Dimitri Kalavrouziotis; Siamak Mohammadi

doi:10.1093/icvts/ivad117

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

Interdiscip Cardiovasc Thorac Surg. 2023 Jul 19;37(1):ivad117. doi: 10.1093/icvts/ivad117.

Authors

Jérémy Bernard¹, Gabriel Georges², Sébastien Hecht¹, Philippe Pibarot¹, Marie-Annick Clavel¹, Shervin Babaki³, Dimitri Kalavrouziotis², Siamak Mohammadi²

Affiliations

¹ Cardiology Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.
² Cardiac Surgery Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.
³ Research Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.

Abstract

Objectives: The INSPIRIS aortic valve combines the RESILIA proprietary tissue preservation process and an expandable stent frame to benefit future transcatheter valve-in-valve procedures. As the INSPIRIS valve became commercially available in 2017, mid-term outcome reports are scarce. We aimed to evaluate mid-term safety and echocardiographic performance of the INSPIRIS valve in comparison to its predecessor, the Carpentier Edwards Perimount Magna Ease (ME).

Methods: This study was a retrospective single-centre study. Clinical results included early postoperative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up (FU) was performed at discharge and 1-3, 6, 12 and 24 months. Clinical end point analyses were accomplished with a propensity score matching analysis and FU echocardiographic data comparisons using pairwise analyses and linear mixed-effect models.

Results: We included 953 patients who received an INSPIRIS (n = 488) or ME (n = 463) bioprosthesis between January 2018 and July 2021. In the matched population (n = 217 per group), no significant difference in short-term outcomes was observed, survival was similar at 30 months (INSPIRIS: 94% vs ME: 91%, P = 0.89), but freedom from readmission was higher in the INSPIRIS group (94% vs 86%, P = 0.014). INSPIRIS valves had a lower gradient at discharge (∼10 vs 14 mmHg, P < 0.001), 1-3 months (∼10 vs 12 mmHg, P < 0.001) and 24 months (∼11 vs 17 mmHg, P < 0.001) in paired analyses and significantly lower evolution of mean transvalvular gradients compared to ME.

Conclusions: This study represents the largest comparative evaluation of the INSPIRIS to the ME valves, which demonstrated safe clinical outcomes and favourable haemodynamic performance at 2 years. Long-term FU is underway.

Keywords: INSPIRIS RESILIA; Magna Ease; Patient–prosthesis mismatch; Structural valve deterioration; Surgical aortic valve replacement; Transvalvular gradient.

Grants and funding

CAPMC/ CIHR/Canada