~5mMid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic bioprosthesis – a retrospective comparison to the Carpentier-Edwards Magna Ease
Georges G, Bernard J, Pibarot P, Kalavrouziotis D and Mohammadi S.
Presented at 36th European Association for Cardio-Thoracic Surgery Annual Meeting, 2022.
Key points
- The INSPIRIS RESILIA valve showed comparable early and mid-term outcomes in patients who underwent surgical aortic valve replacement (SAVR), to the Carpentier-Edwards PERIMOUNT Magna Ease valve.
- The INSPIRIS RESILIA valve facilitated significantly lower mean pressure gradients at discharge, 1–3 months and 2 years compared with the Carpentier-Edwards PERIMOUNT Magna Ease valve.
Background information
- The number of younger patients receiving aortic bioprostheses is rising, creating a need for devices with better haemodynamic performance and durability.
- The INSPIRIS RESILIA valve is a relatively new device, for which only limited data are available currently.
Aims
- To evaluate the real-world mid-term clinical and echocardiographic outcomes in patients with INSPIRIS RESILIA valve.
Type of study
- A single-centre, retrospective registry study.
Endpoints
- Endpoints included haemodynamic outcomes, survival, and incidence of structural valve deterioration (SVD).
Methods
- The study included adults who underwent SAVR with an INSPIRIS RESILIA valve or a PERIMOUNT Magna Ease valve between January 2018 and July 2021 with ≥1 postoperative echocardiography examination.
- To account for baseline differences, patients were propensity score-matched for age, sex, prosthesis size, body surface area, body mass index and left ventricular ejection fraction.
Results
Patients
- The study originally enrolled 953 patients, 434 of whom were included in the propensity score-matched cohort (Table 1).
- The study achieved complete clinical follow-up (100%; median follow-up time: 2.5 years).
Table 1. Baseline characteristics of the propensity score-matched population.
Table 2. Post-operative adverse events and complications for the propensity score-matched cohort
Clinical outcomes
- Early post-operative outcomes were similar between groups (Table 2).
- Survival was not significantly different between groups throughout follow-up (p=0.89).
- Readmission for cardiovascular events or stroke was more frequent among patients with PERIMOUNT Magna Ease valve (proportion of patients with readmission after 30 months: 6% with INSPIRIS RESILIA valve, 14% with PERIMOUNT Magna Ease valve; p=0.01).
- SVD was rare, with only two moderate SVD cases by Year 2 (both in the 21-mm INSPIRIS RESILIA valve group; p=0.87).
Haemodynamic outcomes
- The INSPIRIS RESILIA valve showed significantly lower mean pressure gradients at discharge, at 1–3 months and 2 years versus the PERIMOUNT Magna Ease valve (Figure 1).
Figure 1. Mean pressure gradient over time (propensity score-matched cohort).
Conclusion
The post-operative and mid-term outcomes were comparable in both study groups. The INSPIRIS RESILIA aortic valve showed stable mid-term haemodynamic performance, with a mean pressure gradient at 2 years that was significantly lower than with the PERIMOUNT Magna Ease valve. Long-term follow-up is underway.
This document is a summary of the Georges G et al. presentation as presented at the EACTS congress, and covers key information including aim, type of study, methods, results and conclusions.
The full publication is available at:
Abbreviations:
No clinical data are available that evaluate the long term impact of RESILIA tissue in patients.
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