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December 6, 2022

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic bioprosthesis – a retrospective comparison to the Carpentier-Edwards Magna Ease
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Mid-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 […]

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Mid-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:

https://bit.ly/Georges2022

Abbreviations:

No clinical data are available that evaluate the long term impact of RESILIA tissue in patients.

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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