At 5 years, COMMENCE results indicate a favourable safety profile and stable haemodynamic performance of a bioprosthetic valve with RESILIA tissue. Ten-year data in an extended follow-up cohort and the RESILIENCE trial with 11-year follow-up are forthcoming.
Promising results for bioprosthetic SAVR in patients under 60 years old
The recently updated ESC/EACTS Guidelines contain two key changes in the recommendations for prosthetic valve selection:1
- A new Class IIb recommendation for bioprostheses in patients already on long-term NOACs
- An upgraded Class I recommendation for bioprostheses in patients for whom good-quality anticoagulation is unlikely or contraindicated, and in patients whose life-expectancy is lower than the presumed durability of the valve
Importantly, the desire of the informed patient remains central to prosthetic valve selection. Valve durability in young patients is an important consideration, but long-term data on bioprosthetic SAVR have been limited.
INDURE registry
INDURE is a prospective, open-label, multicentre registry that is tackling this issue head-on. INDURE has enrolled over 400 patients aged up to 60 years who are undergoing SAVR with the INSPIRIS RESILIA valve in 21 sites across Europe and Canada. Patients are being followed up for five years, with echocardiograms analysed by Echo Core Laboratory at years one and five.2,3
One-year results from the first 435 patients were reported at the 2021 EACTS Annual Meeting. Younger patients (up to 50 years old) in the registry were more likely to have a bicuspid aortic valve or aortic valve regurgitation at baseline than patients aged 51–60 years, but were less likely to have aortic stenosis, hypertension or diabetes.3
Excellent haemodynamic outcomes at 1 year
The excellent haemodynamic outcomes were comparable in the younger and older patient groups.
Plus, preliminary safety outcomes demonstrated low all-cause mortality and no confirmed cases of valve-related mortality up to one year. Rates of endocarditis and stroke were low (<1%). There were no cases of stage 3 SVD.
The INDURE registry will continue to provide clinical evidence on the use of the INSPIRIS RESILIA valve in young patients for the next 5 years.
References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2021.
2. Meuris B, Borger MA, Bourguignon T et al. Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020; 15: 119.
3. De Paulis R. Surgical aortic valve replacement in patients under 60 years old: A prospective, multicentre real-world registry in Europe and Canada. EACTS 2021.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for Use (consult eifi.edwards.com where applicable)
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, INSPIRIS, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-3060 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
The 2021 update of the ESC/EACTS Guidelines for the management of valvular heart disease, recommends treating patients with severe aortic stenosis younger than 75 years and low risk with surgical aortic valve replacement (SAVR), simplifying the initial patient treatment pathway and preferred mode of intervention. The implication is that valve durability is now even more important because of younger patients’ greater longevity.
Edwards Lifesciences has two ongoing trials, COMMENCE and EU Feasibility, that are evaluating the longevity of a bioprosthetic valve with novel RESILIA tissue. Both trials have demonstrated a favourable safety profile and good haemodynamic performance at 5 years, with additional follow-up to be conducted up to 10 years.1,2
The COMMENCE trial
Safety endpoints, probability event-free:
COMMENCE is an FDA pivotal trial designed to evaluate the safety and effectiveness of the INSPIRIS bioprosthetic aortic valve with the novel RESILIA tissue.1 The 5-year data are now available:
· All-cause mortality 89.2%
· Major paravalvular leak 99.5%
· Endocarditis 97.8%
Improved haemodynamic performance from baseline
The absence of structural valve deterioration through 5 years* and the presence of stable gradients, plus freedom from regurgitation support durability over the observational period.
*One case of structural valve deterioration was diagnosed at postoperative Day 1,848.
The RESILIA EU Feasibility study
The RESILIA EU Feasibility study has investigated the safety and performance in aortic valve replacement patients of the bioprosthesis with the novel RESILIA tissue at 5 years.2 Here, we summarise the results at 5 years:
Stable haemodynamic performance:
Mean gradient was 14.8 ± 7.6 mmHg
Average effective orifice area was 1.4 ± 0.5 cm2
Zero structural valve deterioration events and stable transvalvular gradients were observed at 5 years.
At 5-years, results from the EU Feasibility study represent the longest follow-up of aortic valve replacement patients with RESILIA tissue and demonstrate excellent haemodynamic performance and safety outcomes.1
Recommended resources
https://edwardseducation.com/edwardsmasters/the-latest-tissue-valve-technology-responding-to-the-unmet-needs-in-avr/
References
1. Bavaria J, Griffith B, Heimansohn DA et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting, January 29-31, 2021.
2. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg 2020; 59: 434–41.
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
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).
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2948 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
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