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Help your AVR patients feel reborn

The INSPIRIS RESILIA aortic valve –
a class of resilient tissue valves

Although mechanical valves offer extended durability,1 patients are increasingly turning towards tissue valves.2-4 This trend might reflect the patients’ unwillingness to accept the compromises of lifelong anticoagulation as required by mechanical valves.2,4

However, younger patients have a higher risk of tissue valve deterioration and, as life-expectancy is increasing,3 patient preference and the presumed valve durability to life-expectancy ratio are important factors to consider when deciding on which valve replacement to use.5

With this in mind, Edwards Lifesciences developed the INSPIRIS RESILIA valve.

The INSPIRIS RESILIA valve is the latest innovation in Edwards’ range of surgical aortic bioprostheses, bringing together:

INSPIRIS RESILIA valve

The messages presented by non-Edwards affiliated speakers within any of these videos are based on individual opinions and are not directly affiliated with Edwards.

Mechanical vs. tissue valves

The ESC/EACTS guidelines give a Class IIa (level of evidence C) recommendation to the use of mechanical valves for aortic valve replacement (AVR) in patients aged <60 years and tissue valves for those aged >65 years. However, the guidelines are less clear for patients between these ages.5

Structural valve deterioration (SVD) is rare in mechanical valves though other factors such as valve thrombosis, bleeding, pannus growth and endocarditis may lead to reoperation. Mechanical valves are seen to have increased durability with reduced reoperation rates compared to tissue valves. Nevertheless, because they carry a high risk of thrombosis and bleeding, lifelong anticoagulation therapy as well as INR monitoring are required3 – a substantial lifestyle modification.4

Tissue valves do not require lifelong anticoagulation therapy3-5 but have decreased durability compared to mechanical valves. Their main risk is reoperation for SVD due to calcification.3

Similar survival rates were observed for mechanical and tissue valves, in a retrospective analysis study by Chiang et al.‡7

When choosing the right valve for each patient, it is important that discussions include the risks and benefits associated with each valve type. Healthcare professionals and their patients should also consider:5

  • Patient preference – guidelines grant a Class I (level of evidence C) recommendation to decisions that are aligned with the desire of the informed patient
  • Lifestyle
  • Comorbidities
  • Impact of anticoagulation medication and INR monitoring
  • Presumed valve durability to life-expectancy ratio
  • Relative risks of major morbidity
    • Reoperation
    • Major bleeding events

 

Latest innovation in tissue valves

With the use of tissue valves significantly increasing, life-expectancy continuously improving and tissue valve SVD being accelerated in younger patients, there is a demand for tissue valves with longer durability.3

INSPIRIS RESILIA is built on trusted PERIMOUNT platform, the most widely used aortic valve in the world.

Through technological and design innovations, the INSPIRIS RESILIA valve, the latest generation of Edwards tissue valves, has been designed for patients with active lives to provide:

  • Improved anti-calcification properties*8,9
  • Potential for future valve-in-valve (ViV) procedures†6

Initial intermediate-term data is available on RESILIA tissue.

Watch Video

Discover the innovation behind the INSPIRIS RESILIA valve

What is RESILIA tissue?

RESILIA tissue is bovine pericardium that has been transformed by stable capping and glycerolisation. This novel technology permanently blocks free aldehyde groups within the tissue,8 which are known to lead to calcification and SVD.3,8 This also eliminates the need for glutaraldehyde preservation, enabling dry storage with no need for rinsing prior to use.8

RESILIA tissue in pre-clinical testing

The enhanced integrity of RESILIA tissue was proven in a large, randomised, examiner-blinded, controlled trial of juvenile sheep in the mitral position. This pre-clinical model is currently the best-known to assess tissue valve calcification because the use of juvenile sheep (all less than 6 months old) reflects the accelerated calcification often seen in younger humans. This long-term 8 month study was longer than the minimum (5 months) required by the US FDA by more than 50%.8

RESILIA tissue pre-clinical study design

Adapted from Flameng et al. 2015.

Over 8 months, compared with the standard PERIMOUNT valve, the PERIMOUNT valve incorporating RESILIA tissue demonstrated:8

pre-clinical study results

RESILIA tissue in the COMMENCE trial

Prospective, multinational, single-arm, FDA Investigational Device Exemption Trial10,11

In the COMMENCE trial, 689 patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve with RESILIA tissue (Model 11000A).10 At the 2-year (n=689) and 4-year (n=405) follow-ups,10,11 RESILIA tissue demonstrated:

Watch Video

Find out more about RESILIA tissue pre-clinical testing and the COMMENCE trial

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Visit Edwards Masters

For more information related to the INSPIRIS RESILIA valve studies visit Edwards Masters.

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Click here to download the Aortic Stenosis Identification Tool.

This tool lays out key steps in the treatment of aortic stenosis. The first part is aimed at patients and can be used as a visual guide to support consultations. The second part contains in-depth information that you might find helpful to support more detailed discussions.

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Click here to download the INSPIRIS RESILIA Data Compendium.

This healthcare professional focused booklet takes an in-depth look at the impact of AVR, and explores the latest clinical studies involving the INSPIRIS RESILIA valve and RESILIA tissue.

The INSPIRIS RESILIA valve builds on the trusted PERIMOUNT platform…6

…and projects it into the future with VFit technology†6

The INSPIRIS RESILIA valve builds on the trusted PERIMOUNT platform…6

The INSPIRIS RESILIA valve is built upon the Magna Ease valve and is the latest model in the Carpentier-Edwards PERIMOUNT valve portfolio,6 the most widely used aortic valves in the world.

Carpentier-Edwards PERIMOUNT valve portfolio

…and projects it into the future with VFit technology†6

VFit technology incorporates two novel features designed for potential future ViV procedures:†6

INSPIRIS RESILIA VFit Technology
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* RESILIA tissue tested against commercially available bovine pericardial tissue from Edwards in a juvenile sheep model.8 No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

† Refer to device instructions for use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the INSPIRIS RESILIA valve for use in ViV procedures. VFit technology is available in sizes 19–25 mm.6

‡ A retrospective cohort analysis of 4253 patients, aged 50-69 years, who underwent AVR with either mechanical (n=1466) or tissue valves (n=2787). Primary outcome was all-cause mortality; secondary outcomes were stroke, reoperation, and major bleeding. Overall median follow-up time was 10.8 years.7

§ A retrospective study of 373 patients, aged 16-60 years, undergoing AVR using the Carpentier-Edwards PERIMOUNT pericardial aortic bioprosthesis, with a mean follow-up period of 8.6±5.9 years and a cumulative follow-up of 3,299 valve-years. The median valve durability, calculated by the MST based on actuarial freedom from SVD, was 17.6 years (95% CI, 16.3 to 18.8).14

¶ No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.

 

References

  1. Zhao DF, Seco M, Wu JJ, et al. Ann Thorac Surg. 2016;102(1):315-27.
  2. Brown JM, O‘Brien SM, Wu C, et al. J Thorac Cardiovasc Surg. 2009;137:82-90.
  3. Head SJ, MeÇelik M, Kappetein AP, et al. Eur Heart J. 2017;38(28):2183–2191.
  4. Schnittman SR, Adams DH, Itagaki S, et al. J Thorac Cardiovasc Surg. 2018;155:539–547.
  5. Baumgartner H, Falk V, Bax JJ, et al. Eur Heart J. 2017;38:2739–2791.
  6. Edwards Lifesciences. INSPIRIS RESILIA Aortic Valve, Model 11500A, DRAFT. 2018.
  7. Chiang YP, Chikwe J, Moskowitz AJ, et al. JAMA. 2014;312(13):1323-9.
  8. Flameng W, Hermans H, Verbeken E, et al. J Thorac Cardiovasc Surg. 2015;149:340–345.
  9. Griffith BP, Bavaria JE, Gammie JS, et al. Four-year outcomes of aortic valve replacement with a bioprosthetic valve with a novel tissue. Oral presentation at the 99th Annual American Association for Thoracic Surgery Meeting, Canada (May 4–7), 2019.
  10. Puskas JD, Bavaria JE, Svensson LG, et al. Eur J Cardiothorac Surg. 2017;52(3):432–439.
  11. Griffith BP, Bavaria JE, Gammie JS, et al. Intermediate-term outcomes of aortic valve replacement with a bioprosthetic valve with a novel tissue abstract 339. 99th Annual American Association for Thoracic Surgery Meeting, Canada (May 4–7), 2019.
  12. Edwards Lifesciences. Surgical aortic pericardial valves. 2019. Available at: https://www.edwards.com/devices/heart-valves/aortic-pericardial. Accessed May 2019.
  13. Edwards Lifesciences. Magna Ease Pericardial Bioprosthesis Model 3300TFX Aortic. 2006.
  14. Bourguignon T, El-Khoury R, Candolfi P, et al. Ann Thorac Surg. 2015;100:853–859.

 

Abbreviations

AVR, aortic valve replacement; CI, confidence interval; CoCr, cobalt chromium; EACTS, The European Association for Cardio-Thoracic Surgery; ESC, European Society of Cardiology; FDA, Food and Drug Administration; INR, international normalised ratio; MST, median survival time; NYHA, New York Heart Association; PVL, paravalvular leak; SVD, structural valve deterioration; US, United States; ViV, valve-in-valve.

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