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The INSPIRIS RESILIA aortic valve

Get closer to patient lifestyle.

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SAVR patients need a heart valve that works for them in the long-term

With the INSPIRIS RESILIA aortic valve, your patients can live a life without the compromises of warfarin and that does not restrict their future treatment options.

Mechanical valves dictate a life on warfarin1

Patients with a mechanical valve will need to make permanent changes to their lifestyles, such as:

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Frequent and regular monitoring 

During treatment with warfarin, patients must undergo blood tests at least once a month to monitor their international normalised ratio (INR).2,3

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Diet and medication restrictions

Many foods rich in vitamin K and common over-the-counter medications alter the anticoagulant effects of warfarin.2 They can affect the patient’s INR which may no longer sit within the effective range, leaving them temporarily unprotected.

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Lifestyle modifications

Due to the risk of major bleeding, patients must limit some aspects of their lives, such as playing contact sports, needing to use soft-bristled toothbrushes, and shaving with electric razors rather than a blade.2

Unlike mechanical valves, the INSPIRIS RESILIA aortic valve does not require life-long treatment with warfarin.1

Some common cardiology medications are contraindicated in patients with mechanical valves 

Direct-acting oral anticoagulants (DOACs, also known as NOACs) are the standard of care for atrial fibrillation (AF) but are contraindicated in patients with mechanical valves.4

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40%

of patients with severe aortic stenosis have atrial fibrillation5

Switching from DOACs to warfarin is necessary for patients with existing AF who receive a mechanical valve, and those who develop AF after receiving a mechanical valve cannot receive the AF standard of care.4

DOACs offer several advantages over warfarin including lower risk of intracranial bleeding, lower mortality and higher patient satisfaction.6–8

Patients prefer minimally invasive procedures with a short recovery time9,10

Whilst designing the INSPIRIS RESILIA aortic valve, Edwards Lifesciences considered how  surgery has evolved towards less invasive procedures and developed an aortic valve that can be implanted via full sternotomy or right anterior thoracotomy.11

Compared to more invasive approaches, minimally invasive surgery can benefit your patients by:

  • Reducing post-operative complications12,13
  • Improving cosmetic outcomes and expediting recovery to functional activity12–16
  • Reducing the need for blood transfusions12–14, 16
  • Shortening length of hospital stay12,13,16,17

Valve choice is for life; involving patients in the decision-making process is critical

Mechanical valve choice can have a major impact on patients’ quality of life.*18 A higher proportion of patients report perceived disability, an effect on work, career or income, and dissatisfaction or doubt toward their choice, compared with patients with tissue valves.*18

*A prospective analysis examining the impact of mechanical or bioprosthetic valves in 500 patients aged 18 to 50 years. Outcomes included rates of mortality, stroke, bleeding events, reoperation; quality of life and additional data were obtained via phone interview in 2003, at a mean of 8±4.9 years after valve replacement.18

The 2021 ESC/EACTS guidelines emphasise patient choice

The mode of intervention and choice of prosthetic valve should be discussed with the patient so they can make an informed decision.1 However patients are not always fully aware of the long-term consequences on their lives and future treatment options. Consequences differ, not just between mechanical and tissue valves, but between each tissue valve option too.

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89%

of patients think it is important to be involved in their valve decision19

General cardiologists, with their close relationships to their patients, are ideally placed to talk through the options and their implications to help patients make the choice that’s right for them.


How far ahead do you plan when you make today's treatment decisions?

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Consider the INSPIRIS RESILIA aortic valve for your next SAVR patient

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Find out about the clinical evidence behind the INSPIRIS RESILIA aortic valve. 

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Visit our resources section for additional information on aortic valve disease and the INSPIRIS RESILIA aortic valve.

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Abbreviations

AF, atrial fibrillation; DOACS, Direct-acting oral anticoagulants; ESC; European Society of Cardiology; EACTS, European Association for Cardio-Thoracic Surgery; INR, international normalised ratio; NOACs, non-vitamin K oral anticoagulants; SAVR, surgical aortic valve replacement.

References

  1. Vahanian A, et al. Eur Heart J. 2022;43:561–632.
  2. Fiumara K, et al. Circulation. 2009;119:e220–e222.
  3. Herijgers P, et al. Eur Heart J. 2007;28:2424–26.
  4. Hindricks G, et al. Eur Heart J. 2021;42:373–98.
  5. Shahim B, et al. Am J Cardiol. 2021;148:116–23.
  6. Connolly SJ, et al. N Engl J Med. 2009;361:1139–51.
  7. Hicks T, et al. Open Heart. 2016;3:e000279.
  8. Ng D, et al. Patient Prefer Adherence. 2019;13:1363–73.
  9. Lauck SB et al. Can J Cardiol. 2021;37:1054–63. 
  10. Heen AF et al. Heart. 2021;107:1289–95. 
  11. Ahmad AE, et al. Adv Ther. 2021;38(5):2435–46.
  12. Ramlawi B, et al. Interv Cardiol Rev. 2014;9(1):32–36. 
  13. Glauber M, et al. J Thorac Cardiovasc Surg. 2013;145(5):1222–6. 
  14. Doesnt T, et al. Dtsch Arztebl Int. 2017; 114(46): 777–784.
  15. Brown ML, et al. J Thorac Cardiovasc Surg. 2009; 137:670–9.e5.
  16. Stoliński J, et al. J Thorac Cardiovasc Surg. 2016;152:1030–9. 
  17. Lim JY, et al. J Card Surg. 2015;30(2):124–34.
  18. Ruel M, et al. Eur J Cardiothorac Surg. 2005;27(3):425–33.
  19. Korteland NM, et al. Interact Cardiovasc Thorac Surg. 2016;22:723–8.

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue. 

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 model 11500A for use in valve-in-valve procedures. VFit technology is available on sizes 19–25 mm.

 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).

Medical device for professional use

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).