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Guidance that gets your patients

A heart‐to‐heart conversation could put your patients on a better path.

Doctor listening to patients pulse
Doctor listening to patients pulse
Doctor listening to patients pulse

Time is of the essence

Aortic valve disease symptoms may not appear until the condition is severe, and waiting for symptoms before treatment could lead to more serious complications and even death.1

Aortic Stenosis
Aortic Stenosis
Aortic Stenosis

The onset of serious symptoms is associated with a steep drop‐off in the survival curve.2

Adapted from Braunwald 2018.

Timely Intervention PDF thumbnail
Timely Intervention PDF thumbnail
Timely Intervention PDF thumbnail

Learn more about the importance of timely intervention: 

If aortic valve disease is left untreated or medically managed, mortality risk is high3‐5

25%
25%
25%
  • 25%
    25%
    25%
    of patients with symptomatic (NYHA
    class III/IV) moderately severe or severe
    aortic regurgitation (AR) could die
    within 1 year of diagnosis
21% and 29%
21% and 29%
21% and 29%
  • 21%
    21%
    21%
    of patients who have moderate AS could
    die within 1 year of diagnosis
  • 29%
    29%
    29%
    of patients who have severe AS could
    die within 1 year of diagnosis
25% and 50%
25% and 50%
25% and 50%
  • 25%
    25%
    25%
    of patients who have asymptomatic
    moderate-to-severe AR could die
    within 5 years of diagnosis
  • 50%
    50%
    50%
    of patients who have asymptomatic
    moderate-to-severe AR could die
    within 10 years of diagnosis
56% and 67%
56% and 67%
56% and 67%
  • 56%
    56%
    56%
    of patients who have moderate AS
    could die within 5 years of diagnosis
  • 67%
    67%
    67%
    of patients who have severe AS could
    die within 5 years of diagnosis
Aortic Regurgitation Page
Aortic Regurgitation Page
Aortic Regurgitation Page

Cardiologists play a key role in treating severe AR. See how you can help AR patients get the care they need before it's too late.

Help patients hold on to their quality of life longer

Guidelines suggest that postoperative outcomes in patients with severe AR are better when surgery is performed early or before the onset of symptoms.6

Monitor Pulse Icon
Monitor Pulse Icon
Monitor Pulse Icon

Echocardiography and other imaging techniques can help identify patients at high risk for symptom progression.2

Heart Plus Icon
Heart Plus Icon
Heart Plus Icon

In severe AR patients, performing surgery early, before symptoms occur, improves postoperative outcomes.6

Chart Down Icon
Chart Down Icon
Chart Down Icon

The risks of aortic valve replacement for severe aortic stenosis, including surgical and transcatheter options, have greatly declined.2

ACC/AHA Guideline Knowledge Check

How well do you know the recommendations for mechanical or tissue valves from the 2020 American College of Cardiology (ACC) /American Heart Association Guideline (AHA) Guideline for the management of valvular heart disease? Take the quiz and test your knowledge.

According to the 2020 ACC/AHA Guideline...

What valve type may be appropriate for patients between the ages of 50 and 65?
If a patient does not want to, or is unable to take VKAs, what valve choice may be appropriate?
If a patient has a medical history that increases the risk for reintervention or has anatomy that may preclude future valve-in-valve procedures, what valve choice may be appropriate?
If a patient is prone to a more active lifestyle and/or has limited access to manage blood thinners, what valve choice may be appropriate?

Quality of life in heart valve selection

You know what matters most to your patients, but they may not know how important it is to consider those things when selecting a heart valve. With your help, patients can make more educated choices on what valve is best for them and their lifestyle.

When adequate information and tools are provided to patients to support the shared decision‐making process in valve selection, it can serve to:7

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Lightbulb icon
Lightbulb icon

improve informed status

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Headplus Icon
Headplus Icon

reduce anxiety and depression

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Smiling Face Icon
Smiling Face Icon

improve the overall mental well‐being of patients

Challenges of lifetime anticoagulation therapy

Vitamin K antagonists (VKAs), such as warfarin, are the recommended anticoagulation therapy for patients with mechanical valves. However, to be successful, VKAs require patient education and adherence to attain and maintain a therapeutic international normalized ratio (INR).

The challenges of lifetime anticoagulant therapy for patients may include:6

Heart Infographic
Heart Infographic
Heart Infographic
Stethoscope Icon
Stethoscope Icon
Stethoscope Icon

more frequent physician visits

Fork Knife Icon
Fork Knife Icon
Fork Knife Icon

dietary restrictions

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Hiker Icon
Hiker Icon

lifestyle and activity restrictions

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Blood test icon
Blood test icon

monitoring of INR with routine blood tests

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Pills Icon
Pills Icon

medical interactions

Anticoagulation brochure
Anticoagulation brochure
Anticoagulation brochure

Use this brochure to review more anticoagulation considerations with your patients:

Heart valve replacement in women of childbearing age

More women living with valvular heart disease are reaching childbearing age and becoming pregnant.8 Their pregnancies present challenges and are linked to an increased incidence of adverse outcomes.9

When implantation of a prosthetic valve is unavoidable in patients who want to become pregnant, valve selection can be challenging.10

Childbearing woman
Childbearing woman
Childbearing woman
Childbearing woman
Childbearing woman
Childbearing woman

Test your knowledge

In the United States, cardiovascular disease complicates about __________ of all pregnancies and causes ___________of maternal mortality.

Consider these decision points to support patients planning to become pregnant in making optimal valve selections

Compared with women who received a tissue valve, women with mechanical valves experienced twice as many adverse events.11

Childbearing brochure
Childbearing brochure
Childbearing brochure

Download the Heart Valve Replacement in Women of Childbearing Age brochure:

Not all tissue valves are the same

Surgical Product Line
Surgical Product Line
Surgical Product Line
Surgical Product Line
Surgical Product Line
Surgical Product Line

References

  1. Wenn P, Zeltser R. Aortic valve disease. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021. Available at: https://www.ncbi.nlm.nih.gov/books/NBK542205/.
  2. Braunwald, E. Aortic Stenosis: Then and now. Circulation. 2018 May 15;137(20):2099-2100.
  3. Griffin B. Valvular heart disease. In: Griffin BP, Callahan TD, Menon V, Wu WM, Cauthen CA, Dunn JM, editors. Manual of Cardiovascular Medicine. 4th ed. Vol 1. Philadelphia, PA: Lippincott Williams & Wilkins; 2013:238-355.
  4. Dujardin KS, Enriquez-Sarano M, Schaff HV, et al. Mortality and morbidity of aortic regurgitation in clinical practice. A long-term follow-up study. Circulation. 1999;99:1851-1857.
  5. Strange G, Stewart S, Celermajer D, et al. National Echocardiography Database of Australia contributing sites. Poor long-term survival in patients with moderate aortic stenosis. J Am Coll Cardiol. 2019;74(15):1851-1863.
  6. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;77(4):e25-e197.
  7. Korteland NM, Ahmed Y, Koolbergen DR, et al. Does the use of a decision aid improve decision making prosthetic heart valve selection? A multicenter randomized trial. Circ Cardiovasc Qual Outcomes. 2017;10:e003178.
  8. Lawley CM, Algert CS, Ford JB, et al. Heart valve prostheses in pregnancy: outcomes for women and their infants. J Am Heart Assoc. 2014;3:e000953.
  9. Nanna M, Steriopoulos K. Pregnancy complicated by valvular heart disease: an update. J Am Heart Assoc. 2014;3:e000712. DOI: 10.1161/JAHA.113.000712
  10. Regitz-Zagrosek V, Roos-Hesselink JW, Bauersachs J, et al. 2018 ESC guidelines for the management of cardiovascular diseases during pregnancy: the task force for the management of cardiovascular diseases during pregnancy of the European Society of Cardiology (ESC). Eur Heart J. 2018;39(34):3165-3241.
  11. Van Hagen IM, Roos-Hesselink JW, Ruys TP, et al. Pregnancy in women with a mechanical heart valve: data of the European Society of Cardiology Registry of Pregnancy and Cardiac Disease (ROPAC). Circulation. 2015;132(2):132-142.
  12. Siu SC, Lam M, Allen B, et al. Attained pregnancy among women with a prosthetic heart valve. Eur J Obstet Gynecol Reprod Biol. 2019;240:172-177.

Important safety information

RESILIA Tissue Devices

Indications: INSPIRIS RESILIA Aortic Valve - For use in replacement of native or prosthetic aortic heart valves. KONECT RESILIA Aortic Valved Conduit - For use in replacement of native or prosthetic aortic heart valves and the associated repair or replacement of a damaged or diseased ascending aorta. MITRIS RESILIA Mitral Valve - For use in replacement of native or prosthetic mitral heart valves.

Contraindications: There are no known contraindications with the use of these RESILIA tissue heart valve devices.

Complications and Side Effects: INSPIRIS RESILIA Aortic Valve - Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, any of which could lead to reoperation, explantation, permanent disability, and death. Additional adverse events potentially associated with the use of polyester vascular grafts in the KONECT RESILIA AVC include hemorrhage, thrombosis, graft infection, embolism, aneurysm, pseudoaneurysm, seroma, occlusion (anastomotic intimal hyperplasia), immunological reaction to collagen (shown to be a weak immunogen; infrequent, mild, localized and self-limiting), intimal peel formation, and conduit dilatation. MITRIS RESILIA Mitral Valve - Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.

Warnings: INSPIRIS RESILIA Aortic Valve - DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO OR DURING IMPLANTATION OF THE SURGICAL VALVE. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. This will cause damage to the valve and may result in aortic incompetence. DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm as this may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.