Mechanical Heart Valves

EXCELLENT FUNCTION AND
DURABILITY THROUGHOUT A
PATIENT’S LIFETIME

Although the prevalence of mitral valve disease is 2 to 3 times higher than aortic valve disease, aortic valve surgeries (excluding transcatheter procedures) are performed 1.6 times more commonly than mitral valve surgeries. The undertreatment of mitral valve disease may be related to the slower progression of symptoms compared with aortic disease, as well as a potential lack of adherence to guidelines for intervention.1

AORTIC STENOSIS (AS) ESC/EACTS TREATMENT GUIDELINES

Severe AS presents with exertional dyspnea, syncope, angina, and progression to heart failure. Early intervention produces a better outcome in preventing the clinical deterioration of AS.2

  • Surgical aortic valve replacement (SAVR) is recommended in patients at low surgical risk who are3:
  • Symptomatic with severe, high-gradient AS (mean gradient ≥ 40 mmHg or peak velocity ≥ 4.0 m/s)
  • Symptomatic with severe low-flow, low-gradient (< 40 mmHg) AS with reduced ejection fraction and evidence of flow (contractile) reserve excluding pseudosevere AS
  • Asymptomatic with severe AS and systolic LV dysfunction (LVEF < 50%) not due to another cause, or an abnormal exercise test showing symptoms on exercise clearly related to AS
  • Undergoing other cardiac surgery and have severe AS

Outcomes after SAVR are excellent in patients who do not have a high procedural risk, resulting in improved survival rates, reduced symptoms, and improved exercise capacity.4

3.4%

Severe AS affects 3.4% of the population over 60 years of age.2

BLEAK PROGNOSIS WITHOUT TREATMENT

Mortality rates are approximately 25% at 1 year and 50% at 2 years in symptomatic AS patients on medical therapy who do not undergo AVR.5

CHOOSING A REGENT™ MECHANICAL HEART VALVE

The Regent™ mechanical heart valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. The device may also be used to replace a previously implanted aortic prosthetic valve.

The primary advantages of a Regent™ mechanical valve include durability, since mechanical valves are designed to last a lifetime.6 Mechanical valves also avoid the potential of eventual calcification, which can occur with tissue valves. The excellent hemodynamics  and low thrombogenicity of the Regent™ aortic valve are other advantages to consider. However, mechanical valves confer a thrombogenic potential and require long-term anticoagulant therapy to preclude thrombus formation.

The choice between a mechanical and a tissue aortic valve is determined mainly by estimating the risk of anticoagulation-related bleeding and thromboembolism with a mechanical valve versus the risk of structural valve deterioration with a bioprosthesis and by considering the patient’s lifestyle and preferences. Bioprostheses should be considered in AS patients whose life expectancy is lower than the presumed durability of the valve, and a mechanical valve should be considered in patients < 60 years of age.3

MITRAL REGURGITATION (mr) ESC/EACTS TREATMENT GUIDELINES

MR is the most common valve disease worldwide.7 Intervention for patients with primary MR consists of either surgical mitral valve repair or replacement, with repair preferred over replacement if a successful and durable repair can be achieved. Mitral valve surgery is recommended in3:

  • Symptomatic patients with chronic, severe primary MR and left ventricular ejection fraction (LVEF) > 30%
  • Asymptomatic patients with chronic, severe primary MR and LVEF ≤ 60% and/or LV end-systolic dimension ≥ 45 mm
  • Patients with chronic, severe secondary MR undergoing other cardiac surgery and LVEF > 30%

Asymptomatic patients with severe MR and LVEF > 60% should be followed clinically and echocardiographically every 6 months (or sooner if significant dynamic changes occur), ideally in a heart valve centre setting. When guideline indications for surgery are reached, early surgery—within 2 months—is associated with better outcomes.3

LATE REFERRAL FOR SURGICAL INTERVENTION IS ASSOCIATED WITH REDUCED SURVIVAL

There remains an important and substantial opportunity to decrease long-term mortality in patients with mitral valve disease by following established guidelines and encouraging earlier referral for intervention.1

CHOOSING THE MASTERS SERIES MITRAL MECHANICAL HEART VALVE

The Masters Series mitral mechanical heart valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning mitral valve. The device may also be used to replace a previously implanted mitral prosthetic valve.

The primary advantages of a Masters Series mitral mechanical valve include durability, since mechanical valves are designed to last a lifetime.6 Mechanical valves also avoid the potential of eventual calcification, which can occur with tissue valves. The excellent hemodynamics and low thrombogenicity of the Masters Series mitral valve are other advantages to consider. However, mechanical valves confer a thrombogenic potential and require long-term anticoagulant therapy to preclude thrombus formation.

The choice between a mechanical and a tissue mitral valve is determined mainly by estimating the risk of anticoagulation-related bleeding and thromboembolism with a mechanical valve versus the risk of structural valve deterioration with a bioprosthesis and by considering the patient’s lifestyle and preferences. Bioprostheses should be considered in MR patients whose life expectancy is lower than the presumed durability of the valve, and a mechanical valve should be considered in patients < 65 years of age.3

 

ADDRESSING AN UNMET NEED FOR HIGH-RISK PEDIATRIC PATIENTS

Only Abbott provides the world's smallest pediatric mechanical heart valve, the 15 mm Masters HP, for aortic and mitral heart valves. Developed to address an unmet need for high-risk pediatric patients who formerly had limited options. The patients who need the valve are usually younger than 1 year old with complex heart defects, have had multiple prior heart surgeries and require a valve replacement.

 

MEET SADIE: A RECIPIENT OF THE WORLD’S SMALLEST 15 MM PEDIATRIC MECHANICAL HEART VALVE

Diagnosed with a heart condition before birth, Sadie received an Abbott mechanical heart valve that saved her life.

Resources to Help Patients Learn More About Their Condition


Mitral Regurgitation

Learn how your mitral valve functions and what happens when you have mitral regurgitation.
 

Learn more


 

 

 

MAT-2010509 v1.0 | Item approved for Global OUS use.

References
  1. Gammie JS, Chikwe J, Badhwar V, et al. Isolated mitral valve surgery: The Society of Thoracic Surgeons Adult Cardiac Surgery Database analysis. Ann Thorac Surg. 2018;106(3):716-727.
  2. Satter Y, Rauf H, Bareeqa S, et al. Transcatheter aortic valve replacement versus surgical aortic valve replacement: A review of aortic stenosis management. Cureus. 2019;11(12):e6431. doi: 10.7759/cureus.6431
  3. Baumgartner H, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease: The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017;38(21):2739-2791.
  4. Nishimura RA. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;136(9):1-123.
  5. Ren X. Aortic stenosis. Medscape. emedicine.medscape.com/article/150638-overview. Updated May 7, 2019.
  6. Korteland NM, Top D, Borsboom GJJM, et al. Quality of life and prosthetic aortic valve selection in non-elderly adult patients. Interact Cardiovasc Thorac Surg. 2016;22:723-728. doi:10.1093/icvts/ivw021.
  7. Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: A community cohort study. Lancet. 2018;391(10124): 960-969.

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