Unique design features have established Abbott mechanical heart valves—including the Regent™ and Masters Series—as a gold standard for reliability and performance, while maintaining low complication rates over the long term.
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.8
Patient Story: Allen
Patient Story: Veronika
Patient Story: Colby
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.9
- Surgical aortic valve replacement (SAVR) is recommended in patients at low surgical risk who are13:
- 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.10
3.4%
Severe AS affects 3.4% of the population over 60 years of age.9
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.11
MR is the most common valve disease worldwide.12 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 in13:
- 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.13
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.8
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 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.
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- Internal Sales Tracking Spreadsheet. Data on file at Abbott.
- MHV Paper List. Data on file at Abbott.
- Jun BH, Saikrishnan N, Yoganathan AP. Micro particle image velocimetry measurements of steady diastolic leakage flow in the hinge of a St. Jude Medical Regent™ mechanical heart valve. Ann Biomed Eng. 2014;42(3):526-540. Published online 2013 Oct 2.doi: 10.1007/s10439-013- 0919-y
- Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000;36(4):1131-1141. doi.org/10.1016/s0735-1097(00)00859-7
- Shipkowitz T, Ambrus J, Kurk J, et al. Evaluation technique for bileaflet mechanical valves. J Heart Valve Dis. 2002;11(2):275-282.
- Internal Design Prints. Data on file at Abbott.
- Alemu Y, Bluestein D. Flow induced platelet activation and damage accumulation in a mechanical heart valve: numerical studies. Artif Organs. 2007;31(9):677-688. doi: 10.1111/j.1525-1594.2007.00446.x.
- 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.
- 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
- 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.
- Ren X. Aortic stenosis. Medscape. emedicine.medscape.com/article/150638-overview. Updated May 7, 2019.
- Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: A community cohort study. Lancet. 2018;391(10124): 960-969.
- Regent Instructions for Use.
- Regent PMA Supplement.
- Okamura H, Yamaguchi A, Morita H, et al. Is the threshold for postoperative prosthesis-patient mismatch the same for all prostheses? Surg Today. 2013;43:871-876.
- Masters Series Instructions for Use.
- 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.