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SURGICAL HEART VALVES

MECHANICAL HEART VALVES

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.

SURGICAL HEART VALVES

MECHANICAL HEART VALVES

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.

CONFIDENTLY IMPLANT THE MOST TRUSTED AORTIC AND MITRAL MECHANICAL VALVES IN THE WORLD

The most trusted aortic and mitral mechanical valves in the world
Over 1000 peer-reviewed publications for Abbott Mechanical Heart Valves
  • Design-driven Hemodynamic Confidence & Low Thrombogenicity

    Abbott mechanical heart valves lead the way with a proven bileaflet design that results in low thrombogenicity and excellent patient outcomes.

    • Leaflets open to an 85-degree angle in systole due to their upstream positioning, enabled by unique pivot guards (shown at right)
    • Strong, uniform velocities within hinge recesses aid washout of blood elements3
    • Low carbon surface area means less thrombus formation
    • Orifice-to-annulus ratio (as high as 84%) ensures large effective orifice areas (EOAs) and reduces prosthesis-patient mismatch4
    Abbott mechanical heart valves have a bileaflet design
  • Unique Design Features

    The Pivot Guard Design 
    An Abbott Hallmark

    Featured in all Abbott Mechanical Heart Valves, the Pivot Guard offers benefits both during implant and post-implant

    • Recessed design minimizes interaction with sub-annular native mitral valve apparatus
    • Minimized carbon surface area can lessen thrombus formation
    • Pivot guards help shield pivot mechanism from pannus ingrowth
    • Enables a consistent 85-degree opening angle, promoting minimized leaflet flutter and more laminar flow through the orifice5
    Abbott mechanical heart valves feature the pivot guard design

    Low Thrombogenicity 
    A Necessity in MHV Replacements

    Designed with Low Thrombogenicity at the Forefront

    • Large internal diameters up to 26.1 mm available promote low pressure gradients6
      • Low gradients can help minimize shear stress and thrombogenicity7
    • Uniform velocities within hinge recesses help aid washout of blood elements3
      • Abbott hinge design enables complete leaflet sweep, further aiding washout
         
    Abbott mechanical heart valve hinge design promote low thrombogenicity

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

  • 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.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

  • Mitral Regurgitation (MR) ESC/EACTS Treatment Guidelines

    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 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.

Sadie

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 more



    SURGICAL MITRAL
    VALVE REPLACEMENT

    Learn more

Regent gives you Implantability Options

Abbott Regent heart valve dimensions: low valve implant height for coronary ostia clearance

LOW VALVE IMPLANT HEIGHT HELPS ENSURE CORONARY OSTIA CLEARANCE

Abbott Regent valve sizer gives the most appropriately sized valve


REPLICA SIZING WITH THE 907 SIZER GIVES YOU CONFIDENCE THAT YOU ARE USING THE MOST APPROPRIATELY SIZED VALVE

TWO DISTINCT CUFF TYPES PROVIDE YOU WITH DIFFERENT OPTIONS

Abbott provides different cuff types for Regent aortic valve




FLEXCUFF™

Abbott provides different cuff types for Regent aortic valve

FLEXCUFF™

Abbott provides different cuff types for Regent aortic valve




STANDARD CUFF

Abbott provides different cuff types for Regent aortic valve

STANDARD CUFF

  • The Regent Aortic Valve Features Exceptional Hemodynamics In Small Aortic Root Patients15,16,*

    .

    Abbott Regent aortic valve features exceptional hemodynamics

    *Measured one-year post-surgery.

    Abbott Regent valve provides laminar flow for optimal hemodynamic performance

Implantability Options with Masters Series

The Masters Series Mechanical Heart Valves are rotatable, bileaflet valves designed for secure implantation. The portfolio includes an expansive range of sizes to help you make the best decisions for your patients and the Hemodynamic Plus™ (HP) models are designed to provide a larger effective orifice area.

Abbott Masters Series mechanical heart valves offers pediatric treatment

THE 15 MM PEDIATRIC HEART VALVES JOIN THE FAMILY OF
17–27 MM MASTERS HP MECHANICAL HEART VALVES AND IS SUITABLE FOR TREATING NEWBORNS AND BABIES

Abbott Masters mitral valve features low implant height

LOW VALVE IMPLANT HEIGHT MINIMIZES INTERFERENCE WITH SUBVALVULAR STRUCTURES
IN THE MITRAL POSITION

TWO DISTINCT CUFF TYPES PROVIDE YOU WITH DIFFERENT OPTIONS

Abbott Masters Series heart valve expanded cuff type




EXPANDED CUFF

Abbott Masters Series heart valve expanded cuff type

EXPANDED CUFF

Abbott Masters Series heart valve standard cuff type




STANDARD CUFF

Abbott Masters Series heart valve standard cuff type

STANDARD CUFF

CLINICAL DATA


See the latest clinical data for Regent and Masters Series.
 

see clinical data

MAT-2010509 v6.0 | Item approved for OUS use only.

References
  1. Internal Sales Tracking Spreadsheet. Data on file at Abbott.
  2. MHV Paper List. Data on file at Abbott.
  3. 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
  4. 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
  5. Shipkowitz T, Ambrus J, Kurk J, et al. Evaluation technique for bileaflet mechanical valves. J Heart Valve Dis. 2002;11(2):275-282.
  6. Internal Design Prints. Data on file at Abbott.
  7. 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.
  8. 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.
  9. 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
  10. 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.  
  11. Ren X. Aortic stenosis. Medscape. emedicine.medscape.com/article/150638-overview. Updated May 7, 2019.
  12. Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: A community cohort study. Lancet. 2018;391(10124): 960-969.
  13. Regent Instructions for Use.
  14. Regent PMA Supplement.
  15. 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.
  16. Masters Series Instructions for Use.
  17. 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.
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MAT-2000631 v18.0 | Item approved for OUS use only.

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