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Medtronic Open Pivot Mechanical Heart Valves

Medtronic Open Pivot Mechanical Heart Valves

While mechanical valves have been used for heart valve replacement for nearly 50 years, the Medtronic Open Pivot™ platform brings a fundamentally different design to bileaflet mechanical valves. The Medtronic Open Pivot AP360®, AP®, and Standard valves provide exceptional implantability, performance, and durability.1-3

Summary

Medtronic Open Pivot™ mechanical heart valves represent a fundamental change in bileaflet valve design. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6 While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.7,8

Medtronic open pivot mechanical valves offer exceptional performance:

  • Remarkable thromboresistance: Continuous passive washing provides for gentle treatment of blood cells and low levels of hemolysis and thromoembolic events. 2,6,9
  • Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics.2,9,10
  • Outstanding durability: Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).1,2
  • Easy implantability: Single plane orifice facilitates valve seating and implant regardless of suture technique.
  • Notably quiet: Open Pivot valves are remarkably quiet.9,11
     

Open Pivot AP360

The Open Pivot AP360 provides these additional features:

  • Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability
  • Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement
     

Open Pivot AP

The Open Pivot AP provides these additional features:

  • Supra-annular compact cuff configuration for excellent suturability and conformability
  • Valve sizes ranging from 16 mm to 26 mm for aortic and mitral valve replacement
     

Open Pivot Standard Aortic Heart Valve

The Open Pivot Standard Aortic Valve provides these additional features:

  • Intra-annular valve with generous, compliant cuff for exceptional implantability
  • Valve sizes ranging from 19 mm to 31 mm
     

Open Pivot Standard Mitral Heart Valve

The Open Pivot Standard Mitral Valve provides these additional features:

  • Intra-annular valve with generous, compliant cuff for exceptional implantability
  • Valve sizes ranging from 25 mm to 33 mm
     

Open Pivot Heart Valve Accessories

A variety of accessories are available to quickly and easily select the optimal valve type, appropriate valve size, and ideal placement for valve positioning.

  • Medtronic Open Pivot Sizer Kit includes AP Series and Standard Heart Valve sizers, a bendable holder handle, and a sterilization tray
  • Mitral Hex End Rotators and Holder provide additional length and flexibility when needed for rotation of mitral valves
     

Important Safety Information

Risks: Certain complications may occur with heart valve procedures. The adverse events potentially associated with the use of mechanical heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.

It is possible that these complications could lead to: reoperation, explantation, permanent disability, or death.



REFERENCES

1

Van Nooten GJ, Caes F, Francois K, et al. Fifteen years’ single-center experience with the ATS bileaflet valve. J Heart Valve Dis. 2009;18(4):445-452.

2

ATS Medical, Inc. Pre-market Approval Application – Summary of Safety and Effectiveness: 2000. Washington D.C.: U.S. Food and Drug Administration; 2000.

3

Sezai A, Hata M, Niino T, et al. Fifteen years of experience with ATS mechanical heart valve prostheses. J Thorac Cardiovasc Surg. 2010;139:1494-1500.

4

Emery RW, Van Nooten GJ, Tesar PJ. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Ann Thorac Surg. 2003;75(2):444-452.

5

Emery RW, Petersen RJ, Kersten TE, et al. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Surgery Forum. 2001; 4(4):346-353.

6

Kelly SGD, Verdonck PR, Vierendeels JAM, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Int J Artif Organs. 1999; 22:754-763.

7

Shiono M, Sezai Y, Sezai A, et al. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Ann Thorac Cardiovasc Surg. 1996; 2(1):51-58.

8

Krian A. Clinical results of a large series of ATS valve implants. In: Krian A, Matloff JM, Nicoloff DM, eds. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71.

9

Emery RW, Krogh CC, Jones DJ, et al. Five-year follow up of the ATS mechanical heart valve. J Heart Valve Dis. 2004 Mar;13(2):231-238.

10

Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Eur J Cardio-thorac Surg. 1996(10):660-665.

11

Sezai A, Shiono M, Orime Y, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Ann Thorac Surg. 2000;69:507-512.