Frequently Asked Questions

Non-clinical testing has demonstrated that St. Jude Medical® heart valves and repair devices are MR Conditional. They can be scanned safely under the following conditions:

• Static magnetic field of 3 Tesla or less
• Spatial gradient of 525 Gauss/cm or less
• Maximum whole-body-averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning

In non-clinical testing, St. Jude Medical valves and repair devices produced a temperature rise of less than or equal to 0.5˚ C at a maximum whole body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 3-Tesla Signa model (GE) MR scanner. MR image quality may be compromised if the area of interest is the exact same area or relatively close to the position of the device.

Review heart valve model numbers.

MRI safety document – St. Jude Medical Valves and Annuloplasty Rings During MRI [PDF]

Yes. The leaflets of the St. Jude Medical valve are impregnated with a small amount of tungsten to allow X-ray visualization. In addition, rotatable valves (SJM® Masters Series and SJM Regent® Valves) incorporate a radiopaque mechanism that allows visualization of the valve orifice.

St. Jude Medical does not make recommendations regarding patient anticoagulation. We urge you to contact your physician directly regarding any questions specific to your particular situation.

Additional resources on International Normalized Ratios (INR) guidelines are available at:

American Heart Association -
http://www.acc.org/clinical/guidelines/valvular/Valvularpocketguide.pdf

American College of Chest Physician's Guidelines -
http://www.chestjournal.org/cgi/reprint/126/3_suppl/457S

St. Jude Medical, as a manufacturer, does not provide clinical or medical treatment recommendations to patients.

In each case, a risk or benefit assessment must be made to determine whether anticoagulant medication should be temporarily discontinued, reduced, or replaced by heparin or another substitute therapy. While St. Jude Medical does not make anticoagulation treatment recommendations, the following studies report on the safety of temporary discontinuation and the resulting thromboembolic rates in patients with mechanical valves.

References
Tinker, et al.: Discontinuing anticoagulant therapy in surgical patients with cardiac valve prostheses. JAMA 1978;239(8):738-739.

Goldenberg, et al.: Safety of temporary discontinuation of oral anticoagulation in patients with St. Jude Medical prosthetic valves. J Am Coll Cardiol 1990;15:237A.

Saour, et al.: Dental procedures in patients receiving oral anticoagulation therapy. J Heart Valve Dis 1994;3(3):315-317.

Stein, et al.: Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 1995;108(4 suppl):S371-S379.

Two prominent facilities, one in the United States and one in France, collected data on pressure gradients found in patients who had received St. Jude Medical mechanical heart valves and summarized their findings in the following charts, based on whether patients had received an aortic or mitral valve.

Table 1 – Shows Doppler ECHO findings according to valve size in 180 patients with normally functioning St. Jude Medical® standard aortic valve prostheses.¹ Values are expressed as mean±standard deviation. Gradients are representative of other studies.

Table 2 – Shows Doppler-derived mean St. Jude Medical® mitral valve transvalvular gradients.²

¹Perin, et al.: Doppler echocardiography in 180 normally functioning St. Jude Medical aortic valve prostheses. Early and late postoperative assessments. Chest 1991;100(4):988-990.

²Habib, et al.: Assessment of normal and abnormal prosthetic mitral valves by Doppler echocardiography. Doppler in prosthetic mitral valves. Int J Card Imaging 1990-1991;6(1):11-21.

The St. Jude Medical mechanical valve sizer set (model 905) is supplied in non-sterile condition and must be cleaned and sterilized with steam (autoclaving) prior to each use. The recommended steam sterilization parameters are as follows:

Dry time, following completion of the sterilization time, may vary due to differences between sterilizers and load configurations. Contact your sterilizer manufacturer for more information regarding sterilization procedures.

Note: The temperature cannot exceed 137° C (280° F). Ethylene oxide (ETO) sterilization is contraindicated.

St. Jude Medical mechanical valves are supplied sterile and ready for use. If resterilization is necessary, use only the recommended steam cycles and follow the instructions below. The St. Jude Medical mechanical valve must not be resterilized more than once (one time).

1. Remove both the inner tray containing the valve and the inner tray seal.
2. Place the inner tray inside a sterilization bag for sterilization. Exercise extreme care when handling the valve assembly to avoid structural damage to the valve.
3. Follow these recommended sterilization cycle parameters for St. Jude Medical mechanical heart valves:

St. Jude Medical does not validate ETO sterilization methods.

Hospitals are encouraged to return valves to St. Jude Medical for resterilization rather than resterilizing the valves themselves. Contact your local St. Jude Medical sales representative. For contact info, go to Locations.

The St. Jude Medical sizer (model 905) is used for all St. Jude Medical mechanical heart valves. The barrel of the sizer is used to measure the annulus. The flanged end may be used to show the positioning of the supra-annularly cuffed valve about the annulus.

The mitral expanded cuff has 25% more cuff material. The aortic has 10% more.

There have been no studies performed with St. Jude Medical heart valves to determine their safety under the impact of a deployed airbag. It is possible that a sudden blunt force to the chest may inflict internal damage to the heart and possibly interfere with a prosthetic valve. It is also possible that the benefits of airbags may prevent blunt force to the chest and protect the heart and the heart valve.

In a clinical study of 95 patients with 6 different mechanical valve types, St. Jude Medical mechanical heart valves were the quietest.

BlomeEberwein et al, Impact of mechanical heart valve prosthesis sound on patients' quality of life. Annals of Thoracic Surgery 1996; 61(2):594-602

No.