BlueCross BlueShield of Tennessee Medical Policy Manual

Total Artificial Heart (TAH)

DESCRIPTION

Total artificial heart (TAH) is a pulsatile biventricular device that is implanted in the thoracic cavity to temporarily replace both native cardiac ventricles and all cardiac valves. The mechanical circulation support device is intended to act as a bridge to heart transplantation and perform the pumping function of a natural heart for an individual who is eligible for cardiac transplantation and at risk of imminent death from biventricular failure.

Currently, the SynCardia temporary Total Artificial Heart, formerly known as the CardioWest Total Artificial Heart, is the only TAH available in the United States.  The device was originally approved for in-hospital use.  In 2014, the FDA approved the SynCardia Freedom portable driver for use in individuals who have been implanted with the TAH and are clinically stable.  The portable driver allows the individuals to be discharged from the hospital while waiting for a donor heart.  The total artificial heart is intended for individuals who are not candidates for LVADs or BiVADs.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

SOURCES

American College of Cardiology Foundation/American Heart Association. (2013). 2013 ACCF/AHA guideline for the management of heart failure. Retrieved February 1, 2017 from http://circ.ahajournals.org/content/128/16/e240.

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2016). Total artificial hearts and implantable ventricular assist devices (7.03.11). Retrieved January 31, 2017 from BlueWeb. (80 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for artificial hearts and related devices (20.9). Retrieved February 1, 2017 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246&ncdver=6&DocID=20.9&from2=search.asp&bc=gAAAABAAAAAAAA%3d%3d&.

Copeland, J.G., Copeland, H., Gustafson, M., Mineburg, N., Covington, D., Smith, R.G., & Friedman, M. (2012). Experience with more than 100 total artificial heart implants. Journal of Thoracic Cardiovascular Surgery, 143 (3), 727-734. Abstract retrieved February 1, 2017 from PubMed database.

International Society for Heart and Lung Transplantation. (2013). The 2013 international society for heart and lung transplantation guidelines for mechanical circulatory support: executive summary. The Journal of Heart and Lung Transplantation, 32 (2), 157-187.

Nguyen, A., Pozzi, M., Mastroianni, C., Léger, P., Loisance, D., Pavie, A., et al. (2015). Bridge to transplantation using paracorporeal biventricular assist devices or the syncardia temporary total artificial heart: is there a difference? Journal of Cardiovascular Surgery (Torino), 56 (3), 493-502. Abstract retrieved February 3, 2017 from PubMed database.

Torregrossa, G., Anyanwu, A., Zucchetta, F., & Gerosa, G. (2014). Syncardia: the total heart. Art of Operative Techniques, 3 (6), 612-620. (Level 5 evidence)

U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological health. Pre-market approval decisions for October 2004. Retrieved February 1, 2017 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030011.

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, May; last update May 2016). Total artificial heart, temporary or permanent, biventricular mechanical circulatory support device. Retrieved February 1, 2017 from www.Hayesinc.com/subscribers (79 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  3/1996

MOST RECENT REVIEW DATE:  4/29/2017

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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