Total Artificial Heart (TAH)
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.
Total artificial heart is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Total artificial heart for use as destination therapy is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Total artificial heart is considered medically appropriate if ALL of the following are met:
Used as a bridge to heart transplant
Imminent risk of death from biventricular failure with no other appropriate medical or surgical options
Meets selection criteria for heart transplantation - Refer to MCG Care Guidelines Heart Transplant guideline
Has sufficient space in the chest area vacated by the natural ventricles (general body surface areas greater than 1.7 m2 and a distance between the sternum and 10th anterior rib greater than or equal to 10cm) measured by computed tomography imaging
Ineligible for other univentricular or biventricular devices
Survival is not expected unless a donor heart can be obtained
ABSENCE of other clinically significant conditions, including, but not limited to, ALL of the following:
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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. Evidence Positioning System. (8:2018). Total artificial hearts and implantable ventricular assist devices (7.03.11). Retrieved January 2, 2019 from https://www.evidencepositioningsystem.com/ (84 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.
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.
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 2018). Total artificial heart, temporary or permanent, biventricular mechanical circulatory support device. Retrieved January 2, 2019 from www.Hayesinc.com/subscribers. (79articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1996
MOST RECENT REVIEW DATE: 2/14/2019
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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