Ventricular Assist Devices (VAD) and Total Artificial Hearts (TAH)
DESCRIPTION
Ventricular assist devices (VAD) provide mechanical circulatory support for those individuals not expected to survive until a heart becomes available for their transplantation. VAD are used to sustain individuals awaiting heart transplantation, to facilitate cardiac recovery in individuals suffering from reversible cardiac dysfunction, and to provide permanent circulatory support in individuals with end-stage heart failure who are not candidates for transplantation. Examples of different ventricular assist devices are: CardioVAD™, CorAide™, HeartQuest™, LVAD, Heart Mate®, Novacor®, etc.
The 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 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 a cardiac transplantation and at risk of imminent death from biventricular failure. At this time there is no total artificial heart that has received FDA approval for long-term use. An example of a total artificial heart is the CardioWest Total Artificial Heart (TAH-t).
POLICY
Ventricular assist devices used as a bridge to heart transplantation for individuals with end-stage heart failure are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ventricular assist devices used as destination therapy for individuals with end-stage heart failure who are ineligible for human heart transplantation are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ventricular assist devices used in the post-cardiotomy setting for individuals who cannot be weaned off cardiopulmonary bypass is considered medically necessary.
Total artificial hearts used as a bridge to heart transplantation are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Other applications of left ventricular devices or total artificial hearts are considered investigational, including but not limited to the use of total artificial hearts as destination therapy.
Any ventricular assist device or total artificial heart utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
MEDICAL APPROPRIATENESS
Ventricular assist devices are considered medically appropriate if ALL of the following conditions are met.
Ventricular assist devices are considered medically appropriate for ANY ONE of the following conditions:
Ventricular assist devices used as a bridge to heart transplantation are considered medically appropriate for an individual if ANY ONE of the following criteria are met:
Diagnosis of severe congestive heart failure and approved heart transplantation candidate on the transplantation list
Imminent risk of dying before donor heart procurement
Receiving optimal inotropic support and, if possible, is on an intra-aortic balloon pump (IABP)
Meets the selection criteria for Heart Transplantation
Ventricular assist devices used as destination therapy are considered medically appropriate if ALL of the following criteria are met:
Class IV heart failure symptoms and failure to respond to optimal medical management including dietary salt restriction, diuretics, digitalis, beta-blockers, and ACE inhibitors (if tolerated) for at least 60 of the last 90 days
Demonstrated functional limitation with a peak oxygen consumption of less than 12 ml/kg/min or has the continued need for IV inotropic therapy owing to symptomatic hypotension, decreasing renal function or worsening pulmonary congestion
Life expectancy of less than 2 years and not a candidate for heart transplantation;
Appropriate body size (greater than or equal to 1.5 m2) to support the VAD implantation
ABSENCE of ALL of the following contraindications:
Severe irreversible hepatic or renal dysfunction
Respiratory failure
Systemic infection
Current, untreated malignancy
Uncorrected valvular disease (this is due to potential problems with adequate function of the VAD)
Total artificial hearts used as a bridge to heart transplantation are considered medically appropriate if ALL of the following criteria are met:
The Individual is in Imminent risk of death from biventricular failure
Is an approved heart transplantation candidate on the transplantation list
Meets the selection criteria for Heart Transplantation
Has sufficient space in the chest area vacated by the natural ventricles (generally body surface areas greater than 1.7 m2 and a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging greater than or equal to 10cm) to support the TAH
Is capable of adequate anti-coagulation on the total artificial heart
ADDITIONAL INFORMATION
There is inadequate scientific evidence to permit conclusions regarding the use of ventricular assist devices or total artificial hearts for other conditions or disease including, but not limited to the use of total artificial hearts as destination therapy.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2008). Ventricular assist devices and total artificial hearts (7.03.11). Retrieved April 22, 2009 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2008, November). Artificial hearts and related devices (NCD 20.9, p. 2-16 to 2-17). The Ingenix Complete Guide to Medicare Coverage Issues.
Copeland, J. G., Smith, R. G., Arabia, F. A., Nolan, P. E., Sethi, G. K., Tsau, P. H., et al. (2004). Cardiac replacement with a total artificial heart as a bridge to transplantation. The New England Journal of Medicine, 351(9), 859 - 86. (Level 4 Evidence)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2007, January). Artificial heart as a bridge to transplantation. Retrieved February 26, 2007 from ECRI Institute. (14 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2007, January). Permanent total artificial heart (TAH) for irreversible heart failure. Retrieved February 26, 2007 from ECRI Institute. (17 articles and/or guidelines reviewed)
El-Banayosy, A., Arusoglu, L., Kizner, L., Tenderich, G., Minami, K., Inoue, K., et al. (2000). Novacor left ventricular assist system versus HeartMate vented electric left ventricular assist system as a long-term mechanical circulatory support device in bridging patients: A prospective study. Journal of Thoracic and Cardiovascular Surgery, 119 (3), 581 - 587. (Level 4 Evidence)
Hayes. Medical Technology Directory. (2005, July). Total Artificial Heart, Temporary or Permanent Biventricular Support Device. Retrieved February 27, 2007 from www.Hayesinc.com/subscribers. (44 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2005, May). Ventricular Assist Devices. Retrieved April 16, 2009 from www.Hayesinc.com/subscribers. (98 articles and/or guidelines reviewed)
Hirsch, D. J., & Cooper, J. R. (2003). Cardiac failure and left ventricular assist devices. Anesthesiology Clinics of North America, 21 (3), 625 - 638. (Level 5 Evidence)
Oz, M. C., Gleijns, A. C., Miller, L., Wang, C., Nickens, P., Arons, R., et al. (2003). Left ventricular assist devices as permanent heart failure therapy: The price of progress. Annals of Surgery, 238 (4), 577 - 583. (Level 5 Evidence)
Rose, E. A., Gelijns, A. C., Moskowitz, A. J., Heitjan, D. F., Stevenson, L. W., Dembitsky, W., et al. (2001). Long-term use of left ventricular assist device for end-stage heart failure. The New England Journal of Medicine, 345 (20), 1435 - 1443. (Level 4 Evidence)
The Technology Evaluation Center. (2002, December). Left-ventricular assist devices as destination therapy for end-stage heart failure (Vol. 17, No. 19). Chicago: BlueCross BlueShield Association. (13 articles and/ or guidelines reviewed)
The Technology Evaluation Center. (2004, April). Special report: Cost-effectiveness of left-ventricular assist devices as destination therapy for end-stage heart failure (Vol. 19, No. 2). Chicago: BlueCross BlueShield Association. (21 articles and / or guidelines reviewed)
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. National Coverage Analyses. (May 2008). NCD for Artificial Hearts and Related Devices (20.9). Retrieved April 16, 2009 from http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=20.9&ncd_version=4&basket=ncd%3A20%2E9%3A4%3AArtificial+Hearts+and+Related+Devices.
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. National Coverage Analyses. (May 2008). NCD for Heart Transplants (260.9). Retrieved April 16, 2009 from http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=260.9&ncd_version=3&basket=ncd%3A260%2E9%3A3%3AHeart+Transplants.
U. S. Food and Drug Administration. (1998, May). Center for Devices and Radiological Health. Summary of safety and effectiveness data. Retrieved April 22, 2009 from http://www.fda.gov/cdrh/pdf/p870072s005b.pdf.
U. S. Food and Drug Administration. (2004, February). Center for Devices and Radiological Health. FDA talk paper. Retrieved April 22, 2009 from http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01280.html.
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. Summary of safety and effectiveness data. Retrieved April 22, 2009 from http://www.fda.gov/cdrh/PDF3/P030011b.pdf.
ORIGINAL EFFECTIVE DATE: 3/1996
MOST RECENT REVIEW DATE: 6/11/2009
ID_BT
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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