Ventricular Assist Devices

A ventricular assist device (VAD) is used to assist a damaged or weakened heart in pumping blood. VADs are used as either a bridge to a heart transplant, destination therapy, or for support of blood circulation postcardiotomy, which is the period following open-heart surgery.

VADs are covered only if they have received approval from the FDA for that purpose, and the VADs are used in accordance with the following FDA approved usages.

Covered Indications

1. Postcardiotomy ventricular dysfunction
   
   
2. Treatment of right heart failure following insertion of an implantable left ventricular device
   
   
3. Treatment of cardiogenic shock following cardiac transplantation
   
   
4. Bridge-to-Transplant
   
   

   All of the following criteria must be met in order for coverage to be provided for a VAD used as a bridge-to-transplant:

   • candidate for cardiac transplantation,
   • imminent risk of dying before donor heart procurement, and
   • dependence on, or incomplete response to, continued vasopressor support.

   Ventricular assist devices with FDA approval, including humanitarian device exemptions, may be considered medically necessary as a bridge to heart transplantation in children when used in accordance with the FDA’s Humanitarian Device Exception (HDE) requirements when all of the following are met:

   • age 5-16;
   • body surface area (BSA) ≥ 0.7 m² and < 1.5 m²;
   • in NYHA Class IV end-stage (i.e., left ventricular) heart failure refractory to medical therapy;
   • listed candidate for cardiac transplantation.

   Pediatric ventricular assist devices are contraindicated and are considered not medically necessary in children who meet any one of the following:

   • Are younger than 5 years old; OR
   • Have right ventricular failure; OR
   • Have a blood-clotting (primary coagulopathy) or platelet disorder such as hemophilia or Von Willebrand's disease; OR
   • Have a known allergy or sensitivity to the blood thinner heparin; OR
   • Have anatomical anomalies that would prevent surgical connection of the outflow graft to the ascending aorta.

   Only one ventricular assist device (VAD) has approval from the U.S. Food and Drug Administration (FDA) for the pediatric population. The DeBakey VAD® Child device has FDA approval (HDE process) for use in children ages 5 to 16 years who are awaiting a heart transplant, i.e., as a bridge to transplant.

5. Destination therapy - Defined as permanently implanting a device for patients who are not considered candidates for a heart transplant and have end-stage heart failure (an alternative to heart transplantation).

   All of the following criteria must be met for coverage to be provided for a VAD used as destination therapy:

   • The device has received FDA approval for a destination therapy indication; and
   • Member has New York Heart Association (NYHA) Class III or IV end-stage ventricular heart failure and is not a candidate for heart transplant; and
   • Member has failed to respond to optimal medical management (including beta-blockers, and angiotensin-converting enzyme (ACE) inhibitors if tolerated) for at least 45 of the last 60 days, or has been balloon pump dependent for 7 days, or has been IV inotrope dependent for 14 days; and
   • Has a left ventricular ejection fraction (LVEF) less than 25%; and
   • Has demonstrated functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min.
   • Is at least 18 years of age

   The exclusion criteria are:

   • Any medical condition that, if corrected, would improve heart function;
   • Any condition that could result in a poor surgical risk;
   • Prior cardiac transplant, left ventricular reduction, or cardiomyoplasty;
   • Stroke, impaired cognitive function, history of severe cerebral vascular disease;
   • Severe end organ damage.
     
     
6. Irreversible left ventricular congestive failure:
   
   
   • awaiting a donor heart for transplantation;
   • on the hospital's transplant list.

In addition, the TandemHeart (CardiacAssist) is a covered device specifically designed for short-term stabilization of patients in the postoperative setting. This device is unique in that it allows for percutaneous access through the femoral vein, permitting rapid deployment. In addition, it is the first ventricular assist device that uses continuous axial flow, as opposed to pulsatile flow.

For prolonged extracorporeal percutaneous transseptal ventricular assist device, use not otherwise classified code 33999.

The use of non-FDA approved or cleared ventricular assist device (VAD) is considered experimental/investigational and therefore, non-covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Total Artificial Hearts

The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed.  TAHs are covered only if they have received approval from the FDA for that purpose, and the TAHs are used in accordance with the following FDA approved usages.

Covered indications

Total artificial hearts with FDA-approved devices may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who have no other reasonable medical or surgical treatment options, who are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates, and not expected to survive until a donor heart can be obtained.

The use of total artificial hearts as destination therapy is considered experimental/investigational and therefore, non-covered. A participating, preferred, or network provider can bill the member for the non-covered service.

The use of non-FDA approved or cleared implantable total artificial hearts is considered experimental/investigational and therefore, non-covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Contraindications for Bridge-to-Transplant Ventricular Assist Devices and Total Artificial Hearts

• Conditions that would generally exclude patients for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. 
• Due to potential problems with adequate function of the VAD or TAH, implantation is also contraindicated in patients with uncorrected valvular disease.

Any artificial heart and or ventricular assist devices that do not meet the above coverage criteria will be considered experimental/investigational and therefore, non-covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Place of Service: Inpatient

Description

Artificial hearts and ventricular assist devices are devices which either replace all or part of a human heart, or assist the heart in performing its pumping function. Artificial hearts may be used as a permanent replacement for a human heart, or as a temporary life-support system until a human heart becomes available for transplant. Ventricular assist devices are used as a temporary method of supporting heart functions.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

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Left Ventricular Assist Device and Drug Therapy for the Reversal of Heart Failure, The New England Journal of Medicine, Vol. 355, No. 18, November 2, 2006

Left Ventricular Assist Devices as Destination Therapy: A New Look at Survival, The Journal of Thoracic and Cardiovascular Surgery, Vol. 129, No. 1: 9-17

Cardiac Replacement with a Total Artificial Heart as a Bridge to Transplantation, The New England Journal of Medicine, Vol. 351, No. 9, August 26, 2004

The Thoratec Implantable Ventricular Assist Device (IVAD): Initial Clinical Experience, The Heart Surgery Forum, Vol. 9, No. 4: E690-E692, June 2006

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Long JW, Healy AH, Rasmusson BY, et al. Improving outcomes with long-term “destination” therapy using left ventricular assist devices. J Thorac Cardiovasc Surg. 2008 June;135(6):1353-60.

John R, Kamdar F, Liao K, et al. Improved survival and decreasing incidence of adverse events with the HeartMate II left ventricular assist device as bridge-to-transplant therapy. Ann Thorac Surg. 2008 Oct;86(4):1227-34.

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Lam K, Sjauw KD, Henriques JP, et al. Improved microcirculation in patients with an acute ST-elevation myocardial infarction treated with the Impella LP2.5 percutaneous left ventricular assist device. Clin Res Cardiol. 2009;98(5):311-318.

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Heart Failure Society of America. HFSA 2010 Comprehensive heart failure practice guideline. J Card Fail. 2010 Jun;16(6):e1-194.

Morales DL, Zafar F, Rossano JW, et al. Use of ventricular assist devices in children across the United States: analysis of 7.5 million pediatric hospitalizations. Ann Thorac Surg. 01-OCT-2010;90(4):1313-8; discussion 1318-9.

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