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 fulfilled 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.
     
     
5. Destination therapy - Defined as permanently implanting a device for patients who are not considered candidates for a heart transplant.

   Both of the following criteria must be met:

   1. The patient has end-stage heart failure; and,
      
      
   2. The patient is not eligible for cardiac transplantation.

   In addition to the criteria listed above, the following enrollment criteria must be met:

   • At least 18 years of age;
   • Chronic heart failure (NYHA Class IV or III on inotropes/IABAP);
   • Patients ineligible for cardiac transplant due to age, diabetes, kidney failure, or other co-morbidity;
   • Receiving therapeutic doses of: diuretics, ACE Inhibitors (unless intolerant), and angiotensin receptive blockers (ARBs);
   • Left Ventricular Ejection Fraction ≤ 25%;
   • VO2 max ≤ 14 ml/kg/min (unless failed inotrope wean).

   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.

Total artificial hearts in which the recipient undergoes a cardiectomy, represent a natural extension of ventricular assist devices as destination therapy. The CardioWest Total Artificial Heart is a covered device specifically as a bridge to transplantation. This device is unique in that a pulsatile biventricular device is placed after the native ventricles are excised. The labeled indication states that this device should only be used in an inpatient setting.

Total artificial hearts with FDA-approved devices may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who are currently listed as heart transplant candidates.

Other artificial hearts and other ventricular assist devices are still considered experimental/investigational as they do not have FDA approval. Therefore, claims reporting services in connection with the implantation of these devices should be denied.

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

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.

Results of a Multicenter Clinical Trial with the Thoratec Implantable Ventricular Assist Device, The Journal of Thoracic and Cardiovascular Surgery, Vol. 133, No. 6: 1573-1580

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

Birks EJ, et al. Left Ventricular Assist Device and Drug Therapy for the Reversal of Heart Failure. The New England Journal of Medicine. 2007 Mar;355(18):1873-1884.

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.