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Medical Policy: 07.03.02
Original Effective Date: September 1996
Reviewed: December 2011
Revised: December 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Ventricular assist devices (VAD) are a method of providing mechanical circulatory support for those patients not expected to survive until a heart becomes available for their transplant.
A number of devices have received approval from the U.S. Food and Drug Administration (FDA), including biventricular and left ventricular devices, as well as devices that are intended to be used in the hospital and outpatient setting.
Left ventricular assist devices (LVAD) are most commonly used as a bridge to transplantation. The successful use of LVADs for prolonged periods of time has led to their use as permanent or "destination" therapy for patients with end-stage heart disease who are not candidates for heart transplant due to age or other co-morbidity.
Total artificial hearts, in which the recipient undergoes cardiectomy, represents a natural extension of ventricular assist devices as destination therapy. In 2004, the CardioWest™ Total Artificial Heart received FDA approval as a bridge to donor heart transplantation. This device is unique in that a pulsatile biventricular device is placed after the native ventricles are excised. The FDA approved indication states that this device should only be used in an inpatient setting.
The FDA has granted a humanitarian use device exemption to the AbioCor® Implantable Replacement Heart. This device is the first implantable artificial heart designed as destination therapy for patients.
Percutaneous ventricular assist devices (pVAD)s have been developed for short-term use in patients who require acute circulatory support. These devices are placed through the femoral artery. Two different pVADs have been developed, the TandemHeart™ (Cardiac Assist™, Pittsburgh, PA), and the Impella® device (AbioMed™, Aachen, Germany). In the TandemHeart™ system, a catheter is introduced through the femoral artery and passed into the left atrium via transseptal puncture. Oxygenated blood is then pumped from the left atrium into the arterial system via the femoral artery. The Impella device is also introduced through a femoral artery catheter. In this device, a small pump is contained within the catheter that is placed into the left ventricle. Blood is pumped from the left ventricle, through the device, and into the ascending aorta. Adverse events associated with pVAD include access site complications such as bleeding, aneurysms, or leg ischemia. Cardiovascular complications can also occur, such as perforation, myocardial infarction (MI), stroke, and arrhythmias.
There are several situation in which pVAD may offer possible benefits: cardiogenic shock that is refractory to medications and intra-aortic balloon pump (IABP); cardiogenic shock, as an alternative to IABP; and high-risk patients undergoing invasive cardiac procedures who need circulatory support.
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Prior Approval:
Not applicable
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Policy:
Ventricular assist devices may be considered medically necessary as a bridge to heart transplantation for patients who are currently listed as heart transplantation candidates.
Ventricular assist devices may be considered medically necessary in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.
Ventricular assist devices may be considered medically necessary as destination therapy for patients with end-stage heart failure who are ineligible for human heart transplant and who meet the following criteria*:
- New York Heart Association (NYHA) class IV heart failure for 60 days or longer, OR patients in NYHA class III/IV for 28 days, received 14 or more days of support with intraaortic balloon pump or dependent on IV inotropic agents, with 2 failed weaning attempts
In addition, patients must not be candidates for human heart transplant for one or more of the following reasons:
- Age greater than 65 years
- Insulin dependent diabetes mellitus with end-organ damage
- Chronic renal failure (serum creatinine greater than 2.5 mg/dL for 90 days or longer
- Presence of another clinically significant condition
*Patient selection criteria based on the REMATCH study.
Temporary total artificial hearts may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who are currently listed as heart transplantation candidates.
Use of the AbioCor® Implantable Replacement Heart is subject to individual review in accordance with Wellmark medical policy 10.01.14 Humanitarian Use Devices.
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.
Percutaneous ventricular assist devices (pVADs) are considered investigational for all indications.
The evidence on percutaneous ventricular assist devices does not support that these devices improve health outcomes. Three randomized controlled trials of pVAD versus intra-aortic balloon pump for patients in cardiogenic shock failed to demonstrate a mortality benefit and reported higher complications associated with pVAD use. A moderately large RCT of pVAD support versus usual care in patients undergoing high-risk PCI procedures was terminated early due to futility. It was determined that the study would not meet the prespecified endpoint of 10% absolute decrease in complications. Case series of patients with cardiogenic shock refractory to IABP have reported improved hemodynamic parameters following pVAD placement. However, these uncontrolled series cannot determine if pVAD improves mortality, and high rates of complications are reported with pVAD use. Because of the lack of demonstrated benefits in high-quality trials, and the high complication rates reported, the use of pVAD for all indications is considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 33975 Insertion of ventricular assist device; extracorporeal, single ventricle
- 33976 Insertion of ventricular assist device; extracorporeal, biventricular
- 33977 Removal of ventricular assist device; extracorporeal, single ventricle
- 33978 Removal of, ventricular assist device; extracorporeal, biventricular (Removal of the device prior to heart transplantation is considered part of the global fee and incidental to the heart transplant)
- 33979 Insertion of ventricular assist device, implantable intracorporeal, single ventricle
- 33980 Removal of ventricular assist device, implantable intracorporeal, single ventricle
- 33981 Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump
- 33982 Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass
- 0048T Implantation of a VAD, extracorporeal, percutaneous transseptal access, single or dual cannulation
- 0050T Removal of VAD, extracorporeal, percutaneous transseptal access, single or dual cannulation
- 0051T implantation of a total replacement heart system (artificial heart) with recipient cardiectomy
- 0052T replacement or repair of thoracic unit of a total replacement heart system
- 0053T replacement or repair of implantable component or components of total replacement heart system, excluding thoracic unit
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Selected References:
- Meyns B, Sergeant P, Herijgers P, Flament W, VanHaecke J, Van Cleemput J, Droogne W. Daenen W. Bridging procedures to heart transplantation. World Journal of Surgery, February 2002; 26 (2): 212-7.
- Piccione W Jr. Bridge to transplant with the HeartMate device. Journal of Cardiac Surgery; 2001; 16(4): 272-9.
- Franco KL. New devices for chronic ventricular support. Journal of Cardiac Surgery; 2001 May-Jun; 16(3): 178-92.
- TARGET [database online].Plymouth Meeting (PA): ECRI; June, 2006. Artificial heart as bridge to transplantation. Target Report 868; Available: http://www.ecri.org.
- Copeland JG, Smith RG, Arabia FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004; 351(9):859-67.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; September, 2006. Total artificial heart (TAH) for irreversible heart failure. Target Report 867; Available: http://www.ecri.org.
- Samuels L. The AbioCor totally implantable replacement heart. Am Heart Hosp J. 2003 Winter;1(1):91-6.
- Copeland JG, Arabia FA, et al. Total artificial hearts: bridge to transplantation. Cardiol Clin. 2003 Feb;21(1):101-13.
- Dowling RD, Gray LA Jr, et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg. 2004 Jan;127(1):131-41.
- Frazier OH, Dowling RD, et al. The total artificial heart: where we stand. Cardiology. 2004;101(1-3):117-21.
- Rose EA, Gelijns AC, Moskowitz AJ et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001; 345(20):1435-43.
- ECRI Institute. Tandemheart percutaneous ventricular assist device for heart failure/cardiogenic shock. Plymouth Meeting (PA): ECRI Institute; 2010 March 15. 6 p. [ECRI hotline response]. Also available: http://www.ecri.org.
- ECRI Institute. Ventricular assist devices as destination therapy for irreversible heart failure. Plymouth Meeting (PA): ECRI Institute; 2010 March 9. 6p. [ECRI hotline response]. Also available: http://www.ecri.org.
- Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2004 Sep 9. [updated 2010 Apr 20]. Artificial heart as a bridge to transplantation. Available: http://www.ecri.org.
- TARGET [database online]. Plymouth Meeting (PA); ECRI Institute; 2007 Nov 6. [updated 2010 Jun 29]; Ventricular-assist devices (CentriMag) as temporary support for severe heart failure. Available: http://www.ecri.org
- Schwartz BG, Ludeman DJ, Mayeda GS et al. High-risk percutaneous coronary intervention with the TandemHeart and Impella devices: a single-center experience. J Invasive Cardiol. 2011 Oct; 23(10):417-24.
- Arroyo D, Cook S. Percutaneous ventricular assist devices: new deus ex machina? Minim Invasive Surg. 2011;2011:604397. Epub 2011 Jul 31.
- Shavelle DM, Clavijo L, Matthews RV. Percutaneous devices to support the left ventricle. Expert Rev Med Devices. 2011 Nov; 8(6):681-94.
- Basra SS, Loyalka P, Kar B. Current status of percutaneous ventricular assist devices for cardiogenic shock. Curr Opin Cardiol. 2011 Nov;26(6):548-54.
- Kapur NK, Paruchuri V, Korabathina R et al. Effects of a percutaneous mechanical circulatory support device for medically refractory right ventricular failure. J heart Lung Transplant. 2011 Dec;30(12):1360-7. Epub 2011 Aug 24.
- Burkhoff D, Cohen H, Brunckhorst C et al. A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock. Am Heart J. 2006 Sep;152(3):469.e1-8.
- Seyfarth M, Sibbing D, Bauer I et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. 2008 Nov 4; 52(19):1584-8.
- Thiele H, Sick P, Boudriot E et al. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J 2005; 26(13):1276-83.
- Cheng JM, den Uil CA, Hoeks SE et al. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a meta-analysis of controlled trials. Eur Heart J 2009; 30(17):2102-8.
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Policy History:
Date Reason Action
December 2010 Annual review Policy renewed
December 2011 Annual review Policy revised
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
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and, therefore, cannot guarantee any results or outcomes.
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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