CAM 70160

Dynamic Cardiomyoplasty

Category:Surgery   Last Reviewed:August 2019
Department(s):Medical Affairs   Next Review:August 2999
Original Date:November 1997    

Description:
Dynamic cardiomyoplasty is a surgical technique that uses paced, conditioned skeletal muscle to reinforce the failing heart. Briefly, the surgical procedure is as follows: the left latissimus dorsi, the muscle most commonly used, is dissected from its surrounding tissues, preserving the neurovascular bundle. The muscle is then transposed into the left hemithorax through a window created by partial resection of an adjacent rib. A median sternotomy is then performed to provide access to the heart. The latissimus dorsi is wrapped around the ventricular surface. After a 2-week postoperative period to allow for adhesion between the latissimus dorsi and heart, the skeletal muscle is electrostimulated and conditioned to induce fatigue resistance. An epicardial lead attached to the right ventricle, pacing leads attached to the muscle itself and an implanted pacemaker provide the electrostimulation. The conditioning program requires about 2 to 3 months. After that time, the skeletal muscle graft can be paced synchronously with the heart.

Cardiomyoplasty requires the use of a unique pacemaker manufactured by Medtronic (the Cardiomyostimulator), which has not yet received approval from the U.S. Food and Drug Administration (FDA). Thus, at the present time, cardiomyoplasty is only offered in the context of an FDA investigational device exemption (IDE) trial.

Policy:
Dynamic cardiomyoplasty is considered INVESTIGATIONAL

Rationale
At the present time, dynamic cardiomyoplasty is being investigated as an alternative to medical therapy or as an alternative/bridge to heart transplantation in patients with congestive heart failure, particularly given the shortage of donor hearts for transplant. Thus, pertinent outcomes include improvement in hemodynamics of the heart, patient functional capacity and long-term survival rates compared to medical management or transplantation.

Most recently, Furnary and colleagues have reported on a multicenter trial of cardiomyoplasty in 68 patients, comparing outcomes to a non-randomized group of patients with heart failure. (1) There were modest improvements in various hemodynamic measures, such as left ventricular ejection fraction. Modest improvements were also noted in the New York Heart Association Function class and activity of daily living score. However, there was no difference in 12-month mortality between the 2 groups. This lack of effect on mortality may be related to the fact that cardiomyoplasty does not address the underlying cardiac pathology, and patients remain at risk for lethal arrhythmias, a major cause of death in patients with congestive heart failure. Some investigators have hypothesized that any improvement may be primarily related to a simple girdling effect of the wrapped latissimus dorsi muscle, which interrupts further dilation of the heart. If this is true, then the primary effect of cardiomyoplasty occurs during diastole, not systole, and pacing of the latissimus dorsi may be unnecessary. In addition, there may be simpler methods to provide a girdling effect. It should also be noted that this study focused on patients with Class III heart failure, since prior studies had shown an unacceptably high mortality rate among patients with Class IV heart failure undergoing cardiomyoplasty. Patients with Class III heart failure are also those who respond well to medical management. (2-6)

Finally, at the present time, dynamic cardiomyoplasty requires the use of a unique pacing device, the Cardiomyostimulator, which has not received final FDA approval.

References:

  1. Furnary AP, Jessup FM, Moreira LP. Multicenter trial of dynamic cardiomyoplasty for chronic heart failure. J Am Coll Cardiol 1996; 28(5):1175–80.
  2. Leier CV. Cardiomyoplasty: is it time to wrap it up? J Am Coll Cardiol 1996; 28(5):1181–2.
  3. Letsou GV, Austin L, Grandjean PA et al. Dynamic cardiomyoplasty. Cardiol Clin 1995; 13(1):121–4.
  4. Silverman NA. Invited letter concerning: clinical and left ventricular function outcomes up to five years after dynamic cardiomyoplasty. J Thorac Cardiovasc Surg 1995; 109(2):397–8.
  5. Moreira LF, Stolf NA, Bocchi EA et al. Clinical and left ventricular function outcomes up to five years after dynamic cardiomyoplasty. J Thorac Cardiovas Surg 1995; 109(2):353–63.
  6. Kass DA, Baughman KL, Pak PH et al. Reverse remodeling from cardiomyoplasty in human heart failure. External constraint versus active assist. Circulation 1995; 91(9):2314–8.

Coding Section

Codes Number Description
CPT 33999 Unlisted procedure, cardiac surgery
ICD-9 Procedure   No Code
ICD-9 Diagnosis   Investigational for all codes
HCPCS   No Code
ICD-10-PCS (effective 10/01/15)   No Code
ICD-10-CM (effective 10/01/15)   Investigational for all codes
Type of Service Cardiac Surgery  
Place of Service Inpatient  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

08/07/2019 

Annual review, no change to policy intent. 

08/28/2018 

Annual review, no change to policy intent. 

08/23/2017

Annual Review. No change in policy intent. 

08/09/2016 

Annual review, no change to policy intent. 

08/10/2015 

Annual review, no change to policy intent. Added coding.

08/06/2014

Annual review, no changes made.

 


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