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DESCRIPTIONSurgical ventricular restoration (SVR) is a procedure designed to restore or remodel the left ventricle to its normal, spherical shape and size in patients with akinetic segments of the heart, secondary to either dilated cardiomyopathy or post-infarction left ventricular aneurysm. The SVR procedure is usually performed after coronary artery bypass grafting (CABG) and may proceed or be followed by mitral valve repair or replacement and other procedures such as endocardectomy and cryoablation for treatment of ventricular tachycardia. A key difference between surgical ventricular restoration and ventriculectomy (i.e., for aneurysm removal) is that in SVR, the ventricle is reconstructed using patches of autologous or artificial material that are placed to close the defect while maintaining the desired ventricular volume and contour. In addition, SVR is distinct from partial left ventriculectomy (i.e., the Batista procedure, see the Partial Left Ventriculectomy policy), which does not attempt to specifically resect akinetic segments and restore ventricular contour.
The SVR procedure may also be referred to as ventricular remodeling, surgical anterior ventricular endocardial restoration (SAVER), or the Dor procedure after Vincent Dor, MD. Dr. Dor pioneered the expansion of techniques for ventricular reconstruction and is credited with treating congestive heart failure patients with SVR in conjunction with CABG.
The CorRestore™ Patch System is a device approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process that is specifically labeled for use “as an intracardiac patch for cardiac reconstruction and repair.” The device consists of an oval tissue patch made from glutaraldehyde-fixed bovine pericardium. It is identical to other marketed bovine pericardial patches except that it incorporates an integral suture bolster in the shape of a ring that is used along with ventricular sizing devices, to restore the normal ventricular contour.
POLICYSurgical ventricular restoration is considered investigational for the treatment of ischemic dilated cardiomyopathy or post-infarction left ventricular aneurysm.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/11/2008: Policy added
11/20/2008: Approved by Medical Policy Advisory Committee (MPAC)
04/23/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
09/28/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
10/22/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Policy # 7.01.103
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.