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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 may also be referred to as ventricular remodeling, surgical anterior ventricular endocardial restoration (SAVER), left ventricular reconstructive surgery, left ventricular aneurysmectomy reconstruction, endoventricular circular plasty, or the Dor procedure after Vincent Dor, MD. Dr. Dor pioneered the expansion of techniques for ventricular reconstruction and is credited with treating heart failure patients with SVR in conjunction with coronary artery bypass grafting (CABG).
The SVR procedure is usually performed after 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, circular “purse string” suturing is used around the border of the aneurysmal scar tissue. Tightening of this suture is believed to isolate the akinetic or dyskinetic scar, bring the healthy portion of the ventricular walls together, and restore a more normal ventricular contour. If the defect is large (ie, an opening >3 cm), the ventricle may also be reconstructed using patches of autologous or artificial material to maintain the desired ventricular volume and contour during closure of the ventriculotomy. In addition, SVR is distinct from partial left ventriculectomy (ie, the Batista procedure), which does not attempt to specifically resect akinetic segments and restore ventricular contour.
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.
Surgical ventricular restoration involves increased physician work compared with standard ventriculectomy. For example, the procedure includes evaluation of the ventricular septum and reshaping of the geometry of the heart. Surgical ventricular restoration is described as a global treatment of left ventricular failure, while conventional left ventricular aneurysmectomy represents a local treatment of a transmural infarct.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
10/08/2014: Policy reviewed; description updated. Policy statement unchanged. Policy guidelines updated.
08/27/2015: Code Reference section updated to add ICD-10 codes.
10/22/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
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.