Surgical Ventricular Restoration
DESCRIPTION
Surgical 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 in conjunction with coronary artery bypass grafting (CABG) and other procedures, such as mitral valve repair or replacement, using an oval tissue patch made of glutaraldehyde-fixed bovine pericardium (e.g., CorRestore™ Patch System) or artificial material (e.g., TR3ISVR™ Surgical Ventricular Restoration System) when reconstructing the left ventricle.
The SVR procedure is also referred to as ventricular remodeling, ventricular reduction surgery, surgical anterior ventricular endocardial restoration (SAVER), endoventricular circular patch or the Dor procedure.
POLICY
Surgical ventricular restoration for the treatment of other conditions/diseases, including, but not limited to, ischemic dilated cardiomyopathy and post-infarction left ventricular aneurysm is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
No randomized controlled trials comparing SVR to other surgical or medical technologies were found in the available data to permit conclusions regarding the efficacy of SVR.
SOURCES
American Heart Association. (2009). 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults. Retrieved July 19, 2011 from http://circ.ahajournals.org/content/119/14/e391.full.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2010). Surgical ventricular restoration (7.01.103). Retrieved July 19, 2011 from BlueWeb. (17 articles and/or guidelines reviewed)
Castelvecchio, S., Menicanti, L., & Donato, M. D. (2010). Surgical ventricular restoration to reverse left ventricular remodeling. Current Cardiology Reviews, 6 (1), 15-23.
Cirillo, M. (2009). A new surgical ventricular restoration technique to reset residual myocardium's fiber orientation: The "KISS" procedure. Annals of Surgical Innovation and Research, 3 (6).
Jones, R. H., Velazquez, E. J., Michler, R. E., Sopko, G., Oh, J. K., O’Connor, C. M., et al. Coronary bypass surgery with or without surgical ventricular reconstruction. The New England Journal of Medicine, 360 (17), 1705-1717.
Shanmugam, G. & Ali, I. S. (2009). Surgical ventricular restoration: An operation to reverse remodeling - the basic science (Part I). Current Cardiology Reviews, 5 (4), 343-349.
Shanmugam, G. & Ali, I. S. (2009). Surgical ventricular restoration: An operation to reverse remodeling - clinical application (Part II). Current Cardiology Reviews, 5 (4), 350-359.
U. S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082139. Retrieved July 21, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/k040162.pdf.
U. S. Food and Drug Administration. (2004, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040162. Retrieved July 21, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082139.pdf.
ORIGINAL EFFECTIVE DATE: 8/12/2006
MOST RECENT REVIEW DATE: 8/11/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.