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.
ADDITIONAL INFORMATION
No randomized controlled trials comparing SVR to other surgical or medical technologies were found in the available data to permit conclusions of the efficacy of SVR.
SOURCES
Alfieri, O., Maisano, F., & Schreuder, J. J. (2003). Surgical methods to reverse left ventricular remodeling in congestive heart failure. The American Journal of Cardiology, 91 (9A), 81-87.
American College of Cardiology and the American Heart Association. (2005, August). ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult. Retrieved December 27, 2005 from http://content.onlinejacc.org/cgi/reprint/46/6/e1. (694 articles and/or guidelines reviewed)
Athanasuleas, C. L., Buckberg, G. D., Stanley, A. W., Siler, W., Dor, V., Di Donato, M., et. al. (2004). Surgical ventricular restoration in the treatment of congestive heart failure due to post-infarction ventricular dilation. Journal of the American College of Cardiology, 44 (7), 1439-1445.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2007). Surgical ventricular restoration (7.01.103). Retrieved February 5, 2008 from BlueWeb. (13 articles and/or guidelines reviewed)
Di Donato, M., Frigiola, A., Benhamouda, M., & Menicanti, L. (2004). Safety and efficacy of surgical ventricular restoration in unstable patients with recent anterior myocardial infarction. Circulation, 110 (Suppl.II), 169-173.
Hayes. Medical Technology Directory. (2003, August). Ventricular reduction surgery. Retrieved December 27, 2005 from http://www.Hayesinc.com/subscribers. (29 articles and/or guidelines reviewed)
Hayes. Updater Search. (2008, January). Ventricular reduction surgery. Retrieved February 5, 2008 from http://www.Hayesinc.com/subscribers. (15 articles and/or guidelines reviewed)
Frazier, O. H., Gradinac, S., Segura, A. M., Przybylowski, P., Popovic, Z., Vasiljevic, J., et al. (2000). Partial left ventriculectomy: Which patients can be expected to benefit? Annals of Thoracic Surgery, 69 (6), 1836-1841. Abstract retrieved March 9, 2006 from PubMed database.
Replogle, R. L., Kaiser, G. C., Cohn, L. H., Esposito, R. A., Lerut, T. E., Mack, M. J., et al. (1997). Society position paper. Left ventricular reduction surgery. The Annals of Thoracic Surgery, 63 (3), 909-911.
Sartipy, U., Albage, A., & Lindblom, D. (2005). The Dor procedure for left ventricular reconstruction. Ten-year clinical experience. European Journal of Cardio-Thoracic Surgery, 27 (6), 1005-1010. Abstract retrieved December 27, 2005 from PubMed database.
U. S. Food and Drug Administration. (2002, September). 510(k) Pre-Market Notification Database - K022093. Retrieved March 3, 2006 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
U. S. Food and Drug Administration. (2003, August). 510(k) Pre-Market Notification Database - K031586. Retrieved December 27, 2005 from http://www.fda.gov/cdrh/pdf3/k031586.pdf.
Westaby, S. (2003). Surgical restoration of the failing left ventricle. The Medical Clinics of North America, 87 (2), 523-552.
ORIGINAL EFFECTIVE DATE: 8/12/2006
MOST RECENT REVIEW DATE: 3/27/2008
ID_BT
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.