Surgical Ventricular Restoration
Surgical ventricular restoration (SVR) is a procedure designed to restore or remodel the left ventricle to its normal, spherical shape and size in individuals with akinetic segments of the heart, secondary to ischemic dilated cardiomyopathy. The SVR procedure is usually performed after coronary artery bypass grafting (CABG) and may precede 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 SVR 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 (i.e., an opening larger than 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 (i.e., the Batista procedure), which does not attempt specifically to resect akinetic segments and restore ventricular contour.The SVR procedure is also referred to as left ventricular reconstructive surgery, ventricular reduction surgery, surgical anterior ventricular endocardial restoration (SAVER), endoventricular circular plasty, or the Dor procedure.
Surgical ventricular restoration for the treatment of conditions/diseases, including, but not limited to, ischemic dilated cardiomyopathy is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
To date, studies addressing SVR have failed to demonstrate a positive impact on net health outcomes. The 2012 STICH trial, a pivotal randomized clinical trial, did not find any improvements in clinical outcomes or quality-of-life measures for individuals undergoing SVR in addition to standard CABG surgery.
American Heart Association. (2017). 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Practice Guidelines and Heart Failure Society of America. Retrieved August 23, 2019 from http://circ.ahajournals.org. (205 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (3:2019). Surgical ventricular restoration (7.01.103). Retrieved August 23, 2019 from https://www.evidencepositioningsystem.com/. (20 articles and/or guidelines reviewed)
European Heart Journal. (2019, January). 2018 ESC/EACTS guidelines on myocardial revascularization. Retrieved August 23, 2019 from PubMed database.
Furukawa, K., Yano, M., Nishimura, M., Nakamura, E., Watanabe, N., Nishino, S., et al. (2019). Significance of preoperative right ventricular function on mid-term outcomes after surgical ventricular restoration for ischemic cardiomyopathy. General Thoracic and Cardiovascular Surgery, doi:10.1007/s11748-019-01123-5. Abstract retrieved August 26, 2019 from PubMed database.
Holly, T., Bonow, R., Arnold, M., Oh, J., Varadarajan, P., Pohost, G., et al. (2014). Myocardial viability and impact of surgical ventricular reconstruction on outcomes of patients with severe left ventricular dysfunction undergoing coronary artery bypass surgery: results of the surgical treatment for ischemic heart failure (STICH) trial. Journal of Thoracic Cardiovascular Surgery, 148 (6), 2677-2684. (Level 2 evidence)
Kukulski, T., She, L., Racine, N., Gradinac, S., Panza, J., Velaquez, E., et al. (2015). Implication of right ventricular dysfunction on long-term outcome in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting with or without surgical ventricular reconstruction. Journal of Thoracic Cardiovascular Surgery, 149 (5), 1312-1321. (Level 2 evidence)
Prior, D.L., Stevens, S.R., Holly, T.A., Kreica, M., Paraforos, A., Pohost, G.M., et al. (2017). Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery. Heart, 103 (17), 1359-1367. (Level 2 evidence)
U. S. Food and Drug Administration. (2001, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K011487 (CorRestore™ Patch). Retrieved February 28, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082139 (PeriPatch™ Sheet). Retrieved July 21, 2011 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 8/12/2006
MOST RECENT REVIEW DATE: 10/10/2019
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.