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 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 endocardiectomy 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.
POLICY
Surgical ventricular restoration for the treatment of conditions/diseases, including, but not limited to, ischemic dilated cardiomyopathy is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
To date, there is a lack of high quality, large, randomized controlled studies addressing SVR that 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.
SOURCES
Adhyapak, S.M., Menon, P.G., Parachuri, V, R., Michael, J., & Thomas, T. (2020). Surgical ventricular restoration-meta-analysis of observational studies. Indian Journal of Thoracic and Cardiovascular Surgery, 36 (4), 347-355. (Level 1 evidence)
American Heart Association. (2022). 2022 ACC/AHA/HFSA 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 May 18, 2022 from https://professional.heart.org/.
BlueCross BlueShield Association. Evidence Positioning System. (4:2024). Surgical ventricular restoration (7.01.103). Retrieved September 9, 2024 from https://www.bcbsaoca.com/eps/. (22 articles and/or guidelines reviewed)
Castelvecchio, S., Milani, V., Ambrogi, F., Volpe, M., Ramputi, L., Soletti, J.G., et al. (2022). Surgical ventricular restoration for ischemic heart failure: A glance at a real-world population. Journal of Personalized Medicine, 12 (4), 567. (Level 4 evidence)
European Society of Cardiology (ESC) and European Association of Cardio-Thoracic Surgery (EACTS). (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.
Yang, T., Yuan, X., Li, B., Zhao, S., Sun, H., & Lu, M. (2023). Long-term outcomes after coronary artery bypass graft with or without surgical ventricular reconstruction in patients with severe left ventricular dysfunction. Journal of Thoracic Disease, 15 (4), 1627-1639. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 8/12/2006
MOST RECENT REVIEW DATE: 10/10/2024
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