Download Surgical Ventricular Restoration

MEDICAL POLICY
POLICY TITLE
SURGICAL VENTRICULAR RESTORATION
POLICY NUMBER
MP- 1.110
Original Issue Date (Created):
November 1, 2006
Most Recent Review Date
(Revised):
May 16, 2006
Effective Date:
March 7, 2007- RETIRED
I.
DESCRIPTION/BACKGROUND
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 after coronary artery bypass grafting
(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 the ventricle is reconstructed using patches of
autologous or artificial material that are placed to close the defect while maintaining the
desired ventricular volume and contour. In addition, SVR is distinct from partial left
ventriculectomy (i.e., the Batista procedure), which does not attempt to specifically resect
akinetic segments and restore ventricular contour.
The SVR procedure may also be referred to as ventricular remodeling, surgical anterior
ventricular endocardial restoration (SAVER), or the Dor procedure after Vincent Dor, MD.
Dr. Dor pioneered the expansion of techniques for ventricular reconstruction and is
credited with treating congestive heart failure patients with SVR in conjunction with
CABG.
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.
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MEDICAL POLICY
POLICY TITLE
SURGICAL VENTRICULAR RESTORATION
POLICY NUMBER
MP- 1.110
II.
DEFINITIONS
510 (K) is a premarketing submission made to FDA to demonstrate that the device to be
marketed is as safe and effective, that is, substantially equivalent (SE), to a legally
marketed device that is not subject to premarket approval (PMA). Applicants must
compare their 510(k) device to one or more similar devices currently on the U.S. market
and make and support their substantial equivalency claims.
ANEURYSM refers to a localized abnormal dilatation of a blood vessel, usually an artery,
due to a congenital defect or weakness in the wall of a vessel.
CARDIOMYOPATHY is a disease of the myocardium (heart muscle) causing enlargement.
CONGESTIVE HEART FAILURE is an abnormal condition that reflects impaired cardiac
pumping. Its causes include myocardial infarction, ischemic heart disease, and
cardiomyopathy. Failure of the ventricles to eject blood efficiently results in volume
overload, ventricular dilation, and elevated intracardiac pressure.
LEFT VENTRICLE is the cavity of the heart that receives blood from the left atrium and
pumps it into the systemic circulation via the aorta.
MITRAL VALVE is the cardiac valve between the left atrium and left ventricle.
PERICARDIUM is The membranous fibroserous sac enclosing the heart and the bases of the
great vessels.
TACHYCARDIA is an abnormally rapid heart rate, greater than one hundred (100) beats per
minute.
III.
POLICY
Surgical ventricular restoration is considered investigational for the treatment of ischemic
dilated cardiomyopathy or post-infarction left ventricular aneurysm as there is insufficient
evidence to support a conclusion concerning the health outcomes or benefits associated
with this procedure.
Cross-reference
MP-1.082 Surgical Treatment of Heart Failure
IV.
EXCLUSIONS
N/A
V.
BENEFIT VARIATIONS
The existence of this medical policy does not mean that this service is a covered benefit
under the member's contract. Benefit determinations should be based in all cases on the
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MEDICAL POLICY
POLICY TITLE
SURGICAL VENTRICULAR RESTORATION
POLICY NUMBER
MP- 1.110
applicable contract language. Medical policies do not constitute a description of benefits.
A member’s individual or group customer benefits govern which services are covered,
which are excluded, and which are subject to benefit limits and which require
preauthorization. Members and providers should consult the member’s benefit information
or contact Capital for benefit information.
VI.
DISCLAIMER
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute
medical advice and are subject to change. Treating providers are solely responsible for medical advice and
treatment of members. Members should discuss any medical policy related to their coverage or condition
with their provider and consult their benefit information to determine if the service is covered. If there is a
discrepancy between this medical policy and a member’s benefit information, the benefit information will
govern. Capital considers the information contained in this medical policy to be proprietary and it may only
be disseminated as permitted by law.
VII. REFERENCES
ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart
Failure in the Adult. [Website]: http://www.acc.org/clinical/guidelines/failure/index.pdf
Accessed March 29, 2006.
Athanasuleas CL. Buckberg GD. Stanley AW. Siler W. Dor V. Di Donato M. Menicanti L.
Almeida de Oliveira S. Beyersdorf F. Kron IL. Suma H. Kouchoukos NT. Moore W.
McCarthy PM. Oz MC. Fontan F. Scott ML. Accola KA. RESTORE group. Surgical
ventricular restoration in the treatment of congestive heart failure due to postinfarction ventricular dilation. Journal of the American College of Cardiology.
44(7):1439-45, 2004 Oct 6.
Athanasuleas CL, Stanley AW Jr, Buckberg GD et al. Surgical anterior ventricular
endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior
myocardial infarction. RESTORE group. Reconstructive Endoventricular Surgery,
returning Torsion Original Radius Elliptical Shape to the LV. J Am Coll Cardiol 2001;
37(5):1199-209.
Athanasuleas CL, Stanley AW, Buckberg GD et al. Surgical anterior ventricular
endocardial restoration (SAVER) for dilated ischemic cardiomyopathy. Semin Thorac
Cardiovasc Surg 2001; 13(4):448-58.
Bolooki H, DeMarchena E, Mallon SM et al. Factors affecting late survival after surgical
remodeling of left ventricular aneurysms. J Thorac Cardiovasc Surg 2003; 126(2):37485.
Di Donato M. Frigiola A. Benhamouda M. Menicanti L. Safety and efficacy of surgical
ventricular restoration in unstable patients with recent anterior myocardial infarction.
Circulation. 110(11 Suppl 1):II169-73, 2004 Sep 14.
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[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
SURGICAL VENTRICULAR RESTORATION
POLICY NUMBER
MP- 1.110
Di Donato M, Sabatier M, Dor V et al. Surgical ventricular restoration in patients with
postinfarction coronary artery disease: effectiveness on spontaneous and inducible
ventricular tachycardia. Semin Thorac Cardiovasc Surg 2001; 13(4):480-5.
Di Donato M, Toso A, Maioli M et al. Intermediate survival and predictors of death after
surgical ventricular restoration. Semin Thorac Cardiovasc Surg 2001; 13(4):468-75.
Doenst T. Velazquez EJ. Beyersdorf F. Michler R. Menicanti L. Di Donato M. Gradinac S.
Sun B. Rao V. STICH investigators. To STICH or not to STICH: we know the answer,
but do we understand the question? Journal of Thoracic & Cardiovascular Surgery.
129(2):246-9, 2005 Feb.
Dor V, Di Donato M, Sabatier M et al. Left ventricular reconstruction by endoventricular
circular patch plasty repair: a 17-year experience. Semin Thorac Cardiovasc Surg
2001; 13(4):435-47.
ECRI HTAIS Custom Hotline Response: TRISVR Surgical Ventricular Restoration System
for Left Ventricular Reconstruction in Patients with Congestive Heart Failure. 1/2006.
Loebe, Matthias MD, PhD; Soltero, Ernesto MD; Thohan, Vinay MD; Lafuente, Javier A.
MD; Noon, George P. MD New surgical therapies for heart failure. Current Opinion in
Cardiology. 18(3):194-198, May 2003.
Menicanti L, Di Donato M, Frigiola A et al. Ischemic mitral regurgitation: intraventricular
papillary muscle imbrication without mitral ring during left ventricular restoration. J
Thorac Cardiovasc Surg 2002; 123(6):1041-50.
Menicanti L, Di Donato M, RESTORE Group. Surgical ventricular reconstruction and
mitral regurgitation: what have we learned from 10 years of experience? Semin Thorac
Cardiovasc Surg 2001; 13(4):496-503.
Menicanti L. Di Donato M. Surgical left ventricle reconstruction, pathophysiologic
insights, results and expectation from the STICH trial. European Journal of CardioThoracic Surgery. 26 Suppl 1:S42-6; discussion S46-7, 2004 Dec.
Mickleborough LL, Merchant N, Ivanov J et al. Left ventricular reconstruction: early and
late results. J Thorac Cardiovasc Surg 2004; 128(1):27-37.
National Heart, Lung, and Blood Institute (NHLBI) Clinical Trial Description. Surgical
Treatment for Ischemic Heart Failure (STICH). [Website]:
http://www.clinicaltrials.gov/ct/show/NCT00023595?order=2 Accessed March 29,
2006.
Sartipy U, Albage A, Lindblom D. The Dor Procedure for left ventricular reconstruction.
Ten-year clinical experience. Eur J Cardiothorac Surg 2005; 27(6):1005-10.
Somanetics product page. The CorRestore® System. [Website]:
http://www.somanetics.net/correstore_patch.htm Accessed March 29, 2006.
Taber’s Cyclopedic Medical Dictionary, 19th edition.
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MEDICAL POLICY
POLICY TITLE
SURGICAL VENTRICULAR RESTORATION
POLICY NUMBER
MP- 1.110
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance
Company® and Keystone Health Plan® Central. Independent licensees of the Blue Cross and Blue Shield Association.
Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies.
VIII. PRODUCT VARIATIONS
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] CHIP PPO
[N] Indemnity
[N] PPO
[N] SpecialCare
[N] HMO
[N] POS
[N] CHIP HMO
[Y] FEP HMO*
[N] SeniorBlue
[Y] FEP PPO*
[N] SeniorBlue PPO
* The FEP program dictates that all devices approved by the U.S. Food and Drug
Administration (FDA) may not be considered investigational. Therefore FDA-approved
devices may be assessed on the basis of medical necessity.
X.
POLICY HISTORY
MP-1.110
CAC 4/25/06
Policy approved for retirement effective 3/7/2007.
Information added into Policy 1.082, Surgical Treatment of Heart Failure.
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