This policy addresses partial left ventriculectomy and other surgical ventricular remodeling procedures.  Partial left ventriculectomy (PLV) is a surgical procedure aimed at improving the hemodynamic status of patients with end-stage congestive heart failure (CHF) by directly reducing left ventricular size.  This surgical approach to the treatment of CHF (also known as the Batista procedure, cardio-reduction, or left ventricular remodeling surgery) is primarily directed at patients with an underlying dilated cardiomyopathy awaiting cardiac transplantation.

Surgical ventricular remodeling/restoration procedures refer to other techniques designed to restore or remodel the left ventricle to its normal shape and/or size and may also be referred to as ventricular remodeling, left ventricular reconstruction, endoventricular circular patch plasty, surgical anterior ventricular endocardial restoration (SAVER), or the Dor procedure after Vincent Dor, MD. 

This policy also addresses another surgical procedure closely aligned with ventricular restoration and ventriculectomy which is called dynamic cardiomyoplasty.  This surgical procedure involves wrapping skeletal muscle tissue around the diseased ventricle which is then electrically stimulated to beat in synchrony with the heart, and is purported to thereby improve ventricular functioning.

Investigational/Not Medically Necessary:

Partial left ventriculectomy (PLV) is considered investigational/not medically necessary in all cases.

Other methods of remodeling or reshaping of the cardiac ventricles to reduce ventricle size with or without surgical removal, (e.g., ventricular remodeling or reshaping procedures using ventricular wrapping, piercing, or clasping techniques) are considered investigational/not medically necessary in all cases.

Partial Left Ventriculectomy (PLV)
The published medical literature consists primarily of single institution case series.  This data is inadequate to permit conclusions regarding health benefits associated with partial left ventriculectomy. Specifically, the lack of any controlled comparison of partial left ventriculectomy to medical therapies or other types of “bridge to transplantation” (i.e., ventricular assist devices) made scientific assessment of the efficacy of this technique  impossible, either in its role as a potential bridge to transplant or as an adjunct to medical therapy. In addition, in 1997, the Society of Thoracic Surgeons issued a policy statement recommending that PLV be considered an investigational procedure, and that it should not be used as a primary strategy for the management of end-stage congestive heart failure (STS, 1997).  To date, the STS has not revised its position regarding PLV.

As an example of the published literature, Franco-Cereceda and colleagues reported on the 1- and 3-year outcomes of 62 patients with dilated cardiomyopathy who underwent partial left ventriculectomy. At the time of surgery, all patients were either in New York Heart Association functional Class III or IV. Survival was 80% and 60% at one and three years after surgery, and freedom from failure was 49% and 26%, respectively. Although 80% of the patients were alive at one year, this survival was achieved with the aggressive use of ventricular assist devices and transplantation as a salvage therapy. The authors concluded that partial left ventriculectomy is not a predictable reliable alternative to transplantation. Further investigations may be warranted, focusing on the use of the procedure as a bridge to transplant, or its use in those not considered candidates for transplantation (Franco-Cereceda, 2001). In 2003, the results of the Third International Registry Report were published, including data through 2002.  This report noted that the incidence of left ventriculectomy reached a peak by 1998 and was largely abandoned by 2000, except in Asia, where experienced institutions continue to perform the procedure in patients in better condition with preserved myocardial contractility (Kawaguchi, 2003).

Surgical Ventricular Restoration (SVR)
A review of the peer-reviewed literature on Medline through July 2006 revealed many publications on a variety of approaches to surgical ventricular restoration (SVR).  These publications consist primarily of case series reports and retrospective reviews from single centers with the exception of publications from the multi-center RESTORE Group (Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV).  The RESTORE Group is an international group of cardiologists and surgeons from 13 centers that has investigated SVR in over 1,000 patients with ischemic cardiomyopathy, following anterior infarction in the past 20 years (Kawaguchi, 2003; DiDonato, 2004; Menicanti, 2002; Menicanti, 2001; DiDonato, 2001; Dor, 2001; Athanasuleas, 2002; Athanasuleas, 2001). The following discussion summarizes a representative sample of some of the reports on SVR. 

Athanasuleas and colleagues from the RESTORE Group, reported on early and 3-year outcomes in 662 patients who underwent SVR following anterior myocardial infarction during the period of January 1998 to July 2000 (Athanasuleas, 2002).  In addition to SVR, patients also concomitantly underwent CABG (92%), mitral repair (22%), and mitral replacement (3%).  The authors reported overall mortality during hospitalization was 7.7%; postoperative ejection fractions increased from 29.7% ± 11.3% to 40.0% ± 12.3% (P <. 05).  The survival rate and freedom from hospitalization for heart failure at three years was 89.4% ± 1.3% and 88.7% respectively.  In a separate publication on 439 patients from the RESTORE Group, Athanasuleas, et al. reported outcomes improved in patients with lower patient age, higher ejection fractions and lack of need for mitral valve replacement (Athanasuleas, 2001).

Mickleborough, et al. reported on 285 patients who underwent SVR by a single surgeon for Class III or IV congestive heart failure, angina or ventricular tachyarrhythmia during the period of 1983 to 2002 (Mickleborough, 2004).  In addition to SVR, patients also concomitantly underwent CABG (93%), patch septoplasty (22%), arrhythmia ablation (41%), mitral repair (3%), and mitral replacement (3%).  SVR was performed on the beating heart in 7% of patients.  The authors reported hospital mortality of 2.8%; postoperative ejection fractions increased 10% ± 9% from 24% ± 11% (p<.000) and symptom class in 140 patients improved 1.3 ± 1.1 functional class per patient.  Patients were followed up for up to 19 years (mean, 63 ± 48 months), and overall actuarial survival was reported as 92%, 82%, and 62% at 1, 5 and 10 years respectively.  The authors suggested wall-thinning should be used as a criterion for patient selection.

Bolooki and colleagues reported on 157 patients that underwent SVR by a single surgeon for Class III or IV congestive heart failure, angina, ventricular tachyarrhythmia or myocardial infarction using three operative methods during the period of 1979 to 2000 (Bolooki, 2003). SVR procedures consisted of radical aneurysm resection and linear closure (n=65), septal dyskinesis reinforced with patch septoplasty (n = 70), or ventriculotomy closure with an intracavitary oval patch (n = 22).  The authors reported hospital mortality of 16%. The mean preoperative ejection fraction was 28% ± 0.9%.  Patients were followed up for up to 22 years, and overall actuarial survival was reported as 53%, 30%, and 18% at 5, 10 and 15 years respectively.  The authors found factors improving long-term survival included SVR with intraventricular patch repair and ejection fraction of 26% or greater preoperatively.

Sartipy, et al reported on 101 patients who underwent SVR using the Dor procedure at a single center for Class III or IV congestive heart failure, angina and ventricular tachyarrhythmia during the period of 1994 to 2004 (Sartipy, 2005).  In addition to SVR, patients also concomitantly underwent CABG (98%), arrhythmia ablation (52%) and mitral valve procedure (29%).  The authors reported early mortality (within 30 days of operation) was 7.9%; and left ventricular ejection fractions increased from 27% ± 9.9% to 33% ± 9.3% postoperatively.  Patients were followed up 4.4 ± 2.8 years, and overall actuarial survival was reported as 88%, 79%, and 65% at 1, 3 and 5 years respectively. 

Summary
While the SVR procedure has been performed for many years, the available data are inadequate to permit conclusions regarding health benefits associated with SVR.  Specifically, the lack of any randomized controlled trials comparing SVR to other surgical or medical therapies does not permit scientific assessment of the efficacy of SVR.  Additionally, patient selection criteria and optimal surgical techniques are still undetermined. 

In January 2002, a randomized multicenter international clinical trial on the Surgical Treatment of Ischemic Heart Failure (STICH) was initiated to compare medical therapy with CABG and/or SVR for patients with congestive heart failure and coronary heart disease (Clinical Trials.gov). The STICH trial is sponsored by the National Heart, Lung, and Blood Institute and will recruit 2,800 patients with heart failure, left ventricular ejection fraction < 35, and coronary artery disease amenable to CABG at 50 clinical sites.  Patients with extensive anterior ischemia assigned to the surgical arm of the study will be further randomized to CABG surgery alone versus bypass surgery plus SVR.  Completion of the trial is expected in December 2008.

Partial Left Ventriculectomy(PLV)
Partial left ventriculectomy (PLV) is a surgical procedure aimed at improving the hemodynamic status of patients with end stage congestive heart failure (CHF) by directly reducing left ventricular size.  This surgical approach to the treatment of CHF, (a.k.a. Batista procedure, cardio-reduction, and left ventricular remodeling surgery) is primarily directed at patients with an underlying dilated cardiomyopathy awaiting cardiac transplantation.  PLV has been investigated as either a “bridge” to transplantation or as an alternative to heart transplantation.

Surgical Ventricular Restoration (SVR)
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 precede or be followed by mitral valve repair or replacement.  A key difference between PLV and SVR 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.     

Additional techniques of ventricular reshaping include, but are not limited, to: 

• Wrapping a mesh sling (Acorn CorCap™ Wrap) around the right and left ventricle to decrease the size of the ventricles;
• Applying pads to each side of the enlarged ventricle and attaching them via cords/cables that are then tightened resulting in a decrease in the size of the ventricle (Myosplint®).

As of the date of this annual review update (September 14, 2006), the Acorn CorCap™ Cardiac Support Device (Acorn Cardiovascular, St. Paul, MN) and the Myosplint® device (Myocor, Maple Grove, MN) have not received FDA approval because the safety and efficacy of these devices has not yet been established in the published literature.  Both devices are currently limited to investigational use in the United States.

Partial Left Ventriculectomy (also known as the Batista procedure):  a surgical procedure that reduces the size of the left ventricle by resecting (removing) a portion of the left ventricle, the pumping chamber of the heart that delivers blood to the body.  This is typically done in an attempt to relieve some of the symptoms of severe congestive heart failure and is usually done in conjunction with additional cardiac surgical procedures, such as mitral valve annuloplasty or replacement.

Surgical Ventricular Restoration (also known as the Dor procedure):  a surgical procedure that involves an incision into the left ventricle to exclude, but not remove, the damaged area.  A remodeling device is then temporarily inserted into the ventricle around which the heart wall is then stretched, thereby reducing the diameter and restoring the shape of the left ventricle.  Thereafter, the device is removed, and the opening is closed with sutures and/or a patch.

Dynamic Cardiomyoplasty:  a surgical procedure in which a latissimus dorsi muscle flap is transposed into the chest and wrapped around the ventricles of the failing heart.  This skeletal muscle flap is then electrically stimulated to contract in synchrony with ventricular pumping of the heart.  Researchers have proposed that this muscle wrap may provide an external constraint that reduces progressive ventricular dilatation and remodeling, thereby decreasing wall tension in the ventricle and improving ventricular function.

The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:

CPT

ICD-9 Procedure

ICD-9 Diagnosis

Peer Reviewed Publications:

1. 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. Comment in: J Am Coll Cardiol. 2001; 37(5):1210-3.
2. 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.  Erratum in: Semin Thorac Cardiovasc Surg. 2002; 14(1):119.
3. Athanasuleas CL, Buckberry GD, Stanley AWH, et al.  RESTORE Group.  Surgical ventricular restoration in the treatment of congestive heart failure due to post-infarction ventricular dilation.  J Am Coll Cardiol. 2004; 44(7):1439-45. 
4. 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):374-83; discussion 383-5.  Comment in: J Thorac Cardiovasc Surg. 2003; 126(2):323-5.
5. Cotrufo M, Romano G, DeSanto LS, et al. Treatment of extensive ischemic cardiomyopathy: quality of life following two different surgical strategies.  Eur J Cardiothorac Surg. 2005; 27(3):481-7.
6. Di Donato M, Toso A, Maioli M, et al. Intermediate survival and predictors of death after surgical ventricular restoration.  Semin Thorac Cardiovasc Surg. 2001a; 13(4):468-75.  Erratum in: Semin Thorac Cardiovasc Surg. 2004a Spring;16(1):113.
7. DiDonato M, Frigiola A, Benhamouda M, Menicanti L.  Safety and efficacy of surgical ventricular restoration in unstable patients with recent anterior myocardial infarction.  Circ. 2004b; 110(Suppl 1):1169-73.
8. DiDonato M, Toso A, Dor V, et al.  RESTORE Group. Surgical ventricular restoration improves mechanical intraventricular dyssynchrony in ischemic cardiomyopathy.  Circ. 2004c; 109(21):2536-43.
9. Di Donato M, Sabatier M, Dor V; RESTORE Group. Surgical ventricular restoration in patients with postinfarction coronary artery disease: effectiveness on spontaneous and inducible ventricular tachycardia.  Semin Thorac Cardiovasc Surg. 2001b; 13(4):480-5.
10. 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.
11. Dor V. Surgical remodeling of left ventricle.  Surg Clin North Am. 2004; 84(1):27-43.
12. Franco-Cereceda A, McCarthy PM, Blackstone EH et al. Partial left ventriculectomy for dilated cardiomyopathy: is this an alternative to transplantation? J Thorac Cardiovasc Surg. 2001; 121(5):879-93.
13. 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. 
14. 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.
15. Mickleborough LL, Merchant N, Ivanov J, et al.  Left ventricular reconstruction: Early and late results. J Thorac Cardiovasc Surg. 2004; 128(1):27-37. Comment in: J Thorac Cardiovasc Surg. 2004; 128(1):21-6.
16. Sartipy U, Albage A, Lindblom D.  The Dor Procedure for left ventricular reconstruction.  Ten-year clinical experience.  Eur J Cardio-thoracic Surg. 2005; 27(6):1005-1010.
17. Weston MW, Vijayangar R, Overton RM, Vesely DL.  Prospective evaluation of the Batista procedure with circulating atrial natriuretic peptides.  Int J Cardiol. 2000; 74(2-3):145-52.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Hunt SA, Abraham WT, Chin MH, et al.  ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to update the 2001 guidelines for the evaluation and management of heart failure).  American College of Cardiology Web site.  Available at:  http://www.acc.org/clinical/guidelines/failure//index.pdf.  Accessed on:  July 14, 2006.
2. Kawaguchi AT, Isomura T, Konertz W, et al. Partial left ventriculectomy – The Third International Registry Report 2002. J Card Surg. 2003; 18(Suppl 2):S33-S42.
3. Centers for Medicare and Medicaid Services. National Coverage Determination: Partial Ventriculectomy. NCD #20.26. Effective April 15, 1997.  Available at: http://www.cms.hhs.gov. Accessed on: July 14, 2006.
4. National Institute for Clinical Excellence (NICE).  Partial left ventriculectomy (the Batista procedure).  Interventional procedure guidance 41.  London, UK: NICE; 2004 Feb.  Available at:  www.nice.org.uk/.  Accessed on:  July 14, 2006.
5. Society of Thoracic Surgeons. Committee on New Technology Assessment. Left ventricular reduction surgery. Ann Thorac Surg. 1997; 63(3):909-10.
6. Hayes, Inc. Hayes Medical Technology Directory. Ventricular reduction surgery. Lansdale, PA: Hayes, Inc.; May 11, 1997. Search updated August 4, 2003.
7. U.S. Food and Drug Administration Center for Devices and Radiological Health.  Brief Summary from the Circulatory System Devices Panel Meeting; June 22/23, 2005.  Available at: http://www.fda.gov/cdrh/panel/summary/circ-062205.html.  Accessed on:  July 14, 2006.

1. ClinicalTrials.gov. Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STITCH).  National Heart, Lung, and Blood Institute (NHLBI).  Available at: http://clinicaltrials.gov/show/NCT00023595.  Accessed on: July 14, 2006.

Batista Procedure
Cardiomyoplasty
Dor Procedure
Partial Left Ventriculectomy (PLV)
Surgical Ventricular Restoration (SVR)
Ventricular Reduction Surgery

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