Medical Policy



Subject: Partial Left Ventriculectomy
Document #: SURG.00005 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description/Scope

This document addresses partial left ventriculectomy, surgical ventricular remodeling/restoration procedures, and dynamic cardiomyoplasty. 

Partial left ventriculectomy (PLV) is a surgical procedure aimed at improving the hemodynamic status of individuals 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 or cardio-reduction) is primarily directed at individuals 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 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. 

This document also addresses dynamic cardiomyoplasty, a surgical procedure during which skeletal muscle tissue is wrapped around the diseased ventricle. The skeletal muscle is then electrically stimulated to beat in synchrony with the heart and is purported to thereby, improve ventricular functioning.

Position Statement

Investigational and Not Medically Necessary:

Partial left ventriculectomy (PLV) is considered investigational and 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, (for example, ventricular remodeling or reshaping procedures using ventricular wrapping [dynamic cardiomyoplasty], piercing, or clasping techniques) are considered investigational and not medically necessary in all cases.

Rationale

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 (PLV).  Specifically, the lack of any controlled comparison of PLV to medical therapies or other types of "bridge to transplantation" (that is, 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 (STS) 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.  Within updated STS information related to coding, the STS states the following:

Since the mortality rate is high and there are no published scientific articles or clinical studies regarding partial ventriculectomy, this procedure cannot be considered reasonable and necessary within the meaning of §1862(a)(1) of the Social Security Act. Therefore, partial ventriculectomy is not covered by Medicare (STS, 2005).

The American College of Cardiology/American Heart Association (ACC/AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult states, "Partial left ventriculectomy is not recommended in patients with nonischemic cardiomyopathy and refractory end-stage HF (Class III recommendation; Level of Evidence: C)." (Jessup, 2009)

No additional specialty society recommendations or consensus statements were found that address ventriculectomy procedures with the exception of an updated 2013 Guideline for the Management of Heart Failure from the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines which gave a Class IIb recommendation for surgical reverse remodeling, based on preliminary results of the ongoing Surgical Treatment of Ischemic Heart Failure (STICH) trial (Jones, 2009), as follows:

Surgical reverse remodeling or LV aneurysmectomy may be considered in HFrEF for specific indications, including intractable HF and ventricular arrhythmias (Class IIb; Level of Evidence:  B). (HFrEF is heart failure with reduced ejection fraction; Yancy, 2013.)

Franco-Cereceda reported on the 1- and 3-year outcomes of 62 subjects with dilated cardiomyopathy who underwent PLV.  At the time of surgery, all subjects were either in New York Heart Association (NYHA) functional Class III or IV congestive heart failure (CHF).  Survival was 80% and 60% at 1 and 3 years after surgery, and freedom from failure was 49% and 26%, respectively.  Although 80% of the trial subjects were alive at 1 year, this survival was achieved with the aggressive use of ventricular assist devices and transplantation as a salvage therapy.  The authors concluded that PLV is not a predictable, reliable alternative to transplantation and that further investigations may be warranted that focus 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 PLV reached a peak by 1998 and was largely abandoned by 2000, except in Asia, where experienced institutions continue to perform the procedure in individuals in better condition with preserved myocardial contractility (Kawaguchi, 2003).  According to the Fourth International Registry Report, published in 2005, the former 2002 Third International Registry was updated and expanded to include 568 cases voluntarily reported from 52 hospitals in 12 countries.  The report concluded that avoidance of risk factors appears to have contributed to recent improvements in survival and restated that PLV has been largely abandoned except in Asia (Kawaguchi, 2005). 

Surgical Ventricular Restoration (SVR)
The available evidence for SVR consists 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 1000 individuals with ischemic cardiomyopathy, following anterior myocardial infarction (MI) in the past 20 years (Athanasuleas, 2001a; Athanasuleas, 2001b; Asthanasuleas, 2004; DiDonato, 2004b, 2004c; DiDonato, 2001; Dor, 2001; Kawaguchi, 2003; Menicanti, 2001; Menicanti, 2002).    

Athanasuleas from the RESTORE Group reported on early and 3-year outcomes in 662 individuals who underwent SVR following anterior MI during the period of January 1998 to July 2000.  In addition to SVR, trial subjects also concomitantly underwent coronary artery bypass grafting - CABG (92%), mitral repair (22%), and mitral replacement (3%).  The authors reported overall mortality during hospitalization was 7.7%; postoperative left ventricular ejection fractions (LVEF) increased from 29.7% ± 11.3% to 40.0% ± 12.3% (p<0.05).  The survival rate and freedom from hospitalization for CHF at 3 years was 89.4% ± 1.3% and 88.7% respectively.  In a separate publication on 439 subjects from the RESTORE Group, Athanasuleas reported outcomes improved in those with younger age, higher LVEF and lack of need for mitral valve replacement (Athanasuleas, 2001a; 2001b).

Mickleborough reported on 285 trial subjects who underwent SVR by a single surgeon for Class III or IV CHF, angina or ventricular tachyarrhythmia during the period of 1983 to 2002.  In addition to SVR, trial subjects 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 subjects.  The authors reported hospital mortality of 2.8%; postoperative LVEF increased 10% ± 9% from 24% ± 11% (p<0.000) and symptom class in 140 subjects improved 1.3 ± 1.1 functional class per subject.  Trial participants were followed 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 case selection (Mickleborough, 2004).

Bolooki reported on 157 individuals that underwent SVR by a single surgeon for Class III or IV CHF, angina, ventricular tachyarrhythmia or MI using three operative methods during the period of 1979 to 2000.  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 LVEF was 28% ± 0.9%.  Trial participants were followed 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 having an LVEF of 26% or greater preoperatively (Bolooki, 2003).

Another small study reported on 101 individuals who underwent SVR using the Dor procedure at a single center for Class III or IV CHF, angina and ventricular tachyarrhythmia during the period of 1994 to 2004.  In addition to SVR, trial subjects also concomitantly underwent CABG (98%), arrhythmia ablation (52%) and a mitral valve procedure (29%).  The authors reported early mortality (within 30 days of operation) was 7.9%; and LVEF increased from 27% ± 9.9% to 33% ± 9.3% postoperatively.  Trial participants 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 (Sartipy, 2005). 

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.  Additionally, 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 individuals with CHF and coronary artery disease – CAD (Clinical Trials.gov NCT00023595).  The STICH trial was sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) and Duke University.  There were 2136 subjects recruited with CHF, LVEF less than 35, and CAD amenable to CABG at 99 clinical sites.  Trial participants with extensive anterior ischemia assigned to the surgical arm of the study were further randomized to CABG surgery alone versus CABG plus SVR.  The initial estimated primary completion date of the trial was expected in December 2011.  However, this study has been extended to April 2016 and is listed as ongoing but no longer recruiting.  The primary outcome was established as the rate of death from any cause.  Major secondary outcomes included the rates of death from cardiovascular causes and of death from any cause or hospitalization for cardiovascular causes.  Preliminary published information about this trial indicated that adding SVR to CABG reduced the left ventricular volume, as compared with CABG alone.  However, this anatomical change was not associated with a greater improvement in symptoms or exercise tolerance or with a reduction in the rate of death or hospitalization for cardiac causes (Buckberg, 2009; Jones, 2009; Mark, 2009; Zembala, 2010).  Additional articles about the STICH trial continue to show no significant difference between the medical therapy alone group and medical therapy plus CABG with regard to the primary endpoint of death from any cause.  The primary outcome occurred in 244 trial participants (41%) in the medical therapy alone group and 218 (36%) in the CABG group (hazard ratio [HR] with CABG: 0.86; 95% confidence interval [CI], 0.72 to 1.04; p=0.12).  A total of 201 subjects (33%) in the medical therapy alone group and 168 (28%) in the CABG group died from an adjudicated cardiovascular cause (HR with CABG: 0.81; 95% CI, 0.66 to 1.00; p=0.05).  Death from any cause or hospitalization for cardiovascular causes occurred in 411 subjects (68%) in the medical therapy alone group and 351 (58%) in the CABG group (HR with CABG: 0.74; 95% CI, 0.64 to 0.85; p<0.001).  By the end of the follow-up period (median, 56 months), 100 subjects in the medical therapy alone group (17%) underwent CABG, and 555 subjects in the CABG group (91%) underwent CABG (Velazquez, 2011).  A more recent published article about the available results of the STICH trial have also indicated that the addition of SVR to coronary bypass grafting did not lead to improved survival in trial participants with dilated ischemic cardiomyopathy (Athanasuleas, 2015).  Another study of 71 subjects who underwent SVR between 1999 and 2012 has provided 5-year outcomes data that showed freedom from death and cardiac events as 78 % ± 5 % and 64 % ± 6 %, respectively.  The authors concluded that the impact of diastolic function on the clinical outcome of SVR remains unclear (Shimamoto, 2013).

Additional subgroup analysis, conducted to determine the overall benefit (if any) to SVR when it was added to CABG in STICH participants with ischemic cardiomyopathy, provided hazard ratios (HR) comparing the randomized arms by subgroups of left ventricular end-systolic volume index (LVESVI) and LVEF measured by echocardiography.  The investigators found that subjects with smaller ventricles (LVESVI < 60 mL/m2 ) and better LVEF (≥ 33%) may have benefited by SVR, while those with larger ventricles (LVESVI > 90 mL/m2 ) and lower LVEF (≤ 25%) did worse with SVR.  Algorithms using all three imaging modalities utilized in this study (echocardiography, cardiovascular magnetic resonance and radionuclide imaging) found a weaker relationship between LV global function and the effects of SVR, and the extent of regional wall motion abnormality did not influence the effects of SVR (Oh, 2013).

Background/Overview

Partial Left Ventriculectomy (PLV)
PLV is a surgical procedure aimed at improving the hemodynamic status of individuals with end stage CHF by directly reducing the left ventricular size.  This surgical approach to the treatment of CHF, (also known as the Batista procedure, cardio-reduction, and left ventricular remodeling surgery) is primarily directed at those 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)
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 either dilated cardiomyopathy or post MI left ventricular aneurysm.  The SVR procedure is usually performed after 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:

The Acorn CorCap Cardiac Support Device (Acorn Cardiovascular, St. Paul, MN) has not received FDA clearance, because sufficient evidence regarding its safety and efficacy has not yet been established in the published literature.  Another device, the Myosplint® formerly manufactured by Myocor Inc. (Maple Grove, MN) is no longer being produced or investigated, since Myocor went out of business in 2008.  Additional devices and patches used for SVR that have received FDA clearance include the CorRestore System (Somanetics Corp., Troy, MI) and the Surgical Ventricular Restoration (SVR® ) System using the Mannequin® device (Chase Medical, Inc., Richardson, TX).

Definitions

Dynamic Cardiomyoplasty: This surgical procedure involves a latissimus dorsi muscle flap which 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.

Partial Left Ventriculectomy (PLV [also known as the Batista procedure]): This surgical procedure reduces the size of the left ventricle by resecting (removing) a portion of the left ventricle, which is 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 CHF and is usually done in conjunction with additional cardiac surgical procedures, such as mitral valve annuloplasty or replacement.

Surgical Ventricular Restoration (SVR [also known as the Dor procedure]): This surgical procedure 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.

Coding

The following codes for treatments and procedures applicable to this document 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 and Not Medically Necessary: 

CPT  
33548 Surgical ventricular restoration procedure, includes prosthetic patch, when performed (eg, ventricular remodeling, SVR, SAVER, DOR procedures) 
33999 Unlisted procedure, cardiac surgery [when specified as Batista procedure (partial left ventriculectomy) or dynamic cardiomyoplasty]
   
ICD-10 Diagnosis  
  All diagnoses

When services are also Investigational and Not Medically Necessary: 

ICD-10 Procedure  
02BL0ZZ Excision of left ventricle, open approach
02HL0DZ Insertion of intraluminal device into left ventricle, open approach
02UA07Z Supplement heart with autologous tissue substitute, open approach
02UK07Z Supplement right ventricle with autologous tissue substitute, open approach
02UL07Z Supplement left ventricle with autologous tissue substitute, open approach
   
ICD-10 Diagnosis  
I42.0 Dilated cardiomyopathy
I50.1-I50.9 Heart failure
   
References

Peer Reviewed Publications:

  1. Acker MA, Bolling S, Shemin R, et al. Mitral valve surgery in heart failure: insights from the Acorn Clinical Trial. J Thorac Cardiovasc Surg. 2006; 132(3):568-577, e1-4.
  2. Athanasuleas CL, Buckberg G. Surgical ventricular restoration: Where do we go from here? Heart Fail Rev. 2015; 20(1):89-93.
  3. Athanasuleas CL, Buckberry GD, Stanley AW, 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):1439-1445.
  4. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy  Semin Thorac Cardiovasc Surg. 2001a; 13(4):448-458. Erratum in: Semin Thorac Cardiovasc Surg. 2002; 14(1):119.
  5. 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):1199-1209. Comment in: J Am Coll Cardiol. 2001b; 37(5):1210-1213.
  6. Batista RJ, Verde J, Nery P, et al. Partial left ventriculectomy to treat end-stage heart disease. Ann Thorac Surg. 1997; 64(3):634-638.
  7. 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):374-383; discussion 383-385. Comment in: J Thorac Cardiovasc Surg. 2003; 126(2):323-325.
  8. Bonow RO, Castelvecchio S, Panza JA, et al.; STICH Trial Investigators. Severity of remodeling, myocardial viability, and survival in ischemic LV dysfunction after surgical revascularization. JACC Cardiovasc Imaging. 2015; 8(10):1121-1129.
  9. Bonow RO, Maurer G, Lee KL, et al.; STICH Trial Investigators. Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med. 2011; 364(17):1617-1625.
  10. Buckberg GD, Athanasuleas CL. The STICH trial: misguided conclusions. J Thorac Cardiovasc Surg. 2009; 138(5):1060-1064.
  11. 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):481-487.
  12. Di Donato M, Fantini F, Toso A, et al. Impact of surgical ventricular reconstruction on stroke volume in patients with ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2010; 140(6):1325-1331; e1-2.
  13. DiDonato M, Frigiola A, Benhamouda M, Menicanti L. Safety and efficacy of surgical ventricular restoration in unstable patients with recent anterior myocardial infarction. Circulation. 2004b; 110(11 Suppl 1):1169-1173.
  14. DiDonato 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. 2001; 13(4):480-485.
  15. DiDonato M, Toso A, Dor V, et al.; RESTORE Group. Surgical ventricular restoration improves mechanical intraventricular dyssynchrony in ischemic cardiomyopathy. Circulation. 2004c; 109(21):2536-2543.
  16. DiDonato M, Toso A, Maioli M, et al. Intermediate survival and predictors of death after surgical ventricular restoration. Semin Thorac Cardiovasc Surg. 2001a; 13(4):468-475. Erratum in: Semin Thorac Cardiovasc Surg. 2004a; 16(1):113.
  17. Doenst T, Cleland JG, Rouleau JL, et al.; STICH Investigators. Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease. Circ Heart Fail. 2013; 6(3):443-450.
  18. Dor V. Surgical remodeling of left ventricle. Surg Clin North Am. 2004; 84(1):27-43.
  19. Dor V, Civaia F, Alexandrescu C, et al. Favorable effects of left ventricular reconstruction in patients excluded from the Surgical Treatments for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2011; 141(4):905-916; 916.e1-4.
  20. 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):435-447.
  21. Dzemali O, Risteski P, Bakhitary F, et al. Surgical left ventricular remodeling leads to better long-term survival and exercise tolerance than coronary artery bypass grafting alone in patients with moderate ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2009; 138(3):663-668.
  22. Eisen HJ. Surgical ventricular reconstruction for heart failure. N Engl J Med. 2009; 360(17):1781-1784.
  23. 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):879-893.
  24. Jones RH, White H, Velazquez EJ, et al. STICH (Surgical Treatment for Ischemic Heart Failure) trial enrollment. J Am Coll Cardiol. 2010; 56(6):490-498.
  25. Jones RH, Velazquez EJ, Michler RE, et al.; STICH Hypothesis 2 Investigators. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. 2009; 360(17):1705-1717.
  26. Mann DL, Acker MA, Jessup M, et al. Clinical evaluation of the CorCap Cardiac Support Device in patients with dilated cardiomyopathy. Ann Thorac Surg. 2007; 84(4):1226-1235.
  27. McCarthy JF, McCarthy PM, Starling RC, et al. Partial left ventriculectomy and mitral valve repair for end-stage congestive heart failure. Eur J Cardiothorac Surg. 1998; 13(4):337-343.
  28. 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):1041-1050.
  29. 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.
  30. 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):21-26.
  31. Nicolini F, Gherli T. Alternatives to transplantation in the surgical therapy for heart failure. Eur J Cardiothorac Surg. 2009; 35(2):214-228.
  32. Oh JK, Velazquez EJ, Menicanti L, et al.; STICH Investigators. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischemic cardiomyopathy. Eur Heart J. 2013; 34(1):39-47.
  33. Panza JA, Holly TA, Asch FM, et al. Inducible myocardial ischemia and outcomes in patients with coronary artery disease and left ventricular dysfunction. J Am Coll Cardiol. 2013; 61(18):1860-1870.
  34. Patel ND, Nwakanma LU, Weiss ES, et al. Impact of septal myocardial infarction on outcomes after surgical ventricular restoration. Ann Thorac Surg. 2008; 85(1):135-145; discussion 145-146.
  35. Petrie MC, Jhund PS, She L, et al.; STICH Trial Investigators. Ten-year outcomes after coronary artery bypass grafting according to age in patients with heart failure and left ventricular systolic dysfunction: an analysis of the extended follow-up of the STICH Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2016; 134(18):1314-1324.
  36. Prucz RB, Weiss ES, Patel ND, et al. Coronary artery bypass grafting with or without surgical ventricular restoration: a comparison. Ann Thorac Surg. 2008; 86(3):806-814; discussion 806-814.
  37. Ribeiro GA, da Costa CE, Lopes MM, et al. Left ventricular reconstruction benefits patients with ischemic cardiomyopathy and non-viable myocardium. Eur j Cardiothorac Surg. 2006; 29(2):196-201.
  38. Rubino AS, Onorati F, Santarpino G, et al. Neurohormonal and echocardiographic results after CorCap and mitral annuloplasty for dilated cardiomyopathy. Ann Thorac Surg. 2009; 88(3):719-725.
  39. 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.
  40. Shimamoto T, Sakaguchi G, Komiya T. Clinical impact of diastolic function after surgical ventricular restoration. Asian Cardiovasc Thorac Ann. 2013; 22(5):558-565.
  41. Starling RC, Jessup M, Oh JK, et al. Sustained benefits of the CorCap Cardiac Support Device on left ventricular remodeling: three year follow-up results from the Acorn clinical trial. Ann Thorac Surg. 2007; 84(4):1236-1242.
  42. Stewart RA, Szalewska D, She L, et al. Exercise capacity and mortality in patients with ischemic left ventricular dysfunction randomized to coronary artery bypass graft surgery or medical therapy: an analysis from the STICH trial (Surgical Treatment for Ischemic Heart Failure). JACC Heart Fail. 2014; 2(4):335-343.
  43. Suma H, Tanabe H, Uejima T, et al. Selected ventriculoplasty for idiopathic dilated cardiomyopathy with advanced congestive heart failure: midterm results and risk analysis. Eur J Cardiothorac Surg. 2007; 32(6):912-916.
  44. Suma H, Tanabe H, Uejima T, et al. Surgical ventricular restoration combined with mitral valve procedure for endstage ischemic cardiomyopathy. Eur J Cardiothorac Surg. 2009; 36(2):280-284; discussion 284-285.
  45. Tulner SA, Bax JJ, Bleeker GB, et al. Beneficial hemodynamic and clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy. Ann Thorac Surg. 2006; 82(5):1721-1727.
  46. Tulner SA, Steendijk P, Klautz RJ, et al. Clinical efficacy of surgical heart failure therapy by ventricular restoration and restrictive mitral annuloplasty. J Card Fail. 2007; 13(3):178-183.
  47. Velazquez EJ, Lee KL, Deja MA, et al.; STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011; 364(17):1607-1616.
  48. Velazquez EJ, Lee KL, Jones RH, et al.; STICHES Investigators. Coronary-artery bypass surgery in patients with ischemic cardiomyopathy. N Engl J Med. 2016; 374(16):1511-1520.
  49. Velazquez EJ, Lee KL, O'Connor CM, et al.; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007; 134(6):1540-1547.
  50. 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):145-152.
  51. Williams JA, Weiss ES, Patel ND, et al. Outcomes following surgical ventricular restoration for patients with clinically advanced congestive heart failure (New York Heart Association Class IV). J Card Fail. 2007; 13:431-436.
  52. Williams JA, Weiss ES, Patel ND, et al. Surgical ventricular restoration versus cardiac transplantation: a comparison of cost, outcomes and survival.  J Card Fail. 2008; 14(7):547-554.
  53. Wrobel K, Stevens SR, Jones RH, et al. Influence of baseline characteristics, operative conduct, and postoperative course on 30-day outcomes of coronary artery bypass grafting among patients with left ventricular dysfunction: results from the Surgical Treatment for Ischemic Heart Failure (STICH) Trial. Circulation. 2015; 132(8):720-730.
  54. Zembala M, Michler RE, Rynkiewicz A, et al. Clinical characteristics of patients undergoing surgical ventricular reconstruction by choice and by randomization. J Am Coll Cardiol. 2010; 56(6):499-507.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Blue Cross Blue Shield Association. Partial Left Ventriculectomy. TEC Assessment, 1998; 4.
  2. Centers for Medicare and Medicaid Services. National Coverage Determination: Partial Ventriculectomy. NCD #20.26. Effective April 15, 1997. Reviewed 10/03/2003. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=122&ncdver=1&bc=AAAAQAAAAAAA&. Accessed on June 26, 2017.
  3. Dickstein K, Vardas PE, Auricchio A, et al. 2010 Focused update of ESC guidelines on device therapy in heart failure: an update of the 2008 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Eur Heart J. 2010: 31(21):2677-2687. Available at:  http://eurheartj.oxfordjournals.org/content/early/2010/08/27/eurheartj.ehq337.full.pdf. Accessed on June 26, 2017.
  4. Hernandez AF, Velazquez EJ, Dullum MK, et al. Contemporary performance of surgical ventricular restoration procedures: data from the Society of Thoracic Surgeons' National Cardiac Database. Am Heart J. 2006; 152(3):494-499.
  5. 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://circ.ahajournals.org/cgi/reprint/112/12/e154. Accessed on June 26, 2017.
  6. Jessup M, Abraham WT, Casey DE, et al.; 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult Writing Committee. 2009 focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009; 119(14):1977-2016. Available at:  http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.109.192064. Accessed on June 26, 2017.
  7. Jones RH, Velazquez EJ, Michler RE, et al. ; STICH Hypothesis 2 Investigators. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. 2009; 360(17):1705-1717.
  8. 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.
  9. Kawaguchi AT, Suma H, Konertz W, et al. Left ventricular volume reduction surgery: the 4th International Registry Report 2004. J Card Surg. 2005; 20(6):S5-11.
  10. Lindenfeld J, Albert NM, Boehmer JP, et al; Heart Failure Society of America (HFSA). 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010; 16(6):e1-e194. Available at: http://www.onlinejcf.com/article/S1071-9164(10)00174-0/pdf. Accessed on June 26, 2017.
  11. Mark DB, Knight JD, Velazquez EJ, et al.; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J. 2009; 157(5):837-844, e1-3.
  12. National Heart Lung and Blood Institute (NHLBI). National Institutes of Health (NIH)  Duke University Medical Center. Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH). NLM Identifier: NCT00023595. Last updated on July 22, 2016. Available at: https://clinicaltrials.gov/ct2/show/NCT00023595 . Accessed on June 26, 2017.
  13. Society of Thoracic Surgeons. Committee on New Technology Assessment. Left ventricular reduction surgery. Ann Thorac Surg. 1997; 63(3):909-910.
  14. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness. CoreRestore Patch System (Somanetics Corp., Troy, MI). No. K031586.  August 7, 2003. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/K031586.pdf. Accessed on June 26, 2017.
  15. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff. January 31, 2001.  Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073644.htm. Accessed on June 26, 2017.
  16. Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization. Eur Heart J. 2010;  31(20):2501-2555.
  17. Yancy CW, Jessup M, Bozkurt B, et al. 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 Practice Guidelines. Circulation. 2013; 128(16):e240-e327. Available at: http://circ.ahajournals.org/content/128/16/e240.short?rss=1&ssource=mfr. Accessed on June 26, 2017.
Websites for Additional Information
  1. Heart failure online. Available at: http://www.heartfailure.org/heart-failure/. Accessed on June 26, 2017.
  2. National Heart, Lung and Blood Institute (NHLBI). What is heart failure? Available at:  http://www.nhlbi.nih.gov/health/dci/Diseases/Hf/HF_WhatIs.html. Accessed on June 26, 2017.
Index

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

The use of specific product names is illustrative 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.

Document History
Status Date Action
Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. The References were updated.
Reviewed 08/04/2016 MPTAC review. The References were updated. Removed ICD-9 codes from Coding section.
Reviewed 08/06/2015 MPTAC review. The Rationale and References were updated.
Reviewed 08/14/2014 MPTAC review. The Rationale and References were updated.
Reviewed 08/08/2013 MPTAC review. The Rationale and References were updated.
Reviewed 08/09/2012 MPTAC review. The Rationale and References were updated.
Reviewed 08/18/2011 MPTAC review. The Rationale, Coding and References were updated.
Reviewed 08/19/2010 MPTAC review. The Rationale and References were updated.
Reviewed 08/27/2009 MPTAC review. The Rationale and References were updated.
Reviewed 08/28/2008 MPTAC review. References were updated.
  02/21/2008 The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Reviewed 08/23/2007 MPTAC review. Rationale, Background, and References were updated.
Reviewed 09/14/2006 MPTAC review. References and definitions were updated.
  01/01/2006 Updated Coding section with 01/01/2006 CPT/HCPCS changes.
  11/21/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. 
     
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

04/27/2004

SURG.00005 Partial Left Ventriculectomy, Dynamic Cardiomyoplasty
WellPoint Health Networks, Inc.

 

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