Surgery Section - Surgical Ventricular Restoration

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

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. Additionally, SVR is distinct from partial left ventriculectomy (i.e., the Bastista procedure, see policy No.86) which does not attempt to specifically resect akinetic segments and restore ventricular conture.

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 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 FDA approved 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 glutaldehyde 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.

Policy/Criteria

Surgical ventricular restoration is considered investigational for the treatment of ischemic dilated cardiomyopathy or post infarction left ventricular aneurysm.

Scientific Background

Data from two randomized, controlled trials are available.  Ribeiro and colleagues randomized 74 patients with viable anterior wall myocardium following anterior myocardial infarction to coronary artery bypass (CABG) alone or CABG plus surgical ventricular restoration (SVR). (2) Indications for revascularization included angina, heart failure or both.  Patients were randomized on a 1:1 ratio.  Patients randomized to the SABG + SVR arm received endoventricular reconstruction developed by Dor.  Patients in both groups were followed for two years.  After surgery both groups exhibited improvement in LVEF:  CABG only patients improved from 3240.1 and CABG+SVR improved from 34.5 to 44.2.  After two years, there was a further significant difference in LVEF between the groups; 41 versus 49 respectively. The two-year survival was not significantly different between the groups.  The CABG+SVR group had significantly improved freedom from heart failure compared with the CABG only group (p=0.016).  As the authors noted in their discussion and as noted in an accompanying editorial, (13, 14) while SVR provided significant improvement in left ventricular volumes compared to CABG alone, the number of patients was small and the follow-up short term.  Recurrence of heart failure is likely to occur at higher rates after more time has passed.  The authors further stated that it is not clear whether SVR can revert or stop the remodeling processes after myocardial infarction.

Jones and colleagues randomized 1000 patients to either CABG alone (n=499) or CABG with SVR (n=501). (3) At median follow-up of 48 months, reduction in end-systolic volume index remained significantly greater in the SVR group than in the CABG alone group (19% and 6%, respectively).  There was no between-group difference for the primary endpoint, which was a composite of death from any cause and hospitalization for cardiac causes.

The remainder of the published literature 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 patients with ischemic cardiomyopathy following anterior infarction in the past 20 years. (4-10) 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. (9) 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 3 years was 89.4% ± 1.3% and 88.7% respectively. In a separate publication on 439 patients from the RESTORE Group, Athanasuleas and colleaguesreported outcomes improved in patients with lower patient age, higher ejection fractions and lack of need for mitral valve replacement. (10)

Mickleborough and colleagues 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. (11) 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 3 operative methods during the period of 1979 to 2000. (12) 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 and colleagues 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. (13) 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%; left ventricular ejection fraction 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.

Another article reported on the contemporary performance of SVR based on data from the Society of Thoracic Surgeons’ (STS) Database. (14) From January 2002 to June 2004, 731 patients underwent procedures at 141 hospitals.  The operative mortality was 9.3%; combined death or major complications occurred in 33.5%.  The authors commented that further studies of SVR are needed to improve patient selection and procedural performance.

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. Therefore, the available evidence does not permit scientific conclusions regarding the efficacy of SVR. Additionally, patient selection criteria and optimal surgical techniques are still undetermined.

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 (ClinicalTrials.gov Identifier: NCT00023595). (14) 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. This trial is ongoing but is no longer recruiting patients.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.103
2. Ribeiro GA, da Costa CE, Lopes MM et al. Left ventricular reconstruction brings benefit for patients with ischemic cardiomyopathy. 2006; J Cardiac Failure 2006;12(3):189-194
3. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical ventricular reconstruction.  NEJM 2009;360(17):1705-17
4. Di Donato M, Toso A, Maioli M et al. Intermediate survival and predictors of death after surgical ventricular restoration. Semin Thorac Cardiovasc Surg. 2001 Oct;13(4):468-75. Erratum in: Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):113
5. 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 Jun;123(6):1041-50
6. 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 Oct;13(4):496-503
7. 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. 2001 Oct;13(4):480-5
8. 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 Oct;13(4):435-47
9. Athanasuleas CL, Stanley AW, Buckberg GD et al. Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy. Semin Thorac Cardiovasc Surg. 2001 Oct;13(4):448-58. Erratum in: Semin Thorac Cardiovasc Surg 2002 Jan;14(1):119
10. 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 Apr;37(5):1199-209. Comment in: J Am Coll Cardiol. 2001 Apr;37(5):1210-3
11. Mickleborough LL, Merchant N, Ivanov J et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovasc Surg. 2004 Jul;128(1):27-37. Comment in: J Thorac Cardiovasc Surg. 2004 Jul;128(1):21-6
12. Bolooki H, DeMarchena E, Mallon SM et al. Factors affecting late survival after surgical remodeling of left ventricular aneurysms. J Thorac Cardiovasc Surg. 2003 Aug;126(2):374-83; discussion 383-5. Comment in: J Thorac Cardiovasc Surg. 2003 Aug;126(2):323-5
13. Sartipy U, Albage A, Lindblom D. The Dor Procedure for left ventricular reconstruction. Ten-year clinical experience. Eur J Cardio-thoracic Surg 2005;27:1005-1010
14. Hernandez AF, Velazques 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;152:494-9
15. http://www.clinicaltrials.gov/ct/show/NCT00023595?order=1  (Verified 2/6/09)

Cross References

Ventricular Assist Devices and Total Artificial Hearts, Regence Medical Policy Manual, Surgery, Policy No. 52

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