Archived Policies - Surgery


Surgical Ventricular Restoration (SVR)

Number:SUR707.026

Effective Date:10-01-2008

End Date:11-14-2010

Coverage:

Surgical ventricular restoration (SVR) is considered experimental, investigational and unproven for patients with akinetic segments of the heart caused by:

  • ischemic dilated cardiomyopathy, or
  • post-infarction left ventricular aneurysm, or
  • congestive heart failure, or
  • coronary artery disease, or
  • coronary valve insufficiency or stenosis, or
  • any other coronary etiology.

Description:

SVR is a procedure designed to restore or remodel the left ventricle to its normal, irregular shape and size in patients with akinetic (lack of muscle movement) segments of the heart, secondary to either dilated cardiomyopathy or post infarction left ventricular aneurysm.  The SVR procedure is usually performed in conjunction with coronary artery bypass grafting (CABG) and may precede or be followed by mitral valve repair or replacement, as well as other procedures such as endocardectomy and cryoablation for treatment of ventricular tachycardia (VT).

A key difference between SVR and ventriculectomy for aneurysm removal is that in SVR the ventricle is sometimes reconstructed using patches of autologous or artificial material, which are placed to close the defect while maintaining the desired ventricular volume and contour.  Additionally, SVR is distinct from partial left ventriculectomy (PLV), known as 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 (VR), surgical anterior ventricular endocardial restoration (SAVER) or the Dor procedure named after Vincent Dor, M.D., who pioneered expansion of techniques for VR and is credited with treating congestive heart failure (CHF) patients with SVR in conjunction with CABG.  Other terms describing the same or similar procedure are left ventricular reconstructive surgery, endoventricular circular patch plasty (EVCPP) repair, left ventricular infarct exclusion surgery, and left ventricular aneurysmectomy reconstruction.

The CorRestore ™ Patch System is a device the U.S. Food and Drug Administration (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, which is used along with ventricular sizing devices, to restore the normal ventricular contour.  Several other patch systems are available, having been approved through the FDA 510(k) process, such as the TR3ISVR™ Surgical Ventricular Restoration System.  The system utilizes an endoventricular shaper, known as the Mannequin™ in addition to the SVR procedure to more accurately reshape and resize the left ventricle.

Rationale:

A review of the peer-reviewed literature on Medline through July 2005 revealed many publications on a variety of approaches to SVR.  These publications consist primarily of case series reports and retrospective reviews from single centers with the exception of publications from the multi-centered RESTORE Group (Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to 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 (CM) following anterior myocardial infarction (MI) in the past 20 years.  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 three-year outcomes on 332 patients who underwent SVR following anterior MI during the period of January 1998 to July 2000.  In addition to SVR, 92% of the patients also concomitantly underwent CABG, 22% mitral valve repair, and 3% mitral valve replacement.  The authors reported overall mortality during hospitalization was 7.7%.  Postoperative ejection fractions increased from 29.7% ± 11.3% to 40.0% ± 12.3%.  At three-years, the survival rate was 89.4% ± 1.3% and 88.7% respectively.  Freedom from readmission to the hospital for heart failure was at 88.7% at three-years.  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.

Mickleborough, et al., reported on 285 patients who underwent SVR by a single surgeon for class III or IV CHF, angina or VT during the period of 1983 to 2002.  In addition to SVR, 93% of the patients also concomitantly underwent CABG, 22% patch septoplasty, 41% arrhythmia ablation, 3% mitral valve repair, and 3% mitral valve replacement.  SVR was performed on the beating heart in 7% of patients.  The authors reported hospital mortality of 2.8%.  Postoperative ejections fractions increased 10% ± 9% from 24% ± 11%.  Among survivors, symptom class improved in 140 of 208 patients, a mean improvement of 1.3% ± 1.1% function class per patient.  Patients were followed up for 63 ± 48 months, and overall actuarial survival was reported as 92%, 82%, and 62% at one-, five-, and ten-years respectfully.  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 CHF, angina, VT, 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 intracavity 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 five-, ten-, 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 CHF, angina, and VT during the time period of 1994 to 2004.  In addition to SVR, 98% of patients also concomitantly underwent CABG, 52% arrhythmia ablation, and 29% mitral valve procedure.  The authors reported early mortality, within 30 days of surgery, 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 one-, three-, and five-years respectively.

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.  SVR has been suggested as an alternative to heart transplantation; however, a literature search did not identify any published studies regarding the utilization of SVR in lieu of a heart transplantation to effectively treat cardiomyopathy or any other coronary etiology.

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 CHF and coronary heart disease (CHD).  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 <0.35, and coronary artery disease (CAD) 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 plus SVR.  Completion of the trial is expected in December 2008.

2008 Update

A MedLine search was performed from January 2006 through July 2008.  Riberio and colleagues from Brazil reported on 137 patients with anterior MI and ejection fraction less than 50%.  Those patients who had viable anterior myocardium were randomized to SVR or SVR plus revascularization, and those patients with nonviable anterior myocardium received SVR.  Ejection fraction improved in all groups, but the most improvement was in the SVR plus revascularization group. 

Other publications reported on case series.  For example, Tulner reported on six-month follow-up on 21 patients with ischemic dilated CM who underwent SVR and bypass grafting; some also had valve annuloplasty.  Improvement in a number of clinical variables was noted, including decreased left-ventricular dyssynchrony, reduced tricuspid regurgitation, and improved ejection fraction (27-36%).  Another article reported on the contemporary performance of SVR based on data from the Society of Thoracic Surgeons’ (STS) Database.  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. 

Tulner completed another study and reported on six-month outcomes on 33 patients with New York Heart Association (NYHA) Class III/IV heart failure (HF) who underwent SVR and/or restrictive mitral annuloplasty.  Operative mortality was 3%; additional hospital mortality was 9%.  Quality of life scores improved as did six-minute walking distance of 248 to 422 meters.  Williams reported on a retrospective review of outcomes following SVR in a series of 34 patients with Class IV HF and 44 patients with Class II/III who had surgery between January 2002 and December 2005.  There were three operative deaths in each group.  While there was symptomatic improvement in both groups, there was a trend toward reduced survival at 32 months in those with Class IV versus Class II/III disease (68% versus 88%). 

Williams and Patel et al reported several concurrent retrospective studies during the period of January 2002 through December 2005 (SVR compared to septal MI, to anterior MI, and to CHF respectively) and January 2002 through June 2005 (SVR for patients greater or lesser than 65 with ischemic CM and for ischemic CM patients with or without pulmonary hypertension [PHTN] respectively). 

#

Study

n=

Criteria

Results

1.

SVR to Septal MI

78

Extent of Septal MI damage was graded as < 50%, 50% to 74%, and > 75%.  Those with > 75% had the greatest involvement of damage with NYHA Class designation of III/IV. 

Follow-up was 100%.  Cardiac function improved and was similar among all three groups postoperatively. Three quarters of those with >75% improved their NYHA Class to I/II.  

2.

SVR to Anterior MI

78

Lateral wall MI damage was included with the extent subdivided into four groups as < 25%, 25% to 49%, 50% to 75%, and > 75%.  Lateral wall MI patients were more likely to be NYHA Class IV preoperatively. 

Follow-up was 100%.  Improved ejection fraction and end-systolic volume index for patients with or without lateral wall MI.  Their NYHA Class improved to I/II.  For patients with anterior-inferior-lateral MI survival was 60% at three years.

3.

SVR to CHF

78

Thirty four patients were NYHA Class IV with the balance of these patients being Class II/III.  Class IV patients had significantly worse ejection fraction, left ventricular end systolic volume index , and stroke volume index preoperatively.

Three deaths in each group reported.  NYHA Class improved for most patients with Class IV (65%) and Class II/III (82%) reaching Class I/II postoperatively.  Reported that using SVR had better survival outcomes compared to medical management.

4.

Ischemic CM patients, < or > than age 65

69

Outcome comparison of 27 patients > 65 years versus 42 patients < 65 years, all with end stage HF. 

Improved ejection fraction and left ventricular end-systolic volume index for all age groups.  NYHA Class designations improved from III/IV to I/II.  Actuarial survival was 68.8% at 2.5 years.

5.

Ischemic CM patients with or without PTHN

69

PTHN was determined during cardiac catherization as either > or = to 25 mm Hg or those without PTHN at < 25 mm Hg.

Follow-up was 100%.

With each group, improvement of NYHA Class improvements were demonstrated and promising, the authors noted further studies are needed to confirm the findings for many of the groups reviewed.

No additional publications have been reported from the STICH trial that is ongoing.  STICH trial completion is expected in December 2008 with reporting to follow.

While the above studies, and similar studies, show that some clinical improvement occurs following this surgery, larger controlled clinical trials (larger number of patients with longer follow-up time spans) are still needed to compare outcomes of this treatment to other alternatives.  Thus, given the uncertain impact on clinical outcomes, this is considered investigational.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position.  Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed or changed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Beyersdorf, F., Doenst, T., et al.  The beating open heart for rebuilding ventricular geometry during surgical ventricular restoration.  Seminars in Thoracic and Cardiovascular Surgery (2001 January) 13(1):42-51.

Athanasuleas, C.L., Stanley, A.W., et al.  Surgical anterior ventricular endocardial restoration (SAVER) in their dilated remodeled ventricle after anterior myocardial infarction RESTORE group.  Journal of the American College of Cardiology (2001 April) 37(5):1199-209.

Dor, V., Di Donato, M., et al.  Left ventricular reconstruction by endovascular circular patch plasty repair:  A 17-year experience.  Seminars in Thoracic and Cardiovascular Surgery (2001 October) 13(4):435-47.

Athanasuleas, C.L., Stanley, A.W., et al.  Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy.  Seminars in Thoracic and Cardiovascular Surgery (2001 October) 13(4):448-58.

Di Donato, M., Toso, A., et al.  Intermediate survival and predictors of death after surgical ventricular restoration.  Seminars in Thoracic and Cardiovascular Surgery (2001 October) 13(4):468-75.

Di Donato, M., Sabatier, M., et al.  Surgical ventricular restoration in patients with postinfarction coronary artery disease:  Effectiveness on spontaneous and inducible ventricular tachycardia.  Seminars in Thoracic and Cardiovascular Surgery (2001 October) 13(4):480-5.

Menicanti, L. and M. Di Donato.  Surgical ventricular reconstruction and mitral regurgitation:  What have we learned from 10 years experience?  Seminars in Thoracic and Cardiovascular Surgery (2001 October) 13(4):496-503.

Menicanti, L., Di Donato, M., et al.  Ischemic mitral regurgitation: Intraventricular papillary muscle imbrication without mitral ring during left ventricular restoration.  Journal of Thoracic and Cardiovascular Surgery (2002 June) 123(6):1041-50.

Bolooki, H., DeMarchena, E., et al.  Factors affecting late survival after surgical remodeling of left ventricular aneurysms.  Journal of Thoracic and Cardiovascular Surgery (2003 August) 126(2):374-83.

McConnell, P.I., and R.E. Michler.  Clinical trials in the surgical management of congestive heart failure: Surgical ventricular restoration and autologous skeletal myoblast and stem cell cardiomyoplasty. Cardiology (2004) 101(1-3):48-60.

McConnell, P.I., and R.E.  Surgical ventricular restoration and other approaches to heart failure. Current Heart Failure Reports (2004 April-May) 1(1):21-9.

Mickleborough, L.L., Merchant, N., et al.  Left ventricular reconstruction:  Early and late results. Journal of Thoracic and Cardiovascular Surgery (2004 July) 128(1):27-37.

Conte, J.V.  Surgical ventricular restoration: technique and outcomes.  Congestive Heart Failure (2004 September-October) 10(5):248-51.

Stanley, A.W., Athanasuleas, C.L., et al.  Heart failure following anterior myocardial infarction: An indication for ventricular restoration, a surgical method to reverse post-infarction remodeling. Heart Failure Review (2004 October) 9(4):241-54.

Athanasuleas, C.L., Buckberg, G.D., et al.  Surgical ventricular restoration in the treatment of congestive heart failure due to post-infarction ventricular dilation.  Journal of the American College of Cardiology (2004 October 6) 44(7):1439-45.

Sartipy, U., Albage, A., et al.  The Dor procedure for left ventricular reconstruction.  Ten-year clinical experience.  European Journal of Cardio-Thoracic Surgery (2005 June) 27(6): 1005-10.

Surgical Ventricular Restoration.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2005 October) Surgery 7.01.103.

Heart and Vascular Institute – Heart Failure: Left ventricular Reconstructive Surgery (Dor Procedure).  The Cleveland Clinic (2005 December).  Available at <http://www.clevelandclinic.org> (accessed – 2006 January 24).

Ribeiro, GA., de Costa, C.E., et al.  Left ventricular reconstruction benefits patients with ischemic cardiomyopathy and non-viable myocardium.  European Journal of Cardio-Thoracic Surgery (2006 February) 29(2):196-201.

Hernandez, A.F., Velazquez, E.J., et al.  Contemporary performance of surgical ventricular restoration procedures: data from the Society of Thoracic Surgeons’ National Cardiac Database.  American Heart Journal (2006 September) 152(3):494-9.

Patel, N.D., Williams, J.A., et al.  Surgical ventricular restoration for advanced congestive heart failure: should pulmonary hypertension be a contraindication?  Annals of Thoracic Surgery (2006 September) 82(3):879-88; discussion 888.

Tulner, S.A., Bax, J.J., et al.  Beneficial hemodynamic a clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy.  Annals of Thoracic Surgery (2006 November) 82(5):1721-7.

Williams, J.A., Patel, N.D., et al.  Outcomes following surgical ventricular restoration in elderly patients with congestive heart failure.  American Journal of Geriatric Cardiology (2007 March-April) 16(2):67-75.

Tulner, S.A., Steendijk, P., et al.  Clinical efficacy of surgical heart failure therapy by ventricular restoration and restrictive mitral annuloplasty.  Journal of Cardiac Failure (2007 April) 13(3):178-83.

Patel, N.D., Williams, J.A., et al.  Impact of lateral wall myocardial infarction on outcomes after surgical ventricular restoration.  Annals of Thoracic Surgery (2007 June) 83(6):2017-27; discussion 2027-8.

Williams, J.A. Weiss, E.S., et al.  Outcomes following surgical ventricular restoration for patients with clinically advanced congestive heart failure (New York Heart Association Class IV).  Journal of Cardiac Failure (2007 August) 13(6):431-6.

Patel, N.D., Nwakanma, L.U., et al.  Impact of septal myocardial infarction on outcomes after surgical ventricular restoration.  Annals of Thoracic Surgery (2008 January) 85(1):135-45; discussion 145-6.

Surgical Ventricular Restoration. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2008 June) Surgery 7.01.103.

Policy History:

10/1/2008        Revised/updated entire document

5/1/2006          Revised/updated entire document

1/1/2006          New medical document

Archived Document(s):

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