Archived Policies - Surgery


Cardiac Restoration and Remodeling Procedures

Number:SUR707.026

Effective Date:07-15-2016

End Date:07-14-2017

Coverage:

For the purposes of this policy, cardiac restoration and remodeling procedures include surgical ventricular restoration (SVR) and partial left ventriculectomy (PLV).

Surgical Ventricular Restoration (SVR)

Surgical ventricular restoration is considered experimental, investigational and/or unproven for patients with akinetic segments of the heart caused by the following indications, including but not limited to:

Ischemic dilated cardiomyopathy,

Post-infarction left ventricular aneurysm,

Congestive heart failure (CHF),

Coronary artery disease (CAD),

Coronary valve insufficiency or stenosis, or

Any other coronary etiology.

Partial Left Ventriculectomy (PLV)

Partial left ventriculectomy is considered experimental, investigational and/or unproven for all indications.

EXCEPTION: Ventricular aneurysmectomy (ventricular aneurysm repair) may be done with or without SVR or PLV in patients undergoing a coronary artery bypass graft (CABG) for severe unresponsive CHF and ejection fraction (EF) equal to or less than 30%.

Description:

For the purposes of this policy, cardiac restoration and remodeling procedures include surgical ventricular restoration (SVR) and partial left ventriculectomy (PLV).

Background

Surgical Ventricular Restoration (SVR)

SVR is a procedure designed to restore or remodel the left ventricle to its normal, spherical shape and size in patients with akinetic (lack of muscle movement) segments of the heart, secondary to ischemic dilated cardiomyopathy.

The SVR procedure is also known as surgical anterior ventricular endocardial restoration (SAVER), left ventricular reconstructive surgery, endoventricular circular plasty (EVCPP), or the Dor procedure (named after Vincent Dor, MD). Dr. Dor pioneered the expansion of techniques for ventricular reconstruction (VR) and is credited with treating heart failure patients with SVR in conjunction with coronary artery bypass grafting (CABG).

The SVR procedure is usually performed after CABG and may proceed or be followed by mitral valve repair or replacement and other procedures such as endocardiectomy and cryoablation for treatment of ventricular tachycardia (VT). A key difference between SVR and ventriculectomy (i.e., for aneurysm removal) is that in SVR, circular “purse string” suturing is used around the border of the aneurysmal scar tissue. Tightening of this suture is believed to isolate the akinetic or dyskinetic scar, bring the healthy portion of the ventricular walls together, and restore a more normal ventricular contour. If the defect is large (i.e., an opening >3 cm), the ventricle may also be reconstructed using patches of autologous or artificial material to maintain the desired ventricular volume and contour during closure of the ventriculotomy. In addition, SVR is distinct from partial left ventriculectomy (PLV), which does not attempt to specifically resect akinetic segments and restore ventricular contour.

Regulatory Status

In 2004, the CorRestore™ Patch System (Somanetics Corp.) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use “as an intracardiac patch for cardiac reconstruction and repair.” The device consists of an oval tissue patch made from glutaraldehyde-fixed bovine pericardium. It is identical to other marketed bovine pericardial patches, except that it incorporates an integral suture bolster in the shape of a ring that is used along with ventricular sizing devices to restore the normal ventricular contour. Product code: DXZ.

Partial Left Ventriculectomy (PLV):

PLV is a surgical procedure aimed at improving the hemodynamic status of patients with end-stage congestive heart failure by directly reducing left ventricular size, and thereby improving the pump function of the left ventricle.

This surgical approach to the treatment of congestive heart failure (also known as the Batista procedure, cardio-reduction, or left ventricular remodeling surgery) is primarily directed at patients with an underlying non-ischemic dilated cardiomyopathy. Initially, the procedure was intended for patients awaiting cardiac transplantation, either as a “bridge” to transplantation or as an alternative to transplantation. The theoretical rationale for this procedure is that by reducing left ventricular wall volume, left ventricle wall tension is reduced and left ventricle pumping function will be improved.

Treatment of heart failure is generally through lifestyle modifications and medications. Medications are effective for controlling the symptoms of heart failure, but progression of disease can still occur. For end-stage heart failure, consideration of cardiac transplantation is the main alternative. Ventricular assist devices have been tested for this purpose, and total artificial hearts are also in development.

The original PLV procedure, as developed by Batista, involves a wide excision of the postero-lateral wall and apex of the heart and removal of a wedge-shaped portion of the left ventricle. PLV may be accompanied by repair of the mitral valve, either through valvuloplasty or annuloplasty. A variety of complications of PLV have been reported, including sudden death, progressive heart failure, arrhythmias, bleeding, renal failure, respiratory failure, and infection. More recently, modifications have been suggested that remove the septal-anterior wall preferentially, also called anterior PLV. The decision on the optimal approach may be determined by the degree of fibrosis seen in the apex and lateral walls.

Regulatory Status

PLV is a surgical procedure and, as such, is not subject to regulation by the FDA.

Rationale:

The policy for partial left ventriculectomy was created in 1999 and was included in the surgical ventricular restoration policy, created in 2006, in 2010 to the existing policy that was originated in 1999, The policy has been regularly updated with peer-reviewed scientific literature searches of the MedLine database through June 11, 2016 and/or the review compiled in a 1998 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment. The following is a summary of the key literature of both surgical procedures separately.

Surgical Ventricular Restoration (SVR)

Randomized Controlled Trials (RCT)

In 2002, a randomized international clinical trial on the Surgical Treatment of Ischemic Heart Failure (STICH) was initiated to compare medical therapy with coronary artery bypass grafting (CABG) and/or SVR for patients with heart failure and coronary heart disease (NCT00023595). The STICH trial was sponsored by the National Heart, Lung, and Blood Institute. Results of the STICH trial were published in 2009. (1) This unblinded study was performed at 127 clinical sites in 26 countries. A total of 1000 patients with coronary artery disease (CAD) and ejection fraction of 35% or less were randomized to CABG alone (n=499) or CABG plus SVR (n=501). The primary outcome was a composite of death from any cause and hospitalization for cardiac reasons. While SVR reduced the end-systolic volume index by 19% compared with 6% with CABG alone, there was no difference between groups in the primary outcome, which occurred in 292 (59%) of 499 of the CABG alone group compared with 289 (58%) of 501 of the CABG plus SVR group (hazard ratio [HR], 0.99; 95% confidence interval [CI], 0.84 to 1.17; p=0.90). Death from any cause occurred in 141 (28%) of 499 in the CABG alone group compared with 138 (28%) of 501 in the CABG plus SVR group (HR=1.00; 95% CI, 0.79 to 1.26; p=0.98). Cardiac symptoms and exercise tolerance also improved to similar degrees between groups. Other secondary outcomes, such as stroke, myocardial infarction (MI), and subsequent procedures, did not differ between groups. Subgroup analysis did not reveal any patient groups that benefited from SVR significantly more than the entire group.

STICH investigators have subsequently conducted additional analyses in attempts to identify patient groups that might have improved outcomes with CABG plus SVR over CABG alone. A 2014 analysis evaluated whether, in the STICH study, myocardial viability was associated with patient outcomes. (2) A total of 267 patients in the study underwent single-photon emission computed tomography (SPECT) viability studies, and 191 were found to have myocardial viability. The investigators found no significant interaction between myocardial viability status and treatment group for the outcomes mortality (p=0.36) or mortality plus cardiac hospitalization (p=0.55).

Subgroup analyses published in 2013 did not find significantly better outcomes in patients with better preoperative left ventricular function, using measures such as left-ventricular ejection fraction (LVEF), end-systolic volume index, and/or end-diastolic volume index. (3, 4) A 2015 subanalysis found that patients with moderate-to-severe preoperative right ventricular dysfunction had worse outcomes when they underwent SVR plus CABG compared with CABG alone. (5) In an analysis adjusting for other prognostic factors, the interaction between right ventricular function and treatment group was statistically significant for all-cause mortality (p=0.022). Because subgroup analyses were performed post-hoc, they are considered hypothesis generating, and any findings would need to be confirmed in prospective trials.

A separate publication from the STICH trial reported on quality-of-life (QOL) outcomes. (6) The main QOL outcome measure used was the Kansas City Cardiomyopathy Questionnaire (KCCQ), which is a 23-item scale meant to measure the effect of heart failure symptoms on QOL. Secondary QOL measures included the Seattle Angina Questionnaire, the 12-Item Short-Form Health Survey, the Center for Epidemiologic Studies Depression Scale, the Cardiac Self-Efficacy Questionnaire, and the EuroQoL 5-D. The questionnaires were administered at baseline and 4, 12, 24, and 36 months post-randomization. Available numbers of patients at each time point were 991, 897, 828, 751, and 669, respectively. Scores on the KCCQ QOL measures improved for both groups to a similar degree; there was no incremental benefit for the SVR group compared with the CABG alone group. Similarly, there were no group differences noted on any of the secondary QOL measures.

A second RCT was published in 2011 by Marchenko et al. (7) Performed in Russia, this study randomized 236 patients with ischemic heart failure to CABG alone or CABG plus SVR. Mean follow-up was 31 (SD=13) months. Outcome measures reported were perioperative mortality and survival at 1-, 2-, and 3-year follow-ups. Perioperative mortality was 5.8% in the CABG alone group compared with 3.5% in the CABG plus SVR group (p=NS). Survival at 1 and 3 years was 95% and 78%, respectively, in the CABG plus SVR group, compared with 83% and 78%, respectively, in the CABG alone group (statistical comparisons not reported). There were reductions in New York Heart Association (NYHA) functional class and angina class for both groups after surgery, but between-group statistical testing was not reported. For example, mean (SD) NYHA functional class decreased in the CABG plus SVR group from 3.1 (0.4) at baseline to 2.2 (0.6) at 3 years, compared with a decrease in the CABG alone group from 2.9 (0.5) to 2.4 (0.9).

Uncontrolled Studies

The Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV (RESTORE) Group is an international group of cardiologists and surgeons from 13 centers that had investigated SVR in more than 1000 patients with ischemic cardiomyopathy following anterior infarction. Athanasuleas et al. from the RESTORE Group, reported on early and 3-year outcomes in 662 patients who underwent SVR following anterior MI during the period of January 1998 to July 2000. (8) In addition to SVR, patients concomitantly underwent CABG (92%), mitral repair (22%), and mitral replacement (3%). The authors reported that overall mortality during hospitalization was 7.7%; postoperative ejection fractions increased from 29.7%±11.3% to 40.0%±12.3% (p<0.05). The survival rate and freedom from hospitalization for heart failure at 3 years was 89.4% 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. (9)

Mickleborough et al. reported on 285 patients who underwent SVR by a single surgeon for class III or IV heart failure, angina, or ventricular tachyarrhythmia during the period of 1983 to 2002. (10) In addition to SVR, patients 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<0.000), and symptom class in 140 patients improved 1.3±1.1 functional classes per patient. Patients 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 patient selection.

Bolooki et al. reported on 157 patients who underwent SVR by a single surgeon for class III or IV heart failure, angina, ventricular tachyarrhythmia, or MI using 3 operative methods during the period of 1979 to 2000. (11) SVR procedures consisted of radical aneurysm resection and linear closure (n=65), septal dyskinesia reinforced with patch septoplasty (n=70), or ventriculotomy closure with an intracavitary oval patch (n=22). The authors reported hospital mortality of 16%. Mean preoperative ejection fraction was 28%±0.9%. Patients 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 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 heart failure, angina, and ventricular tachyarrhythmia during the period of 1994 to 2004. (12) 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%; LVEF 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.

In 2006, Hernandez et al. reported on the contemporary performance of SVR based on data from the Society of Thoracic Surgeons’ database. (13) 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 et al. reported on 6-month follow-up for 21 patients with ischemic dilated cardiomyopathy who underwent SVR and bypass grafting; some also had valve annuloplasty. (14) Improvement in a number of clinical variables was noted, including decreased left ventricular dyssynchrony, reduced tricuspid regurgitation, and improved ejection fraction (27%-36%).

Searches of the Medline database have found that the published studies continue to primarily report on case series. In many, SVR was performed in conjunction with additional cardiac procedures. For example, Tulner et al. reported on 6-month outcomes on 33 patients with class III or IV heart failure who underwent SVR and/or restrictive mitral annuloplasty. (15) Operative mortality was 3%, and additional in-hospital mortality was 9%. QoL scores improved, as did 6-minute walking distance (248-422 meters). Williams et al. reported a retrospective review of outcomes following SVR in a series of 34 patients with NYHA class IV heart failure and 44 patients with class II or III heart failure who had surgery between January 2002 and December 2005. (16) There were 3 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 or III disease (68% versus 88%, respectively). A nonrandomized comparative study from Europe involving patients with coronary artery disease who underwent CABG or CABG plus SVR and had an ejection fraction of 30% to 40% was published in 2009. (17) In this nonrandomized study, the authors concluded that patients in whom SVR was possible experienced more perioperative complications but had improved early and midterm outcomes. While these and similar studies show that some clinical improvement occurs following this surgery, the nonrandomized nature of these studies limits the ability to draw conclusions. Controlled trials are needed to compare the outcomes of SVR to other alternatives.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT00023595

Surgical Treatment for Ischemic Heart Failure

2136

Apr 2016

Table Key:

NCT: National Clinical Trial.

Practice Guidelines and Position Statements

In 2010, a Task Force of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) developed guidelines on myocardial revascularization. (18) These guidelines consider SVR combined with CABG to be a surgical option for patients with ischemic heart failure and left ventricular ejection fraction of 35% or less (based on opinion and evidence that is not well-established). The guidelines also recommend SVR with CABG only be performed in centers with a high level of surgical expertise.

The 2014 ESC/EACTS guidelines on myocardial revascularization did not discuss SVR. (19)

Section Summary: SVR

The evidence for SVR in individuals who have ischemic dilated cardiomyopathy includes a single RCT and a number of uncontrolled studies. Relevant outcomes are overall survival, symptom, quality of life, hospitalizations, resource utilization, and treatment-related morbidity. The RCT, the STICH trial, did not report significant improvements in quality of life outcomes for patients undergoing SVR in addition to standard CABG surgery. Several uncontrolled studies have suggested that SVR can improve hemodynamic functioning in selected patients with ischemic cardiomyopathy; however, these studies are considered lower quality evidence. The evidence is insufficient to determine the effects of the technology on health outcomes.

Partial Left Ventriculectomy (PLV)

This coverage for PLV was based on a 1998 BCBSA TEC Assessment, (21) which concluded that the available data were inadequate to permit conclusions regarding health benefits associated with PLV. Specifically, the TEC Assessment concluded that the lack of any controlled comparison of PLV to medical therapies or other types of “bridge to transplantation” (i.e., ventricular assist devices) made scientific assessment of the efficacy of PLV impossible, either in its role as a potential bridge to transplant or as an adjunct to medical therapy.

In 2003, the results of the Third International Registry Report were published, (22) 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.

Results from an International Registry of patients undergoing left ventricular volume reduction surgery were published in 2005. (23) This publication reported on 568 patients from 12 countries in North America, Europe, and Asia, including patients with non-ischemic cardiomyopathy undergoing PLV, as well as patients with ischemic cardiomyopathy undergoing SVR. The number of procedures peaked in the years 1997-2000 and has subsequently declined since that time. The largest decline has been in North America and Europe, where few of these procedures have been performed since 2001, while use has persisted in Asia. Of the 568 patients enrolled in the registry, 271 (47.7%) died or were lost to follow-up. The main causes of death were progressive heart failure (48.4%), sudden death (10.3%), and arrhythmias (6.6%).

Case Series

Suma et al. treated 95 patients with idiopathic dilated cardiomyopathy between 1999 and 2006. (24) A total of 57 of 95 (60%) underwent PLV with excision of the lateral wall, and 38 of 95 (40%) underwent a septal anterior ventricular exclusion (SAVE or pacopexy procedure with excision of the anteroseptal wall). Hospital mortality was 11.6% (11/95), and 1-, 3-, and 5-year survival was 72.8%, 61.4%, and 50.5%, respectively. LV ejection fraction improved from 22.3% presurgery to 27.2% postsurgery (p<0.001), and cardiac index improved from 2.3±0.5 to 2.8+0.5 m2/min. There was an improvement in mean NYHA class from 3.5 to 1.7. The lack of a control group in this trial makes it difficult to determine the impact of PLV on clinical outcomes.

Franco-Cereceda et al. reported on the 1- and 3-year outcomes of 62 patients with dilated cardiomyopathy who underwent PLV. (25) At the time of surgery, all patients were either in NYHA functional class III or IV. Survival was 80% and 60% at 1 and 3 years after surgery, and freedom from heart failure was 49% and 26%, all respectively. Although 80% of the patients were alive at 1 year, this survival was achieved with the aggressive use of VADs and transplantation as a salvage therapy. The authors concluded that partial left ventriculectomy is not a predictable reliable alternative to transplantation.

Starling et al. treated 59 patients with dilated cardiomyopathy and advanced heart failure with PLV and mitral valve repair. (26) Hospital mortality was 3.5%, and actuarial survival at 1 year was 82%. Freedom from treatment failure (defined as death or relisting for transplantation) was 58% at 1 year. In patients with event-free survival at 12 months, there were improvements in NYHA class (3.6 to 2.1, p<0.001), left ventricular ejection fraction (13 to 24%, p<0.001), and peak oxygen consumption (10.8-16.0 mL/kg/min). However, worsening of heart failure was common among survivors over time, and the 3-year estimate of freedom from death, left ventricle assist device, transplantation, or worsening heart failure, was only 26%.

Sugiyama et al. reported on 11 children under the age of 3 years diagnosed with severe dilated cardiomyopathy. (27) Eight procedures were done on 6 of the children: 5 PLV and 3 mitral valve replacement. Two of them underwent mitral valve replacement after PLV. Follow up after PLV ranged from 2 months to 8 years. During follow up period, 4 patients remain alive, of whom 1 eventually underwent a heart transplant.

In 2009 Nishina et al. reported a study that aimed to investigate the effectiveness of an apex-sparing PLV compared to conventional PLV, to restore the ellipsoidal shape of the left ventricle, in 13 patients with dilated cardiomyopathy. (28) The authors reported left ventricular function improvement as the ejection fraction increased from 28% to 39% and the NYHA class improved from III to I. Survival rates were not reported in this small study.

In 2015, a systematic review of PLV over the last 12 years was conducted by Domingues et al. (29) The authors reported the following, “There has been a considerable number of reported successful cases and highly significant findings in regard to determining the most suitable region for the section [of the ventricular wall], proper selection of the patients indicated to the procedure, including the influence of the coronary artery anatomy in the nomination procedure and the need for preservation of ventricular geometry to ensure better quality of ventricular contractions after the sectioning. This surgical procedure has been successfully performed, mainly in Japan, improvements in its efficiency were found and the need for a mathematical modeling of the slice to be severed is a prominent factor in many studies.”

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in June 2016 did not identify any ongoing or unpublished trials that would likely influence this review.

Practice Guidelines and Position Statements

American College of Cardiology/American Heart Association (ACC/AHA)

In 2005, the ACC/AHA Guideline addressed PLV. The ACC guidelines considered PLV as a treatment for heart failure, and included the following as a Class III recommendation, “Partial left ventriculectomy is not recommended in patients with nonischemic cardiomyopathy and refractory end-stage heart failure.” (30) As of June 10, 2016, there is no longer an ACC/AHA guideline addressing PLV.

Society of Thoracic Surgeons (STS)

In 1997, the 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. (31) As of June 10, 2016, there is no longer a STS guideline addressing PLV.

Section Summary: PLV

The evidence review for PLV in individuals with end-stage congestive heart failure includes several case series. Over the years, some clinical series have reported improvement in ejection fraction and symptoms following PLV; however, there is a lack of RCTs comparing this procedure to alternative treatments. Perioperative mortality and complications are high, and the improvements reported in symptoms may not be a result of the surgical procedure. The high rates of perioperative morbidity and mortality, the lack of demonstrated long-term outcome benefits, and the high relapse rates, have led to diminished enthusiasm for this procedure. Additionally, there are no professional guidelines or position statements that exist to support the PLV procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

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:

Surgical ventricular restoration involves increased physician work compared to standard ventriculectomy (also known as ventricular remodeling, SVR, SAVER, DOR procedure) and should be billed using CPT code 33548, not the same as PLV.

Partial left ventriculectomy (also known as the Batista procedure) should be billed using CPT code 33999. CPT codes 33542 and 33548 are not the same as PLV and should not be used to bill for PLV.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

33542, 33548, 33999

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


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 have a national Medicare coverage position.

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

References:

(Surgical Ventricular Restoration 1-20; Partial Left Ventriculectomy 21-32)

1. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. Apr 23 2009; 360(17):1705-17. PMID 19329820

2. Holly TA, Bonow RO, Arnold JM, et al. Myocardial viability and impact of surgical ventricular reconstruction on outcomes of patients with severe left ventricular dysfunction undergoing coronary artery bypass surgery: results of the Surgical Treatment for Ischemic Heart Failure trial. J Thorac Cardiovasc Surg. Dec 2014; 148(6):2677-84 e2671. PMID 25152476

3. Oh JK, Velazquez EJ, Menicanti L, et al. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy. Eur Heart J. Jan 2013; 34(1):39-47. PMID 22584648

4. Michler RE, Rouleau JL, Al-Khalidi HR, et al. Insights from the STICH trial: change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. Nov 2013; 146(5):1139-45 e1136. PMID 23111018

5. Kukulski T, She L, Racine N, et al. Implication of right ventricular dysfunction on long-term outcome in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting with or without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. May 2015; 149(5):1312-21. PMID 25451487

6. Mark DB, Knight JD, Velazquez EJ, et al. 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. May 2009; 157(5):837-44, 44 e1-3. PMID 19376309

7. Marchenko A, Chernyavsky A, Efendiev V, et al. Results of coronary artery bypass grafting alone and combined with surgical ventricular reconstruction for ischemic heart failure. Interact Cardiovasc Thorac Surg. Jun 2011; 13(1):46-51. PMID 21402600

8. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy. Semin Thorac Cardiovascul Surg. Oct 2001; 13(4):448-58. PMID 11807740

9. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) in their dilated remodeled ventricle after anterior myocardial infarction RESTORE group. J Amer Coll Cardiol. Apr 2001; 37(5):1199-209. PMID 11300423

10. Mickleborough LL, Merchant N, Ivanov J, et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovascul Surg. Jul 2004; 128(1):27-37. PMID 15224018

11. Bolooki H, DeMarchena E, Mallon SM, et al. Factors affecting late survival after surgical remodeling of left ventricular aneurysms. J Thorac Cardiovascul Surg. Aug 2003; 126(2):374-83. PMID 12928633

12. Sartipy U, Albage A, Lindblom D, et al. The Dor procedure for left ventricular reconstruction. Ten-year clinical experience. Eur J Cardio-Thorac Surg. Jun 2005; 27(6): 1005-10. PMID 15896609

13. 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. Amer Heart J. Sep 2006; 152(3):494-9. PMID 16923420

14. Tulner SA, Bax JJ, Bleeker GB, et al. Beneficial hemodynamic a clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy. Ann Thorac Surg. Nov 2006; 82(5):1721-7. PMID 17062236

15. Tulner SA, Steendijk P, Klautz RJ, et al. Clinical efficacy of surgical heart failure therapy by ventricular restoration and restrictive mitral annuloplasty. J Card Failure. Apr 2007; 13(3):178-83. PMID 17448414

16. 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 Failure. Aug 2007; 13(6):431-6. PMID 17675056

17. Dzemali O, Risteski P, Bakhtiary 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 Cardiovascul Surg. Sep 2009; 138(3):663-8. PMID 19698853

18. Task Force on Myocardial Revascularization of the European Society of Cardiology, the European Association for Cardio-Thoracic S, European Association for Percutaneous Cardiovascular Interventions, Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization. Eur Heart J. Oct 2010; 31(20):2501-55. PMID 20802248

19. Windecker S, Kolh P, Alfonzo F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. Oct 1 2014; 35(37):2541-2619. PMID 25173339

20. Surgical Ventricular Restoration. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 February) Surgery 7.01.103.

21. Partial Left Ventriculectomy. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1998) Tab 4.

22. Kawaguchi AT, Isomura T, Konertz W, et al. Partial left ventriculectomy-The Third International Registry Report 2002. J Card Surg. Jul-Aug 2003; 18(supplement 2):S33-42. PMID 12930269

23. Kawaguchi AT, Suma H, Konertz W, et al. Left ventricular volume reduction surgery: the 4th International Registry Report 2004. J Card Surg. Nov-Dec 2005; 20(6):S5-11. PMID 16305637

24. Suma H, Horii T, Isomura T, et al. A new concept of ventricular restoration for nonischemic dilated cardiomyopathy. Eur J Cardio-Thorac Surg. Apr 2006; 29 Supplement 1:S207-12. PMID 16567106

25. Franco-Cereceda A, McCarthy PM, Blackstone EH, et al. Partial left ventriculectomy for dilated cardiomyopathy: is this an alternative to transplantation? J Thorac Cardiovascul Surg. May 2001; 121(5):879-93. PMID 11326231

26. Starling RC, McCarthy PM, Buda T, et al. Results of partial left ventriculectomy for dilated cardiomyopathy: hemodynamic, clinical and echocardiographic observations. J Am Coll Cardiol. Dec 2000; 36(7):2098-103. PMID 11127447

27. Sugiyama H, Hoshiai M, Naitoh A, et al. Outcome of non-transplant surgical strategy for end-stage dilated cardiomyopathy in young children. Circ J. Jun 2009; 73(6):1045-8. PMID 19359814

28. Nishina T, Shimamoto T, Mauri A, et al. Impact of apex-sparing partial left ventriculectomy on left ventricular geometry, function, and long-term survival of patients with end-stage dilated cardiomyopathy. J Card Surg. Sep-Oct 2009; 24(5):499-502. PMID 19740283

29. Domingues JS, Vale Mde P, Barbosa MP. Partial left ventriculectomy: have well-succeeded cases and innovations in the procedure been observed in the last 12 years? Braz J Cardiovasc Surg. Oct 2015; 30(5):579-85. PMID 26735606

30. 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): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. Sep 20 2005; 112(12):e154-235. PMID 1616

31. Committee on New Technology Assessment, The Society of Thoracic Surgeons. Left ventricular reduction surgery. Ann Thorac Surg. Mar 1997; 63(3):909-10. PMID 9066437

32. Partial Left Ventriculectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 August) Surgery 7.01.66 – ARCHIVED.

Policy History:

Date Reason
7/15/2016 Document updated with literature review. Coverage unchanged.
11/1/2015 Reviewed. No changes.
4/15/2014 Document updated with literature review. Coverage unchanged.
3/1/2013 Document updated with literature review. Coverage remains unchanged. This medical document is no longer scheduled for routine literature review and update.
11/15/2010 Document updated with literature review. The following changes were made: 1) Partial Left Ventriculectomy (PLV) was combined into this document; PLV was previously addressed on SUR707.019, Partial Left Ventriculectomy. Coverage of PLV is unchanged. 2) Coverage of Surgical Ventricular Restoration is unchanged. 3) The following exception was added to Coverage section: Ventricular aneurysmectomy (ventricular aneurysm repair) may be done with or without SVR or PLV in patients undergoing coronary artery bypass grafting for severe unresponsive congestive heart failure and ejection fraction of equal to or greater than 30%. 4) Document title changed from Surgical Ventricular Restoration. Document title change to “Cardiac Restoration and Remodeling Procedures”. Surgical Ventricular Restoration :
10/1/2008 Revised/updated entire document
5/1/2006 Revised/updated entire document
1/1/2006 New medical document Partial Left Ventriculectomy :
6/1/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
5/1/2007 Revised/updated entire document
1/1/1999 New medical document

Archived Document(s):

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