BlueCross and BlueShield of Montana Medical Policy/Codes
Cardiac Restoration and Remodeling Procedures
Chapter: Surgery: Procedures
Current Effective Date: December 27, 2013
Original Effective Date: December 11, 2012
Publish Date: September 27, 2013
Revised Dates: October 04, 2012; September 13, 2013
Description

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 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 or after coronary artery bypass grafting (CABG) and may precede or be followed by mitral valve repair or replacement, as well as other procedures, such as endocardiectomy and cryoablation for treatment of ventricular tachycardia (VT).

The SVR procedure may also be referred to as ventricular remodeling (VR), surgical anterior ventricular endocardial restoration (SAVER) left ventricular reconstructive surgery, left ventricular aneurysmectomy reconstruction, endoventricular circular patch plasty (EVCPP) repair, left ventricular infarct exclusion surgery 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.

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. This system utilizes an endoventricular shaper, known as the Mannequin™ in addition to the SVR procedure to more accurately reshape and resize the left ventricle.

Partial Left Ventriculectomy (PLV):

Partial left ventriculectomy is a surgical procedure aimed at improving the hemodynamic status of patients with end-stage or irreversible CHF by directly reducing left ventricular size. This is accomplished by reducing cardiac volume and left ventricular wall tension through resection of the posterolateral wall of the left ventricle.

This surgical approach to the treatment of CHF (also known as the Batista procedure, cardio-reduction, or left ventricular remodeling surgery) is primarily directed at patients with an underlying dilated cardiomyopathy awaiting cardiac transplantation. 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 (LV) wall tension is reduced and LV 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 (VADs) 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 posterolateral wall and apex of the heart and removal of a wedge-shaped portion of the LV. 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.

SVR versus Ventriculectomy for Aneurysm Removal or PLV:

A key difference between SVR and ventriculectomy for aneurysm removal is that in SVR a 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.

Policy

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.

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 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 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%.

Policy Guidelines

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.

Rationale

Surgical Ventricular Restoration (SVR):

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 following anterior myocardial infarction (MI) in the past 20 years. (1, 2, 3, 4, 5, 6) The following discussion summarizes a representative sample of some of the reports on SVR.

Athanasuleas and colleagues (5) 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 (EF) 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. (7) reported on 285 patients who underwent SVR by a single surgeon for New York Heart Association (NYHA) Class III or IV CHF (congestive heart failure), angina or ventricular tachycardia (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 EFs 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 (8) reported on 157 patients that underwent SVR by a single surgeon for NYHA 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 EF 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 EF of 26% or greater preoperatively.

Sartipy et al. (9) reported on 101 patients who underwent SVR using the Dor procedure at a single center for NYHA 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 EF 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.

Clinical Guidelines and Trials

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 (NHLBI) 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.

Summary

While the SVR procedure has been performed for many years, the available data are inadequate to permit conclusions regarding health benefits associated with SVR. Specifically, the lack of any randomized controlled trials (RCTs) 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.

2008 Update

A MedLine search was performed from January 2006 through July 2008. Riberio and colleagues (10) 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. EF improved in all groups, but the most improvement was in the SVR plus revascularization group.

Other publications reported on case series. For example, Tulner et al. (11) reported on six-month follow-up on 21 patients with ischemic dilated cardiomyopathy 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 EF (27-36%). Another article reported by Hernandez et al. (12) on the contemporary performance of SVR based on data from the Society of Thoracic Surgeons’ 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 et al. (13) completed another study and reported on six-month outcomes on 33 patients with NYHA Class III or IV CHF 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 and colleagues (14) reported on a retrospective review of outcomes following SVR in a series of 34 patients with NYHA Class IV heart failure and 44 patients with NYHA Class II or 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 NYHA Class IV versus NYHA Class II or III disease (68% versus 88%).

Williams and Patel et al. (15, 16) 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 cardiomyopathy and for ischemic cardiomyopathy patients with or without pulmonary hypertension 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 or 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 or 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 EF 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 or III. Class IV patients had significantly worse EF, 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 or III (82%) reaching Class I or II postoperatively. Reported that using SVR had better survival outcomes compared to medical management.

4.

Ischemic cardiomyopathy patients, < or > than age 65

69

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

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

5.

Ischemic cardiomyopathy patients with or without pulmonary hypertension

69

Pulmonary hypertension was determined during cardiac catheterization as either > or = to 25 mm Hg or those without pulmonary hypertension 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.

Summary

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 experimental, investigational and unproven.

2010 Update

A search of MedLine was performed for the period of August 2008 through July 2010. Many of the identified studies were case series that are not adequate to evaluate this technology. Results of the STICH trial have been published. (17) In this study 1,000 patients with CAD and ejection fraction of 35% or less were randomized to CABG alone (n=499) or CABG with SVR (n=501). While SVR reduced the end-systolic volume index by 19% compared to 6% with CABG alone, cardiac symptoms and exercise tolerance improved to similar degrees. Also, the addition of SVR did not result in a reduction in the rate of death or hospitalization for cardiac causes. A non-randomized comparative study (18) from Europe involving patients with CAD who underwent CABG or CABG plus SVR and had an EF of 30% to 40% has also been published. In this non-randomized study, Jones and colleagues concluded that patients in whom SVR was possible experienced more peri-operative complications but had improved early and midterm outcomes. However, the non-randomized nature of this study limits its conclusions.

Summary

The impact of SVR on net health outcome remains uncertain. The policy statement remains unchanged and is considered experimental, investigational and unproven.

2012 Update

A search of peer reviewed literature through November 2012 was completed. The following is a summary of the clinical trial publications and information to date.

A second RCT was published in 2011 by Marchenko et al. (19) This was a study performed in Russia of 236 patients with ischemic heart failure who were randomized to CABG alone or CABG plus SVR. The mean follow-up was 31 plus13 months. Outcome measures reported were perioperative mortality and survival at 1, 2, and 3 years’ follow-up. Perioperative mortality was 5.8% in the CABG alone group compared with 3.5% in the CABG plus SVR group (p=NS, statistical tests not reported). 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 tests not reported). There were reductions in NYHA functional class and angina class for both groups after surgery, but between-group statistical testing was not reported. For example, the NYHA functional class decreased in the CABG plus SVR 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.

A separate publication from the STICH trial reported on quality-of-life (QOL) outcomes. (20) 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 short form (SF)-12, the CES-D depression measure, 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 to the CABG alone group. Similarly, there were no group differences noted on any of the secondary QOL measures.

Clinical Guidelines and Trials

In 2010, a Task Force of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery developed guidelines on myocardial revascularization. (21) These guidelines consider SVR combined with CABG to be a surgical option for patients with ischemic heart failure and left ventricular EF 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.

A search of online site ClinicalTrials.gov in July 2012 found the only active Phase III trial on SVR is the STICH a randomized, multicenter, international, clinical trial to compare medical therapy with CABG and/or SVR for patients with heart failure and coronary heart disease (NCT00023595). Although this trial is listed as ongoing, the main results of the CABG alone versus CABG plus SVR have already been published and are reviewed in this reference policy.

Summary

The recent review to date of the scientific data identified no new clinical trial or any additional information that would change the coverage position of this medical policy. Therefore, SVT remains experimental, investigational and unproven.

Partial Left Ventriculectomy (PLV):

This policy is based on a 1998 Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment, (23) which concluded that the available data were inadequate to permit conclusions regarding health benefits associated with partial left ventriculectomy. 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 [VADs]) 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.

Clinical Guidelines and Trials

In addition, in 1997, the Society of Thoracic Surgeons (24) 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 CHF.

2004 Update

A search of the literature based on the MedLine database from the period of 1998 to July 2004 did not identify any published articles that would change the above conclusions. As an example of the published literature, Franco-Cereceda and colleagues (25) reported on the one-year and three-year outcomes of 62 patients with dilated cardiomyopathy who underwent PLV. At the time of surgery all patients were either in NYHA functional Class III or IV. Survival was 80% and 60% at one and three years after surgery, and freedom from failure was 49% and 26%, respectively. Although 80% of the patients were alive at one year, this survival was achieved with the aggressive use of VADs and transplantation as a salvage therapy. The authors concluded that PLV is not a predictable, reliable alternative to transplantation. Further investigations may be warranted, focusing on the use of the procedure as a bridge to transplant, or its use in those not considered candidates for transplantation.

In 2003, the results of the Third International Registry Report were published, (26) 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.

Summary

The impact of PLV on net health outcome remains uncertain. The policy statement remains unchanged and is considered experimental, investigational and unproven.

2007 Update

A further search of the MedLine database through November 2006 did not identify any new evidence in the peer-reviewed medical literature that:

  • Permits conclusions on the effect of PLV on health outcomes.
  • Demonstrates an improvement in net health outcome through use of PLV.
  • Demonstrates that use of PLV is as beneficial as established alternatives.

Summary

The impact of PLV on net health outcome remains uncertain. The policy statement remains unchanged and is considered experimental, investigational and unproven.

2010 Update

A search of peer reviewed literature through August 2010 identified several small studies focusing on the treatment of end-stage dilated cardiomyopathy. Sugiyama and colleagues (27) reported on 11 children under the age of three years diagnosed with severe dilated cardiomyopathy. Eight procedures were done on six of the children: five PLV and three mitral valve replacement. Two of them underwent mitral valve replacement after PLV. Follow up after PLV ranged from two months to eight years. During follow up period, four patients remain alive, of whom one eventually underwent a heart transplant.

Suma et al. (28) reported a study of 107 patients with idiopathic dilated cardiomyopathy, for determination of the approach to the left ventriculoplasty. Either the lateral wall was excluded by PLV or septal anterior ventricular exclusion (known as SAVE or pacopexy) if the septum was diseased. For the entire cohort of PLV and SAVE study population, the overall EF increased from 20 to 31% and the NYHA Class improved from III to I. The one, five, and seven year survival rates were 66.9, 46.0, and 36.2% respectively.

In 2009 Nishina et al. (29) 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. The authors reported left ventricular function improvement as the EF increased from 28% to 39% and the NYHA Class improved from III to I. Survival rates were not reported in this small study.

Summary

In conclusion, the studies identified did not lead to a change in the coverage statement; these technologies are still considered experimental, investigational and unproven.

2012 Update

Since the TEC Assessment was published in 1998, periodic updates of the policy with literature search have been performed. The most recent literature search was completed through November 2012. There were no controlled trials comparing PLV to alternative treatments identified as part of this search. The available literature consists of uncontrolled series of patients undergoing PLV and a representative sample of this literature is discussed below.

Results from an international registry of patients undergoing left ventricular volume reduction surgery were published in 2005. (30) 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%).

Starling et al. (31) treated 59 patients with dilated cardiomyopathy and advanced heart failure with PLV and mitral valve repair. 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<0.0001), left ventricular EF (13 to 24%, p<0.0001), 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 VAD, transplantation, or worsening heart failure, was only 26%.

Clinical Guidelines and Trials

The American College of Cardiology/American Heart Association (ACC/AHA) Guideline (32) 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.”

In 1997, the Society of Thoracic Surgeons issued a policy statement recommending that PLV be considered an investigational procedure and that it should not be used as a primary strategy for the management of end-stage congestive heart failure. (33)

Summary

Over the years, some clinical series have reported improvement in EF and symptoms following PLV; however, there is a lack of controlled trials 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. As a result of the lack of evidence on benefits from the procedure, and the possibility of harms, PLV is considered not medically necessary.

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. 

ICD-9 Codes
37.35, 394.0, 394.1, 394.2, 394.9, 411.1, 411.81, 411.89, 414.00, 414.01, 414.02, 414.03, 414.04, 414.05, 414.06, 414.07, 414.10, 414.11, 414.12, 414.19, 414.8, 414.9, 424.0, 425.1, 425.2, 425.4, 425.5, 425.7, 425.8, 425.9, 428.0, 428.1, 428.20, 428.22, 428.23, 428.9, 429.3
ICD-10 Codes

I25.3, I25.5, I42.0, I50.20-I50.9, 02BK0ZZ, 02BK3ZZ, 02BK0ZZ, 02BK4ZZ, 02BL3ZZ, 02BL0ZZ, 02BL4ZZ

Procedural Codes: 33542, 33548, 33999
References
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. Jones, R.H., Velazquez, E.J., et al. Coronary bypass surgery with or without surgical ventricular reconstruction. New England Journal of Medicine (2009 April 23) 360(17):1705-17.
  18. Dzemali, O., Risteski, P., 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. Journal of Thoracic and Cardiovascular Surgery (2009 September) 138(3):663-8.
  19. 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 2011; 13(1):46-51.
  20. 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 2009; 157(5):837-44, 44 e1-3.
  21. Wijns W, Kolh P, Danchin N et al. Guidelines on myocardial revascularization. Eur Heart J 2010; 31(20):2501-55.
  22. Surgical Ventricular Restoration. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 August) Surgery 7.01.103.
  23. Partial Left Ventriculectomy. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1998) Tab 4.
  24. Committee on New Technology Assessment, The Society of Thoracic Surgeons. Left ventricular reduction surgery. Annals of Thoracic Surgery (1997) 63(3):909-10.
  25. Franco-Cereceda, A., McCarthy, P.M., et al. Partial left ventriculectomy for dilated cardiomyopathy: is this an alternative to transplantation?  Journal of Thoracic Cardiovascular Surgery (2001) 121(5):879-93.
  26. Kawaguchi, A.T., Isomura, T., et al. Partial left ventriculectomy – The Third International Registry Report 2002. Journal of Cardiac Surgery (2003) 18(supplement 2):S33-42.
  27. Sugiyama, H., Hoshiai, M., et al. Outcome of non-transplant surgical strategy for end-stage dilated cardiomyopathy in young children. Circulation Journal (2009 June) 73(6):1045-8.
  28. Suma, H., Horii, T., et al. A new concept of ventricular restoration for nonischemic dilated cardiomyopathy. European Journal of Cardio-Thoracic Surgery (2006 April) 29 Supplement 1:S207-12.
  29. Nishina, T., Shimamoto, T., 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. Journal of Cardiac Surgery (2009 September-October) 24(5):499-502.
  30. 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.
  31. 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 2000; 36(7):2098-103.
  32. 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 2005; 112(12):e154-235.
  33. Left ventricular reduction surgery. Ann Thorac Surg 1997; 63(3):909-10.
  34. Partial Left Ventriculectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 August) Surgery 7.01.66 – ARCHIVED.
History
October 2012  New Policy created from MEDLINE literature search.
September 2013 Policy formatting and language revised.  Title changed from "Surgical Ventricular Restoration" to "Cardiac Restoration and Remodeling Procedures".  Added congestive heart failure and coronary artery disease to the surgical ventricular investigational statement.  Added "Partial left ventriculectomy is considered experimental, investigational and unproven for all indications".  Added CPT codes 33542 and 33999.
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CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Cardiac Restoration and Remodeling Procedures