Subject:
Partial Left Ventriculectomy
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Partial left ventriculectomy (PLV) is a surgical procedure aimed at improving the hemodynamic status of patients with end-stage congestive heart failure (CHF) by directly reducing left ventricular size, and thereby improving the pump function of the left ventricle (LV).
This surgical approach to the treatment of congestive heart failure (CHF) (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, LV wall tension is reduced and left ventricle (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 partial left ventriculectomy (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.
Related Policies
- Surgical Ventricular Restoration (Policy #063 in the Surgery Section)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Partial left ventriculectomy is not considered medically necessary.
Medicare Coverage:
Per the National Coverage Determination (NCD) for Partial Ventriculectomy 20.26, partial ventriculectomy is not considered reasonable and necessary within the meaning of §1862(a)(1) of the Act, and therefore, is not covered. For additional information, refer to National Coverage Determination (NCD) for Partial Ventriculectomy (20.26). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=122&ncdver=1&bc=AAAAgAAAAAAAAA%3d%3d&.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: This policy is based on a 1998 TEC Assessment, (1) which concluded that the available data were inadequate to permit conclusions regarding health benefits associated with partial left ventriculectomy. Specifically, the 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.
Since the TEC Assessment was published in 1998, periodic updates of the policy with literature search have been performed. The most recent literature search did not identify any controlled trials comparing partial left ventriculectomy (PLV) to alternative treatments. 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 (LV) volume reduction surgery were published in 2005. (2) 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 surgical ventricular restoration (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%).
Suma et al. (3) treated 95 patients with idiopathic dilated cardiomyopathy between 1999 and 2006. A total of 57/95 (60%) underwent PLV with excision of the lateral wall, and 38/95 (40%) underwent a SAVE 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% pre-surgery to 27.2% post-surgery (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 New York Heart Association (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 and colleagues reported on the 1- and 3-year outcomes of 62 patients with dilated cardiomyopathy who underwent partial left ventriculectomy. (4) 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. (5) 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), LV ejection fraction (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 ventricle assist device (LVAD), transplantation, or worsening heart failure, was only 26%.
Summary
Partial left ventriculectomy (PLV) is a surgical procedure aimed at improving the hemodynamic status of patients with end-stage congestive heart failure (CHF) by directly reducing left ventricular size, and thereby improving the pump function of the left ventricle (LV).
Some clinical series have reported improvement in ejection fraction 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.
Practice Guidelines and Position Statements
The American College of Cardiology/American Heart Association (ACC/AHA) Guideline (6) 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. (7)]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Partial Left Ventriculectomy
Heart Volume Reduction Surgery (HVRS)
Batista Procedure
Cardio-Reduction
Left Ventricular Reduction Surgery
Left Ventriculectomy, Partial
Ventricular Remodeling
Ventricular Volume Reduction
References:
1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Partial left ventriculectomy. TEC Assessments 1998; Volume 13, Tab 4.
2. 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.
3. Suma H, Tanabe H, Uejima T et al. Selected ventriculoplasty for idiopathic dilated cardiomyopathy with advanced congestive heart failure: midterm results and risk analysis. Eur J Cardiothorac Surg 2007; 32(6):912-6.
4. Franco-Cereceda A, McCarthy PM, Blackstone EH et al. Partial left ventriculectomy for dilated cardiomyopathy: is this an alternative to transplantation? J Thorac Cardiovasc Surg 2001; 121(5):879-93.
5. 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.
6. 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.
7. Left ventricular reduction surgery. Ann Thorac Surg 1997; 63(3):909-10.
8. National Coverage Determination for partial ventriculectomy (20.26). Center for Medicare and Medicaid Services . Available online at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=122&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&KeyWord=partial+ventriculectomy&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAA&.
9. UpToDate. Surgical management of heart failure. Literature review current through March 2016.
10. Fang JC, Surgical management of heart failure. In: UpToDate, Colucci WS, Aldea GS, Verrier E (Eds), UpToDate, Waltham, MA. (Accessed on April 10, 2017.)
11. Fang, JC. Surgical management of heart failure. In: UpToDate, Yeon SB (Ed), UpToDate, Waltham, MA. (Accessed on February 26, 2018.)
12. Fang, JC. Surgical management of heart failure. In: UpToDate, Colucci WS, Aldea GS, Verrier E, Yeon SB (Eds), UpToDate, Waltham, MA. (Accessed on March 11, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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