Description:
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.

Policy:
Partial left ventriculectomy is considered NOT MEDICALLY NECESSARY.

Benefit Application
BlueCard/National Account Issues
Partial left ventriculectomy may be coded as CPT code 33542 (myocardial resection). Plans located in the same areas as hospitals performing partial left ventriculectomy may consider requiring precertification or prior approval for CPT code 33542, or performing a retrospective audit focused on CPT code 33542.

Rationale:
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 was during the period of July 2011 through June 2012. There were no controlled trials comparing partial left ventriculectomy (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 (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 percent) died or were lost to follow-up. The main causes of death were progressive heart failure (48.4 percent), sudden death (10.3 percent) and arrhythmias (6.6 percent).

Suma et al.³ treated 95 patients with idiopathic dilated cardiomyopathy between 1999 and 2006. A total of 57/95 (60 percent) underwent PLV with excision of the lateral wall, and 38/95 (40 percent) underwent a SAVE procedure with excision of the anteroseptal wall. Hospital mortality was 11.6 percent (11/95), and one-, three- and five-year survival was 72.8 percent, 61.4 percent, and 50.5 percent, respectively. LV ejection fraction improved from 22.3 percent pre-surgery to 27.2 percent 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 one- and three-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 percent and 60 percent at one and three years after surgery, and freedom from heart failure was 49 percent and 26 percent, all respectively. Although 80 percent 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 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 percent, and actuarial survival at one year was 82 percent. Freedom from treatment failure (defined as death or relisting for transplantation) was 58 percent at one 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 percent, 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 three-year estimate of freedom from death, left ventricle assist device (LVAD), transplantation or worsening heart failure, was only 26 percent.

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) Guideline⁶ 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

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.  

Coding Section

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. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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