Clinical Policy Bulletin: Lung Volume Reduction Surgery
Aetna considers lung volume reduction surgery (LVRS) medically necessary for members who meet the selection criteria outlined below. The standards for pre-operative assessment and criteria for surgery have been evolving and have varied from institution to institution. There is medical consensus that the candidate for LVRS should have severe emphysema, disabling dyspnea, and evidence of severe air trapping.
The selection criteria, which are based on the results of the National Emphysema Treatment Trial, are as follows:
For members with cardiac ejection fraction less than 45 %, there is no history of congestive heart failure or myocardial infarction within 6 months of consideration for surgery; and
The member has a history and physical examination consistent with emphysema; and
The member has not smoked for 4 or more months; and
The member has all of the following on pre-operative work-up:
CT scan evidence of bilateral emphysema; and
Forced expiratory volume in 1 second (FEV1) (maximum of pre- and post-bronchodilator values) less than or equal to 45 % of predicted and, if aged 70 year or older, FEV1 15 % of predicted or more; and
Plasma cotinine less than or equal to 13.7 ng/ml (if not using nicotine products) or carboxyhemoglobin less than or equal to 2.5 % (if using nicotine products); and
Post-bronchodilator total lung capacity (TLC) greater than or equal to 100 % of the predicted value and residual volume (RV) greater than or equal to 150 % of predicted value; and
Resting partial pressure of carbon dioxide (PaCO2) less than or equal to 60 mm Hg on room air; and
Resting partial pressure of oxygen (PaO2) 45 mm Hg or greater; and
Six-minute walk test greater than 140 meters
Lung volume reduction surgery is considered experimental and investigational if the member has either of the following contraindications:
Post-bronchodilator FEV1 is 20 % or less than its predicted value and member has either
a carbon monoxide diffusion capacity (DLCO) is 20 % or less than its predicted value. (Persons in this category have been found to be at high risk for death after LVRS, with little chance of functional benefit); or
a homogenous distribution of emphysema on CT scan
Members with predominantly non-upper lobe emphysema and a high maximal work-load.
For purposes of this policy, a high maximal workload is defined as a maximal workload (on cycle ergometry with an increment of 5 or 10 W/min after 3 mins of pedaling with the ergometer set at 0 W and the person breathing 30 % oxygen) above the sex-specific 40th percentile (25 W for women, 40 W for men).
For purposes of this policy, predominantly non-upper lobe predominance of emphysema is defined to exclude disease on CT that is judged by the radiologist as affecting primarily the upper lobes of the lung, and to include disease that is judged to be predominantly lower lobe, diffuse, or predominantly affecting the superior segments of the lower lobes.
(Note: Persons with predominantly non-upper-lobe emphysema and a high maximal work-load have been found to have higher mortality from LVRS than from medical therapy alone, and have been found to have little chance of functional improvement regardless of the treatment they receive).
The member should have none of the following exclusion criteria:
Alpha-1 antitrypsin deficiency
Clinically significant bronchiectasis
Evidence of systemic disease or neoplasia that is expected to compromise survival
Giant bulla (greater than 1/3 the volume of the lung in which the bulla is located)
History of recurrent infections with clinically significant production of sputum
Oxygen requirement greater than 6 L/min during resting to keep oxygen saturation greater than or equal to 90 %
Pleural or interstitial disease which precludes surgery
Previous LVRS (laser or excision)
Pulmonary hypertension, defined as mean pulmonary artery pressure of 35 mm Hg or greater on right heart catheterization or peak systolic pulmonary artery pressure of 45 mm Hg or greater. (Right heart catheterization is required to rule out pulmonary hypertension if peak systolic pulmonary artery pressure is greater than 45 mm Hg on echocardiogram)
Pulmonary nodule requiring surgery
Resting bradycardia (less than 50 beats/min), frequent multifocal premature ventricular contractions (PVCs), of complex ventricular arrhythmia or sustained supraventricular tachycardia (SVT)
Uncontrolled hypertension (systolic greater than 200 mm Hg or diastolic greater than 110 mm Hg)
Unplanned weight loss greater than 10 % within 3 months prior to consideration for surgery.
Aetna considers lung volume reduction surgery experimental and investigational for all other indications because its effectiveness for indications other than the ones listed above has not been established.
Aetna considers bullectomy medically necessary for the treatment of dyspneic members with giant bulbous emphysema when they have a single large bulla producing significant respiratory compromise (FEV1 of less than 50 % predicted).
Aetna considers bullectomy experimental and investigational for all other indications because its effectiveness for indications other than the one listed above has not been established.
Aetna considers thoracoscopic laser bullectomy experimental and investigational in the treatment of members with emphysematous lung disease because the benefit of this procedure has not been conclusively demonstrated. Furthermore, outcomes of thoracoscopic laser surgery for persons with diffuse disease need to be compared with current non-laser surgical techniques and medical therapy. Additionally, the long-term benefits of this surgery, including decreased symptoms and improved pulmonary function compared to persons without surgical intervention, need to be demonstrated.
Aetna considers bronchoscopic lung volume reduction procedures experimental and investigational because of insufficient evidence of their effectiveness, including:
The placement of bronchial valves (e.g., IntraBronchial Valve (IBV); Spiration IBV; Emphasys Endobronchial Valve (EBV) (formerly known as the Zephyr EBV)).
Lung volume reduction surgery (LVRS) is a general term encompassing a variety of surgical procedures that are offered to alleviate the symptoms of advanced chronic obstructive pulmonary disease (COPD) due to emphysema. Currently the operations used to treat emphysema include the excision of large bullae by thoracotomy or thoracoscopy and the resection of diffusely emphysematous lung tissue.
This latter surgery, variably referred to as a lung reduction surgery, pneumectomy, and reduction pneumoplasty can be accomplished through a variety of incisions (sternotomy, clam shell, thoracotomy) or by thoracoscopy using a staple procedure or laser applications. Currently the choice of techniques depends on the surgical expertise and preference of the operator.
Based on results reported in peer review journals, abstracts and presentations at national meetings, LVRS appears efficacious for some, but not all, patients with advanced COPD due to emphysema.
Several centers have documented post-operative improvement in exertional dyspnea, measurements of pulmonary function, exercise capacity and objectively scored quality of life indices. Improvements in exercise capacity have been reported in patients undergoing a comprehensive program of pulmonary rehabilitation in preparation for surgery.
It appears that bilateral pneumectomy yields improvements in spirometry that are roughly twice as great as unilateral procedures.
In the 1 available randomized prospective trial that compared stapled lung reduction to laser bullectomy surgery, patients who received the latter procedure were more likely to develop a delayed pneumothorax and less likely to eliminate dependency on supplemental oxygen. Also, the mean post-operative improvement in the FEV1 at 6 months was greater in those who received the stapled lung reduction technique (32.9 % improvement) than the laser treatment (13.4 % improvement).
Fishman et al (2003) reported on the results of the National Emphysema Treatment Trial, a randomized, multi-center clinical trial comparing LVRS with medical treatment. A total of 1,218 patients with severe emphysema were randomly assigned to undergo LVRS or to receive continued medical treatment. Lung volume reduction surgery was found to improve exercise capacity in a significant proportion of patients, but to have no significant effect on overall mortality. After 24 months, exercise capacity had improved by more than 10 W in 15 % of the patients in the surgery group, as compared with 3 % of patients in the medical-therapy group.
Lung volume reduction surgery was found to yield a survival advantage for patients with both predominantly upper-lobe emphysema and low base-line exercise capacity (Fishman et al, 2003). Among patients with predominantly upper-lobe emphysema and low exercise capacity, mortality was more than 50 % lower in the surgery group than in the medical-therapy group.
In contrast, LVRS was associated with an increase in mortality and negligible functional gain among patients with predominantly non-upper lobe emphysema and a high base-line exercise capacity (Fishman et al, 2003). Among patients with non-upper-lobe emphysema and high exercise capacity, mortality was twice as high in the surgery group as in the medical-therapy group.
Lung volume reduction surgery was also associated with an increase in mortality among persons who were, in previous reports (National Emphysema Treatment Trial Research Group, 2001) considered to be at high-risk of death after surgery, namely patients with a low FEV1 (20 % or less than predicted) and either homogenous emphysema or a very low carbon monoxide diffusing capacity (20 % or less than predicted) (Fishman et al, 2003). A meta analysis (Berger et al, 2005) reported that a selected subset of patients with advanced, heterogeneous emphysema and low exercise tolerance (as indexed by the 6-min walk distance) experienced better outcomes from LVRS than from medical therapy.
Functional benefits but no improvements in survival were found in patients with predominantly upper-lobe emphysema and a high base-line exercise capacity and patients with non-upper lobe emphysema and a low base-line exercise capacity (Fishman et al, 2003).
Patients usually need pulmonary rehabilitation after LVRS to better ensure return to function.
Stoller et al (2007) noted that the role of LVRS for individuals with alpha-1 antitrypsin (AAT) deficiency is unclear. These investigators evaluated the role of LVRS in individuals with severe deficiency of AAT, and analyzed outcomes within the National Emphysema Treatment Trial. Of 1,218 randomized subjects, 16 (1.3 %) had severe AAT deficiency (serum level less than 80 mg/dL) and a consistent phenotype (when available). Characteristics of these 16 patients were 87.5 % male; median serum AAT level of 55.5 mg/dL; age of 66 years; FEV1 27 % predicted; and 50 % had upper-lobe-predominant emphysema. All 10 subjects randomized to LVRS underwent the procedure. Although the small number of subjects hampered statistical analysis, 2-year mortality was higher with surgery (20 % versus 0 %) than with medical treatment. Comparison of outcomes between the 10 AAT-deficient and the 554 AAT-replete subjects undergoing LVRS showed a greater increase in exercise capacity at 6 months in replete subjects and a trend toward lower and shorter duration FEV1 rise in deficient individuals. The authors concluded that the findings of this study extended to 49 cases the published experience of LVRS in severe AAT deficiency. Although the small number of subjects precluded firm conclusions, trends of lower magnitude and duration of FEV1 rise after surgery in AAT-deficient versus AAT-replete subjects and higher mortality in deficient individuals randomized to surgery versus medical treatment suggest caution in recommending LVRS in AAT deficiency.
Giant bullous emphysema (GBE) is a rare subset of patients with COPD in whom single or multiple large bullae encompass 30 % or more of a hemi-thorax, often displacing potentially functional lung tissue as these large airspaces increase in volume. In appropriate cases, surgical resection of these bullae can restore significant pulmonary function and improve symptoms. Computed tomography (CT) scan is essential in evaluating these patients.
According to guidelines from the Institute for Clinical Systems Improvement (ICSI, 2004), bullectomy is indicated in these patients. This is in accordance with guidelines on COPD from the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) (NHLBI, 2005): “In carefully selected patients, this procedure is effective in reducing dyspnea and improving lung function. A thoracic computed tomography scan, arterial blood gas measurement, and comprehensive respiratory function tests are essential before making a decision regarding a patient's suitability for resection of a bulla.”
Furthermore, according to guidelines from National Institute for Clinical Excellence (NICE, 2004), patients who are breathless, and have a single large bulla on a CT scan and an FEV1 less than 50 % predicted should be referred for consideration of bullectomy.
In a prospective study, Palla and colleagues (2005) evaluated patients who have undergone elective surgery due to GBE, early and late mortality following surgery, the early and late reappearance of bullae, and the early and late modifications of clinical and functional data. A total of 41 consecutive patients who underwent elective surgery for GBE were studied both before and after undergoing bullectomy for a 5-year-follow-up period. Analyses were performed on the whole population and on 2 subgroups of patients who were divided on the basis of the absence of underlying diffuse emphysema (group A; n = 23) or the presence of underlying diffuse emphysema (group B; n = 18). The early mortality rate was 7.3 % (within the 1st year), and the late mortality rate was 4.9 % (overall mortality rate at 5 years, 12.2 %; mortality rate in group B, 27.8 %). Bullae did not re-appear and residual bullae did not become enlarged in any patients at the site of the bullectomy. During the follow-up, the dyspnea score was reduced significantly soon after bullectomy and up to the fourth year of follow-up; intra-thoracic gas volume also was reduced significantly (average, 0.7 L). The same was true for the FEV1 percent predicted and the FEV1/vital capacity ratio, which kept increasing until the 2nd year; then, from the 3rd year of follow-up these values were reduced, yet remained above the pre-bullectomy values until the 5th year of follow-up. When considered separately, the patients in group B appeared to be the most impaired, clinically and functionally (e.g., FEV1 showed a similar significant increase up to the 2nd year in both groups after surgery, while a different mean annual decrease was appreciable from the second to the 5th year of follow-up: group A, 25 ml/year; group B, 83 ml/year. Furthermore, patients in group B were the only ones who contributed to the mortality rate, on the whole showing a behavior similar to that of patients who had undergone LVRS. These investigators concluded that in patients with GBE who were enrolled in the study prospectively and were investigated yearly during a 5-year-follow-up period, bullectomy appears to have been fairly safe, and allowed clinical and functional improvement for at least 5 years. Better results may be expected in patients without underlying diffuse emphysema.
Donahue and Cassivi (2009) noted that currently alpha-1 antitrypsin deficiency (A1AD) is recognized in approximately 2 % of patients who have emphysema, although this may be an under-estimation of the prevalence of this disease. Given the relatively young age at which patients who have A1AD present with emphysema, therapies aimed at slowing the progression of this disease are imperative. In addition to abstaining from smoking, the use of augmentation therapy may benefit some patients who have moderate airflow obstruction. For patients who have severe airflow obstruction, the most effective therapy is surgical. Despite a possible increased risk for infectious complications, transplantation remains a viable option for these patients who have long-term results mirroring those of patients transplanted for smoking-related COPD. Given limited donor availability, however, LVRS must be considered in these patients possibly as definitive therapy but more likely as a bridge to transplantation. Lung volume reduction surgery for patients who have A1AD remains relatively uncommon despite a general perception that it remains a surgical option. In a survey of European thoracic surgical centers, Hamacher and colleagues found that 2/3 of respondents included A1AD in their list of indications for LVRS. Although the durability of the benefits derived from LVRS in patients who have A1AD seems inferior to that of patients who have COPD, the available data show improved 6-min walk distances and decreased dyspnea persisting for 1 to 2 years after LVRS in patients who had A1AD. The authors stated that further experience is needed to determine whether or not subgroups of patients who have A1AD, such as those who have clear heterogeneous distribution, may derive more long-lasting improvement from LVRS.
Since LVRS is associated with high morbidity, mortality, and cost, several bronchoscopic methods for reducing lung volume in patients with advanced emphysema have been developed and are currently being evaluated in clinical trials as potential alternatives to LVRS. These techniques include: (i) placement of endobronchial 1-way valves designed to promote atelectasis by blocking inspiratory flow; (ii) formation of airway bypass tracts using a radiofrequency catheter designed to facilitate emptying of damaged lung regions with long expiratory times; and (iii) instillation of biological adhesives designed to collapse and remodel hyper-inflated lung. The limited clinical data currently available suggest that all 3 techniques are reasonably safe. However, efficacy signals have been substantially smaller and less durable than those observed after LVRS. Clinical studies to optimize patient selection, refine treatment strategies, characterize procedural safety, elucidate mechanisms of action, and characterize short- and long-term effectiveness of these approaches are ongoing (Ingenito et al, 2008).
Bronchoscopic placement of small self-expanding 1-way valves into airways is a minimally invasive approach currently under investigation as an alternative to open LVRS. The valves are designed to prevent incoming airflow from reaching over-inflated regions of the lung while permitting trapped gas to escape. In addition to isolating non-functional areas of the lungs, the valves have the potential to reduce hypoxemia and hypercarbia by directing airflow to areas where gas exchange is less impaired.
The Zephyr Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA) consists of a 1-way silicone duckbill valve attached to a self-expanding nitinol stent retainer. It is currently being evaluated in a phase III clinical trial, the Endobronchial Valve for Emphysema PalliatioN Trial (VENT), that compares it to optimal medical management in patients aged 40 to 75 years with heterogeneous emphysema. Patients were randomized into 2 groups: EBV procedure (n = 180) and optimal medical therapy (n = 90). Efficacy end-points include pulmonary function, exercise tolerance, and quality of life compared to baseline at various times throughout the course of 1 year. The valves are designed to be removable so the procedure has the potential to be fully reversible. The device is not yet commercially available in the United States; however, in September 2007 Emphasys Medical, Inc. submitted a pre-market application to the U.S. Food and Drug Administration (FDA) seeking approval to market the device in the U.S.
The Umbrella Implantable IntraBronchial Valve (IBV) (Spiration, Inc., Redmond, WA) consists of a polyurethane membrane over an umbrella-shaped nitinol (nickel/titanium) frame. The proximal portion is made up of 6 support stents that expand radially. The valve is designed to limit airflow distally, but the membrane and support stents allow mucociliary clearance, air and mucous to flow proximally past the valve in order to allow decompression of collateral ventilation and to reduce the hazards of mucous impaction and obstruction pneumonia. The valve design includes a proximal center rod that allows re-positioning or removal if needed. The FDA approved the IBV Valve system to control prolonged air leaks of the lung or significant air leaks that are likely to become prolonged following lobectomy, segmentectomy or LVRS via the humanitarian device exemption process. It is also currently under investigation in the U.S. as a new treatment option for patients with severe emphysema, however, the effectiveness of this device has not been demonstrated in the peer-reviewed medical literature and it has not received FDA approval for this indication.
The Biologic Lung Volume Reduction (BLVR) System (Aeris Therapeutics, Inc., Woburn, MA) is an investigational procedure that uses pharmacologic agents to selectively collapse over-inflated regions of the lung. During a BLVR procedure, the physician targets diseased portions of the lung tissue with a bronchoscope and applies a washout solution to disrupt pulmonary surfactant and remove pulmonary epithelium. This causes air space to collapse on exhalation. A fibrin-based hydrogel is then applied to the treated tissue sealing it off from the rest of the lung and causing it to scar and shrink. The procedure is intended to reduce lung volume over a period of weeks as diseased lung tissue continues to collapse. It is performed in a hospital under general anesthesia and requires an overnight stay.
Aeris Therapeutics, Inc. is currently conducting a phase III study to evaluate the safety and effectiveness of the BLVR procedure. Unpublished results from two U.S. phase II studies indicated that the treatment was well-tolerated and improved pulmonary function in some emphysema patients.
The BLVR procedure may be a promising treatment for individuals with advanced upper lobe predominant emphysema; however, there is insufficient evidence of its effectiveness. Studies to determine patient selection, safety, mechanism of action, as well as short- and long-term effectiveness in patients with advanced emphysema are on-going.
In a pilot study, Snell et al (2009) reported the safety and feasibility of novel 2nd-generation bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation. A total of 11 patients with severe heterogeneous emphysema underwent unilateral bronchoscopic application of vapor thermal energy (mean of 4.9 cal/g alveolar tissue; range of 3 to 7.5) with bronchial thermal vapor ablation (BTVA) aiming to induce a controlled inflammatory airway and parenchymal response with resultant LVR. Nine women and 2 men, with a mean age of 61 years, FEV1 of 0.77 +/- 0.17 L (32 % predicted), residual volume (RV) of 4.1 +/- 0.9 L (219 % predicted), and gas transfer of 7.8 +/- 2.2 (34 % predicted), underwent unilateral upper lobe treatments. Serious adverse events in 5 included probable bacterial pneumonia and exacerbations of airways disease in 2. Although no important FEV1 or RV changes occurred during 6 months of follow-up, gas transfer improved, 16 % to 9.0 % +/- 2.1 % (38 % predicted), the Medical Research Council Dyspnoea Score improved from 2.6 to 2.1, and the St. George Respiratory Questionnaire Total Score improved from 64.4 at baseline to 49.1. The authors conclued that these preliminary data on unilateral BTVA therapy confirm feasibility, an acceptable safety profile, and the potential for efficacy.
Eberhardt and colleagues (2009) stated that after bronchoscopic LVR, improvement in pulmonary function and exercising tolerance can be achieved in patients with severe heterogeneous lung emphysema. Feasibility and safety for 1-way valve placement in homogeneous emphysema were evaluated. A total of 10 patients entered this prospective study. In all cases, a homogeneous distribution was confirmed by computer analysis of the CT-scans. These researchers performed unilateral LVR and occluded the lobe with the lowest perfusion, measured by nuclear scintigraphy. Endpoints of the study were changes in lung function test, quality of life and 6-minute walk-test (6-MWT) at day 30 and 90 and the safety of the procedure. Pre-operative mean FEV1 was 0.93 L (range of 0.55 to 1.35 L), mean residual volume was 5.23 L (3.55 to 8.24 L) and 6-MWT was 325 m (150 to 480 m). Improvement of dyspnoe and exercising tolerance was reported in 7 cases. No major changes in lung function were evident at days 30 and 90. A trend towards improvement was observed in 6-MWT (DeltaMW + 10.4 +/- 9.8 %). One pneumothorax was noticed, in 1 case the valves were removed after 90 days because of recurrent infections. The authors concluded that the findings of this study showed that bronchoscopic LVR in patients with severe homogeneous emphysema is feasible and seems to be safe. In contrast to surgical LVR, patients may have a cinical benefit by bronchoscopic treatment. They stated that long-term follow-up and patient selection criteria have to be examined in larger trials.
In a clinical pilot study, Herth et al (2010) examined the safety and feasibility of a new endoscopic LVR approach independent of the effects of collateral ventilation (CV). Patients with severe emphysema were eligible. Inclusion and exclusion criteria were modeled after the National Emphysema Treatment Trial (NETT) study. Homogenous and heterogeneous disease was allowed. Treatment consisted of the placement of coils into the parenchyma of the most diseased area with the intent of achieving parenchymal compression. Primary end points were safety and feasibility assessments. Secondary endpoints were efficacy outcomes. A total of 11 patients underwent 21 procedures. Procedures were performed under general anesthesia and lasted 45 +/- 15 mins and per procedure 4.9 +/- 0.6 coils were placed. All procedures were well-tolerated. The total follow-up time was 7 to 11 months and in that time 33 adverse events were reported, none of them severe. No pneumothorax occurred. Efficacy seemed better in heterogeneous rather than homogenous disease. The authors concludedthat endoscopic LVR with coils is safe and feasible. Moreover, they stated that further studies of the efficacy are indicated.
Simoff et al (2013) noted that the management of obstructive lung disease, particularly emphysematous lung disease, is aggressively being pursued. The patient populations that will experience the greatest benefit with lung volume reduction are those that are the worst candidates for surgical intervention. Identifying a bronchoscopic approach that has a true impact on this patient population will be a major accomplishment in the management of patients with COPD. The authors highlighted the work currently ongoing in the area of bronchoscopic lung volume reduction. They stated that there are tools now clinically available in some locations throughout the world, but no standardized technique exists.
Song et al (2013) described the self-expanding endobronchial occluder, as utilized in bronchoscopic lung volume reduction, with a 36 month follow-up procedure. A total of 23 subjects with severe emphysema were recruited and underwent flexible bronchoscopic placement of self-expanding endobronchial occluders. Outcomes were assessed at 1 week, 1-month, 3-, 6-, 12-, 24-, and 36-month intervals. Feasibility, safety, and effectiveness were analyzed by means of pulmonary function testing, 6-min walk test, dyspnea score, BODE (body mass index, air-flow obstruction, dyspnea, and exercise capacity) index, and St George's Respiratory Questionnaire. A total of 58 self-expanding endobronchial occluders were implanted into 23 lobes previously selected. No displacement was found during the follow-up. Five subjects experienced post-operative complications of cough, and 6 subjects had lobar pneumonia, which were not located in any of the blocked segments. The FEV1 in 18 subjects was improved by greater than 15 %, compared with baselines (p < 0.001), and the mean first efficacy time and maximal efficacy time were 5.65 ± 1.51 months and 6.35 ± 3.08 months, respectively. No significant changes were observed in FVC or the ratio of residual volume to TLC. The 6-min walk distance, dyspnea score, and St George's Respiratory Questionnaire total score were improved in 22 subjects over a 24-month period, and a minority of subjects continued to improve through to the end of the study. Mean baseline BODE index had improved during follow-up, but not at the study's conclusion. The authors concluded that these preliminary findings demonstrated early significant improvements in pulmonary function, 6-min walk distance, dyspnea score, BODE index, and quality of life after placement of the self-expanding endobronchial occluder in bronchoscopic lung volume reduction. Its placement also proved both easy and safe. However, they noted that the initial improvements were maintained long-term for only a minority of subjects.
Stratakos et al (2013) stated that a number of bronchoscopic techniques have been developed under the term "bronchoscopic lung volume reduction", aiming to lower the complications and the cost while facilitating the procedure of lung volume approach in patients with emphysema. These include airway bypass by creation of airway/parenchyma communications, 1-way endobronchial valves occluding the airways of the targeted lobes, endobronchial coils which mechanically contract the parenchyma, hot vapor ablation thermally destroying the targeted sites and sealant that fill the alveoli with polymer material. These methods are generally simple and safe, with a favorable complications profile, requiring less infra-structure and interventional experience than the open surgical approach. Bronchial valves have produced promising results in a very narrow phenotype of emphysema patients and have the major advantage of being reversible in their action. Parenchymal interventions at the cost of producing permanent effects and a transient inflammatory syndrome, may be effective in larger group of patients regardless of the fissure integrity and the presence of collateral ventilation. The authors noted that new, more extensive multi-center studies are underway that aim at better selection and stratification of patients in order to further evaluate the safety and effectiveness of these techniques, before wider use of this revolutionary approach for severe lung emphysema can be advocated.
Shah and Herth (2014) stated that COPD is a major cause of morbidity and mortality worldwide. Emphysema is a component of COPD characterized by hyper-inflation resulting in reduced gas exchange and interference with breathing mechanics. Endoscopic lung volume reduction using 1-way valves to induce atelectasis of the hyper-inflated lobe has been developed and studied in clinical trials over the last decade. These investigators performed searches for appropriate studies on PubMed and Clinical Trials Databases using the search terms COPD, emphysema, lung volume reduction and endobronchial valves. The evidence from the randomized clinical trials suggested that complete lobar occlusion in the absence of collateral ventilation or where there is an intact lobar fissure are the key predictors for clinical success. Other indicators were greater heterogeneity in disease distribution between upper and lower lobes. The proportion of patients that respond to treatment improved from 20 % in the unselected population to 75 % with appropriate patient selection. The safety profile for endobronchial valves in this severely affected group of patients with emphysema was acceptable and the main adverse events observed were an excess of pneumothoraces. The authors concluded that selected patients have the potential of significant benefit in terms of lung function, exercise capacity and possibly even survival.
The GOLD’s clinical guideline on “Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease” (2013) states that “In a post-hoc analysis, BLVR (Bronchoscopic Lung Volume Reduction) in COPD patients with severe airflow limitation (FEV1 15 % - 45 % predicted), heterogeneous emphysema on computed tomography (CT) scan, and hyperinflation (total lung capacity [TLC] > 100 % and residual volume [RV] > 150 % predicted) has been demonstrated to result in modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation. Additional data are required to define the optimal technique and patient population”.
Furthermore, the ICSI’s clinical guideline on “Diagnosis and management of chronic obstructive pulmonary disease (COPD)” (Anderson et al, 2013) states that “Bronchoscopic LVR is being assessed in clinical trials; its role in management of COPD is yet to be defined”.
Cohen (2014) noted that COPD is a progressive, debilitating disease that in its final stages cripples the patient. The disappointing results of the National Emphysema Treatment Trial study led to a decrease in the acceptance of LVRS as a therapy. Thus, it became clear that debilitated COPD patients would need innovative alternative non-surgical procedures to potentially alleviate their symptoms. This investigator addressed the various techniques of BLVR. In recent years, a variety of non-invasive BLVR procedures were developed in the hope of improving the respiratory status of these patients. Bronchoscopic lung volume reduction aims to decrease the extent of hyper-inflation due to emphysema and result in a beneficial effect similar to that from surgical resection. The most widely used BLVR devices are: endobronchial valves, foam sealant, metallic coils, airway bypass stents and vapor thermal ablation. In the USA, BLVR remains in the experimental phase. The treatment modalities should be individually tailored for each patient. Endobronchial valves are designed to exclude the most affected emphysematous regions from ventilation in order to induce lobar absorption atelectasis. Airway bypass stents target homogenous emphysema, whereas valves and thermal vapor ablation target heterogeneous emphysema. Biological sealants and endoscopic coil implants have been used in both homogenous and heterogeneous emphysema. The author concluded that BLVR appears to be safer than surgery and presents an attractive alternative for the treatment of COPD patients. Unfortunately, the outcome data to date are inconclusive; the procedures remain experimental and any benefits unproven. However, the data that are emerging continue to appear promising.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
Thoracotomy; with resection-plication of bullae, includes any pleural procedure when performed
Removal of lung, other than pneumonectomy; with resection-plication of emphysematous lung(s) (bullous or non-bullous) for lung volume reduction, sternal split or transthoracic approach, includes any pleural procedure when performed
Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non-bullous) for lung volume reduction (LVRS), unilateral includes any pleural procedure, when performed
CPT codes not covered for indications listed in the CPB:
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure[s])
Other CPT codes related to the CPB:
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure)
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; diagnostic, with cell washing, when performed (separate procedure)
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, with assessment of air leak, with administration of occlusive substance (eg, fibrin glue), if performed
Thoracotomy; with open intrapleural pneumonolysis
32440 - 32488, 32501 - 32540
Excision of lung and pleura (other than for volume reduction)
Thoracoscopy, surgical; with resection-plication of bullae, includes any pleural procedure when performed
Hemoglobin, quantitative, transcutaneous, per day; carboxyhemoglobin
HCPCS codes covered if selection criteria are met:
Preoperative pulmonary surgery services for preparation for LVRS, complete course of services, to include a minimum of 16 days of services
Preoperative pulmonary surgery services for preparation for LVRS, 10 to 15 days of services
Preoperative pulmonary surgery services for preparation for LVRS, 1 to 9 days of services
Post discharge pulmonary surgery services after LVRS, minimum of 6 days of services
ICD-9 codes covered if selection criteria are met:
Other emphysema [except due to alpha-1-antitrypsin deficiency]
ICD-9 codes not covered for indications listed in the CPB:
416.0 - 416.9
Chronic pulmonary heart disease
Paroxysmal supraventricular tachycardia
Sinoatrial node dysfunction
Other ICD-9 codes related to the CPB:
140.0 - 239.9
Neoplasms [expected to compromise survival excluded]
Tobacco use disorder [members who have smoked in last 4 months excluded]
401.0 - 401.9
Essential hypertension [uncontrolled excluded]
410.00 - 412
Acute and old myocardial infarction [history within 6 months of surgical consideration excluded]
Acute cor pulmonale
Primary pulmonary hypertension or other chronic pulmonary heart diseases [35 mm Hg or > on R heart cath or peak systolic of 45 mm Hg or > excluded]
427.0 - 427.9
Cardiac dysrhythmias [resting bradycardia < than 50 BPM, frequent PVCs, or sustained SVT excluded]
Congestive heart failure, unspecified [history within 6 months of surgical consideration excluded]
Bronchiectasis without acute exacerbation
Bronchiectasis with acute exacerbation [clinically significant excluded]
Abnormal loss of weight [unplanned > than 10% within 3 months of surgical consideration excluded]
V12.00 - V12.09
Personal history of infectious and parasitic diseases [recurrent infections with clinically significant sputum production excluded]
History of tobacco use [members who have smoked in last 4 months excluded]
Acquired absence of lung [previous LVRS or lobectomy excluded]
V46.0 - V46.2
Dependence on aspirator, respirator, or supplemental oxygen [requirement > than 6 liters per minute during rest excluded]
The above policy is based on the following references:
Fein AM, Branman SS, Casaburi R, et al. Lung volume reduction surgery. Am J Respir Crit Care Med. 1996;154(4 Pt 1):1151-1152.
U.S. Department of Health and Human Services, Agency for Healthcare Policy and Research (AHCPR). Lung-volume reduction surgery for end-stage chronic obstructive pulmonary disease. AHCPR Health Technology Assessment No. 10. AHCPR Pub. No. 96-0062. Bethesda, MD: AHCPR; September 1996.
Yusen RD, Lefrak SS. Evaluation of patients with emphysema for lung volume reduction surgery. Washington University Emphysema Surgery Group. Semin Thorac Cardiovasc Surg. 1996;8(1):83-93.
Hazelrigg SR. Thoracoscopic management of pulmonary blebs and bullae. Semin Thorac Cardiovasc Surg. 1993;5(4):327-331.
Brenner M, Kayaleh RA, Milne EN, et al. Thoracoscopic laser ablation of pulmonary bullae. Radiographic selection and treatment response. J Thorac Cardiovasc Surg. 1994;107(3):883-890.
Wakabayashi A. Thoracoscopic technique for management of giant bullous lung disease. Ann Thorac Surg. 1993;56(3):708-712.
Keenan RJ, Ferson PF, Landreneau RJ, Hazelrigg SR. Use of lasers in thoracoscopy. Semin Thorac Cardiovasc Surg. 1993;5(4):294-297.
Hazelrigg S, Boley T, Henkle J, et al. Thoracoscopic laser bullectomy: A prospective study with three-month results. J Thorac Cardiovasc Surg. 1996;112(2):319-326.
McKenna RJ, Brenner M, Gelb AF, et al. A randomized, prospective trial of stapled lung reduction versus laser bullectomy for diffuse emphysema. J Thorac Cardiovasc Surg. 1996;111(2):317-321; discussion 322.
Hensley M, Coughlan JL, Davies HR, Gibson P. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. 1999;(4):CD001001.
U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Lung volume reduction surgery (reduction pneumoplasty, also called lung shaving or lung contouring), unilateral or bilateral by open or thoracoscopic approach for the treatment of emphysema and chronic obstructive pulmonary disease - not generally covered. Medicare Coverage Issues Manual §35-93. HCFA Pub. 6. Baltimore, MD: HCFA; 2000.
National Emphysema Treatment Trial Research Group. Patients at high risk of death after lung-volume-reduction surgery. N Engl J Med. 2001;345(15):1075-1083.
Ramsey SD, Berry K, Etzioni R, et al., and the National Emphysema Treatment Trial Research Group. Cost effectiveness of lung-volume-reduction surgery for patients with severe emphysema. N Engl J Med. 2003;348(21):2092-2102.
Fishman A, Martinez F, Naunheim K, et al., and the National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003;348(21):2059-2073.
Ware JH. The National Emphysema Treatment Trial--how strong is the evidence? N Engl J Med. 2003;348(21):2055-2056.
Babidge W. A systematic review of lung volume reduction surgery (update and re-appraisal). 2nd Ed. ASERNIP-S Report No. 18. Stepney, SA: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S); May 2000.
Meyers BF, Patterson GA. Chronic obstructive pulmonary disease. 10: Bullectomy, lung volume reduction surgery, and transplantation for patients with chronic obstructive pulmonary disease. Thorax. 2003;58(7):634-638.
Institute for Clinical Systems Improvement (ICSI), Technology Assessment Committee. Lung volume reduction surgery for emphysema. Technology Assessment No. 023. Bloomington, MN: ICSI; updated October 2003. Available at:http://www.icsi.org/knowledge/detail.asp?catID= 107&itemID= 291. Accessed February 3, 2004.
BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Lung volume reduction surgery for severe emphysema. TEC Assessment Program. Chicago, IL: BCBSA; December 2003;18(17). Available at: http://www.bcbs.com/tec/vol18/18_17.html. Accessed February 5, 2004.
Stein K. Lung volume reduction surgery for diffuse emphysema. STEER: Succinct and Timely Evaluated Evidence Review. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; March 2002;2(9).
Trow TK. Lung-volume reduction surgery for severe emphysema: Appraisal of its current status. Curr Opin Pulm Med. 2004;10(2):128-132.
Wood DE. Quality of life after lung volume reduction surgery. Thorac Surg Clin. 2004;14(3):375-383.
Banerjee S, Babidge W, Miller J, et al. Comparison of lung volume reduction surgery with medical management for emphysema. Technology Report No. 48. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment; December 2004.
Banerjee S, Babidge W, Noorani HZ, et al. Lung volume reduction surgery for emphysema: Aystematic review of studies comparing different procedures. Technology Report No. 57. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); August 2005.
Banerjee S, Babidge W, Cuncins-Hearn A, et al. Lung volume reduction surgery for emphysema. Technology Overview No 17. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment; November 2005.
National Institute for Clinical Excellence (NICE). Lung volume reduction surgery for advanced emphysema. Interventional Procedure Guidance 114. London, UK: NICE; February 2005. Available at: http://www.nice.org.uk/page.aspx?o=244275. Accessed February 6, 2006.
National Institute for Clinical Excellence (NICE). Chronic obstructive pulmonary disease -- Management of adults with chronic obstructive pulmonary disease in primary and secondary care. Clinical Guideline 12. London, UK: NICE; February 2004. Available at: http://www.nice.org.uk/page.aspx?o=104441. Accessed January 31, 2006.
Institute for Clinical Systems Improvement (ICSI). Chronic obstructive pulmonary disease. ICSI Healthcare Guidelines. Bloomington, MN: ICSI; December 2005. Available at: http://www.icsi.org/knowledge/detail.asp?catID= 29&itemID= 157. Accessed January 31, 2006.
Global Initiative for Chronic Obstructive Lung Disease (GOLD), World Health Organization (WHO), National Heart, Lung and Blood Institute (NHLBI). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, MD: NHLBI; 2005. Available at: http://www.goldcopd.com/. Accessed January 31, 2006.
Palla A, Desideri M, Rossi G, et al. Elective surgery for giant bullous emphysema: A 5-year clinical and functional follow-up. Chest. 2005;128(4):2043-2050.
Berger RL, Wood KA, Cabral HJ, et al. Lung volume reduction surgery: A meta-analysis of randomized clinical trials. Treat Respir Med. 2005;4(3):201-209.
Bartels MN, Kim H, Whiteson JH, Alba AS. Pulmonary rehabilitation in patients undergoing lung-volume reduction surgery. Arch Phys Med Rehabil. 2006;87(3 Suppl 1):S84-S88; quiz S89-S90.
Tiong LU, Davies R, Gibson PG, et al. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. 2006;(4):CD001001.
Miller JD, Malthaner RA, Goldsmith CH, et al. A randomized clinical trial of lung volume reduction surgery versus best medical care for patients with advanced emphysema: A two-year study from Canada. Ann Thoracic Surg. 2006;81(1):314-321.
Stoller JK, Gildea TR, Ries AL, et al. Lung volume reduction surgery in patients with emphysema and alpha-1 antitrypsin deficiency. Ann Thorac Surg. 2007;83(1):241-251.
Botter M, Saad R Jr, Botter DA, et al. Surgical treatment of giant emphysematous lung bullae. Rev Assoc Med Bras. 2007;53(3):217-221.
Lederer DJ, Thomashow BM, Ginsburg ME, et al. Lung-volume reduction surgery for pulmonary emphysema: Improvement in body mass index, airflow obstruction, dyspnea, and exercise capacity index after 1 year. J Thorac Cardiovasc Surg. 2007;133(6):1434-1438.
Washko GR, Fan VS, Ramsey SD, et al; for the National Emphysema Treatment Trial Research Group. The effect of lung volume reduction surgery on chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008;177(2):164-169.
Reilly J, Washko G, Pinto-Plata V, et al. Biological lung volume reduction: A new bronchoscopic therapy for advanced emphysema. Chest. 2007;131(4):1108-1113.
Ingenito EP, Tsai LW. Evolving endoscopic approaches for treatment of emphysema. Semin Thorac Cardiovasc Surg. 2007;19(2):181-189.
Ingenito EP, Wood DE, Utz J. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008;5(4):454-460.
Aeris Therapeutics, Inc. BLVR phase 3 program [website]. Woburn, MA: Aeris Therapeutics, Inc; 2008. Available at: http://www.aerist.com/. Accessed September 26, 2008.
DeCamp MM Jr, McKenna RJ Jr, Deschamps CC, Krasna MJ. Lung volume reduction surgery: Technique, operative mortality, and morbidity. Proc Am Thorac Soc. 2008;5(4):442-446.
Toma TP, Hopkinson NS, Hillier J, et al. Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Lancet. 2003 Mar 15;361(9361):931-933.
Noppen M, Tellings JC, Dekeukeleire T, et al. Successful treatment of a giant emphysematous bulla by bronchoscopic placement of endobronchial valves. Chest. 2006;130(5):1563-1565.
Venuta F, Rendina EA, De Giacomo T, et al. Bronchoscopic procedures for emphysema treatment. Eur J Cardiothorac Surg. 2006;29(3):281-287.
Crespo MM, Johnson BA, McCurry KR, et al. Use of endobronchial valves for native lung hyperinflation associated with respiratory failure in a single-lung transplant recipient for emphysema. Chest. 2007;131(1):214-216.
Strange C, Herth FJ, Kovitz KL, et al. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): A non-surgical method of lung volume reduction. BMC Pulm Med. 2007;7:10.
Wood DE, McKenna RJ Jr, Yusen RD, et al. A multicenter trial of an intrabronchial valve for treatment of severe emphysema. J Thorac Cardiovasc Surg. 2007;133(1):65-73.
Ramsey SD, Shroyer AL, Sullivan SD, Wood DE. Updated evaluation of the cost-effectiveness of lung volume reduction surgery. Chest. 2007;131(3):823-832.
Donahue JM, Cassivi SD. Lung volume reduction surgery for patients with alpha-1 antitrypsin deficiency emphysema. Thorac Surg Clin. 2009;19(2):201-208.
Snell GI, Hopkins P, Westall G, et al. A feasibility and safety study of bronchoscopic thermal vapor ablation: A novel emphysema therapy. Ann Thorac Surg. 2009;88(6):1993-1998.
Eberhardt R, Heussel CP, Kreuter M, et al. Bronchoscopic lung volume reduction in patients with severe homogeneous lung emphysema: A pilot study. Dtsch Med Wochenschr. 2009;134(11):506-510.
Refaely Y, Dransfield M, Kramer MR, et al. Biologic lung volume reduction therapy for advanced homogeneous emphysema. Eur Respir J. 2010;36(1):20-27.
Herth FJ, Eberhard R, Gompelmann D, et al. Bronchoscopic lung volume reduction with a dedicated coil: A clinical pilot study. Ther Adv Respir Dis. 2010;4(4):225-231.
Huang W, Wang WR, Deng B, et al. Several clinical interests regarding lung volume reduction surgery for severe emphysema: Meta-analysis and systematic review of randomized controlled trials. J Cardiothorac Surg. 2011;6:148.
Institute for Clinical Systems Improvement (ICSI). Diagnosis and management of chronic obstructive pulmonary disease (COPD). Bloomington, MN: Institute for Clinical Systems Improvement (ICSI); March 2011.
Zahid I, Sharif S, Routledge T, Scarci M. Is lung volume reduction surgery effective in the treatment of advanced emphysema? Interact Cardiovasc Thorac Surg. 2011;12(3):480-486.
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.