Medical Policy

 

Subject: Endobronchial Valve Devices
Document #: SURG.00119 Publish Date:    10/17/2018
Status: Reviewed Last Review Date:    09/13/2018

Description/Scope

This document addresses the use of endobronchial valve devices (EBVs).  This type of device is intended to provide one-way airflow blockage in segmental or subsegmental bronchi for individuals with pulmonary conditions complicated by air leaks or hyperinflation.  Endobronchial valve devices are usually placed transorally into the lungs using flexible bronchoscopic tools.

Note: Please see the following documents for related information:

Position Statement

Investigational and Not Medically Necessary:

The use of endobronchial valve devices is considered investigational and not medically necessary for the treatment of any condition including, but not limited to, emphysema and pulmonary air leaks.

Rationale

The use of endobronchial valves (EBVs) has been investigated for the treatment of various pulmonary conditions complicated by air leaks or hyperinflation.  The available literature addresses several different devices, the Emphasys EBV® and the Zephyr® endobronchial valve (both manufactured by Pulmonx; Redwood City, CA), the IBV® Valve (Spiration, Inc., Redmond, WA), and the Endobronchial Watanabe Spigots (EWS®, Novatech, France).  At this time, only the IBV device has U.S. Food and Drug Administration (FDA) approval for use in the U.S.

EBV for Emphysema

The vast majority of the available literature regarding the use of EBVs addresses the treatment of severe emphysema (Coxson, 2008; de Oliveira, 2006; Gulsen, 2017; Lee, 2017; Snell, 2003; Sterman, 2010; Toma, 2003; Venuta, 2005; Wan, 2006; Wood, 2007; Yim, 2004).  There are additional studies that describe the use of EBVs as a bridge to transplantation (Venuta, 2010), and as treatment for pulmonary air leaks due to a variety of etiologies (Travaline, 2009).  Without exception, these reports are all case series studies involving small study populations.  The largest study included 98 subjects (Wan, 2006), but the majority involved fewer than 40 subjects.  Most of these studies, including the larger ones, have reported significant loss to follow-up and are of short duration, with most reporting data from between 3 and 6 months follow-up.  Only three reports have followed subjects 12 months or longer, but these studies suffered significant (42% to 80%) loss to follow-up.

The initial data from these limited studies demonstrates mixed results, with some studies reporting significant improvements in pulmonary function (Gulsen; 2017; Klooster, 2017; Lee, 2017; Oliveira, 2006; Toma, 2003; Venuta, 2005; Wan, 2006; Yim, 2004) and others reporting none (Coxson, 2008; Snell, 2003; Sterman, 2010; Wood, 2007).  Additionally, there is a wide reporting gap with regard to complications.  While some studies report no serious complications, most studies report serious device- or procedure-related complications such as pneumothorax, pneumonia, exacerbation of COPD, brochospasm, and in one case, death.  Due to the limited utility of these studies, because of the aforementioned methodological flaws and conflicting results, the reported results from these studies are not particularly useful in assessing the long-term safety and efficacy of EBVs.

One large-scale randomized clinical trial (RCT) addressed the use of Zephyr endobronchial valves.  The VENT Study was an international trial conducted at 31 sites in the U.S and 32 in Europe.  In 2010, Sciurba and others published the findings from the U.S. study for individuals with advanced heterogeneous emphysema (n=321).  Study participants were randomized in a 2:1 fashion to receive EBV placement procedure or standard medical care.  Study subjects were followed for 12 months post intervention.  The authors reported modest improvements in lung function, exercise tolerance, and symptoms.  The 6-minute walk test increased 9.3 m in the EBV group as compared to 10.7 m in the control group (p=0.02).  The clinical significance of this small change is not clear.  Similarly, while the St. George's Respiratory Questionnaire (SGRQ) score decreased 2.8 points for the EBV group as compared to a 0.6 point decrease in the control group (p=0.04), the clinical significance of this change is also unclear.  No significant difference was reported between groups in relation to composite complication scores.  However, when individual complications were addressed separately, subjects in the EBV group experienced significantly more episodes of COPD exacerbations requiring hospitalization, massive hemoptysis, pneumothorax and air leaks.  The authors reported that at the 12 month follow-up, 8 participants were removed from the study due to implant migration.  No data was presented regarding tissue erosion.  The authors stated that their findings indicate that the use of EBVs may be more beneficial for individuals with severe heterogeneous emphysema and intact interlobar fissures.  In 2012, Herth and colleagues reported on the results of the VENT study in the European study population.  The report includes 111 subjects randomized to receive treatment with the Zephyr device and 60 to receive standard medical management.  A total of 157 subjects (92%) completed the study.  At 6 months, the EBV subjects demonstrated a significant improvement compared with the controls for mean change in cycle ergometry (2 ± 14 W vs. -3 ± 10 W; p=0.04) and SGRQ (-5 ± 14 points vs. 0.3 ± 13 points; p=0.047).  No significant change was noted with regard to FEV1 (7 ± 20% vs. 0.5 ± 19%; p=0.067).  At 12 months, subjects in the EBV group had significantly improved FEV1 (6 ± 26% vs. -2 ± 20%; p=0.0499) and cycle ergometry workload (1 ± 13 W vs. -5 ± 12 W; p=0.03) scores compared with controls.  Complete fissure as measured by CT scan was noted in 63 subjects (37.1%, 44 EBV group vs. 19 control, no p-value provided).  In these individuals, EBV therapy was associated with significant (p≤0.05) or borderline significant (p≤0.10) improvement for FEV1, cycle ergometry workload and SGRQ score.  Target lung volume reduction (TLVR) was achieved in a significantly greater number of EVB subjects vs. controls, when complete fissure was noted on CT.  Lobular occlusion was noted in 48% (53 of 111) of EBV subjects.  Among these subjects, those with complete fissure (n=20) had significantly higher lung volume reduction.  Furthermore, in those EBV subjects with lobular occlusion, both 6- and 12-month clinical outcomes were better than in those without lobular occlusion or controls.  Rates for serious complications did not differ significantly at either endpoint.  Over the 12 month follow-up, the rates for valve expectoration, aspiration or migration was 12.6% (14 of 111) over 386 days.  While these reports provide some data regarding the short-term safety of the Zephyr device, further data is needed to evaluate the efficacy and long-term safety of these devices, as well as optimal candidate selection criteria.

Ninane (2012) reported the results of a multicenter, blinded, sham-controlled study involving 73 subjects with advanced emphysema assigned to treatment with bronchoscopy with (n=37) or without (n=36) IBV Valve placement for a 3-month blinded phase.  The authors reported that positive response, defined as having both a ≥ 4 point improvement in SGRQ and a lobar volume shift as measured by quantitative computed tomography, was seen in 8 (24%) of the valve group vs. none in the control group (p=0.002).  They also noted that there was a significant shift in volume in the valve group from the upper lobes to the non-treated lobes, with minimal change in the control group (p<0.05).  Mean SGRQ total score improved in both groups (treatment: -4.3 ± 16.2; control: -3.6 ± 10.7, p=NS).  The procedure and devices were well tolerated and there were no differences in adverse events reported in the treatment and control groups.  Their conclusion was that treatment with bronchial valves without complete lobar occlusion in both upper lobes was safe, but not effective in the majority of subjects.

Kemp and others (2017) published the results of the prospective, multicenter TRANSFORM study, which involved 97 subjects with severe heterogeneous emphysema assigned in a 2:1 fashion to treatment with either EBVs plus standard of care (n=65) or standard of care alone (n=32).  At 3 months postoperative, FEV1 improvement ≥ 12% was reported in 55.4% of the EBV group subjects and 6.5% of control subjects (p<0.001).  These improvements were maintained to the 6 month follow-up point (56.3% vs. 3.2%, respectively; p<0.001).  The mean change in FEV1 at 6 months was reported to be 20.7 ± 29.6% and -8.6 ± 13.0%, respectively.  Target lobe volume reduction (TLVR) ≥ 350 ml was reported in 89.9% of EBV subjects (mean 1.09 ± 0.62 L, p<0.001).  Between-group differences for changes at 6 months were statistically and clinically significant, with the ΔEBV-SoC for residual volume (RV) =700 ml; 6-minute walk distance (6MWD) +78.7 m; SGRQ -6.5 points; Modified Medical Research Council (mMRC) Dyspnea score -0.6 points; and BODE Index -1.8 points (p<0.05 for all).  Pneumothorax was the most common adverse event, occurring in 19/65 (29.2%) of EBV subjects.

The results of the Sciurba, Herth, and Ninane studies described above were the subject of a meta-analysis by Liu et al. (2015).  The overall results indicated that EBV use yielded greater increase in FEV1% than standard medications (p=0.0001), and resulted in a significant change in SGRQ score (p=0.002), mMRC dyspnea score (p=0.004), and cycle ergometry workload (p<0.0001).  They also reported that a similar level was evident for 6MWD (p=0.13).  Alternatively, they stated that EBV use may increase the rate of hemoptysis (RR=5.15; p=0.03), but did not increase the adverse events including mortality, respiratory failure, empyema, pneumonia, or pneumothorax.  The overall rates for complications for EBV compared with standard medications and sham EBV were not significant (RR=2.03; p=0.06).  The authors concluded that,

EBV lung volume reduction for advanced emphysema showed superior efficacy and a good safety and tolerability compared with standard medications and sham EBV. More randomized controlled trial (RCT) studies are needed to pay more attention to the long-term efficacy and safety of bronchoscopic lung volume reduction with EBV in advanced emphysema.

Retrospective data from the VENT study, which was analyzed by Argula and colleagues (2013), investigated the impact of perfusion on the 6 month improvement in 6-minute walk test distance (6MWTD).  They reported that subjects with a low target lobe regional perfusion had a significant improvement in 6MWTD when compared with those with a high baseline target lobe regional perfusion (30.24 m vs. 3.72 m, p=0.03).  Shifts in perfusion after EBV therapy occurred only in subjects with high baseline perfusion and did not correlate with improved 6MWTD.  They also reported an interesting interaction between gender and baseline perfusion of the target lobe, where women had a better improvement in 6MWTD compared with men, as long as lobar exclusion was achieved.  This effect was independent of baseline perfusion.  These results may help identify subpopulations of individuals with emphysema who could benefit from EBV treatment, but additional data from prospective trials is warranted to fully understand which populations stand to benefit from EBVs. 

Another retrospective analysis of VENT data was published by Valipour in 2013, who reported on the impact of EBV treatment on BODE Index scores.  The BODE is a multidimensional grading system, which has been shown to be useful in predicting the risk of future COPD exacerbations, hospitalizations and/or death in individuals with COPD.  The authors reported clinically significant improvement in BODE scores in 44% of EBV subjects and in 24.7% of controls (p=0.001).  Worsening BODE scores were noted in 25% of EBV subjects and 39% of controls (p=0.001).  The degree of target lobar volume reduction (TLVR) was reported to have a significant impact on BODE scores, with improvements in the BODE index of at least 1 point observed in 67%, 37%, and 41% of subjects with TLVR > 50%, TLVR between 20% and 50%, and TLVR < 20%, respectively (p=0.011 for intergroup differences).  Baseline BODE score was reported as the only independent predictor of changes in BODE scores at 6 months.  A safety analysis found significant differences in the rate of pulmonary/thoracic adverse events, with a higher rate occurring in EBV subjects compared with controls.  This difference was mainly driven by the following subcategories of adverse events: hemoptysis (42% in EBV subjects vs. 2% in control subjects, p<0.0001), and noncardiac chest pain (16% compared with 3% respectively, p=0.0018).

The BeLieVeR-HIFi study was a randomized controlled double-blind study involving 50 subjects with heterogeneous emphysema and intact interlobar fissures who were assigned to treatment with either the Zephyr endobronchial valve (n=25) or a sham procedure (n=25) (Davey, 2015).  All subjects were followed for 3 months post-operatively.  Significant improvements in the EBV group vs. controls were noted with regard to increased FEV1 (median 8.77% vs. 2.88%; Mann-Whitney p=0.0326), 6-minute walking time (25 meters vs. 3 meters; p=0.0119), and change in endurance time (25 seconds vs -10.8 seconds, p=0.0256).  In the EBV group, 8 subjects were scored as having complete lung collapse in the isolated portion of the lung, 5 with a band of atelectasis, 2 with some volume reduction, and 8 with no change.  There were two deaths in the EBV group and 1 control subject was unable to attend the follow-up assessment because of a prolonged pneumothorax.  Additionally, 2 EBV subjects had pneumothorax responding to standard therapy, and 4 EBV subjects expectorated the valves before 3 months.  These were replaced in 3 of the 4 subjects.  The authors concluded that unilateral lobar occlusion with EBVs produced significant improvements in lung function, but there was a risk of significant complications.  They noted that further trials are needed that compare valve placement with lung volume reduction surgery.

An open-label extension study of the BeLieVeR-HIFi trial involving 12 subjects from the control group subsequently treated with EBVs and 19 from the experimental group without collateral ventilation were followed for an additional 3 months (Zoumot, 2017).  The authors reported that FEV1 increased by 27.3%, residual volume reduced by 0.49 L, the 6-min walk distance increased by 32.6 m and the SGRQ for COPD score improved by 8.2 points.  Atelectasis or complete lobar collapse on CT were reported in 8 of 12 subjects treated with valves and another 2 had significant volume loss.

In 2015, Klooster published the results of a STELVIO Trial, a blinded RCT involving 34 subjects with severe emphysema assigned to treatment with the Zephyr endobronchial valve compared to 34 subjects assigned to standard medical care.  Subjects were followed for 6 months following EVB placement.  The EBV group had 9 subjects lost to follow-up vs. 1 subject in the control group.  In the intent-to-treat analysis, the authors report that there was significant improvement noted in the EBV group vs. the control group in FEV1, forced vital capacity (FVC), and 6-minute walk distance (p<0.01 for all).  Similar findings were reported in the per-protocol analysis (p=0.001 for all).  Additional improvements in the EBV group vs. controls in the per-protocol analysis included SGRQ (p<0.001) and the Clinical COPD Questionnaire (CCQ; p=0.002).  The authors reported that EBV-related “unacceptable adverse events” had occurred in 7 of 34 (21%) of EBV group subjects.  Overall 23 serious adverse events were noted in the EBV group vs. 5 in the control group (p<0.001), including pneumothorax (p=0.02) and additional events requiring valve removal or replacement procedures.  Pneumothorax was reported in 6 of 34 EBV subjects (18%).  The high rate of complications in this study with carefully selected subjects warrants additional investigation.

In 2017, this group published 1-year follow-up results for 40 of the original 64 subjects (62.5%) involved in the STELVIO trial.  They reported that significant improvements (defined as p<0.001), were found for FEV1, residual volume, 6 minute walk distance, and SGRQ.  A total of 2 subjects died; 1 after 58 days due to progressive respiratory failure and 1 after 338 days of follow-up due to a myocardial infarction.  Valve replacement was done in 17% of subjects and 22% had permanent valve removal.  Pneumothoraces occurred in 22% of subjects before 6 months, and none occurred between 6 and 12 months.

Kotecha and colleagues published the results of a small retrospective case series of individuals with emphysema treated with the Emphasys endobronchial device (2009).  Only 16 of the original 23 subjects completed the study with greater than 15 months follow-up. The authors report that small but statistically significant improvements in FEV1 were found in 6 of 16 subjects (30.8% pre-treatment vs. 34.1% post-treatment).  Small but statistically significant improvements in DLco were also noted in 11 of 16 subjects (34.7% pre-treatment vs. 39.5% post-treatment).  However, these improvements were not correlated with functional changes in the study population, so it is difficult to assess their clinical relevance.  Three subjects who failed to have any significant improvement post valve placement subsequently underwent lung transplantation.  All three explanted lungs were examined macroscopically.  In all three cases extensive mature granulation tissue had formed around the valves, possibly obstructing the valve opening and interfering with valve patency. 

A case series study by Lee (2017) involving 21 subjects with emphysema who had undergone bronchoscopic lung volume reduction surgery (LVRS) with an unspecified valve device reported improvement in ventilation-perfusion mismatch.  The authors reported significant improvement in FEV1 (p<0.001) and 6-minute walking distance (p=0.002).  Additionally, both ventilation per voxel (p<0.001) and total ventilation (p=0.01) improved.  However, neither perfusion per voxel (p=0.16) nor total perfusion (p=0.49) changed significantly.  They did note that subjects who had undergone lung volume reduction of 50% or greater had significantly better improvement in FEV1 (p=0.02) and ventilation per voxel (p=0.03) compared to those receiving less than 50% reduction.  Finally, the ventilation/perfusion ratio (V/Q mismatch) also improved (p=0.005), mainly owing to the improvement in ventilation.

A meta-analysis by Kumar and others (2017) involved four trials encompassing 159 subjects who had received EBV treatment.  They reported that the pooled mean difference for FEV1 was 0.146 L (p<0.001), 6 minute walk time was 45.225 meters (p<0.001), and SGRQ was -8.825 points (p=0.004).  All the pooled mean differences were statistically significant and higher than their respective minimal clinically important difference.  However, this article highlights the small number of quality studies available, and the low number of subjects studied.

A meta-analysis published by Low (2018) evaluated the evidence from five RCTs including 703 subjects who received EBVs for emphysema. The authors reported that percentage change of FEV1 in EBV subjects was significantly improved vs. controls (p<0.0001).  Similar benefits were reported in the SGQR score (p=0.0002).  No differences were demonstrated in the 6-minute walking test (p=0.14).  The overall complication rate of EBV was not significantly different except for an increased rate of pneumothorax [relative risk (RR), 8.16; p=0.002), any hemoptysis (RR, 5.01; p=0.04)] and valve migration (RR, 8.64; p=0.004).  They concluded that EBV use results in short-term improvement in lung function and quality of life.  However, there is an increased risk of minor hemoptysis, pneumothorax, and valve migration.

Fiorelli (2017) described the results of a retrospective case series study involving 33 subjects with heterogeneous emphysema treated with the Zephyr device followed for a minimum of 5 years.  Subjects were stratified into those with post-treatment lobar collapse (n=27) and those without (n=9).  The mean number of valves used was 2.3.  Overall, a mild improvement was reported for FEV1 (p=0.03), FVC (p=0.03); RV (p=0.03); 6MWT (p=0.04) and SGQR (P=0.01).  When looking at these measures by group, the collapse group had a significant improvement in FEV1% (+17%; p=0.001); in FVC (+18%; p=0.002); in RV (−39%; p=0.003); in 6MWT (p=0.001), and in SGRQ (p=0.001) after 12 months of follow-up.  These results were retained for the entire follow-up without significant decline, as confirmed by Bonferroni post-hoc analysis. The no-collapse Group had no significant benefits for these measures.  The 1-, 2-, 3-, 4- and 5-year survival rates were 100%, 90%, 78%, 71% and 71%, respectively.  The collapse group had a better survival than the no-collapse group (45 vs. 24 months; p=0.001).  No major complications or deaths were reported.  Removal of valves was required in 3 subjects due to hemoptysis, bronchospasm, and migration.  A single subject expectorated one valve, which was replaced.

Further investigation into the safety and efficacy of EBV therapy in subjects with emphysema is warranted.

EBV for Pulmonary Air Leaks

EBVs have also been proposed for the treatment of pulmonary air leaks.  The vast majority of the available literature addressing this approach has been in the form of case reports (Anile, 2006; Dalar, 2013; De Giacomo, 2006; Feller-Kopman, 2006; Ferguson, 2006; Mitchell, 2006; Schweigert, 2010; Snell, 2005).  However, there is a growing body of literature, in the form of small case series studies.  The largest available case series study published to date was conducted by Travaline and others (2009), and reported on the outcomes of 40 subjects with prolonged pulmonary air leaks treated with the Zephyr device.  At the end of a mean 66 days of follow-up (range 7-166 days), 47.5% of subjects had complete resolution, 45.0% had a significant reduction, and 5.0% had no change in condition.  No correlation was found between the location of the valve placement or air leak etiology and outcomes.  Six of the 40 subjects had adverse reactions due to valve placement including valve expectoration, oxygen desaturation, valve malpositioning requiring replacement, and pneumonia.  Eight of the subjects had the valves removed at the end of the study period.  While these findings are promising, further studies with larger populations and longer follow-up time are warranted to provide additional data regarding the safety and efficacy of this treatment method.

A series involving 24 subjects with persistent pulmonary air leaks treated with the EWS device was published by Sasada and others (2011).  Treatment was indicated for air leaks due to pneumothorax (n=15), empyema (n=8), or postsurgical complications (n=1).  Twelve subjects (50%) had complete resolution of air leaks and 7 (29.2%) had a reduction in air leaks.  Five (20.8%) showed no improvement.  Twenty-three subjects required thoracic drainage tubes, which were successfully removed after EBV treatment in 15 subjects (65.2%).  Of the 24 subjects, 4 experienced severe respiratory failure requiring mechanical ventilation but were successfully treated.  Complications included EBV migration (n=4), atelectasis (n=3), pneumonia (n=2), fever (n=2), and lung abscess (n=1), but none resulted in death.  Six subjects underwent removal of the EBV devices including 4 subjects with abscess and atelectasis.  Two additional subjects underwent removal at their request.

Firlinger (2013) reported on 13 consecutive subjects with high comorbidity and evidence of continuous air leaks and chest tubes for at least 7 days.  Each subject received treatment with the EWS device.  Ten subjects were considered responders, and 3 were non-responders.  After valve implantation, air leak flow decreased significantly from 871 ± 551 mL/min to 61 ± 72 mL/min immediately after the intervention (p<0.001).  The mean duration of chest tube drainage was 18 ± 8 days before and 9 ± 6 days after the intervention (p<0.01).  Long-term follow-up was available for 9 subjects.  No adverse events related to the valve implantation were reported.  Seven subjects underwent valve removal without any further complications.

Dooms and colleagues described the use of EBVs in 10 subjects who had undergone lung cancer resection surgery with subsequent persistent air leaks refractory to conservative therapy.  The median air leak cessation was reported to be 2 days after treatment.  Overall, a significant decrease in FEV1 was found at airway closure by valve implantation (p=0.0002).  Chest tube removal occurred at a median of 4 days (range 1-14 days).  Three subjects experienced a recurrence of limited air leaks (<50% of initial value) due to valve displacement without migration.  Upon bronchoscopic evaluation, shallow depth of the bronchus was reported as the cause.  No deaths, no cardiovascular complications, and no implant-related events were reported.  One subject suffered from respiratory insufficiency requiring negative positive pressure ventilation for 2 weeks until the valves were removed. 

Yu and others described a retrospective case series study involving 37 subjects with persistent (at least 1 week) air leaks complicating spontaneous pneumothorax in which surgical intervention is not feasible.  The Zephyr device was implanted in 19 subjects and the remaining 18 subjects underwent standard care.  The mean number of valves used in the EBV group was 3.6.  The authors reported successful treatment in 8 of 19 subjects.  However 1 subject had recurrence within 2 hours of treatment.  Of the remaining 7, chest tube removal occurred within 2 days.  In the remaining 11 subjects with EBV treatment failure, 3 subjects had immediate success with failure soon afterwards and persisting beyond 72 hours.  The other 8 subjects had temporary air leak reduction which persisted beyond 72 hours.  There was a statistically significant difference between the EBV and no-EBV groups with regard to the number of days from first bronchoscopy to air-leak cessation, according to the Gehan-Breslow-Wilcoxon test (p=0.027), but not the log-rank test (p=0.138).  EBV use was significantly associated with air leak cessation (adjusted Hazard Ratio [HR], 2.39).  No incidences of valve displacement were reported.  All subjects in the no-EBV group survived, whereas 3 subjects in the EBV group died within 30 days of endobronchial valve implantation.  In 2 of these subjects, death was deemed not related to the EBV, and in the third the relationship was uncertain.  The surviving 16 subjects had their valves removed at a median of 43 days.

Huang (2018) describe the use of Zephyr device in 11 subjects with persistent postoperative air leaks (n=6) or secondary spontaneous pneumothorax (n=5) who had evidence of continuous air leak flow with whose chest tubes remained in place for more than 7 days.  The authors reported that the number of valves used varied from 1 to 3 (median=1), with significant heterogeneity in anatomic placement.  Complete resolution of air leaks was reported in 8 subjects (72.7%), including all 5 with spontaneous pneumothorax.  For this latter group, the mean duration of air leak before and after valve deployment was 19.4 and 6 days, respectively.  In the post-op group, 3 subjects were considered responders, and 1 expectorated the valve 1 day following placement and underwent subsequent operative treatment.  The remaining 2 had some improvement with EBV placement, but also underwent subsequent operative treatment.  The mean duration of air leak before and after valve deployment in this group was 58.5 and 4.5 days, respectively.  There were no complications related to the valve deployment reported.

Based on the limited evidence available, the use of EBVs for pulmonary air leaks is promising.  However, the available studies are not rigorous in their methodology or in their sample sizes.  Further study is warranted with well-designed and conducted trials.

Background/Overview

In individuals with severe emphysema, diseased tissues progressively lose their elasticity and fail to expand and contract properly, impeding air flow and gas exchange.  In more advanced forms of the disease, the elasticity of lung tissue is completely lost, leading to permanently open air sacs that cannot contribute to ventilation.  The diseased tissue fails to contract normally, which results in portions of the chest cavity being taken up by nonfunctional tissue.  This constricts the existing healthy tissue, making it less efficient and results in poorer overall lung function.  In emphysema, diseased tissue may occur throughout the lung or may be heterogeneous, occurring more severely in certain areas. 

One method of treating heterogeneous emphysema is LVRS.  This procedure has been developed to remove the most diseased lung tissue, providing more space in the chest cavity for healthier lung tissue to expand, and resulting in improved ventilation and lung function.  LVRS is a drastic and permanent surgical procedure and it has only been used in the most serious cases.

Some individuals may develop air leaks in lung tissue due to a wide variety of reasons, including trauma, disease or due to complications of surgery.  An air leak in the pulmonary tract may be due to a hole between the lung and the pleural space, or a passageway that has been created between functional lung tissue and adjacent tissues.  Air leaks significantly impair lung function and usually require surgical treatment if they do not spontaneously resolve. 

Endobronchial valve devices have been developed as a method to isolate diseased or problematic portions of the lung without a major surgical procedure.  These devices are designed to fit snugly into segmental or subsegmental bronchi and allow the flow of air and secretions out of the targeted portion of the lung but prevent return flow.  The devices may be permanently implanted or can be removed at a later date, if needed.  In cases of emphysema, these devices have been proposed as an alternative to LVRS.  The placement of endobronchial valve devices has been used in experimental studies to isolate diseased portions of the lung without the need for a major surgical procedure.  The valves allow the air trapped in severely diseased portions of the lung to be forced out with normal respiratory movement.  Prevention of return air flow causes a reduction in the size of diseased portions of the lung, allows expansion of healthier tissue and improves function of healthier tissue.  This procedure may be referred to transbronchoscopic lung volume reduction surgery.

In the case of air leaks, the use of endobronchial valves allows isolation of the area of the lung where the air leak is located, allowing normal function in the rest of the lung.  This procedure isolates the problematic area of the lung, and may allow tissues to heal, resolving the air leak problem.

Currently, only one bronchial valve device has been reviewed by the FDA.  The IBV Valve System, (Spiration, Inc. Redmond, WA) was granted a humanitarian device exemption (HDE) for the indication of controlling prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).  The IBV device consists of an endobronchial valve and a deployment catheter.  Using a flexible bronchoscope, the catheter is used to place the small umbrella-shaped valve into the lung.  Other valves have been described in the medical research literature including: the Emphasys EBV and the Zephyr endobronchial valve (both manufactured by Pulmonx; Redwood City, CA), and Endobronchial Watanabe Spigots (EWS, Novatech, France). 

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

31647

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

31648

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe

31649

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), each additional lobe

31651

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

 

 

ICD-10 Procedure

 

0BH30GZ-0BH38GZ

Insertion of endobronchial valve into right main bronchus [by approach; includes codes 0BH30GZ, 0BH33GZ, 0BH34GZ, 0BH37GZ, 0BH38GZ]

0BH40GZ-0BH48GZ

Insertion of endobronchial valve into right upper lobe bronchus [by approach; includes codes 0BH40GZ, 0BH43GZ, 0BH44GZ, 0BH47GZ, 0BH48GZ]

0BH50GZ-0BH58GZ

Insertion of endobronchial valve into right middle lobe bronchus [by approach; includes codes 0BH50GZ, 0BH53GZ, 0BH54GZ, 0BH57GZ, 0BH58GZ]

0BH60GZ-0BH68GZ

Insertion of endobronchial valve into right lower lobe bronchus [by approach; includes codes 0BH60GZ, 0BH63GZ, 0BH64GZ, 0BH67GZ, 0BH68GZ]

0BH70GZ-0BH78GZ

Insertion of endobronchial valve into left main bronchus [by approach; includes codes 0BH70GZ, 0BH73GZ, 0BH74GZ, 0BH77GZ, 0BH78GZ]

0BH80GZ-0BH88GZ

Insertion of endobronchial valve into left upper lobe bronchus [by approach; includes codes 0BH80GZ, 0BH83GZ, 0BH84GZ, 0BH87GZ, 0BH88GZ]

0BH90GZ-0BH98GZ

Insertion of endobronchial valve into lingula bronchus [by approach; includes codes 0BH90GZ, 0BH93GZ, 0BH94GZ, 0BH97GZ, 0BH98GZ]

0BHB0GZ-0BHB8GZ

Insertion of endobronchial valve into left lower lobe bronchus [by approach; includes codes 0BHB0GZ, 0BHB3GZ, 0BHB4GZ, 0BHB7GZ, 0BHB8GZ]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Anile M, Venuta F, De Giacomo T, et al. Treatment of persistent air leakage with endobronchial one-way valves. J Thorac Cardiovasc Surg. 2006; 132(3):711-712.
  2. Argula RG, Strange C, Ramakrishnan V, Goldin J. Baseline regional perfusion impacts exercise response to endobronchial valve therapy in advanced pulmonary emphysema. Chest. 2013; 144(5):1578-1586.
  3. Coxson HO, Nasute Fauerbach PV, Storness-Bliss C, et al. Computed tomography assessment of lung volume changes after bronchial valve treatment. Eur Respir J. 2008; 32(6):1443-1450.
  4. Dalar L, Kosar F, Eryuksel E, et al. Endobronchial Watanabe spigot embolisation in the treatment of bronchopleural fistula due to tuberculous empyema in intensive care unit. Ann Thorac Cardiovasc Surg. 2013; 19(2):140-143.
  5. Davey C, Zoumot Z, Jordan S, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. 2015; 386(9998):1066-1073.
  6. De Giacomo T, Venuta F, Diso D, Coloni GF. Successful treatment with one-way endobronchial valve of large air-leakage complicating narrow-bore enteral feeding tube malposition. Eur J Cardiothorac Surg. 2006; 30(5):811-812.
  7. de Oliveira HG, Macedo-Neto AV, John AB, et al. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006; 130(1):190-199.
  8. Dooms CA, Decaluwe H, Yserbyt J, et al. Bronchial valve treatment for pulmonary air leak after anatomic lung resection for cancer. Eur Respir J. 2014; 43(4):1142-1148.
  9. Feller-Kopman D, Bechara R, Garland R, et al. Use of a removable endobronchial valve for the treatment of bronchopleural fistula. Chest. 2006; 130(1):273-275.
  10. Ferguson JS, Sprenger K, Van Natta T. Closure of a bronchopleural fistula using bronchoscopic placement of an endobronchial valve designed for the treatment of emphysema. Chest. 2006; 129(2):479-481.
  11. Fiorelli A, Santoriello C, De Felice A, et al. Bronchoscopic lung volume reduction with endobronchial valves for heterogeneous emphysema: long-term results. J Vis Surg. 2017; 3:170.
  12. Firlinger I, Stubenberger E, Müller MR, et al. Endoscopic one-way valve implantation in patients with prolonged air leak and the use of digital air leak monitoring. Ann Thorac Surg. 2013; 95(4):1243-1249.
  13. Gulsen A, Sever F, Girgin P, et al. Evaluation of bronchoscopic lung volume reduction coil treatment results in patients with severe emphysema. Clin Respir J. 2017; 11(5):585-592.
  14. Herth FJ, Noppen M, Valipour A, et al.; International VENT Study Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. 2012; 39(6):1334-1342.
  15. Huang X, Ding L, Xu H. Bronchoscopic valve placement for the treatment of persistent air leaks. Medicine (Baltimore). 2018; 97(13):e0183.
  16. Kemp SV, Slebos DJ, Kirk A, et al.; TRANSFORM Study Team. A multicenter RCT of Zephyr® endobronchial valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017; 196(12):1535-1543.
  17. Klooster K, Hartman JE, Ten Hacken NH, Slebos DJ. One-year follow-up after endobronchial valve treatment in patients with emphysema without collateral ventilation treated in the STELVIO trial. Respiration. 2017; 93(2):112-121.
  18. Klooster K, Ten Hacken NH, Hartman JE, et al. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med. 2015; 373(24):2325-2335.
  19. Kotecha S, Westall GP, Holsworth L, et al. Long-term outcomes from bronchoscopic lung volume reduction using a bronchial prosthesis. Respirology. 2011; 16(1):167-173.
  20. Kumar A, Dy R, Singh K, Mador MJ. Early trends in bronchoscopic lung volume reduction: a systematic review and meta-analysis of efficacy parameters. Lung. 2017; 195(1):19-28.
  21. Lee SW, Lee SM, Shin SY, et al. Improvement in ventilation-perfusion mismatch after bronchoscopic lung volume reduction: quantitative image analysis. Radiology. 2017; 285(1):250-260.
  22. Liu H, Xu M, Xie Y, et al. Efficacy and safety of endobronchial valves for advanced emphysema: a meta analysis. J Thorac Dis. 2015; 7(3):320-328.
  23. Low SW, Lee JZ, Desai H, et al. Endobronchial valves therapy for advanced emphysema: a meta-analysis of randomized trials. J Bronchology Interv Pulmonol. 2018 Jun 12. [Epub ahead of print]
  24. Mitchell KM, Boley TM, Hazelrigg SR. Endobronchial valves for treatment of bronchopleural fistula. Ann Thorac Surg. 2006; 81(3):1129-1131.
  25. Ninane V , Geltner C, Bezzi M, et al. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012; 39(6):1319-1325.
  26. Sasada S, Tamura K, Chang YS, et al. Clinical evaluation of endoscopic bronchial occlusion with silicone spigots for the management of persistent pulmonary air leaks. Intern Med. 2011; 50(11):1169-1173.
  27. Schweigert M, Kraus D, Ficker JH, Stein HJ.  Closure of persisting air leaks in patients with severe pleural empyema - use of endoscopic one-way endobronchial valve. Eur J Cardiothorac Surg. 2011; 39(3):401-403.
  28. Sciurba FC, Ernst A, Herth FJ, et al.; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema.  N Engl J Med. 2010; 363(13):1233-1244.
  29. Snell GI, Holsworth L, Fowler S, et al. Occlusion of a bronchocutaneous fistula with endobronchial one-way valves. Ann Thorac Surg. 2005; 80(5):1930-1932.
  30. Snell GI, Holsworth L, Borrill ZL, et al. The potential for bronchoscopic lung volume reduction using bronchial prostheses: a pilot study. Chest. 2003; 124(3):1073-1080.
  31. Sterman DH, Mehta AC, Wood DE, et al.; IBV Valve US Pilot Trial Research Team. A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. Respiration. 2010; 79(3):222-233.
  32. Toma TP, Hopkinson NS, Hillier J, et al. Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Lancet. 2003; 361(9361):931-933.
  33. Travaline JM, McKenna RJ Jr, De Giacomo T, et al.; Endobronchial Valve for Persistent Air Leak Group. Treatment of persistent pulmonary air leaks using endobronchial valves. Chest. 2009; 136(2):355-360.
  34. Valipour A, Herth FJ, Burghuber OC, et al.; VENT study group. Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy. Eur Respir J. 2014; 43(2):387-396.
  35. Venuta F, de Giacomo T, Rendina EA, et al. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005; 79(2):411-416.
  36. Venuta F, Diso D, Anile M, et al. Bronchoscopic lung volume reduction as a bridge to lung transplantation in patients with chronic obstructive pulmonary disease. Eur J Cardiothorac Surg. 2011; 39(3):364-367.
  37. Wan IY, Toma TP, Geddes DM, et al. Bronchoscopic lung volume reduction for end-stage emphysema: report on the first 98 patients. Chest. 2006; 129(3):518-526.
  38. 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.
  39. Yim AP, Hwong TM, Lee TW, et al. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004; 127(6):1564-1573.
  40. Yu WC, Yu EL, Kwok HC, et al. Endobronchial valve for treatment of persistent air leak complicating spontaneous pneumothorax. Hong Kong Med J. 2018; 24(2):158-165.
  41. Zoumot Z, Davey C, Jordan S, et al. Endobronchial valves for patients with heterogeneous emphysema and without interlobar collateral ventilation: open label treatment following the BeLieVeR-HIFi study. Thorax. 2017; 72(3):277-279.
Index

Bronchial valve
Bronchoscopic lung volume reduction surgery
Emphasys EBV
IBV Valve System
Spiration, Inc.
Transbronchoscopic lung volume reduction surgery
Zephyr Endobronchial Valve System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

09/13/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References sections.

Reviewed

02/27/2018

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale and References sections.

Reviewed

02/02/2017

MPTAC review. Updated Rationale and References sections. 

Reviewed

02/04/2016

MPTAC review. Updated Rationale and Reference sections. Removed ICD-9 codes from Coding section.

Reviewed

02/05/2015

MPTAC review.

Reviewed

02/13/2014

MPTAC review. Updated Rationale and Reference sections.

Reviewed

02/14/2013

MPTAC review. Updated rationale and reference sections.

 

01/01/2013

Updated Coding section with 01/01/2013 CPT changes; removed 0250T, 0251T, 0252T deleted 12/31/2012.

Reviewed

02/16/2012

MPTAC review.  

Reviewed

02/17/2011

MPTAC review. Updated Rationale and Reference sections.

New

11/18/2010

MPTAC review. Initial document development.