CAM 701128

Bronchial Valves

Category:Surgery   Last Reviewed:August 2019
Department(s):Medical Affairs   Next Review:August 2020
Original Date:August 2013    

Description
Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow. They have been investigated for use in patients who have prolonged bronchopleural air leaks and as an alternative to lung volume reduction surgery in patients with lobar hyperinflation from severe or advanced emphysema.

For individuals who have pulmonary air leaks who receive bronchial valves, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. The only available data on bronchial valves for treating persistent air leaks are uncontrolled trials with small numbers of heterogeneous patients. Data on the Spiration IBV device (the only device approved by the U.S. Food and Drug Administration) are particularly limited. These valves were successfully placed in 40 patients in a multicenter case series and other series. These case series do not provide any comparative evidence with alternatives. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have severe or advanced emphysema who receive bronchial valves, the evidence includes 7 randomized controlled trials and a systematic review of these trials. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. Of the 7 randomized controlled trials, 5 did not use a U.S. Food and Drug Administration-approved valve. For the U.S. Food and Drug Administrationapproved Spiration IBV, there was no improvement in quality of life or exercise capacity in the combined results. Although some outcomes of the larger trials were statistically significant for bronchial valve treatment, the magnitude of the difference was generally of uncertain clinical significance. Moreover, the numerous adverse events experienced by patients who received bronchial valves in these trials raise concerns about treatment safety. Overall, it is not possible to determine whether there is a clinically meaningful benefit. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background 
Proper lung functioning depends on the separation between the air-containing parts of the lung and the small vacuum-containing space around the lung called the pleural space. When air leaks into the pleural space, the lung is unable to inflate, resulting in hypoventilation and hypoxemia; this condition is known as a pneumothorax. A pneumothorax can result from trauma, high airway pressures induced during mechanical ventilation, lung surgery, and rupture of lung blebs or bullae, which may be congenital or a result of chronic obstructive pulmonary disease.

Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow. They have been investigated for use in patients who have prolonged bronchopleural air leaks and as an alternative to lung volume reduction surgery in patients with lobar hyperinflation from severe or advanced emphysema. 

Emphysema
In emphysematous chronic obstructive pulmonary disease, peripheral lung tissue may form bullae. These diseased portions of the lung ventilate poorly, cause air trapping, and hyperinflate, compressing relatively normal lung tissue. They also may rupture, causing a pneumothorax.

Treatment
Use of a bronchial valve is thought to prevent hyperinflation of bullae. Their use to treat chronic obstructive pulmonary diseaseis based on the improvement observed in patients who have undergone lung volume reduction surgery. Lung volume reduction surgery involves excision of peripheral emphysematous lung tissue, generally from the upper lobes. The precise mechanism of clinical improvement for patients undergoing lung volume reduction has not been firmly established. However, it is believed that elastic recoil and diaphragmatic function are improved by reducing the volume of the diseased lung. The procedure is designed to relieve dyspnea and improve functional lung capacity and quality of life; it is not curative. Bronchial valves have been investigated as a nonsurgical alternative to lung volume reduction surgery.

Regulatory Status
In October 2008, the Spiration® IBV Valve System (Spiration) was approved by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (H060002) process for use in 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. An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: (1) continuous, (2) present during the normal inhalation phase of inspiration, or (3) present on normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Use of the intrabronchial Valve System is limited to 6 weeks per prolonged air leak. FDA product code: OAZ. 

Currently, two bronchial valve systems are FDA approved for treatment of patients with severe emphysema. In June 2018, FDA granted the Zephyr Valve system breakthrough device status with expedited approval for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. In December 2018, FDA approved the Spiration Valve System for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. FDA product code: NJK. 

Table 1. Bronchial Valves Approved by FDA

Device

Manufacturer

Location

Date Approved

HDE/PMA No.

IBV® Valve System

To control 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).

Spiration, Inc

Redmond, WA

10/24/08

H060002

         

Spiration® Valve System

One-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation

Breakthrough designation status

Spiration, Inc

Redmond, WA

12/03/18

 06/18/15

P180007

         

Zephyr® Endobronchial Valve System

Implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation

Breakthrough designation status

Pulmonx Corporation

Redwood City, CA

06/29/18

 05/04/17

P180002

FDA: Food and Drug Administration, HDE: human device exemption; PMA: premarket approval application. 

Related Policies
70171 Lung Volume Reduction Surgery for Severe Emphysema

Policy
Bronchial valves are considered INVESTIGATIONAL in all situations including, but not limited to: 

  • Treatment of prolonged air leaks, and 
  • Treatment for patients with chronic obstructive pulmonary disease or emphysema.

Policy Guidelines
Only 1 endobronchial valve device has approval from FDA through the Humanitarian Device Exemption (HDE) process for use in prolonged pulmonary air leaks.

Effective in 2013, there are CPT category I codes for this procedure:

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
31651: 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])
31648: with removal of bronchial valve(s), initial lobe
31649: with removal of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure)

Benefit Application
BlueCard®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (FDA)-approved devices may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function -- including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Treatment of Air Leaks
Clinical Context and Therapy Purpose
The purpose of placing bronchial valves in patients who have pulmonary air leaks is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does placement of bronchial valves improve the net health outcome in patients with pulmonary air leaks?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest is individuals with pulmonary air leaks.

Interventions
The therapy being considered is the placement of bronchial valves. A bronchial valve is a device that permits one-way air movement. During inhalation, the valve is closed, preventing air flow into the diseased area of the lung. The valve opens during exhalation to allow air to escape from the diseased area of the lung. When used to treat persistent air leak from the lung into the pleural space, the bronchial valve theoretically permits less air flow across the diseased portion of the lung during inhalation, aiding in air leak closure. The valve may be placed, and subsequently removed, by bronchoscopy.

Comparators
The following practices are currently being used:

  • Inserting a chest tube (tube thoracostomy) and employing a water seal or one-way valve to evacuate air collected in the pleural space and prevent it from reaccumulating;
  • Lowering airway pressures by adjusting the mechanical ventilator;
  • Using autologous blood patches; and
  • Performing a thoracotomy with mechanical or chemical pleurodesis. 

Outcomes
The general outcomes of interest, in addition to overall survival, are a reduction in symptoms (eg, pneumothorax) and improvements in functional outcomes. Placement of bronchial valves requires an inpatient surgical procedure. Bronchial valves can be utilized for up to six weeks to effect resolution of a persistent pulmonary leak.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Case Series
No RCTs or comparative observational studies were identified. Only case series and case reports are available.

In the largest case series, Travaline et al (2009) reported on 40 patients treated at 17 sites in the United States and Europe.1, The Zephyr Endobronchial Valve (EBV) was used. This device is not approved by the U.S. Food and Drug Administration. All patients in the series had prolonged pulmonary air leak (mean duration, 119 days; median, 20 days). The most common comorbidities were cancer and chronic obstructive pulmonary disease (COPD). After valve placement, 19 (47.5%) patients had complete resolution of acute air leak, 18 (45%) had a reduction in air leak, 2 (5%) had no change, and no data were available for 1 patient. The mean time from valve placement to chest tube removal was 21 days (median time, 7.5 days). Six patients experienced adverse events related to valve placement, including valve expectoration, moderate oxygen desaturation, initial malpositioning of a valve, pneumonia, and Staphylococcus aureus colonization. The length of follow-up varied, ranging from 5 to 1109 days. At last follow-up, 16 patients had died, though none of the deaths was attributed to the valve or the implantation procedure.

Firlinger (2013) et al studied 13 patients with persistent, continuous air leak (ie, having an intrathoracic chest tube for >7 days despite conservative and/or surgical therapy) in Austria.2, Spiration valves were used in 9 patients and Zephyr valves in 4 patients. Ten (77%) of 13 patients were considered responders, defined as successful chest tube removal without need for further intervention. The Spiration IBV (intrabronchial valve) was used in six of ten responders and all three nonresponders.

Gillespie et al (2011) reported on a case series of 7 patients with pulmonary air leaks treated with Spiration IBV.3, The median duration of air leaks in the 7 patients before valve placement was 4 weeks (range, 2 weeks to 5 months). One patient had a second valve implanted due to an additional air leak. Complete air leak cessation occurred in 6 of 8 procedures after a mean duration of 5.2 days. The other 2 procedures resulted in a reduction of air leak. There were no operative or postoperative complications attributed to the bronchial valves. The valves were removed in 5 of the 7 patients at a mean of 37 days after placement (range, 14-55 days). Valves were not removed from a patient who entered hospice care or the patient who underwent 2 procedures because the patient declined removal.

The Humanitarian Device Exemption approval of the IBV Valve required post-approval study (PAS). The study was a prospective observational study to collect safety information about the IBV Valve System for the treatment of prolonged air leak. Eligible subjects were into the study on the day of valve treatment. The subjects were monitored after treatment until discharge from the hospital (a minimum of 1 night stay after the procedure). After discharge, the subjects were seen by the investigator for assessment of air leak status as clinically indicated. Valves were to be removed after the air leak is resolved. If the air leak was not resolved, the valves were to be removed no longer than 6 weeks after device placement and other options were to be considered. A summary of the FDA PAS is provided in Table 2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?c_id=249&t_id=367937

Table 2. Summary of IBV Valve PA

Study

Countries

Sites

Dates

Participants 

SAEEffect Findings
Air Leak Resolution

H060002 / PAS001
Prospective Cohort Study

US

11

2009-2014

39 post IBV valve placement for prolonged air leak

2

32/39 per protocol follow-up
2/32: no response
30/32:positive response)
11/30:complete resolution
19/30: improvement

AS: Post-Approval Study; SAE: serious adverse event.

1 AE: One systolic arrest secondary to hypercapnia resolved prior to IBV placement and one mucus impaction of a bronchial valve

Section Summary: Treatment of Air Leaks
Data on the Spiration IBV are limited to reports of the first patients submitted to the Food and Drug Administration for the Humanitarian Device Exemption for use for prolonged air leaks as well as the results of the post-approval study completed in 2014. Other reports are small series of heterogeneous patients. There are no comparative data with alternatives. This evidence is inadequate to determine the impact of this technology on the net health outcome.

Treatment of Severe or Advanced Emphysema
Clinical Context and Therapy Purpose
The purpose of placing bronchial valves in patients who have severe or advanced emphysema is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does placement of bronchial valves improve the net health outcome in patients with severe or advanced emphysema?

The following PICOs were used to select literature to inform this review.

Patients
The relevant population of interest is individuals with severe/advanced emphysema. In emphysematous chronic obstructive pulmonary disease, peripheral lung tissue may form bullae. These diseased portions of the lung ventilate poorly, cause air trapping, and hyperinflate, compressing relatively normal lung tissue. They also may rupture, causing a pneumothorax.

Interventions
The therapy being considered is the placement of bronchial valves. Bronchial valves are placed in selected regions of the bronchial airways using a flexible bronchoscope after assessment to ensure little or no collateral ventilation in the region. Valves allow air to escape while blocking airflow into the treated lobe. This is intended to result in a reduction in lung volume and hyperinflation in the targeted area. Their use to treat chronic obstructive pulmonary disease is based on the improvement observed in patients who have undergone lung volume reduction surgery.

Placement of bronchial valves requires an inpatient surgical procedure. 

Comparators
The following practices are currently being used: medical management and lung reduction surgery.

Alternatives for the treatment of severe emphysema include m edications for relief of the symptoms, smoking cessation, pulmonary rehabilitation, long-term administration of oxygen, lung volume reduction surgery, and lung transplantation.

Lung volume reduction surgery involves excision of peripheral emphysematous lung tissue, generally from the upper lobes. The precise mechanism of clinical improvement for patients undergoing lung volume reduction has not been firmly established. However, it is believed that elastic recoil and diaphragmatic function are improved by reducing the volume of the diseased lung. Currently, and at the time the clinical trials were designed, very few lung volume reduction procedures are/were performed. Medical management remains the most common treatment for a majority of these patients.

Outcomes
The general outcomes of interest, in addition to overall survival, are a reduction in symptoms, improvements in functional outcomes, and quality of life.

Measures of lung function include residual volume and forced expiratory volume in the first second (FEV1). Residual volume is the volume of air that remains in the lungs after maximum forceful expiration. FEV1 is determined by the volume of air a patient can force out in one second after taking a deep breath. In clinical trials of bronchial valves, response rates have been defined as an increase in FEV1 from baseline of 15%, 12% or 10%.

The 6-minute walk test (6MWT) measures physical function. Healthy subjects can typically walk 400 to 700 meters during a 6MWT. An improvement of about 30 meters in distance walked is considered the minimally important difference.

The St. George Respiratory Questionnaire (SGRQ) is used to measure quality of life in patients with emphysema. Scores range from 0 to 100, with higher scores indicating a worse quality of life. A 4-point change (decrease) is generallyconsidered to represent a clinically meaningful difference.

The Medical Research Council (MRC) Dyspnea Scale is a measure of perceived respiratory disability. Patients indicate the degree of breathlessness related to activities on a scale from 1 (not troubled by breathlessness except on strenous exercise) to 5 (too breathless to leave the house, or breathless when undressing).

Improvement in lung function after use of bronchial valves as part of multimodality pulmonary care should be assessed at 6 months after insertion. 

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought. 

Systematic Reviews
Three recent systematic reviews with meta-analyses have assessed the use of bronchial valves for patients with severe emphysema.4,5,6, The individual studies included in these reviews are shown in Table 3 and discussed in the RCT sections, below. The most recent and comprehensive review, conducted by van Geffen et al (2019), included 7 trials of the Zephyr valve. Characteristics and results of this SR are shown in Tables 4 and 5. None of the reviews included studies of the Spiration valve.

Authors of all of the systematic reviews came to similar conclusions: In patients with severe emphysema and low collateral ventilation, RCTs provide evidence of clinically meaningful benefit for bronchial valves compared to standard medical management.on measures of lung function, exercise tolerance, and quality of life, but these benefits should be measured against the greater risk of serious adverse events compared to usual care. Limitations of the evidence included a lack of comparisons to lung volume reduction surgery and significant heterogeneity for some analyses.

Table 3. Comparison of Studies Included in SR & M-A

Study

van Geffen et al (2019)

NICE (2018)

van Agteren et al(2017)
Cochrane

LIBERATE, Criner et al 2018

   
TRANSFORM, Kemp et al, 2017  
IMPACT, Valipour et al, 2016
BeLieVeR-HiFi, Davey et al, 2015
STELVO, Klooster et al, 2015
VENT EU, Herth et al, 2012  
VENT US (2010) Sciurba et al, 2010

Table 4. SR & M-A Characteristics 

Study

Search end date

RCTs

Participants

N (Range)

Duration (Range)

van Geffen et al (2019)6,

June 2018

7

Patients with emphysema, older than 35 years, post-bronchodilator FEV1 < 60% of predicted, and residual volume
>150% of predicted

620 (50-190)

3 months-12 months

RCT: randomized controlled trial; FEV1: forced expiratory volume in 1 second.

Table 5. SR & M-A Results

Study

Residual Volume

FEV11

6-min walk tests2

SGRQ

Adverse Events (all, including mortality) Pneumothorax Overall Mortality

van Geffen et al (2019)6,

             

Total N

 

600

620

620

609 620 620 620

Mean difference (95% CI), p

 

MD -0.57 (-0.71 to -0.43), <0•0001

MD 21.77 (17.63 to 25.90), 0•0001

MD 49.00 (31.89 to 66.10), <0•0001 MD –9.13 (–12.37 to –5.89), <0•0001 OR 9.58 (5.56 to 16.50), <0.00001 Range 1.4% to 25% in treatment groups OR 1.84 (0.62 to 5.42), 0.27

I2 (p)

 

23% (0.26)

20% (0.29) 56% (0.05) 52% (0.06) 0% (1.00)   0% (0.88)

1mililiters; 2distance in meters.
FEV1: forced expiratory volume in 1 second.; SGRQ: St. George Respiratory Questionnaire; CI: confidence interval; 

Randomized Controlled Trials- Zephyr Valve
Seven RCTs have evaluated the Zephyr valve in patients with severe emphysema Tables 4 and 5). Only one trial (BELIEVER) used a sham procedure as a comparator; the rest were open label and compared the Zephyr valve to usual care. The BELIEVER trial was limited in that it only had a 3-month followup duration. The other trials followed patients for 6 or 12 months.

The trials showed statistically and clinically significant improvements on most measures of lung function (residual volume, FEV1), symptoms (MRC dyspnea scale), and quality of life (SGRQ). An exception was no difference from baseline to 3 months in SGRQ and MRC Dyspnea scale in the sham-controlled BELIEVER trial.

As noted by the authors of the Cochrane review conducted by van Agteren et al. (2017) a post hoc analysis of the two earlier trials (VENT EU 2012 and VENT US 2010) showed better response rates in participants who had intact fissures. As a result, the newer trials altered their inclusion criteria to only select participants with intact fissures, thereby lowering the chance of selecting participants who had collateral ventilation, which resulted in better functional outcomes.4,

Table 6. Summary of Key RCT Characteristics- Zephyr Valve

Trial

Countries

Sites

Dates

Participants

Interventions

         

Active

Comparator

LIBERATE, Criner et al (2018)7,

NCT01796392

US and other

24

2013-2016

Heterogeneous emphysema
distribution and little to no collateral
ventilation

Zephyr valve

(n=128)

Standard care (n=62)

 

TRANSFORM, Kemp et al (2017)8,

NCT02022683

Europe

 

17

2014-2016

Heterogeneous emphysema and absence of collateral
ventilation.

Zephyr valve

(n=65)

Standard care

(n=32)

IMPACT, Valipour et al (2016)9,

NCT02025205

Austria, Germany, Netherlands

15

2014-2016

Homogenous emphysema and absence of collateral ventilation

Zephyr valve

(n=43)

Standard care

(n=50)

STELVIO, Klooster et al (2015)7,

NTR2876 (Netherlands)

Netherlands

1 NR Severe emphsema and confirmed absence of collateral ventilation

Zephyr valve

(n=34)

Standard care

(n=34)

BELIEVER HI-FI, Davey et al (2015)10,

ISRCTN04761234

England

1

2012-2013

Heterogeneous emphysema
and intact interlobar fissures

Zephyr valve (n=25)

Sham procedure

(n=25)

VENT EUROPE, Herth et al (2012)9,

NCT00129584.

Multiple European

23

2005-2009

Severe heterogenous emphysema

Zephyr valve

(n=111, 44 with complete fissure)

Standard care

(n=60, 19 with complete fissure)

VENT US, Sciurba et al (2010)11,

NCT00129584

US

31

2004-2006

Severe heterogenous emphysema

Zephyr valve (n=220)

Standard care (n=101)

RCT: randomized controlled trial, NCT: National Clinical Trial; NR: Not reported.

Table 7. Summary of Key RCT Results- Zephyr Valve

Study

FEV1

6-MInute Walk Distance

SGRQ

MRC Dsypnea Scale

Adverse events Pneumothorax Mortality

LIBERATE (2018)

Patients with 15% or greater improvement at 12 months

Change from baseline at 12 months

Change from baseline at 12 months

Change from baseline at 12 months

Respiratory serious AEs at 45 days

At 12 months at 12 months

Total N

190

190

190 190 190 190 190

Zephyr valve

47.7%

12.98 (81.54)

-7.55 (15.71)

- 0.5 (1.17)

35.2%

34/128 (26.6) 4/128 3.1%)

Standard care

16.8%

-26.33 (81.50)

-0.50 (15.50)

0.3 (1.03)

4.8%

0/62 (0%) 0/62 (0%)

Between-group difference (95% CI)

Difference 31.0%

(18.0-43.9), p<0.001

39.31 (14.64 to 63.98)

-7.05 (-11.84 to -2.27)

-0.8 (-1.1 to -0.4)

     

p-value

<0.001

0.002

0.004

<0.001

<0.001

<0.05

NS

TRANSFORM (2017)

 

Patients with 12% or greater improvement at 6 months

 

Change from baseline at 6 months

Change from baseline at 6 months

Change from baseline at 6 months

Respiratory serious AEs at 6 months

At 6 months At 6 months
Total N 97 97 97 97      
Zephyr valve 55.4% 36.2 (76.9) -7.2 (15.1) -0.56 (1.04) 31/65 (47.7%) 19/65 (29.2%) 1/65 (1.5%)
Standard care 6.5% -42.5 (68.2) -0.7 (10.4) 0.00 (0.86) 3/32 (9.4%) 0/32 (0%) 0/32 (0%)
Difference   78.7 (46.3 to 111.0) -6.5 (-12.4 to -0.6) -0.56 (-0.99 to -0.14)      

P-value

<0.001

<0.001

0.031

0.010

<0.001

NR

NR

IMPACT (2016)

Improvement at 3 months, L

Change from baselline at 3 months, M

Change from baseline at 3 months

Change from baseline at 3 months

Respiratory serious AEs at 3 months

   
Total N 93 90 85 91 93 93 93
Outcome (3 months)       Change from baseline      
Zephyr valve 0.10 (0.18) 22.6 (66.6) -8.63 (11.2) -0.39 (1.00) 26/43 (44.2%) 12/43 (25.6%) 0/43 (0%)
Standard care -0.02 (0.10) -17.3 (52.8) 1.01 (9.3) 0.18 0.98) 8/50 (12.0%) 0/50 (0%) 1/50 (2.0%)
Difference 0.12 (0.06 to 0.18) 40.0 (15.0 to 65.0) -9.64 (-14.09 to -5.20 -0.57 (-0.98 to -0.16)      

P-value

<0.0001

0.002

<0.0001

0.007

<0.001

<0.001

NS

STELVIO (2015)

Improvement at 6 months,mL

Change from baseline at 6 months, meters

   

Serious AEs at 6 months

at 6 months All deaths at 6 months
Total N 68 68     68 68 68
Zephyr valve 161 (80 to 142) 60 (35 to 85)     23/34 6/34 (18%) 1/34 (3%)
Standard care 21 (-9 to 52) -14 (-25 to -3)     5/34 0/5 (0%) 0/34 0%)
Difference 17.8 (7.6 to 28.0) 74 (47 to 100)          
P-value 0.002 <0.001     <0.001 0.02 1.00
BELIEVER HI-FI (2015) Improvement at 3 months, L, median (IQR) Change from baseline at 3 months, median (IQR) Change from baseline at 3 months,median (IQR) Change from baseline at 3 months, median (IQR)      
Total N 50 50 50 50 50 50 50
Zephyr valve 0.06 (0.02 to 0.38) 25 (7 to 64) -4.40 (-16.93 to 6.76) 0 (-1 to 0)   2/25 (8.0%) 2/25 (8.0%)
Sham 0.03 (0 to 0.06) 3 (-14 to 20) -3.57 (-7.67 to 2.55) 0 (-1 to 0)   1/25 (4.0%) 0/25 (0%)
p-value 0.0326 0.0119 0.3454 0.4037   1.0 0.49
VENT Europe % change at 12 months, mean (SD), patients with complete fissure only % change at 12 months, patients with complete fissure only Change at 12 months, points, patients with complete fissure only   Serious complications up to 3 months Up to 3 months At 12 months, patients with complete fissure only
Total N 63 63 63   171 171 63
Zephyr valve 15% (29%) 13% (35%) 0 (15)   xx xx 2/44 (5%)
Standard care -2% (22%) 10% (44%) 4 (11)       1/19 (5%)
p-valiue 0.04 0.8 0.10       NR
VENT US % chhange at 6 months Median % change at 6 months Mean change at 6 months, points Mean change at 6 months, points Major AEs at 90 days At 90 days At 90 days
Total N 321 321 321 321 301 301 301
Zephyr valve 4.3% (1.4 to 7.2) 2.5 (-1.1 to 6.1) -2.8 (-4.7 to -1.0) -0.1 (-0.21 to 0.09) 9/214 (4.2%) 4.2% 2/214 (0.9%)
Standard care -2.5% (-5.4 to 0.4) -3.2 (-8.9 to 2.4) 0.6 (-1.8 to 3.0) 0.2 (0.01 to 0.37) 0/87 (0%) 0% 0/87 (0%)
Difference 6.8 (2.1 to 11.5) 5.8 (0.5 to 11.2) -3.4 (-6.7 to 0.2) -0.3 (-0.50 to -0.01)      
p-value 0,005 0.04 0.04 0.04 0.06 0.07 1.00

Summary2

Range             

CI: confidence interval; HR: hazard ratio; NNT: number needed to treat; OR: odds ratio; RCT: randomized controlled trial; RR: relative risk. 

Randomized Controlled Trials- Spiration Valve
Two RCTs of the Spiration valve in patients with emphysema have been published.12,13, A third trial has not been published in a peer-reviewed medical journal, but partial results have been presented as a conference poster and results were submitted to the FDA as part of the Spiration PMA application.14,

The EMPROVE trial showed improvements in FEV1, SGRQ, and MRC Dyspnea Scale in the Spiration group compared to usual care, but no significant difference between groups in the 6MWT.14, Serious AEs and pneumothorax were more frequent in the Spiration group. Results of the REACH trial were mostly positive but also mixed, with improvements in FEV1, 6MWT, and SGRQ, but not the MRC Dsypnea Scale. The sham-controlled IBV Valve trial showed statistically significant results favoriing the Spiration valve, but confidence intervals were wide and the study authors concluded that the trial did not obtain clinically meaningful results.12, Across the 1 trials, the incidence of pneumothorax ranged from 2.1% to 14%.

Table 8. Summary of Key RCT Characteristics- Zephyr Valve

Trial

Countries

Sites

Dates

Participants

Interventions

         

Active

Comparator

EMPROVE14,

IDE #G 120192.

US and Canada 31 2013-2017 Severe emphysema without interlobular collateral ventilation

Spiration valve

(n=113)

Standard care

(n=59)

REACH, Li et al (2018)13,

NCT01989182

China

12

2013-2017

Severe emphysema and intact interlobular fissures

Spiration valve

(n=72)

Standard care

(n=35)

IBV Valve, Wood et al (2014)12,

NCT00475007

US

36

2007-2017

Emphysema, airflow obstruction,
hyperinflation, and severe dyspnea

Spiration valve (n=142)

Sham procedure (n=135)

RCT: randomized controlled trial; NCT: national clinical trial.

Table 9. Summary of Key RCT Results- Spiration Valve

Study

FEV1

6-MInute Walk Distance

SGRQ

MRC Dsypnea Scale

Adverse events Pneumothorax Mortality
         

Thoracic serious AEs at 6 months

   
EMPROVE14, 15% improvement from baseline at 6 months Change from baseline at 6 months, meters Change from baseline at 6 months Change from baseline at 6 months      
Total N 172       172 172 172
Spiration valve 36.8%       31% 14% 6 (5.3%)
Standard care 10.0%       11.9% 0% 1 (1.7%)
Difference (95% CI) 26.8% 6.9 (-14.2, 28.2) -13 points (-17.4, -8.7) -0.6 (-0.9, -0.3).      
p-value              
REACH13, Change from baseline at 6 months (liters) Change from baseline at 6 months, meters Change from baseline at 6 months Change from baseline at 6 months Total serious AEs at 6 months    
Total N 96 96 95 96 99 99 99
Spiration valve 0.091 (0.156, 0.052) 20.82 (-0.58, 42.22) -8.39 (-12.69, -4.08) -0.73 (-0.96, -0.50) 22/66 (33.3%) 5/66 (7.6%) 0/66 (0%)
Standard care -0.24 (0.142, -0.072) -15.58. (-40.12, 8.96) 2.11 (-3.87, 8.08) -0.36 (-0.71, -0.01) 8/33 (24.2%) 0% 1/33 (3.0%)
Difference              
p-value 0.001 0.042 0.007 0.091 NR NR 99

IBV Valve12,

Change from baseline at 6 months (liters)

Change from baseline at 6 months, meters

Change from baseline at 6 months

Change from baseline at 6 months

Total serious AEs at 6 months

At 6 months

 
Total N 250 253 277 242 277 277 277
Spiration valve -0.07 (SD 0.17) -24.02 (SD 69.81) 2.15 (16.36) -0.24 (1.02) 20/142 (14.1%) 3/142 (2.1%) 6/142 (4.2%)
Sham 0.00 (SD 0.16) -3.0 (76.63) -1.41 (11.26) -0.14 (1.00) 5/135 (3.7%) 0/135 (0%) 1/135 (0.7%)
Difference (-0.11, -0.02) (-38.84, -2.44) (0.04, 7.07)   10.4% (4.0, 17.1) 2.1% (0.3, 5.1) 3.5% (0.2, 7.5)

CI: confidence interval; HR: hazard ratio; NNT: number needed to treat; OR: odds ratio; RCT: randomized controlled trial; RR: relative risk; SD: standard deviation 

Tables 1 and 2 summarize the design and conduct limitations of the included RCTs. In all but 2 trials, a major limitation was a lack of blinding, which could have influenced performance on the primary efficacy outcomes (e.g., it might have affected clinicians' coaching of patients and/or the degree of effort exerted by patients). The initial publication of the VENT study data included only the USA arm since its size was sufficient to support the a priori power calculation. The size of the European arm of the VENT study was smaller than the a priori estimate. Two trials had followup durations less than 6 months None of the studies compared bronchial valves to lung volume reduction surgery. Although used for FDA approval, results of the EMPROVE trial have not yet been fully published.

Table 10. Relevance Limitations

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

LIBERATE          
TRANSFORM          
IMPACT         1,2
STELVIO          
BELIEVER HI-FI         1,2
VENT Europe 4        
VENT US          
EMPROVE          
REACH          
IBV Valve           

The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms. 

Table 11. Study Design and Conduct Limitations

Study

Allocationa

Blindingb

Selective Reportingc

Data Completenessd

Powere

Statisticalf

LIBERATE 3 1        
TRANSFORM   1        
IMPACT   1        
STELVIO   1        
BELIEVER HI-FI            
VENT Europe   1     3  
VENT US   1        
EMPROVE   1 2,3      
REACH   1        
IBV Valve              

The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. 
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Section Summary: Treatment of Severe or Advanced Emphysema
In patients with severe emphysema and low collateral ventilation, RCTs provide evidence of clinically meaningful benefit for bronchial valves compared to standard medical management on measures of lung function, exercise tolerance, and quality of life, but there was a greater risk of serious adverse events compared to usual care. Because of limitations in study designs, especially a lack of blinding, significant heterogeneity across studies on some measures, and a higher risk of serious adverse events, with up to 29% of patients experiencing pneumothorax, the evidence is insufficient to determine that the technology improves the net health outcome.

Summary of Evidence
For individuals who have pulmonary air leaks who receive bronchial valves, the evidence includes the case series and a prospective cohort observational study related to the Humanitarian Device Exemption for the Spiration IBV Valve device. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. Other reports are small series of heterogeneous patients. There are no comparative data with alternatives. This evidence is inadequate to determine the impact of this technology on the net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have severe or advanced emphysema who receive bronchial valves, the evidence includes 11 RCTs and 3 systematic reviews. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. In patients with severe emphysema and low collateral ventilation, RCTs provide evidence of clinically meaningful benefit for bronchial valves compared to standard medical management on measures of lung function, exercise tolerance, and quality of life, but there was a greater risk of serious adverse events compared to usual care. Because of limitations in study designs, especially a lack of blinding, significant heterogeneity across studies on some measures, and a higher risk of serious adverse events, with up to 29% of patients experiencing pneumothorax, the evidence is insufficient to determine that the technology improves the net health outcome.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 1 physician specialty society and 3 academic medical centers while this policy was under review in 2011. Input generally agreed that use of bronchial valves is investigational for treating emphysema. Regarding the use of bronchial valves for treating prolonged air leaks, reviewers acknowledged that only limited case series are available. Of the 4 reviewers, 1 supported the investigational indication, 2 supported the compassionate use of valves for treating prolonged air leaks and the fourth thought that treatment of prolonged air leaks might be reasonable but had concerns about potential complications.

Practice Guidelines and Position Statements
In 2011, the British Thoracic Society published guidelines on advanced diagnostic and therapeutic flexible bronchoscopy in adults.15, The guidelines indicated the evidence insufficient to recommend routine use of bronchial valves for treatment of emphysema.

In December 2017, NICE issued the following recommendations on endobronchial valve insertion to reduce lung volume in emphysema:16,

1.1Current evidence on the safety and efficacy of endobronchial valve insertion to reduce lung volume in emphysema is adequate in quantity and quality to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit.

1.2Patient selection should be done by a multidisciplinary team experienced in managing emphysema, which should typically include a chest physician, a radiologist, a thoracic surgeon and a respiratory nurse.

1.3Patients selected for treatment should have had pulmonary rehabilitation.

1.4The procedure should only be done to occlude volumes of the lung where there is no collateral ventilation, by clinicians with specific training in doing the procedure. 

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some ongoing trials that might influence this review are listed in Table 6.

Table 12. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

     

NCT02382614a

Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks (VAST)

200

Dec 2018
(suspended)

NCT02022683a

A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema (TRANSFORM)

97

Dec 2018 ((long-term safety)

NCT01796392a

Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE) 

183

Sep 2021 (long-term safety)

NCT01812447a

A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration® Valve System for the Single Lobe Treatment of Severe Emphysema (EMPROVE)

172

May 2022

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.   

References 

  1. Travaline JM, McKenna RJ, Jr., De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves. Chest. Aug 2009;136(2):355-360. PMID 19349382.
  2. Firlinger I, Stubenberger E, Muller 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. Apr 2013;95(4):1243-1249. PMID 23434254.
  3. Gillespie CT, Sterman DH, Cerfolio RJ, et al. Endobronchial valve treatment for prolonged air leaks of the lung: a case series. Ann Thorac Surg. Jan 2011;91(1):270-273. PMID 21172529.
  4. van Agteren JE, Hnin K, Grosser D, et al. Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. Feb 23 2017;2:CD012158. PMID 28230230.
  5. National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: Diagnosis and management. Available at: https://www.nice.org.uk/guidance/ng115. Accessed May 9, 2019.
  6. van Geffen, WW, Slebos, DD, Herth, FF, Kemp, SS, Weder, WW, Shah, PP. Surgical and endoscopic interventions that reduce lung volume for emphysema: a systemic review and meta-analysis. Lancet Respir Med, 2019 Feb 13;7(4). PMID 30744937.
  7. Criner, GG, Sue, RR, Wright, SS, Dransfield, MM, Rivas-Perez, HH, Wiese, TT, Sciurba, FF, Shah, PP, Wahidi, MM, de Oliveira, HH, Morrissey, BB, Cardoso, PP, Hays, SS, Majid, AA, Pastis, NN, Kopas, LL, Vollenweider, MM, McFadden, PP, Machuzak, MM, Hsia, DD, Sung, AA, Jarad, NN, Kornaszewska, MM, Hazelrigg, SS, Krishna, GG, Armstrong, BB, Shargill, NN, Slebos, DD, Criner, GG, Cordova, FF, Desai, PP, Marchetti, NN, Kim, VV, Shenoy, KK, Travaline, JJ, Thomas, JJ, Criner, LL, Sue, RR, Wright, SS, Thornburg, AA, Thomas, TT, Dransfield, MM, Bhatt, SS, Wells, JJ, Seabron-Harris, NN, Rivas-Perez, HH, Gauhar, UU, Wiese, TT, Despirito, CC, Sciurba, FF, Bon Field, JJ, Chandra, DD, Leader, JJ, Semaan, RR, Ledezma, CC, Shah, PP, Kemp, SS, Garner, JJ, Aboelhassan, AA, Srikanthan, KK, Tenda, EE, Abraham, AA, Sim, CC, Wahidi, MM, Mahmood, KK, Shofer, SS, Coles, KK, de Oliveira, HH, Oliveira, GG, Machado, BB, Benedetto, II, Svartman, FF, de Macedo Neto, AA, Schreiner, LL, Vieira, TT, Morrissey, BB, Yoneda, KK, Tham, TT, Tompkins, DD, Guerreiro Cardoso, PP, Athanazio, RR, Nominando, FF, Rached, SS, Cassimiro, LL, Hays, SS, Seeley, EE, Shrestha, PP, Dincheva, GG, Majid, AA, Alape-Moya, DD, Parikh, MM, Paton, AA, Agnew, AA, Pastis, NN, Strange, CC, Beiko, TT, Woodford, DD, Blanton, MM, Kopas, LL, Connolly, TT, Santacruz, JJ, Shah, BB, Vollenweider, MM, Herrera, LL, Khan, RR, Sernulka, KK, McFadden, PP, Barbers, RR, Hernandez, MM, Machuzak, MM, Almeida, FF, Cicenia, JJ, Gildea, TT, Mehta, AA, Sethi, SS, Meli, YY, Hsia, DD, Casaburi, RR, Stringer, WW, Diaz, LL, Sung, AA, Ramsey, MM, Van Wert, RR, Morris, KK, Jarad, NN, Batchelor, TT, Sequeiros, II, Tucker, KK, Kornaszweska, MM, Fallouh, HH, Sabit, RR, Naase, HH, George, JJ, Salimian, AA, Dyer, HH, Hazelrigg, SS, Adams, KK, Bade, KK, Krishna, GG, Benn, BB, Canfield, MM, Vetri Villalan, SS, Stewart, TT, Slebos, DD, Ten Hacken, NN, Klooster, KK, Hartman, JJ, Augustijn, SS. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am. J. Respir. Crit. Care Med., 2018 May 23;198(9). PMID 29787288.
  8. Kemp, SS, Slebos, DD, Kirk, AA, Kornaszewska, MM, Carron, KK, Ek, LL, Broman, GG, Hillerdal, GG, Mal, HH, Pison, CC, Briault, AA, Downer, NN, Darwiche, KK, Rao, JJ, Hübner, RR, Ruwwe-Glosenkamp, CC, Trosini-Desert, VV, Eberhardt, RR, Herth, FF, Derom, EE, Malfait, TT, Shah, PP, Garner, JJ, Ten Hacken, NN, Fallouh, HH, Leroy, SS, Marquette, CC. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am. J. Respir. Crit. Care Med., 2017 Sep 9;196(12). PMID 28885054.
  9. Herth FJ, Noppen M, Valipour A, et al. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. Jun 2012;39(6):1334-1342. PMID 22282552.
  10. 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. Sep 12 2015;386(9998):1066-1073. PMID 26116485.
  11. Sciurba FC, Ernst A, Herth FJ, et al. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. Sep 23 2010;363(13):1233-1244. PMID 20860505.
  12. Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. Oct 2014;21(4):288-297. PMID 25321447.
  13. Li, SS, Wang, GG, Wang, CC, Gao, XX, Jin, FF, Yang, HH, Han, BB, Zhou, RR, Chen, CC, Chen, LL, Bai, CC, Shen, HH, Herth, FF, Zhong, NN. The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema. Respiration, 2018 Dec 17;1-12:1-12. PMID 30554211.
  14. U.S. Food & Drug Administration. Spiration Valve System. Summary of Safety and Effectiveness Data. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180007B.pdf. Accessed May 9, 2018.
  15. Du Rand IA, Barber PV, Goldring J, et al. Summary of the British Thoracic Society guidelines for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. Nov 2011;66(11):1014-1015. PMID 22003155.
  16. National Institute for Health and Care Excellence. Endobronchial valve insertion to reduce lung volume in emphysema. Available at: https://www.nice.org.uk/guidance/IPG600/chapter/1-Recommendations. Accessed May 9, 2019.

Coding Section

Codes Number Description
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

  31651

; 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])

  31648

; with removal of bronchial valve(s), initial lobe

  31649

; with removal of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure)

ICD-9-CM Diagnosis   

Investigational for all diagnoses

ICD-9-CM Procedure 

33.71 

Endoscopic insertion or replacement of bronchial valve(s),single lobe 

   33.73 Endoscopic insertion or replacement of bronchial valve(s),multiple lobes
   33.78

Endoscopic removal of bronchial device(s) or substances 

ICD-10-CM (effective 10/01/15)   

Investigational for all diagnoses 

  J43.0-J43.9 

Emphysema code range 

  J44.0-J44.9 

code range (used for emphysema with chronic obstructive bronchitis) 

ICD-10-PCS (effective 10/01/15)   

ICD-10-PCS codes are only used for inpatient services. 

 

0BH38GZ, 0BH48GZ,0BH58GZ, 0BH68GZ, 0BH78GZ, 0BH88GZ, 0BH98GZ, 0BHB8GZ 

Surgical, respiratory system, insertion, via natural or artificial opening endoscopic, endobronchial valve; codes specific to type of bronchus and left or right 

Type of Service Surgery   
 Place of Service Inpatient, outpatient   

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

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

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

08/01/2019 

Annual review, no change to policy intent. Updating background, regulatory status, rationale and references. 

08/16/2018 

Annual review, no change to policy intent. Updating background and rationale. 

08/29/2017 

Annual review, removing "endo" from the title and policy verbiage, "Bronchial Valves" will be the verbiage used. Also updating background, description, rationale and references. 

08/11/2016

Annual review, no change to policy intent. Updating background, description, rationale and references. 

08/19/2015 

Annual review, no change to policy intent, but policy verbiage reworded for clarity to include: "Endobronchial valve are considered investigational in all situations including, but not limited to....". Updated background, description, guidelines, rationale and references. Added coding. 

08/04/2014

Annual review. Updated rationale and references. No change to policy intent. 

 


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