The Zephyr Endobronchial Valve has the most clinical evidence of any endoscopic lung volume reduction therapy, supported by four published randomized controlled clinical trials, two more underway, and extensive scientific research into safety and efficacy. Click here to see our key publications.
Two additional randomized controlled clinical trials – the US LIBERATE pivotal trial and TRANSFORM – have completed enrollment.
The evidence is accumulating that this is a powerful treatment for emphysema patients.
This technology has the biggest evidence base and the greatest clinical use.
| RCT | Design |
Sample Size & Follow-up period |
Difference EBV vs Control Groups | ||
|---|---|---|---|---|---|
|
Lung Function (FEV1%) MCID = 10%-15% |
Exercise Capacity (6MWD) MCID = 26 m |
Quality of Life (SGRQ) MCID = – 4 pts |
|||
| LIBERATE1 |
2:1 Randomization Heterogeneous only Multi-Center |
n=190 12 months |
18.0%* | 39.3 m* | -7.1 pts* |
| TRANSFORM2 |
2:1 Randomization Heterogeneous only Multi-Center |
n = 97 6 months |
29.3%* | 79 m* | -6.5 pts* |
| IMPACT3 |
1:1 Randomization Homogeneous only Multi-Center |
n=93 6 months |
16.3%* | 28 m* | -7.5 pts* |
| STELVIO4 |
1:1 Randomization Heterogeneous & Homogeneous Single Center |
n = 68 6 months |
17.8%* | 74 m* | -14.7 pts |
* Intention to treat analysis
✝︎ Difference between valve and control groups
1 Criner et al. Am J Resp Crit Care Med.2018, in press
2 Kemp S et al. Am J Resp Crit Care Med 2017; (196)12: 1535-1543
3 Valipour et al. Am J Respir Crit Care Med. 2016; Vol 194, Iss 9, pp 1073-1082 and Data on file at Pulmonx
4 Klooster K. et al. N Engl J Med. 2015; 373: 2325-2336 + Supplementary Appendix
Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study
American Journal of Respiratory and Critical Care Medicine, Vol. 194, No. 9, Nov 01, 2016
Patients with homogeneous emphysema also benefit from therapy with endobronchial valves
This new clinical study demonstrates the benefits of Pulmonx Zephyr Endobronchial Valves in patients with homogeneous emphysema.
The positive results of the IMPACT STUDY, published in the American Journal of Respiratory and Critical Care Medicine online (Sept. 2016), demonstrate that patients with homogeneous emphysema benefit from treatment with the Zephyr Endobronchial Valve (EBV®) from Pulmonx. Patients pre-selected with the Chartis® System and treated with EBV, experienced significant improvements in lung function, exercise capacity and quality of life following therapy.
The IMPACT STUDY is the first prospective, randomized, multi-centre study examining the effectiveness of the Zephyr EBV specifically in patients with homogeneous emphysema. The study enrolled and randomized 93 patients with severe homogeneous emphysema to compare the safety and effectiveness of Zephyr EBV treatment versus medical management. The Chartis System was used to select patients with little or no collateral ventilation, and thus most likely to benefit from treatment whilst advanced imaging technology was used to select a target lobe for treatment.
The three-month results from the IMPACT STUDY showed that patients with homogeneous emphysema and little or no collateral ventilation in the target lobe (assessed using the Chartis System) treated with the Zephyr Endobronchial Valve experienced a 17 percent improvement in FEV1 compared to the control group. EBV-treated patients also experienced improved exercise tolerance, with a 40-meter increase over the control group in the Six Minute Walk Test (6MWD), and improved quality of life, with a 10-point improvement in the St. Georges Respiratory Questionnaire (SGRQ) score over the control group. The results also showed that 97 percent of EBV subjects experienced target lobe volume reduction, indicating effective occlusion of the target lobe following Zephyr EBV placement. These data indicate that EBV therapy can benefit substantially more patients than previously believed.
Click here to see detailed information about the IMPACT STUDY.
Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation
The New England Journal of Medicine 2015; 373:2325-2335.
Karin Klooster, Jorine E. Hartman, Nick H.T. ten Hacken, Dirk-Jan Slebos, University of Groningen, and Department of Pulmonary Diseases, University Medical Center Groningen, Groningen, The Netherlands
See also
One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial
American Journal of Respiratory and Critical Care Medicine, Vol. 194, No. 9, Nov 01, 2016
The STELVIO STUDY, published in the New England Journal of Medicine, was independently conducted and is the first prospective RCT validating use of Chartis System to pre-select patients with low or no collateral ventilation in the target lobe. Following selection, patients were then randomized to EBV therapy or medical management. The results showed that the EBV group had statistically and clinically greater improvements than the control group in pulmonary function, exercise capacity and quality of life. Patients in the control group were allowed to crossover to EBV therapy at the end of six months. Control patients that crossed over to receive EBV therapy achieved improvements in pulmonary function and exercise capacity that were similar to the original EBV-treated group. In addition, EBV therapy was shown to be effective in patients with both heterogeneous and homogeneous emphysema with low collateral ventilation.
Click here to read about the one-year follow-up.
| Study title | Bronchoscopic Lung Volume Reduction with endobronchial valves using best responder criteria in patients with severe COPD – The STELVIO Trial (Netherlands Trial Register number NTR2876). |
| Design | Single-centre, randomized (1:1 EBV vs standard of care) controlled trial |
| Purpose | STELVIO is a prospective, randomized controlled trial comparing use of endobronchial valves (EBV) to standard medical care in patients with severe emphysema and low collateral ventilation as measured by the Chartis System. |
| Number of patients enrolled |
|
| Results |
Primary Outcomes in the Intention to Treat Population
Significantly Greater Responder Rates for EBV-treated Patients than Standard of Care
|
| Conclusions | Endobronchial valve treatment significantly improved pulmonary function and exercise capacity in patients with severe emphysema characterized by an absence of interlobar collateral ventilation. |
Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi STUDY): a randomised controlled trial
The Lancet. 2015; 386(9998):1066-1073.
See also
Endobronchial valves for patients with heterogeneous emphysema and without interlobar collateral ventilation: open label treatment following the BeLieVeR-HIFi study
Thorax Online First, published on December 20, 2016,
The BeLieVeR-HIFi STUDY published in the Lancet was an independent, randomized, double-blind, sham-controlled study in patients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax. The study included patients with low collateral ventilation determined by chest CT imaging; Chartis System assessments were also performed to evaluate collateral ventilation, but not used to determine inclusion in the study. Using the most rigorous study design available, a sham procedure as a control, the study exceeded its primary endpoint, with a 20.9% greater average improvement in FEV1 (% predicted) than control. The median improvement vs. control was less pronounced, with 5.9% greater average improvement in FEV1 in treated patients than control, in part due to the inclusion of 7 out of 25 patients in the treatment group who had tested positive for collateral ventilation or had indeterminate Chartis results.
| Study title | Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and interlobar fissures (the BeLieVeR-HIFi STUDY): a randomised controlled trial (ISRCTN04761234) |
| Design | Single centre, randomized (1:1), parallel group, double-blind sham bronchoscopy controlled trial |
| Purpose | BeLieVeR-HIFi is a prospective, double-blind, randomized, sham-controlled trial comparing use of endobronchial valve for severe emphysema patients to a sham bronchoscopy procedure. |
| Number of patients enrolled |
|
| Results |
|
| Conclusions | This study demonstrates that, in patients with heterogeneous emphysema and intact interlobar fissures, endobronchial valve placement is effective in improving lung function to a clinically significant extent. However, this is not without risks, including, in particular, the possibility of pneumothorax. |
A Randomized Study of Endobronchial Valves for Advanced Emphysema
The New England Journal of Medicine 2010; 363:1233-1244.
Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort
European Respiratory Journal 2012; 39: 1334-1342.
The VENT study is a multicenter, prospective, randomized, controlled trial conducted to evaluate safety and effectiveness of the unilateral treatment of emphysema by endobronchial valves (EBV). It was conducted in the USA and Europe from 2004 to 2009 and sponsored by Emphasys
Note: this study was conducted prior to the availability of devices to measure the collateral ventilation (CV) e.g. Chartis system. Collateral ventilation was not used to select patients for inclusion in the study, and investigators frequently did not completely occlude the targeted lobe for treatment. Only 68 of 214 treated patients had complete fissures (and thereby a low likelihood of collateral ventilation); of these 68, only 37 had complete occlusion of the target lobe with valves. Thus of the 214 treated patients, only 17% received treatment consistent with current clinical practice of selecting lobes without collateral ventilation and completing occluding them. The result was to decrease the average effect of the treatment, as was shown later in post hoc analysis*.
Data were analyzed and reported for two cohorts (US VENT cohort (321 patients) and EURO VENT cohort (171 patients).
A study publication overview is provided in Table 3
| Study title | Endobronchial Valve for Emphysema Palliation Trial (VENT) (NCT00129584) |
| Design | Multicenter, randomized (2:1), controlled trial |
| Purpose | Compare efficacy and safety of endobronchial valve (EBV) therapy in patients with heterogeneous emphysema versus standard medical care (control) |
| Number of patients enrolled |
|
| Published Results |
* 12 month SGRQ score not reported in publication |
| Post hoc analysis |
|
| Conclusions | Both publications conclude that unilateral lobar volume reduction using endobronchial valve treatment result in modest improvements in lung function, exercise tolerance, and symptoms. Superior clinical results correlated with CT suggestive of complete fissures and successful lobar occlusion. |
*On file at Pulmonx
Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, haemoptysis, pneumonia, dyspnoea and, in rare cases, death.
