This post was reviewed by Xavier Soler, MD.
The following resource provides respiratory therapists and other allied health professionals key clinical information regarding a new minimally invasive treatment option, Bronchoscopic Lung Volume Reduction (BLVR), for patients suffering from severe emphysema.
The respiratory therapy community is committed to providing optimal patient care to those with cardiopulmonary health issues. These dedicated healthcare professionals provide critical respiratory services and often follow the patient throughout their entire treatment plan. Chronic obstructive pulmonary disease (COPD) is a common diagnosis among a respiratory therapist’s patient base; COPD is one of the leading causes of death worldwide and in the United States, with nearly 16 million people diagnosed.1 Of those 16 million, at least 5 million people suffer from emphysema, one of COPD’s main presentations, involving progressive damage of lung tissue and distal airway (alveoli). This condition often results in hyperinflation of the lung, causing significant breathing challenges for patients.1
Until recently, treatment options for emphysema were limited to pharmacological treatment, or for patients that qualified, invasive procedures, such as lung volume reduction surgery (LVRS) or lung transplant. Bronchoscopic lung volume reduction (BLVR) with endobronchial valves is a relatively new, minimally invasive treatment option available for a subgroup of patients suffering from the debilitating symptoms of severe emphysema. This procedure has shown significant clinical benefits including improvements in lung function, shortness of breath, and quality of life. Specifically, for some patients with emphysema with hyperinflation, these benefits were achieved by ultimately improving gas exchange and allowing healthier parts of the lung to re-expand.
As published in recent clinical trials, 2 endobronchial valves provide a strong risk-benefit profile on the selected patient population with statistically significant and clinically meaningful improvements in FEV1, target lobe volume reduction, dyspnea score, and quality of life parameters. Treatment with endobronchial valves is intended to be permanent, although removal of the valves is possible, if required. The procedure is typically performed under general anesthesia or deep sedation.
Who is eligible for this treatment option?
Like any surgical intervention, patient selection is very important in ensuring success of the BLVR procedure. This treatment option is not suitable for all emphysema patients. To determine which patients are likely to benefit the most, an expert clinical evaluation, pulmonary function tests (PFTs), examination of comorbidities, as well as a medical workup and radiographic assessment of a patient’s CT scan are necessary. In accordance with the GOLD Guidelines, 3 patients with Stage III or Stage IV emphysema will be most likely to benefit from this procedure. Common characteristics of a potential candidate can include severe dyspnea, and those with heterogenous emphysema and significant hyperinflation.
Eligible Patient Profile
Patient selection is the most important element of this procedure. Selecting the right candidate will potentially determine success of the treatment, with clinically significant improvements in lung function and quality of life. However, eligibility does not guarantee optimal response to the treatment.
The following criteria have been factored into recommendations for selecting patients for BLVR with endobronchial valves as stated in clinical trials:2
Key Patient Selection Criteria2
- Patient is not an active smoker.
- Patient is diagnosed with GOLD stage III or IV COPD (severe emphysema).
- FEV1: >15 and ≤ 45 % predicted.
- mMRC: ≥ 2.
- Patient is on optimized medical management within standard of care.
- Patient does not have a known or suspected sensitivity or allergy to nickel.
Additional Testing Requirements2
- Residual Volume (RV): >150% predicted.
- Total Lung Capacity: ≥100% predicted.
- 6MWD: >100 meters.
- DLCO: > 20%.
Radiographic Assessment Recommendations2
After full medical assessment and required tests are complete and met, the physician can assess the patient’s CT scan to determine eligibility based on the key metrics of emphysema severity, fissure completeness integrity, and heterogeneity of the emphysema distribution. These measures are determined via a specialized high-resolution computed tomography(HRCT) analysis and results provided in an easy-to-read report to assist in selecting qualified patients and potential target lobes for BLVR. CT criteria to determine eligible patients for the treatment are based upon findings from clinical studies.4 These recommendations are not meant to replace patient-specific clinical judgement by a treating physician:
- Fissure Integrity ≥ 90% completeness of the fissure separating the target lobe.
- High Heterogeneity ≥10-point severity difference between target and the ipsilateral lobe.
- Emphysema Severity – target lobe with ≥ 40% emphysema involvement.
- Patient does not have a giant bulla > 30% volume in either lung.
It is recommended that treating physicians follow the guidelines to achieve good clinical results.
Treatment Timeline
Once the patient has met eligibility criteria, they can be scheduled for the BLVR procedure. It is recommended that that the procedure occur within 6 months of testing and patient assessment. Each individual patient may respond somewhat differently, but most patients respond favorably. Response time varies from very rapid (within days) to a few weeks, or up to 3-4 months. Physicians typically recommend a pulmonary rehabilitation program following the procedure to maximize the benefits of this procedure; some treating physicians recommend rehab prior to the procedure as well.
Post-Procedure Management
It is important to ensure that each facility is equipped with the proper resources to help build a successful BLVR program to the patient community. Post-procedure management and follow up are important elements to ensuring each patient is monitored properly prior to discharge. BLVR therapy is a minimally invasive procedure that is well tolerated by most patients but is not without risks. Complications which may be associated with the bronchoscopic procedure and/or bronchoscopic lung volume reduction with endobronchial valves include, but are not limited to, pneumothorax (air in the chest cavity), worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea, and in rare cases, death.5.
What is the main risk associated with BLVR?
The main and common risk associated with BLVR is pneumothorax. Typically, a pneumothorax will develop within 72 hours post-procedure. Therefore, patients should remain in the hospital for proper observation in order to decrease the risk of complications. To monitor for pneumothorax, it is recommended that a chest x-ray, chest ultrasound, and potentially chest CT scan are completed post-procedure. A chest x-ray should be completed within four hours of the procedure and then daily until discharge. An immediate post-procedure assessment for lobar occlusion and lung sliding analysis via a chest ultrasound is also an option. A low threshold should be used for CT imaging, if pneumothorax is suspected and the patient has rapid major lobar collapse, in order to quickly diagnose or rule out an associated pneumothorax.
Should we prepare a pneumothorax cart?
Treating physicians are recommended to have a designated pneumothorax cart in the patient room after the procedure, including:
- Needle/catheter for needle decompression (16G).
- Seldinger chest tubes 14Fr.
- Surgical chest tubes and tray 20–28Fr for “open” chest tubes.
- Gloves, scalpel, suture, dressing materials, pleuro vac.
- Lastly, always be prepared to place a chest tube within 15-30 minutes during hospital stay.
Is there a recommended hospital stay for these patients?
Hospital stay is based upon physician’s discretion and should be considered if there is a persistent chest discomfort or pain on the treated side. The general recommendation is to keep the patients at the hospital until the initial risk of post-procedural pneumothorax have passed, which is approximately 72 hours.
Summary
BLVR provides another therapeutic option for patients with COPD. It is an innovative procedure that is improving the quality of patient’s lives daily when properly prescribed and utilized. “As a respiratory therapist, having treated and been an advocate for COPD patients for many years, it gives me joy to help bring this procedure to patients and their caregivers. This procedure gives patients and their caregivers the opportunity to improve the quality of their lives.” Jen Gerenraich, Respiratory Territory Manager, Respiratory Therapist.
This post was sponsored by Olympus.
1 Centers for Disease Control. Chronic Obstructive Pulmonary Disease: Basics About COPD. https://www.cdc.gov/dotw/copd/index.html
2 Criner GJ, Delage A, Voelker K. Late Breaking Abstract - Endobronchial Valves for Severe Emphysema – 12-month Results of the EMPROVE Trial. Eur Respir J. 2018;52(suppl 62). doi:10.1183/13993003.congress-2018.OA4928. https://err.ersjournals.com/content/28/152/180121
3 Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of COPD, 2019. http://goldcopd.org
4 Criner, Gerard J et al. “Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial.” American journal of respiratory and critical care medicine vol. 200,11 (2019): 1354-1362. doi:10.1164/rccm.201902-0383OC.
5 Hogarth DK, Delage A, Zgoda MA, Reed MF. American Thoracic Society International Conference Abstracts. American Thoracic Society; 2018:A7754-A7754. doi:10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A775