Running head: TREATMENT OF ADVANCED EMPHYSEMA Emphysematous Lung Sealant (ELS) for Treatment of Advanced Emphysema: A Clinical Appraisal Topic (CAT) Jaydee M. Unruh University of Mary 1 TREATMENT OF ADVANCED EMPHYSEMA 2 Emphysematous Lung Sealant for Treatment of Advanced Emphysema: A Clinical Appraisal Topic (CAT) Appraised by Jaydee M. Unruh, RN, BSN, FNP-S May 29, 2015 Emphysema is recognized far and wide as a chronic obstructive pulmonary disease (COPD) phenotype. Emphysema is an incurable, widespread, and under-diagnosed condition, which has become the third leading cause of death in the United States (Armstrong, et al., 2015; Pompeo, 2014). It is termed as an atypical irreversible enlargement of air spaces distal to the terminal bronchiole linked to destruction of their walls. Within the last couple decades lung volume reduction surgery (LVRS) has transpired as an valuable surgical option that can undo harmful effects for a subgroup of patients with emphysema, leading to significant and ongoing improvements in respiratory function, exercise tolerance, quality of life, and overall survival (Armstrong, et al., 2015; Pompeo, 2014). However, the common LVRS-related morbidity has lead to the development of emphysematous lung sealant (ELS). ESL (AeriSeal System therapy) is an innovative, minimally invasive alternative to LVRS for treatment of patients with advanced emphysema. AeriSeal is injected into the peripheral airways and alveoli where it polymerizes and acts as tissue glue on the surface of the lung in order to seal the target area to cause durable permanent absorption atelectasis (Falkenstern, Ingerl, & Kohlhäuf, 2013). Clinical Scenario M.T. is a 65-year old male who presents to your clinic with worsening shortness of breath. M.T. was diagnosed with emphysema approximately 2 years ago; since diagnosis he has quit smoking. Past CT images demonstrate that M.T. has predominantly upper lobe emphysema. TREATMENT OF ADVANCED EMPHYSEMA 3 He reports having minimal exercise tolerance that has seemed to worsen over the past month or so. Aside from emphysema, M.T. has an unremarkable history and has no co-existing conditions. M.T.’s emphysema has notably exacerbated despite his diligent compliance with medical therapy. He asks you about “new options and surgeries that he keeps hearing about” for people with emphysema. PICO Question Among people with advanced emphysema, is treatment with emphysematous lung sealant more effective in reducing lung volume, compared to surgical lung volume reduction surgery? Summary and Appraisal of Key Evidence Falkenstern, Ingerl and Kohlhäuf (2013) identified that emphysematous lung sealant (ELS) treatment minimizes air trapping, which results in improved pulmonary function, exercise tolerance and quality of life. In the study, ELS treatment was accompanied with a ‘flulike’ reaction beginning 8–24 hours post-treatment in all study patients. The most common side effects included: elevated inflammatory markers, dyspnea, fever, leukocytosis, chest infiltrates on x-ray, and chest pain. The symptoms tended to be self-limited and resolved within 24–96 hours. To further support Falkenstern, Ingerl and Kohlhäuf ‘s (2013) study, Herth, et al. (2011) yielded results that indicated ELS treatment was a safe option for patients with advanced emphysema, and can reduce gas trapping and enhance quality of life for up to six months in ELS appropriate patients (Herth, et al., 2011). Another clinical study was conducted to assess the safety and efficacy of bilateral AeriSeal Emphysematous Lung Sealant System (ELS) treatment in patients with advanced emphysema out to one year. In this study twenty patients received treatment and were evaluated at 3, 6, and 12 months to assess the effectiveness. The ELS treatment was deemed to have a TREATMENT OF ADVANCED EMPHYSEMA 4 short procedure time and length of hospital stay. The follow-up evaluations at 3, 6, and 12 months demonstrated that physiologic and functional improvement was noted at one year (Kramer, Refaely, Maimon, Rosengarten & Fruchter, 2012). In light of lung volume reduction surgery (LVRS), Brown, et al. (2012) completed a literature review, which deemed LVRS to be a highly effective palliative treatment modality for patients with severe emphysema, predominantly for those who have CT verification of heterogeneous upper-lobe predominant disease associated with impaired exercise capacity. By the application of different strategies of treatment including one-stage bilateral, unilateral and staged surgical approaches, there were considerable and long-lasting improvements, including respiratory function, exercise capacity, and quality of life (Pompeo, 2014). LVRS has been a highly debated topic due to the potential benefit being outweighed by harms. Tiong (2008) examined eight trials involving 1663 participants and found that people who underwent LVRS ran an increased risk of death at three months post-operatively. However, by the end of follow up in the studies, there was no significant difference in mortality between surgery and non-surgically managed participants. The mortality rates suggested that the number of deaths in each treatment group were similar after two to three years, but LVRS led to an increase in the odds of death in the first 90 days post-operatively (Tiong, 2008). Clinical Bottom Line In conclusion, ELS therapy is an effective, novel approach to reducing lung volume in patients with advanced emphysema. Although current studies involve small populations in which drawing definitive conclusions can be made difficult, the safety and effectiveness of ELS therapy has promising indications and further testing is supported. In contrast, the research that has accrued over the past couple decades examining the efficacy of LVRS has ultimately TREATMENT OF ADVANCED EMPHYSEMA demonstrated to be a favorably effective method of improving respiratory function, exercise tolerance, and quality of life in patients with advanced emphysema (Pompeo, 2014). LVRS remains a promising solution to reducing lung volume, but study findings are still needed from large trials with lengthy follow-up research to help identify the most effective treatment option for patients with advanced emphysema. This is mainly due to the mortality statistics associated with LVRS. 5 TREATMENT OF ADVANCED EMPHYSEMA 6 References Armstrong, H. F., Dussault, N. E., Thirapatarapong, W., Lemieux, R. S., Thomashow, B. M., & Bartels, M. N. (2015). Ventilatory efficiency before and after lung volume reduction surgery. Respiratory Care, 60(1), 63-71. doi:10.4187/respcare.03233 Brown, M. S., Kim, H. J., Abtin, F. G., Strange, C., Galperin-Aizenberg, M., Pais, R., & ... Goldin, J. G. (2012). Emphysema lung lobe volume reduction: Effects on the ipsilateral and contralateral lobes. European Radiology, 22(7), 1547-1555. doi:10.1007/s00330-0122393-6 Falkenstern-Ge, R. F., Ingerl, H., & Kohlhäuf, M. (2013). Severe emphysema treated by endoscopic bronchial volume reduction with lung sealant (AeriSeal). Case Reports In Pulmonology, 1-4. doi:10.1155/2013/361391 Herth, F. F., Gompelmann, D., Stanzel, F., Bonnet, R., Behr, J., Schmidt, B., & ... Eberhardt, R. (2011). Treatment of advanced emphysema with emphysematous lung sealant (AeriSeal®). Respiration; International Review Of Thoracic Diseases, 82(1), 36-45. doi:10.1159/000322649 Kramer, M.R., Refaely, Y., Maimon, N., Rosengarten, D., & Fruchter, O. (2012). Bilateral endoscopic sealant lung volume reduction therapy for advanced emphysema. Chest, 142(5), 1111-1117. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/22722233 Pompeo, E. (2014). Lung volume reduction surgery for emphysema treatment: State-of-the-art and perspectives. ISRN Otolaryngology, 1-17. doi:10.1155/2014/418092 Tiong, L. U. (2008). Lung volume reduction surgery for diffuse emphysema. Cochrane Database Of Systematic Reviews, (1), doi:10.1002/14651858.CD001001.pub2