Treatment of Advanced Emphysema with Emphysematous Lung Sealant (AeriSeal®)

Abstract

Background: This report summarizes initial tests of an emphysematous lung synthetic polymer sealant (ELS) designed to reduce lung volume in patients with advanced emphysema. Objectives: The primary study objective was to define a therapeutic strategy to optimize treatment safety and effectiveness. Methods: ELS therapy was administered bronchoscopically to 25 patients with heterogeneous emphysema in an open-label, noncontrolled study at 6 centers in Germany. Treatment was performed initially at 2–4 subsegments. After 12 weeks, patients were eligible for repeat therapy to a total of 6 sites. Safety and efficacy were assessed after 6 months. Responses were evaluated in terms of changes from baseline in lung physiology, functional capacity, and health-related quality of life. Follow-up is available for 21 of 25 patients. Results: Treatment was well tolerated. There were no treatment-related deaths (i.e. within 90 days of treatment), and an acceptable short- and long-term safety profile. Physiological and clinical benefits were observed at 24 weeks. Efficacy responses were better among Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III patients [n = 14; change in residual volume/total lung capacity (ΔRV/TLC) = –7.4 ± 10.3%; Δ forced expiratory volume in 1 s (ΔFEV₁) = +15.9 ± 22.6%; change in forced vital capacity (ΔFVC) = +24.1 ± 22.7%; change in carbon monoxide lung diffusion capacity (ΔDLCO) = +19.3 ± 34.8%; change in 6-min walk test (Δ6MWD) = +28.7 ± 59.6 m; change in Medical Research Council Dyspnea (ΔMRCD) score = –1.0 ± 1.04 units; change in St. George’s Respiratory Questionnaire (ΔSGRQ) score = –9.9 ± 15.3 units] than for GOLD stage IV patients (n = 7; ΔRV/TLC = –0.5 ± 6.4%; ΔFEV₁ = +2.3 ± 12.3%; ΔFVC = +2.6 ± 21.1%; ΔDLCO = –2.8 ± 17.2%; Δ6MWD = +28.3 ± 58.4 m; ΔMRCD = 0.3 ± 0.81 units; ΔSGRQ = –6.7 ± 7.0 units). Conclusions: ELS therapy shows promise for treating patients with advanced heterogeneous emphysema. Additional studies to assess responses in a larger cohort with a longer follow-up are warranted.

Status of and prospects for bronchoscopic lung volume reduction for patients with severe emphysema

“…Previous studies indicated that BioLVR achieved a reduction in lung volume. Six months after BioLVR, patients had significant improvement in their FEV 1 and scores on the SGRQ, and patients with advanced heterogeneous emphysema generally tolerated the procedure (74). Another study indicated that BioLVR improved lung function and quality of life for patients with homogeneous emphysema (75).…”

Lung emphysema treated successfully using volume reduction with lung sealant (AeriSeal®)

“…20 ml of liquid foam sealant was injected over 10-20 s. Wedge position was maintained for 1 min following delivery to allow complete in situ polymerization. The scope was then repositioned at the next treatment site, and the procedure repeated until all treatments were completed [1]. The bronchoscopic images (Figure 3 a,b) showed that AeriSeal foam Sealant fills the targeted diseased alveolar region right and left upper lobe segment 1, where it is intended to induce atelectasis and to block collateral air flow.…”

Lung Volume Reduction in Pulmonary Emphysema from the Radiologist’s Perspective

“…While these so-called Sealants have yielded overall good therapeutic results comparable to those of EBV, severe pneumonia and death were observed more frequently with this therapy. In addition, the majority of patients exhibited peri-interventional flu-like symptoms [32], and the time between the onset of effect and measureable therapeutic success took longer than EBV, requiring 6 -12 weeks [33]. In the meantime, the active substance AeriSeal (Aeris Therapeutics Inc., USA) is no longer commercially available.…”