Bilateral Endoscopic Sealant Lung Volume Reduction Therapy for Advanced Emphysema

doi:10.1378/chest.12-0421

Chest

Volume 142, Issue 5, November 2012, Pages 1111-1117

https://doi.org/10.1378/chest.12-0421 Get rights and content

Background

A clinical study was performed to assess the safety and efficacy of bilateral AeriSeal Emphysematous Lung Sealant System (ELS) treatment in patients with advanced emphysema out to 1 year.

Methods

Twenty patients received treatment at four subsegments, two in each upper lobe. Ten had upper lobe disease, and 10 had homogeneous disease. Treatments were administered under moderate sedation. Efficacy was assessed at 3, 6, and 12 months.

Results

Procedure times were short (15.2 ± 9.6 min), and hospital length of stay averaged 1.1 days. The study was successful in reaching its primary end point of a reduction at 3 months in upper lobe lung volume assessed by quantitative CT scan analysis (−895 ± 484 mL, P < .001). Treatment was associated with improvements in spirometry (ΔFEV₁ at 6 months = 31.2% ± 36.6%, 12 months = 25.0% ± 33.4%), gas trapping (Δresidual volume/total lung capacity at 6 months = −7.2% ± 12.7%, 12 months = −10.9% ± 14.0%), diffusing capacity of lung for carbon monoxide (6 months = 12.7% ± 16.4%, 12 months = 12.3% ± 21.1%), symptom scores (ΔMedical Research Council dyspnea score at 6 months = median 0, range −2 to 1, 12 months = median −1, range −3 to 0), and health-related quality of life (ΔSt. George Respiratory Questionnaire at 6 months = −8.0 ± 17.2 U, 12 months = −7.0 ± 15.8 U). There was one serious procedural complication and seven all-cause significant respiratory adverse events over 17 patient-years of follow-up.

Conclusions

Bilateral ELS treatment administered under conscious sedation in patients with advanced emphysema is associated with short procedure time and length of hospital stay and produces physiologic and functional improvement out to 1 year.

Trial registration

ClinicalTrials.gov; No.: NCT01181466; URL: www.clinicaltrials.gov

Section snippets

Study Design

This was a single arm, prospective study performed at two academic-affiliated medical centers in Israel. All participants were nonsmokers (≥ 4 months) and had severe airflow obstruction, evidence of hyperinflation, clinical symptoms despite optimal medical management, and no prohibitive comorbid conditions. All participants signed an informed consent approved by the ethics committees at the participating institutions (Rabin Medical Center IRB protocol # 5975; Soroka Medical Center IRB protocol

Patient Characteristics

The majority of patients were older men (64 ± 8 years, 17 men) with significant smoking histories (34.2 ± 9.2 pack-years) and BMI values in the low-normal range (23.0 ± 4.1 kg/m²). All patients were receiving medical treatment in accordance with GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.¹¹ Baseline physiology confirmed severe airflow obstruction (FEV₁ = 1.04 ± 0.39 L, 32.7% ± 8.7% predicted; FVC = 2.89 ± 0.85 L, 69.0% ± 14.6% predicted), hyperinflation (RV = 5.12

Discussion

Results of this study indicate that bilateral ELS treatment performed at two subsegments in each upper lobe produces durable lung volume reduction in patients with advanced heterogeneous ULP and homogeneous emphysema that is associated with physiologic and functional benefit. Although the study is small and open label, improvements from baseline in objective, relatively effort-independent end points, including lobar volume reduction assessed by quantitative CT analysis, FEV₁, Dlco, and RV/TLC

Acknowledgments

Author contributions: Dr Kramer is the guarantor of the manuscript and is responsible for the integrity and accuracy of the data.

Dr Kramer: contributed to data collection and analysis and manuscript preparation and review.

Dr Refealy: contributed to data collection and analysis and manuscript review.

Dr Maimon: contributed to data collection and analysis and manuscript review.

Dr Rosengarten: contributed to data collection and revision of the manuscript.

Dr Fruchter: contributed to data collection

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Funding/Support: This study was supported by Aeris Therapeutics, Woburn, MA.

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Chest

Original ResearchCOPDBilateral Endoscopic Sealant Lung Volume Reduction Therapy for Advanced Emphysema

Background

Methods

Results

Conclusions

Trial registration

Section snippets

Study Design

Patient Characteristics

Discussion

Acknowledgments

J Thorac Cardiovasc Surg

Lancet

Improvement in spirometry following lung volume reduction surgery: application of a physiologic model

Am J Respir Crit Care Med

Lung elastic recoil in acute and chronic asthma

Curr Opin Pulm Med

National Emphysema Treatment Trial: the major outcomes of lung volume reduction surgery in severe emphysema

Proc Am Thorac Soc

A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema

N Engl J Med

Original Research
COPD
Bilateral Endoscopic Sealant Lung Volume Reduction Therapy for Advanced Emphysema