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Effects of a Novel Implantable Elastomer Device for Lung Volume Reduction Surgery in a Rabbit Model of Elastase-Induced Emphysema^*

^* From the Pulmonary and Critical Care Medicine Division (Dr. Brenner), Departments of Surgery (Drs. Jones and Milliken), University of California Irvine Medical Center, Orange, CA; Cedars Sinai Medical Center (Dr. McKenna); Los Angeles, CA; Spiration Inc., (Dr. Gonzalez), Redmond, WA; and the Beckman Laser Institute and Medical Clinic (Mr. Ha and Dr. Osann), Irvine, CA.

Correspondence to: Matthew Brenner, MD, FCCP, Pulmonary and Critical Care Division, University of California Irvine Medical Center, 101 City Dr South, Orange, CA 92868-3298

Objectives: There is intense interest in lung volume reduction surgery (LVRS) for treatment of severe symptomatic emphysema. LVRS results in objective and subjective improvement in lung function in selected patients. However, LVRS is complicated by substantial morbidity, including prolonged pulmonary air leak associated with resection of emphysematous lung tissue. In this study, we investigated the use of a novel implanted silicone elastomer device that reduces lung volume without surgical resection, in a previously reported emphysematous animal model. The purpose of this investigation was to determine the applicability, physiologic effects, complications, and air-leak results of this lung volume reducer (LVR) approach. Design: Controlled, randomized, prospective animal study. Emphysema was induced in 20 New Zealand white rabbits with three nebulizations of 10,000 U of porcine elastase. After 6 weeks, the animals were randomized to control sham surgery (n = 10) vs implanted silicone elastomer LVR (n = 10) treatment groups. Lung function, including helium-dilution lung volumes, static respiratory system compliance curves, and diffusion capacity of the lung for carbon monoxide (DLCO), was measured at baseline, following emphysema induction (week 6), and when the animals were killed (1 week after LVR or sham surgery). Histologic evaluation was performed in all lung specimens after fixation. Results: Moderate emphysema developed after elastase nebulization, assessed by lung function and postmortem histology. Functional residual capacity (FRC) and an upward shift of lung compliance curves was observed with development of emphysema at 6 weeks (p < 0.05). Following LVR, FRC decreased (p = 0.005) and compliance curves shifted back downward (p = 0.002), without reduction in DLCO. There was no change in control sham animals. DLCO did not change in either group. Conclusions: In this short-term, randomized, controlled animal model study, the implantable LVR approach produced safe and effective lung volume reduction without tissue resection in the treated animals. The implant procedure produced minimal morbidity, no mortality, and no observed air-leak complications in the treated animals. Limitations include the short-term follow-up and moderate degree of emphysema in this animal model. Further research is required to assess long-term effects and complications of this method for lung volume reduction.

Key Words: air leak • lung volume reducer • lung volume reduction surgery • silicon

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