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Title: Endobronchial Valves Show Promise for Treatment of Emphysema: Presented at ERS

"Endobronchial Valves Show Promise for Treatment of Emphysema: Presented at ERS"

By David Owen STOCKHOLM, SWEDEN -- September 20, 2007 -- A small one-way valve inserted deep into the lungs may offer new hope to patients with emphysema, according to preliminary results from the Endobronchial Valve for Emphysema Palliation Trial (VENT), reported here at the Annual Congress of the European Respiratory Society (ERS). Professor Felix Herth, MD, Chief, Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany, said that the new technique could offer emphysema patients an alternative to surgical treatments such as lung-volume reduction surgery. The valve is about the size of a pencil eraser and is described by Dr. Herth as being "like a bicycle valve". It sits in a stent-like framework that keeps it anchored in the airway. The valve can be inserted via a bronchoscope, and similarly removed if it is not working, Dr. Herth explained. The valve allows air and mucus to escape from lobes of the lung that have become hyperinflated, thus relieving dyspnoea. The VENT study is the first prospective, randomised, multi-centre trial to study endobronchial valves. VENT enrolled 321 participants across the United States and Europe (220 patients were randomised to endobronchial valve treatment and 101 controls received standard optimal medical management). The study's primary efficacy endpoints were improvement in lung function and exercise tolerance. Professor Charles Marquette, MD, Centre Hospitalier Universitaire de Nice, Nice, France said that the study met both its primary endpoints. "Change in forced expiratory volume 1 and change in 6-minute walk test [measured at 6 months] were both significantly improved in treated [patients] compared to control patients," ([P <.025) he said.

Three secondary efficacy endpoints (change in maximum workload, St George's Respiratory Questionnaire [SGRQ] and Modified Medical Research Council Dyspnoea Scale), all measured at 6 months, were also significantly improved. "The procedure appears generally well tolerated with no increased risk of mortality," Dr. Marquette added.

Dr. Herth said that the valves cost around 2000 Euros each, and a typical patient might require three or four valves to be inserted. "A major advantage is the reversibility of this technique," he noted. "Two days after the valve has been removed, the patient is returned to…baseline condition." Based on current data, Dr. Herth said that 80% of the emphysema patients in whom valves were inserted appeared to benefit from the technique. Professor Marquette was more conservative, and said that his experience indicated that 50% of valve recipients benefited.

In another presentation here at ERS, US researchers also presented results on an intra-bronchial valve. Daniel Sterman, MD, Assistant Professor, Department of Medicine, University of Pennsylvania, and colleagues reported that the intra-bronchial valve they studied significantly improved SGRQ in emphysema patients, with 65% of valve recipients responding. Further trials are in progress.

[Presentation title: International Multicenter Trial of Bronchial Valve Treatment for Severe Emphysema. Abstract 4221]

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