Treatment of Heterogeneous Emphysema Using the Spiration IBV Valves
Section snippets
Study Population
This case series includes all patients where the intent was bilateral treatment of UL-predominant emphysema. Details on inclusion and exclusion criteria have been published,3 and these remained consistent throughout the study. In summary, patients who had severe airflow obstruction, hyperinflation, and severe UL predominant emphysema were selected. The National Emphysema Treatment Trial (NETT) method for determination for UL predominance was used.1
Patients were on maximal medical management
Results
Ninety-eight subjects were enrolled for bilateral treatment at 13 clinical centers from January 2004 to August 2006. There were 57% males, and the mean age was 65 plus or minus 8 years. Average procedure time for the initial procedure was 58 minutes (range 15 to 187). Valves were placed in segmental airways 74% of the time and 26% in subsegmental airways. Six hundred fifty-nine valves were placed, and all desired airways were treated with the exception of two instances where the catheter could
Discussion
This series of pilot studies with the umbrella-shaped IBV valve showed acceptable safety and risk factors for complications, along with significant effectiveness in over half of the subjects, and a novel mechanism of action. This is the only published experience with bronchial valves where multicenter studies were done prospectively with a common protocol. An equal sized series using the Emphasys valve is a summary of data from selected sites using variable selection criteria and different
Note
The IBV Valve System has been approved by the Food and Drug Administration as a humanitarian device for use in the control of prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy and LVRS. The effectiveness for this use has not been demonstrated. Please see the Instructions for Use available at http://www.fda.gov/cdrh/ode/H060002sum.html, or contact Spiration Inc. for further information. The IBV Valve System
IBV vavle pilot trials research teams
Cedars Medical Center, Los Angeles: Robert McKenna, MD (principal investigator); Zab Mohsenifar, MD (coprincipal investigator); Carol Geaga, RN (principal clinic coordinator); Cleveland Clinic Foundation (CCF), Cleveland, Ohio: Atul Mehta, MD (principal investigator); Thomas Gildea, MD (coprincipal investigator); Yvonne Meli, RN (principal clinic coordinator); Michael Machuzak, MD; Sudish Murthy, MD; Columbia University Medical Center New York: Roger Maxfield, MD (principal investigator); Mark
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Doctors Springmeyer and Gonzalez are employees of Spiration Incorporated. Doctors Wood and Bolliger received support for research and consulting fees. Dr. Waddell received support for research.