PURPOSE: Medical devices are generally permanent implants but not all patients will be responsive to device treatment, and some patients may have complications requiring implant removal. It is desirable that a new airway device be removable. We review here details about removal of bronchial valves.
METHODS: The IBV® Valve (Spiration, Inc. Redmond, WA) was designed with a removal feature. This feature is like the handle of an umbrella that can be grasped with biopsy forceps during flexible bronchoscopy. The IBV® Valve was used in a multi-center study with 91 patients between January 2004 and August 2006. The patients were selected for severe airflow obstruction, hyperinflation, and UL predominant emphysema. Patients were treated with bronchial valves in the upper lobes and followed for a year. Information provided about valve removals during and after the study was collected.
RESULTS: 609 valves treated 482 (75%) segments and 157 (25%) subsegments. Treatment in the desired location had a 99.7% success rate. Follow-up procedures by protocol resulted in removal of 54 valves, replacement with 24 valves, and placement of 24 additional valves. Complete removal occurred in 4 patients in the first 3 months (25 valves) because of lack of benefit (2), bronchospasm (1), respiratory distress (1). Valves were removed electively after study completion or withdrawal in 11 subjects and 79 of 80 valves. Overall valve removal success was 97% of attempts and the longest duration of implant with removal was 15 months. There were 4 episodes of pneumonia in an area of valves. Removals associated with pneumonia occurred at day 96, 105, 264, and 358 with 10 valves removed and a 100% success rate.
CONCLUSION: Bronchial valves designed for removal can be successfully removed with a high success rate giving patients and clinicians the alternative to reverse the treatment in the event of a complication or lack of benefit.
CLINICAL IMPLICATIONS: Devices in the respiratory tract may be safer if removal is incorporated into the design.
DISCLOSURE: Douglas Wood, Grant monies (from industry related sources) Spiration, Inc.; Consultant fee, speaker bureau, advisory committee, etc. Spiration, Inc. - scientific consultant; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Intrabronchial valve (IBV)