New technologyEndobronchial Valve Treatment for Prolonged Air Leaks of the Lung: A Case SeriesDisclaimer
Section snippets
Technology
The IBV Valve System comprises umbrella-shaped valves (Fig 1), an airway sizing kit, and a deployment catheter. The valve features have been previously described [2, 3].
Technique
Investigators participating in investigational trials of the IBV Valve for the treatment of emphysema selected the patients. All procedures had local Institutional Review Board approval, signed informed consent forms, and FDA approval. Patient preparation, anesthetic management, recovery, and procedure location varied and were directed by clinical circumstances at the site. One procedure was performed bedside with intravenous anesthesia and the others with general anesthesia. Flexible
Clinical Experience
From July 2007 through October 2008, 9 patients had 10 procedures. Valve treatment did not proceed in 2 of the 9 patients because target airways could not be identified with catheter balloon occlusions. One patient, a 47-year-old man, had bilateral bullectomy with severe air leaks. One leak resolved after a repeat operation but the other did not. A balloon occlusion identified a treatment site, but this was absent 2 days later when valves were available. The other patient, a 62-year-old man,
Comment
This consecutive case series describes 7 patients and eight procedures with severe, complex, and life-threatening air leaks persistent for a median of 4 weeks after the usual therapeutic measures had failed. With bronchial valve treatment, the air leaks were improved after a median of 1 day and resulted in hospital discharge within 3 days in 57% of patients.
This case series was initiated to support an application with the FDA for humanitarian use of the IBV Valve for the treatment of prolonged
Disclosure and Freedom of Investigation
Spiration provided product, and Drs Gonzalez and Springmeyer are employees and stockholders. The authors had full control of the design, methods, outcome parameters, analysis, and production of the written report.
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Cited by (85)
Hypoxemia and Endobronchial Valves
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2019, Annals of Thoracic SurgeryAir Leak Management Program With Digital Drainage Reduces Length of Stay After Lobectomy
2018, Annals of Thoracic SurgeryPersistent air leak - review
2018, Respiratory MedicineCitation Excerpt :After the valve is placed, the chest tube drainage chamber should be observed for 4–5 ventilatory cycles to assess any change in the degree of the air leak [50]. Prior studies have demonstrated that 1–10 valves (mean 2–3) are typically required to control each PAL [40,41,53]. These valves are well tolerated and can be removed easily with forceps.
- Disclaimer
The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.