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Endobronchial Valve Treatment for Prolonged Air Leaks of the Lung: A Case SeriesDisclaimer

https://doi.org/10.1016/j.athoracsur.2010.07.093Get rights and content

Purpose

An endobronchial valve developed for treatment of severe emphysema has characteristics favorable for bronchoscopic treatment of air leaks. We present the results of a consecutive case series treating complex alveolopleural fistula with valves.

Description

Patients with air leaks that persisted after treatment gave consent and compassionate use approval was obtained. Bronchoscopy with balloon occlusion was used to identify the airways to be treated. IBV Valves (Spiration, Redmond, WA) were placed after airway measurement.

Evaluation

During a 15-month period, 8 valve placement procedures were performed in 7 patients and all had improvement in the air leak. The median duration of air leakage was 4 weeks before and 1 day after treatment, with a mean of 4.5 days. Discharge within 2 to 3 days of the procedure occurred in 57% of the patients. A median of 3.5 valves (mode, 2.4) were used, and all valve removals were successful. There were no procedural or valve-related complications.

Conclusions

Removable endobronchial valves appear to be a safe and effective intervention for prolonged air leaks.

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.

References (10)

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    Citation 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.

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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.

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