Ann Thorac Surg 2011;91:270-273. doi:10.1016/j.athoracsur.2010.07.093
© 2011 The Society of Thoracic Surgeons
New Technology
Endobronchial Valve Treatment for Prolonged Air Leaks of the Lung: A Case Series
Colin T. Gillespie, MDa,
Daniel H. Sterman, MDa,*,
Robert J. Cerfolio, MDb,
Daniel Nader, DOc,
Michael S. Mulligan, MDd,
Richard A. Mularski, MDe,
Ali I. Musani, MDf,
John C. Kucharczuk, MDg,
H. Xavier Gonzalez, MDh,
Steven C. Springmeyer, MDh
a Department of Medicine, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania
b Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Alabama
c Department of Medicine, Oklahoma State University Center, Oklahoma City, Oklahoma
d Department of Surgery, University of Washington, Seattle, Washington
e Kaiser Permanente Northwest, Portland, Oregon
f Department of Medicine, University of Colorado, Denver, Colorado
g Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania
h Spiration Inc, Redmond, Washington
Accepted for publication July 21, 2010.
* Address correspondence to Dr Sterman, University of Pennsylvania Medical Center, 833 West Gates Bldg, 3400 Spruce St, Philadelphia, PA 19104 (Email: daniel.sterman{at}uphs.upenn.edu).
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Abstract
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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.
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Introduction
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| Drs Gonzalez and Springmeyer disclose that they have financial relationships with Spiration Inc.
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Prolonged pulmonary air leaks are an important clinical problem associated with significant morbidity and mortality. The usual approaches to persistent air leaks include prolonged thoracostomy tube drainage, pleurodesis, and attempts at thorascopic or open surgical repair. Bronchoscopic techniques using various agents and devices have been attempted, but with only anecdotal benefit reported.
Endobronchial valves were initially developed as an investigational approach for emphysema [1–3]. Because the Spiration IBV Valve (Spiration Inc, Redmond WA) blocks distal airflow, it was hypothesized that the valve would be beneficial for treating pulmonary air leaks. Spiration applied in 2003 to the United States Food and Drug Administration (FDA) to treat certain postoperative air leaks under humanitarian use regulations. During the approval process, the FDA requested clinical experience, so these compassionate-use cases were initiated to support humanitarian device exemption approval [4].
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Technology
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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].
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Technique
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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 bronchoscopy was performed through an endotracheal tube, except once with a rigid bronchoscope.
The airway leading to the air leak was identified using intermittent balloon occlusion. A balloon catheter was advanced and inflated while observing for diminution of the air leak in the water seal chamber. Occlusion was generally initiated at the lobar level and then moved distally. If reduction or cessation of air leakage were identified, then a valve was placed before additional airways were evaluated. In one case, a second balloon catheter was used simultaneously to identify multiple sites for treatment.
Airway sizing was done with a calibrated balloon catheter (B5-2C; Olympus America, Center Valley, PA). Valve placement techniques have been previously described [2, 3].
Data were extracted from the clinical records. All patients proposed for treatment are described. Air leak improvement was defined as (1) improvement allowing Heimlich valve use, (2) improvement of 1 Cerfolio classification [4], or (3) complete cessation of the air leak. Data are presented descriptively.
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Clinical Experience
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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, underwent lung biopsy for pulmonary fibrosis. A balloon occlusion identified the airway at day 40, but this was absent 5 days later when valves were available.
The median age of the 7 patients (4 men, 3 women) who received valves was 58 years (range, 17 to 60 years). One patient (Fig 2) had two procedures because after valve treatment resolved the original air leak, another extensive operation was required that involved additional lung resection. This resulted in a second severe air leak, but additional valve placements were successful.
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Fig 2. A coronal computed tomography image of a patient (procedures 4 and 5), day 12 after undergoing the second procedure shows 5 of 6 bronchial valves in the left hilum. Also seen is the metal support for the spine and left lower lobe/left perihilar consolidation from radiation pneumonitis.
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A median of 3.5 valves (mode, 2.4; range, 2 to 10) were used during a single procedure. Three patients presented with spontaneous pneumothorax, and 4 occurred after an operation. The patients all had underlying diseases as listed in Table 1
with example images for one patient shown (Fig 3). These included emphysema, neoplasia (2 lung cancer, 1 spinal tumor involving lung), pulmonary embolism, radiation fibrosis, and rheumatoid arthritis complicated by aspergillus cavitary lung and pleural infection. In 4 patients, empyema complicated chest tube management. All patients except 1 had undergone previous procedures, including 6 surgical interventions and 4 pleural procedures (pleurodesis or pleurectomy).
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Fig 3. (A) Computed tomography image before patient procedure 2 showing pulmonary and subcutaneous emphysema, left pneumothorax, left lower lobe consolidation, and pleural fluid. (B) Day 5 after left-upper lobe bronchial valve treatment there is resolution of the pneumothorax and greatly improved subcutaneous emphysema.
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The duration of air leak before bronchial valve treatment was a median of 4 weeks (range, 2 weeks to 5 months; Table 1). The treatment locations were the upper lobe in 5 and the lower lobe in 3, with treatment extending to an ipsilateral lobe twice.
The bronchial valve treatment response is summarized in Table 2, with details provided in Table 1. The time to air leak improvement was a mean of 4.5 days (median, 1 day) after valve insertion. Complete air leak cessation occurred in 6 of 8 procedures after a mean of 5.2 days. In the patient in procedure 3, a reduced air leak returned after valve removal on day 15. In the patient in procedure 8, a leak managed with a Heimlich valve also did not completely resolve, and recovery was complicated with chest tube infection and malnutrition. After valve placement, the air leak reduced from occurring with expiration (Cerfolio E) to occurring only with cough (Cerfolio FE) [5] by day 27. The patient subsequently improved so that a pleural tent rather than a muscle flap was sufficient to resolve the air leak at 41 days after valve placement.
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Table 2 Summary of Days After Bronchial Valve Treatment to Air Leak Improvement, Discharge, or Chest Tube Removal
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The time to discharge after valve treatment of air leak was a median of 3 days (range, 1 to 31 days). Four patients (57%), were discharged within 2 to 3 days after valve placement. Chest tube removal was a median of 16 days after valve treatment (range, 10 to 36 days).
No complications attributed to the bronchial valves occurred, and there were no procedural complications during the valve placements. Likewise, valve removals were performed without complications and in one session. The bronchial valves were removed in 5 of the 7 patients at a mean of 37 days after valve placement (range, 14 to 55 days). Valves were not removed in a patient discharged for hospice care. The valves were not removed in the patient who underwent two procedures because they were placed in airways leading to lung parenchyma with extensive radiation fibrosis, and the patient and family declined valve removal. The patient has reported no adverse sequelae in 36 months of regular follow-up.
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Comment
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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 air leaks after lobectomy, segmentectomy or lung volume-reduction operations. The humanitarian device exemption program supports the development of medical devices intended to benefit patients in the treatment of diagnosis of diseases or conditions affecting fewer than 4000 people in the United States per year. FDA approval for humanitarian use of the IBV Valve for postoperative air leak was obtained [4], and the details of this approval have been reviewed [6].
Before bronchial valves, the Watanabe spigot (Novatech, Grasse, France) was produced commercially to reduce a persistent air leak by occluding the affected bronchus [7, 8]. Watanabe [7] and colleagues treated 60 patients, with 78% overall improvement, but reported device expectoration and Toma [9] reported a 9% rate of pneumonia.
Travaline and colleagues [10] reported 37 of 40 patients (93%) at multiple centers responded to bronchial valve treatment using several versions of an endobronchial valve (Emphasys Medical, Redwood City, CA). A mean of 2.9 ± 1.9 valves were used, adverse events occurred in 6 (15%), and they concluded that bronchial valves are an effective intervention for prolonged air leak.
A limitation of this and the previous case series is the lack of a control group. Without a control group, it is not conclusive that the air leak improvement is directly related to the valve placement. However, the temporal relationship is in contradistinction to the prolonged duration of significant air leak before the intervention and is highly suggestive of a therapeutic benefit of valve placement.
In summary, we report prolonged air leaks refractory to usual treatment measures in a series of patients with complex underlying pulmonary pathology. These patients were treated with the IBV Valve and all had subsequent improvement of the air leaks. Our experience adds evidence that endobronchial valves are an effective intervention for prolonged air leaks.
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Disclosure and Freedom of Investigation
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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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Footnotes
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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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References
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- Toma TP, Hopkinson NS, Hillier J, et al. Bronchoscopic volume reduction with valve implants in patients with severe emphysema Lancet 2003;361:931-933.[Medline]
- Wood DE, McKenna Jr. RJ, Yusen RD, et al. A multicenter trial of an intrabronchial valve for treatment of severe emphysema J Thorac Cardiovasc Surg 2007;133:65-73.[Abstract/Free Full Text]
- Sterman DH, Mehta AC, Wood DE, et al. A multicenter pilot study of a bronchial valve for the treatment of severe emphysema Respiration 2010;79:222-233.[Medline]
- U.S. Food and Drug Administration News and events. FDA approves lung valve to control some air leaks after surgery. Oct 24, 2008http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116970.htm Oct 24, 2008Accessed Dec 16, 2009.
- Cerfolio RJ. Advances in thoracostomy tube management Surg Clin N Am 2002;82:833-848.[Medline]
- Wood DE, Cerfolio RJ, Gonzalez X, Springmeyer SC. Bronchoscopic management of prolonged air leaks with bronchial valves Clin Chest Med 2010;31:127-133.[Medline]
- Watanabe Y, Matsuo K, Tamaoki A, et al. Bronchial occlusion with endobronchial Watanabe spigot J Bronchol 2003;10:264-267.
- Weinreb N, Riker D, Beamis J, et al. Ease of use of Watanabe spigot for alveolopleural fistulas J Bronchol Intervent Pulmonol 2009;16:130-132.
- Toma TP, Matsuo K, Tamaoki A, et al. Endoscopic bronchial occlusion with spigots in patients with emphysema Am J Respir Crit Care Med 2002;165:B9.
- Travaline JM, McKenna RJ, De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves Chest 2009;136:355-360.[Medline]
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Abstract
Introduction
