- Email: [email protected]
Endobronchial Valve Treatment for Prolonged Air Leaks of the Lung: A Case Series
NEW TECHNOLOGY
Endobronchial Valve Treatment for Prolonged Air Leaks of the Lung: A Case Series Colin T. Gillespie, MD, Daniel H. Sterman, MD, Robert J. Cerfolio, MD, Daniel Nader, DO, Michael S. Mulligan, MD, Richard A. Mularski, MD, Ali I. Musani, MD, John C. Kucharczuk, MD, H. Xavier Gonzalez, MD, and Steven C. Springmeyer, MD Department of Medicine, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania; Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Alabama; Department of Medicine, Oklahoma State University Center, Oklahoma City, Oklahoma; Department of Surgery, University of Washington, Seattle, Washington; Kaiser Permanente Northwest, Portland, Oregon; Department of Medicine, University of Colorado, Denver, Colorado; Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania; and Spiration Inc, Redmond, Washington
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. NEW TECHNOLOGY
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 valverelated complications. Conclusions. Removable endobronchial valves appear to be a safe and effective intervention for prolonged air leaks. (Ann Thorac Surg 2011;91:270 –3) © 2011 by The Society of Thoracic Surgeons
P
rolonged 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].
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 manage-
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; e-mail: [email protected].
© 2011 by The Society of Thoracic Surgeons Published by Elsevier Inc
Drs Gonzalez and Springmeyer disclose that they have financial relationships with Spiration Inc. 0003-4975/$36.00 doi:10.1016/j.athoracsur.2010.07.093
Fig 1. The Spiration IBV Valve. Reproduced with permission from Spiration.
ment, 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.
NEW TECHNOLOGY GILLESPIE ET AL BRONCHIAL VALVE TREATMENT OF AIR LEAKS
271
went 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. 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). 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
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-yearold 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, under-
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.
NEW TECHNOLOGY
Ann Thorac Surg 2011;91:270 –3
272
NEW TECHNOLOGY GILLESPIE ET AL BRONCHIAL VALVE TREATMENT OF AIR LEAKS
Ann Thorac Surg 2011;91:270 –3
Table 1. Summary of Demographics, Procedures, and Outcomes
Procedure
Underlying Lung Disease
Prior Interventions
1
Emphysema
2
Lung Ca, DVT/PE, emphysema
VATS wedge resection and pleurectomy Radiographic CT placement
3
RA, DVT/PE, fungus, emphysema
4
Leak Duration Before Valves
Lobe(s) Treated
Valves used (No.)
NEW TECHNOLOGY
5 wks
LUL in lingula segments
2
Several wks
LLL
4
VATS for drainage and pleurodesis
5 mos
RUL
4
Spinal tumor, radiation, fibrosis
Operation with muscle flap
⬃2 wksa
LLL
2
5
Spinal tumor, radiation, fibrosis
Re-op with revised muscle flap
18 days
LLL and post seg of LUL
4
6
Lung Ca, empyema
Operation, pleurodesis ⫻2
6 wks
RUL
3
7
Emphysema, prior PTX
Operation, pleurodesis
23 days
LUL and sup seg LLL
8
Emphysema, LVRS
CT management alone
66 days
LUL
10
2
Time to Improvement or Event (days) Air leak, 1 Discharge, 2 CT removal, 10 Air leak, 3 Discharge, 14 CT removal, 16 Air leak, 0 Discharge, 31 CT removal, NK Air leak, 1 Discharge, 3 CT removal, 14 Air leak, 1 Discharge, 3 CT removal, 36 Air leak, 2 Discharge, 8 CT out, 15 Air leak, 1 Discharge, 2 CT removal, 30 Air leak, 27 Discharge, 1 Operation, 41
a Patient had intermittent bronchodural and bronchocutaneous air leaks before the listed operation. The estimate of 2 weeks is the air leak duration after the listed operation.
Ca ⫽ cancer; CT ⫽ chest tube; DVT/PE ⫽ deep vein thrombosis/pulmonary embolus; LLL ⫽ left lower lobe; LUL ⫽ left upper lobe; LVRS ⫽ lung volume reduction surgery; post seg ⫽ posterior segment; PTX ⫽ pneumothorax; RA ⫽ rheumatoid arthritis; RUL ⫽ right upper lobe; sup seg ⫽ superior segment; VATS ⫽ video-assisted thoracic surgery
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. 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.
Comment This consecutive case series describes 7 patients and eight procedures with severe, complex, and lifethreatening 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
Ann Thorac Surg 2011;91:270 –3
273
Table 2. Summary of Days After Bronchial Valve Treatment to Air Leak Improvement, Discharge, or Chest Tube Removal Outcome Days to air leak improvement Days after valve treatment to discharge Days after valve treatment to chest tube removal a
Mean
Median
Range
4.5
1
0–27
8.0
3
1–31
19.4
16
10–36a
Two cases not included. Procedures 3 and 8 in Table 1.
subsequent improvement of the air leaks. Our experience adds evidence that endobronchial valves are an effective intervention for prolonged air leaks.
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 1. Toma TP, Hopkinson NS, Hillier J, et al. Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Lancet 2003;361:931–3. 2. Wood DE, McKenna RJ Jr., Yusen RD, et al. A multicenter trial of an intrabronchial valve for treatment of severe emphysema. J Thorac Cardiovasc Surg 2007;133:65–73. 3. Sterman DH, Mehta AC, Wood DE, et al. A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. Respiration 2010;79:222–33. 4. U.S. Food and Drug Administration. News and events. FDA approves lung valve to control some air leaks after surgery. Oct 24, 2008. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2008/ucm116970.htm. Accessed Dec 16, 2009. 5. Cerfolio RJ. Advances in thoracostomy tube management. Surg Clin N Am 2002;82:833– 48. 6. Wood DE, Cerfolio RJ, Gonzalez X, Springmeyer SC. Bronchoscopic management of prolonged air leaks with bronchial valves. Clin Chest Med 2010;31:127–33. 7. Watanabe Y, Matsuo K, Tamaoki A, et al. Bronchial occlusion with endobronchial Watanabe spigot. J Bronchol 2003; 10:264 –7. 8. Weinreb N, Riker D, Beamis J, et al. Ease of use of Watanabe spigot for alveolopleural fistulas. J Bronchol Intervent Pulmonol 2009;16:130 –2. 9. 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. 10. Travaline JM, McKenna RJ, De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves. Chest 2009;136:355– 60.
Disclaimer 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.
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.
NEW TECHNOLOGY
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
NEW TECHNOLOGY GILLESPIE ET AL BRONCHIAL VALVE TREATMENT OF AIR LEAKS
Endobronchial Valve Treatment for Prolonged Air Leaks of the Lung: A Case Series Colin T. Gillespie, MD, Daniel H. Sterman, MD, Robert J. Cerfolio, MD, Daniel Nader, DO, Michael S. Mulligan, MD, Richard A. Mularski, MD, Ali I. Musani, MD, John C. Kucharczuk, MD, H. Xavier Gonzalez, MD, and Steven C. Springmeyer, MD Department of Medicine, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania; Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Alabama; Department of Medicine, Oklahoma State University Center, Oklahoma City, Oklahoma; Department of Surgery, University of Washington, Seattle, Washington; Kaiser Permanente Northwest, Portland, Oregon; Department of Medicine, University of Colorado, Denver, Colorado; Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania; and Spiration Inc, Redmond, Washington
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. NEW TECHNOLOGY
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 valverelated complications. Conclusions. Removable endobronchial valves appear to be a safe and effective intervention for prolonged air leaks. (Ann Thorac Surg 2011;91:270 –3) © 2011 by The Society of Thoracic Surgeons
P
rolonged 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].
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 manage-
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; e-mail: [email protected].
© 2011 by The Society of Thoracic Surgeons Published by Elsevier Inc
Drs Gonzalez and Springmeyer disclose that they have financial relationships with Spiration Inc. 0003-4975/$36.00 doi:10.1016/j.athoracsur.2010.07.093
Fig 1. The Spiration IBV Valve. Reproduced with permission from Spiration.
ment, 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.
NEW TECHNOLOGY GILLESPIE ET AL BRONCHIAL VALVE TREATMENT OF AIR LEAKS
271
went 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. 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). 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
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-yearold 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, under-
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.
NEW TECHNOLOGY
Ann Thorac Surg 2011;91:270 –3
272
NEW TECHNOLOGY GILLESPIE ET AL BRONCHIAL VALVE TREATMENT OF AIR LEAKS
Ann Thorac Surg 2011;91:270 –3
Table 1. Summary of Demographics, Procedures, and Outcomes
Procedure
Underlying Lung Disease
Prior Interventions
1
Emphysema
2
Lung Ca, DVT/PE, emphysema
VATS wedge resection and pleurectomy Radiographic CT placement
3
RA, DVT/PE, fungus, emphysema
4
Leak Duration Before Valves
Lobe(s) Treated
Valves used (No.)
NEW TECHNOLOGY
5 wks
LUL in lingula segments
2
Several wks
LLL
4
VATS for drainage and pleurodesis
5 mos
RUL
4
Spinal tumor, radiation, fibrosis
Operation with muscle flap
⬃2 wksa
LLL
2
5
Spinal tumor, radiation, fibrosis
Re-op with revised muscle flap
18 days
LLL and post seg of LUL
4
6
Lung Ca, empyema
Operation, pleurodesis ⫻2
6 wks
RUL
3
7
Emphysema, prior PTX
Operation, pleurodesis
23 days
LUL and sup seg LLL
8
Emphysema, LVRS
CT management alone
66 days
LUL
10
2
Time to Improvement or Event (days) Air leak, 1 Discharge, 2 CT removal, 10 Air leak, 3 Discharge, 14 CT removal, 16 Air leak, 0 Discharge, 31 CT removal, NK Air leak, 1 Discharge, 3 CT removal, 14 Air leak, 1 Discharge, 3 CT removal, 36 Air leak, 2 Discharge, 8 CT out, 15 Air leak, 1 Discharge, 2 CT removal, 30 Air leak, 27 Discharge, 1 Operation, 41
a Patient had intermittent bronchodural and bronchocutaneous air leaks before the listed operation. The estimate of 2 weeks is the air leak duration after the listed operation.
Ca ⫽ cancer; CT ⫽ chest tube; DVT/PE ⫽ deep vein thrombosis/pulmonary embolus; LLL ⫽ left lower lobe; LUL ⫽ left upper lobe; LVRS ⫽ lung volume reduction surgery; post seg ⫽ posterior segment; PTX ⫽ pneumothorax; RA ⫽ rheumatoid arthritis; RUL ⫽ right upper lobe; sup seg ⫽ superior segment; VATS ⫽ video-assisted thoracic surgery
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. 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.
Comment This consecutive case series describes 7 patients and eight procedures with severe, complex, and lifethreatening 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
Ann Thorac Surg 2011;91:270 –3
273
Table 2. Summary of Days After Bronchial Valve Treatment to Air Leak Improvement, Discharge, or Chest Tube Removal Outcome Days to air leak improvement Days after valve treatment to discharge Days after valve treatment to chest tube removal a
Mean
Median
Range
4.5
1
0–27
8.0
3
1–31
19.4
16
10–36a
Two cases not included. Procedures 3 and 8 in Table 1.
subsequent improvement of the air leaks. Our experience adds evidence that endobronchial valves are an effective intervention for prolonged air leaks.
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 1. Toma TP, Hopkinson NS, Hillier J, et al. Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Lancet 2003;361:931–3. 2. Wood DE, McKenna RJ Jr., Yusen RD, et al. A multicenter trial of an intrabronchial valve for treatment of severe emphysema. J Thorac Cardiovasc Surg 2007;133:65–73. 3. Sterman DH, Mehta AC, Wood DE, et al. A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. Respiration 2010;79:222–33. 4. U.S. Food and Drug Administration. News and events. FDA approves lung valve to control some air leaks after surgery. Oct 24, 2008. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2008/ucm116970.htm. Accessed Dec 16, 2009. 5. Cerfolio RJ. Advances in thoracostomy tube management. Surg Clin N Am 2002;82:833– 48. 6. Wood DE, Cerfolio RJ, Gonzalez X, Springmeyer SC. Bronchoscopic management of prolonged air leaks with bronchial valves. Clin Chest Med 2010;31:127–33. 7. Watanabe Y, Matsuo K, Tamaoki A, et al. Bronchial occlusion with endobronchial Watanabe spigot. J Bronchol 2003; 10:264 –7. 8. Weinreb N, Riker D, Beamis J, et al. Ease of use of Watanabe spigot for alveolopleural fistulas. J Bronchol Intervent Pulmonol 2009;16:130 –2. 9. 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. 10. Travaline JM, McKenna RJ, De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves. Chest 2009;136:355– 60.
Disclaimer 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.
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.
NEW TECHNOLOGY
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
NEW TECHNOLOGY GILLESPIE ET AL BRONCHIAL VALVE TREATMENT OF AIR LEAKS