Use of One-Way Intrabronchial Valves in Air Leak Management After Tube Thoracostomy Drainage

doi:10.1016/j.athoracsur.2015.10.113

The Annals of Thoracic Surgery

Volume 101, Issue 5, May 2016, Pages 1891-1896

https://doi.org/10.1016/j.athoracsur.2015.10.113 Get rights and content

Background

A persistent air leak represents significant clinical management problems, potentially affecting morbidity, mortality, and health care costs. In 2008, a unidirectional, intrabronchial valve received humanitarian device exemption for use in managing prolonged air leak after pulmonary resection. Since its introduction, numerous reports exist but no large series describe current utilization or outcomes. Our aim was to report current use of intrabronchial valves for air leaks and review outcome data associated with its utilization.

Methods

A multicenter, retrospective review of intrabronchial valve utilization from January 2013 to August 2014 was performed at eight centers. Data regarding demographics, valve utilization, and outcomes were analyzed.

Results

We identified 112 patients undergoing evaluation for intrabronchial valve placement, with 67% (75 of 112) undergoing valve implantation. Nearly three quarters of patients underwent valve placement for off-label usage (53 of 75). A total of 195 valves were placed in 75 patients (mean 2.6 per patient; range, 1 to 8) with median time to air leak resolution of 16 days (range, 2 to 156).

Conclusions

We present the largest, multicenter study of patients undergoing evaluation for intrabronchial valve use for air leak management. Our data suggest the majority of intrabronchial valve placements are occurring for off-label indications. Although the use of intrabronchial valves are a minimally invasive intervention for air leak management, the lack of rigorously designed studies demonstrating efficacy remains concerning. Prospective randomized controlled studies remain warranted.

Section snippets

Patients and Methods

Data were requested from 10 active clinical sites from January 2013 to August 2014 for patients undergoing IBV evaluation; eight sites agreed to participate. The Food and Drug Administration mandates manufacturer maintenance of a database of all IBV purchase orders (Doug Sheffield, Spiration, current IBV usage; personal communication, 2015) [14]. This database was initially queried and utilized for deidentified data collection under The Johns Hopkins Institutional Review Board (NA_00071445).

Results

In all, 117 patients were identified from January 2013 to August 2014. Four patients did not meet inclusion criteria as they did not posses an air leak (IBV placement for bullous disease), and 1 patient was excluded because of an incomplete medical record. The final population analyzed consisted of 112 patients, and demographics are displayed in Table 1. All patients were initially evaluated for IBV placement, but not all underwent placement. Figure 2 displays the pathway of evaluation and

Comment

We present the largest, multicenter study of patients undergoing evaluation for IBV use in the setting of air leak and an in situ chest tube as well as the largest report of both on-label and off-label use of IBV. Before this report, only two multicenter studies offered IBV data; however, they were limited by small series size [13] and use of IBV that are no longer available in the United States [16].

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The endobronchial silicone spigot, also known as the endobronchial Watanabe spigot, is used in bronchoscopic interventions to manage prolonged pulmonary air leakage. However, the outcomes of this procedure have not been thoroughly investigated.
Using a Japanese national inpatient database from April 2014 to March 2022, we assessed the clinical characteristics and outcomes of all eligible patients who received the endobronchial spigot. We also investigated risk factors associated with treatment failure. Treatment failure was defined as in-hospital death or the need for surgery after bronchial occlusion.
We analyzed data of 1095 patients who underwent bronchial occlusion using the endobronchial spigot. Among them, 252 patients (23.0%) died during hospitalization, and 403 patients (36.8%) experienced treatment failure. Factors associated with treatment failure included age between 85 and 94 years (odds ratio [OR] 1.83; 95% confidence intervals [CI], 1.04–3.21); male sex (OR 2.43; 95% CI, 1.44–4.11); low Barthel index score; comorbidities of interstitial pneumonia (OR 1.71; 95% CI, 1.18–2.48); antibiotics treatment (OR 1.45; 95% CI, 1.02–2.07); steroids treatment (OR 1.59; 95% CI, 1.07–2.36); and surgery prior to bronchial occlusion (OR 2.08; 95% CI, 1.29–3.35). In contrast, pleurodesis after bronchial occlusion (OR 0.49; 95% CI, 0.32–0.75), and admission to high-volume hospitals were inversely associated with treatment failure (OR 0.58; 95% CI, 0.37–0.90).
The endobronchial Watanabe spigot could be a nonsurgical treatment option for patients with prolonged pulmonary air leaks. Our findings will help identify patients who may benefit from such bronchial interventions.
Pressure-dependent persistent air leak in a patient with secondary spontaneous pneumothorax
2022, American Journal of the Medical Sciences
Citation Excerpt :
Due to the inherent mechanism of action, EBVs are an excellent option for the management of PAL. However, the success of the procedure depends on the isolation of the correct airway and the absence of any significant collateral ventilation.17 Air leak after lung resection is common.
An air leak lasting more than 5–7 days (persistent air leak, PAL) can complicate up to 40% of patients with secondary spontaneous pneumothorax. Chronic obstructive pulmonary disease is the most common cause of secondary spontaneous pneumothorax, and early surgical intervention has been recommended for patients with PAL. Bullectomy or blebectomy with concomitant mechanical pleurodesis by medical thoracoscopy or video assisted thoracoscopic surgery is considered definitive therapy. Unfortunately, the perioperative course following lung resection can also be complicated by air leaks leading to worse clinical outcomes. Post lung resection air leak can be pressure independent or pressure dependent (also known as drainage-related air leak). The distinction between these two entities is crucial as the management varies drastically. Pleural manometry may play an important role in the early diagnosis of pressure-dependent PAL preventing further unnecessary surgical procedures from being performed.
[Translated article] Combined Endoscopic Treatment for the Closure of a Large Bronchopleural Fistula
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Endobronchial valve placement in secondary pneumothorax related to allergic bronchopulmonary aspergillosis
2021, Respiratory Medicine Case Reports
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The efficacy of EBVs in infectious or inflammatory PAL is uncertain. EBVs were approved for use in post-operative PAL through a Humanitarian Device Exemption (HDE) from the Food and Drug Administration after case report data demonstrated a reduction in hospital length of stay (LOS) and associated complications [3,4,11,12]. Notably, the HDE is intended for temporary valve use (roughly 6 weeks) in conditions where the visceral pleura will in fact heal.
Secondary pneumothorax is a rare but serious complication of allergic bronchopulmonary aspergillosis (ABPA) and bronchiectasis [1,2]. Persistent air leak (PAL) after secondary pneumothorax is an ongoing abnormal communication between bronchi or alveoli and the pleural space, despite drainage. Ongoing PAL for 5 days after initial chest tube insertion necessitates prolonged ambulatory drainage or aggressive management with video-assisted thoracoscopic surgery (VATS) or pleurodesis [3,4]. There are no randomized trials examining the efficacy of endobronchial valves (EBVs) for PAL with underlying inflammatory pulmonary disease. We describe the successful use of an EBV for PAL in a man with ABPA on high dose steroids, with a large bronchopleural fistula (BPF).
Assessment of Fissure Integrity in Patients With Intrabronchial Valves for Treatment of Prolonged Air Leak
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Only 33 of those 59 patients (55%) had complete resolution of the air leak within 1 day of valve implantation—more than 33% of patients required more than 7 days to achieve air leak resolution. Fifteen out of 75 patients (20%) required additional procedures to manage air leaks after IBV placement [9]. Complications were reported in 2 patients, and 10 patients were eventually discharged home with continued chest tube drainage.
Intrabronchial valves (IBVs) are a treatment alternative for persistent air leak (PAL). However, there is a paucity of evidence regarding whether the absence of collateral ventilation (CV) can predict successful treatment of PAL with IBV placement. We assessed whether absence of CV measured by fissure integrity could predict successful resolution of PAL with IBV placement.
A multicenter, retrospective study was performed. Patients who underwent IBV placement for PAL were identified. Chest computed tomography analysis via VIDA Diagnostics was used to assess CV. CV was present if the treated lobe was adjacent to a fissure that was <90% complete.
A total of 81 valves were placed in 26 patients (median, 3 per patient). A total of 16 patients without CV underwent IBV placement: 14 patients had complete resolution of PAL with a median time from IBV placement to air leak resolution of 4.5 days and 2 patients required subsequent procedures to manage the PAL. In a subset of patients without CV who underwent complete lobar occlusion with IBV (n = 8), median time to PAL resolution was 3 days, whereas in patients without CV who underwent incomplete lobar occlusion with IBV (n = 6), median time PAL resolution was 6.5 days (p = 0.045). All 10 patients with CV underwent IBV placement and complete lobar occlusion: 4 patients had complete PAL resolution with a median time from IBV placement to PAL resolution of 17.5 days and 6 patients required subsequent procedures to manage their PAL.
PAL treatment with IBV is more successful in patients without CV, especially when complete lobar occlusion with IBV is achieved.
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Original articleGeneral thoracicUse of One-Way Intrabronchial Valves in Air Leak Management After Tube Thoracostomy Drainage

Background

Methods

Results

Conclusions

Section snippets

Patients and Methods

Results

Comment

Ann Thorac Surg

Ann Thorac Surg

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Chest

Ann Thorac Surg

Thorac Surg Clin

Thorac Surg Clin

Chest

Ann Thorac Surg

J Thorac Cardiovasc Surg

Chest

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Ann Thorac Surg

J Heart Lung Transplant

Chest

J Pediatr Surg

Original article
General thoracic
Use of One-Way Intrabronchial Valves in Air Leak Management After Tube Thoracostomy Drainage