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Ann Thorac Surg 2006;81:1867-1871
© 2006 The Society of Thoracic Surgeons

New technology

A Novel Approach: Treatment of Bronchial Stump Fistula With a Plugged, Bullet-Shaped, Angled Stent

Xinwei Han, MD, PhD a , * , Gang Wu, MD a , Yongdong Li, MD, PhD b , Minghua Li, MD, PhD b

a Department of Radiology, The First Affiliated Hospital, Zheng Zhou, China
b Department of Radiology, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University, Shanghai, China

Accepted for publication December 2, 2005.

* Address correspondence to Dr Han, No. 1, East Jian She Rd, Zheng Zhou, Henan Province, Zheng zhou, 450052 China (Email: hanxinwei{at}tom.com).


   Abstract
Top
 Abstract
Introduction
 Technology
 Technique
 Clinical Experience
 Comment
 Disclosures and Freedom of...
 Footnotes
 Acknowledgments
 References
 
PURPOSE: The purpose of this study was to evaluate the initial clinical efficacy of a plugged, bullet-shaped, angled stent for managing bronchial stump fistula.

DESCRIPTION: The stent consisted of two parts. The body part had a diameter of 18 ~ 25 mm and was 30 mm long in a tubular configuration covered with polyethylene at the lower part. The bronchial limb was a bullet-shaped configuration with a dead end, 11 ~ 14 mm in diameter, 10 ~ 30 mm long covered with polyethylene. The body part and the bronchial limb were connected at the angled portion without overlap with use of nitinol wire and polyethylene. The stents were placed in 6 patients under fluoroscopic guidance.

EVALUATION: Stent placement was technically successful in all patients without complications. Immediate closure of the bronchial stump fistula was achieved in all patients after stent placement. Follow-up of 4 ~ 16 months, permanent closure of the bronchial pleural fistula was achieved in 4 patients (66.67%), and permanent closure of the bronchial stump fistula was achieved in 5 patients (83.33%). No complications occurred.

CONCLUSIONS: Closure of the bronchial stump fistula with the stent was a simple, safe, and effective procedure.


   Introduction
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 Introduction
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Bronchial pleural fistula (BPF) is defined as a communication between a lobar or segmental pulmonary bronchus and the pleural space after pneumonectomy or lobectomy with the incidence reported in the literature varying from 0.3 to 20% [1], and it is one of the most severe and life-threatening complications frequently encountered after surgery for lung cancer, with perioperative mortality remaining as high as 15% [2]. Although the BPF has decreased in recent years, this complication remains a major challenge. Recently, treatment of BPFs with stents including the expandable metallic stent [3] and nonmetallic stent [4–6] have been reported in the literature. The stents they used were the most commonly used silicone Dumon (model BD 400; Novatech, Plan de Grasse, France) and expandable metallic stent, and not the stent especially designed for the treatment of BPFs. Since April 2003, we designed a bullet-shaped, angled stent (Han's closure stent [Micro-Tech, Nanjing, China]) specialized for managing bronchial stump fistula after pneumonectomy or lobectomy. The purpose of this study was to evaluate the initial clinical efficacy of a bullet-shaped, angled stent for the treatment of bronchial stump fistula.


   Technology
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 Technology
Technique
 Clinical Experience
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Patients
Between April 2003 and March 2005, 6 patients (5 men and 1 women; age range, 40 to 66 years; mean age, 53.3 years) with bronchial stump fistula after pneumonectomy or lobectomy were referred to our radiology department from four surgical units; their hospital charts were retrospectively reviewed and none of the patients were considered candidates for surgical treatment at the time of stent placement. The preliminary operative procedures included five pneumonectomies and one lobectomy resulting from lung cancer in 5 patients (ie, squamous carcinoma in all) and tuberculosis in another. The symptoms included fever, ranging from 38.0°C to 39.1°C, cough, purulent sputum, and dyspnea, in combination with a rise of white blood cell count and C-reactive protein. The interval between pneumonectomy or lobectomy and fistula occurrence ranged from 30 to 306 days.

If BPF was suspected, immediate pleural drainage was performed through a thoracic puncture under ultrasound or computed tomographic guidance. Diagnosis was established by reviewing the patient's history and findings at computed tomography and bronchoscopy. The diameter of normal trachea and bronchus, the length of the residual bronchial stump, and the fistula site and size were measured by multislice computed tomography (three-dimensional reconstructions) and bronchoscopy. Locations of the fistulas were (1) left main bronchial stump (3 patients), (2) right lower lobar bronchial stump (1 patient), and (3) right main bronchial stump (2 patients). The clinical features and the fistula site and diameter are summarized in Table 1.


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  		Table 1. Summary of Clinical Features in Patient with Bronchial Pleural Fistula
 
Stent Construction
The plugged, bullet-shaped, angled stent was woven from a single thread of 0.16-mm in diameter, highly elastic nitinol wire, which consisted of two parts (ie, the body part and the bronchial limbs). The body part (tracheal stent) had a diameter of 18 ~ 25 mm when fully expanded and was 30 mm long in a tubular shape. To prevent migration of the stent, the upper one half of the tracheal stent remained uncovered. The bronchial limbs (bronchial stent) was bullet-shaped in configuration with a dead end, 11 ~ 14 mm in diameter and 10 ~ 30 mm long. To prevent tissue hyperplasia extensively through the stent wires, the lower one half of the tracheal stent and the bronchial stent were covered with polyethylene. The angled stent was placed in the bifurcation area, a tracheal stent was placed in the lower trachea, and a bronchial stent was placed in the bronchus. To make an angled stent, the ends of a tracheal stent and a bronchial stent were connected at the angled portion without overlap with use of nitinol wire and polyethylene. Three radiopaque markers were attached at the ends of the tracheal stent, the bronchial stent, and the angled portion to facilitate precise placement of the stent (Fig 1). The stent was constructed by a manufacturer (Micro-Tech, Nanjing, China) according to our specifications.


Figure 1
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  		Fig 1. Plugged, bullet-shaped angled stent.

 
The indications of the stent were applied for the patients with main bronchial stump fistula, intermediate bronchial fistula, and right middle and lower lobar bronchial fistula after pneumonectomy or lobectomy. We selected stents with a smaller diameter for the patients with intermediate bronchial fistulas, lower lobar bronchial fistulas, and right middle lobar bronchial fistulas.


   Technique
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 Technology
 Technique
Clinical Experience
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Stent Placement
Informed consent was obtained from each patient before the procedure, and this pilot study was approved by our institutional review board from September 2001. Prior to the operation, all patients were pre-medicated with aggressive antibiotics intravenously for at least 3 days to facilitate their postoperative recovery.

The patient was placed in the right anterior oblique or supine position with the neck extended. After topical anesthesia (lidocaine, 2%), a 0.035-inch guidewire (Radiofocus M; Terumo, Tokyo, Japan) with a 5-French catheter (Torcon NB; Cook, Bloomington, IN) was advanced perorally until the tip reached the fistula and into the empyema or the distal portion of the bronchus under fluoroscopic guidance, and then indicated the orifice of the fistula with 3 ~ 5 mL of 30% diluted nonionic contrast medium (Ultravist 300 [Schering, Guang Zhou, China]) (Fig 2A). After exchanging the guidewire with a 0.035-inch super stiff J-tip guidewire (Boston Scientific/Medi-Tech, Watertown, MA), a 16-French delivery system (Micro-Tech Co, Nanjing, East China) was passed over the guidewire into the bronchus and advanced until the distal tip of the sheath reached 1 cm beyond the fistula, and the stent was then deployed by pulling back the introducer sheath. Correct placement of the stent and satisfactory fistula occlusion was confirmed by contrast-enhanced fluoroscopy with injection of a water-soluble contrast (Ultravist [Schering]) after deploying the stent (Fig 2B).


Figure 2
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  		Fig 2. Bronchial pleural fistula in a 56-year-old man with fever and cough who had undergone left pneumonectomy for adenocarcinoma of the lung. (A) Contrast medium obtained 105 days after surgery injected through the catheter showed the contrast medium entered into the empyema through the left main bronchial stump fistula. (B) Contrast medium injected through the catheter immediately demonstrated that the fistula was sealed off with no contrast media leakage after placement of a bullet-shaped angled stent.

 
After the fistula was completely sealed off, we would ask a surgeon to amplify the chest tube, pleural hygiene, and antibiotic management, and provide indications when chest tubes could be removed. The patient continued to be treated with appropriate antibiotics according to culture sensitivity to control infection. Chest tube drainage was continued until the air or purulent fluid drainage disappeared or the empyema was closed. A follow-up chest roentgenogram was obtained at 3 and 7 days after stent placement to verify the state of pulmonary expansion, position of the stent, and changes of the empyema. A contrast study including helical computed tomography and bronchoscopy were performed to evaluate the efficacy at sealing off the fistula, and patency or migration of the stent 2 weeks after the procedure and then at 1 or 2 months after the procedure until the BPF was healed. Specimens for bacteriologic cultures were obtained twice a week from the chest tube drainage. After three negative cultures, empyema was considered eradicated. The chest tube was then removed if no signs of persistent fistula were detectable by air bubbles or incomplete radiologic lung expansion.


   Clinical Experience
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 Abstract
 Introduction
 Technology
 Technique
 Clinical Experience
Comment
 Disclosures and Freedom of...
 Footnotes
 Acknowledgments
 References
 
Stent Placement
Stent placement was technically successful and was well tolerated in all patients, with no direct procedure-related complications. Initially all patients required placement of only one stent in the tracheobronchial tree and had complete stent expansion. The contrast medium injected through the catheter into the bronchial stent immediately demonstrated the bronchial stump fistula was closed thoroughly after deploying the stent. Immediate closure of the BPF was also achieved in all patients. Symptoms improved immediately in all patents after successful stent placement. Five patients felt dull chest pain for 1 to 5 days after stent placement.

Follow-Up
Follow-up for 30 days and clinical improvements were obtained in all patients except one (ie, the tuberculosis patient, case 4). Helical computed tomography and bronchoscopy showed the stents remained in place and had sealed off the fistula tightly with consequent improvement in respiratory and nutritional status.

Follow-up of 4 ~ 16 months showed that permanent closure of the BPFs (including fistula and empyema) were achieved in 4 of 6 patients (66.67%; cases 1, 2, 3, and 5), permanent closure of the orifice of the bronchial stump fistula were achieved in 5 patients (83.33%; cases 1, 2, 3, 5, and 6), and no clinical complications had occurred. In 1 patient (case 6) with a right main bronchial fistula, follow-up with multislice computed tomography, contrast medium, and bronchoscopy at 2 and 4 months after the procedure confirmed the fistula had completely closed, but obliteration of the empyema had failed. Closure of the BPF (including fistula and empyema) failed in 1 patient (case 4). The midterm outcome is summarized in Table 2.


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  		Table 2. Mid-Term Treatment and Outcome
 

   Comment
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With recent advancements in technology, placement of tracheobronchial stents are gaining popularity with interventional radiologists and chest physicians because they are effective in extraluminal and intraluminal lesions and offer prompt relief from acute airway distress caused by obstructions or fistulas.

We believe there are two main types of airway stents currently available: (1) tube stents made of silicone and (2) expandable metallic stents. The most commonly used nonmetallic stent is the silicone Dumon stent, which is inserted using a rigid bronchoscope under general anesthesia. Tayama and colleagues [4], Pospisil and colleagues [5], and Watanabe and colleagues [6] reported that they had successfully managed a patient with a BPF after lobectomy or pneumonectomy using a Dumon stent. However, one of the most frequent complications of a silicone stent is their tendency to shift in the airway and migrate from its initial position; this occurs in 10% to 19% of cases [7], and repeated rigid bronchoscopy and stent repositioning have been reported to be more frequently necessary for Dumon stents than for expandable metallic stents [8].

However, stent migration is also a particular problem associated with metal stents, occurring more often with covered types (ie, Gianturco-Z stent, 47 of 419 [11%], William Cook Europe A/S, Bjaeverskov, Denmark; and covered wallstent, 21 of 60 [13%]) than with uncovered types of metal stents [Schneider Worldwide, Bülach, Switzerland] (ie, Ultraflex stent [Boston Scientific Meditech, Inc, Natick, MA], 4 of 400 [1%] and wallstent, 4 of 118 [3%]) [9]. Recently, Shin and colleagues [10] reported the use of a covered, retrievable, expandable tracheobronchial nitinol stent for the treatment of tracheobronchial strictures, but stent migration occurs in 17% (6 of 35 patients) of these cases. The reason for stent migration is probably due to insufficient anchoring of the cover of the metal to the esophageal or tracheal wall.

To overcome the shortcomings and prevent stent migration, we designed the plugged, bullet-shaped, angled stent. The tracheal stent prevents stent migration, and the bronchial stent occludes the fistula. The stent has the following advantages: (1) the body part (tracheal stent) plays an important role of fixing the bronchial stent to prevent bronchial stent migration and lessen complication occurrence, such as occlusion of a main bronchus, because they are connected together; (2) the uncovered upper tracheal stent enhances friction against the tracheal wall, which not only prevents stent migration but also facilitates the stent relocation; and (3) fracture of the stent is unlikely because the stent was woven from a single thread of nitinol wire.

This study had limitations. First, this study was a retrospective case analysis and the amount of the patient was small. Second, the covered stent may impede mucociliary clearance, thereby fostering sputum retention. Finally, the study lacked an animal mode experiment ahead of the clinical research, and determining how the novel stent performs effectively remains to be seen.

In conclusion, although further clinical trials and expanded follow-up studies are needed, our preliminary results indicate that a bullet-shaped, angled stent for the treatment of the bronchial stump fistula was simple, safe, atraumatic, and effective. We believe that the procedure is more quickly and accurately placed through bronchoscopic and fluoroscopic viewing. In a sense, this procedure may benefit patients with intractable and refractory bronchial stump fistulas after surgical repair.


   Disclosures and Freedom of Investigation
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 Abstract
 Introduction
 Technology
 Technique
 Clinical Experience
 Comment
 Disclosures and Freedom of...
Footnotes
 Acknowledgments
 References
 
The authors have performed a free and independent evaluation of this new technology and have no financial relationship with Micro-Tech, Nanjing, China. The tested technology was donated to Micro-Tech, and the stents were provided without charge by Micro-Tech. In addition, the new method of treatment is our original contribution, and we had full control of the design of the study, the methods used, the outcome measurement analysis of data, and the production of the written report.


   Acknowledgments
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References
 
We would like to acknowledge Yinghui Ge from the radiology department at the People's Hospital, Henan Province, for providing the patient data, and Xiuxian Xu from the thoracic surgery department at The First Affiliated Hospital, Zheng Zhou University, Henan Province, for supporting the project.


   Footnotes
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 Technology
 Technique
 Clinical Experience
 Comment
 Disclosures and Freedom of...
 Footnotes
Acknowledgments
 References
 
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.


   References
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 Abstract
 Introduction
 Technology
 Technique
 Clinical Experience
 Comment
 Disclosures and Freedom of...
 Footnotes
 Acknowledgments
 References
 

  1. Cerfolio RJ. The incidence, etiology, and prevention of postresectional bronchopleural fistula Semin Thorac Cardiovasc Surg 2001;13:3-7.[Medline]
  2. Turk AE, Karanas YL, Cannon W, Chang J. Staged closure of complicated bronchopleural fistulas Ann Plast Surg 2000;45:560-564.[Medline]
  3. Madden BP, Sheth A, Ho TB, McAnulty GR, Sayer RE. A novel approach to the management of persistent postpneumonectomy bronchopleural fistula Ann Thorac Surg 2005;79:2128-2130.[Abstract/Free Full Text]
  4. Tayama K, Eriguchi N, Futamata Y, et al. Modified Dumon stent for the treatment of a bronchopleural fistula after pneumonectomy Ann Thorac Surg 2003;75:290-292.[Abstract/Free Full Text]
  5. Pospisil R, Smutny S, Marel M. Occlusion of a post-pneumonectomy bronchopleural fistula using the Dumon stent Rozhl Chir 2001;80:339-342.[Medline]
  6. Watanabe S, Shimokawa S, Yotsumoto G, Sakasegawa K. The use of a Dumon stent for the treatment of a bronchopleural fistula Ann Thorac Surg 2001;72:276-278.[Abstract/Free Full Text]
  7. LM Seijo, J Ancochea. In search of the ideal tracheobronchial stentmetal or silicone?. Arch Bronconeumol 2004;40:293-294.[Medline]
  8. Wan IY, Lee TW, Lam HC, Abdullah V, Yim AP. Tracheobronchial stenting for tuberculosis airway stenosis Chest 2002;122:370-374.[Medline]
  9. Siersema PD, Hop WC, van Blankenstein M, Dees J. A new design metal stent (Flamingo stent) for palliation of malignant dysphagiaa prospective study. Gastrointest Endosc 2000;51:139-145.[Medline]
  10. Shin JH, Kim SW, Shim TS, et al. Malignant tracheobronchial stricturespalliation with covered retrievable expandable nitinol stent. J Vasc Interv Radiol 2003;14:1525-1534.[Medline]



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