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DOI: 10.1148/radiol.2401042169
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(Radiology 2006;240:273-282.)
© RSNA, 2006

Vascular and Interventional Radiology

Outcomes of Tracheobronchial Stent Placement for Benign Disease1

Raymond H. Thornton, MD, Roy L. Gordon, MD, Robert K. Kerlan, MD, Jeanne M. LaBerge, MD, Mark W. Wilson, MD, Kristen A. Wolanske, MD, Michael B. Gotway, MD, Geoffrey S. Hastings, MD and Jeffrey A. Golden, MD

1 From the Department of Radiology (R.H.T., R.L.G., R.K.K., J.M.L., M.W.W., K.A.W.) and Department of Medicine, Pulmonology and Critical Care Medicine (J.A.G.), University of California, San Francisco, San Francisco, Calif; and Department of Radiology, San Francisco General Hospital, San Francisco, Calif (M.B.G., G.S.H.). Received December 22, 2004; revision requested February 16, 2005; revision received June 17; accepted June 27; final version accepted September 22. Address correspondence to R.H.T., Department of Interventional Radiology and Image-Guided Therapies, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, H201, New York, NY 10021 (e-mail: thorntonraymond{at}yahoo.com).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
Purpose: To retrospectively determine long-term outcomes in patients who have undergone tracheobronchial stent placement for benign diseases.

Materials and Methods: Institutional Review Board approval was obtained for this retrospective HIPAA-compliant study, with waiver of informed consent. Forty patients (22 female, 18 male; mean age, 52.0 years) who were treated with metallic airway stents for benign stenosis were identified from an interventional radiology database. Causes of airway stenosis included transplant stricture (n = 13), tracheal tube injury (n = 10), inflammation (n = 6), tracheobronchomalacia (n = 4), infection (n = 3), and extrinsic compression (n = 4). Follow-up, which ranged from 6 to 2473 days, was performed by means of chart review for deceased patients and by means of clinical visit or telephone interview for surviving patients. Survival, primary patency, and assisted patency were estimated by using the Kaplan-Meier product limits method.

Results: Initial technical success was achieved in all cases. Symptomatic improvement was present in 39 of 40 cases. At review, 15 patients were alive and had clinical improvement, 18 had died of comorbid causes, one had died of uncertain causes, three had undergone subsequent airway surgery, two had undergone airway stent retrieval, and one was lost to follow-up. Survival at 1, 2, 3, 4, 5, and 6 years was 79%, 76%, 51%, 47%, 38%, and 23%, respectively. Loss of primary patency was most rapid during the 1st year. With repeat intervention, assisted patency was 90% at 6.8 years.

Conclusion: Attrition of tracheobronchial stent patency is most rapid during the 1st year, and a high rate of long-term patency can be achieved with secondary interventions. Metallic airway stents are well-tolerated and useful adjuncts for management of select benign tracheobronchial stenoses.

© RSNA, 2006


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
Tracheobronchial stenosis that causes flow-limiting compromise of major airways may be the result of a heterogeneous group of disorders that includes neoplasm, inflammatory disease, extrinsic compression, tracheomalacia, trauma, and strictures that can occur after intubation or surgery. Narrowing of the airway lumen may produce respiratory symptoms ranging from shortness of breath to asphyxiation. Placement of metallic stents within narrowed airways has been shown to restore airway caliber and to relieve or diminish respiratory symptoms (1).

This procedure has most often been applied to malignant stenoses that are not amenable to surgical or bronchoscopic repair (2). In multiple series and reports, researchers have reviewed experience with tracheobronchial stent placement for palliation in patients with inoperable malignant airway stenosis (3,4). With the exception of reports on patients treated for anastomotic strictures after lung transplantation (5), there are few reviews that include information on long-term follow-up in patients who are treated with metallic stents for benign indications.

Placement of a metallic stent in the airway of a patient whose life expectancy is not limited by malignant airway disease raises questions regarding the long-term patency, tolerance, and clinical success of this therapy. This procedure has been performed at our institution for the past 10 years for a variety of nonmalignant indications, and approximately 6 years of follow-up data are now available. Thus, the purpose of our study was to retrospectively determine long-term outcomes in patients who have undergone tracheobronchial stent placement for benign diseases.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 References
 
Patients
A computer search of our interventional radiology database from 1992 to 2003 revealed that 40 patients had undergone placement of metallic stents for nonneoplastic causes of tracheobronchial stenosis. The medical records for these patients were reviewed by one author (R.H.T.) for data that were related to clinical presentation, preprocedural imaging, stent placement, secondary procedures, and clinical and imaging follow-up. This retrospective study was conducted with the permission of the Internal Review Board of the University of California, San Francisco, with waiver of informed consent, and was compliant with the Health Insurance Portability and Accountability Act.

The mean age of the study group was 52.0 years (range, 10 weeks to 89 years). Twenty-two patients were female (mean age, 56.0 years; range, 22–89 years) and 18 were male (mean age, 47.3 years; range, 10 weeks to 67 years).

The cause of airway stenosis was transplant stricture in 13 patients, endotracheal tube or tracheostomy tube injury in 10 patients, inflammation in six patients, tracheobronchomalacia in four patients, infection in three patients, and extrinsic compression in four patients. Inflammatory causes included three cases of relapsing polychondritis, one case of Wegener granulomatosis, and two cases idiopathic inflammatory processes. Of the four cases of tracheobronchomalacia, two were idiopathic. One case of tracheobronchomalacia resulted from the placement of a standard vascular clip across the trachea during fetal endoscopic surgery in order to promote lung development in a fetus with congenital diaphragmatic hernia. The other case of tracheobronchomalacia was related to the repair of a congenital tracheoesophageal fistula. Tuberculosis was the infectious cause in three patients. Causes of extrinsic airway compression were gastric pull-up (6), thoracic aortic aneurysm, substernal goiter, and massive right atrial enlargement.

Presenting symptoms were dyspnea in 35 patients, desaturation and bradycardia ("dying spells") in two patients, failed extubation in two patients, and multiple pneumonias in one patient (Table 1).


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  		Table 1. Patient Characteristics

 
Stent Placement
Preprocedural imaging evaluation of the airway anatomy was accomplished with computed tomography (CT) and bronchoscopy. To evaluate airway caliber throughout the respiratory cycle, inspiratory and expiratory chest CT and free-breathing bronchoscopy in the nonintubated patient were routinely performed. Coronal reformatted CT scans were reviewed and used for the sizing and selection of the airway stent.

Informed consent for airway stent placement was obtained from each patient or from a parent or guardian. At our institution, tracheobronchial stent placement is performed by a multidisciplinary team that includes an anesthesiologist, a pulmonologist (J.A.G.), and either one or two interventional radiologists (R.L.G., R.K.K., J.M.L., M.W.W., G.S.H., R.H.T.). In the interventional radiology suite, the patient receives an anesthetic that is administered by using a laryngeal mask airway or an endotracheal tube. Bronchoscopy is then performed to confirm and localize the stenotic airway. The stenosis is subsequently localized with fluoroscopy, and the stent is delivered over a guidewire by using fluoroscopic guidance. Both the fluoroscopic and bronchoscopic results are immediately reviewed, permitting revision if necessary (Fig 1).


Figure 1
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  		Figure 1: Patient 11. Fluoroscopic image of Wallstent in right upper lobe. Stent is delivered over a guidewire through the endotracheal tube and is released to bridge the stenosis. Tracheal and right and left bronchial stents are also in place to treat airway collapse due to relapsing polychondritis.

 
A total of 54 lesions were treated in 40 patients (Table 1). Twenty-nine lesions were located in the main bronchi (left main bronchus, 19 lesions; right main bronchus, 10 lesions). Twenty-two lesions occurred in the trachea, two occurred in the bronchus intermedius, and one occurred in the right upper lobe bronchus. Although our current stent of choice for use in the trachea and bronchi is the Wallstent (Boston Scientific, Natick, Mass), the study included patients previously treated with a variety of other stents, including Gianturco (Cook, Bloomington, Ind), Palmaz (Cordis, Miami, Fla), Nitinol Symphony (Boston Scientific), and Luminexx (Bard, Covington, Ga) stents. Bare stents were routinely used except in one patient (patient 32) in whom bronchoscopic findings suggested a focus of airway necrosis in the segment that was to undergo stent placement, which prompted the use of a covered stent.

A total of 93 procedures (range, 1–18 procedures per patient) were performed. Of these, 46 procedures were primary stent placements (Table 2). Forty-seven secondary procedures were subsequently performed for optimization of airway stent patency in 15 patients. Of these, 21 were stent replacement procedures, eight were balloon dilations of preexisting stents, 13 were laser procedures performed during direct laryngoscopy, three were surgical resections, one was trimming of several unwoven stent wires, and one was radiation therapy in the stent-containing lesion. Twenty-five patients, including one pediatric patient (patient 27) whose patent stent was removed after the patient had outgrown it, required no additional intervention to maintain patency after initial stent placement.


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  		Table 2. Initial Procedure

 
Follow-up Data
The results of clinical follow-up (range, 6–2473 days) were available for all patients. Evidence of symptomatic improvement, as clinically assessed by the referring physician and noted in the medical record, was recorded. Of the 15 surviving patients, seven were evaluated during a visit to the clinic between November 2002 and March 2003 and eight had documented telephone follow-up with the referring pulmonologist (J.A.G.) in March 2003.

Primary patency was defined as the time from initial stent implantation to death from comorbid causes, removal of a patent stent, or identification of stent restenosis. Treated patients who remained asymptomatic during the follow-up period were considered to have patent airway stents. While asymptomatic clinical follow-up is considered an unsatisfactory determinant of patency for a vascular stent, we speculate that it is a reasonable indicator for patency of major airway stents. Occlusion of a vascular stent may elude clinical detection due to collateral circulatory pathways, but occlusion of a major airway stent would be expected to yield clinical signs and symptoms.

Primary patency was considered lost at the time of documented stent restenosis, migration, explantation, or expectoration. One patient was treated under special conditions in the operating room. When the tracheal stent migrated inferiorly several days later, retrieval and replacement were performed under routine conditions in the interventional radiology suite. For this patient, patency was calculated from the date of stent deployment in the interventional radiology suite.

Assisted patency was defined as the total length of time from stent implantation to stent explantation or death in those patients who required procedures to maintain or optimize patency.

Data Analysis
The duration of patency was calculated in days by using a duration between two dates function (www.timeanddate.com/date/duration.html). Survival and patency were analyzed by using the Kaplan-Meier method.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 References
 
Initial technical success was achieved in all cases (Table 3). As noted, 15 patients with airway stents were alive at follow-up and had no recurrent symptoms. Nineteen patients died. Eighteen of these deaths were attributable to comorbid conditions (cardiovascular conditions in eight patients, allograft rejection in six patients, sepsis in two patients, lung carcinoma in one patient, and trauma in one patient), and one death was unexplained. Five patients underwent explantation of airway stents (three during subsequent definitive airway surgery, one during a subsequent interventional radiology procedure, and one during surgery performed specifically for stent retrieval). One patient was lost to follow-up after 637 days.


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  		Table 3. Follow-up Results

 
Symptomatic improvement was noted in 39 of 40 cases. One patient did not improve. Patient 40, who was critically ill and had respiratory failure, heart failure, and severe mitral valve disease, underwent stent implantation in the left main bronchus to relieve compression caused by massive left atrial enlargement. After stent deployment, generalized collapse of the distal airways was noted at bronchoscopy. Despite stent placement, the patient could not be extubated and expired after care was changed to comfort measures. There was no evidence that the stent contributed to the patient's death.

Postprocedural laryngeal edema requiring intubation occurred in one patient (patient 25). This patient was successfully extubated 5 days later; respiratory symptoms abated, and no further airway interventions were required to maintain stent patency.

One patient (patient 12) died of uncertain causes that were possibly related to the airway stent. Mass effect on the left main bronchus by a thoracic aortic aneurysm caused failed extubation after emergency repair of an abdominal aortic aneurysm. At the time of abdominal aortic aneurysm repair, the patient was not surgically fit for repair of the thoracic aorta. After the left main bronchus was opened with a stent, the patient was successfully extubated and discharged from hospital. Two hundred and thirty days later, the patient died after sudden massive hemoptysis. No autopsy was performed to ascertain the relationship between the bronchial stent and the presumed thoracic aortic aneurysm rupture.

Short-term Reinterventions
Two patients required reintervention within 30 days of the primary procedure.

Early revision at 7 days was necessary in patient 8. The initial stent procedure, which was performed for stenosis related to tracheostomy, was special in that it was performed in the operating room with a mobile C-arm fluoroscope and direct laryngoscopic guidance. Suboptimal stent position became apparent several days later. The patient was brought to the interventional radiology suite for successful stent retrieval and replacement under routine conditions. The stent has subsequently remained patent without reintervention for more than 5 years.

Another patient (patient 11) who was treated with tracheal and bilateral main bronchial stents for tracheobronchomalacia related to relapsing polychondritis had coughing and minor hemoptysis after the procedure. This patient expectorated the right main bronchus stent 4 days after stent placement. The patient was treated with a larger caliber Wallstent in the right main bronchus and, because the left main bronchus stent appeared to be loose at the time of the second procedure, it too was removed and a larger stent was implanted. Six days later, a routine chest radiograph obtained in this asymptomatic patient revealed migration of the left main bronchus stent into the trachea. The stent was retrieved and the left main bronchus was successfully treated with a larger Wallstent. The stents have remained patent without need for further intervention for more than 18 months.

Delayed Reinterventions
Patients who needed reintervention 30 days after the initial procedure included four who had mechanical stent failure and 11 who had restenosis of the stent-containing airway.

Mechanical stent failures.—Mechanical stent failure occurred with use of a Gianturco stent in the trachea (patient 37) and Palmaz stents in the main bronchi (patients 16, 30, and 31) (7). Patients 30, 31, and 37 underwent successful retrieval of the deformed stents, which was followed by stent replacement. These stents remained patent without further need for reintervention. Patient 16 underwent successful retrieval of the deformed stent, but airway dilation from the initial procedure appeared durable, and therefore no stent was replaced.

Restenosis.—The group of patients who required reintervention to assist patency included four patients who acquired airway stenosis due to prior endotracheal tube or tracheostomy tube placement, five who had inflammatory stenosis, and two who had anastomotic strictures after transplantation. In patients who were treated with stent replacement, the new stent was deployed coaxially, without retrieval of the preexisting stent.

Stent Explantation
Patients who underwent stent explantation included one patient in whom retrieval of a crushed Palmaz stent was not followed by stent replacement because the dilation that was associated with the initial stent placement proved durable. One patient who had a focal tracheal stenosis that was related to intubation and who had been previously treated with five laser submucosal scar resections required balloon dilation of the tracheal stent 1 month after stent placement. A month later, this patient chose to have partial tracheal resection. Another patient with tuberculosis underwent stent resection and patch repair of the right main bronchus after multiple reinterventions for granulomatous stenosis. After multiple reinterventions, one patient finally underwent left pneumonectomy for postobstructive pneumonia with severe ventilation-perfusion mismatch. Finally, one stent was explanted from a pediatric patient who had outgrown the stent.

There was no uniform imaging-based follow-up for this group of patients. Thirty of the 40 patients underwent follow-up chest CT (range, 1–9 scans). Recurrent airway narrowing was identified at CT in 10 of 11 patients who required reintervention to optimize stent patency. In one patient, granulation was identified inside the stent during the course of surveillance laryngoscopy, without the use of CT. All restenoses were bronchoscopically confirmed.

At 1 year, primary patency had decreased to approximately 60% (Fig 2), but the loss of patency slowed thereafter so that 46% of the stent-containing airways retained primary patency at 6.8 years.


Figure 2
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  		Figure 2: Kaplan-Meier product limits estimate of airway stent patency. Attrition of primary patency was most rapid during the 1st year, but assisted patency was greater than 90% during the study period. At 1, 2, 3, 4, 5, and 6 years, primary patency was 0.61, 0.56, 0.56, 0.46, 0.46, and 0.46, respectively, and the number of stent-containing lesions that were at risk was 28, 24, 15, 7, 4, and 3, respectively.

 
Assisted patency was 90% at 6.8 years. Stent patency was lost in three patients. One patient (patient 16) who had Wegener granulomatosis involving the airway (discussed previously in the section on mechanical failures) underwent retrieval of a Palmaz stent after it had deformed. Patient 17, who had tuberculous stenosis of the right main bronchus, underwent multiple reinterventions, the final intervention being sleeve resection of a stent-containing airway that was almost completely occluded at surgery. Patient 19 underwent left main bronchial stent placement for narrowing due to idiopathic inflammation in the setting of human immunodeficiency virus and histoplasmosis. After 46 months and multiple revisions, the left lung was resected for postobstructive pneumonia and severe ventilation-perfusion mismatch.

Survival was 79% at 1 year, 76% at 2 years, 51% at 3 years, 47% at 4 years, 38% at 5 years, 23% at 6 years, and 15% at 6.8 years (Fig 3).


Figure 3
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  		Figure 3: Kaplan-Meier product limits estimate of patient survival. Significant comorbid conditions limited survival in patient population treated for benign airway narrowing. At 1, 2, 3, 4, 5, and 6 years, proportional survival was 0.79, 0.76, 0.51, 0.47, 0.38, and 0.23, respectively, and the number of patients who were at risk was 31, 26, 16, 12, 7, and 5, respectively.

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
References
 
Airway stents have been most commonly used for palliation in patients with malignant airway narrowing. The application, durability, and clinical effectiveness of this technique in patients with benign disease, however, raises special concerns. In this population, issues of long-term patency and tolerance of a metallic foreign body in the tracheobronchial tree are added to the clinical endpoint of symptom alleviation. In our retrospective review, we determined the outcomes of a cohort of patients treated with metallic stents for benign tracheobronchial stenosis at our instituation in the past 10 years.

Investigators who have reported on the use of metallic stents for benign tracheobronchial stenoses uniformly describe high technical success rates and prompt symptomatic improvement—often noted to be dramatic—after the restoration of airway caliber (5,8–25). Similar success has been reported in patients undergoing airway stent placement to facilitate extubation (11,14,26,21). Likewise, in our series, initial stent placement, which was performed by a multidisciplinary team that included an anesthesiologist, a pulmonologist, and either one or two interventional radiologists, was successful in all cases. The sole case requiring reintervention for supobtimal stent placement was performed outside of these routine conditions in the operating room.

Thirty-nine of 40 patients in this series reported subjective clinical improvement in respiratory function following the stent procedure. Such clinical findings have been corroborated with improvement in forced expiratory volume in 1 second after stent placement (1,5,12,19,25,27,28).

Findings in patients with tracheobronchial involvement resulting from relapsing polychondritis have been particularly encouraging (8,29,30) because there are few other effective therapeutic options for this population.

Fifteen patients required secondary interventions to optimize or maintain the patency of their airway stent. This includes patient 16 in whom a stent was removed but not replaced. Because the loss of primary patency was most rapid during the 1st year in this series, close attention to findings at clinical and imaging follow-up during this period seems warranted. Assisted patency rates that approach 90% appear to be achievable on the basis of our experience.

Because the study spans 10 years, a variety of stents were placed, which makes it impossible to demonstrate a superior choice. We did, however, experience and report several mechanical failures for the Palmaz stent early in our experience with tracheobronchial stent placement (7). Since that time, we have not used the Palmaz stent for this indication. In a series of lung transplantation patients, Lonchyna et al (19) demonstrated that when Wallstents were used rather than Palmaz stents, fewer interventions were needed to maintain patency.

The geometry of the tracheal bifurcation presents a challenge for currently available stents. When bronchial stents are brought up to the main bronchial orifices and a tracheal stent is extended down to this level, there remains a triangular portion of carina that does not contain a stent. In our experience, uncovered residual or recurrent disease at this location has prompted repeat procedures. The development of a Y-shaped stent to match the carinal geometry may prove beneficial in such cases.

In reviewing survival data for this patient cohort, it is important to note that although these patients did not have a neoplastic cause for their respiratory compromise, they did have serious disease and few remaining medical or surgical treatment options. Therefore, it is in the light of substantial comorbidities that the mortality of this group should be interpreted. Of the 18 patients who died of comorbid conditions, none had premorbid clinical or imaging evidence of stent nonpatency.

The principal limitations of this study include the retrospective nature of the review and the lack of a uniform imaging-based protocol for patient follow-up. Assumptions regarding patency for patients who died of comorbid conditions may be viewed as a bias favorable to our calculation of stent patency. In the absence of clinical or imaging evidence to the contrary, we considered stents to be patent in treated asymptomatic patients. Conversely, the subset of patients referred for this procedure had no clear medical or surgical alternative, often having undergone numerous prior airway injuries or repairs. For these patients, stent placement was often viewed as a last resort. This selection factor may have unfavorably biased patency determination.

We believe that the results of our study affirm that metallic stents placed in the tracheobronchial tree are well tolerated for years and can be beneficial in patients being treated for select benign indications. Symptomatic improvement can be anticipated. Attrition of patency is most rapid during the 1st year of stent placement, but a high rate of assisted patency can be achieved with repeat interventions. Further advances in stent design, including the development of stents to match the carinal geometry and those that are removable (17) and absorbable (31), may further augment the durability and use of this procedure.


   FOOTNOTES
 
Authors stated no financial relationship to disclose.

Author contributions: Guarantors of integrity of entire study, R.H.T., R.L.G.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, R.H.T.; clinical studies, all authors; statistical analysis, R.H.T.; and manuscript editing, R.H.T.


   References
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 

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J. H. Kim, J. H. Shin, H.-Y. Song, T. S. Shim, C. J. Yoon, and G.-Y. Ko
Benign Tracheobronchial Strictures: Long-Term Results and Factors Affecting Airway Patency After Temporary Stent Placement
Am. J. Roentgenol., April 1, 2007; 188(4): 1033 - 1038.
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