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Bronchoscopic Treatment in the Management of Benign Tracheal Stenosis: Choices for Simple and Complex Tracheal Stenosis
Bronchoscopic Treatment in the Management of Benign Tracheal Stenosis: Choices for Simple and Complex Tracheal Stenosis € Levent Dalar, MD, Levent Karasulu, MD, Yasin Abul, MD, Cengiz Ozdemir, MD, Sinem Nedime S€ ok€ uc€ u, MD, Merve Tarhan, MS, and Sedat Altin, MD Department of Pulmonary Medicine, Istanbul Bilim University Faculty of Medicine, Istanbul, Turkey; Interventional Pulmonology Unit, Yedikule Thoracic Diseases and Thoracic Surgery Hospital, Istanbul, Turkey; Department of Pulmonary and Critical Care Medicine, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
Background. Bronchoscopic treatment is 1 of the treatment choices for both palliative and definitive treatment of benign tracheal stenosis. There is no consensus on the management of these patients, however, especially patients having complex stenoses. The aim of the present study was to assess, in the largest group of patients with complex stenoses yet reported, which types of tracheal stenosis are amenable to optimal management by bronchoscopic treatment. Methods. The present study was a retrospective cohort study including 132 consecutive patients with benign tracheal stenoses diagnosed between August 2005 and January 2013. The mean age of the study population was 52 ± 18 years; 62 (47%) were women and 70 (53%) were men. Their lesions were classified as simple and complex stenoses. Results. Simple stenoses (n [ 6) were treated with 12 rigid and flexible bronchoscopic procedures (mean of 2 per patient); 5 stents were placed. The total success rate
was 100%. Among the 124 complex stenoses, 4 were treated directly with surgical intervention. In total, 481 rigid and 487 flexible bronchoscopic procedures were performed in these patients. In this group, the success rate was 69.8%. Conclusions. From the present study, we propose that after accurate classification, interventional bronchoscopic management may have an important role in the treatment of benign tracheal stenosis. Bronchoscopic treatment should be considered as first-line therapy for simple stenoses, whereas complex stenoses need a multidisciplinary approach and often require surgical intervention. However, bronchoscopic treatment may be a valid conservative approach in the management of patients with complex tracheal stenosis who are not eligible for operative treatment.
T
selected complex tracheal stenosis cases. There is no definitive or proven consensus about the endoluminal treatment of complex tracheal stenosis. The aim of the present study was to contribute a previously defined as correct therapeutic algorithm for the management of patients with benign tracheal stenoses, especially complex benign tracheal stenoses, in a large series of patients.
he most common causes of acquired benign tracheal stenosis are endotracheal intubation and tracheostomy [1]. Tracheal stenosis caused by tracheal intubation or tracheostomy, or both, is a surgical problem that can also be managed by nonoperative techniques, including interventional bronchoscopic dilation, endoluminal treatment with lasers, and stenting [2–8]. Tracheal sleeve resection is the first and definitive treatment, particularly for complex tracheal stenosis [7]. However, bronchoscopic management has been reported to have a good success rate in selected patients [5, 6]. In complex lesions, operative treatment has been considered the first option [2, 7]. Although it has been proposed that bronchoscopic management of tracheal stenosis is an alternative to operation only in those selected cases not eligible for a surgical approach, endoluminal treatment can have an important role in the management of both simple and
Accepted for publication Oct 1, 2015. Address correspondence to Dr Dalar, Sisli Florence Nightingale Hospital, Abidei Hurriyet cad. No. 164 Sisli, Istanbul, Turkey; e-mail: leventdalar@ gmail.com.
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2015;-:-–-) Ó 2015 by The Society of Thoracic Surgeons
Material and Methods Clinical Definitions Tracheal stenoses with extensive scarring (1 cm) and varying degrees of cartilage involvement or circumferential contraction scarring or tracheal stenoses associated with malacia and inflammation were defined as complex; simple stenoses were defined as lesions having endoluminal occlusion of a short segment (<1 cm), with the absence of tracheomalacia or loss of cartilaginous support [7, 8]. A thoracic computed tomographic scan was used as a noninvasive method of evaluation to identify all degrees of tracheal stenosis in all nonemergency cases 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.10.005
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preoperatively and during follow-up. A bronchoscopic view was used to identify all degrees of tracheal stenosis in all the patients in the study population [9, 10]. Patients were considered “cured” when there was no recurrence after 1 year from the last interventional procedure [2]. According to the American Society of Anesthesiologists classification for preoperative evaluations, advanced renal, cardiac, pulmonary, neuromuscular, or hepatic dysfunction was used as an inoperability criterion for the present patients [11, 12].
Study Population and Study Design The present study was designed as a retrospective cohort study including 132 consecutive patients with benign tracheal stenosis who were diagnosed between August 2005 and January 2013. Our tertiary center is a referral center especially for complex benign tracheal stenosis. All the patients had a history of intubation or tracheostomy, or both. The mean age of the study population was 52 18 years; 62 (47%) of them were women.
Bronchoscopic Techniques First, diagnostic flexible bronchoscopy was performed to define the type, localization, and severity of the stenosis in most patients (n ¼ 91). All patients were then intubated with a rigid bronchoscope (Efer Endoscopy, La Ciotat, France) under general anesthesia using standardized intravenous techniques. Argon plasma coagulation (40 W, blended mode/continuous flow) was applied using an instrument manufactured by ERBE Elektromedizin GmbH, (T€ ubingen, Germany). A diode laser operating at a wavelength of 980 nm with 4 to 25 W in pulsed mode (Biolitec Ceralas D25; Biolitec, Jena, Germany) was used for the endoluminal treatment. Cryotherapy was performed using the ERBOKRYO system (Elektromedizin GmbH, Tubingen, Germany). The stenotic area was dilated with a rigid bronchoscope. Dumon stents (Novatech, La Ciotat, France) were inserted using appropriate equipment, as described by Dumon [13]. All the patients were followed with fiberoptic bronchoscopy at 1, 3, 6, 9, 12, 18, and 24 months after the initial treatment. In cases of recurrent stenosis, the patients were reevaluated for a potential surgical approach. In case of contraindications, additional bronchoscopic treatments were performed until new stent placement.
Mitomycin Application The stenotic region was treated with topical mitomycin C after the endoluminal treatment. Small pieces of gauze were wetted with mitomycin C (0.2 mg/mL) and applied to the stenotic region radially using rigid forceps. The total time that the stenotic region was exposed to topical mitomycin C was about 10 minutes.
Results Patient Characteristics and Follow-Up Of the 132 patients treated for benign tracheal stenosis from August 2005 to January 2013, all were included in
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the study. Table 1 shows the clinical characteristics of the patients. Respiratory causes were the most common underlying medical condition for initial respiratory failure in the current population. Trauma was the most common surgical reason for respiratory failure. The most common symptom was dyspnea. Only 2 patients of those with tracheal stenosis were asymptomatic . They were referred by their primary physicians after a history of difficult weaning, and their stenoses were visualized by computed tomography followed by bronchoscopy. We decided not to defer the endoscopic treatment based on the computed tomographic and bronchoscopic findings. Most patients (n ¼ 122) had a history of intubation, and 42 patients had a history of tracheostomy. The mean duration of followup was 1.2 0.08 years for patients having simple stenoses and 1.6 1.45 years for patients having complex stenoses.
Bronchoscopic Findings, Type and Localization of the Tracheal Stenosis, and Treatment Choice The total numbers of rigid and flexible bronchoscopic procedures were 495 and 501, respectively. In total, 124 complex and 6 simple stenoses were included in this
Table 1. Clinical Characteristics of the Study Populationa Age (y) Male to female ratio Underlying diseases and comorbidities Respiratory failure Coronary heart diseases Congestive heart failure Diabetes mellitus Chronic obstructive pulmonary disease Asthma Hypertension Obstructive sleep apnea syndrome Cause of initial respiratory insufficiency Medical causes Respiratory Cardiac Neurologic Surgical causes Trauma Postoperative Patients without respiratory failure Major presenting symptoms and signs Dyspnea Wheezing Cough Sputum production Stridor Asymptomatic Previous intubation history Previous tracheostomy history
52 18 70:62 120 9 18 22 28 3 31 4 88 46 22 20 32 22 10 12 99 35 22 16 2 2 122 42
Data are expressed as mean standard deviation or number of patients.
a
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Table 2. Clinical, Treatment, and Follow-Up Data for Patients With Tracheal Stenosisa Type of Stenosis
Degree of Stenosis (%)
Length of Stenosis (cm)
No. of Stenting Procedures/Restenting Procedures/Stenting Index
Duration of Follow-Up (years)
Cure Rate of Endoluminal Treatment (%)
Simple stenosis Complex stenosis
25 23.9 24 18.5
2.1 0.89 2.3 1.36
5/0/0.83 84/38/1.01
1.2 0.08 1.6 1.45
100 69.8
a
Data are expressed as mean standard deviation or number of patients with percentages.
study. Two patients had undefined benign tracheal stenoses. The 124 patients with complex stenoses were first evaluated for surgical intervention; 4 of them underwent surgical treatment directly. At the beginning of follow-up, 120 patients not eligible for operative treatment because of clinical or surgical contraindications, or both, were directed to endoluminal treatment. Of the 120 patients with complex stenoses, 14 were directed to operative treatment after initial endoluminal treatment when their clinical conditions were deemed appropriate.
Simple Stenoses In total, 12 rigid and flexible bronchoscopic procedures were performed for the treatment of patients with simple stenoses (n ¼ 6), with a mean of 2 per patient (Table 2). The degree of residual lumen and the length of a simple tracheal stenosis were 25% 23.9% and 2.1% 0.89 cm (range, 1–3 cm), respectively (Tables 3, 4).
Complex Stenoses In total, 481 rigid and 487 flexible bronchoscopic procedures were performed in patients with complex stenoses (n ¼ 124), with a mean of 7.8 per patient (Table 2). The degree of residual lumen and lengths of the complex tracheal stenosis were 24% 18.5% and 2.3 1.36 cm (range, 1–7 cm), respectively (Tables 3, 4).
Bronchoscopic Treatments and Stenting Procedures Five endotracheal stents were placed in patients with simple stenoses with a stent/patient rate (stenting index) of 0.83. There were no surgical procedures in the simple-stenoses group (Fig 1). Three diode
SIMPLE STENOSIS.
laser procedures were performed in patients with simple stenoses. In total, 2 mitomycin C applications were performed in 6 patients with simple tracheal stenoses. Mitomycin C application when added to dilation decreased the need for consecutive dilations in patients with simple stenoses, although it was not statistically significant. COMPLEX STENOSES. In total, 84 endotracheal stents were placed in patients with complex stenoses as a first stent placement, and then 70 restenting procedures were needed in 38 patients with complex stenoses in a total of up to 6 sessions because of recurrent stenosis or stent complications, or both. The stenting index (stent/patient rate) of complex stenoses was 1.28 (Fig 2). The 36 patients with complex tracheal stenoses who were not eligible for surgical intervention because of clinical or surgical contraindications, or both, and who were also not eligible for stenting because of the position of the complex stenosis were treated by dilation with rigid bronchoscopy and 1 of the endoluminal treatments—argon plasma coagulation, diode laser irradiation, or cryotherapy. The mean number of interventions for the complex group was high (Table 3). In total, 30 mitomycin C applications were performed in 12 patients with complex tracheal stenoses in multiple sessions. The need for multiple stent applications and recurrence was not decreased significantly by the application of topical mitomycin in patients with complex stenoses. However, mitomycin delayed the time to necessary consecutive dilations for those patients with complex stenoses, although it was not statistically significant. Five Montgomery T tubes were applied in 5 patients with complex
Table 3. Type of Endoluminal Treatment Choices Used No. of Patients Type of Procedure Rigid bronchoscopy and mechanical debulking Flexible bronchoscopy Balloon or rigid dilation Argon plasma coagulation Diode laser Cryotherapy Montgomery T tube Stent Mitomycin C application Surgical procedure
No. of Procedures
Simple Stenosis
Complex Stenosis
Simple Stenosis
Complex Stenosis
6 6 6 0 2 0 0 5 1 0
124 124 124 41 13 4 5 120 12 18
6 6 6 0 3 0 0 5 2 0
481 487 361 82 15 4 5 154 30 18
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Table 4. Location and Residual Lumen of Tracheal Stenosis Stenoses
Simple
Complex
4 2 ... ...
86 15 11 12
3 2 1 ... ...
87 25 11 3 ...
a
Location I II III IV Degree of residual lumen Total obstruction to 25% 26%–50% 51%–75% 76%–90% 90% to completely open a
Location was defined bronchoscopically as the starting level of stenosis in centimeters from the tracheal opening: I, stenosis localized 1–2 cm from zero starting level of trachea; II, stenosis localized 2.1–3 cm from zero starting level of trachea; III, stenosis localized 3.1–4 cm from zero starting level of trachea; and IV, stenosis localized 4.1–6 cm from zero starting level of trachea.
stenoses. Of the 120 patients with complex stenoses who had surgical contraindications at initial presentation, 14 were directed to surgical intervention after initial endoluminal treatment when their clinical conditions were deemed appropriate.
Cure Rate, Complications, and Mortality SIMPLE STENOSES. The overall success rate of endoluminal treatment for patients having simple stenoses was 100% (6 of 6). All the stents were removed from the patients with simple stenoses at the end of the follow-up period. The mean duration of the stenting time was 5.4 months for simple stenoses. Two patients had stent dislocations that required repositioning. There were no major complications in the patients with simple stenoses during or after endoluminal treatment. COMPLEX STENOSES. The overall success rate of bronchoscopic treatment for the patients having complex stenoses was 69.8% (74 of 106; 95% confidence interval, 61.06– 78.54). Those patients with successful bronchoscopic treatment no longer required any intervention and functioned without the need for further stenting. The mean duration of stenting time was 11.9 months for complex stenoses. In total, 51 (41.1%) patients had stent dislocations that required repositioning. There were no major complications in the patients with complex stenoses during or after endoluminal treatment. In total, of 38 patients with complex stenoses needed restenting procedures because of recurrent stenosis of 5.43 months’ duration. Granuloma formation at the distal edge of the stent was present in 24 (19.3%) patients with complex stenoses, and granuloma formation at the proximal edge of the stent was present in 17 (13.8%) patients with complex stenoses. Mucostasis was present in 52 (43%) patients with complex stenoses and in 1 (16%) patient with simple stenosis. Granulomas were treated with argon plasma coagulation or cryotherapy, or both. The recurrence rate was 30.2%; the patients with recurrent
stenoses (n ¼ 32) and the patients who did not respond continued to receive palliative bronchoscopic treatment only. We did not use stents for patients with frequent migration. If operative treatment was not applicable, bronchoscopic dilation was used in a limited number of patients with an interval of 1 to 4 months. However, in most patients, stenting or tracheostomy and Montgomery T tubes were used. Figures 3–5 show bronchoscopic views under different conditions.
Comment There is no definitive consensus on the management of tracheal stenosis because the efficacy of surgical treatment in comparison with endoluminal treatment modalities mostly depends on the experience of the different referral centers. Mortality in the surgical approach has been reported to be up to 5%, and operation failure rates vary from 5% to 15% [2, 14, 15]. It has been proposed that only simple weblike stenoses can be cured using laser and mechanical dilation, with cure rates ranging from 60% to 95% [2, 6, 16, 17]. Complex stenosis with cartilaginous involvement requires stent placement. Relapse rates with laser treatment and dilation alone have been reported to be as high as 90% for complex tracheal stenosis [17]. Brichet and colleagues [7] also reported a 17.6% success for complex tracheal stenosis that was directly treated with endotracheal stenting. However, in cases of surgical ineligibility, endoscopic treatment may
Fig 1. Therapeutic management algorithm for patients with simple stenoses.
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Fig 2. Therapeutic management algorithm for patients with complex stenoses. (APC ¼ argon plasma coagulation; Cryo ¼ cryotherapy.)
potentially be a good choice even for complex stenosis, at least as a bridge to operative treatment. It has been reported that it is possible to obtain good results with stenting as a definitive treatment in cases of surgical ineligibility in tracheal stenosis [18, 19]. It may be that stenting or another intervention could extend the length of stenosis in those patients, particularly those having high-level subglottic stenoses. However in our study cohort, stenting or other endoscopic interventions did not extend the length of stenosis in those patients with subglottic stenoses. Endoscopic treatment provided temporary management of timing until surgical intervention in initially inoperable patients. Galluccio and associates [2] reported a 69% success rate for complex tracheal stenosis with endoluminal treatment and proposed a multidisciplinary approach for patients having complex stenoses. Cavaliere and colleagues [8] reported favorable results in the treatment of both simple and complex tracheal stenoses. They reported a 100% success rate for weblike stenoses and a 22% success rate for complex tracheal stenoses and emphasized the importance of an appropriate bronchoscopic, clinical, and radiologic evaluation to improve the outcome of endoscopic treatment. Unfortunately, there are no definitive criteria for stent removal. However as a general approach, removal of the stent has been recommended after 6 to 12 months, and patients should be followed with surveillance bronchoscopy [2, 8]. Success rates were 100% and 69.8% for simple
and complex stenoses, respectively, in the present study. Patients with complex stenoses were considerably higher in number in the present study compared with reports in the literature [2, 8] because our center is the only referral center regionally for patients not initially eligible for surgical intervention who needed bronchoscopic treatment. We use bronchoscopic treatment and stent placement as the treatment of choice for simple stenosis. Referral of patients with simple tracheal stenosis for surgical treatment in cases of failure of initial endoluminal treatment is a crucial algorithmic approach. However no patient in the simple tracheal stenosis group was referred for operation in the present cohort. We manage patients with complex stenoses who have surgical or clinical contraindications, or both, with temporary management until time of surgical intervention from the view of endoluminal treatment. Our success rate with bronchoscopic treatment for patients with complex stenoses was similar to that of Galluccio and colleagues [2]. The mean duration of stenting time was reported as 11.6 and 18 months, respectively, for complex stenoses in previous large series [2, 8]. The mean duration of stenting time was 11.9 months for complex stenoses in the present study. Although we have a satisfactory success rate for endoluminal treatment in patients with complex stenoses, we also referred those patients for surgical treatment when their clinical condition was appropriate for operation. We had a relatively high number of stent migrations (41.1%)
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Fig 3. Subglottic postintubation tracheal stenosis in patient with H1N1 pneumonia and acute respiratory distress syndrome. (A) Before bronchoscopic treatment. (B) After bronchoscopic treatment. (C) After stent placement.
and granulation tissue, most likely because of the relatively large number of patients with complex stenoses versus the number of these patients in the literature. Thus the mean number of interventions for this complex group was high. Mucostasis was a big problem in our cohort because of an inadequate number of respiratory care therapists to follow these patients and a lack of family education and training. Mucostasis is also a major reason for stent obstruction and artificial restenosis, another factor that increased interventions in these relatively difficult to manage patients. Those complex stenoses were also high-level stenoses, leading to migration of the stents in many patients. The length of the tracheal stenosis ranged from 1 to 7 cm in our patients. Grillo and associates [4, 10] showed that the length of resection for tracheal stenosis was 1.0 to 7.5 cm in a large series. The Fig 4. Weblike postintubation tracheal stenosis in 39-year-old woman. (A) Before bronchoscopic treatment. (B) Magnified view before bronchoscopic treatment. (C) After 3 consecutive bronchoscopic treatments with topical mitomycin application (follow-up period 46 months with no recurrence). (D) Magnified view after bronchoscopic treatment.
relatively short length of the laryngotracheal region in the patients of the current population [20, 21] may be a predictive factor and the reason for the short length and high-level location of tracheal stenoses in our patients. Highly located tracheal stenosis may also be the reason for the high number of migrations in the present study population. Argon plasma coagulation was the most commonly used bronchoscopic treatment for complex stenoses, followed by diode laser treatment and cryotherapy in the present study. Neodymium-doped yttrium aluminum garnet (Nd-YAG) laser irradiation and stenting have been used as a first step in the treatment of benign tracheal stenosis [7, 22]. Balloon dilation and argon plasma coagulation have also been used for patients with benign tracheal stenosis [23, 24]. Treatment with an Nd-YAG
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Fig 5. (A) Female patient underwent tracheal resection and endto-end anastomosis with diagnosis of complex tracheal stenosis. (B) Because of recurrent stenosis at site of anastomosis, dilation and stenting were applied.
laser is known to be an effective modality for treating airway obstructive lesions; however the operator should be careful to avoid extensive damage to the bronchial wall, leading to further cartilaginous damage, fibrosis, and subsequent endoluminal stenosis [25, 26]. Argon plasma coagulation safely devitalizes the stenotic region, allowing removal with grasping forceps. Application of topical mitomycin C has been reported as a potential contributor to the treatment of tracheal stenosis in case series [27, 28]. Topical mitomycin C was used to compliment dilation in simple stenoses, and it was also used as a modality for preventing recurrent stenosis in patients with complex stenoses. However the need for multiple stent applications and recurrences was not decreased significantly by the application of topical mitomycin C in patients with complex stenoses. Because we used mitomycin in a limited number of patients, it was not possible to demonstrate its effect on the stenotic area. However mitomycin did delay the time to consecutive stent dilations for patients with complex stenoses, although it was not statistically significant. Also, mitomycin C application when added to dilation decreased the need for consecutive dilations in patients with simple stenosis, but it was used in only 2 patients. The present study also confirmed that there was no significant difference between patients with tracheal stenosis after tracheostomy and patients with tracheal stenosis that developed after prolonged endotracheal intubation from the point of view of restenosis development. This is similar to findings of Zias and colleagues [22]. They reported that no correlation was found between the tendency to experience restenosis in patients with tracheal stenosis after tracheostomy and in patients with tracheal stenosis that develops after prolonged endotracheal intubation [22]. There are some reports that cryotherapy is not a useful treatment modality, especially for complex tracheal stenoses resulting from the fibrotic composition of those complex stenoses, which makes them relatively cryoresistant [29]. However Fernando and coworkers [30]
showed the feasibility of spray cryotherapy and balloon dilation for nonmalignant strictures of the airway, including benign tracheal stenosis. We also used cryotherapy safely for the treatment of granulation tissue in a limited number of patients with complex stenoses (n ¼ 4).
Limitations of the Study First, this cohort study population was a specifically selected cohort of patients with complex stenosis because our center is a tertiary referral center. Thus it is not a representative sample of treatment approaches for all patients with tracheal stenoses in a population. Second, this was a retrospective cohort study; we were not able to do an intention-to-treat analysis in this cohort because that requires a prospective randomized clinical trial. Third, because we used mitomycin in a limited number of patients, it was not possible to demonstrate its effect on the stenotic area.
Conclusions The present study confirms that endoluminal treatment should be considered the first treatment of choice for the management of simple stenosis. However complex stenosis requires a multidisciplinary approach and often requires a surgical approach. Despite this, bronchoscopic treatment should not only be reserved as a palliative alternative to operation but should also be considered as a valid therapeutic option for selected cases of complex tracheal stenosis. The present series emphasizes the important role of bronchoscopic treatment as a valid conservative approach in the management of patients with complex tracheal stenosis as an alternative to operative treatment, which remains the definitive primary choice for operable patients with complex tracheal stenosis. The authors wish to thank Prof RW Guillery from Oxford University for the English language editing of the manuscript.
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15. Ciccone AM, De Giacomo T, Venuta F, et al. Operative and non-operative treatment of benign subglottic laryngotracheal stenosis. Eur J Cardiothorac Surg 2004;26:818–22. 16. Dutau H, Breen DP. Endobronchial laser treatment: an essential tool in therapeutic bronchoscopy. Eur Respir Monogr 2010;48:149–60. 17. Baugnee PE, Marquette CH, Ramon P, Darras J, Wurtz A. [Endoscopic treatment of post-intubation tracheal stenosis. Apropos of 58 cases] [Article in French]. Rev Mal Respir 1995;12:585–92. 18. Noppen M, Meysman M, Claes I, D’Haese J, Vincken W. Screw-thread vs Dumon endoprosthesis in the management of tracheal stenosis. Chest 1999;115:532–5. 19. Colt HG, Dumon JF. Tracheobronchial stents: indications and applications. Lung Cancer 1993;9:301–6. 20. Beder S, Kupeli E, Karnak D, Kayacan O. Tracheobronchial variations in Turkish population. Clin Anat 2008;21:531–8. 21. Wooten C, Patel S, Cassidy L, et al. Variations of the tracheobronchial tree: anatomical and clinical significance. Clin Anat 2014;27:1223–33. 22. Zias N, Chroneou A, Tabba MK, et al. Post tracheostomy and post intubation tracheal stenosis: report of 31 cases and review of the literature. BMC Pulm Med 2008;8:18. 23. Noppen M, Schlesser M, Meysman M, D’Haese J, Peche R, Vincken W. Bronchoscopic balloon dilatation in the combined management of postintubation stenosis of the trachea in adults. Chest 1997;112:1136–40. 24. Yasuo M, Tanabe T, Tsushima K, et al. Endobronchial argon plasma coagulation for the management of post-intubation tracheal stenosis. Respirology 2006;11:659–62. 25. Coulter TD, Mehta AC. The heat is on: impact of endobronchial electrosurgery on the need for Nd-YAG laser photoresection. Chest 2000;118:516–21. 26. Verkindre C, Brichet A, Maurage CA, Ramon P, Homasson JP, Marquette CH. Morphological changes induced by extensive endobronchial electrocautery. Eur Respir J 1999;14:796–9. 27. Simpson CB, James JC. The efficacy of mitomycin-C in the treatment of laryngotracheal stenosis. Laryngoscope 2006;116:1923–5. 28. Viveiros F, Gomes J, Oliveira A, Neves S, Almeida J, Moura e Sa J. Topical application of mitomycin-c as an adjuvant treatment to bronchoscopic procedures in post-intubation tracheal stenosis. Rev Port Pneumol 2013;19:276–80. 29. Morgan RK, Ernst A. Cryosurgery. Eur Respir Monog 2010;48:161–72. 30. Fernando HC, Dekeratry D, Downie G, et al. Feasibility of spray cryotherapy and balloon dilation for non-malignant strictures of the airway. Eur J Cardiothorac Surg 2011;40: 1177–80.
Background. Bronchoscopic treatment is 1 of the treatment choices for both palliative and definitive treatment of benign tracheal stenosis. There is no consensus on the management of these patients, however, especially patients having complex stenoses. The aim of the present study was to assess, in the largest group of patients with complex stenoses yet reported, which types of tracheal stenosis are amenable to optimal management by bronchoscopic treatment. Methods. The present study was a retrospective cohort study including 132 consecutive patients with benign tracheal stenoses diagnosed between August 2005 and January 2013. The mean age of the study population was 52 ± 18 years; 62 (47%) were women and 70 (53%) were men. Their lesions were classified as simple and complex stenoses. Results. Simple stenoses (n [ 6) were treated with 12 rigid and flexible bronchoscopic procedures (mean of 2 per patient); 5 stents were placed. The total success rate
was 100%. Among the 124 complex stenoses, 4 were treated directly with surgical intervention. In total, 481 rigid and 487 flexible bronchoscopic procedures were performed in these patients. In this group, the success rate was 69.8%. Conclusions. From the present study, we propose that after accurate classification, interventional bronchoscopic management may have an important role in the treatment of benign tracheal stenosis. Bronchoscopic treatment should be considered as first-line therapy for simple stenoses, whereas complex stenoses need a multidisciplinary approach and often require surgical intervention. However, bronchoscopic treatment may be a valid conservative approach in the management of patients with complex tracheal stenosis who are not eligible for operative treatment.
T
selected complex tracheal stenosis cases. There is no definitive or proven consensus about the endoluminal treatment of complex tracheal stenosis. The aim of the present study was to contribute a previously defined as correct therapeutic algorithm for the management of patients with benign tracheal stenoses, especially complex benign tracheal stenoses, in a large series of patients.
he most common causes of acquired benign tracheal stenosis are endotracheal intubation and tracheostomy [1]. Tracheal stenosis caused by tracheal intubation or tracheostomy, or both, is a surgical problem that can also be managed by nonoperative techniques, including interventional bronchoscopic dilation, endoluminal treatment with lasers, and stenting [2–8]. Tracheal sleeve resection is the first and definitive treatment, particularly for complex tracheal stenosis [7]. However, bronchoscopic management has been reported to have a good success rate in selected patients [5, 6]. In complex lesions, operative treatment has been considered the first option [2, 7]. Although it has been proposed that bronchoscopic management of tracheal stenosis is an alternative to operation only in those selected cases not eligible for a surgical approach, endoluminal treatment can have an important role in the management of both simple and
Accepted for publication Oct 1, 2015. Address correspondence to Dr Dalar, Sisli Florence Nightingale Hospital, Abidei Hurriyet cad. No. 164 Sisli, Istanbul, Turkey; e-mail: leventdalar@ gmail.com.
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2015;-:-–-) Ó 2015 by The Society of Thoracic Surgeons
Material and Methods Clinical Definitions Tracheal stenoses with extensive scarring (1 cm) and varying degrees of cartilage involvement or circumferential contraction scarring or tracheal stenoses associated with malacia and inflammation were defined as complex; simple stenoses were defined as lesions having endoluminal occlusion of a short segment (<1 cm), with the absence of tracheomalacia or loss of cartilaginous support [7, 8]. A thoracic computed tomographic scan was used as a noninvasive method of evaluation to identify all degrees of tracheal stenosis in all nonemergency cases 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.10.005
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preoperatively and during follow-up. A bronchoscopic view was used to identify all degrees of tracheal stenosis in all the patients in the study population [9, 10]. Patients were considered “cured” when there was no recurrence after 1 year from the last interventional procedure [2]. According to the American Society of Anesthesiologists classification for preoperative evaluations, advanced renal, cardiac, pulmonary, neuromuscular, or hepatic dysfunction was used as an inoperability criterion for the present patients [11, 12].
Study Population and Study Design The present study was designed as a retrospective cohort study including 132 consecutive patients with benign tracheal stenosis who were diagnosed between August 2005 and January 2013. Our tertiary center is a referral center especially for complex benign tracheal stenosis. All the patients had a history of intubation or tracheostomy, or both. The mean age of the study population was 52 18 years; 62 (47%) of them were women.
Bronchoscopic Techniques First, diagnostic flexible bronchoscopy was performed to define the type, localization, and severity of the stenosis in most patients (n ¼ 91). All patients were then intubated with a rigid bronchoscope (Efer Endoscopy, La Ciotat, France) under general anesthesia using standardized intravenous techniques. Argon plasma coagulation (40 W, blended mode/continuous flow) was applied using an instrument manufactured by ERBE Elektromedizin GmbH, (T€ ubingen, Germany). A diode laser operating at a wavelength of 980 nm with 4 to 25 W in pulsed mode (Biolitec Ceralas D25; Biolitec, Jena, Germany) was used for the endoluminal treatment. Cryotherapy was performed using the ERBOKRYO system (Elektromedizin GmbH, Tubingen, Germany). The stenotic area was dilated with a rigid bronchoscope. Dumon stents (Novatech, La Ciotat, France) were inserted using appropriate equipment, as described by Dumon [13]. All the patients were followed with fiberoptic bronchoscopy at 1, 3, 6, 9, 12, 18, and 24 months after the initial treatment. In cases of recurrent stenosis, the patients were reevaluated for a potential surgical approach. In case of contraindications, additional bronchoscopic treatments were performed until new stent placement.
Mitomycin Application The stenotic region was treated with topical mitomycin C after the endoluminal treatment. Small pieces of gauze were wetted with mitomycin C (0.2 mg/mL) and applied to the stenotic region radially using rigid forceps. The total time that the stenotic region was exposed to topical mitomycin C was about 10 minutes.
Results Patient Characteristics and Follow-Up Of the 132 patients treated for benign tracheal stenosis from August 2005 to January 2013, all were included in
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the study. Table 1 shows the clinical characteristics of the patients. Respiratory causes were the most common underlying medical condition for initial respiratory failure in the current population. Trauma was the most common surgical reason for respiratory failure. The most common symptom was dyspnea. Only 2 patients of those with tracheal stenosis were asymptomatic . They were referred by their primary physicians after a history of difficult weaning, and their stenoses were visualized by computed tomography followed by bronchoscopy. We decided not to defer the endoscopic treatment based on the computed tomographic and bronchoscopic findings. Most patients (n ¼ 122) had a history of intubation, and 42 patients had a history of tracheostomy. The mean duration of followup was 1.2 0.08 years for patients having simple stenoses and 1.6 1.45 years for patients having complex stenoses.
Bronchoscopic Findings, Type and Localization of the Tracheal Stenosis, and Treatment Choice The total numbers of rigid and flexible bronchoscopic procedures were 495 and 501, respectively. In total, 124 complex and 6 simple stenoses were included in this
Table 1. Clinical Characteristics of the Study Populationa Age (y) Male to female ratio Underlying diseases and comorbidities Respiratory failure Coronary heart diseases Congestive heart failure Diabetes mellitus Chronic obstructive pulmonary disease Asthma Hypertension Obstructive sleep apnea syndrome Cause of initial respiratory insufficiency Medical causes Respiratory Cardiac Neurologic Surgical causes Trauma Postoperative Patients without respiratory failure Major presenting symptoms and signs Dyspnea Wheezing Cough Sputum production Stridor Asymptomatic Previous intubation history Previous tracheostomy history
52 18 70:62 120 9 18 22 28 3 31 4 88 46 22 20 32 22 10 12 99 35 22 16 2 2 122 42
Data are expressed as mean standard deviation or number of patients.
a
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Table 2. Clinical, Treatment, and Follow-Up Data for Patients With Tracheal Stenosisa Type of Stenosis
Degree of Stenosis (%)
Length of Stenosis (cm)
No. of Stenting Procedures/Restenting Procedures/Stenting Index
Duration of Follow-Up (years)
Cure Rate of Endoluminal Treatment (%)
Simple stenosis Complex stenosis
25 23.9 24 18.5
2.1 0.89 2.3 1.36
5/0/0.83 84/38/1.01
1.2 0.08 1.6 1.45
100 69.8
a
Data are expressed as mean standard deviation or number of patients with percentages.
study. Two patients had undefined benign tracheal stenoses. The 124 patients with complex stenoses were first evaluated for surgical intervention; 4 of them underwent surgical treatment directly. At the beginning of follow-up, 120 patients not eligible for operative treatment because of clinical or surgical contraindications, or both, were directed to endoluminal treatment. Of the 120 patients with complex stenoses, 14 were directed to operative treatment after initial endoluminal treatment when their clinical conditions were deemed appropriate.
Simple Stenoses In total, 12 rigid and flexible bronchoscopic procedures were performed for the treatment of patients with simple stenoses (n ¼ 6), with a mean of 2 per patient (Table 2). The degree of residual lumen and the length of a simple tracheal stenosis were 25% 23.9% and 2.1% 0.89 cm (range, 1–3 cm), respectively (Tables 3, 4).
Complex Stenoses In total, 481 rigid and 487 flexible bronchoscopic procedures were performed in patients with complex stenoses (n ¼ 124), with a mean of 7.8 per patient (Table 2). The degree of residual lumen and lengths of the complex tracheal stenosis were 24% 18.5% and 2.3 1.36 cm (range, 1–7 cm), respectively (Tables 3, 4).
Bronchoscopic Treatments and Stenting Procedures Five endotracheal stents were placed in patients with simple stenoses with a stent/patient rate (stenting index) of 0.83. There were no surgical procedures in the simple-stenoses group (Fig 1). Three diode
SIMPLE STENOSIS.
laser procedures were performed in patients with simple stenoses. In total, 2 mitomycin C applications were performed in 6 patients with simple tracheal stenoses. Mitomycin C application when added to dilation decreased the need for consecutive dilations in patients with simple stenoses, although it was not statistically significant. COMPLEX STENOSES. In total, 84 endotracheal stents were placed in patients with complex stenoses as a first stent placement, and then 70 restenting procedures were needed in 38 patients with complex stenoses in a total of up to 6 sessions because of recurrent stenosis or stent complications, or both. The stenting index (stent/patient rate) of complex stenoses was 1.28 (Fig 2). The 36 patients with complex tracheal stenoses who were not eligible for surgical intervention because of clinical or surgical contraindications, or both, and who were also not eligible for stenting because of the position of the complex stenosis were treated by dilation with rigid bronchoscopy and 1 of the endoluminal treatments—argon plasma coagulation, diode laser irradiation, or cryotherapy. The mean number of interventions for the complex group was high (Table 3). In total, 30 mitomycin C applications were performed in 12 patients with complex tracheal stenoses in multiple sessions. The need for multiple stent applications and recurrence was not decreased significantly by the application of topical mitomycin in patients with complex stenoses. However, mitomycin delayed the time to necessary consecutive dilations for those patients with complex stenoses, although it was not statistically significant. Five Montgomery T tubes were applied in 5 patients with complex
Table 3. Type of Endoluminal Treatment Choices Used No. of Patients Type of Procedure Rigid bronchoscopy and mechanical debulking Flexible bronchoscopy Balloon or rigid dilation Argon plasma coagulation Diode laser Cryotherapy Montgomery T tube Stent Mitomycin C application Surgical procedure
No. of Procedures
Simple Stenosis
Complex Stenosis
Simple Stenosis
Complex Stenosis
6 6 6 0 2 0 0 5 1 0
124 124 124 41 13 4 5 120 12 18
6 6 6 0 3 0 0 5 2 0
481 487 361 82 15 4 5 154 30 18
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Table 4. Location and Residual Lumen of Tracheal Stenosis Stenoses
Simple
Complex
4 2 ... ...
86 15 11 12
3 2 1 ... ...
87 25 11 3 ...
a
Location I II III IV Degree of residual lumen Total obstruction to 25% 26%–50% 51%–75% 76%–90% 90% to completely open a
Location was defined bronchoscopically as the starting level of stenosis in centimeters from the tracheal opening: I, stenosis localized 1–2 cm from zero starting level of trachea; II, stenosis localized 2.1–3 cm from zero starting level of trachea; III, stenosis localized 3.1–4 cm from zero starting level of trachea; and IV, stenosis localized 4.1–6 cm from zero starting level of trachea.
stenoses. Of the 120 patients with complex stenoses who had surgical contraindications at initial presentation, 14 were directed to surgical intervention after initial endoluminal treatment when their clinical conditions were deemed appropriate.
Cure Rate, Complications, and Mortality SIMPLE STENOSES. The overall success rate of endoluminal treatment for patients having simple stenoses was 100% (6 of 6). All the stents were removed from the patients with simple stenoses at the end of the follow-up period. The mean duration of the stenting time was 5.4 months for simple stenoses. Two patients had stent dislocations that required repositioning. There were no major complications in the patients with simple stenoses during or after endoluminal treatment. COMPLEX STENOSES. The overall success rate of bronchoscopic treatment for the patients having complex stenoses was 69.8% (74 of 106; 95% confidence interval, 61.06– 78.54). Those patients with successful bronchoscopic treatment no longer required any intervention and functioned without the need for further stenting. The mean duration of stenting time was 11.9 months for complex stenoses. In total, 51 (41.1%) patients had stent dislocations that required repositioning. There were no major complications in the patients with complex stenoses during or after endoluminal treatment. In total, of 38 patients with complex stenoses needed restenting procedures because of recurrent stenosis of 5.43 months’ duration. Granuloma formation at the distal edge of the stent was present in 24 (19.3%) patients with complex stenoses, and granuloma formation at the proximal edge of the stent was present in 17 (13.8%) patients with complex stenoses. Mucostasis was present in 52 (43%) patients with complex stenoses and in 1 (16%) patient with simple stenosis. Granulomas were treated with argon plasma coagulation or cryotherapy, or both. The recurrence rate was 30.2%; the patients with recurrent
stenoses (n ¼ 32) and the patients who did not respond continued to receive palliative bronchoscopic treatment only. We did not use stents for patients with frequent migration. If operative treatment was not applicable, bronchoscopic dilation was used in a limited number of patients with an interval of 1 to 4 months. However, in most patients, stenting or tracheostomy and Montgomery T tubes were used. Figures 3–5 show bronchoscopic views under different conditions.
Comment There is no definitive consensus on the management of tracheal stenosis because the efficacy of surgical treatment in comparison with endoluminal treatment modalities mostly depends on the experience of the different referral centers. Mortality in the surgical approach has been reported to be up to 5%, and operation failure rates vary from 5% to 15% [2, 14, 15]. It has been proposed that only simple weblike stenoses can be cured using laser and mechanical dilation, with cure rates ranging from 60% to 95% [2, 6, 16, 17]. Complex stenosis with cartilaginous involvement requires stent placement. Relapse rates with laser treatment and dilation alone have been reported to be as high as 90% for complex tracheal stenosis [17]. Brichet and colleagues [7] also reported a 17.6% success for complex tracheal stenosis that was directly treated with endotracheal stenting. However, in cases of surgical ineligibility, endoscopic treatment may
Fig 1. Therapeutic management algorithm for patients with simple stenoses.
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Fig 2. Therapeutic management algorithm for patients with complex stenoses. (APC ¼ argon plasma coagulation; Cryo ¼ cryotherapy.)
potentially be a good choice even for complex stenosis, at least as a bridge to operative treatment. It has been reported that it is possible to obtain good results with stenting as a definitive treatment in cases of surgical ineligibility in tracheal stenosis [18, 19]. It may be that stenting or another intervention could extend the length of stenosis in those patients, particularly those having high-level subglottic stenoses. However in our study cohort, stenting or other endoscopic interventions did not extend the length of stenosis in those patients with subglottic stenoses. Endoscopic treatment provided temporary management of timing until surgical intervention in initially inoperable patients. Galluccio and associates [2] reported a 69% success rate for complex tracheal stenosis with endoluminal treatment and proposed a multidisciplinary approach for patients having complex stenoses. Cavaliere and colleagues [8] reported favorable results in the treatment of both simple and complex tracheal stenoses. They reported a 100% success rate for weblike stenoses and a 22% success rate for complex tracheal stenoses and emphasized the importance of an appropriate bronchoscopic, clinical, and radiologic evaluation to improve the outcome of endoscopic treatment. Unfortunately, there are no definitive criteria for stent removal. However as a general approach, removal of the stent has been recommended after 6 to 12 months, and patients should be followed with surveillance bronchoscopy [2, 8]. Success rates were 100% and 69.8% for simple
and complex stenoses, respectively, in the present study. Patients with complex stenoses were considerably higher in number in the present study compared with reports in the literature [2, 8] because our center is the only referral center regionally for patients not initially eligible for surgical intervention who needed bronchoscopic treatment. We use bronchoscopic treatment and stent placement as the treatment of choice for simple stenosis. Referral of patients with simple tracheal stenosis for surgical treatment in cases of failure of initial endoluminal treatment is a crucial algorithmic approach. However no patient in the simple tracheal stenosis group was referred for operation in the present cohort. We manage patients with complex stenoses who have surgical or clinical contraindications, or both, with temporary management until time of surgical intervention from the view of endoluminal treatment. Our success rate with bronchoscopic treatment for patients with complex stenoses was similar to that of Galluccio and colleagues [2]. The mean duration of stenting time was reported as 11.6 and 18 months, respectively, for complex stenoses in previous large series [2, 8]. The mean duration of stenting time was 11.9 months for complex stenoses in the present study. Although we have a satisfactory success rate for endoluminal treatment in patients with complex stenoses, we also referred those patients for surgical treatment when their clinical condition was appropriate for operation. We had a relatively high number of stent migrations (41.1%)
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Fig 3. Subglottic postintubation tracheal stenosis in patient with H1N1 pneumonia and acute respiratory distress syndrome. (A) Before bronchoscopic treatment. (B) After bronchoscopic treatment. (C) After stent placement.
and granulation tissue, most likely because of the relatively large number of patients with complex stenoses versus the number of these patients in the literature. Thus the mean number of interventions for this complex group was high. Mucostasis was a big problem in our cohort because of an inadequate number of respiratory care therapists to follow these patients and a lack of family education and training. Mucostasis is also a major reason for stent obstruction and artificial restenosis, another factor that increased interventions in these relatively difficult to manage patients. Those complex stenoses were also high-level stenoses, leading to migration of the stents in many patients. The length of the tracheal stenosis ranged from 1 to 7 cm in our patients. Grillo and associates [4, 10] showed that the length of resection for tracheal stenosis was 1.0 to 7.5 cm in a large series. The Fig 4. Weblike postintubation tracheal stenosis in 39-year-old woman. (A) Before bronchoscopic treatment. (B) Magnified view before bronchoscopic treatment. (C) After 3 consecutive bronchoscopic treatments with topical mitomycin application (follow-up period 46 months with no recurrence). (D) Magnified view after bronchoscopic treatment.
relatively short length of the laryngotracheal region in the patients of the current population [20, 21] may be a predictive factor and the reason for the short length and high-level location of tracheal stenoses in our patients. Highly located tracheal stenosis may also be the reason for the high number of migrations in the present study population. Argon plasma coagulation was the most commonly used bronchoscopic treatment for complex stenoses, followed by diode laser treatment and cryotherapy in the present study. Neodymium-doped yttrium aluminum garnet (Nd-YAG) laser irradiation and stenting have been used as a first step in the treatment of benign tracheal stenosis [7, 22]. Balloon dilation and argon plasma coagulation have also been used for patients with benign tracheal stenosis [23, 24]. Treatment with an Nd-YAG
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Fig 5. (A) Female patient underwent tracheal resection and endto-end anastomosis with diagnosis of complex tracheal stenosis. (B) Because of recurrent stenosis at site of anastomosis, dilation and stenting were applied.
laser is known to be an effective modality for treating airway obstructive lesions; however the operator should be careful to avoid extensive damage to the bronchial wall, leading to further cartilaginous damage, fibrosis, and subsequent endoluminal stenosis [25, 26]. Argon plasma coagulation safely devitalizes the stenotic region, allowing removal with grasping forceps. Application of topical mitomycin C has been reported as a potential contributor to the treatment of tracheal stenosis in case series [27, 28]. Topical mitomycin C was used to compliment dilation in simple stenoses, and it was also used as a modality for preventing recurrent stenosis in patients with complex stenoses. However the need for multiple stent applications and recurrences was not decreased significantly by the application of topical mitomycin C in patients with complex stenoses. Because we used mitomycin in a limited number of patients, it was not possible to demonstrate its effect on the stenotic area. However mitomycin did delay the time to consecutive stent dilations for patients with complex stenoses, although it was not statistically significant. Also, mitomycin C application when added to dilation decreased the need for consecutive dilations in patients with simple stenosis, but it was used in only 2 patients. The present study also confirmed that there was no significant difference between patients with tracheal stenosis after tracheostomy and patients with tracheal stenosis that developed after prolonged endotracheal intubation from the point of view of restenosis development. This is similar to findings of Zias and colleagues [22]. They reported that no correlation was found between the tendency to experience restenosis in patients with tracheal stenosis after tracheostomy and in patients with tracheal stenosis that develops after prolonged endotracheal intubation [22]. There are some reports that cryotherapy is not a useful treatment modality, especially for complex tracheal stenoses resulting from the fibrotic composition of those complex stenoses, which makes them relatively cryoresistant [29]. However Fernando and coworkers [30]
showed the feasibility of spray cryotherapy and balloon dilation for nonmalignant strictures of the airway, including benign tracheal stenosis. We also used cryotherapy safely for the treatment of granulation tissue in a limited number of patients with complex stenoses (n ¼ 4).
Limitations of the Study First, this cohort study population was a specifically selected cohort of patients with complex stenosis because our center is a tertiary referral center. Thus it is not a representative sample of treatment approaches for all patients with tracheal stenoses in a population. Second, this was a retrospective cohort study; we were not able to do an intention-to-treat analysis in this cohort because that requires a prospective randomized clinical trial. Third, because we used mitomycin in a limited number of patients, it was not possible to demonstrate its effect on the stenotic area.
Conclusions The present study confirms that endoluminal treatment should be considered the first treatment of choice for the management of simple stenosis. However complex stenosis requires a multidisciplinary approach and often requires a surgical approach. Despite this, bronchoscopic treatment should not only be reserved as a palliative alternative to operation but should also be considered as a valid therapeutic option for selected cases of complex tracheal stenosis. The present series emphasizes the important role of bronchoscopic treatment as a valid conservative approach in the management of patients with complex tracheal stenosis as an alternative to operative treatment, which remains the definitive primary choice for operable patients with complex tracheal stenosis. The authors wish to thank Prof RW Guillery from Oxford University for the English language editing of the manuscript.
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