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Ann Thorac Surg 2003;76:167-174
© 2003 The Society of Thoracic Surgeons
a Section of General Thoracic Surgery, University of Washington, Seattle, Washington, USA
* Address reprint requests to Dr Wood, University of Washington, Box 356310, 1959 NE Pacific, AA-115, Seattle, WA 98195-6310 USA
e-mail: dewood{at}u.washington.edu
Presented at the Thirty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 2830, 2002.
| Abstract |
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METHODS: University of Washington patients undergoing bronchoscopy with stent placement or revision from May 1992 through December 2001 were extracted from a prospective patient database. Details of the stent procedure were obtained from the medical records and office charts. Early outcomes were assessed by patient symptoms and signs, and late outcomes were assessed by patient follow-up visits, follow-up bronchoscopy, or discussions, or a combination of these with the patient, patients family, or referring physician.
RESULTS: One hundred forty-three patients underwent 309 stent procedures of which 67% were for malignant disease. Eighty-two percent required urgent or emergent intervention, and 77% had compromise of more than three fourths of the airway lumen. Eighty-seven percent of stents placed were silicone rubber and 15% of patients required multiple stents to achieve airway palliation. Significant improvement was achieved in 94% of patients but required multiple endoscopies to maintain improvement in 41%. There was no stent-related mortality and only one major complication required surgery.
CONCLUSIONS: Airway stenting provides prompt and durable palliation in unresectable patients with central airway obstruction. Frequently multiple stents and multiple procedures will be necessary to maintain a satisfactory airway.
| Introduction |
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Although many published reports emphasize a single technique for bronchoscopic palliation of central airway obstruction, a variety of techniques are needed to achieve the optimal outcome in this patient population with diverse airway anatomy and pathology [13]. Benign stenosis can be managed with dilation, with or without laser resection. Malignant lesions are managed by core-out of tumor, laser vaporization, photodynamic therapy, brachytherapy, cryotherapy, and electrocautery. Airway stents are a valuable adjunct to these techniques and can provide prolonged palliation from an unresectable recalcitrant benign stenosis or rapidly recurrent endoluminal tumor. However, none of the other therapeutic bronchoscopy techniques provide a remedy for intrinsic airway pathology or extrinsic compression. Airway stenting is critical to achieve a stable airway in this group of patients, and stenting results in reliable and durable relief of airway symptoms.
Frequently thoracic surgeons play a nonexistent or secondary role in the endoscopic management of central airway obstruction, which may be directed by an interventional pulmonary physician or interventional radiologist. Thoracic surgeons have the benefit of considering the options for surgical tracheobronchial reconstruction along with therapeutic bronchoscopy, and the use of rigid or flexible bronchoscopy, or both, for a diverse armamentarium of therapeutic interventions. Thoracic surgeons are also frequently faced with unresectable patients referred with airway pathology or postoperative patients with airway complications that will benefit from endoscopic intervention.
In 1992 the Section of Thoracic Surgery at the University of Washington (Seattle, WA) established an airway surgery program directed at the surgical management of central airway obstruction. A large number of referred patients were surgically unresectable, yet suffered severe and life-threatening symptoms from airway obstruction. This resulted in the development of a large interventional bronchoscopy program as an adjunct to airway surgery, now with additional patients being referred from a large geographic area for therapeutic bronchoscopy. This report provides the details of the indications, techniques, and results of airway stenting in our practice.
| Patients and methods |
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Anesthetic induction permitted continued spontaneous ventilation by the patient until rigid bronchoscopy secured a stable airway. Rigid bronchoscopy was performed in all patients except 2 who had placement of expandable metal stents under flexible bronchoscopic and fluoroscopic guidance. Flexible bronchoscopy usually supplemented rigid bronchoscopy, with the flexible bronchoscope used through the rigid scope to improve distal airway visualization, perform initial exploration distal to an obstructive lesion, and assist in aspirating blood and secretions. Rigid bronchoscopy was performed with the 10-mm Storz bronchoscope ("Shapshay" Laser-Bronch-Tracheoscope; Karl Storz Endoscopy America, Inc, Culver City, CA), which has no internal light carrier and a smooth lumen that allows placement of silicone rubber stents (14 mm in diameter or smaller) directly through the lumen of the bronchoscope. Larger stents were placed by removing the rigid bronchoscope, performing direct laryngoscopy, and directly placing the stent through the vocal cords with grasping forceps, and then reintroducing the rigid bronchoscope for positioning of the stent under direct vision. Carinal Y-stents were placed in a similar fashion; this has been previously described by Acuff and colleagues [4]. Details of airway preparation for stenting by dilation or coring out a tumor have been previously described [1, 5].
The majority of stents were molded silicone rubber (Hood Laboratories, Pembroke, MA) with proximal and distal flanges or external studs to engage the airway and avoid dislodgment (Fig 1). Y-stents were smooth or surfaced with studs, but these were predominately held in place by their geometry at the carina. Silicone stents were frequently modified. These stents can be easily shortened or cut at an angle and the rough edges sanded smooth to conform to anatomy and preserve ventilation of adjacent lobes.
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| Results |
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Of 143 patients, a solitary stent was placed in 121 (85%), two stents in 16 (11%), and three stents in 6 (4%). A total of 209 stents were placed, and the type of stent and stent sizes are listed in Table 3. Eighty-seven percent of stents in this series were molded silicone rubber and 13% were expandable metal stents. The majority of patients (59%) required only one stent procedure, but a significant number of patients required two stent procedures (21%), 3 stent procedures (6%), 4 stent procedures (6%), 5 stent procedures (4%), or 6 or more stent procedures (4%) to maintain stent patency and airway palliation. Stent revisions made up 166 of 309 of the stent procedures: 16 (10%) for stent migration, 27 (16%) for stent granulations, 84 (51%) for stent secretions, and 39 (23%) for disease progression.
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After airway interventions 135 of 143 patients (95%) noted a significant improvement of their symptoms. Early patient outcomes were graded on a subjective clinical scale of no symptoms (27%), improved with mild symptoms (54%), improved with moderate symptoms (14%), minimal or no improvement (4%), or worsening of symptoms (1%).
The majority of patients were referred from outside of the Puget Sound region, representing 11 states. Most patients also had advanced disease, usually terminal cancer, combined with geographic considerations, which limited the practicality of returning to Seattle for follow-up care. The majority of patients with follow-up care had benign disease and often multiple stents for complex underlying pathology (eg, relapsing polychondritis). These patients are not necessarily representative of the overall patient population. Ninety-two patients (64%) had follow-up data beyond 1 month with a range of 1 to 86 months (mean, 14 months). There were 39 of 47 follow-up patients (83%) with benign disease and 53 of 96 follow-up patients (55%) with malignant disease. Thirty-seven of 39 patients with benign disease (95%) maintained good to excellent palliation at 2 to 86 months (mean, 28 months) after their original stent, although requiring further bronchoscopies for stent revision or cleaning in 30 of 39 (77%). Five patients with benign disease died, 2 from massive hemoptysis (no stent erosion on autopsy in either patient), 2 from respiratory failure independent of a patent stent, and 1 from a myocardial infarction. Forty-five of 53 patients with malignant disease (85%) maintained airway palliation for follow-up periods of 1 to 13 months (mean, 4 months), with 15 of 53 (28%) requiring further bronchoscopic interventions to maintain patency. Forty-six of 53 patients (87%) with malignant disease died, all apparently of expected disease progression. There were no known early or late deaths due to complications or malfunction.
| Comment |
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Although there are a variety of possible airway interventions, stenting is the principal endoscopic treatment available to manage intrinsic long-segment tracheobronchial stenosis (eg, tracheal amyloid, relapsing polychondritis) and extrinsic compression, predominately from adjacent unresectable tumors. An airway prosthesis is also an alternative treatment for a recalcitrant, unresectable benign stricture or for a recurrent obstructive endoluminal tumor.
It is difficult to assess the true effect of airway stenting because these patients are usually managed in a tertiary referral center that have limited follow-up data. In this series, 17% of patients with benign disease and 45% of patients with malignant disease had no follow-up data available beyond that of their original intervention. This certainly is a weakness of the current study and also most other similar series. It is difficult to determine, without 100% follow-up at the endoscopy center, whether patients failing to return are because of excellent results, poor results with an unwillingness to return for further intervention, or because of death from progression of the underlying disease. In fact, without careful radiologic and endoscopic evaluation, it is also difficult to determine whether recurrence of respiratory symptoms in cancer patients is caused by a failure of the stent procedure, or by the disease progression independent of the stent. Usually these patients have a terminal disease; without a randomized controlled series it is not possible to directly measure the impact of airway intervention on survival or quality of life. However, randomization would not be feasible because of the experience of interventional bronchoscopists with the immediate and gratifying relief patients gain after airway stenting, as well as the difficulty for dyspneic patients with anatomic airway obstruction to accept observation alone when a known intervention is available [7]. Therefore, we are limited to patient-controlled series to estimate the impact of tracheobronchial stenting. Using subjective patient symptoms to assess success in this series, 94% of patients had an immediate and significant improvement in their respiratory symptoms with no known stent related mortality and only one (< 1%) major complication requiring surgical management. This palliation also can be expected to be reasonably durable, with other patients showing a significant decrease in dyspnea at 3 months when stented for inoperable tracheobronchial cancer [8].
The increasing availability of expandable stents has resulted in a proliferation of interventional bronchoscopists and interventional bronchoscopy procedures. The ease of delivery of expandable stents is attractive, resulting in a lower threshold for consideration of airway stenting. Because of this, a number of patients with minimal symptoms or patients who are candidates for definitive surgical correction may have airway stents placed inappropriately. Unfortunately, these patients will likely require life-long management and can have stent obstruction develop, which requires revision. In the present series, 41% of patients required additional endoscopic interventions to maintain airway patency. This probably underestimates the true experience in patients with benign disease and a prolonged life-expectancy in which 77% of patients needed further intervention, even with only 28 months of mean follow-up. Our experience, along with other published reports, emphasizes the palliative nature of airway stenting, not replacing more reliable and durable surgical correction when possible.
Neither silicone nor the available metal stents conform to all the ideal characteristics for an endobronchial stent. Although each has their advocates, both of these general type of stents have their advantages and disadvantages. The primary advantage of the silicone stent is that it can be repositioned and removed easily. The molded silicone rubber has very little tissue reactivity with minimal granulations. Because it is a solid stent, there is no tumor ingrowth or granulations, although each may occur at the ends of the stent. Silicone stents are inexpensive and can be easily modified by cutting a portion of the stent to allow customization to the applicable airway anatomy. Finally, silicone stents have a defined diameter that prevents uncontrolled expansion. The major criticisms of silicone stents are the need for rigid bronchoscopy and general anesthesia, more difficult initial delivery, reduced inner diameter, and the potential for dislodgment or distortion [10].
Expandable metal stents overcome some of the disadvantages of the silicone stents. Perhaps the most profound characteristic, but the least important one is the ease of delivery of expandable stents, utilizing flexible bronchoscopy with fluoroscopy under topical anesthesia. These stents are stable with minimal complications of stent migration and conform well to distortions or curves within the airway. Uncovered stents have the theoretical benefit of neoepithelialization with incorporation of the stent into the airway wall and resumption of mucociliary clearance [9]. Unfortunately, the disadvantages of the expandable stents are significant. The most serious disadvantage of this kind of stent is that it is permanent, and once the stent is seated, it is nearly impossible to reposition or remove it. This may be especially troubling when tumor ingrowth or granulation tissue produces recurrent obstruction inside the stent, requiring repeated debridement or repeat stenting within the preexisting stent. Covered stents have much less difficulty with tumor and granulation ingrowth and are easier to remove, but still use bare metal portions at each end of the stent to allow stable seating. These areas still limit the ability to remove the stent and can be complicated by growth of tissue through the interstices [10].
Therapeutic bronchoscopy, including airway stenting, is an important component of a general thoracic surgical practice. The thoracic surgeon is uniquely able to consider the complex alternatives between surgery (nonstent endoscopic interventions) and tracheobronchial stenting. Thoracic surgeons are also the principal physicians still adept at rigid bronchoscopy, with its advantages in interventional bronchoscopy and the ability to place both kinds of stents (ie, silicone or expandable metal stents). Airway stenting provides an alternative that surgeons can offer to patients who present with unresectable central airway obstruction and may be useful to treat airway complications of thoracic surgery after lung transplantation or airway surgery.
It would be valuable to know how stent placement impacts longevity and quality of life in these patients. Temporary relief of dyspnea could possibly result in prolonged suffering in patients with end-stage cancer and may not necessarily provide meaningful palliation from the patients point of view. Although patients have a prompt improvement in their symptoms, and relief of impending suffocation, the lack of an untreated control group, or systematic follow-up, prevent firm conclusions about the intermediate and long-term efficacy of airway stenting. The dramatic improvement in patient symptoms, seen in 94% of patients in this series, creates enthusiasm and optimism in the interventional bronchoscopist, but frequently without the pragmatism that would be acquired by continued management of the patient. This issue was addressed in a recent study published in the Netherlands where physician-assisted suicide is accepted and end of life issues are dealt with directly between the general practitioner and patient. In this series of patients who were stented for airway obstruction from advanced lung and esophageal cancer, the general practitioner determined the efficacy of airway stenting for their patients. Although all patients expressed immediate symptomatic relief of dyspnea, only half of these patients were considered to have meaningful palliation as determined by their general practitioner. In approximately one quarter of the patients, the general practitioners were ambivalent about the benefit of airway stenting, and in another 22% of the patients, the survival was so brief that the stent procedure was considered futile [7]. It is likely that the apparent favorable results of this and similar series do not account for these factors that are best evaluated by a randomized controlled series or by this type of treatment evaluation from a neutral and unbiased physician.
Airway stenting does not replace tracheobronchial resection and reconstruction for resectable benign or malignant airway lesions, but it does offer immediate palliation of respiratory symptoms with an improved quality of life and frequently length of life as well. Therapeutic bronchoscopy and airway stenting should be a part of the general thoracic surgical practice, allowing the complete consideration of surgical or endoscopic management. Rigid bronchoscopy provides the largest variety of therapeutic interventions, including use of silicone stents with the advantages of ease of repositioning or removal. Long-term results are less clear, usually requiring repeated procedures to maintain airway patency.
| Discussion |
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DR WOOD: Well, your first question in terms of how we select patients, I have put an algorithm for the selection of patients up as the next slide. I did not show that before. Basically if we have patients with symptomatic obstruction that are resectable by the standard principles of airway resection, they would go on to resection. Patients with benign disease generally can be managed with repeated dilation, and it depends on how frequently you need to do that as to whether you may ultimately require a stent. For malacia or for amyloid or relapsing polychondritis, you are going to end up with a stent primarily. For malignant disease, if they have endobronchial tumor, we would core them out, laser, maybe perform brachytherapy depending on the extent of the tumor, and reserve a stent for recurrence of endobronchial tumor, but place a stent primarily if there is extrinsic compression.
In terms of whether it is appropriate outside of a referral center, I really think that it is only appropriate for a referral center, but the unfortunate nature of these patients is that they are patients that we are treating palliatively. They often do require repeated procedures, and when they are coming at a distance, it can be a complicating factor in coordinating their subsequent management. One of the problems is referring physicians thinking that stent placement is an end-therapy, and no further therapy is needed, and that is not usually the case.
DR LESLIE J. KOHMAN (Syracuse, NY): Doug, tell us a little bit more about relapsing polychondritis. And also, in those patients with the long tracheomalacia that you showed, how successful are you really? Some of these are young patients with no other very serious disease. How successful are you at managing them with stents for a prolonged period of time? Is it a very good therapy?
DR WOOD: It is a horrible therapy, but there is no reasonable other solution. I have 4 patients with relapsing polychondritis, and fortunately all 4 are still alive, and their airway disease is really their only disease. They have been the patients who have required the most repeated procedures with progression of airway stenting, until I have virtually a complete prosthetic airway from the subglottic larynx to lobar orifices. But one of my longest has been in place for 7 years now, and actually, as I was telling Dr. Grillo a couple of days ago, I have started to decannulate her. Where she previously had a TY-tube and a bronchus intermedius stent, she is now down to a T-tube because her distal areas have firmed up with time. Her proximal airways still have not. It is a terrible disease and stents are not a good therapy for it, but there is no other alternative, unfortunately. They will die otherwise.
DR HIRAN C. FERNANDO (Pittsburgh, PA): I enjoyed the presentation very much. Can you tell us in the benign group about your stent reintervention rate and whether the use of steroids or immunosuppression had any impact on your reintervention rate?
DR WOOD: I do not have data on that. Because that is such a varied group, your question implies that they are all anastomotic or benign stenoses and that it is related to granulations, in which case the use of steroids or other factors may help. The fact is that many of the benign lesions were systemic disorders such as tracheal amyloid or relapsing polychondritis, which were many of the repeated procedures. Except for the systemic treatment aspects of relapsing polychondritis, I do not know that any other local intervention is going to be beneficial to decrease the need for repeated procedures.
DR WALTER KLEPETKO (Vienna, Austria): I congratulate you on your large experience. I would like you to elaborate a little bit more on those patients who had more than one stent. Have these stents been within the trachea or in the distal bronchial system, and did those patients have even more problems than the other ones? The reason I ask you is that there is a stent available from Rusch Company in Germany, which is a metal-reinforced silicone stent that allows you to stent all the trachea for the whole length, going even in a Y-shape over the carina, and at least, in our experience, we have found an increasing use for that stent, which is able to carry very heavy tumor or pressure from outside. Do you have any experience with that?
DR WOOD: Well, I think that stent is very useful if one needs to stent all of the trachea and both main stem bronchi, but my philosophy has been to stent as little as possible and leave as much of the native airway uncovered by stent to improve mucociliary clearance and secretions management. You will probably next tell me about the flexible posterior wall of the stent and that it improves that as well. But where we have used multiple stents is in the setting where there is bilateral mainstem disease but not disease in the trachea. I do not generally think that those are great candidates for a Y-stent. I would much rather have a tubular stent in each main stem bronchus. And you saw in one of the patients that I showed, the disease had extended into the bronchus intermedius, and there I used two stents with an angled bevel on the right main stem stent that allows ventilation of the right upper lobe, yet the stents intussuscept along the medial wall, and then a separate stent in the left main stem. I do not think we have enough numbers to be able to tell you that the stent complications from them are greater or not than patients who require one stent. I would expect them to be greater just because the patients anatomy was more complicated.
DR JOSEPH S. FRIEDBERG (Philadelphia, PA): Doug, I enjoyed the talk. I have two questions for you: (1) have you been using the newer nitinol stents? I have found that they seem to have the advantage of ease of placement like the wall stents, but I have been able to take them out more easily. They do seem less reactive, but I dont have any long-term experience with them. (2) The algorithm question Mark Allen asked you for your additional slide, was that a plant?
DR WOOD: Fortunately it was not. As I reorganized the slides, that one ended up going out because of time considerations, but I knew it was there. And Mark just asked the question. It was perfect for the algorithm.
But back to your first question, the Ultraflex stent is a nitinol stent, and yes, that is what I have converted to completely for expandable stents over the Wall stent or Permalume stent. The reason that it is far easier to adjust or remove is because of its single-woven structure, as well as grabbing the suture at the proximal end of it which helps to collapse it down. The covered stents also are less incorporated, and when you pull the stent out, it comes out as one piece instead of a thousand pieces like a Wall stent does. For all of those reasons, I think that it has been a nice step up in expandable stents, but I have also suffered dealing with the complications of Ultraflex stents that have been placed by others. I still do not think that they are an automatic replacement for silicone rubber, which is still my stent of choice.
DR FRIEDBERG: Unless you are going across the right upper lobe, do you always use a coated stent?
DR WOOD: I prefer not to cover lobar orifices with stents.
DR FRIEDBERG: Do you use the covered stent all the time then?
DR WOOD: Yes, if the appropriate size is available. One of the problems with the covered stents is, because they require a bare end, in the very short lengths those stents are not covered. So if I need to stent, for example, the right main stem bronchus where I need a 2-cm stent, those stents do not come in the covered variety, so there it is not covered because it is just not available.
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T. Miyazawa, Y. Miyazu, Y. Iwamoto, A. Ishida, K. Kanoh, H. Sumiyoshi, M. Doi, and N. Kurimoto Stenting at the Flow-limiting Segment in Tracheobronchial Stenosis due to Lung Cancer Am. J. Respir. Crit. Care Med., May 15, 2004; 169(10): 1096 - 1102. [Abstract] [Full Text] [PDF] |
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