IP 938

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of endoscopic balloon dilatation for subglottic or tracheal stenosis

Treating narrowed airways by inserting an inflatable balloon Subglottic or tracheal stenosis is a narrowing of the airway between the throat and the , which can cause wheezing, hoarseness and shortness of breath. It often occurs after a person has needed to use a breathing tube. In this procedure, a balloon device is inserted into the airway and inflated to apply pressure and widen the airway. Introduction

The National Institute for Health and Clinical Excellence (NICE) has prepared this overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared

This overview was prepared in July 2011 and updated in December 2011. Procedure name

Endoscopic balloon dilatation for subglottic or tracheal stenosis Specialty societies

British Association of Otorhinolaryngologists, Head and Neck Surgeons (ENT UK) British Association of Paediatric Otolaryngologists (BAPO) British Paediatric Respiratory Society (BPRS).

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Description

Indications and current treatment

Subglottic or tracheal stenosis is a narrowing of the airway that can be congenital, traumatic or, most commonly, iatrogenic after prolonged endotracheal intubation. Symptoms include hoarseness, stridor, exercise intolerance and respiratory distress. In severe cases complete obstruction may occur, requiring continued intubation or tracheostomy.

Treatment options include inhaled or oral steroids to treat inflammation and reduce the severity of stenosis. A cricoid-split operation can decompress the subglottis and prevent development of stenosis in neonates. For people with severe and established stenosis, endoscopic techniques such as stent insertion or laser ablation are used. Alternatively, open surgical repair is performed to either increase the diameter of the stenosed segment with a graft or stent (expansion surgery) or to remove the stenotic area (resection surgery).

What the procedure involves

The aim of endoscopic balloon dilatation is to dilate airway strictures with minimal mucosal trauma by applying pressure to an area of stenosis.

The procedure is usually done under general anaesthesia and using direct laryngoscopic or bronchoscopic visualisation. A balloon device is introduced into the airway and the balloon is gently inflated, applying radial pressure circumferentially to the stricture. After dilatation, the balloon is deflated and the device withdrawn. The procedure may be used in combination with other measures and techniques such as steroid treatment and the endoscopic techniques described above. The procedure can be repeated if required. Literature review

Rapid review of literature

The medical literature was searched to identify studies and reviews relevant to endoscopic balloon dilatation for subglottic/tracheal stenosis. Searches were conducted of the following databases, covering the period from their commencement to 25 November 2011: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

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The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved.

Table 1 Inclusion criteria for identification of relevant studies Characteristic Criteria Publication type Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patient Patients with subglottic or tracheal stenosis. Intervention/test Endoscopic balloon dilatation. Outcome Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Language Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base.

List of studies included in the overview

This overview is based on approximately 209 patients from 7 case series and one case report1–8.

Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A.

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Table 2 Summary of key efficacy and safety findings on endoscopic balloon dilatation for subglottic or tracheal stenosis

Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Durden F (2007)1 Number of patients analysed: 10 The report states that there were no Follow-up issues: complications. There were no losses to Case series Operative success follow-up. USA In all patients, control of the airway was established. Study design issues: Recruitment period: not reported (1-year period) Small sample size. Study population: infants with acquired subglottic 4 patients were completely asymptomatic after stenosis secondary to a history of intubation the initial balloon dilatation and had a residual Study population issues: n = 10 grade 1 subglottic stenosis noted on control 3 of the 10 patients had Mean age: 5 months (range 2–12) endoscopy 2−4 weeks after extubation. gastroesophageal reflux, 1 Sex: 30% (3/10) female of which was described as An additional 3 patients had recurrent stridor severe. Patient selection criteria: patients were excluded if they during the post-operative period and required 3 patients had a coexisting had other coexisting tracheal pathologic conditions, a second balloon dilatation before having subglottic cyst. congenital subglottic stenosis, previous intervention for complete, persistent resolution of symptoms. 1 patient had a vascular their subglottic stenosis, or comorbidities requiring a ring that required high likelihood of prolonged ventilation in the future. In The procedure failed in 3 patients, of whom 2 concurrent management. all patients, the stenosis was limited to the subglottis went on to undergo single-staged and was less than 1 cm in thickness. laryngotracheal reconstruction and 1 with severe reflux to undergo tracheostomy. Technique: oesophageal or angioplasty balloon catheter inserted into the stenotic segment under direct telescopic visualisation. An endotracheal tube was inserted into the dilated airway for oxygenation and then removed to perform a bronchoscopy. Patients were left intubated for 24−48 hours and treated with systemic steroids. A proton pump inhibitor was administered during the post-operative period.

Mean follow-up: 3.5 months

Conflict of interest/source of funding: none

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Bent JP (2010)2 Number of patients analysed: 10 The report states that there were no Follow-up issues: complications. There were no losses to Case series Operative success follow-up. USA Stridor or respiratory symptoms were One balloon ruptured uneventfully during eliminated or improved in all patients on post- dilatation in a patient who was excluded Study design issues: Recruitment period: 2007–09 operative day 1 or post-extubation day 1. The from the study on the basis of age (21 Retrospective case series. Study population: children with subglottic or tracheal immediate post-dilatation airway increased by years old). Small sample size. stenosis an average factor of 4.9 (range 1.9–9). n = 10 Study population issues: Mean age: 24.5 months (range 3 months–9 years) 6 patients required repeat procedures (with a 3 patients had Sex: 40% (4/10) female maximum of 3), with an average interval tracheostomies. between dilatations of 67 days (range 6–337). 6 patients had recurrent Patient selection criteria: age younger than 18 years; stenosis after previous subglottic or tracheal stenosis. Outcome of balloon dilatation at follow-up laryngotracheoplasty. (mean 10 months): 9 patients had subglottic Technique: endotracheal intubation was avoided when Symptoms resolved = 40% (4/10) stenosis and 1 had tracheal possible. An appropriately sized angioplasty balloon Symptoms improved = 30% (3/10) stenosis. catheter was inserted in the stenosis and dilated. After Tracheostomy still required = 30% (3/10) dilatation of the airway, the patient was awakened. (all patients had previous Although the initial patients were intubated overnight if laryngotracheoplasty; all patients were they did not have a tracheostomy, more recent patients described as progressing toward were managed as outpatients. All patients received a decannulation). single dose of intraoperative systemic steroids, with additional doses if clinically indicated. All patients The 3 tracheostomy-dependent patients were received empiric antacid therapy until the subglottis noted to have more diffuse and chronic healed. inflammation of the larynx in comparison with those whose condition had responded to Mean follow-up: 10 months (range 4–23) treatment.

Conflict of interest/source of funding: not reported. 6 patients had undergone previous laryngotracheoplasties. Symptoms of subglottic stenosis resolved or improved in 3 of these (including 2 children aged over 2 years at presentation), but tracheostomy was required in 3 (mean follow-up of 12.5 months).

Patients who were intubated after surgery did not fare as well as those who did not have tracheostomy or intubation.

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Bétrémieux P (1995)3 Number of patients analysed: 11 (1 patient Complications: Study design issues: recovered without treatment and 1 died before Small sample size. Case series endoscopy could be performed) 1 infant went into cardiac arrest during the France dilatation session and was resuscitated Study population issues: Operative success without sequelae. In 6 patients, stenosis was Recruitment period: 1988–92 1 patient had 6 balloon dilatation sessions, 1 observed in the Study population: infants with tracheobronchial stenosis patient had 3 sessions, 3 patients had 2 1 patient had postdilatation rather than the . n = 13 sessions and 6 patients had only 1 session. pneumothorax, which was successfully One of these patients Mean age: 29 days drained. recovered without Sex: 54% (7/13) female Treatment was beneficial for 63.6% (7/11) of treatment. patients. Within a few hours of dilatation, there One patient developed Patient selection criteria: mechanically ventilated were improvements in respiratory function, severe cerebral lesions and newborn babies with tracheobronchial stenosis (7 lower atelectasis disappeared and ventilation died before endoscopy trachea, 3 right main bronchus, 4 left main bronchus). requirements were reduced. Patients were could be performed. extubated within 6 to 39 days after the start of Technique: A Fogarty 2F arterial embolectomy catheter the dilatation sessions. (Edwards, USA) was introduced through a bronchoscope and the balloon inflated with air 3 or 4 ‘Within a 5-month to 5-year perspective, these times during the same session. The patient was then 7 infants had no clinical respiratory sequelae reintubated, anaesthesia suspended and the child was and their chest radiographs were normal.’ transferred under conventional ventilation. When the lesions looked inflamed, glucocorticoid treatment was Of the remaining 4 patients, stenosis persisted given after endoscopy. despite several dilatation sessions. 2 patients died after developing severe Follow-up: not reported bronchopulmonary dysplasia (at 41 and 75 days respectively); 1 patient died from Conflict of interest/source of funding: not reported pulmonary infection on day 150 and the fourth patient died from tension pneumothorax with cardiac arrest within hours of a second dilatation on day 28.

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Hebra A (1991)4 Number of patients analysed: 37 (158 Complications: Study design issues: procedures) Atelectasis = 1.9% (3/158) Retrospective review. Case series Tracheitis = 1.3% (2/158) USA Mean number of procedures per patient = 4 Asymptomatic pneumomediastinum Study population issues: = 0.6% (1/158) 48.6% of patients had Recruitment period: 1975–90 Operative success Tracheal laceration = 1.3% (2/158) previously undergone an Study population: patients with airway stenosis Immediate improvement (subjective Carbon dioxide retention = 0.6% open procedure with less n = 37 improvement in breathing patterns) = 90% (1/158) than satisfactory results. (142/158) Stent displacement = 1.3% 54% of patients required Mean age: 5 years (range 34 days to 22 years) (2/158)(outcome not described) previous tracheostomies for Sex: not reported ‘Long-term’ improvement (with a minimum management of their airway follow-up of 2 months) = 54% (20/37) There were 4 deaths, 1 of which was obstruction. Patient selection criteria: not reported. Patients had (includes patients who had their tracheostomy reported to be related to the procedure. A 2 patients had bronchial laryngeal stenosis (n = 2), congenital tracheal stenosis tubes successfully removed, patients free of patient with severe stenosis at the carina stenosis. (4 subglottic, 5 complete rings), acquired tracheal airway problems, and patients weaned from following open tracheoplasty for complete stenosis (12 prolonged intubation as newborn, 8 endotracheal intubation) tracheal rings and pulmonary artery sling Other issues: prolonged intubation, 1 caustic inhalation, 2 smoke syndrome developed a bronchial leak The authors noted that inhalation, 1 external trauma) and bronchial stenosis 50% (10/20) of patients with tracheostomy had following his fourth dilatation (he was chronic strictures that are (n = 2) proceeded to extubation at the time of report. undergoing weekly dilatations). Although calcific or well formed do a repair was done, the post-operative not respond well to balloon Technique: A balloon-tipped catheter initially developed course was extremely complicated and dilatation. for percutaneous transluminal angioplasty was used. respiratory insufficiency led to his death. Methods used to assess The balloon was inserted under direct vision. Once fully effects of the procedure not dilated with 1 balloon, a larger size may be inserted to 2 patients died at home, probably described. dilate the stenosis incrementally. Adjuvant techniques secondary to airway obstruction from a used included electrocautery for removal of exuberant mucus plug. The fourth death occurred in tissue, steroids and intraluminal stents. All patients had a child treated by a different surgical team a short-term stent inserted, consisting of a pliable with laser for recalcitrant laryngeal endotracheal tube, used with systemic steroids and stenosis. Acute laryngeal obstruction antibiotics given for a period of 72 hours. occurred after discharge, presumably from oedema. Follow-up: not reported

Conflict of interest/source of funding: not reported

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Kim JH (2007)5 Number of patients analysed: 97 (124 balloon Complications: Follow-up issues: dilatation sessions) 7 sessions of balloon Case series Tracheobronchial lacerations occurred dilatation were lost to Korea Operative success after 51.6% (64/124) of procedures. follow-up immediately after Stenosis recurrence rate during follow-up: the procedure. Recruitment period: 1998–2006 Overall = 35.9% (42/117) 94% (60/64) of the lacerations were Study population: patients who underwent balloon Patients with lacerations = 31.7% (19/60) superficial, 6% (4/64) were deep and Study design issues: dilatation for benign tracheobronchial strictures Patients without lacerations = 40.4% none were transmural. The main aim of the study n = 97 (23/57) was to determine the Of the 64 patients with lacerations, 5 (8%) incidence and clinical Mean age: 42 years (range 10–82) Median cumulative airway patency rate had mild chest pain and 21 (33%) patients significance of Sex: 72% (90/97) female (months): had blood-tinged sputum − all resolved tracheobronchial Patients with lacerations = 24 ± 12.4 within 24 hours. lacerations after balloon Patient selection criteria: exclusion criteria were Patients without lacerations = 4 ± 0.8, dilatation. multiple strictures (n = 4), patients without follow-up p < 0.05 Of the 4 patients with deep lacerations, 2 bronchoscopy after balloon dilatation (n = 2), those in had pneumomediastinum and 1 had Study population issues: whom the procedure failed (n = 1). Stenotic sites: subcutaneous emphysema − all resolved Most patients had bronchial 22 trachea, 67 main bronchus, and 8 lobar bronchus. within 24 hours. stenosis; 23% (22/97) of patients had tracheal Technique: the patients were sedated and an All 60 superficial lacerations healed stenosis. angioplasty balloon catheter (Boston Scientific) was spontaneously within 1 month. Strictures were caused by inserted under fluoroscopic guidance. Bronchoscopy tuberculosis (n = 72), post- was done in all patients before and after dilatation. The deep lacerations healed after 2−9 tracheostomy/post- months with conservative treatment. intubation (n = 12), post- Mean follow-up: 6 months (range 0.2–66) operative anastomotic 3 risk factors were identified for stricture (n = 13). Conflict of interest/source of funding: none lacerations: female gender; lesions at the trachea; and strictures caused by Other issues: tuberculosis, tracheostomy or intubation. The authors note that a superficial or deep laceration could be regarded as an expected result of sufficient balloon dilatation rather than as a complication.

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Shitrit D (2010)6 Number of patients analysed: 35 The report states that there were no minor or major complications attributable to Study design issues: Case series All patients had initial success characterised balloon dilatation procedure (including Retrospective. Israel by increased luminal dimensions and laceration or chest pain). symptom relief. There were no technical Study population issues: Recruitment period: 2002–08 failures. The patient population is Study population: patients with confirmed symptomatic heterogeneous, including stenosis Increase in FEV1 and FEV1/FVC = 10.5% benign and malignant n = 35 (14 bronchial stenosis after (p = 0.03 for both parameters) aetiologies. transplantation, 6 bronchial and 1 tracheal stenosis Other issues: due to malignancy, 11 tracheal stenosis due to Increased lung function was still evident at 1- The authors describe prolonged , 2 tracheal month follow-up. balloon dilatation as a stenosis due to Wegener granulomatosis, and 1 temporary measure, as broncheal stenosis due to sarcoidosis) 71% (25/35) of all patients required stent many patients will require placement (at 210 ± 91 days after balloon definitive or additional Mean age: 49 years dilatation) for long-term improvement. treatment with laser or stent Sex: 51% (18/35) female placement. Patients with tracheal stenosis due to Patient selection criteria: not reported prolonged ventilation (n = 11): Requirement for stent insertion during Technique: a flexible fibreoptic endoscope was used follow-up = 36% (4/11) with fluoroscopy. An angioplastic balloon catheter was Mean number of dilatations = 1 used for dilatation (Medi-tech, USA). The balloon Time from balloon dilatation to stent = 30 inflations were repeated until the stenosis disappeared. days Bronchoscopic examination was repeated to check for local trauma or bleeding. All 11 patients were alive at last follow-up (total follow-up reported as 420 ± 255 days). Mean follow-up: 33 months

Conflict of interest/source of funding: not reported

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Lee KH (2008)7 Number of patients analysed: 6 The report states that there were no Follow-up issues: complications. 4 of the 6 patients were Case series Operative success followed up for at least 10 USA A consecutive dilatation was done within 7 months, 1 was followed up days for 2 patients. for 6 months and another Recruitment period: 2004–07 for 4 months. Study population: adults with idiopathic subglottic All patients were asymptomatic after the stenosis procedure. In all patients, the airway was Study design issues: n = 6 dilated 2−3.5 endotracheal tube sizes larger Small sample size. than the initial size. Mean age: 51 years (range 41–60) Study population issues: Sex: 100% (6/6) female 2 patients required additional dilatations 1 of the 6 patients had prior beyond their initial treatments (1 at 22 months laser treatments and a Patient selection criteria: adults with a single discrete and 1 at 6 months post-operatively). Both of cricotracheal resection, and stenosis in the subglottis; diagnosis of idiopathic these patients developed slowly progressive 1 patient had a previous subglottic stenosis based on ruling out other causes. dyspnoea on exertion. scar band lysis procedure.

Technique: New Blue Max balloon catheters (Boston 4 patients were followed up for 10−30 months Other issues: Scientific) were used. Airway size was determined without symptoms of recurrent airway The authors noted that this before and after dilatation with endotracheal tubes. stenosis. procedure was used as a temporary treatment for Follow-up: up to 30 months idiopathic subglottic stenosis but that it may Conflict of interest/source of funding: not reported potentially be used in a select group of patients as a definitive treatment.

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Abbreviations used: FEV1, forced expiratory volume in the first second; FVC, forced vital capacity Study details Key efficacy findings Key safety findings Comments Knott PD (2004)8 Number of patients analysed: 1 Transmural tracheobronchial The main aim of the case disruption report was to describe the Case report reconstruction of the USA Patient with multiple comorbidities was tracheobronchial tree admitted to hospital for recurrent disruption with bovine Recruitment period: not reported pneumonia with respiratory failure and pericardium. ultimately required tracheostomy. The Study population: patient with high-grade tracheal patient was decannulated shortly after stenosis hospital discharge. n = 1 Age: 72 years 6 weeks later, the patient had expiratory Sex: female stridor. Bronchoscopy revealed a high- grade stenosis at the level of the tracheal Patient selection criteria: not reported stoma. Balloon dilatation was partially effective and uncomplicated. After a Technique: manometrically monitored dilatation with a second dilatation procedure, some 20 Fr FogartyTM balloon cather (Baxter, USA). bleeding was noted and bronchoscopy revealed a 1.5 cm mucosal rent of the Follow-up: not reported membranous trachea. A tracheostomy tube was placed but ventilation became Conflict of interest/source of funding: not reported difficult and bronchoscopy showed dehiscence of the membranous tracheal wall.

An emergency thoracotomy was done and the injury was repaired. The patient made an uneventful recovery.

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Efficacy

Symptom relief A case series of 10 infants with acquired subglottic stenosis reported that 70% (7/10) had resolution of symptoms after the first or second balloon dilatation1. A case series of 10 children with subglottic or tracheal stenosis reported that symptoms were resolved or improved in 70% (7/10) at follow-up (mean 10 months)2.

A case series of 13 infants with tracheobronchial stenosis reported that balloon dilatation was beneficial for 64% (7/11) of patients. Within a few hours of dilatation, there were improvements in respiratory function, atelectasis was resolved and ventilation requirements were reduced. Patients were extubated between 6 and 39 days after the dilatation sessions started3.

A case series of 37 patients reported immediate improvement after 90% (142/158) of balloon dilatation sessions. ‘Long-term’ improvement (with a minimum follow-up of 2 months) was reported in 54% (20/37) of patients. At the time of report, 50% (10/20) of patients with tracheostomy had proceeded to extubation4.

A case series of 35 patients, which included 11 patients with tracheal stenosis after prolonged mechanical ventilation, reported that all patients had initial symptom relief6.

Restenosis rates A case series of 97 patients reported restenosis after 36% (42/117) of procedures during a mean follow-up of 6 months5.

A case series of 35 patients, which included 11 patients with tracheal stenosis after prolonged mechanical ventilation, reported that 36% (4/11) of patients required stent insertion 30 days after balloon dilatation6.

Safety

Death A case series of 37 patients reported 1 death which was thought to be related to balloon dilatation. A patient with severe stenosis at the carina following open tracheoplasty for complete tracheal rings and pulmonary artery sling syndrome developed a bronchial leak following his fourth dilatation (he was undergoing weekly dilatations). Although a repair was done, the post-operative course was extremely complicated and respiratory insufficiency led to his death4.

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Tracheal laceration A case series of 37 patients reported tracheal laceration after 1% (2/158) of procedures4. A case series of 97 patients reported tracheobronchial lacerations after 52% (64/124) of procedures, all of which resolved spontaneously; 94% (60/64) of the lacerations were described as superficial and 6% (4/64) were deep; none was transmural5.

A case report described a patient who had a transmural tracheobronchial disruption after a second balloon dilatation procedure for tracheal stenosis. The injury was repaired by open surgery and the patient recovered8.

Asymptomatic pneumomediastinum The case series of 37 patients reported asymptomatic penumomediastinum in 0.6% (1/158) of procedures4.

Carbon dioxide retention The case series of 37 patients reported carbon dioxide retention in 0.6% (1/158) of procedures (outcome not reported)4.

Other A case series of 13 infants reported that 1 infant went into cardiac arrest during the dilatation session and was resuscitated without sequelae. Another patient had post- dilatation pneumothorax, which was successfully drained3.

Two case series, each including 10 infants with subglottic or tracheal stenosis, reported that there were no complications.

Validity and generalisability of the studies

The studies were heterogeneous with regard to patient populations and included adults, children and infants with acquired and congenital subglottic or tracheal stenosis. Three studies included patients with bronchial stenosis as well as those with subglottic or tracheal stenosis3,4,5. Studies that only included patients with bronchial stenosis were excluded. Most of the studies had small sample sizes. In one study, patients had a short-term stent inserted as well as balloon dilatation4. None of the studies used the CE marked device available for use in airways. The studies did not use objective validated methods to compare symptoms before and after the procedures Most studies reported that several sessions of dilatation were required to achieve an improvement in symptoms.

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Existing assessments of this procedure

There were no published assessments from other organisations identified at the time of the literature search.

Related NICE guidance

There is currently no NICE guidance related to this procedure. Specialist Advisers’ opinions

Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The advice received is their individual opinion and does not represent the view of the society.

John Rubin, Gurpreet Sandhu (British Association of Otorhinolaryngologists, Head and Neck Surgeons [ENT UK]), Neil Bateman, Haytham Kubba (British Association of Paediatric Otolaryngologists) Three Specialist Advisers perform the procedure regularly. Three Advisers consider the procedure to be established practice and no longer new, one Adviser described the procedure as a minor variation of an existing procedure (radial laser incisions). Adverse events known from reports or experience include bleeding, tracheobronchial tears and airway obstruction. Theoretical safety concerns include rupture of the trachea or bronchi, pneumothorax, arytenoid dislocation, aspiration of balloon fragments or acute airway obstruction from balloon fragments if balloon ruptures, and tracheobronchomalacia. There are anecdotal reports of vocal cord avulsion. Key efficacy outcomes include anatomical improvements (seen in endoscopy or radiological imaging), spirometry/flow volume loops, tracheostomy decannulation rates or avoidance of tracheostomy, avoidance of major open airway surgery, improvement in stridor, exercise tolerance, shortness of breath and voice. One Adviser noted that there is controversy in the management of subglottic stenosis relating to external surgical excision versus endotracheal laser versus endotracheal steroid injection versus stenting. Patient selection is important. Patients should be managed with multidisciplinary support. One Adviser stated that practitioners should be experienced in suspension laryngoscopy and/or rigid bronchoscopy. Another stated that paediatric anaesthetists with good airway experience are essential. Facilities should include an established paediatric airway service in a large regional children’s hospital with experienced surgeons and hopefully sufficient back-up to deal with rare adverse events such as tracheal rupture – paediatric cardiac team on site and/or extracorporeal membrane oxygenation (ECMO) facilities would be ideal, plus a paediatric intensive care unit (PICU). There are currenly 8–0 tertiary referral centres for paeditric airway surgery where the procedure is likely to be used.

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All four Specialist Advisers thought that the procedure would have a minor impact on the NHS, in terms of patient numbers and use of resources. Patient Commentators’ opinions

NICE’s Patient and Public Involvement Programme was unable to gather patient commentary for this procedure. Issues for consideration by IPAC

Although the original scope for this procedure was restricted to children, it was decided to include evidence for all age groups in the overview. Studies that only included patients with bronchial stenosis were excluded. Although there is a balloon catheter device that has been CE marked for use in the airways, none of the identified studies used it.

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References

1. Durden F, Sobol SE (2007) Balloon laryngoplasty as a primary treatment for subglottic stenosis. Archives of Otolaryngology − Head and Neck Surgery 133: 772–5.

2. Bent JP, Shah MB, Nord R et al. (2010) Balloon dilation for recurrent stenosis after pediatric laryngotracheoplasty. Annals of Otology, Rhinology and Laryngology 119: 619–27.

3. Bétrémieux P, Treguier C, Pladys P et al. (1995) Tracheobronchography and balloon dilatation in acquired neonatal tracheal stenosis. Archives of Disease in Childhood Fetal and Neonatal Edition 72: F3–7.

4. Hebra A, Powell DD, Smith CD et al. (1991) Balloon tracheoplasty in children: results of a 15-year experience. Journal of Pediatric Surgery 26: 957–61.

5. Kim JH, Shin JH, Shim TS et al. (2007) Tracheobronchial laceration after balloon dilation for benign strictures: incidence and clinical significance. Chest 131: 1114–7.

6. Shitrit D, Kuchuk M, Zismanov V et al. (2010) Bronchoscopic balloon dilatation of tracheobronchial stenosis: long-term follow-up. European Journal of Cardiothoracic Surgery 38: 198–202.

7. Lee KH, Rutter MJ (2008) Role of balloon dilation in the management of adult idiopathic subglottic stenosis. Annals of Otology, Rhinology and Laryngology 117: 81–4.

8. Knott PD, Lorenz RR, Eliachar I et al. (2004) Reconstruction of a tracheobronchial tree disruption with bovine pericardium. Interactive Cardiovascular and Thoracic Surgery 3: 554–6.

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Appendix A: Additional papers on endoscopic balloon dilatation for subglottic or tracheal stenosis

The following table outlines the studies that are considered potentially relevant to the overview but were not included in the main data extraction table (table 2). It is by no means an exhaustive list of potentially relevant studies.

Article Number of Direction of conclusions Reasons for patients/ non-inclusion follow-up in table 2 Andrews BT, Graham SM, Ross A et n = 18 Combined Nd:YAG laser incision and balloon Combined laser al. (2007) Technique, utility, and dilation in an awake, spontaneously breathing radial incision safety of awake tracheoplasty using patient is a safe and effective management and balloon combined laser and balloon dilation. FU = 22 tool in the treatment of dilatation. Laryngoscope 117: 2159-2162.. months laryngotracheostenosis. Asai T (2006) Unexpected subglottic n = 1 Paediatric Case report. stenosis in an infant. Anaesthesia 61: Successful balloon dilatation of subglottic 302–3. stenosis. Axon PR, Hartley C, Rothera MP n = 1 Paediatric Case report. (1995) Endoscopic balloon dilatation Successful balloon dilatation of subglottic of subglottic stenosis. Journal of stenosis in a child who had not responded to Laryngology and Otology 109: 876–9. conventional endoscopic techniques. Bagwell CE, Talbert JL, Tepas JJ III n = 4 Paediatric Larger studies (1991) Balloon dilatation of long- All 4 children improved following dilatation are included. segment tracheal stenoses. Journal and 3 were doing well at 2.5, 3 and more than of Pediatric Surgery 26: 153–9. 3 years’ follow-up. One infant eventually died of airway obstruction incurred by severe . Cohen MD, Weber TR, Rao CC n = 1 Paediatric Case report. (1984) Balloon dilatation of tracheal Successful balloon dilatation of tracheal and and bronchial stenosis. AJR bronchial stenosis. American 142: 477–8. Hoffman GS, Thomas-Golbanov CK, n = 21 Intralesional corticosteroids with dilatation is Combination of Chan J et al. (2003) Treatment of an effective treatment for Wegener’s technigues used subglottic stenosis, due to Wegener’s granulomatosis. (microsurgical granulomatosis, with intralesional Mean lysis, steroid, corticosteroids and dilation. Journal follow-up = ditation with of Rheumatology 30: 1017–21. 41 months bougies or balloon). Number of balloon dilatations not stated. Jaffe RB (1997) Balloon dilation of n = 6 Paediatric Small case congenital and acquired stenosis of Symptomatic improvement and increased series including the trachea and bronchi. Radiology lumen diameter occurred in 4 of the 6 2 patients with 203: 405–9. patients. bronchial stenosis. Serial dilations were necessary to effect a long-term cure. There were no complications.

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Lee KH, Ko GY, Song HY et al. n = 14 Initial symptomatic improvement = 83% Results reported (2002) Benign tracheobronchial (trachea) (49/59). together for stenoses: long-term clinical FU = Recurrence of symptoms during follow-up = bronchial and experience with balloon dilation. 32 months 80% (39/49). tracheal Journal of Vascular and stenoses. Interventional Radiology 13: 909–14. Complications: 2 deep mucosal lacerations and 1 bronchospasm. Low SY, Hsu A, Eng P (2004) n = 7 Adults Combination of Interventional bronchoscopy for (trachea) Mean increase in diameter of tracheal lesions techniques was tuberculous tracheobronchial was from 4.5 mm at baseline to 12 mm post- used stenosis. European Respiratory procedure. (mechanical or Journal 24: 345–7. balloon All patients had immediate relief of symptoms. dilatation, laser Repeated sessions may be required to and stenting). maintain improvement. Mayse ML, Greenheck J, Friedman M n = 20 Balloon dilatation was the only Combination of et al. (2004) Successful (tracheal intervention in 26% of patients. techniques used bronchoscopic balloon dilation of stenosis) (mechanical nonmalignant tracheobronchial debridement, obstruction without fluoroscopy. 1 balloon ruptured during inflation without stenting, laser Chest 126: 634-637. clinically significant effect. No other photoresection complications occurred. and balloon 100% of airway obstructions were improved. dilatation).

Messineo A, Forte V, Joseph T et al. n = 3 Paediatric Larger studies (1991) The balloon posterior tracheal FU = 2 children died of complications of congenital are included. split: a technique for managing 9 months heart disease 2 weeks after balloon dilatation tracheal stenosis in the premature but the 3rd child was alive and well without infant. Journal of Pediatric Surgery airway symptoms at 9 months old. 27: 1142–4. Mirabile L, Serio PP, Baggi RR et al. n = 18 Endoscopic anterior cricoid split and Combination of (2010) Endoscopic anterior cricoid Median FU balloon dilatation. techniques. split and balloon dilation in pediatric = 15 Four patients (22.2%) needed one and 14 subglottic stenosis. International months patients (77.7%) required several (from 4 to 7) Journal of Pediatric additional balloon dilations during the Otorhinolaryngology 74: 1409-1414. postoperative endoscopic controls. Treatment was efficient in 83% (15/18) of patients. Noppen M, Meysman M, D'Haese J n = 93 Bronchoscopic balloon dilatation was helpful Combination of et al. (1997) Interventional (mixed in the mechanical dilatation of stenoses, and techniques used bronchoscopy: 5-year experience at indications) in the unfolding of unopened stents. (laser surgery, the academic hospital of the Vrije stenting and Universiteit Brussel (AZ-VUB).Acta balloon Clinica Belgica 52: 371-380. dilatation).

Noppen M, Schlesser M, Meysman M n = 3 Adults Larger studies et al. (1997) Bronchoscopic balloon Bronchoscopic balloon dilatation is a simple, are included. dilatation in the combined inexpensive, safe, and efficient adjunct in the management of postintubation combined treatment of severe post-intubation stenosis of the trachea in adults. rigid tracheal stenosis in selected adults Chest 112: 1136-1140. Nouraei SAR, Obholzer R, Ind PW et n = 18 Intralesional steroid therapy and conservative Combination of al. (2008) Results of endoscopic endoluminal surgery is an effective strategy techniques used surgery and intralesional steroid for treating airway compromise due to active (steroids, laser therapy for airway compromise due tracheal and bronchial Wegener’s surgery and to tracheobronchial Wegener’s granulomatosis. balloon granulomatosis. Thorax 63: 49–52. dilatation).

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Article Number of Direction of conclusions Reasons for patients/ non-inclusion follow-up in table 2 Nouraei SAR, Ghufoor K, Patel A et n = 62 Adults Combination of al. (2007) Outcome of endoscopic 98% of reinterventions occurred within 6 techniques used treatment of adult postintubation months. (steroids, laser tracheal stenosis. Laryngoscope 117: surgery and 1073–9. Patients with old and long lesions are less balloon likely to be cured endoscopically. dilatation). Nouraei SAR, Singh A, Patel A et al. n = 21 Adults Combination of (2006) Early endoscopic treatment of Early intervention has the potential to improve techniques used acute inflammatory airway lesions the outcome of post-intubation airway (steroids, laser improves the outcome of stenosis. surgery and postintubation airway stenosis. balloon Laryngoscope 116: 1417–21. dilatation). Rahman NA, Fruchter O, Shitrit D et n = 115 All patients underwent balloon dilatation as an Patients also al. (2010) Flexible bronchoscopic initial temporary relieving procedure. treated by laser, management of benign tracheal stent insertion stenosis: long term follow-up of 115 Median FU and/or patients. Journal of cardiothoracic = 51 brachytherapy. surgery 5: 2. months Rees CJ (2007) In-office unsedated n = 12 No tracheal disruptions after balloon dilation Review with no transnasal balloon dilation of the of the trachea. detailed patient esophagus and trachea. Current outcomes. Opinion in Otolaryngology and Head and Neck Surgery 15: 401–5. Tsui KY, Yu HR, Hwang KP et al. n = 1 Paediatric Case report. (2009) When parents opted not to Long-segment congenital tracheal stenosis perform surgery for a long-segment managed by several sessions of balloon congenital tracheal stenosis child: dilatation as the primary treatment. flexible bronchoscopic balloon tracheoplasty as the primary treatment. European Journal of Cardio-Thoracic Surgery 36:219–21. Watters K, Russell, J (2008) The n = 1 Paediatric Case report. cutting balloon for endoscopic Endoscopic dilatation using a cutting balloon. dilatation of pediatric subglottic stenosis. International Journal of Pediatric Otorhinolaryngology Extra 3: 39-43. Weber TR, Connors RH, Tracy TFJr. n = 20 (rigid Paediatric Combination of (1991) Acquired tracheal stenosis in or balloon Most patients required several techniques and techniques infants and children. Journal of dilatation) repeated procedures to achieve used. Thoracic and Cardiovascular Surgery ‘decannulation’. 102: 29–34. Zias N, Chroneou A, Tabba MK et al. n = 9 Tracheal stenosis after endotracheal Combination of (2008) Post tracheostomy and post (balloon intubation and tracheal stenosis after techniques intubation tracheal stenosis: report of dilatation) tracheostomy differ in aetiology and used. 31 cases and review of the literature. pathogenesis and should be considered as 2 BMC pulmonary medicine 8: 18. different entities.

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Appendix B: Related NICE guidance for endoscopic balloon dilatation for subglottic or tracheal stenosis There is currently no NICE guidance related to this procedure.

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Appendix C: Literature search for endoscopic balloon dilatation for subglottic or tracheal stenosis

Database Date searched Version/files Cochrane Database of 25/11/2011 Issue 6, June 2011 Systematic Reviews – CDSR (Cochrane Library) Database of Abstracts of 25/11/2011 Reviews of Effects – DARE (CRD website) HTA database (CRD website) 25/11/2011 Cochrane Central Database of 25/11/2011 Issue 6, June 2011 Controlled Trials – CENTRAL (Cochrane Library) MEDLINE (Ovid) 25/11/2011 1948 – June Week 3 2011 MEDLINE In-Process (Ovid) 25/11/2011 June 28, 2011 EMBASE (Ovid) 25/11/2011 1980 to 2011 Week 25 CINAHL (NLH Search 2.0) 25/11/2011

Trial sources searched on 29 June 2011

Current Controlled Trials metaRegister of Controlled Trials – mRCT Clinicaltrials.gov National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN CC) Portfolio Database

Websites searched on 29 June 2011 National Institute for Health and Clinical Excellence (NICE) Food and Drug Administration (FDA) − MAUDE database French Health Authority (FHA) Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP – S) Australia and New Zealand Horizon Scanning Network (ANZHSN) Conference search General internet search

The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases.

1 trachea/

2 glottis/

3 (trache* or glotti* or laryngotrach* or subglot* or windpip* or airway*).tw.

4 or/1-3

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5 constriction, pathologic/

6 (steno* or narrow* or constric* or contract* or reduc* or tighten* or malform* or stricture*).tw.

7 5 or 6

8 4 and 7

9 laryngostenosis/

10 laryngosteno*.tw.

11 tracheal stenosis/

12 (trache* adj3 steno*).tw.

13 (respiratory adj3 (distress* or difficult*)).tw.

14 edema/

15 or/9-14

16 8 or 15

17 balloon dilation/

18 (balloon* adj3 (dilat* or expand* or inflat* or catheter*)).tw.

19 17 or 18

20 endoscopy/

21 laryngoscopy/

22 endoscope/

23 laryngoscope/

24 (endoscop* or laryngoscop*).tw.

25 or/20-24

26 19 and 25

27 16 and 19

28 16 and 26

29 27 or 28

30 animals/ not humans/

31 29 not 30

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32 Limit 31 to English language

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