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National Institute for Health and Clinical Excellence 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 lungs, 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). IP overview: endoscopic balloon dilatation for subglottic or tracheal stenosis Page 1 of 23 IP 938 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. IP overview: endoscopic balloon dilatation for subglottic or tracheal stenosis Page 2 of 23 IP 938 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. IP overview: endoscopic balloon dilatation for subglottic or tracheal stenosis Page 3 of 23 IP 938 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 IP overview: endoscopic balloon dilatation for subglottic or tracheal stenosis Page 4 of 23 IP 938 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
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