aryngotracheal stenosis (LTS) is a broad set of diagnoses encompassing a heterogeneous group of fibroinflammatory conditions relating to narrowing of the glottis, supraglottis, subglottis, and trachea. 1 The subset of patients with isolated subglottic stenosis accounts for nearly half of LTS cases. 2 Idiopathic subglottic stenosis (iSGS) is a rare and slowly progressive condition with an unknown primary cause that results in fibrosis of the subglottic airway. It generally presents in otherwise healthy middle-aged white women with symptoms of dyspnea and stridor. [3][4][5][6] Current management of iSGS relies on a combination of surgical and adjuvant therapies based on physician preference and individual patient needs. Many patients can be treated suc-cessfully through endoscopic intervention, but owing to the recurrent nature of iSGS, greater than 85% of these patients required repeated intervention within 5 years. 7 Routine follow-up is necessary to monitor for recurrence of stenosis between interventions and as a means of quantifying response to treatment.The use of pulmonary function tests (PFTs) for the diagnosis of upper airway obstruction was first described in the 1960s, and several studies have since identified PFT values that can be used to follow gradual change in the degree of stenosis over time. [8][9][10][11][12][13][14] In 2013, Nouraei et al 9 established the expiratory disproportion index (EDI) as a highly sensitive and specific tool for differentiating LTS from other illnesses that pre-IMPORTANCE Because of the recurrent nature of idiopathic subglottic stenosis, routine follow-up is necessary for monitoring progression of stenosis. However, no easily accessible, standardized objective measure exists to monitor disease progression.OBJECTIVE To determine whether peak expiratory flow (PEF) can be used as a reliable and easily accessible biometric indicator of disease progression relative to other validated spirometry measures in patients with idiopathic subglottic stenosis.
DESIGN, SETTING, AND PARTICIPANTSProspectively collected data on PEF, expiratory disproportion index (EDI), and total peak flow (TPF) from 42 women with idiopathic subglottic stenosis without comorbid lower airway or parenchymal lung disease who were treated at a single tertiary referral center between 2014 and 2018 were analyzed. The mean follow-up period was 18.2 months (range, 2-40 months). Ten patients initially screened were not included in the analysis owing to comorbid glottic or supraglottic stenosis or nonidiopathic etiology.
MAIN OUTCOMES AND MEASURESMeasurements of PEF, EDI, and TPF were taken at preoperative visits and at all other visits. RESULTS Forty-two women (mean age, 51.5 years; 98% white [n = 41]) met the inclusion criteria. The area under the curve for PEF was 0.855 (95% CI, 0.784-0.926). The optimal cutoff value was 4.4 liters per second (264 L/min), with a sensitivity and specificity of 84.4% and 82.0%, respectively. The area under the curve for EDI was 0.853 (95% CI, 0.782-0.925). For TPF, this was 0.836 (...
Objectives/Hypothesis
The purpose of this study was to develop and provide evidence of a novel permanent injectable biomaterial for vocal fold augmentation with the potential to treat glottic incompetence by evaluating its performance in two animal models.
Study Design
Animal model.
Methods
Microporous annealed particle (MAP) hydrogel was fabricated using a water‐in‐oil emulsion method and synthetically tuned to match the stiffness modulus of native vocalis muscle. Thirty‐two New Zealand White rabbits were administered unilateral injections of MAP (n = 16), saline (n = 8), and the clinical standard hyaluronic acid (Restylane‐L) (n = 8), and evaluated at day 0, and 6‐week, 4‐month, and 6‐month endpoints. Induced vocal fold vibration was recorded with a high‐speed camera prior to euthanization, with glottic closure and mucosal wave characteristics assessed both quantitatively and qualitatively by an experienced voice clinician. Histologic analysis was performed to assess scaffold permanence, immunogenicity, and vascularization within the scaffold.
Results
Histologic analysis confirmed the MAP gel treatment group maintained its volume without migration for 6 months postimplantation. Immune staining showed minimal to nonexistent immunogenicity over the course of the implant lifetime. Extensive tissue integration and vascularization was observed histologically within the MAP gel group by immunofluorescence staining. Mucosal wave was not impaired by any of the injected materials, including the MAP gel augmentation.
Conclusions
MAP gel is a nonresorbable biostimulatory injectable implant that provides superior tissue integration, stiffness matching, and permanence compared to current injectable implants, with retained biomechanical function, suggesting its potential as a new therapeutic for glottic incompetence.
Level of Evidence
NA Laryngoscope, 130:2432–2441, 2020
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