Biocompatibility of “On-command” dissolvable tympanostomy tube in the rat model

Objectives/Hypothesis

A prototype tympanostomy tube, composed of polybutyl/methyl methacrylate-co-dimethyl amino ethyl methacrylate (PBM), was tested to 1) evaluate the effect of PBM tubes on rat dermis as a corollary for biocompatibility and (2) to observe the efficacy of dissolution with isopropyl alcohol (iPrOH) and ethanol (EtOH).

Study Design

Original animal experiment and bench testing.

Methods

A two-part study was conducted to assess biocompatible substance with inducible dissolvability as a critical characteristic for a newly engineered tympanostomy tube. First, tympanostomy tubes were inserted subcutaneously in 10 rats, which served as an animal model for biosafety, and compared to traditional tubes with respect to histologic reaction. Tissue surrounding the PBM prototype tubes was submitted for histopathology and demonstrated no tissue reactivity or signs of major inflammation. In the second part, we evaluated the dissolvability of the tube with either isopropyl alcohol, ethanol, ofloxacin, ciprodex, water, and soapy water. PBM tubes were exposed to decreasing concentrations of iPrOH and EtOH with interval qualitative assessment of dissolution.

Results

Histologic examination did not reveal pathology with PBM tubes. Concentrations of at least 50% iPrOH and EtOH dissolve PBM tubes within 48 hours, whereas concentrations of at least 75% iPrOH and EtOH were required for dissolution when exposure was limited to four 20-minute intervals.

Conclusions

PBM is biocompatible in the rat model. Additionally, PBM demonstrates rapid dissolution upon alcohol-based stimuli, validating the proof-of-concept of dissolvable on-command or biocommandible ear tubes. Further testing of PBM is needed with a less ototoxic dissolver and in a better simulated middle ear environment before testing can be performed in humans.

Level of Evidence

NA Laryngoscope, 2016

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Rapid maxillary expansion for pediatric obstructive sleep apnea: A systematic review and meta-analysis

Objectives/Hypothesis

To perform a systematic review with meta-analysis for sleep study outcomes in children who have undergone rapid maxillary expansion (RME) as treatment for obstructive sleep apnea (OSA).

Data Sources

PubMed/MEDLINE and eight additional databases.

Review Methods

Three authors independently and systematically reviewed the international literature through February 21, 2016.

Results

Seventeen studies reported outcomes for 314 children (7.6 ± 2.0 years old) with high-arched and/or narrow hard palates (transverse maxillary deficiency) and OSA. Data were analyzed based on follow-up duration: ≤3 years (314 patients) and >3 years (52 patients). For ≤3-year follow-up, the pre- and post-RME apnea–hypopnea index (AHI) decreased from a mean ± standard deviation (M ± SD) of 8.9 ± 7.0/hr to 2.7 ± 3.3/hr (70% reduction). The cure rate (AHI <1/hr) for 90 patients for whom it could be calculated was 25.6%. Random effects modeling for AHI standardized mean difference (SMD) is −1.54 (large effect). Lowest oxygen saturation (LSAT) improved from 87.0 ± 9.1% to 96.0 ± 2.7%. Random effects modeling for LSAT SMD is 1.74 (large effect). AHI improved more in children with previous adenotonsillectomy or small tonsils (73–95% reduction) than in children with large tonsils (61% reduction). For >3-year follow-up (range = 6.5–12 years), the AHI was reduced from an M ± SD of 7.1 ± 5.7/hr to 1.5 ± 1.8/hr (79% reduction).

Conclusions

Improvement in AHI and lowest oxygen saturation has consistently been seen in children undergoing RME, especially in the short term (<3-year follow-up). Randomized trials and more studies reporting long-term data (≥3-year follow-up) would help determine the effect of growth and spontaneous resolution of OSA. Laryngoscope, 2016

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Management of acute complicated mastoiditis at an urban, tertiary care pediatric hospital

Objectives/Hypothesis

To describe the presentation and management of acute complicated mastoiditis in children.

Study Design

Retrospective case series.

Methods

An analysis of pediatric patients with acute complicated mastoiditis treated at an urban, tertiary care children's hospital from 2007 to 2014 was performed.

Results

Forty-eight patients presented with a total of 67 complications of acute mastoiditis. Mean age at presentation was 4.8 years (range = 0.1–15.3 years). The most common complications were subperiosteal abscess (n = 22, 45.8%), epidural abscess (n = 16, 33.3%), and sigmoid sinus thrombosis (n = 14, 29.2%). The most common pathogens isolated included Streptococcus pneumoniae (n = 14, 29.2%) and group A streptococcus (n = 10, 20.8%). Multidrug resistance was not associated with complication type. Surgical management included myringotomy ± tympanostomy tube placement in 46 (95.8%) patients (the only surgery in 10), drainage of subperiosteal abscess without mastoidectomy in 18 (37.5%) patients, and mastoidectomy in 21 (43.8%) total patients. Patients presenting with intracranial complications were the most likely to undergo a mastoidectomy. Anticoagulation was used in the management of nine of 14 (64.3%) patients presenting with sigmoid sinus thrombosis. Neurosurgical interventions (n = 7, 14.6% patients) were primarily performed to manage increased intracranial pressure.

Conclusions

Subperiosteal abscess was the most common complication of acute mastoiditis, and when occurring as the sole complication was successfully managed with antibiotics and surgical intervention that did not include mastoidectomy. Epidural abscess and sigmoid sinus thrombosis were more prevalent than reported in prior series and were managed more aggressively. These patients were more likely to need neurosurgical interventions.

Level of Evidence

4. Laryngoscope, 2016

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Does drug-induced sleep endoscopy predict surgical success in transoral robotic multilevel surgery in obstructive sleep apnea?

Objectives/Hypothesis

The aim of this study was to determine if drug-induced sleep endoscopy (DISE) was predictive of success for patients undergoing transoral robotic surgery (TORS) and multilevel procedures for sleep apnea.

Study Design

Retrospective case series of patients who underwent TORS surgery for sleep apnea

Methods

Before and after polysomnograms were analyzed to assess improvement, success, and cure. Improvement was defined as any decrease in apnea-hypopnea index (AHI), success as an AHI <20 with a decrease >50%, and cure as an AHI <5. DISE videos were scored using the NOHL (nose, oropharynx, hypopharynx, larynx) and VOTE (velum, oropharynx, tongue, epiglottis) classification systems.

Results

One hundred one patients were available for analysis. Eighty-seven percent of patients had an improvement in their AHI. Fifty-one percent met criteria for success, whereas 17% were cured. The degree of collapse at individual NOHL and VOTE subsites as well as total additive scores did not predict improvement, success, or cure. Patients with no oropharyngeal lateral collapse in the VOTE classification system were more likely to improve following surgery (P = .001); however, this effect did not hold for success or cure. Multivariate analysis of DISE variables was not predictive of success.

Conclusions

In obstructive sleep apnea patients, there is a 51% success rate and a 17% cure rate. DISE, as scored by the NOHL and VOTE system, did not readily identify patients who would benefit most from surgery. Patients with lateral oropharyngeal collapse may be poorer candidates. Prospective, larger studies are required to further evaluate the use of DISE in predicting success following TORS.

Level of Evidence

4 Laryngoscope, 2016

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Optimal anesthetic regimen for ambulatory laser microlaryngeal surgery

Objectives/Hypothesis

Laser microlaryngeal surgery (LMS) is a short operation requiring brief and intense paralysis. Adequate muscle relaxation and rapid recovery of neuromuscular function are essential for improving surgical conditions and reducing the incidence of complications during LMS. However, the ideal muscle relaxant with a rapid onset and short duration of action is not yet available. Rocuronium has rapid onset at higher doses, but with a prolonged duration of action. Sugammadex is a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced neuromuscular blockade. This study aimed to compare the surgical conditions and anesthesia time between two combinations of neuromuscular blocker and reversal agent, rocuronium-sugammadex (R-S) and succinylcholine-cisatracurium-pyridostigmine (S-C-P), and propose an optimal anesthetic regimen for improving the surgical conditions in LMS patients.

Study Design

Prospective, randomized, double-blinded clinical study.

Methods

Patients in the R-S group received 1 mg/kg rocuronium bromide, whereas those in the S-C-P group received 1 mg/kg succinylcholine. After endotracheal intubation, 0.08 mg/kg cisatracurium was injected in S-C-P patients. After the procedure, R-S patients received 2 mg/kg sugammedex, whereas S-C-P patients received 0.2 mg/kg pyridostigmine plus 10 μg/kg atropine.

Results

In the R-S group, surgical condition scores were significantly higher and anesthesia time was significantly shorter. The use of additive neuromuscular blocking agents was significantly higher in the S-C-P group.

Conclusions

Muscle relaxation with rocuronium and reversal with sugammadex resulted in better surgical conditions and a shorter anesthesia time in patients undergoing LMS when compared to the S-C-P regimen.

Level of Evidence

1b Laryngoscope, 2016

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Is bevacizumab effective for reducing epistaxis in hereditary hemorrhagic telangiectasia?

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In reference to “Review of videolaryngoscopy pharyngeal wall injuries”

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