Intraoperative Bleeding Control with Terlipressin in Functional Endoscopic Sinus Surgery.

OBJECTIVE: To evaluate the use of terlipressin for intraoperative bleeding reduction in functional endoscopic sinus surgery (FESS). METHODS: This prospective, randomized, single-center, single-blinded cohort study included 74 cases of FESS performed under general anesthesia (GA). The patients were randomized into two groups: WT (without terlipressin, n = 39) and T (with 200 µg terlipressin, n = 35). Bleeding intensity (BI) was assessed using a 6-point scale. Heart rate (HR), mean blood pressure (MBP), perfusion index (PI), and BI were recorded at 10, 30, and 60 min after surgery. A BI score ≥2 qualified as significant. RESULTS: The T group had significantly higher MBP compared with the WT group, but HR values did not differ significantly. PI and BI scores were significantly reduced in the T group compared with the WT group. The risk of significant bleeding in the treatment group was 35.5 times lower (odds ratio [OR], 0.028; 95% confidence interval [CI], 0.006-0.138) at 30 min and 7.1 times lower (OR, 0.140; 95% CI, 0.049-0.402) at 60 min. The prognostic model for significant bleeding at 60 min showed that only terlipressin played a significant role in bleeding control (p < 0.05). The model predicted a 13.9-fold decrease in significant bleeding risk in the T group. CONCLUSION: Low doses (200 µg) of terlipressin reduced intraoperative bleeding without decreasing blood pressure during FESS under GA. LEVEL OF EVIDENCE: 2 Laryngoscope, 133:3313-3318, 2023.

Safety of high-power short pulse single spot diode laser stapedotomy: an experimental animal study.

BACKGROUND: We present a new method of diode laser stapedoplasty - high-power short-pulse mode with preliminary carbonization of the waveguide and a single spot of laser ablation. AIMS/OBJECTIVE: The aim of our research is the safety evaluation of presented mode 0.98 µm diode laser cochleostomy in guinea pigs. MATERIAL AND METHODS: Guinea pigs (n = 10) received 0.98 µm diode laser cochleostomy on one ear under general anesthesia. The control group was based on untreated ears (n = 10). The assessment of auditory function was performed using the distortion product otoacoustic emission (DPOAE) before and 7 d after surgery. To assess the degree of damage from the laser cochleas were extracted for histological examination. RESULTS: To evaluate the negative impact of laser energy on OHCs and auditory function, we analyzed DPOAE amplitudes for 6400 and 8000 Hz since high frequency. The paired Student's t-test showed no statistically significant difference between the two groups. The histological examination yielded no statistically significant difference in the number of intact OHCs in the two groups. CONCLUSION AND SIGNIFICANCE: Our study confirms that the proposed method of high-power short pulse diode laser stapedotomy is safe for the inner ear. Further prospective and randomized clinical trials are required to evaluate the possible benefits of this method.

Using thermal effect of 970 nm diode laser to reduce nasal swell body.

In recent decades, semiconductor lasers have been successfully used in rhinology. However, their usage in the reduction of the nasal swell body (NSB) is barely studied. Our research aimed to conduct an experimental selection of the laser exposure mode in the NSB zone using a 970 nm diode laser for safe and effective NSB reduction. The thermometric parameters of a diode laser with a wavelength of 970 nm were evaluated in a continuous contact mode of exposure at the power from 2 W to 10 W with 2 W step. The laser was targeted at the liver of cattle, given its similar optical properties to the NSB region. After a series of experiments with every power rate and the analysis of temperature data, we estimated an optimal exposure mode at a power of 4 W. The collected thermometric data demonstrate the safety of this mode in a clinical setting for NSB reduction due to causing no thermal damage to the adjacent tissue. Based on the experiment, a technique for laser reduction of the NSB was developed to improve nasal breathing in patients with severe hypertrophy of this area. The proposed technique was applied to 39 patients with chronic vasomotor rhinitis and the NSB. All patients were divided into 2 groups. Group 1 consisted of 20 patients who underwent surface contact laser-turbinectomy and the NSB reduction using a 970 nm diode laser. Group 2 included 19 patients with the same pathology who underwent laser-turbinectomy, without reduction of the NSB. No statistically significant difference was observed during the dynamic observation with an objective assessment of nasal respiration according to active anterior rhinomanometry when comparing these subgroups with each other according to the t-criterion for independent samples (p > 0.05). As a result of comparing the data obtained on the NOSE scale using the Student's t-test, a statistically significant difference is observed (p < 0.001). Thus, patients who did not perform the reduction of the NSB subjectively noted the insufficiency of nasal breathing. This fact indicates that the NSB is involved in the regulation of airflow.

Comparison of the efficiency and safety of endonasal and open rhinosurgery in children.

OBJECTIVES/HYPOTHESIS: The objective of this study was to compare the efficiency and safety of endonasal endoscopic maxillary surgery and the Caldwell-Luc approach in children. STUDY DESIGN: Case series. METHODS: A total of 121 children aged 9 to 17 years with chronic rhinosinusitis were included in the study. The patients were operated on using Caldwell-Luc (n = 36) and endoscopic maxillary surgery (n = 85) procedures. Efficiency and safety of the surgeries were assessed using pre- and postoperative endoscopic evaluation of the mucosa of the nasal cavity, 20-item Sino-Nasal Outcome Test (SNOT-20), and subjective (both children's and parents') evaluation of the outcomes. RESULTS: Endoscopic investigation of the mucosa of the nasal cavity demonstrated a significant improvement after both Caldwell-Luc and endoscopic surgery, although the Caldwell-Luc procedure did not result in significant improvement in mucosal color. However, no significant group difference was observed. Both techniques resulted in a significant improvement of mucosal edema and fluid characteristics. Based on the results of the SNOT-20, endoscopic maxillary surgery was characterized by a significant improvement in headache frequency, waking up at night, reduced concentration, ear pain, and emotional suppression as compared to Caldwell-Luc surgery. Although no significant group difference in efficiency between the Caldwell-Luc approach and endoscopic surgery was observed, the latter was characterized by a lower rate of scar formation, and reduced sensitivity, local painfulness, lacrimation, and psychologic discomfort. CONCLUSIONS: The obtained data demonstrate the higher efficiency and safety of endoscopic sinus surgery as compared to the Caldwell-Luc approach in children. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:1056-1063, 2020.

Efficacy and Safety of AM-111 in the Treatment of Acute Unilateral Sudden Deafness-A Double-blind, Randomized, Placebo-controlled Phase 3 Study.

OBJECTIVE: To confirm the efficacy and safety of AM-111 (brimapitide), a cell-penetrating c-Jun N-terminal Kinase (JNK) inhibitor, in patients suffering from severe to profound acute unilateral idiopathic sudden sensorineural hearing loss (ISSNHL). STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled phase 3 study with follow-up visits on Days 3, 7, 28, and 91. SETTING: Fifty-one European and Asian sites (tertiary referral centers, private ENT practices). PATIENTS: Two hundred fifty-six patients aged 18 to 65 years presenting within 72 hours following ISSNHL onset with mean hearing loss ≥ 40 dB and mean threshold ≥ 60 dB at the 3 worst affected contiguous test frequencies. INTERVENTIONS: Single-dose intratympanic injection of AM-111 (0.4 or 0.8 mg/ml) or placebo; oral prednisolone as reserve therapy if hearing improvement < 10 dB at Day 7. MAIN OUTCOME MEASURES: Hearing improvement to Day 28 was the primary efficacy endpoint; complete hearing recovery, frequency of reserve therapy used, complete tinnitus remission, improvement in word recognition were secondary endpoints. Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events. RESULTS: While the primary efficacy endpoint was not met in the overall study population, post-hoc analysis showed a clinically relevant and nominally significant treatment effect for AM-111 0.4 mg/ml in patients with profound ISSNHL. The study drug and the administration procedure were well tolerated. CONCLUSIONS: AM-111 provides effective otoprotection in case of profound ISSNHL. Activation of the JNK stress kinase, AM-111's pharmacologic target, seems to set in only following pronounced acute cochlear injury associated with large hearing threshold shifts.