37. Effect of topical steroid on swallowing following ACDF: results of a prospective randomized double blind control trial

BACKGROUND CONTEXT Dysphagia is a common complication in the setting of ACDF surgery. There is controversy in the literature regarding the effectiveness of Local Intraoperative Corticosteroids (LIC) in reducing postoperative dysphagia. This study aims to evaluate the effectiveness of LIC in decreasing the severity of swallowing difficulty following ACDF. PURPOSE To determine if the application of local intraoperative corticosteroids (LIC) during multilevels ACDF surgery impacts early postoperative dysphagia severity STUDY DESIGN/SETTING Double blinded randomized clinical trial early postoperative results. PATIENT SAMPLE A total of 106 adult patients undergoing primary multilevel ACDF (2-4 levels) at a single institution. OUTCOME MEASURES SWAL-QOL, Eat-10 (standard and modified). METHODS Patients who sustained a multilevel ACDF were enrolled and randomized in a double blinded fashion. Arm S (steroid) received 1ml (40mg) of methylprednisolone delivered with an absorbable hemostatic matrix (vehicle) to the retro-esophageal space prior to closure. The control arm (C) only received the vehicle prior to closure. Dysphagia specific instruments (EAT-10 and the SWAL-QOL) were collected preoperatively, and at day 1 (POD1), day 2 (POD2), and 1 month (M1) postoperatively. Potential randomization biases were assessed by comparing the preoperative characteristics and surgical treatment of the 2 arms. A Friedman test was used to investigate change over time in patient-reported outcomes (PRO); a Mann-Whitney U test was performed to compare the median PRO scores (S vs C) at each time points. RESULTS Out of the 106 enrolled patients, 95 (90%) had complete dataset and were included in the analysis. The overall mean age was 57.6 year-old, for a BMI of 29.4kg/m2, and 48.4% of female patients. The most common diagnoses were cervical spondylosis (63.2%), radiculopathy (48.4%), myeloradiculopathy (30.5%) and myelopathy (24.2%). The comparison of the C arm (n=47) and S arm (n=48) revealed no significant difference in demographics, diagnosis, or surgical information in terms of number of levels fused (1.5±0.6 vs 1.4±0.6, p = 0.521), Op time (150min±37 vs 136min±33 p = 0.065), or EBL (100cc±43 vs 91cc±52 p = 0.358). Preoperatively, there was also no significant difference in PRO, with the exception of the Eat-Desire domain (p=0.049, but similar median, 25th and 75th percentile). Overall and for each randomized arm, significant change in dysphagia scores were observed from pre- to postop. The comparison of postoperative PRO across the study arms revealed that the S arm had significantly better dysphagia scores than the control arm. At POD1, the S arm had better SWALL-QOL in ood selection (p=0.049, 87.5 [50-100] vs 75 [37.5-100]), and Fear (p=0.027, 100 [89-100] vs 93.7 [75-100]); at POD2 the S arm had better dysphagia scores in Burden (p=0.02), Eat Duration (p=0.008), Fear (p = 0.017), Fatigue (p=0.047), and modified Eat-10 (p=0.013). Finally, better dysphagia scores were maintained at M1 in terms of Eat Desire (p = 0.015), East duration (p=0.046), Fear Swallow (p=0.016), and Fatigue (p=0.003) CONCLUSIONS Both arms demonstrated similar preoperative characteristics and underwent similar surgical procedure. Our study demonstrated the benefit of LIC with this delivery method to prophylactically reduce dysphagia following ACDFs. Early postop results were superior for treatment group, especially postop days 2, and maintained at 1 month. FDA DEVICE/DRUG STATUS Unavailable from authors at time of publication. Dysphagia is a common complication in the setting of ACDF surgery. There is controversy in the literature regarding the effectiveness of Local Intraoperative Corticosteroids (LIC) in reducing postoperative dysphagia. This study aims to evaluate the effectiveness of LIC in decreasing the severity of swallowing difficulty following ACDF. To determine if the application of local intraoperative corticosteroids (LIC) during multilevels ACDF surgery impacts early postoperative dysphagia severity Double blinded randomized clinical trial early postoperative results. A total of 106 adult patients undergoing primary multilevel ACDF (2-4 levels) at a single institution. SWAL-QOL, Eat-10 (standard and modified). Patients who sustained a multilevel ACDF were enrolled and randomized in a double blinded fashion. Arm S (steroid) received 1ml (40mg) of methylprednisolone delivered with an absorbable hemostatic matrix (vehicle) to the retro-esophageal space prior to closure. The control arm (C) only received the vehicle prior to closure. Dysphagia specific instruments (EAT-10 and the SWAL-QOL) were collected preoperatively, and at day 1 (POD1), day 2 (POD2), and 1 month (M1) postoperatively. Potential randomization biases were assessed by comparing the preoperative characteristics and surgical treatment of the 2 arms. A Friedman test was used to investigate change over time in patient-reported outcomes (PRO); a Mann-Whitney U test was performed to compare the median PRO scores (S vs C) at each time points. Out of the 106 enrolled patients, 95 (90%) had complete dataset and were included in the analysis. The overall mean age was 57.6 year-old, for a BMI of 29.4kg/m2, and 48.4% of female patients. The most common diagnoses were cervical spondylosis (63.2%), radiculopathy (48.4%), myeloradiculopathy (30.5%) and myelopathy (24.2%). The comparison of the C arm (n=47) and S arm (n=48) revealed no significant difference in demographics, diagnosis, or surgical information in terms of number of levels fused (1.5±0.6 vs 1.4±0.6, p = 0.521), Op time (150min±37 vs 136min±33 p = 0.065), or EBL (100cc±43 vs 91cc±52 p = 0.358). Preoperatively, there was also no significant difference in PRO, with the exception of the Eat-Desire domain (p=0.049, but similar median, 25th and 75th percentile). Overall and for each randomized arm, significant change in dysphagia scores were observed from pre- to postop. The comparison of postoperative PRO across the study arms revealed that the S arm had significantly better dysphagia scores than the control arm. At POD1, the S arm had better SWALL-QOL in ood selection (p=0.049, 87.5 [50-100] vs 75 [37.5-100]), and Fear (p=0.027, 100 [89-100] vs 93.7 [75-100]); at POD2 the S arm had better dysphagia scores in Burden (p=0.02), Eat Duration (p=0.008), Fear (p = 0.017), Fatigue (p=0.047), and modified Eat-10 (p=0.013). Finally, better dysphagia scores were maintained at M1 in terms of Eat Desire (p = 0.015), East duration (p=0.046), Fear Swallow (p=0.016), and Fatigue (p=0.003) Both arms demonstrated similar preoperative characteristics and underwent similar surgical procedure. Our study demonstrated the benefit of LIC with this delivery method to prophylactically reduce dysphagia following ACDFs. Early postop results were superior for treatment group, especially postop days 2, and maintained at 1 month.