Cervical Fibrosis as a Predictor of Dysphagia.

OBJECTIVE: Radiotherapy of head and neck cancer (HNCA) causes dysfunction through radiation-induced fibrosis (RIF). We hypothesize that the degree of cervical fibrosis is associated with swallowing dysfunction. This study evaluated the association between cervical fibrosis and swallowing dysfunction in patients after radiation therapy for HNCA. STUDY DESIGN: Cross sectional study. METHODOLOGY: A convenience sample of patients with dysphagia who were at least 1 year post radiation therapy for HNCA underwent simultaneous cervical ultrasound (US) and video-fluroscopic swallow study (VFSS). US determinants of fibrosis were measurements of sternocleidomastoid fascia (SCMF) thickness bilaterally at the level of the cricoid. Primary and secondary outcome variables on VFSS were pharyngeal constriction ratio, a validated measure of pharyngeal contractility, and penetration aspiration scale (PAS). A qualitative assessment of lateral neck rotation was performed as a functional measure of neck fibrosis. RESULTS: Simultaneous cervical US and VFSS examinations were performed on 18 patients with a history of radiotherapy for HNCA and on eight controls. The mean (±SD) age of the entire cohort (N = 26) was 66 (±10) years. Individuals with a history of radiation had significantly thinner mean SCMF (0.26 [±0.04 mm]) compared to controls (0.48 [±0.06 mm]; P < .05). Individuals with thinner SCMF were more likely to have moderate to severe restriction in lateral neck rotation, a higher PCR, and a higher PAS (P < .05). CONCLUSION: Thinner sternocleidomastoid fascia on ultrasound in patients having undergone radiotherapy for head and neck cancer was associated with reduced lateral neck movement, poorer pharyngeal constriction and greater penetration/aspiration scale. The data suggest that cervical fibrosis is associated with swallowing dysfunction in head and neck cancer survivors and support the notion that, "As the neck goes, so does the swallow." LEVEL OF EVIDENCE: 3. Laryngoscope, 131:548-552, 2021.

Fluoroscopic Swallowing Abnormalities in Dysphagic Patients Following Anterior Cervical Spine Surgery.

OBJECTIVES: To evaluate the precise objective fluoroscopic abnormalities in persons with dysphagia following anterior cervical spine surgery (ACSS). METHODS: 129 patients with dysphagia after ACSS were age and sex matched to 129 healthy controls. All individuals underwent videofluoroscopic swallow study (VFSS). VFSS parameters abstracted included upper esophageal sphincter (UES) opening, penetration aspiration scale (PAS), and pharyngeal constriction ratio (PCR). Other data collected included patient-reported outcome measures of voice and swallowing, number of levels fused, type of plate, vocal fold immobility, time from surgery to VFSS, and revision surgery status. RESULTS: The mean age of the entire cohort was 63 (SD ± 11) years. The mean number of levels fused was 2.2 (±0.9). 11.6% (15/129) were revision surgeries. The mean time from ACSS to VFSS was 58.3 months (±63.2). The majority of patients (72.9%) had anterior cervical discectomy and fusion (ACDF). For persons with dysphagia after ACSS, 7.8% (10/129) had endoscopic evidence of vocal fold immobility. The mean UES opening was 0.84 (±0.23) cm for patients after ACSS and 0.86 (±0.22) cm for controls (P > .0125). Mean PCR was 0.12 (±0.12) for persons after ACSS and 0.08 (±0.08) for controls, indicating significant post-surgical pharyngeal weakness (P < .0125). The median PAS was 1 (IQR 1) for persons after ACSS as well as for controls. For ACSS patients, PCR had a weak correlation with EAT-10 (P < .0125). CONCLUSION: Chronic swallowing dysfunction after ACSS appears to be secondary to pharyngeal weakness and not diminished UES opening, the presence of aspiration, vocal fold immobility, or ACSS instrumentation factors.Level of Evidence: 3b.

Swallowing Characteristics in Zenker's-like Diverticulum After Anterior Cervical Spine Surgery.

OBJECTIVES: A Zenker's diverticulum (ZD) is a hypopharyngeal pulsion diverticula caused by dysfunction of the cricopharyngeus muscle with herniation of hypopharyngeal mucosa through Killian's dehiscence. Anterior cervical spine surgery (ACSS) can cause a Zenker's-like traction diverticulum (ZTD) with a similar presentation but different pathophysiology. The purpose of this investigation was to compare the fluoroscopic parameters and surgical outcomes of ZTD after ACSS to those of typical ZD. STUDY DESIGN: Case-control study. METHODS: The charts of patients undergoing a videofluoroscopic swallow study after ACSS between January 1, 2014, and January 1, 2018, were evaluated for evidence of ZTD. Patients with ZTD were age and gender matched to persons with ZD. Fluoroscopic parameters and patient-reported outcomes were compared between groups. RESULTS: Eleven patients with ZTD were identified. The mean pharyngeal constriction ratio (PCR) was significantly higher for persons with ZTD (0.87 [±0.07] vs. 0.17 [±0.08]; P < 0.05). Mean hyolaryngeal elevation was significantly less (2.5 [±0.9] cm vs. 3.5 [±0.7] cm) and mean diverticulum size significantly smaller (1.3 [±1.0] cm vs. 2.3 [±2.0] cm) for persons with ZTD (P < 0.05). Five ZTD patients had exposed hardware necessitating open approach for removal. CONCLUSION: We report the largest cohort of ZTD after ACSS. ZTD are smaller than traditional Zenker's and associated with more pharyngeal weakness, poorer laryngeal elevation, and worse treatment outcomes. Although these diverticula can be managed endoscopically, the high percentage of exposed cervical hardware necessitates a thorough preoperative assessment and frequent need for open management and pharyngeal repair. LEVEL OF EVIDENCE: 3b Laryngoscope, 130:1383-1387, 2020.

A late-binding, distributed, NoSQL warehouse for integrating patient data from clinical trials.

Clinical trial data are typically collected through multiple systems developed by different vendors using different technologies and data standards. That data need to be integrated, standardized and transformed for a variety of monitoring and reporting purposes. The need to process large volumes of often inconsistent data in the presence of ever-changing requirements poses a significant technical challenge. As part of a comprehensive clinical data repository, we have developed a data warehouse that integrates patient data from any source, standardizes it and makes it accessible to study teams in a timely manner to support a wide range of analytic tasks for both in-flight and completed studies. Our solution combines Apache HBase, a NoSQL column store, Apache Phoenix, a massively parallel relational query engine and a user-friendly interface to facilitate efficient loading of large volumes of data under incomplete or ambiguous specifications, utilizing an extract-load-transform design pattern that defers data mapping until query time. This approach allows us to maintain a single copy of the data and transform it dynamically into any desirable format without requiring additional storage. Changes to the mapping specifications can be easily introduced and multiple representations of the data can be made available concurrently. Further, by versioning the data and the transformations separately, we can apply historical maps to current data or current maps to historical data, which simplifies the maintenance of data cuts and facilitates interim analyses for adaptive trials. The result is a highly scalable, secure and redundant solution that combines the flexibility of a NoSQL store with the robustness of a relational query engine to support a broad range of applications, including clinical data management, medical review, risk-based monitoring, safety signal detection, post hoc analysis of completed studies and many others.