COVID-19 Airway Management Isolation Chamber.

OBJECTIVE: During the coronavirus pandemic (COVID-19), health care workers are innovating patient care and safety measures. Unfortunately, many of these are not properly tested for efficacy. The objective of this study was to determine the efficacy of the novel COVID-19 Airway Management Isolation Chamber (CAMIC) to contain and evacuate particulate. STUDY DESIGN: Multi-institutional proof-of-concept study. SETTING: Two academic institutions: Walter Reed National Military Medical Center (WRNMMC) and Madigan Army Medical Center (MAMC). SUBJECTS AND METHODS: Smoke, saline nebulizer, and simulated working port models were developed to assess the efficacy of the CAMIC to contain and remove ultrafine particles. Particulate counts were collected at set time intervals inside and outside the system. RESULTS: With the CAMIC on, smoke particulate counts inside the chamber significantly decreased over time: r(18) = -0.88, P < .001, WRNMMC; r(18) = -0.91, P < .001, MAMC. Similarly, saline nebulizer particulate counts inside the chamber significantly decreased over time: r(23) = -0.82, P < .001, WRNMMC; r(23) = -0.70, P < .001, MAMC. In the working port model, particulate counts inside the chamber significantly decreased over time: r(23) = -0.95, P < .001, WRNMMC; r(23) = -0.85, P < .001, MAMC. No significant leak was detected in the smoke, saline nebulizer, or working port model when the CAMIC was turned on. CONCLUSIONS: The CAMIC system appears to provide a barrier that actively removes particles from within the chamber and limits egress. Further studies are necessary to determine clinical applicability. The CAMIC may serve as an adjunct to improve health care worker safety and patient outcomes.

A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials.

IMPORTANCE: Transoral endoscopic head and neck surgery now plays an important role in the multidisciplinary management of oropharyngeal carcinoma. Previous generations of robotic surgical systems used a multiport system with a rigid stereo-endoscope and 2 wristed instruments that facilitated transoral robotic surgery. OBJECTIVE: To evaluate a new single-port robotic surgical system in head and neck surgery prospectively through concurrent nonrandomized clinical trials. DESIGN, SETTING, AND PARTICIPANTS: Two prospective clinical trials were conducted from December 16, 2016, to December 26, 2017, to assess the safety, feasibility, and performance of a flexible single-port robotic surgical system in 4 institutions, including 3 in the United States and 1 in Hong Kong. A total of 47 patients with tumors of the oropharynx were enrolled and underwent surgery. All patients were classified as having American Society of Anesthesiologists class I to III status and Eastern Cooperative Oncology Group status 0 to 1. An initial cohort of 7 patients underwent staging and endoscopic procedures for benign disease. The remaining 40 patients all had malignant tumors of the oropharynx. MAIN OUTCOMES AND MEASURES: Safety was measured by the incidence of device-related serious adverse events. Feasibility and performance were measured by the conversion rate from the use of the single-port robotic surgical system to either open surgery or the use of any other transoral technology required to complete the planned procedure. Secondary end points of swallowing function and surgical margins were also measured. RESULTS: All 47 patients (8 women and 39 men; mean [SD] age, 61 [8] years) safely underwent transoral resection with the single-port robotic surgical system without conversion to open surgery, laser surgery, or multiport robotic surgery. There were no intraoperative complications or device-related serious adverse events. Mean (SD) estimated intraoperative blood loss per procedure was 15.4 (23.9) mL; no patients received a transfusion. Two patients underwent a planned tracheotomy owing to medical comorbidity (previous chemoradiotherapy; obesity and severe sleep apnea). Two patients (4%) had grade III or IV postoperative hemorrhage, requiring a return to the operating room; however, both patients had medical comorbidities requiring the use of antithrombotic medication. The incidence of positive margins for patients with oropharyngeal malignancy was 3% (1 of 40). Within 30 days, 45 patients (96%) were eating by mouth and without the need for a percutaneous endoscopic gastrostomy tube. CONCLUSIONS AND RELEVANCE: This study describes the results of phase 2 clinical testing of a next-generation, robotic surgical system using a single-port architecture. The use of the device appears to be feasible, safe, and effective for transoral robotic surgery of oropharyngeal tumors. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT03010813 and NCT03049280.

Litigation Patterns in Inguinal Hernia Surgery: A 25 Year Review.

BACKGROUND: Inguinal herniorraphyis among the most common procedures performed by general surgeons, but risk factors for litigation related to this surgery are poorly defined. METHODS: Cases were retrieved by searching the Westlaw database from 1991 through 2016 using the search terms "inguinal hernia" OR "inguinal herniorrhaphy" OR "inguinal hernioplasty" and "medical malpractice." Data were compiled on the demographics of the patient, operative case details, nature of injury, legal allegations, verdicts, and indemnities. RESULTS: Forty-six cases met inclusion criteria and were selected for review. Verdicts for the defendant predominated (67%). The average plaintiff's monetary award for a plaintiff verdict or settlement was $1.21 million (median $500,000). The most frequent legal argument was improper performance (n = 35, 76%), followed by failure of informed consent (n = 14, 30%). The most common complications were nerve/chronic pain (n = 20, 45%) and testicular damage (n = 10, 23%). No association was discovered between case outcome and patient gender (P = 0.231) or age (P = 0.899). Case outcome was not different between open and laparoscopic repairs (P = 0.722). Patient mortality was not associated with case outcome (P = 0.311). There was no chronological trend in case outcome or award amount. Settlement award amounts were not significantly different than plaintiff awards (P = 0.390). CONCLUSIONS: Successful litigation after inguinal hernia surgery was relatively infrequent-only 21.7%-with an additional 10.9% resulting in settlement awards. Case outcome in litigation for hernia surgery was not predicted by patient demographics, type of procedure, or type of complication in this data set.

Determination of Tumor Margins with Surgical Specimen Mapping Using Near-Infrared Fluorescence.

For many solid tumors, surgical resection remains the gold standard and tumor-involved margins are associated with poor clinical outcomes. Near-infrared (NIR) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, for cancers with difficult imaging conditions, surgical value may lie in tumor mapping of surgical specimens. We thus evaluated a novel approach for real-time, intraoperative tumor margin assessment. Twenty-one adult patients with biopsy-confirmed squamous cell carcinoma arising from the head and neck (HNSCC) scheduled for standard-of-care surgery were enrolled. Cohort 1 (n = 3) received panitumumab-IRDye800CW at an intravenous microdose of 0.06 mg/kg, cohort 2A (n = 5) received 0.5 mg/kg, cohort 2B (n = 7) received 1 mg/kg, and cohort 3 (n = 6) received 50 mg. Patients were followed 30 days postinfusion and adverse events were recorded. Imaging was performed using several closed- and wide-field devices. Fluorescence was histologically correlated to determine sensitivity and specificity. In situ imaging demonstrated tumor-to-background ratio (TBR) of 2 to 3, compared with ex vivo specimen imaging TBR of 5 to 6. We obtained clear differentiation between tumor and normal tissue, with a 3-fold signal difference between positive and negative specimens (P < 0.05). We achieved high correlation of fluorescence intensity with tumor location with sensitivities and specificities >89%; fluorescence predicted distance of tumor tissue to the cut surface of the specimen. This novel method of detecting tumor-involved margins in surgical specimens using a cancer-specific agent provides highly sensitive and specific, real-time, intraoperative surgical navigation in resections with complex anatomy, which are otherwise less amenable to image guidance.Significance: This study demonstrates that fluorescence can be used as a sensitive and specific method of guiding surgeries for head and neck cancers and potentially other cancers with challenging imaging conditions, increasing the probability of complete resections and improving oncologic outcomes. Cancer Res; 78(17); 5144-54. ©2018 AACR.

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers.

Purpose: To demonstrate the safety and feasibility of leveraging therapeutic antibodies for surgical imaging. Procedures: We conducted two phase I trials for anti-epidermal growth factor receptor antibodies cetuximab-IRDye800CW (n=12) and panitumumab-IRDye800CW (n=15). Adults with biopsy-confirmed head and neck squamous cell carcinoma scheduled for standard-of-care surgery were eligible. For cetuximab-IRDye800CW, cohort 1 was intravenously infused with 2.5 mg/m2, cohort 2 received 25 mg/m2, and cohort 3 received 62.5 mg/m2. For panitumumab-IRDye800CW, cohorts received 0.06 mg/kg, 0.5 mg/kg, and 1 mg/kg, respectively. Electrocardiograms and blood samples were obtained, and patients were followed for 30 days post-study drug infusion. Results: Both fluorescently labeled antibodies had similar pharmacodynamic properties and minimal toxicities. Two infusion reactions occurred with cetuximab and none with panitumumab. There were no grade 2 or higher toxicities attributable to cetuximab-IRDye800CW or panitumumab-IRDye800CW; fifteen grade 1 adverse events occurred with cetuximab-IRDye800CW, and one grade 1 occurred with panitumumab-IRDye800CW. There were no significant differences in QTc prolongation between the two trials (p=0.8). Conclusions: Panitumumab-IRDye800CW and cetuximab-IRDye800CW have toxicity and pharmacodynamic profiles that match the parent compound, suggesting that other therapeutic antibodies may be repurposed as imaging agents with limited preclinical toxicology data.

Flexible next-generation robotic surgical system for transoral endoscopic hypopharyngectomy: A comparative preclinical study.

BACKGROUND: The purpose of this cadaveric study was to determine the efficacy of a flexible, next-generation robotic surgical system for transoral robotic hypopharyngectomy. METHODS: A comparative evaluation study of the flexible versus rigid robotic surgical systems for the hypopharynx was conducted using 3 cadavers. Endpoints for assessment were visualization of the hypopharynx, access to the hypopharynx, and difficulty of dissection. Hypopharyngectomy was performed on 3 other cadavers using the da Vinci Sp surgical system. RESULTS: Access to the apex of the pyriform sinus and the esophageal inlet was easier with the da Vinci Sp than with the da Vinci Si. Dissection with the da Vinci Sp was easier in all areas of the hypopharynx than with the da Vinci Si. Robotic hypopharyngectomy was successfully completed on all cadavers using the da Vinci Sp surgical system. CONCLUSION: Preclinical testing in human cadavers suggests that flexible robotic surgery may facilitate successful transoral hypopharyngectomy.

Otolaryngology and medical malpractice: A review of the past decade, 2001-2011.

OBJECTIVES/HYPOTHESIS: To better understand the causes and outcomes of lawsuits involving otolaryngologists in the past decade by analyzing malpractice litigation trends to prevent future litigation and improve physician education. STUDY DESIGN: Analysis of a national database for all US civil trials. METHODS: The Westlaw database was reviewed from 2001 to 2011. Data were compiled on the demographics of the plaintiffs, use of expert witnesses, procedures, nature of the injury, legal allegations, verdicts, and indemnities. RESULTS: One hundred ninety-eight cases met inclusion criteria. Verdicts for the defendant/otolaryngologist predominated (58%), whereas the average award when the verdict favored the plaintiff was $1,782,514. When otolaryngologists were used as expert witnesses by the defense, the verdict outcome statistically favored the defendant. Two of the most commonly cited legal allegations were improper performance and failure to diagnose and treat. Fifty-one cases involved allegations of wrongful death, with the overall outcome favoring the plaintiffs (51%). The average indemnities in these cases were significantly higher for plaintiff verdicts at $2,552,580 versus settlements at $992,896. Forty-two cases involved malignancy, with the two most common allegations being failure to diagnose and treat (79%) and delay in diagnosis (74%). CONCLUSIONS: Our study reveals that in the past decade, in significant malpractice litigations, overall outcomes favored otolaryngologists. The average awards was significantly higher when cases involved malignancy. Our analysis reveals the importance of meticulous surgical techniques and thorough preoperative evaluations. Last, when otolaryngologists are defendants in litigation, our review reiterates the value of the otolaryngologist as the defense's expert witnesses.

Lessons learned in otologic surgery: 30 years of malpractice cases in the United States.

OBJECTIVE: To analyze malpractice litigation trends to better understand the causes and outcomes of suits involving otologic surgeries to prevent future litigation and improve physician awareness. METHODS: Court records of legal trials from 1983 to 2012 were obtained from 2 major computerized databases-WESTLAW and LexisNexis. Data were compiled on the demographics of the defendant, plaintiff, use of otolaryngologists/otologists as expert witnesses, nature of injury, type of surgery, legal allegations, verdicts, and judgments. RESULTS: Fifty-eight unique cases met inclusion criteria and were selected for review. The most common surgeries that went to trial were mastoidectomy (48%), ossiculoplasty (21%), and tympanoplasty (16%). Eleven (19%) of the cases were resolved through a settlement before a verdict was reached. Verdicts in favor of the plaintiffs (31%) were awarded an average of $1,131,189. The most common alleged injuries were hearing loss (45%) and facial nerve injury (38%). Of the cases found in favor of the plaintiff, the most common reasons cited were improper performance of the surgery (50%), failure to properly diagnose and treat (33%), and inadequate informed consent and delay in diagnosis (22% each). Case outcomes involving pediatric patients were not significantly different than those of adults (p = 0.34); however, adults received higher financial awards on average ($1 million versus $232,000; p < 0.0003). CONCLUSION: Obtaining an appropriate diagnosis, thoroughly discussing all options and potential risks, presenting realistic expectations, and executing the surgery correctly are crucial to patient care. Understanding the reasons surgeons go to trial may assist in mitigating risk for potential lawsuits.

Salivary gland surgery and medical malpractice.

OBJECTIVE: To better understand the causes and outcomes of lawsuits involving salivary gland surgery by analyzing malpractice litigation trends to prevent future litigation and improve physician education. STUDY DESIGN: Analysis of a national database. SETTING: All US civil trials. SUBJECTS AND METHODS: The WESTLAW database was reviewed from January 1987 to March 2011. Data were compiled on the demographics of the defendant, anatomic site of injury, initial pathology, nature of injury, legal allegations, verdicts, and indemnities. RESULTS: Twenty-six cases met inclusion criteria and were selected for review. Verdicts/settlements for the plaintiffs predominated (58%), and the average sum of the plaintiff's monetary award was $933,235. Sixteen cases (62%) involved injury to the parotid gland/duct, with 10 cases involving injury to the facial nerve. No cases were filed on the grounds of failure to use facial nerve monitoring. Nine cases (35%) involved injury to the submandibular gland/duct. The most common legal allegations listed were improper performance followed by unnecessary procedures. If failure or inadequate consent was a component of the legal allegations, the verdict outcome significantly favored the defendants. CONCLUSION: Our study reveals that the plaintiffs in litigations involving salivary gland surgery have a slight advantage in outcomes with a fairly substantial award. Our litigation review reiterates the importance of detailed anatomic knowledge of the lingual and facial nerve to avoid the pitfalls of surgical error and consequent litigation. In addition, thorough preoperative evaluation of salivary gland pathology, including radiographic studies and needle biopsy, may help avoid errors in diagnosis and subsequent litigations.