Oropharyngeal Bleeding Research Articles

Computed tomographic features of suspected arterial pseudoaneurysm in the head and neck of four dogs.

Computed tomography is a valuable diagnostic technique in the clinical work-up of dogs with oropharyngeal trauma and bleeding. Traumatic extravasation can manifest as a pseudoaneurysm. A pseudoaneurysm is an extraluminal accumulation of blood that is contained by the adventitia layer or neighboring tissues. The purpose of this retrospective, multicenter, observational case series study was to describe the CT features in dogs with presumed oropharyngeal arterial pseudoaneurysm and its potential association with trauma. Imaging archives were searched for canine patients with head and neck CT studies showing visible extravasation of contrast-enhanced blood contained by soft tissue structures. Medical records of these patients were reviewed for oropharyngeal bleeding or trauma and reported. Four dogs met the inclusion criteria. CT findings included a well-defined, confined area of vascular contrast enhancement adjacent to the common carotid artery or its branches. The mean contrast enhancement in the corresponding artery and pseudoaneurysm lesion was similar, suggesting that these lesions represent active arterial extravasation. Four-dimensional CT was performed in one case and demonstrated contrast medium leaking from an artery and being contained by adjacent soft tissue structures. All dogs had a history and imaging findings consistent with oropharyngeal bleeding and trauma. Arterial pseudoaneurysm should be considered as a differential diagnosis in dogs with oral trauma and CT features of a well-defined, periarterial, strongly contrast-enhancing lesion.

Double aortic arch and aortotracheal fistula as cause of fatal massive bleeding: a rare and dangerous association

To present a clinical case with an unusual association of DAA with ATF and to reinforce the importance of maintaining high diagnostic suspicion in patients with massive aerodigestive bleeding without an obvious source. A 32-week preterm newborn who required prolonged mechanical ventilation and presented intermittent episodes of massive oropharyngeal bleeding with hemodynamic compromise associated with lower airway obstruction without pulmonary hemorrhage. The patient underwent upper endoscopy and exploratory laparotomy without evidence of bleeding. Flexible nasopharyngolaryngoscopy and direct laryngoscopy also showed no abnormalities. A CT angiography showed complete DAA with indentation of the left dominant arch over the trachea, without severe stenosis or evidence of a fistula. AEF was suspected, so exploratory surgery was considered. However, the patient died before surgery due to a massive pulmonary hemorrhage. The autopsy revealed the presence of ATF. In patients with massive aerodigestive bleeding without an obvious source, the presence of DAA and possible AEF/ ATF should be considered. Imaging studies have a poor performance for this diagnosis, so surgery should be considered for diagnosis and treatment in these patients.

Spontaneous Oropharyngeal Bleeding Caused by Lingual Artery Pseudo-Aneurysm.

Spontaneous oropharyngeal bleeding is an uncommon but serious medical emergency mainly caused by accidental trauma or post-tonsillectomy. In extremely rare cases, it can be attributed to arterial pseudoaneurysm (PA) of head and neck vessels. The authors present the case of a young female patient presenting with recurring spontaneous oropharyngeal bleeding who was found to have a lingual artery PA on angiography. Due to the active nature of the hemorrhage and extensive blood loss, embolization of the tonsillar branch of the lingual artery was successfully performed. When evaluating patients with spontaneous oropharyngeal bleeding, one should suspect the presence of an arterial PA, especially if the bleeding recurs following initial conventional interventions.

Acute and definitive management of oropharyngeal hemorrhage in patients with squamous cell carcinoma of the oropharynx.

Massive oropharyngeal bleeding post-chemoradiotherapy is a life-threatening condition that requires emergent management. This retrospective case series included 11 patients with oropharyngeal squamous cell carcinoma who suffered from massive bleeding during or following treatment with definitive chemoradiotherapy. Details of acute and definitive management of oropharyngeal bleeding are reported. Nine of 11 hemorrhagic events occurred a mean (SD) of 88.6 days (53.6) after radiotherapy. Airway intubation and embolization were performed in 10 of 11 patients, followed by surgery in 7 of 11 patients. The most commonly embolized vessels were the external carotid and lingual arteries. At the time of discharge, 3 of 11 patients had a tracheostomy, and 7 of 11 continued to use a gastrostomy tube. Four patients died. Hemorrhagic complications in oropharyngeal cancer treatment require emergent responses. Developing a workflow for coordination between multidisciplinary teams can maximize probability of survival and decrease morbidity.

Oropharyngeal Hemorrhage and Difficult Airway Management: A Decision Not to Intubate

BackgroundBleeding in the upper airways is an important cause of airway-related death. A higher incidence of airway management failure and complications after intubation attempts in the emergency department (ED) had been suggested. Airway management of patients with active oropharyngeal hemorrhage may be challenging, leading the clinician to modify the approach. Case ReportA 57-year-old woman presented to the ED with oropharyngeal hemorrhage after an extensive invasive dental procedure. She was on long-term warfarin therapy due to aortic and mitral valve replacement, which she suspended 5 days prior and restarted the day after the procedure. Besides the active bleeding, swelling, and hematoma of the face, the patient had other signs of “difficult airway,” so there were serious questions on when and how to manage the airway. Several strategies to address the airway were considered, the main point being an early versus later intubation. As the patient remained clinically stable, she was conservatively managed with local hemostasis and coagulopathy reversal. The patient was transferred to the intensive care unit, where she remained stable and was successfully discharged after restart on warfarin. Why Should an Emergency Physician Be Aware of This?When faced with an oropharyngeal hemorrhage, emergency physicians may be compelled to secure and protect the airway. This could be achieved by planning several strategies. Nevertheless, in selected patients, and considering the circumstances, not addressing the airway is a reasonable and justifiable alternative.

Duplication of the internal maxillary artery: Anatomical and clinical considerations.

Duplication of the internal maxillary artery (IMAX) results from a failed regression of either the embryological superficial or deep ring and is reported to be exceedingly rare. We present a patient with this rare anatomical variant who was treated by endovascular technique in the clinical context of an acute oropharyngeal hemorrhage.

Acquired Hemophilia Following COVID-19 and Influenza Vaccination: A Systematic Review

Introduction Acquired hemophilia (AH) is a rare disorder with an incidence of 1.48 per million per year and inhibitor to factor VIII (fVIII) is mostly implicated. The most common identifiable causes of acquired hemophilia A (AHA) include malignancies, pregnancy, and autoimmune disorders. AH following SARS Co-V2 vaccination has recently been reported. Here we provide the results of a comprehensive literature review of AH following SARS Co-V2 and influenza vaccinations. Methods We searched PubMed, Embase and Scopus database for all relevant articles from database inception to July 1, 2022. Articles were included if the study described AH following vaccination. A total 1006 records were screened by title and abstracts out of which 21 full-text articles met eligibility criteria. Title and abstracts of all articles were retrieved using the search strategy were initially screened, reviewed, and verified independently by two authors (KP and SS), with disagreements mediated through discussion with a third review author (DG). Most of the data included case reports except 3 case series and 2 letters. Additionally, Vaccine Adverse Event Reporting System (VAERS) database was also queried to assess for reports of hemophilia associated with receipt of vaccine till July 29, 2022. However these studies were not included in the analysis. Results Out of 21 articles, 18 described AH following SARS Co-V2 vaccination and 3 AH following influenza vaccination with a total of 29 patients (Table 1). All patients developed factor VIII inhibitor except 1 case of factor IX inhibitor described by Chiasakul et al. The median age of AH following SARS Co-V2 vaccination was 68 years (SD 15.4 years) and 66 years (SD 3 years) following influenza vaccination. The complication has been reported more frequently in males (61%). Most patient developed cutaneous hematomas following COVID-19 vaccine but single cases of hemothorax, melena, knee hematoma and oropharyngeal bleeding was also described. Three patients developed hematuria, and 2 patients developed extensive retroperitoneal hemorrhage following vaccination. AH has been described following the Pfizer (53% of the cases we identified), Moderna (28% of the cases we identified), Astra Zeneca (19% of the cases we identified) vaccines. Within this small cohort, most patients (47%) developed AH following second dose of primary vaccination followed by AH developing after first dose (28%). Few patients developed AH following both doses of primary vaccination (19%) and 1 developed AH following booster dose. Only 1 case had history of COVID-19 infection. The average duration for onset of symptoms from SARS Co-V2 vaccination was 2 weeks 4 days and was 2 weeks following influenza vaccination. For inhibitor management, 11 patients received rituximab (RTX) with prednisone and 7 patients received cyclophosphamide with prednisone. Triplet therapy (steroids, RTX and cyclophosphamide) was used in 3 patients. Most patients developing AH following SARS Co-V2 vaccination improved except 2 deaths from abdominal bleeding and sepsis; 1 patient died from severe retroperitoneal bleeding after influenza vaccination. We found 13 cases of AH and 2 cases of bleeding without diagnosis on VAERS database following COVID-19 vaccination and 2 cases developed factor IX inhibitor. Conclusions Autoantibodies to FVIII (or FIX) can develop following SARS Co-V2 and influenza vaccines. The rate of this complication appears to very low, but it can lead to serious bleeding, with an average onset of symptoms 2 weeks from vaccine administration. We found more reports of males who developed AH after SARS Co-V2 vaccination, but neither the overall frequency nor the relative frequency (males vs. females) is known. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Efficacy of proning in acute respiratory distress syndrome on extracorporeal membrane oxygenation.

ObjectivesProning patients with acute respiratory distress syndrome (ARDS) has been associated with increased survival, although few data exist evaluating the safety and feasibility of proning patients with ARDS on extracorporeal membrane oxygenation (ECMO).MethodsA single-institution retrospective review of all patients with ARDS placed on ECMO between March 1 and May 31, 2020, was performed. All proning events were evaluated for complications, as well as change in compliance, sweep, oxygenation, and flow. The primary outcome of this study was the rate major morbidity associated with proning while on ECMO.ResultsIn total, 30 patients were placed on ECMO for ARDS, with 12 patients (40%) proned while on ECMO. A total of 83 proning episodes occurred, with a median of 7 per patient (interquartile range, 3-9). No ECMO cannula-associated bleeding, cannula displacement, or endotracheal tune dislodgements occurred (0%). Oropharyngeal bleeding occurred twice (50%). Four patients were proned with chest tubes in place, and none had complications (0%). Lung compliance improved after proning in 70 events (84%), from a mean of 15.4 mL/mm Hg preproning to 20.6 mL/mm Hg postproning (P < .0001). Sweep requirement decreased in 36 events (43%). Oxygenation improved in 63 events (76%), from a mean partial pressure of oxygen of 86 preproning to 103 postproning (P < .0001). Mean ECMO flow was unchanged.ConclusionsProning in patients with ARDS on ECMO is safe with an associated improvement in lung mechanics. With careful planning and coordination, these data support the practice of appropriately proning patients with severe ARDS, even if they are on ECMO.

Toddler With Fever and Limp.

Toddler With Fever and Limp.

Preliminary experience of transoral robotic surgery for oropharyngeal carcinoma

Objective: To investigate the oncological and functional efficacy and safety of transoral robotic surgery (TORS) in the treatment of oropharyngeal carcinoma. Methods: Twenty-six patients with oropharyngeal cancer were enrolled who underwent TORS at Beijing United Hospital from June 1, 2017 to December 31, 2020. Among them, 22 patients were males and 4 were females, aged 39 to 76 years old. T1-2 patients accounted for 88.5% (23/26). Clinicopathological data including the time of removal of gastric and endotracheal tube were collected. The SPSS software package was used for survival analysis, and the overall survival rate and disease-free survival rate were calculated. Results: All the 26 patients with oropharyngeal cancer received TORS without conversion to open surgery, and 20 of them underwent simultaneous cervical lymph node dissection. TORS operation time ranged from 65 to 360 minutes with an average of 215 minutes. Intraoperative blood loss ranged from 5 to 600 ml with an average of 70 ml. Four patients (15.4%) underwent tracheotomy, of whom 3 patients had the removals of tracheal tubes within 1 month after surgery and 1 case remained to wear a tube by the end of follow-up. Twelve patients (46.2%) underwent gastric tube implantation, among them, 11 patients had removals of gastric tubes within 1 month after surgery and 1 patient died of oropharyngeal hemorrhage 13 days after operation. One patient (3.8%) had a positive surgical margin and others had pathologically negative surgical margins. Sixteen patients (61.5%) received postoperative radiotherapy, of whom 11 patients (42.3%) received platinum-based concurrent chemotherapy. The median follow-up time was 21.5 months (0.4 to 45 months). The overall survival and the disease-free survival rates were 83.0% and 75.8%, respectively. Conclusion: The application of TORS in treatment of oropharyngeal cancer can achieve good oncological and functional outcomes in selected patients.

Management of postradiation late hemorrhage following treatment for HPV-positive oropharyngeal squamous cell carcinoma.

Acute oropharyngeal hemorrhage is a serious complication for patients with oropharyngeal squamous cell carcinoma (OPSCC), particularly in patients with a history of radiation therapy (RT). Retrospective case series from at a tertiary care center for treated patients with HPV-positive OPSCC presenting with oropharyngeal hemorrhage. Median time from completion of chemoradiation to first hemorrhagic event was 186 days (range 66-1466 days). Seven patients (58%) required intervention to secure their airway. All patients were evaluated for endovascular intervention, six (50%) were embolized. Eight patients (67%) had a second hemorrhagic event; median time to second bleed was 22 days (range 3-90 days). Acute oropharyngeal hemorrhage is a sequelae following treatment for HPV-positive OPSCC. The majority of bleeds occurred within a year of completion of treatment. While more research is needed to determine optimal treatment paradigms, endovascular intervention should be considered, even if noninvasive imaging does not demonstrate active bleeding.

Outcomes after endovascular embolization for the treatment of nasal and oropharyngeal hemorrhage: safety, efficacy, and rebleeding.

Intractable nasal and oropharyngeal hemorrhage may be treated with endovascular embolization, but limited data are available. We sought to evaluate the efficacy, safety, and factors associated with rebleeding. A retrospective analysis of consecutive embolizations for nasal and oropharyngeal hemorrhage over a 10-year period at a single institution was performed. Outcomes included procedural success (defined as cessation of hemorrhage in the immediate postoperative period), rebleeding requiring an additional intervention, and procedural complications. A total of 47 embolizations on 39 patients were included. The mean age was 60 years (standard deviation 16.1), 23.1% of patients were women, and 21 (53.8%) patients had a previously diagnosed head/neck malignancy. Bleeding sites were the nose in 20 patients and oropharynx in 21 (two patients presented with both nasal and oral bleeding). Immediate procedural success was achieved in 45 (95.7%) embolizations. Rebleeding requiring an additional intervention occurred after 11 (23.4%) embolizations at a median of one day after the procedure. In the multivariate analysis, preoperative hypotension (odds ratio 4.78, 95% confidence interval 1.04-24.61) and the use of coils (odds ratio 6.09, 95% confidence interval 1.24-46.69) were associated with rebleeding requiring repeat intervention. Complications included two watershed strokes that were anticipated due to occlusion of the internal carotid artery. In our experience endovascular embolization was a safe and effective treatment option for stopping oral and nasal hemorrhage. However, rebleeding was present after 23.4% of treatments and was associated with preoperative hypotension and the use of coils. Further study in a large multi-institutional cohort is warranted.

Observational study of thrombosis and bleeding in COVID-19 VV ECMO patients.

COVID-19 has been associated with increased risk of thrombosis, heparin resistance and coagulopathy in critically ill patients admitted to intensive care. We report the incidence of thrombotic and bleeding events in a single center cohort of 30 consecutive patients with COVID-19 supported by veno-venous extracorporeal oxygenation (ECMO) and who had a whole body Computed Tomography Scanner (CT) on admission. All patients were initially admitted to other hospitals and later assessed and retrieved by our ECMO team. ECMO was initiated in the referral center and all patients admitted through our CT scan before settling in our intensive care unit. Clinical management was guided by our institutional ECMO guidelines, established since 2011 and applied to at least 40 patients every year. We diagnosed a thrombotic event in 13 patients on the initial CT scan. Two of these 13 patients subsequently developed further thrombotic complications. Five of those 13 patients had a subsequent clinically significant major bleeding. In addition, two patients presented with isolated intracranial bleeds. Of the 11 patients who did not have baseline thrombotic events, one had a subsequent oropharyngeal hemorrhage. When analyzed by ROC analysis, the area under the curve for % time in intended anticoagulation range did not predict thrombosis or bleeding during the ECMO run (0.36 (95% CI 0.10-0.62); and 0.51 (95% CI 0.25-0.78); respectively). We observed a high prevalence of VTE and a significant number of hemorrhages in these severely ill patients with COVID-19 requiring veno-venous ECMO support.

Increased Intracranial Hemorrhage Amid Elevated Inflammatory Markers in Those With COVID-19 Supported With Extracorporeal Membrane Oxygenation.

COVID-19-related coagulopathy is a known complication of SARS-CoV-2 infection and can lead to intracranial hemorrhage (ICH), one of the most feared complications of extracorporeal membrane oxygenation (ECMO). We sought to evaluate the incidence and etiology of ICH in patients with COVID-19 requiring ECMO. Patients at two academic medical centers with COVID-19 who required venovenous-ECMO support for acute respiratory distress syndrome (ARDS) were evaluated retrospectively. During the study period, 33 patients required ECMO support; 16 (48.5%) were discharged alive, 13 died (39.4%), and 4 (12.1%) had ongoing care. Eleven patients had ICH (33.3%). All ICH events occurred in patients who received intravenous anticoagulation. The ICH group had higher C-reactive protein (P = 0.04), procalcitonin levels (P = 0.02), and IL-6 levels (P = 0.05), lower blood pH before and after ECMO (P < 0.01), and higher activated partial thromboplastin times throughout the hospital stay (P < 0.0001). ICH-free survival was lower in COVID-19 patients than in patients on ECMO for ARDS caused by other viruses (49% vs. 79%, P = 0.02). In conclusion, patients with COVID-19 can be successfully bridged to recovery using ECMO but may suffer higher rates of ICH compared to those with other viral respiratory infections.

Effect of Cleft Palate Repair Timing on Inpatient Complication Rate: Review of a National Database.

Timing of cleft palate repair is controversial. We aim to assess whether timing of cleft palate repair affects rates of inpatient complications, length of stay (LOS), and cost of stay. The Healthcare Cost and Utilization Project Kids' Inpatient Database 2009 was queried for all admissions with a primary diagnosis of cleft palate during which cleft palate repair was performed as a primary procedure. Age 6 months or less was termed "early" repair, while age >6 months was termed "standard" repair. Patients age >3 years old, inpatient stays >30 days, and those stays in which a cleft lip repair was performed were excluded. Logistic regressions were used to model the probability of complications. Generalized linear models and a natural log link function were used for LOS and hospital charges, using SAS 9.4. We included 223 early and 1482 standard repair patients. Early repairs were exclusively performed in urban hospitals (P < 0.001). Eighty-nine patients experienced a total of 100 complications, including respiratory failure (N = 53), airway obstruction (N = 18), and oropharyngeal hemorrhage (N = 13). We found no significant difference in complication rate or total hospital charges in the 2 groups. The earlier repair group had a slightly longer LOS (P = 0.048). Over 85% of United States cleft palate repairs are performed after 6 months of age. All early repairs were performed at urban hospitals, and had slightly longer LOS. There was a 5.1% overall complication rate. Available data revealed no significant difference in complication rates between early repair and standard repair groups. 3b.

Oncologic Outcomes Following Transoral Robotic Surgery for Human Papillomavirus–Associated Oropharyngeal Carcinoma in Older Patients

While early epidemiologic studies ascribed increases in the incidence of human papillomavirus-associated oropharyngeal cancers to middle-aged patients, recent analyses have demonstrated an increasing median age of diagnosis. Treatment of patients older than 70 years is controversial as their inclusion in the practice-defining clinical trials has been limited and the survival benefit conferred by chemotherapy may be outweighed by treatment toxic effects. To assess the oncologic outcomes of older adults with human papillomavirus-associated oropharyngeal cancer who underwent upfront transoral robotic surgery and pathologic characteristics-guided adjuvant therapy in a large cohort of patients with close follow-up. A retrospective cohort analysis was conducted in a tertiary care academic medical center between January 1, 2010, and December 30, 2017. Patients aged 70 years or older at time of diagnosis with biopsy-proven and surgically resectable p16-positive oropharyngeal cancers were included. Data analysis was conducted from March 1 to June 1, 2020. Transoral robotic surgery oropharyngeal resection and neck dissection with pathologic characteristic-guided adjuvant therapy. Three-year estimates of disease-specific survival, overall survival, and disease-free survival, as well as rates of adjuvant therapy (radiotherapy and chemoradiotherapy) and perioperative complications. Seventy-seven patients were included (median age, 73.0; interquartile range, 71.0-76.0; range, 70-89 years); of these, 58 were men (75.3%). Perioperative mortality was 1.3% and the rate of oropharyngeal hemorrhage was 2.6%. Twenty-seven patients (35.1%) underwent postoperative radiotherapy and 20 patients (26.0%) underwent postoperative chemoradiotherapy. The median length of follow-up was 39.6 (range, 0.1-96.2) months, and the 3-year estimates of survival were 92.4% (95% CI, 82.4%-96.9%) for disease-specific survival, 90.0% (95% CI, 79.4%-95.0%) for overall survival, and 84.3% (95% CI, 73.4%-91.0%) for disease-free survival. The findings of this cohort study suggest that transoral robotic surgery and pathologic characteristic-guided adjuvant therapy can provide beneficial survival outcomes, infrequent perioperative mortality, and, for most carefully selected older adults, obviate the need for chemotherapy.

Catastrophic Hemorrhage After Chemoradiation for Advanced Stage Oropharyngeal Carcinoma: A Case Series.

We have seen several incidences of catastrophic bleeding in patients with advanced oropharyngeal squamous cell carcinoma treated nonoperatively. Aside from advanced disease, these patients have not had traditional risk factors for major hemorrhage. Retrospective chart review. Patients treated nonoperatively for oropharyngeal squamous cell carcinoma were compared to determine characteristics that may predisposed to bleeding. Five patients with bleeding were identified and compared with a cohort of stage- and treatment-matched patients without bleeding. Blinded imaging review was performed to characterize the tumor site and its relationship to vasculature using standardized systems. Comparing the bleeder versus nonbleeder groups pre-treatment, the bleeder group had larger tumors (15.4 vs. 8.3 cm2 ), greater rates of parapharyngeal fat effacement (80% vs. 20%), and always involved the facial artery. Post-treatment, endophytic ulcerated tumor beds occurred in 100% of bleeders versus 0% of nonbleeders. Catastrophic oropharyngeal bleeding may be encountered after cytoreductive therapy. Large deeply invasive tumors seem to set the necessary circumstances. Rapid vascular control with interventional radiology has been largely effective therapy. 3 Laryngoscope, 131:1049-1052, 2021.

Transoral laser microsurgery and radiotherapy for oropharyngeal squamous cell carcinoma: Equitable survival and enhanced function compared with contemporary standards of care

IntroductionWe describe the 5-year oncological and functional outcomes of transoral laser microsurgery, neck dissection (TLM + ND) and adjuvant radiotherapy (PORT) used to treat patients with oropharyngeal carcinoma. The effectiveness of external carotid artery (ECA) ligation in reducing post-operative bleeding, and fibrin glue following ND in reducing wound drainage and length of hospital stay is reported. Materials and methodsThis retrospective case review of consecutive patients undergoing TLM between 2006 and 2017 used the Kaplan-Meier Estimator and Log-Rank Test for univariate, time-to-event analyses, and Cox-Proportionate Hazard modelling for multivariate analysis. Results264 consecutive patients were included. Mean follow-up was 49.4 months. 219 (82.9%) patients received PORT. Five-year overall survival (OS), disease-free survival (DFS), and disease-specific survival (DSS) rates were 74.9%, 73.7%, and 86.2%, respectively. Five-year locoregional control was 89.4%. 65.5% of cases were Human papillomavirus associated (HPV+), for whom OS, DFS and DSS was 85.6%, 84.7% and 92.7%, respectively, and demonstrated significantly higher OS (hazard ratio (HR) 0.28, CI 0.16–0.49, p < 0.0001), DFS (HR 0.28, CI 0.17–0.47, p < 0.0001) and DSS (HR 0.2, CI 0.09–0.44, <0.001). Post-operative oropharyngeal bleeding occurred in 23 patients (8.7%), of which 5 were major/severe, in patients without ECA ligation. Fibrin glue significantly reduced neck drain output (p < 0.001), and length of hospital stay (p < 0.001). One-year gastrostomy dependence rate was 2.3%. ConclusionsTLM + ND + PORT results in favourable 5-year survival and locoregional control rates, and low feeding tube dependency rates. ECA ligation and fibrin glue appear to reduce major post-operative haemorrhage, wound drainage and length of hospital stay.

A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.

Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA. E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections. 120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients. We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.

Abstract A23: Transoral robotic surgery for primary oncologic resection: Outcomes from a rural academic medical center

Abstract Objective: to report the outcomes of oncologic transoral robotic surgery (TORS) performed by a single surgeon. Study Design: Retrospective chart review. Methods: All patients who underwent a TORS primary oncologic resection between the years of 2010-2018 were reviewed. Data regarding demographics, comorbidities, prior treatment, tumor characteristics, surgery, complications, adjuvant therapy, and survival were obtained. Results: Sixty-four patients were included in the chart review with a median age of 60.8 years. Fifty patients were male and 17 were female. Average overall robotic operating time was 137.9 minutes. Forty-one cases were presented using the Da Vinci Si while 23 cases were performed using the Da Vinci Xi. There was no significant difference between these two groups with regards to operative time, complication rate, or survival. Average robotic operative times for tonsil and tongue base primaries were 151.3 and 112.1 minutes, respectively. The difference was approaching statistical significance (p=0.053). Forty-two patients underwent ligation of external carotid artery (ECA) branches whereas 23 patients did not. One major oropharyngeal bleeding complication occurred in a patient who did not receive ECA branch ligation, which resulted in death. No major bleeding complication occurred in the ligation cohort. There was no significant difference in the overall rate of complications between low ACE 27 and high ACE 27 individuals (p = 0.22). However, the number of reported complications is significantly greater in the high ACE 27 group relative to the low ACE 27 group (0.74 vs. 1.82, p = 0.016). There was no significant difference in survival between HPV+ and HPV- tumors. Conclusion: Transoral robotic surgery represents a safe and effective means for resection of malignancies of the oropharynx. Although statistical significance cannot be demonstrated, ECA branch ligation should be considered prior to TORS given the severity of potential complications. Citation Format: Eric Eisen, Christiaan Rees, Isabelle Magro, Karissa LeClair, Joseph Paydarfar. Transoral robotic surgery for primary oncologic resection: Outcomes from a rural academic medical center [abstract]. In: Proceedings of the AACR-AHNS Head and Neck Cancer Conference: Optimizing Survival and Quality of Life through Basic, Clinical, and Translational Research; 2019 Apr 29-30; Austin, TX. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(12_Suppl_2):Abstract nr A23.