Supercharged deep inferior epigastric perforator flap for reconstruction of soft tissue defect after excision of giant invasive squamous cell carcinoma of the thigh in a refractory diabetic with Pseudomonas aeruginosa infection.

Patients with large defects after oncologic surgery often require enhanced surgical planning to optimize reconstructive outcomes. As such, medically complex patients require innovative solutions when utilizing abdominal flaps due to concern for ischemia of the distal tissue. Vascular augmentations, such as supercharging or turbocharging, serve to increase perfusion in these medical complex patients to ensure flap survival. In this report, we highlight the use of a supercharged bilateral pedicled deep inferior epigastric perforator (DIEP) flap in a patient with a 231 cm2 thigh defect in the setting of uncontrolled diabetes. A 57-year-old male with poorly-controlled diabetes (blood sugar prior to surgery 510 mg/dL) and iron deficiency anemia presented with a two-year history of a large nonmetastatic squamous cell carcinoma (SCC) measuring 19 × 9 cm2 on the right thigh. Positron emission tomography/computed tomography and biopsies of the right retroperitoneal and inguinal lymph nodes diagnosed the mass as Stage 3 localized SCC. After excision, we performed immediate reconstruction of the resultant defect with a supercharged bilateral pedicled DIEP flap. The flap was pedicled on the ipsilateral DIEP and the contralateral perforator was anastomosed to the descending branch of the lateral circumflex femoral artery (DLCFA) at the inferior aspect of the defect. A venous coupler was used for the veins and the arteries were hand-sewn in end-to-end fashion. The supercharged bilateral pedicled DIEP flap was utilized for enhanced augmented perfusion to the distal edge of the pedicled flap in a high-risk patient. The patient's clinical course was complicated by a Pseudomonas infection of a small hematoma requiring operative washout and debridement of necrotic fat. However, the flap survived and covered the defect completely. The patient required outpatient antibiotics for the Pseudomonas infection which resolved completely without further need for operative intervention. At 6-month follow up, the reconstruction was stable with no tumor recurrence on clinical exam. Our results suggest that a supercharged pedicled DIEP flap may be a viable option for large defects of the thigh and can may be utilized in medically complex patients with poor capacity for wound healing.

Operating Room-to-ICU Patient Handovers: A Multidisciplinary Human-Centered Design Approach.

BACKGROUND: Patient handovers (handoffs) following surgery have often been characterized by poor teamwork, unclear procedures, unstructured processes, and distractions. A study was conducted to apply a human-centered approach to the redesign of operating room (OR)-to-ICU patient handovers in a broad surgical ICU (SICU) population. This approach entailed (1) the study of existing practices, (2) the redesign of the handover on the basis of the input of hand over participants and evidence in the medical literature, and (3) the study of the effects of this change on processes and communication. METHODS: The Durham [North Carolina] Veterans Affairs Medical Center SICU is an 11-bed mixed surgical specialty unit. To understand the existing process for receiving postoperative patients in the SICU, ethnographic methods-a series of observations, surveys, interviews, and focus groups-were used. The handover process was redesigned to better address providers' work flow, information needs, and expectations, as well as concerns identified in the literature. RESULTS: Technical and communication flaws were uncovered, and the handover was redesigned to address them. For the 49 preintervention and 49 postintervention handovers, the information transfer score and number of interruptions were not significantly different. However, staff workload and team behaviors scores improved significantly, while the hand over duration was not prolonged by the new process. Handover participants were also significantly more satisfied with the new handover method. CONCLUSIONS: An HCD approach led to improvements in the patient handover process from the OR to the ICU in a mixed adult surgical population. Although the specific handover process would unlikely be optimal in another clinical setting if replicated exactly, the HCD foundation behind the redesign process is widely applicable.

The effects of sodium valproate on the renal function of children with epilepsy.

Sodium valproate is one of the most commonly used drugs to treat epilepsy. However, there is growing evidence that valproate can cause renal tubular injury in children, and there are increasing reports of valproate-induced Fanconi's syndrome where the renal tubules lose their ability to reabsorb electrolytes, urea, glucose and protein. In this review article we attempt to bring together all of the studies conducted to date on the effects of valproate on renal function in epileptic children. The research is generally considered in two themes; the first comprises studies which indicate subclinical tubular injury measured by renal enzymes such as N-acetyl-ß-D-glucosaminidase (NAG), and the second comprises clinical reports where Fanconi's syndrome has occurred. This article goes on to analyse the current data and draws on recurring patterns to suggest that a specific subpopulation of severely disabled epileptic children may benefit hugely from the close monitoring of enzymes which are indicative of renal tubular injury, particularly NAG or in the very least periodical urinalysis.

FOCUS: the Society of Cardiovascular Anesthesiologists' initiative to improve quality and safety in the cardiovascular operating room.

The Society of Cardiovascular Anesthesiologists (SCA) introduced the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems) in 2005 in response to the need for a rigorous scientific approach to improve quality and safety in the cardiovascular operating room (CVOR). The goal of the project, which is supported by the SCA Foundation, is to identify hazards and develop evidence-based protocols to improve cardiac surgery safety. A hazard is anything that has the potential to cause a preventable adverse event. Specifically, the strategic plan of FOCUS includes 3 goals: (1) identifying hazards in the CVOR, (2) prioritizing hazards and developing risk-reduction interventions, and (3) disseminating these interventions. Collectively, the FOCUS initiative, through the work of several groups composed of members from different disciplines such as clinical medicine, human factors engineering, industrial psychology, and organizational sociology, has identified and documented significant hazards occurring daily in our CVORs. Some examples of frequent occurrences that contribute to reduce the safety and quality of care provided to cardiac surgery patients include deficiencies in teamwork, poor OR design, incompatible technologies, and failure to adhere to best practices. Several projects are currently under way that are aimed at better understanding these hazards and developing interventions to mitigate them. The SCA, through the FOCUS initiative, has begun this journey of science-driven improvement in quality and safety. There is a long and arduous road ahead, but one we need to continue to travel.

Degenerating regenerating torsades de pointes.

Ventricular fibrillation (VF) commonly ends in death. Isolated case reports describe the uncommon occurrence of spontaneous termination of VF. Torsades de pointes (TdP), a peculiar form of polymorphic ventricular tachycardia associated with a prolonged QT interval on the surface electrocardiogram, most often spontaneously terminates and then returns to the underlying rhythm. Here, we present an unusual case of TdP degenerating into VF, reorganizing into TdP, and then spontaneously terminating. Our case suggests that the mechanisms underlying the maintenance of TdP and VF are not dissimilar. The precipitants to this event and the likely mechanisms operative are discussed.

Tracheoesophageal Fistula as a Complication of Prolonged Ventilation in COVID-19: Description of Reconstruction and Review of the Literature.

Infection with COVID-19 pneumonia may necessitate intubation and mechanical ventilation. Viral inflammation and pressure necrosis may lead to scarring, stenosis, and in severe cases, fistula formation. Nonmalignant tracheoesophageal fistulas (TEF) represent a surgical challenge and may necessitate locoregional tissue transfer and tracheal resection to prevent recurrence and maintain airway patency. We present a case of TEF in a 63-year-old female secondary to prolonged mechanical ventilation in the setting of COVID pneumonia, detailing the clinical findings and surgical repair. Primary closure of the esophageal defect with pectoralis major muscle flap onlay and tracheal resection, with median sternotomy for access, provided successful intervention, allowing for subsequent tracheostomy decannulation and return to a complete oral diet. This case offers further evidence of the increased risk of airway complications in COVID-19 infection and provides otolaryngologists with an example of a rare surgical approach useful in management.

Development of normalized quantitative measures of lumbar disc degeneration.

Background: Lumbar disc degeneration (DD) is widely regarded as a likely contributor to low back pain (LBP), but the association between DD and LBP is relatively weak. No known studies have normalized quantitative measures of DD severity relative to multiple variables such as age, height, and disc level. This study developed normalized quantitative measures (z-scores) of disc signal intensity (DSI) and disc height (DH) to rate relative severity of DD. Methods: Raw (unnormalized) quantitative measures of DSI and DH alongside potential normalization variables were acquired from MRI scans and clinical data of 76 patients. The associations between the raw quantitative measures and potential normalization variables were investigated to develop the normalized quantitative measures (z-scores) of DSI and DH. Construct validity was assessed by comparing the normalized measures to an experienced radiologist's subjective measures of relative severity of DSI and DH loss. Results: CSF signal intensity, age, and disc level were significantly associated with raw DSI (R 2 = 0.06, 0.25, and 0.09, respectively). Lumbar height and disc level were significantly associated with raw DH (R 2 = 0.13 and 0.31). Normalizing DSI and DH by these variables resulted in stronger relationships (R 2 = 0.39 and 0.37) than raw DSI and DH (R 2 = 0.24 and 0.31) with the radiologist's subjective measures. Normalized DSI and DH were both normally distributed (p = 0.32 and 0.12). Conclusions: Construct validity and the distributions suggested that normalized quantitative measures of DSI and DH are better than existing measures of DSI and DH at rating relative DD severity. Determining whether normalized quantitative measures are more predictive of clinical outcomes is important future research.

Greater response to cardiac resynchronization therapy in patients with true complete left bundle branch block: a PREDICT substudy.

AIMS: Cardiac resynchronization therapy (CRT) benefits patients with heart failure and a wide QRS complex. Still, one-third derive no clinical benefit and a majority of patients demonstrate no objective improvement of left ventricular (LV) function. Left bundle branch block (LBBB) is a strong predictor of response to CRT. We evaluated whether absence of electrocardiogram (ECG) markers of residual left bundle (LB) conduction in guideline-defined LBBB predicted a greater response to CRT. METHODS AND RESULTS: An r wave ≥1 mm in lead V1 (r-V1) and/or a q wave ≥1 mm in lead aVL (q-aVL) was used to identify patients with residual LB conduction. Forty patients with a wide QRS were prospectively enrolled and subdivided into three groups: complete LBBB (cLBBB), LBBB without r-V1 or q-aVL (n = 12); LBBB with residual LB conduction (rLBBB), LBBB with r-V1 and/or q-aVL (n = 15); and non-specific intraventricular conduction delay (IVCD), (n = 13). Following CRT: mean change in left ventricular ejection fraction was 11.9 ± 11.9% in cLBBB, 3.8 ± 5.4% in rLBBB (P= 0.045), and 2.5 ± 4.4% in IVCD (P= 0.02 cLBBB vs. IVCD); mean reduction in left ventricular end-systolic volume was 26.4 ± 39.2% in cLBBB, 14.3 ± 22.9% in rLBBB (P= 0.35), and 5.6 ± 17.3% in IVCD (P= 0.11 cLBBB vs. IVCD); mean change in native QRS duration was -8.0 ± 11.0 ms in cLBBB, -0.8 ± 8.24 ms in rLBBB (P= 0.07), and 0.15 ± 8.0 ms in IVCD (P= 0.048 cLBBB vs. IVCD). CONCLUSION: In patients with guideline-defined LBBB, the absence of ECG markers of residual LB conduction was predictive of a greater improvement in LV function with CRT.

Can we make postoperative patient handovers safer? A systematic review of the literature.

Postoperative patient handovers are fraught with technical and communication errors and may negatively impact patient safety. We systematically reviewed the literature on handover of care from the operating room to postanesthesia or intensive care units and summarized process and communication recommendations based on these findings. From >500 papers, we identified 31 dealing with postoperative handovers. Twenty-four included recommendations for structuring the handover process or information transfer. Several recommendations were broadly supported, including (1) standardize processes (e.g., through the use of checklists and protocols); (2) complete urgent clinical tasks before the information transfer; (3) allow only patient-specific discussions during verbal handovers; (4) require that all relevant team members be present; and (5) provide training in team skills and communication. Only 4 of the studies developed an intervention and formally assessed its impact on different process measures. All 4 interventions improved metrics of effectiveness, efficiency, and perceived teamwork. Most of the papers were cross-sectional studies that identified barriers to safe, effective postoperative handovers including the incomplete transfer of information and other communication issues, inconsistent or incomplete teams, absent or inefficient execution of clinical tasks, and poor standardization. An association between poor-quality handovers and adverse events was also demonstrated. More innovative research is needed to define optimal patient handovers and to determine the effect of handover quality on patient outcomes.

Video-Based Tracheostomy Care Education for Medical Students.

Objective: Tracheostomy is a common procedure that requires management by a multidisciplinary team of health care providers across a range of surgical and nonsurgical specialties. Nonsurgical health care providers have demonstrated a lack of knowledge and confidence in tracheostomy care, which improve with tracheostomy education programs. However, tracheostomy care is rarely included in preresidency medical education. The purpose of this study is to evaluate the effectiveness of a tracheostomy care video on third-year medical students' knowledge of and confidence in performing tracheostomy care. Methods: Prior to beginning clinical rotations, third-year medical students completed a 10-question tracheostomy care knowledge test (100 points total) and 11-question confidence survey (110 points total). After watching an 18-minute teaching video on tracheostomy care, students repeated the knowledge test and confidence survey. Results: An overall 147 medical students completed the educational module. After they watched the tracheostomy education video, their average score on the knowledge test improved from 57.8 to 88.9 out of 100 (P < .0001), and their average rating in confidence improved from 12.7 to 49.1 out of 110 (P < .0001). Students rated the helpfulness of the video a 7.4 out of 10. Discussion: Medical students' knowledge of tracheostomy care and confidence in caring for patients with tracheostomies improved after watching the video. Tracheostomy education should be included in early medical education so that future physicians of various specialties can better care for this patient population. Implications for Practice: Internet-published videos are an accessible educational resource with great potential application to various topics within otolaryngology, including tracheostomy care.

Primary cervical ganglioneuroblastoma, nodular subtype.

Primary cervical ganglioneuroblastoma is rare and reports of its subtypes are limited. This case series describes two pediatric patients with the nodular subtype of primary cervical ganglioneuroblastoma with lymphatic spread. Clinical course, diagnosis, and management of this rare tumor are discussed with emphasis on the importance of including neuroblastic tumors in the differential diagnosis of pediatric neck masses. We also report the use of nerve monitoring of the recurrent laryngeal nerve as a surrogate for the vagus nerve during a pediatric neck dissection.

Association of Neoadjuvant Pembrolizumab for Oral Cavity Squamous Cell Carcinoma With Adverse Events After Surgery in Treatment-Naive Patients.

Importance: Pembrolizumab, a monoclonal antibody targeting programmed cell death 1, is currently approved by the US Food and Drug Administration for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The potential neoadjuvant role of programmed cell death 1 inhibitors in primary surgical management of HNSCC and effects on surgical outcomes are poorly understood. Objective: To evaluate the incidence of postoperative adverse events in treatment-naive patients with advanced oral cavity cancer receiving neoadjuvant pembrolizumab when compared with matched controls, as part of a window-of-opportunity multi-institutional clinical trial assessing neoadjuvant pembrolizumab for locally advanced HNSCC. Design, Setting, and Participants: This retrospective cohort study at a single tertiary academic institution included treatment-naive patients with local regionally advanced oral cavity squamous cell carcinoma (OCSCC) who were undergoing surgical resection. Exposures: Patients with local regionally advanced resectable OCSCC who received neoadjuvant pembrolizumab were retrospectively reviewed for postoperative adverse events. Controls were matched by age, race, smoking status, and overall cancer stage based on historical data at the same institution. Matched-cohort analysis was performed using a McNemar test to assess differences between the groups. Main Outcomes and Measures: Incidence of adverse events following surgical resection of advanced OCSCC within 30 days of surgery and on continued follow-up. Results: A total of 64 patients (32 as part of the prospective clinical trial and 32 as controls; mean [SD] age, 59.6 [10.3] years; 28 [44%] women) were included in the analysis. Postoperative adverse events in the 32 patients receiving pembrolizumab included lymphedema (n = 20 [63%]), trismus (n = 7 [22%]), return to operating room (n = 7 [22%]), wound infection (n = 7 [22%]), fistula (n = 6 [19%]), wound dehiscence (n = 4 [13%]), flap failure (n = 3 [9%]), and hematoma (n = 2 [6%]). The matched control group demonstrated similar complication rates without considerable differences, except for trismus (n = 16 [50%]), which was greater by a difference of 28.1% (95% CI, 5.6%-50.6%) in the control group. Conclusions and Relevance: This cohort study examined surgical complications among patients with local regionally advanced OCSCC treated with neoadjuvant pembrolizumab and found that serious adverse events were similar to those in patients who underwent standard-of-care treatment. This suggests that there is no increased perioperative morbidity in the use of preoperative treatment with immunotherapy. Further prospective studies are needed to validate these findings for oral cavity cancer and other subsites of the head and neck.

Phase II Clinical Trial of Neoadjuvant and Adjuvant Pembrolizumab in Resectable Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma.

PURPOSE: Patients with resected, local-regionally advanced, head and neck squamous cell carcinoma (HNSCC) have a one-year disease-free survival (DFS) rate of 65%-69% despite adjuvant (chemo)radiotherapy. Neoadjuvant PD-1 immune-checkpoint blockade (ICB) has demonstrated clinical activity, but biomarkers of response and effect on survival remain unclear. PATIENTS AND METHODS: Eligible patients had resectable squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or oropharynx (p16-negative) and clinical stage T3-T4 and/or two or more nodal metastases or clinical extracapsular nodal extension (ENE). Patients received neoadjuvant pembrolizumab 200 mg 1-3 weeks prior to surgery, were stratified by absence (intermediate-risk) or presence (high-risk) of positive margins and/or ENE, and received adjuvant radiotherapy (60-66 Gy) and concurrent pembrolizumab (every 3 weeks × 6 doses). Patients with high-risk HNSCC also received weekly, concurrent cisplatin (40 mg/m2). Primary outcome was one-year DFS. Secondary endpoints were one-year overall survival (OS) and pathologic response (PR). Safety was evaluated with CTCAE v5.0. RESULTS: From February 2016 to October 2020, 92 patients enrolled. The median age was 59 years (range, 27-80), 30% were female, 86% had stage T3-T4, and 69% had ≥N2. At a median follow-up of 28 months, one-year DFS was 97% (95% CI, 71%-90%) in the intermediate-risk group and 66% (95% CI, 55%-84%) in the high-risk group. Patients with a PR had significantly improved one-year DFS relative to patients without response (93% vs. 72%, hazard ratio 0.29; 95% CI, 11%-77%). No new safety signals were identified. CONCLUSIONS: Neoadjuvant and adjuvant pembrolizumab increased one-year DFS rate in intermediate-risk, but not high-risk, HNSCC relative to historical control. PR to neoadjuvant ICB is a promising surrogate for DFS.

Determining the molecular landscape and impact on prognosis in HPV-associated head and neck cancer.

BACKGROUND: Human papillomavirus (HPV) associated head and neck squamous cell carcinoma (HNSCC) has a better prognosis than HNSCC due to other risk factors. However, there is significant heterogeneity within HPV-associated HNSCC and 25% of these patients still do poorly despite receiving aggressive therapy. We currently have no good molecular tools to differentiate and exclude this "high-risk" sub-population and focus on "low-risk" patients for clinical trials. This has been a potential barrier to identifying successful de-escalation treatment strategies in HPV-associated HNSCC. We conducted an analysis of molecular markers with a well-known role in the pathogenesis of HPV-associated HNSCC and hypothesized that these markers could help independently predict recurrence and prognosis in these patients and therefore help identify at the molecular level "low-risk" patients suitable for de-escalation trials. METHODS: We analyzed 24 tumor specimens of patients with p16+ HNSCC who underwent definitive resection as primary treatment. Tissue microarray (TMA) was generated from the 24 pathology blocks and immunohistochemistry (IHC) was performed using highly specific antibodies for our chosen biomarkers (PI3K-PTEN, AKT pathway, mTOR, 4EBP1, S6, and pAMPK, ERCC-1). Transcriptome data was also obtained for 7 p16+ HNSCC patients from The Cancer Genome Atlas (TCGA). Data from the TMA and TCGA were analyzed for association of relapse-free survival (RFS) and overall survival (OS) with protein and gene expression of the chosen biomarkers. RESULTS: Increased pAMPK protein activity by IHC and AMPK gene expression by TCGA gene expression data was correlated with improved RFS with a trend towards statistical significance. CONCLUSIONS: This data suggests that increased pAMPK activity and expression may portend a better prognosis in HPV-associated HNSCC undergoing primary definitive resection. However, these findings require validation in larger studies.

Predicting pain recovery in patients with acute low back pain: a study protocol for a broad validation of a prognosis prediction model.

BACKGROUND: The clinical course of acute low back pain (LBP) is generally favourable; however, there is significant variability in the prognosis of these patients. A clinical prediction model to predict the likelihood of pain recovery at three time points for patients with acute LBP has recently been developed. The aim of this study is to conduct a broad validation test of this clinical prediction model, by testing its performance in a new sample of patients and a different setting. METHODS: The validation study with a prospective cohort design will recruit 420 patients with recent onset non-specific acute LBP, with moderate pain intensity, seeking care in the emergency departments of hospitals in São Paulo, Brazil. The primary outcome measure will be days to recovery from pain. The predicted probability of pain recovery for each individual will be computed based on predictions of the development model and this will be used to test the performance (calibration and discrimination) in the validation dataset. DISCUSSION: The findings of this study will better inform about the performance of the clinical prediction model, helping both clinicians and patients. If the model's performance is acceptable, then future research should evaluate the impact of the prediction model, assessing whether it produces a change in clinicians' behaviour and/or an improvement in patient outcomes. ETHICS AND DISSEMINATION: Ethics were granted by the Research Ethics Committee of the Universidade Cidade de São Paulo, #20310419.4.0000.0064. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.