Chronic heart failure in patients undergoing major head and neck surgery: A hospital-based study.

OBJECTIVE: To investigate the effects of chronic heart failure on various post-operative outcomes in head and neck cancer patients undergoing major cancer surgery. STUDY DESIGN: For this retrospective cohort study of patients undergoing major head and neck cancer surgery, a sample of 10,002 patients between 2017 and 2019 were identified through the Nationwide Inpatient Sample. SETTING: Patients were selected as undergoing major head and neck cancer surgery, defined as laryngectomy, pharyngectomy, glossectomy, neck dissection, mandibulectomy, and maxillectomy, then separated based on pre-surgical diagnosis of chronic heart failure. METHODS: The effects of pre-operative chronic heart failure on post-surgical outcomes in these patients were investigated by univariable and multivariable logistic regression using ICD-10 codes and SPSS. RESULTS: A diagnosis of chronic heart failure was observed in 265 patients (2.6 %). Patients with chronic heart failure had more preexisting comorbidities when compared to patients without chronic heart failure (mean ± SD; 4 ± 1 vs. 2 ± 1). Multivariable logistic regression showed that chronic heart failure patients had significantly greater odds of dying during hospitalization (OR 2.86, 95 % CI 1.38-5.91) and experiencing non-routine discharge from admission (OR 1.89, 95 % CI 1.41-2.54) after undergoing major head and neck cancer surgery. CONCLUSION: Chronic heart failure is associated with greater length of stay and hospital charges among head and neck cancer patients undergoing major head and neck cancer surgeries. Chronic heart failure patients have significantly greater rates of unfavorable post-operative outcomes, including death during hospitalization and non-routine discharge from admission.

Clinicodemographic Predictors of Tracheotomy Tube Size and Decannulation: A Multiinstitutional Retrospective Cohort Study on Tracheotomy.

OBJECTIVE: We aimed to discern clinico-demographic predictors of large (≥8) tracheostomy tube size placement, and, secondarily, to assess the effect of large tracheostomy tube size and other parameters on odds of decannulation before hospital discharge. SUMMARY OF BACKGROUND DATA: Factors determining choice of tracheostomy tube size are not well-characterized in the current literature, despite evidence linking large tracheostomy tube size with posttracheotomy tracheal stenosis. The effect of tracheostomy tube size on timing of decannulation is also unknown, an important consideration given reported associations between endotracheal tube size and probability of failed extubation. METHODS: We collected information pertaining to patients who underwent tracheotomy at 1 of 10 U.S. health care institutions between 2010 and 2019. Tracheostomy tube size was dichotomized (≥8 and <8). Multivariable logistic regression models were fit to identify predictors of (1) large tracheostomy tube size, and (2) decannulation before hospital discharge. RESULTS: The study included 5307 patients, including 2797 (52.7%) in the large tracheostomy cohort. Patient height (odds ratio [OR] = 1.060 per inch; 95% confidence interval [CI] 1.041-1.070) and obesity (1.37; 95% CI 1.1891.579) were associated with greater odds of large tracheostomy tube; otolaryngology performing the tracheotomy was associated with significantly lower odds of large tracheostomy tube (OR = 0.155; 95% CI 0.131-0.184). Large tracheostomy tube size (OR = 1.036; 95% CI 0.885-1.213) did not affect odds of decannulation. CONCLUSIONS: Obesity was linked with increased likelihood of large tracheostomy tube size, independent of patient height. Probability of decannulation before hospital discharge is influenced by multiple patient-centric factors, but not by size of tracheostomy tube.

Development and Validation of Urological and Appearance Domains of the Post-Affirming Surgery Form and Function Individual Reporting Measure (AFFIRM) for Transwomen following Genital Surgery.

PURPOSE: As feminizing gender-affirming surgery becomes increasingly accessible, functional outcomes are increasingly relevant. We aimed to develop and validate the first patient-reported outcome questionnaire focusing on postoperative symptomatology and quality of life. MATERIAL AND METHODS: Questions were developed from interviews with postoperative transwomen followed by face validation from a multispecialty clinician group. The measure was co-administered with established relevant questionnaires for concurrent validity testing. Participants were asked to complete the questionnaire at baseline and at a 2-week retest interval. RESULTS: The AFFIRM questionnaire is a 33-item patient-reported outcome measure comprising Appearance, Urological and Gynecologic domains, each scored to create a composite AFFIRM score. A total of 102 women participated, with 60% completing the test-retest. The overall Cronbach's α for AFFIRM was 0.79, and domain α for AFFIRM-A, AFFIRM-U and AFFIRM-G was 0.85, 0.87 and 0.42, respectively. Test-retest demonstrated score reliability (z values -1.862 to -0.005, p >0.05) with intraclass coefficients demonstrating moderate to good absolute correlation (0.54 to 0.88). The AFFIRM-A and AFFIRM-U correlated well with the Genital Appearance Satisfaction Measure and Urinary Distress Inventory-6, respectively (ρ 0.556 and 0.618, p <0.001); 89% of participants confirmed congruence between their external genitalia and gender identity, 87.8% reported clitoral sensation and 75.6% expressed satisfaction with vaginal caliber. Reported symptoms included a misdirected urinary stream (68.9%), nocturia (51.3%), urinary frequency (29.7%) and vaginal pain (46.7%). CONCLUSIONS: Transwomen have diverse symptoms not captured by unstructured questions or cisgender questionnaires. The AFFIRM questionnaire is the first tool available to reliably evaluate outcomes following feminizing gender-affirming surgery.

COMBINED VITRECTOMY WITH INTRAVITREAL DEXAMETHASONE IMPLANT FOR REFRACTORY MACULAR EDEMA SECONDARY TO DIABETIC RETINOPATHY, RETINAL VEIN OCCLUSION, AND NONINFECTIOUS POSTERIOR UVEITIS.

PURPOSE: To compare the efficacy of intraoperative intravitreal dexamethasone implant for macular edema secondary to diabetic retinopathy (DME), retinal vein occlusion (RVO), and noninfectious posterior uveitis. METHODS: A retrospective review of 62 patients (29 men and 33 women; mean age 51.19 ± 14.41 years; 65 eyes) was performed. Best-corrected visual acuity (in logarithm of the minimal angle of resolution), central foveal thickness, intraocular pressure, and postoperative edema-free period were postoperatively assessed up to 1 year. The preoperative and postoperative numbers of other intravitreal injections needed were compared. RESULTS: Best-corrected visual acuity gradually improved in the DME group (from 0.87 to 0.51) but failed to improve from Month 3 onward in the RVO and uveitis groups. Central foveal thickness decreased in all groups, especially in the DME group (from 550.93 to 338.10 µm). Edema-free period was longest in the DME group (19.34 ± 15.12 months), followed by the uveitis (12.91 ± 7.85 months) and RVO (8.50 ± 8.76 months) groups. Subjects in the uveitis group used more intraocular pressure-lowering agents (1.00 ± 1.27) than those in the DME (0.13 ± 0.49) and RVO (0.36 ± 0.79) groups. Increased intraocular pressure events were most frequent in postoperative Week 1, especially in the uveitis group. CONCLUSION: Vitrectomy combined with intravitreal dexamethasone implant for DME, RVO, and noninfectious posterior uveitis had a favorable clinical outcome.

Mutation of chromatin regulators and focal hotspot alterations characterize human papillomavirus-positive oropharyngeal squamous cell carcinoma.

BACKGROUND: Human papillomavirus (HPV)-associated oropharyngeal cancer is a disease clinically and biologically distinct from smoking-related head and neck squamous cell carcinoma (HNSCC). Despite its rapidly increasing incidence, the mutational landscape of HPV+ oropharyngeal squamous cell carcinoma (OPSCC) remains understudied. METHODS: This article presents the first mutational analysis of the 46 HPV+ OPSCC tumors within the newly expanded cohort of 530 HNSCC tumors from The Cancer Genome Atlas. A separate exome sequencing analysis was also performed for 46 HPV+ OPSCCs matched to their normal lymphocyte controls from the Johns Hopkins University cohort. RESULTS: There was a strikingly high 33% frequency of mutations within genes associated with chromatin regulation, including mutations in lysine methyltransferase 2C (KMT2C), lysine methyltransferase 2D (KMT2D), nuclear receptor binding SET domain protein 1 (NSD1), CREB binding protein (CREBBP), E1A-associated protein p300 (EP300), and CCCTC-binding factor (CTCF). In addition, the commonly altered genes phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit α (PIK3CA) and fibroblast growth factor receptor 3 (FGFR3) showed distinct domain-specific hotspot mutations in comparison with their HPV- counterparts. PIK3CA showed a uniquely high rate of mutations within the helicase domain, and FGFR3 contained a predominance of hotspot S249C alterations that were not found in HPV- HNSCC. CONCLUSIONS: This analysis represents one of the largest studies to date of HPV+ OPSCC and lends novel insight into the genetic landscape of this biologically distinct disease, including a high rate of mutations in histone- and chromatin-modifying genes, which may offer novel therapeutic targets.

Craniofacial Cleft: A Case of Tessier 10 Cleft With a Novel Method to Repair Large Bilateral Colobomas.

OBJECTIVE: To describe a reliable method utilizing large, rotation flaps to reconstruct a number 10 Tessier cleft. DESIGN: This is a descriptive clinical case report. SETTING: Pediatric teaching hospital affiliated with a university. PATIENTS, PARTICIPANTS: One participant in this clinical case report. INTERVENTIONS: Full-thickness excision of the clefted eyelid, brow, and forehead tissue was performed bilaterally to develop medial and lateral eyebrow and forehead flaps. Right: the forehead/brow flap was rotated caudally to reapproximate the eyebrow and an eyelid rotation flap was also used to reapproximate the lid margin. Left: forehead/brow rotation flap allowed realignment of the eyebrow and a series of Z-plasties were used in the eyelid to reapproximate the lid margin and to lengthen the eyelid. MAIN OUTCOME MEASURE(S): Develop and construct a reliable reconstruction with full-eyelid closure and minimal donor site morbidity. RESULTS: Complete eyelid closure bilaterally was achieved intraoperatively, and was maintained at 6-month follow-up with no evidence of ocular pathology. CONCLUSIONS: Large, bilateral upper eyelid colobomas require repair to prevent blindness. Although free tarsomarginal grafts and lid-sharing procedures have been described, we demonstrate that large rotation flaps designed along the cleft margin can provide a reliable reconstruction and minimize donor-site morbidity.

Characterizing Breast Deformities After Massive Weight Loss: Utilizing the Pittsburgh Rating Scale to Examine Factors Affecting Severity Score and Surgical Decision Making in a Retrospective Series.

BACKGROUND AND OBJECTIVES: Massive weight loss (MWL) can result in variable contour deformities of the breasts. The Pittsburgh Rating Scale (PRS) was designed to describe the multitude of deformities after MWL and recommends operations to consider for surgical improvement. We present the first comprehensive description of breast deformities in a large sample of MWL patients, examine factors affecting the severity of deformities, and report the correlation between PRS score and surgical decision making. METHODS: A retrospective review of all MWL patients presenting for breast surgery at our institution's Life After Weight Loss program from 2004 to 2015 was performed. Information including demographics, body mass indices (BMIs), method of weight loss, and type of surgical intervention was collected. Preoperative breast photographs were blinded and scored according to the PRS. RESULTS: A total of 204 MWL patients were identified; 26% (53) scored 1, 34% (69) scored 2, and 40% (82) scored 3 on the PRS. Greater deformities were seen after weight loss from bariatric surgery versus diet and exercise alone (P = 0.031), in mastopexy versus augmentation/mastopexy (P = 0.001), and in breast reduction versus augmentation/mastopexy patients (P > 0.0001). Patients who underwent reduction mammaplasty had the greatest maximum BMI compared with other procedures (P = 0.016). The PRS scores were positively correlated to maximum BMI (P < 0.001), delta BMI (P < 0.001), and current BMI (P < 0.001). CONCLUSIONS: Massive weight loss patients have variable, and often severe, breast deformities, and the PRS remains a valuable classification tool. Severity scores correlate with BMI, procedure, and weight loss mechanism. Similar scores between mastopexy-only and reduction mammaplasty patients may reflect a composite of personal cosmetic expectations and cost. The PRS scale should also be expanded to include breast reduction as a surgical remedy for PRS grade 3 breast deformities. Understanding breast deformities in this unique population has applications in both preoperative planning and surgical expectations for this unique patient population.

Staged Reconstruction (Delayed-Immediate) of the Maxillectomy Defect Using CAD/CAM Technology.

BACKGROUND: Computer-aided design/computer-aided manufacturing (CAD/CAM) technology has become increasingly popular for free fibula reconstruction of the mandible. The same technology, however, has not been widely utilized in immediate complex midface reconstruction utilizing free fibula flaps. Maxillary defects are difficult to precisely predict or produce matched cutting guides for after the ablative surgery. We present a protocol for "delayed-immediate" two-stage reconstruction for complex mid-facial defects, by delaying lymph node neck dissection and using CAD/CAM technology for delayed bony reconstruction. METHODS: Stage 1 includes the extirpative surgery, placement of a temporary obturator, and an immediate post-excision fine cut computed tomography (CT) of the defect that is used for CAD/CAM planning. The time interval between stages is used for virtual surgical planning (VSP) and provides an opportunity for the final pathologic margins to be evaluated. At stage 2, definitive reconstruction is performed in conjunction with the delayed neck dissection. Briefly delaying the neck dissection until stage 2 allows for recipient vessel dissection and microsurgical anastomoses to safely occur in a surgically naïve neck. CONCLUSION: A two-stage delayed-immediate reconstruction of complex mid-face defects can be safely and effectively performed. This protocol takes advantage of advancing CAD/CAM technology, provides an opportunity to evaluate final margins, and avoids recipient vessel dissection and microsurgery in previously operated or irradiated necks.

Abdominal- versus thigh-based reconstruction of perineal defects in patients with cancer.

BACKGROUND: An abdominoperineal resection is an invasive procedure that leaves the patient with vast pelvic dead space. Traditionally, the vertical rectus abdominus myocutaneous flap is used to reconstruct these defects. Oftentimes, this flap cannot be used because of multiple ostomy placements or previous abdominal surgery. The anterolateral thigh flap can be used; however, the efficacy of this flap has been questioned. OBJECTIVE: We report a single surgeon's experience with perineal reconstruction in patients with cancer with the use of either the vertical rectus abdominus myocutaneous flap or the anterolateral thigh flap to demonstrate acceptable outcomes with either repair modality. DESIGN: From 2010 to 2012, 19 consecutive patients with perineal defects secondary to cancer underwent flap reconstruction. A retrospective chart review of prospectively entered data was conducted to determine the frequency of short-term and long-term complications. SETTINGS: This study was conducted at an academic, tertiary-care cancer center. PATIENTS: Patients in the study were patients with cancer who were receiving perineal reconstruction. INTERVENTIONS: Interventions were surgical and included either abdomen- or thigh-based reconstruction. MAIN OUTCOME MEASURES: The main outcome measures included infection, flap failure, length of stay, and time to radiotherapy. RESULTS: Of the 19 patients included in our study, 10 underwent anterolateral thigh flaps and 9 underwent vertical rectus abdominus myocutaneous flaps for reconstruction. There were no significant differences in demographics between groups (p > 0.05). Surgical outcomes and complications demonstrated no significant differences in the rate of infection, hematoma, bleeding, or necrosis. The mean length of stay after reconstruction was 9.7 ± 3.4 days (± SD) in the anterolateral thigh flap group and 13.4 ± 7.7 days in the vertical rectus abdominus myocutaneous flap group (p > 0.05). LIMITATIONS: The limitations of this study include a relatively small sample size and retrospective evaluation. CONCLUSION: This study suggests that the anterolateral thigh flap is an acceptable alternative to the vertical rectus abdominus myocutaneous flap for perineal reconstruction (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A134).

Congenital platelet disorder and type I von Willebrand disease presenting as prolonged bleeding after cleft lip and palate repair.

Cleft lip and palate can be associated with coagulopathy. Here, we report the first known case of congenital platelet disorder and von Willebrand disease presenting as prolonged bleeding after cleft lip and palate repair. After identifying the underlying pathology, platelet infusions and aminocaproic acid were given to decrease bleeding from a second surgical procedure. Whole exome sequencing identified a von Willebrand factor gene mutation, an adenine to guanine substitution at the c.475A location. A high index of suspicion should be had for coagulopathy in patients with syndromic cleft lip and palate.

Gender Affirming Facial Surgery-Anatomy and Procedures for Facial Masculinization.

For some patients, feminine facial features may cause significant gender dysphoria. Multiple nonsurgical and surgical techniques exist to masculinize facial features. Nonsurgical techniques include testosterone supplementation and dermal fillers. Surgical techniques include soft tissue manipulation, synthetic implants, regenerative scaffolding, or bony reconstruction. Many techniques are derived from experience with cisgender patients, but are adapted with special considerations to differing anatomy between cisgender and transgender men and women. Currently, facial masculinization is less commonly sought than feminization, but demand is likely to increase as techniques are refined and made available.

ctDNA as an Adjunct to Posttreatment PET for Head and Neck Cancer Recurrence Risk Assessment.

OBJECTIVE: Circulating tumor DNA (ctDNA) detection is an emerging technique that identifies minimal residual disease in patients with solid tumors. ctDNA can act as an adjunct method to help overcome the limitations of positron emission tomography (PET) and select patients who are at high risk for recurrence. STUDY DESIGN: Retrospective Single Institutional Study. SETTING: University Hospital Setting. METHODS: Twenty-nine patients who underwent definitive treatment for squamous cell carcinoma of the head and neck (HNSCC) from 8/2021 to 01/2023 had ctDNA levels analyzed at 1 to 3, 6, 9, and 12 months after definitive treatment. A personalized, tumor-informed, multiplex polymerase chain reaction (PCR) next-generation sequencing (NGS) assay was used to detect the ctDNA levels. The primary outcome was recurrence-free probability (RFP), and the secondary outcomes were overall survival (OS), sensitivity, specificity, and the test's negative (NPV) and positive predictive values (PPV). RESULTS: The median age of patients was 65 years (interquartile range: 56-69), with majority being males (n = 22, 76%). The primary sites were larynx (n = 12), oropharynx (n = 10), and oral cavity (n = 6). Posttreatment ctDNA was detected in 7 patients, all of whom had disease recurrence. ctDNA detection after definitive treatment was associated with a higher risk of disease recurrence (hazard ratio: 9.94, 95% confidence interval: 1.56-63.3, P = .015). ctDNA identified recurrence with 100% specificity and 78% sensitivity. The NPV and PPV were 91% and 100%. PET had 78% sensitivity but only 68% specificity with 86% NPV, and 54% PPV. CONCLUSION: Based on our data, ctDNA can be an excellent adjunct test for posttreatment PET and can help guide physicians in cases where PET results are inconclusive and difficult to interpret.

Predictors of Unplanned Reoperation after Gender-affirming Mastectomy: An Analysis of the NSQIP Database.

Background: Gender-affirming mastectomy (GAM) is a gender-affirmation surgery designed to remove or reduce breast tissue, with or without nipple reconstruction. GAM is the most commonly performed gender-affirmation surgery and risk factors associated with unplanned return to the operating room and reoperation continue to be investigated. This is the largest study of transgender and nonbinary patients undergoing GAM to determine predictors of unplanned reoperation. Methods: The National Surgical Quality Improvement Program database was queried for patients undergoing GAM from 2012 to 2020. The primary outcome was the incidence of unplanned reoperation within 30 days postoperatively. The secondary outcome was the indication for unplanned reoperation within this period. Descriptive statistics were calculated. Bivariate analysis and multivariate logistic regression were performed to determine significant predictors of reoperation after GAM. Results: A total of 2316 patients underwent GAM, of whom 2.2% (n = 51) underwent unplanned reoperation of the chest. The most common indication for unplanned reoperation was hematoma (n = 41, 71.9%) followed by abscess (n = 5, 8.8%). Significant predictors of reoperation were corticosteroid use [adjusted odds ratio (aOR) 95% confidence interval (CI) 5.07 (1.07-23.89)] and diabetes [aOR (CI) 10.98 (3.0-40.33)]. Hispanic/Latinx ethnicity [aOR (CI) 3.19 (1.22-8.33)] and corticosteroid use [aOR (CI) 6.81 (1.45-31.98)] were significant predictors of unplanned reoperation for hematoma evacuation after GAM. Conclusions: Diabetes mellitus and corticosteroid use were associated with unplanned reoperation after GAM. Ethnic correlations remain to be better elucidated as well as the effect of intersectionality. These findings can be used to guide patient selection and surgical decision-making.

Risk Factors for Complications in Patients Undergoing Temporal Bone Resection and Neck Dissection: Insights From a National Database.

BACKGROUND: Temporal bone resection (TBR) with or without neck dissection (ND) is performed for otologic malignancies with occult or clinical cervical lymph node metastases. To date, characterization of post-operative complications in single institution case series may be non-representative of real-world outcomes. Here, we used data from the National Inpatient Sample (NIS) to comprehensively assess the complications encountered, their frequencies, and to identify underlying risk factors to improve future outcomes. METHODS: The population was patients undergoing TBR and ND derived from the NIS between the years of 2017 and 2019. We utilized ICD-10 diagnosis codes to identify patients with post-operative complications, those discharged to non-home facilities (DNHF), and those with increased length of stay (LOS). Multivariable regression was performed to identify significant variables related to the above outcomes. RESULTS: Ninety of 277 patients that underwent LTBR with ND had postoperative complications. Wound complications were the most frequent complication, occurring in 11 (4%) of patients, followed by CSF leak (n = 6; 2.2%), with acute respiratory failure being the most common medical complication (n = 4; 1.4%). Sixteen percent (45/277) were discharged to a facility besides home. Dementia (OR = 7.96; CI95 3.62-17.48), anemia (OR = 2.39; CI95 1.15-4.99), congestive heart failure (OR = 5.31; CI95 1.82-15.45), COPD (OR = 3.70; CI95 1.35-10.16), and history of prior stroke (OR = 8.50; CI95 1.55-46.68) increased the odds of DNHF. When evaluating LOS (median = 5 days, IQR = 1, 9), anemia (OR = 5.49; CI95 2.86-10.52), and Medicaid insurance (OR = 3.07; CI95 1.06-10.52) were found to increase the LOS. CONCLUSIONS: The vast majority of patients undergoing LTBR with ND have no complications and are discharged within a week. Liver disease is a risk factor for medical complications and increased charges. Patients with dementia or a prior stroke are at risk for DNHF, and those with prior anemia are at risk for a wound complication. LAY SUMMARY: This study identified factors related to worse post-operative outcomes in patients undergoing temporal bone resection and neck dissection. Although safe for most patients, an existing diagnosis of liver disease, stroke, dementia, and anemia specifically are at risk for developing negative outcomes. LEVEL OF EVIDENCE: 3.

Outcomes of internal mammary artery perforator flap in head and neck reconstruction: A systematic review.

This study aims to evaluate the functional and prognostic outcomes associated with the internal mammary artery perforator (IMAP) flap in various head and neck defect repairs, given the current lack of clarity on its effectiveness. We performed a systematic review of various databases: PubMed, Embase, Scopus, Web of Science, and ScienceDirect using keywords such as "Internal mammary artery perforator flap" and "IMAP." Screening and data extractions were performed by two individual reviewers. Articles were considered eligible if they included sufficient information on IMAP flap features, their applications in the head and neck, and outcomes. From 264 articles analyzed, 24 studies were included for qualitative analysis. Out of which, 125 patients who received internal mammary artery perforator flaps were included. Most of the patients, 103 (88%), received pedicled IMAP flaps, and 22 (12%) received IMAP free flaps. The second internal mammary artery (IMA) was favored as the single perforator (81.5%), with the combination of the first and second IMA being the primary choice for dual perforators (92.5%). IMAP flaps were predominantly single perforator flaps (65%), with 35% being dual perforator flaps. Among various applications, IMAP flaps are commonly employed in the reconstruction of neck defects (25.5%), pharyngocutaneous fistula repair (20.8%), and burn scar contracture restoration (8%). Only seven (5.6%) patients had flap complications, including venous congestion (1.6%), partial necrosis (1.6%), complete necrosis (1.6%), and incision dehiscence (0.8%). Donor sites were predominantly closed by the primary closure (92%). 3.2% of donor sites had minor complications. The average follow-up was 12.6 (IQR: 6-18) months. This systematic review highlights the effectiveness and safety of IMAP flaps in head and neck reconstruction, with positive outcomes and minimal complications.

Impact of Obesity on Timing of Tracheotomy: A Multi-institutional Retrospective Study.

OBJECTIVE: To examine the impact of increased body mass index (BMI) on (1) tracheotomy timing and (2) short-term surgical complications requiring a return to the operating room and 30-day mortality utilizing data from the Multi-Institutional Study on Tracheotomy (MIST). METHODS: A retrospective analysis of patients from the MIST database who underwent surgical or percutaneous tracheotomy between 2013 and 2016 at eight institutions was completed. Unadjusted and adjusted logistic regression analyses were used to assess the impact of obesity on tracheotomy timing and complications. RESULTS: Among the 3369 patients who underwent tracheotomy, 41.0% were obese and 21.6% were morbidly obese. BMI was associated with higher rates of prolonged intubation prior to tracheotomy accounting for comorbidities, indication for tracheotomy, institution, and type of tracheostomy (p = 0.001). Morbidly obese patients (BMI ≥35 kg/m2) experienced a longer duration of intubation compared with patients with a normal BMI (median days intubated [IQR 25%-75%]: 11.0 days [7-17 days] versus 9.0 days [5-14 days]; p < 0.001) but did not have statistically higher rates of return to the operating room within 30 days (p = 0.12) or mortality (p = 0.90) on multivariable analysis. This same finding of prolonged intubation was not seen in overweight, nonobese patients when compared with normal BMI patients (median days intubated [IQR 25%-75%]: 10.0 days [6-15 days] versus 10.0 days [6-15 days]; p = 0.36). CONCLUSION: BMI was associated with increased duration of intubation prior to tracheotomy. Although morbidly obese patients had a longer duration of intubation, there were no differences in return to the operating room or mortality within 30 days. LEVEL OF EVIDENCE: III Laryngoscope, 2024.

Early, precise, and safe clinical evaluation of the pharmacodynamic effects of novel agents in the intact human tumor microenvironment.

Introduction: Drug development is systemically inefficient. Research and development costs for novel therapeutics average hundreds of millions to billions of dollars, with the overall likelihood of approval estimated to be as low as 6.7% for oncology drugs. Over half of these failures are due to a lack of drug efficacy. This pervasive and repeated low rate of success exemplifies how preclinical models fail to adequately replicate the complexity and heterogeneity of human cancer. Therefore, new methods of evaluation, early in the development trajectory, are essential both to rule-in and rule-out novel agents with more rigor and speed, but also to spare clinical trial patients from the potentially toxic sequelae (high risk) of testing investigational agents that have a low likelihood of producing a response (low benefit). Methods: The clinical in vivo oncology (CIVO®) platform was designed to change this drug development paradigm. CIVO precisely delivers microdose quantities of up to 8 drugs or combinations directly into patient tumors 4-96 h prior to planned surgical resection. Resected tissue is then analyzed for responses at each site of intratumoral drug exposure. Results: To date, CIVO has been used safely in 6 clinical trials, including 68 subjects, with 5 investigational and 17 approved agents. Resected tissues were analyzed initially using immunohistochemistry and in situ hybridization assays (115 biomarkers). As technology advanced, the platform was paired with spatial biology analysis platforms, to successfully track anti-neoplastic and immune-modulating activity of the injected agents in the intact tumor microenvironment. Discussion: Herein we provide a report of the use of CIVO technology in patients, a depiction of the robust analysis methods enabled by this platform, and a description of the operational and regulatory mechanisms used to deploy this approach in synergistic partnership with pharmaceutical partners. We further detail how use of the CIVO platform is a clinically safe and scientifically precise alternative or complement to preclinical efficacy modeling, with outputs that inform, streamline, and de-risk drug development.

Reliability of venous couplers for microanastomosis of the venae comitantes in free radial forearm flaps for head and neck reconstruction.

The radial forearm free flap has gained popularity in head and neck reconstruction after oncologic resection because of its versatility. This popularity has only intensified with the advances in technique and instrumentation. Although debated in the past, the success of using the deep venae comitantes system for flap drainage is well documented. Although the use of couplers in a variety of flap anastomoses has been described in the literature, to our knowledge this is the first series presented on the use of couplers in small, deep system venae comitantes. We retrospectively examined our experience in 61 patients who underwent radial forearm free flaps for head and neck reconstruction. Of the 61 patients, 22 anastomoses were hand sewn, and 39 anastomoses were performed using venous couplers. No flap losses occurred in the group in whom venous couplers were used. In addition, no intraoperative thromboses, arterial or venous, were noted with coupler use. Our series demonstrates that the venous coupler is a safe and effective alternative to the hand-sewn anastomosis of the radial forearm free flap venous comitantes in head and neck reconstruction.

Clarification of the margin status by the multidisciplinary tumor board following transoral robotic surgery for p16 positive oropharyngeal squamous cell carcinoma.

Objectives: Margin status interpretation following transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma (OPSCC) is challenging. This study aims to assess the discrepancy between status of margins as reported by the pathologist versus as determined by multi-disciplinary team review (MDTB). Methods: A retrospective study of 57 patients with OPSCC who underwent TORS from January 2010 to December 2016 was conducted. Our primary outcome measure was the discrepancy between the surgical specimen margins as described in the pathology report versus final margin status that was determined after the multi-disciplinary team discussion. Fisher's exact test was used. Results: Based on the pathologist-report, 29 subjects (51%) had positive margins, compared to 2 (4%) after multi-disciplinary team discussion. Receipt of chemotherapy correlated with final margin status as determined by MDTB, not with initial main specimen margins (p = .02 and p = .08, respectively). With a median follow up of 28.4 months, two subjects (4%) had loco-regional recurrence. Conclusion: Following TORS, there was a significant discrepancy between status of margins as reported by the pathologist versus as determined by MDTB review. Chemotherapy was avoided in 93.1% of cases that were originally reported as positive margins by the pathologist with an acceptably low recurrence rate. Level of evidence: 4.