Response Evaluation of Neoadjuvant Therapies in Sarcoma.

OPINION STATEMENT: Sarcoma is a complex and heterogeneous disease with a rapidly evolving treatment landscape. With a growing emphasis on neoadjuvant therapy as a way to improve surgical and oncologic outcomes, our approach to monitor treatment efficacy must also continue to evolve. This is paramount to both clinical trial design, where endpoints must accurately reflect disease outcomes, and individual patient, whose treatment response informs therapeutic decisions. In the era of personalized medicine, the response to neoadjuvant treatment in sarcoma remains most effectively gauged by pathologic review following surgical resection. Although measures of pathologic complete response most effectively predict outcome, the requisite surgical excision precludes their use in real-time monitoring of neoadjuvant treatment response. Current image-based metrics such as RECIST and PERCIST have been utilized in many trials; however, they are limited by their unilateral measurement approach. More effective tools are needed to better measure the response to therapy prior to neoadjuvant regimen completion, so that the medication or regimen may be best tailored to patient response in an ongoing fashion. Delta-radiomics and circulating tumor DNA (ctDNA) represent promising novel tools for real-time monitoring of treatment efficacy. These metrics have been shown to predict pathologic complete response and disease progression at a superior level to traditional CT-based guidelines. Delta-radiomics is currently being utilized in a clinical trial among soft tissue sarcoma patients in which radiation dosage is adjusted based on radiomic data. The ability of ctDNA to detect molecular residual disease is also under study in multiple clinical trials, although none in the field of sarcoma. Future directions in the field include the use of ctDNA and molecular residual disease testing among sarcoma patients, as well as increased utilization of delta-radiomics, to more effectively monitor neoadjuvant treatment response prior to surgical resection.

Patient reported outcomes: Financial toxicity is a barrier to clinical trials and personalized therapy in cholangiocarcinoma.

PURPOSE: Numerous experimental and targeted therapies are under investigation for patients with cholangiocarcinoma (CCA). Objective health-related quality of life (HRQoL) data for patients receiving these therapies are limited. METHODS: Patients engaged in the Cholangiocarcinoma Foundation completed two validated HRQoL surveys: Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary and COmprehensive Score for financial Toxicity (COST). RESULTS: Two hundred eight patients were included. Seventy-five percent had intrahepatic CCA and 57% underwent resection, of which 48% had disease recurrence. Twenty-two percent enrolled in a clinical trial and 80% underwent molecular profiling, of which 29% received targeted therapy. While patients enrolled in a clinical trial or received targeted therapy reported similar HRQoL compared to those who did not, they reported higher financial toxicity (p = 0.05 and p = 0.01, respectively). CONCLUSION: Enrollment in a clinical trial or receipt of targeted therapy do not affect a patient's physical, emotional, social, or functional well-being. However, patients report higher financial burden. These therapies are mainly offered in the advanced setting after significant financial strain has been endured and are often only available at large academic centers, creating a physical barrier to access. These findings underscore the need to increase availability and eliminate physical and financial barriers that threaten access and utilization of personalized and progressive therapies.

Implementation of a Hepatocellular Carcinoma Screening Program for At-risk Patients Safety-Net Hospital: A Model for National Dissemination.

OBJECTIVE: This study aimed to enhance hepatocellular carcinoma (HCC) screening to achieve earlier diagnosis of patients with hepatitis C (HCV) cirrhosis in our Safety-Net population. BACKGROUND: Adherence to HCC screening guidelines at Safety-Net hospitals is poor. Only 23% of patients with HCC at our health system had a screening exam within 1-year of diagnosis and 46% presented with stage IV disease. HCV-induced cirrhosis remains the most common etiology of HCC (75%) in our patients. METHODS: In the setting of an established HCV treatment clinic, an HCC screening quality improvement initiative was initiated for patients with stage 3 fibrosis or cirrhosis by transient elastography. The program consisted of semiannual imaging. Navigators scheduled imaging appointments and tracked compliance. RESULTS: From April 2018 to April 2021, 318 patients were enrolled (mean age 61 years, 81% Black race, 38% uninsured). Adherence to screening was higher than previously reported: 94%, 75%, and 74% of patients completed their first, second, and third imaging tests. Twenty-two patients (7%) were diagnosed with HCC; 55% stage I and 14% stage IV. All patients were referred and 13 (59%) received treatment. Median time to receipt of treatment was 77 days (range, 32-282). Median overall survival for treated patients was 32 months. CONCLUSIONS: Implementation of an HCC screening program at a safety-net hospital is feasible and facilitated earlier diagnosis in this study. Patient navigation and tracking completion of imaging tests were key components of the program's success. Next steps include expanding the program to additional at-risk populations.

Do Oncologic Outcomes From Head and Neck Versus Truncal and Extremity Melanoma Differ? A Single-Institution Single-Subspecialty Experience.

BACKGROUND: Outcomes are thought to be worse in head and neck (H&N) melanoma patients. However, definitive evidence of inferior outcomes in H&N melanoma in the modern era is lacking. We sought to ascertain whether H&N melanomas carry a worse prognosis than melanomas of other sites. METHODS: All patients who underwent excision for primary melanoma by fellowship-trained surgical oncologists at a single institution from 2014 to 2020 were queried from the electronic medical record. Patients who had AJCC eighth edition stage I-III disease were included. RESULTS: Of 1127 patients, 28.7% had primary H&N melanoma. H&N patients were more likely to be male, older, and present with more advanced AJCC stage. Median follow-up was 20.0 months (IQR 26.4). On multivariable analyses controlling for other variables, H&N melanoma was associated with worse RFS. Notably, H&N melanoma was not associated with worse MSS, DMFS, or OS on univariate or multivariable analyses. Among patients who recurred, H&N patients were significantly more likely to recur locally compared to non-H&N patients. On subgroup analysis, scalp melanoma was also associated with worse RFS compared to patients with melanoma in locations other than the scalp. When patients with scalp melanoma were excluded from analysis, non-scalp H&N RFS was not significantly different from the non-H&N group on univariate or multivariable analyses. DISCUSSION: In this series from a high-volume tertiary referral center, the differences in rates and sites of recurrence between H&N and non-H&N melanoma do not impact melanoma-specific or overall survival, suggesting that H&N melanoma patients should be treated similarly with respect to regional and systemic therapies.

Assessment of Functional Rhinoplasty with Spreader Grafting Using Acoustic Rhinomanometry and Validated Outcome Measurements.

BACKGROUND: Rhinoplasty is 1 of the most common aesthetic and reconstructive plastic surgical procedures performed within the United States. Yet, data on functional reconstructive open and closed rhinoplasty procedures with or without spreader graft placement are not definitive as only a few studies have examined both validated measurable objective and subjective outcomes of spreader grafting during rhinoplasty. The aim of this study was to utilize previously validated measures to assess objective, functional outcomes in patients who underwent open and closed rhinoplasty with spreader grafting. METHODS: We performed a retrospective review of consecutive rhinoplasty patients. Patients with internal nasal valve insufficiency who underwent an open and closed approach rhinoplasty between 2007 and 2016 were studied. The Cottle test and Nasal Obstruction Symptom Evaluation survey was used to assess nasal obstruction. Patient-reported symptoms were recorded. Acoustic rhinometry was performed pre- and postoperatively. Average minimal cross-sectional area of the nose was measured. RESULTS: One hundred seventy-eight patients were reviewed over a period of 8 years. Thirty-eight patients were included in this study. Of those, 30 patients underwent closed rhinoplasty and 8 open rhinoplasty. Mean age was 36.9 ± 18.4 years. The average cross-sectional area in closed and open rhinoplasty patients increased significantly (P = 0.019). There was a functional improvement in all presented cases using the Nasal Obstruction Symptom Evaluation scale evaluation. CONCLUSIONS: Closed rhinoplasty with spreader grafting may play a significant role in the treatment of nasal valve collapse. A closed approach rhinoplasty including spreader grafting is a viable option in select cases with objective and validated functional improvement.

Evaluating the Impact of Resident Participation and the July Effect on Outcomes in Autologous Breast Reconstruction.

OBJECTIVE: Although resident involvement in surgical procedures is critical for training, it may be associated with increased morbidity, particularly early in the academic year-a concept dubbed the "July effect." Assessments of such phenomena within the field of plastic surgery have been both limited and inconclusive. We sought to investigate the impact of resident participation and academic quarter on outcomes for autologous breast reconstruction. METHODS: All autologous breast reconstruction cases after mastectomy were gathered from the 2005-2012 American College of Surgeons National Surgical Quality Improvement Program database. Multivariable logistic regression models were constructed to investigate the association between resident involvement and the first academic quarter (Q1 = July-September) with 30-day morbidity (odds ratios [ORs] with 95% confidence intervals). Medical and surgical complications, median operation time, and length of stay (LOS) were also compared. RESULTS: Overall, 2527 cases were identified. Cases with residents (n = 1467) were not associated with increased 30-day morbidity (OR, 1.20; 0.95-1.52) when compared with those without (n = 1060), although complications including transfusion (OR, 2.08; 1.39-3.13) and return to the operating room (OR, 1.46; 1.11-1.93) were more frequently observed in resident cases. Operation time and LOS were greater in cases with resident involvement.In cases with residents, there was decreased morbidity in Q1 (n = 343) when compared with later quarters (n = 1124; OR, 0.67; 0.48-0.92). Specifically, transfusion (OR, 0.52; 0.29-0.95), return to operating room (OR, 0.64; 0.41-0.98), and surgical site infection (OR, 0.37; 0.18-0.75) occurred less often during Q1. No differences in median operation time or LOS were observed within this subgroup. CONCLUSIONS: Our study reveals that resident involvement in autologous breast reconstruction is not associated with increased morbidity and offers no evidence for a July effect. Notably, our results suggest that resident cases performed earlier in the academic year, when surgical attendings may offer more surveillance and oversight, is associated with decreased morbidity.

Image-guided, Minimally Invasive Evacuation of Intracerebral Hematoma: A Matched Cohort Study Comparing the Endoscopic and Tubular Exoscopic Systems.

Introduction Novel image-guided, minimally invasive techniques to evacuate intracerebral hematomas represent a promising new avenue in the management of this disease entity. To our knowledge, a direct comparison of the Penumbra Apollo (Penumbra Inc, Alameda, California, US) and Nico BrainPath (Indianapolis, Indiana, US) system has not yet been performed. Methods A retrospective review of image-guided, minimally invasive evacuation of intracerebral hematomas performed at one academic institution in the United States between July 2015 and July 2017 was performed. Cases performed with the Apollo and BrainPath system were matched based on age, gender, hematoma location and laterality, and volume. Results Twenty-four patients underwent surgery using either of the two minimally invasive surgical systems and five cases in each group were matched for age, gender, hematoma location and laterality, and volume. Median time from symptom onset to evacuation was two days with a mean distance from the brain surface to the clot of approximately 40 millimeters in both groups. Both techniques achieved comparable clot evacuation. The functional outcome was poor with either technique with the majority of patients dependent or dead at last follow-up. Conclusions In the present, small, matched cohort study, both the Apollo and BrainPath techniques achieved satisfactory clot evacuation. Nevertheless, the functional outcome in this patient population remains poor in the majority of cases.

Endovascular Mechanical Thrombectomy in Large-Vessel Occlusion Ischemic Stroke Presenting with Low National Institutes of Health Stroke Scale: Systematic Review and Meta-Analysis.

INTRODUCTION: Mechanical thrombectomy has become the standard of care for management of most large vessel occlusion (LVO) strokes. When patients with LVO present with minor stroke symptomatology, no consensus on the role of mechanical thrombectomy exists. METHODS: A systematic review and meta-analysis were performed to identify studies that focused on mechanical thrombectomy, either as a standalone treatment or with intravenous tissue plasminogen activator (IV tPA), in patients with mild strokes with LVO, defined as a baseline National Institutes of Health Stroke Scale score ≤5 at presentation. Data on methodology, quality criteria, and outcome measures were extracted, and outcomes were compared using odds ratio as a summary statistic. RESULTS: Five studies met the selection criteria and were included. When compared with medical therapy without IV tPA, mechanical thrombectomy and medical therapy with IV tPA were associated with improved 90-day modified Rankin Scale (mRS) score. Among medical patients who were not eligible for IV tPA, those who underwent mechanical thrombectomy were more likely to experience good 90-day mRS than those who were not. There was no significant difference in functional outcome between mechanical thrombectomy and medical therapy with IV tPA, and no treatment subgroup was associated with intracranial hemorrhage or death. CONCLUSIONS: In patients with mild strokes due to LVO, mechanical thrombectomy and medical therapy with IV tPA led to better 90-day functional outcome. Mechanical thrombectomy plays an important role in the management of these patients, particularly in those not eligible for IV tPA.

Initial Assessment, Treatment, and Follow-Up of Minor Pediatric Burn Wounds in Four Patients Remotely: A Preliminary Communication.

BACKGROUND: Close, multidisciplinary collaboration with burn experts is the essential strategy to achieve the best functional and esthetic outcomes in burn wound treatment. Management of minor burn injuries, where no specialized care is available, might be challenging. One concept to achieve a fast and timely result is the application of telemedicine. The objective of this study was to assess and develop a simple telemedicine protocol, which can be applied globally. MATERIAL AND METHODS: We present a pilot study based on a pediatric population of four patients with minor burns. Based on the severity and burn area, two cases of ambulant pediatric patients (mean 1% total body surface area, superficial and deep 2° burn) with minor burn injuries met study criteria and were enrolled. A pediatrician performed the initial assessment, followed by plastic surgery video consultation, using telephone's digital camera. Treatment protocols were designed to optimize outcomes. After the initial treatment phase, which took place at a nonteaching local hospital in Poland from January 1, 2014, to December 31, 2014, clinical follow-up was performed by a plastic surgeon via smartphone in the United States. RESULTS: We have achieved complete burn wound resolution, in all patients, with no scarring and only minor discoloration. A simple, reproducible treatment protocol was designed to include dressing changes and additional outpatient visits. CONCLUSIONS: Implementation of a telemedicine protocol allows for easy access to burn consultations, helps multidisciplinary collaboration, eases follow-ups, and shortens specialists' consult wait times. Real-time evaluation provides fast and flexible treatment, without long distance travels, for patients and their families. Telemedicine increases the frequency of follow-up, contributes to the esthetic outcome, and together with improved cost-effectiveness is beneficial for both the patient and healthcare system.

Differences in the Reporting of Racial and Socioeconomic Disparities among Three Large National Databases for Breast Reconstruction.

BACKGROUND: Research derived from large-volume databases plays an increasing role in the development of clinical guidelines and health policy. In breast cancer research, the Surveillance, Epidemiology and End Results, National Surgical Quality Improvement Program, and Nationwide Inpatient Sample databases are widely used. This study aims to compare the trends in immediate breast reconstruction and identify the drawbacks and benefits of each database. METHODS: Patients with invasive breast cancer and ductal carcinoma in situ were identified from each database (2005-2012). Trends of immediate breast reconstruction over time were evaluated. Patient demographics and comorbidities were compared. Subgroup analysis of immediate breast reconstruction use per race was conducted. RESULTS: Within the three databases, 1.2 million patients were studied. Immediate breast reconstruction in invasive breast cancer patients increased significantly over time in all databases. A similar significant upward trend was seen in ductal carcinoma in situ patients. Significant differences in immediate breast reconstruction rates were seen among races; and the disparity differed among the three databases. Rates of comorbidities were similar among the three databases. CONCLUSIONS: There has been a significant increase in immediate breast reconstruction; however, the extent of the reporting of overall immediate breast reconstruction rates and of racial disparities differs significantly among databases. The Nationwide Inpatient Sample and the National Surgical Quality Improvement Program report similar findings, with the Surveillance, Epidemiology and End Results database reporting results significantly lower in several categories. These findings suggest that use of the Surveillance, Epidemiology and End Results database may not be universally generalizable to the entire U.S.

The New Accreditation Council for Graduate Medical Education Next Accreditation System Milestones Evaluation System: What Is Expected and How Are Plastic Surgery Residency Programs Preparing?

BACKGROUND: The Accreditation Council for Graduate Medical Education Next Accreditation System milestones were implemented for plastic surgery programs in July of 2014. Forward progress through the milestones is an indicator of trainee-appropriate development, whereas regression or stalling may indicate the need for concentrated, targeted training. METHODS: Online software at www.surveymonkey.com was used to create a survey about the program's approaches to milestones and was distributed to program directors and administrators of 96 Accreditation Council for Graduate Medical Education-approved plastic surgery programs. RESULTS: The authors had a 63.5 percent response rate (61 of 96 plastic surgery programs). Most programs report some level of readiness, only 22 percent feel completely prepared for the Next Accreditation System milestones, and only 23 percent are completely satisfied with their planned approach for compliance. Seventy-five percent of programs claim to be using some form of electronic tracking system. Programs plan to use multiple tools to capture and report milestone data. Most programs (44.4 percent) plan to administer evaluations at the end of each rotation. Over 70 percent of respondents believe that the milestones approach would improve the quality of resident training. However, programs were less than confident that their current compliance systems would live up to their full potential. CONCLUSIONS: The Next Accreditation System has been implemented nationwide for plastic surgery training programs. Milestone-based resident training is a new paradigm for residency training evaluation; programs are in the process of making this transition to find ways to make milestone data meaningful for faculty and residents.