Evaluation of Preoperative and Intraoperative Mobile Gamma Camera Imaging in Sentinel Lymph Node Biopsy for Melanoma Independent of Preoperative Lymphoscintigraphy.

INTRODUCTION: Sentinel lymph node biopsy (SLNB) is a standard practice for staging cutaneous melanoma. High false-negative rates have an increased interest in adjunctive techniques for localizing SLNs. Mobile gamma cameras (MGCs) represent potential tools to enhance SLNB performance. METHODS: An institutional review board approval was obtained for this study (ClinicalTrials.gov ID NCT01531608). After obtaining informed consent, 20 eligible melanoma patients underwent 99mTc sulfur colloid injection and standard lymphoscintigraphy with a fixed gamma camera (FGC). A survey using a 20 cm square MGC, performed immediately preoperatively by the study surgeon, was used to establish an operative plan while blinded to the FGC results. Subsequently, SLNB was performed using a gamma probe and a novel 6 cm diameter handheld MGC. RESULTS: A total of 24 SLN basins were detected by FGC. Prior to unblinding, all 24 basins were identified with the preoperative MGC and the operative plan established by preoperative MGC imaging was confirmed accurate by review of the FGC images. All individual sentinel lymph nodes were identified during intraoperative MGC imaging, and in 5/24 (21%) cases, surgeon-reported additional clinically useful information was obtained from the MGC. CONCLUSIONS: Preoperative MGC images provide information consistent with FGC images for planning SLNB and in some cases provide additional information that aided in surgical decision-making.

Impact of the Affordable Care Act Medicaid Expansion on Reimbursement in Emergency General Surgery.

BACKGROUND: Kentucky had one of the nation's largest increases in insurance coverage with the Affordable Care Act's (ACA) Medicaid expansion, quadrupling the proportion of Kentuckians with insurance coverage. This study compares reimbursement rates for surgical procedures performed by emergency general surgery (EGS) services at the University of Kentucky (UK) before and after Medicaid expansion in January 2014. METHODS: This IRB-approved, single-institution study retrospectively evaluated all patients undergoing surgical treatment by our EGS team from 1/1/2011 to 12/31/2016. We queried operative records for the most frequently performed procedures by the EGS service. We reviewed patient electronic medical records and hospital financial records to identify insurance status, diagnosis codes, and expected hospital reimbursements, based on UK Hospital's procedure/payer accounting models. RESULTS: Four thousand six hundred ninety-three patient procedures met inclusion criteria; 46.5% of these came before ACA expansion and 53.5% after expansion. The most frequent procedures performed were incision and drainage, laparoscopic appendectomy, laparoscopic cholecystectomy, and exploratory laparotomy. After ACA expansion, the proportion of patients with Medicaid nearly doubled (19.8% vs. 35.6%, p < 0.001). Concomitantly, there was a more than fivefold decrease in the uninsured patient population after expansion (23.3% vs. 4.6%, p < 0.001), and mean hospital reimbursement increased for laparoscopic appendectomy (13.7%, p < 0.001), laparoscopic cholecystectomy (50.7%, p < 0.001), and incision and drainage (70.2%, p < 0.001). CONCLUSION: After ACA expansion, there was a sustained decrease in proportion of uninsured patients and a concomitant sustained increase in proportion of patients with access to Medicaid services in the EGS operative population, leading to increased mean hospital reimbursements and decreased patient financial burden.

Design, development, and evaluation of a novel retraction device for gallbladder extraction during laparoscopic cholecystectomy.

BACKGROUND: A source of frustration during laparoscopic cholecystectomy involves extraction of the gallbladder through port sites smaller than the gallbladder itself. We describe the development and testing of a novel device for the safe, minimal enlargement of laparoscopic port sites to extract large, stone-filled gallbladders from the abdomen. METHODS: The study device consists of a handle with a retraction tongue to shield the specimen and a guide for a scalpel to incise the fascia within the incision. Patients enrolled underwent laparoscopic cholecystectomy. Gallbladder extraction was attempted. If standard measures failed, the device was implemented. Extraction time and device utility scores were recorded for each patient. Patients returned 3-4 weeks postoperatively for assessment of pain level, cosmetic effect, and presence of infectious complications. RESULTS: Twenty (51 %) of 39 patients required the device. Average extraction time for the first eight patients was 120 s. After interim analysis, an improved device was used in 12 patients and average extraction time was 24 s. There were no adverse events. Postoperative pain ratings and incision cosmesis were comparable between patients with and without use of the device. CONCLUSION: The study device enables safe and rapid extraction of impacted gallbladders through the abdominal wall.

A case of spontaneous systemic immunity to melanoma associated with cure after amputation for extensive regional recurrence.

PURPOSE: Survival after amputation for melanoma is short; however, rare long-term survivors are reported. The mechanism for durable systemic tumor control in patients with regional failure is not known. To explore whether systemic tumor immunity may be implicated, tumor and circulating immune responses were examined in a patient who survived disease-free 14 years after hip disarticulation. METHODS: A 71-year-old female with extensive regional metastases of melanoma in the left lower extremity underwent amputation for palliative reasons. Tumor was collected at surgery, and blood was collected during follow-up. Tumor sections were evaluated for lymphocytic infiltration and NY-ESO-1 expression by immunohistochemistry. Cellular immune responses to defined tumor antigens were evaluated by ELISPOT assay, and antibody responses to a panel of tumor antigens were assayed by ELISA. RESULTS: The patient's tumor had minimal lymphocytic infiltrate (immunotype A). NY-ESO-1 was strongly expressed by the melanoma cells. Circulating T-cell responses to NY-ESO-1 peptides were observed 6 and 12 years postoperatively, and antibodies to NY-ESO-1 were detected 2-6 years after surgery. CONCLUSION: The patient described in this report experienced relentless regional tumor progression, with intravascular metastases, and then 14-year systemic disease-free survival after palliative resection, without evidence of melanoma recurrence before death from other causes. Her immune response to NY-ESO-1 likely failed to control established regional metastases because T cells were unable to infiltrate them. It is possible, however, that among other factors, the host immune response may have contributed to systemic protection.

Surgical management of the patient with metastatic melanoma to the heart.

Melanoma has a high propensity for cardiac seeding, with heart involvement noted in a significant number of patients at autopsy. Therapeutic options are currently limited, and the prognosis of cardiac metastasis is poor. We report two cases of cardiac metastasis of melanoma and review the current literature. In addition, we propose an algorithm for dealing with this difficult problem.

Usefulness of prestudy assessment of patient willingness to undergo tissue biopsy for correlative studies in a melanoma vaccine trial.

BACKGROUND: Performing biopsies for correlative studies in cancer trials raises ethical and regulatory concerns and may impact trial accrual negatively. However, strategies to address these concerns remain largely unexplored. PURPOSE: We sought to assess the perceived risk of mandatory tissue biopsies to be performed for research purposes as part of a clinical trial of a melanoma vaccine by administering a pretrial accrual assessment questionnaire in the population of interest. Furthermore, we explored how such survey data may be used to address potential concerns of regulatory and funding organizations that may not be able to assess the risks of those biopsies. Method A total of 91 melanoma patients, similar to potential participants in a melanoma vaccine pilot study, scored their willingness, on a 9-point Likert scale, to participate in vaccine trials involving no skin biopsy versus a skin biopsy resulting in a 3-, 6-, or 12-cm scar. The vaccine trial was performed with skin biopsies leaving a 6-cm scar. Accrual rate was assessed and that accrual was compared to the accrual of two similar vaccine trials without biopsy requirements. RESULTS: A total of 95% of the participants expressed willingness to enter a vaccine trial (likely to highly likely). This proportion decreased to 74%, 63%, and 59%, respectively, for vaccine trials requiring skin biopsy leaving a 3-, 6-, or 12-cm scar. The trial was designed with an estimated 40% decrease in accrual rate compared to prior studies (2 participants expected/month). The resulting trial with a 6-cm biopsy exceeded that accrual rate estimate and had a similar accrual rate to vaccine trials without a biopsy (4.1 vs 2.7-4.6 participants/month). LIMITATIONS: Potential limitations of this study include the exclusion of some questionnaire responses and the post hoc nature of the analysis. CONCLUSION: Willingness to participate in vaccine trials was decreased by the requirement for skin biopsy, but the size of the biopsy was less of a deterrent than expected. Findings from brief surveys may aid in risk assessment during regulatory review, predict acceptability of tissue collection for correlative studies, and support regulatory approval and meeting accrual goals of the study.