Habermann, Elizabeth B.

ObjectivesTo describe pain experience and opioid use after major head and neck reconstructive surgery.Study DesignRetrospective cohort study.MethodsPatients undergoing major head and neck surgery with microvascular free tissue transfer (free flaps) at a tertiary academic center were included. Pain scores (0–10) and demographic and clinical data were ascertained from medical records. Discharge opioid prescriptions and refills obtained within 30 days were recorded. Patient characteristics were compared with pain scores using nonparametric rank‐sum tests and with likelihood of refill using logistic regression models to calculate adjusted odds ratios (aORs) with 95% confidence intervals (CIs).ResultsThe study population comprised 445 patients. Median age was 60 years (interquartile range 50–68). Most patients had cancer (N = 350, 78%). The majority of free flaps were fibula (N = 153, 34%) or radial forearm (N = 159, 36%). Older patients reported significantly lower pain scores, whereas patients with opioid tolerance, anxiety, current smokers, and those undergoing larger volume resections or boney free flaps reported significantly higher pain scores. One‐quarter (N = 115, 26%) of patients obtained opioid refills. Patients aged ≥ 60 years had one‐half the odds of obtaining a refill compared with patients aged < 60 years (adjusted odds ratio [aOR] = 0.52, 95% confidence interval [CI] = 0.33–0.84), whereas surgical defect volume ≥ 100 cm3 (aOR = 1.92, 95% CI = 1.21–3.07) and higher pain score (aOR = 1.19, 95% CI = 1.07–1.32 per 1 point increase) increased the odds of refill.ConclusionContinued opioid use after discharge is common among patients undergoing major head and neck reconstruction, particularly for younger patients and after more extensive surgery. Older patients reported lower pain intensity and were less likely to obtain opioid refills, highlighting the wisdom of judicious opioid use for this vulnerable population.Level of EvidenceIV Laryngoscope, 130: E469–E478, 2020

Background Frailty increases risk for complications after total joint arthroplasty (TJA). Whether this association is influenced by anesthetic administered is unknown. We hypothesized that use of neuraxial (spinal or epidural) anesthesia is associated with better outcomes compared with general anesthesia, and that the effect of anesthesia type on outcomes differs by frailty status. Methods This single-institution cohort study included all patients (≥50 years) from January 2005 through December 2016 undergoing unilateral, primary and revision TJA. Using multivariable Cox regression, we assessed relationships between anesthesia type, a preoperative frailty deficit index (FI) categorized as non-frail (FI <0.11), vulnerable (FI 0.11 to 0.20), and frail (FI >0.20), and complications (mortality, infection, wound complications/hematoma, reoperation, dislocation, and periprosthetic fracture) within 1 year after surgery. Interactions between anesthesia type and frailty were tested, and stratified models were presented when an interaction (p<0.1) was observed. Results Among 18 458 patients undergoing TJA, more patients were classified as frail (21.5%) and vulnerable (36.2%) than non-frail (42.3%). Anesthesia type was not associated with complications after adjusting for age, joint, and revision type. However, in analyzes stratified by frailty, vulnerable patients under neuraxial block had less mortality (HR=0.49; 95% CI 0.27 to 0.89) and wound complications/hematoma (HR=0.71; 95% CI 0.55 to 0.90), whereas no difference in risk by anesthesia type was observed among patients found non-frail or frail. Conclusions Neuraxial anesthesia use among vulnerable patients was associated with improved survival and less wound complications. Calculating preoperative frailty prior to TJA informs perioperative risk and enhances shared-decision making for selection of anesthesia type.

Abstract Background: Invasive lobular carcinoma (ILC) is typically strongly hormone receptor (HR) positive, with unique characteristics. It has been shown to have poor response to neoadjuvant chemotherapy (NAC) and recent studies describe the benefits of neoadjuvant endocrine therapy (NET). We sought to determine how the primary management strategy in ILC has changed over time, and the impact of ILC tumor biology on its management. Specifically, we hypothesized that use of NAC has decreased, while NET use increased. Additionally, we investigated whether NET is associated with higher rates of breast conservation surgery (BCS) than other primary management strategies. Methods: We queried the NCDB from 2010-2016 and identified all women with ILC who underwent surgical therapy. Patients with stage IV disease were excluded. First course of treatment was classified as: NAC (chemotherapy starting 31-365 days before surgery), NET (short course defined as 7-30 days before surgery; long course defined as 31-365 days before surgery), and primary surgery. Tumors were considered HR+ if they were estrogen receptor and/or progesterone receptor positive. Trends over time in first treatment strategy were compared using Cochrane-Armitage tests. The association between first treatment strategy and use of BCS was assessed using multivariable logistic regression. Results: Among 79,709 women with ILC, 94.0% were HR+/HER2-, 4.7% were HER2+, and 1.3% were triple negative. The most common primary treatment strategy was surgery (92.3%), but the percent undergoing systemic treatment before surgery increased from 7.1% in 2010 to 8.8% in 2016 (p&lt;0.001). The use of NAC increased significantly over the study period in patients with triple negative (12.1% in 2010 to 23.7% in 2016, p=0.007) and HER2+ (12.2% in 2010 to 29.1% in 2016, p&lt;0.001) ILC tumors. Among patients with HR+/HER2- tumors, however, the use of NAC decreased from 4.7% in 2010 to 4.2% in 2016, p=0.007, and the use of long course NET increased significantly, from 1.6% in 2010 to 2.7% in 2016, p&lt;0.001. The use of short course NET in HR+/HER2- patients remained very low over the study period (0.4% in 2010 to 0.5% in 2016, p=0.14). Analyzing the HR+/HER2- subset, 48.4% (295/609) of patients undergoing long course NET with a cT2 tumor underwent BCS compared to 35.3% for primary surgery, 27.3% for NAC, and 24.8% for short course NET (p&lt;0.001). Long course NET was also associated with a higher BCS rate in cT3/cT4 tumors: 22.6% BCS for long course NET, 8.3% BCS for primary surgery, 9.6% BCS for NAC, 7.8% BCS for short course NET (p&lt;0.001). In multivariable analysis including a clinical T category by treatment interaction, long course NET was the only treatment that was associated with higher rates of BCS compared to primary surgery in cT2 (OR 1.51, 95% CI: 1.27-1.79) tumors, while both long course NET (OR 2.52, 95% CI: 1.97-3.22) and NAC (OR 1.54, 95% CI: 1.27-1.88) were associated with increased use of BCS in cT3/cT4 tumors, see Table. Conclusions: The primary management of ILC is slowly evolving over time with a decrease in primary surgery. NAC use has increased appropriately in tumor subtypes with greatest potential benefit (i.e., triple negative or HER2 positive). In HR+/HER2- disease, NAC use has decreased, however NET use has increased and in cT2+ tumors NET was associated with higher rates of BCS. Variable1Odds ratio for BCS (95% CI)p-valueAge, per 1 year increase1.04 (1.03-1.04)&lt;0.001Charlson-Deyo comorbidity score&lt;0.0011 vs 00.86 (0.82-0.90)2+ vs 00.72 (0.66-0.79)Grade2&lt;0.001Moderately/Poorly vsWell Differentiated0.91 (0.88-0.95)Clinical N category2&lt;0.001cN1 vs cN00.49 (0.46-0.52)cN2/cN3 vs cN00.41 (0.35-0.47)Multicentric&lt;0.001Yes vs No0.36 (0.34-0.38)Primary treatment by clinical T category2&lt;0.001For cT1 tumorsLong course NET vs primary surgery0.65 (0.51-0.83)NAC vs Primary surgery0.31 (0.24-0.41)Short course NET vs primary surgery0.85 (0.58-1.24)For cT2 tumorsLong course NET vs primary surgery1.51 (1.27-1.79)NAC vs primary surgery1.04 (0.90-1.20)Short course NET vs primary surgery0.53 (0.33-0.85)For cT3/cT4 tumorsLong course NET vs primary surgery2.52 (1.97-3.22)NAC vs primary surgery1.54 (1.27-1.88)Short course NET vs primary surgery0.79 (0.31-2.02)1Model additionally adjusted for year of diagnosis, race, ethnicity, and insurance status.2Unknown level included in the model but not reported Citation Format: Rita A Mukhtar, Tanya L. Hoskin, Elizabeth B. Habermann, Judy C. Boughey. Trends in primary management of invasive lobular carcinoma: An analysis of the National Cancer Database (NCDB) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-13-01.

OBJECTIVE The nature of the volume-outcome relationship in cases with severe traumatic brain injury (TBI) remains unclear, with considerable interhospital variation in patient outcomes. The objective of this study was to understand the state of the volume-outcome relationship at different levels of trauma centers in the United States. METHODS The authors queried the National Trauma Data Bank for the years 2007–2014 for patients with severe TBI. Case volumes for each level of trauma center organized into quintiles (Q1–Q5) served as the primary predictor. Analyzed outcomes included in-hospital mortality, total hospital length of stay (LOS), and intensive care unit (ICU) stay. Multivariable regression models were performed for in-hospital mortality, overall complications, and total hospital and ICU LOSs to adjust for possible confounders. The analysis was stratified by level designation of the trauma center. Statistical significance was established at p < 0.001 to avoid a type I error due to a large sample size. RESULTS A total of 122,445 patients were included. Adjusted analysis did not demonstrate a significant relationship between increasing hospital volume of severe TBI cases and in-hospital mortality, complications, and nonhome hospital discharge disposition among level I–IV trauma centers. However, among level II trauma centers, hospital LOS was longer for the highest volume quintile (adjusted mean difference [MD] for Q5: 2.83 days, 95% CI 1.40–4.26 days, p < 0.001, reference = Q1). For level III and IV trauma centers, both hospital LOS and ICU LOS were longer for the highest volume quintile (adjusted MD for Q5: LOS 4.6 days, 95% CI 2.3–7.0 days, p < 0.001; ICU LOS 3.2 days, 95% CI 1.6–4.8 days, p < 0.001). CONCLUSIONS Higher volumes of severe TBI cases at a lower level of trauma center may be associated with a longer LOS. These results may assist policymakers with target interventions for resource allocation and point to the need for careful prehospital decision-making in patients with severe TBI.

Background: Evidence-based, procedure-specific guidelines for prescribing opioids are urgently needed to optimize pain relief while minimizing excessive opioid prescribing and potential opioid diversion in our communities. A multidisciplinary panel at our institution recently developed procedure-specific guidelines for discharge opioid prescriptions for common orthopaedic surgical procedures. The purpose of this study was to evaluate postoperative opioid prescription quantities, variability, and 30-day refill rates before and after implementation of the guidelines. Methods: This retrospective cohort study was conducted at a single academic institution from December 2016 to March 2018. Guidelines were implemented on August 1, 2017, with a recommended maximum opioid prescription quantity for 14 common orthopaedic procedures. Patients who underwent these 14 procedures during the period of December 2016 to May 2017 made up the pre-guideline cohort (n = 2,223), and patients who underwent these procedures from October 2017 to March 2018 made up the post-guideline cohort (n = 2,300). Opioid prescription quantities were reported as oral morphine equivalents (OME), with medians and interquartile ranges (IQRs). Four levels were established for recommended prescription maximums, ranging from 100 to 400 OME. Results: In the pre-guideline cohort, the median amount of prescribed opioids across all procedures was 600 OME (IQR, 390 to 863 OME), which decreased by 38% in the post-guideline period, to a median of 375 OME (IQR, 239 to 400 OME) in the post-guideline cohort (p < 0.001). The 30-day refill rate did not change significantly, from a rate of 24% in the pre-guideline cohort to 25% in the post-guideline cohort (p = 0.43). Multivariable analysis demonstrated that guideline implementation was the factor most strongly associated with prescriptions exceeding guideline maximums (odds ratio [OR] = 9.9; p < 0.001). Age groups of <80 years (OR = 2.0 to 2.4; p < 0.001) and males (OR = 1.2; p = 0.025) were also shown to have higher odds of exceeding guideline maximums. Conclusions: Procedure-specific guidelines are capable of substantially decreasing opioid prescription amounts and variability. Furthermore, the absence of change in refill rates suggests that pain control remains similar to pre-guideline prescribing practices. Evidence-based guidelines are a readily employable solution that can drive rapid change in practice and enhance the ability of orthopaedic surgeons to provide responsible pain management.

AbstractIntroductionDue to the rarity of malignant insulinoma, a lack of the literature describing factors affecting outcomes exists. Our aim was to review malignant insulinoma incidence, characteristics and survival trends.MethodsWe identified all patients with malignant insulinoma in the SEER registries from 1973 to 2015. Incidence, neoplasm characteristics and factors affecting cancer‐specific survival (CSS) were described.ResultsA total of 121 patients were identified. The crude annual overall incidence was low (range 0.0–0.27 cases per million person years). The largest proportion had localized disease (40%), while 16% had regional disease, 39% distant metastatic disease, and stage was unreported in 5%. Most neoplasms were in the body/tail of the pancreas, followed by the head of the pancreas. Grade was reported in 40% of patients; only a single patient reported as having grade IV with the remainder all grades I/II. Surgical resection was performed in 64% of patients. Within surgical patients, the median primary neoplasm size was 1.8 cm. Regional lymph nodes were examined in 57.1% of surgical patients, while 34% of examined nodes were positive. The median CSS was 183 months. On multivariable analysis, surgical resection, male sex and absence of metastatic disease were associated with superior survival.ConclusionWhile the greatest proportion of patients with malignant insulinoma present with localized disease, regional lymph node involvement was found in 34% of whose nodes were tested. Further studies are needed to assess the role of lymph node dissection in improving survival and preventing recurrence given the observed frequency of lymph node involvement.

Background: A female survival advantage in cutaneous melanoma has been long recognized. However, whether this extends across all age groups, with risk stratification using the latest prognostic staging system or in the current era of efficacious systemic therapies is unknown. Therefore, we evaluated whether sex-based differences in melanoma survival persisted within a recent population-based patient cohort with consideration of these factors. Materials and Methods: We identified stage II−IV cutaneous melanoma patients from 2010 to 2014 Surveillance, Epidemiology, and End Results cancer registries data. We recalculated stage per American Joint Committee on Cancer 8th edition guidelines. Cancer-specific survival (CSS) was estimated by using the Kaplan–Meier method and multivariable Cox proportional hazards regression. Results: Of 16,807 patients (39.8% female), 8,990 were stage II, 4,826 stage III, and 2,991 stage IV at diagnosis. Unadjusted 3-/5-year CSS estimates for females versus males were 64.2% versus 59.7%, and 53.5% versus 49.9%, respectively, p ≤ 0.0001. Five-year CSS varied within each stage and across age strata of <45, 45 − 59, and ≥60 years. Within each stage, females <45 had better CSS than all other sex/age groups ( p < 0.0001). In multivariable analysis of stage II/III patients, female sex, younger age, and lower mitotic index retained favorable CSS prognostic significance ( p < 0.001). Conclusions: Sex-based differences in melanoma survival persist in a contemporary patient cohort staged with the latest prognostic system. These data may guide decision marking regarding adjuvant therapy, highlight the importance of including sex as a pre-specified clinical trial variable, and suggest that investigation of underlying biologic mechanisms may drive discovery of biomarkers and therapeutic targets to improve patient care.

Abstract Background Although inflammatory breast cancer (IBC) is postulated to be a distinct biological entity, practice guidelines and previous data suggest that treatment and outcomes are influenced by standard approximated biological subtype. The aim of this study was validation in a large recent National Cancer Database (NCDB) patient cohort. Methods Patients with non-metastatic IBC treated in 2010–2015 with neoadjuvant systemic therapy and surgery were identified from the NCDB. Approximated biological subtypes were categorized as oestrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−), ER−/HER2− and HER2+. Total pathological complete response (pCR) was defined as ypT0/ypTis, ypN0. χ2 tests were used to compare pCR rates, and Kaplan–Meier curves and Cox proportional hazards regression to analyse overall survival. Results Among 4068 patients with IBC (median age 56 years), the approximated biological subtype was ER+/HER2− in 1575 (38·7 per cent), HER2+ in 1323 (32·5 per cent) and ER−/HER2− in 1170 (28·8 per cent). A total of 3351 patients (84·0 per cent) were cN+ at presentation, with no differences across subtypes. Total pCR rates varied significantly by subtype: ER+/HER2− (6·2 per cent), HER2+ (38·8 per cent), ER−/HER2− (19·1 per cent) (P &lt; 0·001), as did breast pCR rates (10·4, 44·5 and 25·2 per cent respectively) and nodal pCR rates (16·9, 56·9 and 33·1 per cent). The 5-year overall survival rate varied significantly across subtypes (ER+/HER2− 64·9 per cent, HER2+ 74·0 per cent, ER−/HER2− 44·0 per cent; P &lt; 0·001) and by pCR within subtypes (all P &lt; 0·001). In multivariable analysis, ER−/HER2− subtype (hazard ratio 2·89 versus HER2+ as reference; P &lt; 0·001) and absence of total pCR (hazard ratio 3·23; P &lt; 0·001) predicted worse survival. Conclusion Both treatment response and survival in patients with IBC varied with approximated biological subtype, as among other invasive breast cancers. These data support continued tailoring of systemic treatment to approximated biological subtype and highlight the recent improved outcomes in patients with HER2+ disease.

BACKGROUND: Outcomes after total abdominal colectomy with ileosigmoid or ileorectal anastomosis for Crohn’s colitis and risk factors for requirement of a permanent ileostomy remain poorly understood, particularly in the biologic era. OBJECTIVE: This study aimed to determine long-term ostomy-free survival after ileosigmoid or ileorectal anastomosis for Crohn’s colitis and potential risk factors for requirement of an ileostomy. DESIGN: This is a retrospective cohort study. SETTING: This study was conducted at a single-institution IBD tertiary referral center. PATIENTS: Patients diagnosed with Crohn’s disease and undergoing ileosigmoid or ileorectal anastomosis between 2006 and 2018 were selected. MAIN OUTCOME MEASURE: Long-term ostomy-free survival and hazard ratios of potential predictors of ileostomy requirement were the primary outcomes measured. RESULTS: One hundred nine patients (56% female) underwent ileosigmoid or ileorectal anastomosis for Crohn’s disease. The majority of surgical procedures were completed in 2 or 3 stages (53%). The indication for total abdominal colectomy was predominantly medically refractory disease (77%), with dysplasia the second leading indication (13%). At an overall mean follow-up of 3 years, 16 patients had undergone either proctectomy or diversion with the rectum in situ. This resulted in ostomy-free survival estimates at 5 and 10 years of 78% (95% CI, 68-90) and 58% (95% CI, 35–94). A positive distal microscopic margin was the only risk factor for later requirement of a permanent ileostomy (HR, 5.4; 95% CI, 1.7–17.2). LIMITATIONS: This study is limited because it is a retrospective study at a tertiary referral center. CONCLUSIONS: Long-term ostomy-free survival can be achieved in the majority of patients who undergo restoration of intestinal continuity after total abdominal colectomy for Crohn’s colitis. A positive distal microscopic margin was independently associated with long-term anastomotic failure, and it should be accounted for when risk stratifying patients for postoperative prophylactic medical therapy. See Video Abstract at http://links.lww.com/DCR/B111. ¿QUÉ FACTORES ESTÁN ASOCIADOS CON LA EVENTUAL NECESIDAD DE UNA ILEOSTOMÍA DESPUÉS DE UNA COLECTOMÍA ABDOMINAL TOTAL Y UNA ANASTOMOSIS ILEOSIGMOIDEA O ILEORRECTAL PARA LA COLITIS DE CROHN EN LA ERA BIOLÓGICA? ANTECEDENTES: Los resultados después de la colectomía abdominal total con anastomosis ileosigmoidea o ileorrectal para la colitis de Crohn y los factores de riesgo para el requerimiento de una ileostomía permanente siguen siendo poco conocidos, particularmente en la era biológica. OBJETIVO: Determinar la supervivencia a largo plazo sin ostomía después de una anastomosis ileosigmoidea o ileorrectal para la colitis de Crohn y los factores de riesgo potenciales para la necesidad de una ileostomía. DISEÑO: Estudio de cohorte retrospectivo. AJUSTE: Centro de referencia de tercel nivel para enfermedad inflamatoria intestinal de una sola institución. PACIENTES: Pacientes diagnosticados con enfermedad de Crohn y sometidos a anastomosis ileosigmoidea o ileorrectal entre 2006 y 2018 MEDIDA DE RESULTADO PRINCIPAL: Supervivencia a largo plazo sin ostomías y cocientes de riesgo de predictores potenciales de requerimiento de ileostomía RESULTADOS: 109 pacientes (56% mujeres) se sometieron a anastomosis ileosigmoidea o ileorrectal por enfermedad de Crohn. La mayoría de los procedimientos quirúrgicos se completaron en 2 o 3 etapas (53%). La indicación de colectomía abdominal total fue predominantemente enfermedad médicamente refractaria (77%), con displasia la segunda indicación principal (13%). En un seguimiento medio general de 3 años, 16 pacientes se habían sometido a una proctectomía o a una derivación con el recto in situ. Esto dio como resultado estimaciones de supervivencia sin ostomía a los 5 y 10 años de 78% (intervalo de confianza del 95%: 68–90) y 58% (intervalo de confianza del 95%: 35–94), respectivamente. Un margen microscópico distal positivo fue el único factor de riesgo para el requerimiento posterior de una ileostomía permanente (razón de riesgo: 5.4; intervalo de confianza del 95%, 1.7–17.2). LIMITACIONES: Estudio retrospectivo en un centro de referencia de tercer nivel. CONCLUSIONES: La supervivencia a largo plazo sin ostomía se puede lograr en la mayoría de los pacientes que se someten a la restauración de la continuidad intestinal después de la colectomía abdominal total por colitis de Crohn. Un margen microscópico distal positivo se asoció de forma independiente con la insuficiencia anastomótica a largo plazo, y debe tenerse en cuenta cuando se trata de pacientes con estratificación de riesgo para el tratamiento médico profiláctico postoperatorio. Consulte Video Resumen en http://links.lww.com/DCR/B111.

Background: The authors compared long-term health care use and cost in women undergoing immediate autologous breast reconstruction and implant-based breast reconstruction. Methods: This study was conducted using the OptumLabs Data Warehouse, which contains deidentified retrospective administrative claims data, including medical claims and eligibility information from a large U.S. health insurance plan. Women who underwent autologous or implant-based breast reconstruction between January of 2004 and December of 2014 were included. The authors compared 2-year use rates and predicted costs of care. Comparisons were tested using the t test. Results: Overall, 12,296 women with immediate breast reconstruction were identified; 4257 with autologous (35 percent) and 8039 with implant-based (65 percent) breast reconstruction. The proportion of autologous breast reconstruction decreased from 47.2 percent in 2004 to 32.7 percent in 2014. The mean predicted reconstruction cost of autologous reconstruction was higher than that of implant-based reconstruction in both unilateral and bilateral surgery. Similar results for mean predicted 2-year cost of care were seen in bilateral procedures. However, in unilateral procedures, the 2-year total costs were higher for implant-based than for autologous reconstruction. Two-year health care use rates were higher for implant-based reconstruction than for autologous reconstruction for both unilateral and bilateral procedures. Women undergoing unilateral implant-based reconstruction had higher rates of hospital admissions (30.3 versus 23.1 per 100; p < 0.01) and office visits (2445.1 versus 2283.6 per 100; p < 0.01) than those who underwent autologous reconstruction. Emergency room visit rates were similar between the two methods. Bilateral procedures yielded similar results. Conclusion: Although implant-based breast reconstruction is a less expensive index operation than autologous breast reconstruction, it was associated with higher health care use, resulting in similar total cost of care over 2 years.