Time and Change: The Importance of Innovation and Leadership to the Future of Surgery No abstract available

Survival Outcomes Associated With Clinical and Pathological Response Following Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-Paclitaxel Chemotherapy in Resected Pancreatic Cancer Objective: To compare the survival outcomes associated with clinical and pathological response in pancreatic ductal adenocarcinoma (PDAC) patients receiving neoadjuvant chemotherapy (NAC) with FOLFIRINOX (FLX) or gemcitabine/nab-paclitaxel (GNP) followed by curative-intent pancreatectomy. Background: Newer multiagent NAC regimens have resulted in improved clinical and pathological responses in PDAC; however, the effects of these responses on survival outcomes remain unknown. Methods: Clinicopathological and survival data of PDAC patients treated at 7 academic medical centers were analyzed. Primary outcomes were overall survival (OS), local recurrence-free survival (L-RFS), and metastasis-free survival (MFS) associated with biochemical (CA 19–9 decrease ≥50% vs <50%) and pathological response (complete, pCR; partial, pPR or limited, pLR) following NAC. Results: Of 274 included patients, 46.4% were borderline resectable, 25.5% locally advanced, and 83.2% had pancreatic head/neck tumors. Vein resection was performed in 34.7% and 30-day mortality was 2.2%. R0 and pCR rates were 82.5% and 6%, respectively. Median, 3-year, and 5-year OS were 32 months, 46.3%, and 30.3%, respectively. OS, L-RFS, and MFS were superior in patients with marked biochemical response (CA 19–9 decrease ≥50% vs <50%; OS: 42.3 vs 24.3 months, P < 0.001; L-RFS-27.3 vs 14.1 months, P = 0.042; MFS-29.3 vs 13 months, P = 0.047) and pathological response [pCR vs pPR vs pLR: OS- not reached (NR) vs 40.3 vs 26.1 months, P < 0.001; L-RFS-NR vs 24.5 vs 21.4 months, P = 0.044; MFS-NR vs 23.7 vs 20.2 months, P = 0.017]. There was no difference in L-RFS, MFS, or OS between patients who received FLX or GNP. Conclusion: This large, multicenter study shows that improved biochemical, pathological, and clinical responses associated with NAC FLX or GNP result in improved OS, L-RFS, and MFS in PDAC. NAC with FLX or GNP has similar survival outcomes.

Computer Vision Analysis of Intraoperative Video: Automated Recognition of Operative Steps in Laparoscopic Sleeve Gastrectomy Objective(s): To develop and assess AI algorithms to identify operative steps in laparoscopic sleeve gastrectomy (LSG). Background: Computer vision, a form of artificial intelligence (AI), allows for quantitative analysis of video by computers for identification of objects and patterns, such as in autonomous driving. Methods: Intraoperative video from LSG from an academic institution was annotated by 2 fellowship-trained, board-certified bariatric surgeons. Videos were segmented into the following steps: 1) port placement, 2) liver retraction, 3) liver biopsy, 4) gastrocolic ligament dissection, 5) stapling of the stomach, 6) bagging specimen, and 7) final inspection of staple line. Deep neural networks were used to analyze videos. Accuracy of operative step identification by the AI was determined by comparing to surgeon annotations. Results: Eighty-eight cases of LSG were analyzed. A random 70% sample of these clips was used to train the AI and 30% to test the AI's performance. Mean concordance correlation coefficient for human annotators was 0.862, suggesting excellent agreement. Mean (±SD) accuracy of the AI in identifying operative steps in the test set was 82% ± 4% with a maximum of 85.6%. Conclusions: AI can extract quantitative surgical data from video with 85.6% accuracy. This suggests operative video could be used as a quantitative data source for research in intraoperative clinical decision support, risk prediction, or outcomes studies.

A Novel Validated Recurrence Risk Score to Guide a Pragmatic Surveillance Strategy After Resection of Pancreatic Neuroendocrine Tumors: An International Study of 1006 Patients Objective: Despite heterogeneous biology, similar surveillance schemas are utilized after resection of all pancreatic neuroendocrine tumors (PanNETs). Given concerns regarding excess radiation exposure and financial burden, our aim was to develop a prognostic score for disease recurrence to guide individually tailored surveillance strategies. Methods: All patients with primary nonfunctioning, nonmetastatic well/moderately differentiated PanNETs who underwent curative-intent resection at 9-institutions from 2000 to 2016 were included (n = 1006). A Recurrence Risk Score (RRS) was developed from a randomly selected derivation cohort comprised of 67% of patients and verified on the validation-cohort comprised of the remaining 33%. Results: On multivariable analysis, patients within the derivation cohort (n = 681) with symptomatic tumors (jaundice, pain, bleeding), tumors >2 cm, Ki67 >3%, and lymph node (LN) (+) disease had increased recurrence. Each factor was assigned a score based on their weighted odds ratio that formed a RRS of 0 to 10: symptomatic = 1, tumor >2 cm = 2, Ki67 3% to 20% = 1, Ki67 >20% = 6, LN (+) = 1. Patients were grouped into low- (RRS = 0–2; n = 247), intermediate-(RRS = 3–5; n = 204), or high (RRS = 6–10; n = 9)-risk groups. At 24 months, 33% of high RRS recurred, whereas only 2% of low and 14% of intermediate RRS recurred. This persisted in the validation cohort (n = 325). Conclusions: This international, novel, internally validated RRS accurately stratifies recurrence-free survival for patients with resected PanNETs. Given their unique recurrence patterns, surveillance intervals of 12, 6, and 3 months are proposed for low, intermediate, and high RRS patients, respectively, to minimize radiation exposure and optimize cost/resource utilization.

Trends in Treatment of T1N0 Esophageal Cancer Objective: The purpose of this study was to explore nationwide trends in treatment and outcomes of T1N0 esophageal cancer. Background: Endoscopic treatment has become an accepted option for early-stage esophageal cancer, but nationwide utilization rates and outcomes are unknown. Methods: T1N0 esophageal cancers were identified in the National Cancer Database from 2004 to 2014. We assessed trends in treatment; compared endoscopic therapy, esophagectomy, chemoradiation, and no treatment; and performed a subgroup analysis of T1a and T1b patients from 2010 to 2014 (AJCC 7). Results: A total of 12,383 patients with clinical T1N0 esophageal cancer were analyzed. Over a decade, use of endoscopic therapy increased from 12.7% to 33.6%, whereas chemoradiation and esophagectomy decreased, P < 0.01. The rise in endoscopic treatment of T1a disease from 42.7% to 50.6% was accompanied by a decrease in esophagectomies from 21.7% to 12.8% (P < 0.01). For T1b disease, the rise in endoscopic treatment from 16.9% to 25.1% (P = 0.03) was accompanied by decreases in no treatment and chemoradiation, whereas the rate of esophagectomies remained approximately 50%. Unadjusted median survival was longer for patients undergoing resection: esophagectomy, 98.6 months; endoscopic therapy, 77.7 months; chemoradiation, 17.3 months; no treatment, 8.2 months; P < 0.01. Risk-adjusted Cox modeling showed esophagectomy was associated with improved survival [hazard ratio (HR): 0.85], and chemoradiation (HR: 1.79) and no treatment (HR: 3.57) with decreased survival, compared to endoscopic therapy (P < 0.01). Conclusions: Use of endoscopic therapy for T1 esophageal cancer has increased significantly: for T1a, as an alternative to esophagectomy; and for T1b, as an alternative to no treatment or chemoradiation. Despite upfront risks, long-term survival is highest for patients who can undergo esophagectomy.

Adult Living Donor Versus Deceased Donor Liver Transplant (LDLT Versus DDLT) at a Single Center: Time to Change Our Paradigm for Liver Transplant Objective: The aim of this study was to compare outcomes between living donor liver transplant (LDLT) and deceased donor liver transplant (DDLT) at a single center to demonstrate the advantages of LDLT and provide justification for the increased utilization and application of this procedure. Summary of Background Data: LDLT comprises a very small percentage of all liver transplants performed in the United States, this despite its advantages and a shortage of the availability of deceased donor organs. Methods: A retrospective review of all adult LDLT (n = 245) and DDLT (n = 592) performed at a single center over 10 years (2009–2019), comparing survival outcomes by Kaplan-Meier analysis and comparing other measures of outcome such as recovery times, complications, costs, and resource utilization. Results: Patient survival outcomes were superior in LDLT recipients (3-year 86% vs 80%, P = 0.03). Other outcomes demonstrated shorter length of hospital stay (11 vs 13 days, P = 0.03), less likelihood of intraoperative blood transfusion (52% vs 78%, P < 0.01), and less likelihood of need for posttransplant dialysis (1.6% vs 7.4%, P < 0.01). Early reoperation and biliary/vascular complication rates were similar. Hospital costs related to the transplant were 29.5% lower for LDLT. Complications in living donors were acceptable with no early or late deaths, 3-month reoperation rate of 3.1%, and overall complication rate of 19.5%. Given its advantages, we have expanded LDLT—in 2018, LDLT comprised 53.6% of our transplants (national average 4.8%), and our transplant rate increased from 44.8 (rate per 100-person years) in 2015 to 87.5 in 2018. Conclusions: LDLT offers advantages over DDLT including superior outcomes and less resource utilization. The time has come to change the paradigm of how LDLT is utilized in this country.

Description and Impact of a Comprehensive Multispecialty Multidisciplinary Intervention to Decrease Opioid Prescribing in Surgery Introduction: Diversion of excess prescription opioids contributes to the opioid epidemic. We sought to describe and study the impact of a comprehensive departmental initiative to decrease opioid prescribing in surgery. Methods: A multispecialty multidisciplinary initiative was designed to change the culture of postoperative opioid prescribing, including: consensus-built opioid guidelines for 42 procedures from 11 specialties, provider-focused posters displayed in all surgical units, patient opioid/pain brochures setting expectations, and educational seminars to residents, advanced practice providers, residents and nurses. Pre- (April 2016–March 2017) versu post-initiative (April 2017–May 2018) analyses of opioid prescribing at discharge [median oral morphine equivalent (OME)] were performed at the specialty, prescriber, patient, and procedure levels. Refill prescriptions within 3 months were also studied. Results: A total of 23,298 patients were included (11,983 pre-; 11,315 post-initiative). Post-initiative, the median OME significantly decreased for 10 specialties (all P values < 0.001), the percentage of patients discharged without opioids increased from 35.7% to 52.5% (P < 0.001), and there was no change in opioids refills (0.07% vs 0.08%, P = 0.9). Similar significant decreases in OME were observed when the analyses were performed at the provider and individual procedure levels. Patient-level analyses showed that the preinitiative race/sex disparities in opioid-prescribing disappeared post-initiative. Conclusion: We describe a comprehensive multi-specialty intervention that successfully reduced prescribed opioids without increase in refills and decreased sex/race prescription disparities.

Is Disruptive Behavior Inherent to the Surgeon or the Environment? Analysis of 314 Events at a Single Academic Medical Center Objective: In 2009, the Joint Commission mandated a process to manage disruptive behavior, as evidence suggests it undermines a culture of safety. This process often reviews only the reporter's side of the story as the truth. In this study, we compared both reporter account (RA) and involved party (IP) responses to determine if disruptive behavior was inherent to the surgeon or the hospital environment and its relationship to patient safety. Methods: From 1/1/2015 through 12/31/2017, we prospectively recorded the RA and the IP response. This resulted in 314 reports involving 204 IPs. Four reviewers scored issues, interactions, modifiable stressors, and patient safety. Logistic regression determined factors associated with patient harm. Significance defined as P < 0.05. Results: Surgical, medical, and other specialties were IPs 43%, 35%, and 22%, respectively; 73% had only one event. High-intensity environments (OR, ICU, etc.) made up 56% of the total. Perceived unprofessional or lack of communication was present in 70% and 44% of events. A significant direct relationship existed between the stress of the clinical situation and the egregiousness of the behavior (P < 0.0001). Logistic regression revealed that unclear hospital policies, the IP being a surgeon, and urgent competing responsibilities were associated with potential patient harm (P < 0.05). Conclusions: Unclear policies and urgent competing responsibilities in the surgical environment create stress, leading to conflict. Single events for the majority suggest the environment as the primary contributor. Tactics to improve stressful environments and clearly communicated policies may be more effective and sustainable than individually targeted interventions in enhancing patient safety.

Long-term Patient-reported Outcomes Following Postmastectomy Breast Reconstruction: An 8-year Examination of 3268 Patients Objective: To better understand the long-term patient-reported outcomes (PROs) in satisfaction and health-related quality of life (QOL) following post-mastectomy reconstruction (PMR) using the BREAST-Q, comparing PROs from patients undergoing implant-based breast reconstruction (IBR) or autologous breast reconstruction (ABR). Summary of Background Data: Multiple studies have demonstrated growth in mastectomy rates and concurrent increase in PMR utilization. However, most studies examining PMR PROs focus on short postoperative time periods—mainly within 2 years. Methods: BREAST-Q scores from IBR or ABR patients at a tertiary center were prospectively collected from 2009 to 2017. Mean scores and standard deviations (SDs) were calculated for satisfaction with breast, satisfaction with outcome, psychosocial well-being, physical well-being of the chest, and sexual well-being. Satisfaction with breasts and physical well-being of the chest were compared using regression models at postoperative years 1, 3, 5, and 7. Results: Overall, 3268 patients were included, with 336 undergoing ABR and 2932 undergoing IBR. Regression analysis demonstrated that ABR patients had greater postoperative satisfaction with breast scores at all timepoints compared with IBR patients. Postoperative radiation and mental illness adversely impacted satisfaction with breast scores. Furthermore, mental illness impacted physical wellbeing of the chest at all timepoints. IBR patients had satisfaction scores that remained stable over the study period. Conclusion: This study presents the largest prospective examination of PROs in PMR to date. Patients who opted for ABR had significantly higher satisfaction with their breast and QOL at each assessed time point, but IBR patients had stable long-term satisfaction and QOL postoperatively.

Hereditary Susceptibility for Triple Negative Breast Cancer Associated With Western Sub-Saharan African Ancestry: Results From an International Surgical Breast Cancer Collaborative Objective: To investigate subtype-specific risk of germline alleles associated with triple negative breast cancer (TNBC) in African ancestry populations. Background: Breast cancer (BC) mortality is higher in African American (AA) compared to White American (WA) women; this disparity is partly explained by 2-fold higher TNBC incidence. Methods: We used a surgically maintained biospecimen cohort of 2884 BC cases. Subsets of the total (760 AA; 962 WA; 910 West African/Ghanaian; 252 East African/Ethiopian) were analyzed for genotypes of candidate alleles. A subset of 417 healthy controls were also genotyped, to measure associations with overall BC risk and TNBC. Results: TNBC frequency was highest in Ghanaian and AA cases (49% and 44% respectively; P < 0.0001) and lowest in Ethiopian and WA cases (17% and 24% respectively; P < 0.0001). TNBC cases had higher West African ancestry than non-TNBC (P < 0.0001). Frequency of the Duffy-null allele (rs2814778; an African ancestral variant adopted under selective pressure as protection against malaria) was associated with TNBC-specific risk (P < 0.0001), quantified West African Ancestry (P < 0.0001) and was more common in AA, Ghanaians, and TNBC cases. Additionally, rs4849887 was significantly associated with overall BC risk, and both rs2363956 and rs13000023 were associated with TNBC-specific risk, although none as strongly as the Duffy-null variant. Conclusions: West African ancestry is strongly correlated with TNBC status, as well as germline variants related to BC risk. The Duffy-null allele was associated with TNBC risk in our cohort.