Mortality related to the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database.

BACKGROUND: Surgical staplers and clip appliers are commonly used and have a potential to malfunction, which may result in serious injury or death. These events are self-reported to the Food and Drug Administration and compiled in the Food and Drug Administration's Manufacturer and User Facility Device Experience database. This study characterizes mortality related to surgical stapler and clip applier failure reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience database. METHODS: The Food and Drug Administration's Manufacturer and User Facility Device Experience database was reviewed between 1992 and 2016 for medical device reports related to surgical staplers and clip appliers filed under the following product codes: GAG, FZP, GDO, GDW, KOG, and GCJ. Adverse events including death and the type of device failure were reviewed. Temporal trends in reported deaths related to device failure were analyzed and the Healthcare Cost and Utilization Project database was used to adjust for annual surgical case volume using linear regression analysis. RESULTS: A total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with the use of surgical stapler and clip applier devices. Most deaths occurred postoperatively (N = 516, 76.3%) and were due to infection/sepsis (N = 89, 17.2%) or vascular injuries (N = 110, 21.3%). Intraoperative mortality (N = 79, 11.7%) was primarily due to vascular injuries (N = 73, 92.4%). Device failures resulting in death were noted both intraoperatively (N = 268, 39.6%) and postoperatively (N = 325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier device problem was the most common attributed cause of death (N = 238, 65.4%). In the linear regression analysis, there was a significant increase in the mortality from device failure in the study period after adjusting for annual surgical volume (P < .01). CONCLUSION: Mortality related to the use of surgical staplers and clip appliers is increasing. Most deaths occurred postoperatively, and an increased awareness of potential life-threatening complications is warranted when these devices are used.

Rankings From US News and World Report Have Minimal Correlation With Kidney and Liver Transplant Recipient Survival Results From Retrospective Data.

OBJECTIVES: Increased demand for quality health care has led to lay-press ranking systems, such as the ranking from US News and World Report (US News). Their "Best Hospitals" publication advertises itself as the go-to resource for patients seeking care in a number of specialty areas. We sought to test the relationship between US News rankings and transplant outcomes. MATERIALS AND METHODS: Using data from 2014 to 2018, we compared outcomes from the Scientific Registry of Transplant Recipients database for liver and kidney transplants against US News-ranked centers using the categories "Nephrology" and "GI Surgery and Gastroenterology" as substitutes, as US News does not rank transplant centers specifically. P < .05 was set as significant. RESULTS: Using hazard ratio data, we found that kidney transplant center rank had only a small impact on postoperative outcomes in terms of patient survival (hazard ratio = 0.996, P = .049) but had no impact on graft survival (hazard ratio = 0.997, P = .077). In addition, liver transplant center rank had no impact on liver graft survival (hazard ratio = 1.003, P = .304). The impact of hospital ranking on survival was minimal compared with other variables. CONCLUSIONS: The US News rankings for "Nephrology" and "GI Surgery and Gastroenterology" have minimal values as a measure of liver and kidney transplant outcomes, highlighting that these lay press rankings are not useful to the unique transplant patient population and that providers should help guide patients to transplant-specific resources.

Repurposing metformin, simvastatin and digoxin as a combination for targeted therapy for pancreatic ductal adenocarcinoma.

Patients with pancreatic adenocarcinoma (PDAC) have a 5-year survival rate of 8%, the lowest of any cancer in the United States. Traditional chemotherapeutic regimens, such as gemcitabine- and fluorouracil-based regimens, often only prolong survival by months. Effective precision targeted therapy is therefore urgently needed to substantially improve survival. In an effort to expedite approval and delivery of targeted therapy to patients, we utilized a platform to develop a novel combination of FDA approved drugs that would target pancreaticoduodenal homeobox1 (PDX1) and baculoviral inhibitor of apoptosis repeat-containing 5 (BIRC5) utilizing super-promoters of the target genes to interrogate an FDA approved drug library. We identified and selected metformin, simvastatin and digoxin (C3) as a novel combination of FDA approved drugs, which were shown to effectively target PDX1 and BIRC5 in human PDAC tumors in mice with no toxicity.

Catheter Directed Lysis and Thrombectomy Are Equally Effective for Extensive Deep Vein Thrombosis.

BACKGROUND: There is currently little consensus on the role of thrombectomy compared with catheter-directed lysis (CDL) for acute, extensive, proximal deep vein thrombosis (DVT). We sought to determine whether any differences in outcomes exist between thrombectomy and CDL in terms of postoperative venous patency, pulmonary emboli (PE), and bleeding/hematoma. METHODS: In an institutional review board-approved retrospective cohort study, patients from a single academic medical center with confirmed lower extremity DVT were divided into thrombectomy and CDL cohorts. Demographic information, comorbidities and laboratory data, postoperative patency, postoperative bleeding, postoperative PE, popliteal hematoma, and recurrence of DVT were collected. Type I error level was set at 0.05. RESULTS: Eighty-seven patients were identified, 51.7% received CDL, and 48.3% underwent thrombectomy. Patient comorbidities and hypercoagulable states were not significantly different among the groups. The two techniques did not have significantly different postoperative patency (P = 0.472), bleeding (P = 0.598), PE (P = 0.868), popliteal hematoma (P = 0.331), or recurrence of DVT (P = 0.835). CONCLUSIONS: In selecting optimum treatment for acute, extensive, proximal DVT, our retrospective cohort study found no significant differences among treatment groups in safety, efficacy, recurrence, and progression to PE. We conclude that modality of treatment should be decided based on hospital resources, surgeon experience, and comfort with each technique, patient's physiologic status, and associated costs.

Factors Associated With Increased Mortality After Isolated Abdominal Aortic Dissection Repair.

BACKGROUND: Postoperative mortality after open and endovascular repair of thoracic aortic dissection (AD) has been the focus of previous research. However, a little has been published on the far less common isolated abdominal aortic dissection (IAAD). The aim of our study was to identify risk factors associated with 30-day postoperative mortality in patients with IAAD. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) was queried for patients who underwent open or endovascular AD repair from January 2010 to December 2015. Information regarding patient demographics, comorbidities, preoperative laboratory values, procedure details, and postoperative complications were analyzed, and predictors of 30-day mortality were identified. Risk stratification by the type of aortic repair and surgery setting was performed, and patient characteristics associated with mortality in each setting were determined. We employed chi-squared test, Student's t-test, and Mann-Whitney U test for the univariate analysis, while the multivariate analysis was performed using a stepwise binary logistic regression test. RESULTS: There were 229 patients who met the specified criteria, 15 died within 30 days postoperatively, and 214 survived beyond the same period (mortality rate was 6.5%). Among preoperative factors, a history of chronic obstructive pulmonary disease (COPD), preoperative ventilator dependence, preoperative transfusion of ≥1 unit packed RBCs, emergent operation, and advanced American Society of Anesthesiologists (ASA) class were associated with increased risk of mortality. Postoperative complications associated with a higher risk of mortality were acute kidney injury, mechanical ventilation ≥48 hours, unplanned intubation, myocardial infarction, septic shock, and blood transfusion. On multivariate analysis, risk factors independently associated with increased risk of mortality were a history of COPD (adjusted odds ratio [AOR], 10.5; P = 0.013), postoperative acute renal failure (AOR, 12.8; P = 0.003) and septic shock (AOR, 15.3; P = 0.014). CONCLUSIONS: Multiple preoperative and postoperative factors are associated with a high risk of death after IAAD repair. A better control of COPD and prevention of postoperative acute renal failure and septic shock may result in better outcomes.

BIRC5 is a target for molecular imaging and detection of human pancreatic cancer.

Pancreatic ductal adenocarcinoma (PDAC) is a major cause of cancer mortality with a dismal overall survival rate and an urgent need for detection of minute tumors. Current diagnostic modalities have high sensitivity and specificity for larger tumors, but not for minute PDAC. In this study, we test the feasibility of a precision diagnostic platform for detecting and localizing minute human PDAC in mice. This platform includes: 1) defining BIRC5 as an early PDAC-upregulated gene and utilizing an enhanced BIRC5 super-promoter to drive expression of dual Gaussia luciferase (GLuc) and sr39 thymidine kinase (sr39TK) reporter genes exponentially and specifically in PDAC; 2) utilizing a genetically-engineered AAV2RGD to ensure targeted delivery of GLuc and sr39TK specifically to PDAC; 3) using serologic GLuc and sr39TK microPET/CT imaging to detect and localize minute human PDAC in mice. The study demonstrates feasibility of a precision diagnostic platform using an integrated technology through a multiple-stage amplification strategy of dual reporter genes to enhance the specificity and sensitivity of detection and localization of minute PDAC tumors and currently undetectable disease.

Closing the Disparity in Pancreatic Cancer Outcomes: A Closer Look at Nonmodifiable Factors and Their Potential Use in Treatment.

OBJECTIVES: African Americans (AAs) have disproportionately higher incidence and lower survival rates from pancreatic cancer compared with whites. Historically, this disparity has been attributed to modifiable risk factors. Recent studies suggest that nonmodifiable aspects may also play an important role. We review these new contributions as potential targets for closing the disparity. METHODS: A PubMed search was conducted to review studies of nonmodifiable elements contributing to pancreatic cancer disparities in AAs. RESULTS: Several nonmodifiable risks are associated with the racial disparity in pancreatic cancer. SSTR5 P335L, Kaiso, and KDM4/JMJD2A demonstrate differential racial expression, increasing their potential as therapeutic targets. Many social determinants of health and their associations with diabetes, obesity, and the microbiome are partially modifiable risk factors that significantly contribute to outcomes in minorities. Barriers to progress include the low minority inclusion in research studies. CONCLUSIONS: Genomics, epigenetics, the microbiome, and social determinants of health are components that contribute to the pancreatic cancer disparity in AAs. These factors can be researched, targeted, and modified to improve mortality rates. Closing the disparity in pancreatic cancer will require an integrated approach of personalized medicine, increased minority recruitment to studies, and advanced health care/education access.