Development and Validation of an Electronic Adverse Event Model for Patient Safety Surveillance in Interventional Radiology.

BACKGROUND: Comprehensive adverse event (AE) surveillance programs in interventional radiology (IR) are rare. Our aim was to develop and validate a retrospective electronic surveillance model to identify outpatient IR procedures that are likely to have an AE, to support patient safety and quality improvement. METHODS: We identified outpatient IR procedures performed in the period from October 2017 to September 2019 from the Veterans Health Administration (n = 135,283) and applied electronic triggers based on posyprocedure care to flag cases with a potential AE. From the trigger-flagged cases, we randomly sampled n = 1,500 for chart review to identify AEs. We also randomly sampled n = 600 from the unflagged cases. Chart-reviewed cases were merged with patient, procedure, and facility factors to estimate a mixed-effects logistic regression model designed to predict whether an AE occurred. Using model fit and criterion validity, we determined the best predicted probability threshold to identify cases with a likely AE. We reviewed a random sample of 200 cases above the threshold and 100 cases from below the threshold from October 2019 to March 2020 (n = 20,849) for model validation. RESULTS: In our development sample of mostly trigger-flagged cases, 444 of 2,096 cases (21.8%) had an AE. The optimal predicted probability threshold for a likely AE from our surveillance model was >50%, with positive predictive value of 68.9%, sensitivity of 38.3%, and specificity of 95.3%. In validation, chart-reviewed cases with AE probability >50% had a positive predictive value of 63% (n = 203). For the period from October 2017 to March 2020, the model identified approximately 70 IR cases per month that were likely to have an AE. CONCLUSIONS: This electronic trigger-based approach to AE surveillance could be used for patient-safety reporting and quality review.

Cerebrospinal Fluid Drainage During Endovascular Aortic Aneurysm Repair: A Systematic Review of the Literature and Treatment Recommendations.

INTRODUCTION: Spinal cord injury (SCI) is a known complication of aortic aneurysm repair. Previous reports indicate that cerebrospinal fluid drainage (CSFD) may reduce incidence of SCI during open aortic aneurysm repair but its utility in endovascular repair remains poorly understood. We performed a systematic review of the literature to examine the protocols and outcomes of CSFD in patients undergoing endovascular aortic aneurysm repair. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were utilized to conduct a systematic literature review. PubMed, Scopus, Ovid, Cochrane, and EMBASE were queried for articles published since 2016 using search terms "(cerebrospinal fluid diversion OR CSF diversion OR lumbar drain OR subarachnoid drain OR spinal) AND (aortic aneurysm AND thoracic AND endovascular OR TEVAR)." Ninety-two articles were identified and screened by 2 independent reviewers, and 23 studies met criteria for full-text review after initial screening. RESULTS: A total of 8 studies met full inclusion criteria for final analysis. Six studies reported incidence of SCI in patients with CSFD and 2 compared SCI incidence between patients with and without CSFD. Protocols for drainage most commonly included draining to a target pressure intra- and postoperatively, between 8 and 12 mm Hg. Incidence of SCI ranged from 0% to 17% in patients with CSFD, and from 0% to 50% in those without CSFD. Rates of CSFD-related complications ranged from <1% to 28%. CONCLUSION: There may be a protective benefit of CSFD in preventing SCI, but there remains significant variation in drain placement protocols. Significant potential bias exists in the reviewed data. Higher quality studies on the role of CSFD in endovascular aortic aneurysm repair are needed.

Glomerulopathy in spontaneously obese rhesus monkeys with type 2 diabetes: a stereological study.

BACKGROUND: Animal models could provide insights into the diabetic nephropathy pathogenesis; however, available rodent models do not mirror the heterogeneity of lesions in type 2 diabetic patients, and do not progress to end-stage renal disease. Previous studies showed that spontaneously obese type 2 diabetic rhesus monkeys develop many of the features of human diabetic glomerulopathy, and may progress to end-stage renal disease. Here, in order to further characterize diabetic glomerulopathy in this model, we used electron microscopic stereology. METHODS: Renal biopsies from 17 diabetic, 17 pre-diabetic/metabolic syndrome and 11 non-diabetic monkeys were studied. Fractional volumes of mesangium [Vv(Mes/glom)], mesangial matrix [Vv(MM/glom)] and mesangial cells [Vv(MC/glom)], glomerular basement membrane width and peripheral glomerular basement membrane surface density per glomerulus [Sv(PGBM/glom)] were estimated. Glomerular filtration and albumin excretion rates were measured in a limited number of animals. Glomerular structural and biochemical/metabolic data were compared among the groups. RESULTS: Compared to non-diabetic monkeys, diabetic rhesus monkeys showed classic diabetic nephropathy changes, including glomerular basement membrane thickening (p = 0.001), increased fractional volumes of mesangium (p = 0.02), and reduced peripheral glomerular basement membrane surface density per glomerulus (p = 0.03) compared to non-diabetic monkeys. Increased fractional volumes of mesangium was primarily due to increased mesangial matrix (p = 0.03). Glomerular structural parameter inter-relationships in diabetic monkeys mirrored those of human diabetic glomerulopathy. Albumin excretion rate was greater (p = 0.03) in diabetic vs. non-diabetic monkeys. There was trend for a positive correlation between albumin excretion rate and fractional volumes of mesangium. CONCLUSIONS: This rhesus primate model shares many features of human diabetic glomerulopathy. Mesangial expansion in this model, similar to human diabetic nephropathy and different from available rodent models of the disease, is primarily due to increased mesangial matrix.

Percutaneous fluoroscopically guided jejunostomy placement.

PURPOSE: To describe our experience with fluoroscopically guided direct jejunostomy placement in patients with enterocutaneous fistula, or neoplastic or postsurgical changes of the stomach or duodenum that preclude traditional gastrostomy placement. MATERIALS: Nineteen patients underwent percutaneous direct jejunostomy tube placement with fluoroscopic guidance from August 2004 through March 2006. There were 15 men and four women whose ages ranged from 28 to 82 years (mean, 54 years). Seven patients had surgical changes to the stomach that precluded traditional gastrostomy access, one patient had a duodenal tumor, two had unresectable gastric tumors, and nine had small bowel pathology that required distal access. RESULTS: Jejunal access was initially successful in 18 of 19 (95%) procedures. Follow-up ranged from 10 days to 509 days. Two catheters were removed as they were no longer needed. Seven patients' initial tubes were still functioning at the end of their follow-up. One tube was removed secondary to pain and irritation at the insertion site. Three tubes were occluded. One patients' tube was inadvertently pulled out. In two patients, feeding was not tolerated secondary to fistula distal to the jejunostomy. Two patients died with their initial tubes. Primary patency was 285 days (95% CI 162-407). One death occurred 10 days postprocedure for a 30-day mortality of 1 of 19 (5%). CONCLUSIONS: Percutaneous direct jejunostomy placement is a relatively safe and effective means of gaining enteral access in patients who have enterocutaneous fistula or who have either postsurgical or neoplastic changes of the stomach that preclude traditional gastrostomy placement.

Thoracic angiography and intervention in trauma.

Interventional radiologists are involved less often in the initial diagnostic evaluation of patients who have acute chest trauma today than in the past. Patients are cleared of significant injury by CT, or, when a significant injury is present, they are triaged appropriately to open surgery or endovascular intervention. Significant advances in catheter-based technology, such as stent grafts and embolization coils, allow definitive repair of thoracic aortic and branch vessel injury. The opportunity to treat these types of injury with minimally invasive techniques has reinforced a continuing need for the maintenance and continued development of skills in the performance and interpretation of thoracic angiography. This article reviews these techniques and examines the status and the future of endovascular interventions in thoracic trauma.