UM receives $1 million seed money for new business building

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is used in patients with thoracic aortic aneurysms (TAA) and uncomplicated type B acute aortic dissection (B-AAD) to reduce morbidity and mortality. Limited data are available for comparing outcomes of TEVAR in TAA vs B-AAD. METHODS: 49 patients with TAA and 37 patients with B-AAD between January 2005 and January 2015 were retrospectively identified. Baseline characteristics, thrombosis status of the false lumen with the extent of dissection, aortic pathologies including prior aortic surgeries, emergent vs elective procedures, landing zone location, extra anatomical major vessel bypass, types of grafts and outcome variables were reviewed by two physicians. T-test, Wilcoxon rank-sum test and chi-square test were used to generate pvalues. RESULTS: The sample population with TAA had a higher median age than those with B-AAD (72 years vs 59 years, p¼0.0001) (Table). Early events, 30-day mortality and 5-year outcomes were not significantly different between groups. Endoleak and all-cause mortality with TEVAR were not significantly different in the groups (Fig). CONCLUSION: This study confirms the feasibility of TEVAR for uncomplicated type B aortic dissection in the acute setting with no difference in short- or long-term outcomes of TEVAR between TAA and B-AAD populations

Development and Validation of a Preprocedural Risk Score to Predict Access Site Complications After Peripheral Vascular Interventions Based on the Vascular Quality Initiative Database

Purpose: Access site complications following peripheral vascular intervention (PVI) are associated with prolonged hospitalization and increased mortality. Prediction of access site complication risk may optimize PVI care; however, there is no tool designed for this. We aimed to create a clinical scoring tool to stratify patients according to their risk of developing access site complications after PVI. Methods: The Society for Vascular Surgery’s Vascular Quality Initiative database yielded 27,997 patients who had undergone PVI at 131 North American centers. Clinically and statistically significant preprocedural risk factors associated with in-hospital, post-PVI access site complications were included in a multivariate logistic regression model, with access site complications as the outcome variable. A predictive model was developed with a random sample of 19,683 (70%) PVI procedures and validated in 8,314 (30%). Results: Access site complications occurred in 939 (3.4%) patients. The risk tool predictors are female gender, age > 70 years, white race, bedridden ambulatory status, insulin-treated diabetes mellitus, prior minor amputation, procedural indication of claudication, and nonfemoral arterial access site (model c-statistic = 0.638). Of these predictors, insulin-treated diabetes mellitus and prior minor amputation were protective of access site complications. The discriminatory power of the risk model was confirmed by the validation dataset (c-statistic = 0.6139). Higher risk scores correlated with increased frequency of access site complications: 1.9% for low risk, 3.4% for moderate risk and 5.1% for high risk. Conclusions: The proposed clinical risk score based on eight preprocedural characteristics is a tool to stratify patients at risk for post-PVI access site complications. The risk score may assist physicians in identifying patients at risk for access site complications and selection of patients who may benefit from bleeding avoidance strategies

Clinical Outcomes of Unprotected Left Main Coronary Artery Stenting in Nonsurgical Patients: A Single-Center Experience

Purpose: Coronary artery bypass graft is the standard treatment for unprotected left main disease; however, some patients are poor surgical candidates due to comorbidities. We assessed the safety and clinical outcome of elective, unprotected left main coronary artery stenting in nonsurgical patients. Methods: Between October 2004 and June 2006, 50 consecutive patients underwent elective, unprotected left main coronary artery stenting at our institution. Patients were followed for a median of 16 and 96 months and clinical outcomes monitored. Results: Median logistic euroSCORE was 28.6 (interquartile range: 14.6-43.4). Median baseline left ventricular ejection fraction (LVEF) was 50%. Procedural success rate was 100%. The rates of cerebrovascular accident, myocardial infarction, target vessel revascularization and cardiovascular death were 2%, 4%, 4% and 2%, respectively, at 30 days, 2%, 6%, 6% and 2% at 16 months, and 2%, 6%, 12% and 4% at 96 months. Major adverse cardiac and cerebrovascular event rate was 12% at 30 days, 16% at 16 months and 24% at 96 months. Median LVEF at 16 months was 55%, significantly improved from baseline (P<0.001). Conclusion: In nonsurgical patients with left main disease, stenting of the unprotected left main coronary artery is safe, with acceptable rates of major adverse cardiac and cerebrovascular event up to 96 months poststenting

The development and validation of a scoring tool to predict the operative duration of elective laparoscopic cholecystectomy

Background: The ability to accurately predict operative duration has the potential to optimise theatre efficiency and utilisation, thus reducing costs and increasing staff and patient satisfaction. With laparoscopic cholecystectomy being one of the most commonly performed procedures worldwide, a tool to predict operative duration could be extremely beneficial to healthcare organisations. Methods: Data collected from the CholeS study on patients undergoing cholecystectomy in UK and Irish hospitals between 04/2014 and 05/2014 were used to study operative duration. A multivariable binary logistic regression model was produced in order to identify significant independent predictors of long (> 90 min) operations. The resulting model was converted to a risk score, which was subsequently validated on second cohort of patients using ROC curves. Results: After exclusions, data were available for 7227 patients in the derivation (CholeS) cohort. The median operative duration was 60 min (interquartile range 45–85), with 17.7% of operations lasting longer than 90 min. Ten factors were found to be significant independent predictors of operative durations > 90 min, including ASA, age, previous surgical admissions, BMI, gallbladder wall thickness and CBD diameter. A risk score was then produced from these factors, and applied to a cohort of 2405 patients from a tertiary centre for external validation. This returned an area under the ROC curve of 0.708 (SE = 0.013, p  90 min increasing more than eightfold from 5.1 to 41.8% in the extremes of the score. Conclusion: The scoring tool produced in this study was found to be significantly predictive of long operative durations on validation in an external cohort. As such, the tool may have the potential to enable organisations to better organise theatre lists and deliver greater efficiencies in care

Abstract 17457: PreSERVE-AMI: a randomized, double-blind, placebo-controlled clinical trial of intracoronary administration of autologous CD34+ cells in patients with left ventricular dysfunction post STEMI

Background: ST segment Elevation Myocardial Infarction (STEMI) affects 160,000 annually in the US. Guidelines direct immediate revascularization and adjunctive medical therapies. Yet STEMI victims remain at risk for infarct expansion, heart failure, reinfarction, repeat revascularization and death. In pre-clinical studies, human CD34+ stem cells are angiogenic within ischemic myocardium, improving perfusion and function. A precedent Phase 1 study demonstrated feasibility, safety and bioactivity of intracoronary infusion of autologous CD34+ cells in patients with LV dysfunction (LVD) post-MI and identified a threshold dose of 10M cells associated with improved infarct region perfusion. Methods: PreSERVE-AMI is a Phase 2, randomized, double-blind, placebo-controlled trial performed at 60 sites in the US. Those with LVD (EF≤48% by CMR) ≥4 days post-STEMI underwent mini bone marrow harvest and were randomized 1:1 to (A) autologous CD34+ cells (minimum dose of 10M±20% cells in autologous serum) or (B) autologous serum. (A) or (B) was delivered via stop-flow method for intracoronary infusion. The primary efficacy endpoint was change in resting myocardial perfusion measured by gated SPECT over 6 months. Ventricular function was also assessed (CMR). The primary safety endpoint was occurrence of AEs, SAEs and MACE (CV mortality, heart failure, reinfarction, revascularization). Results: 161 patients were randomized and received intracoronary infusion (from Jan 2012 to Dec 2013). Mean age was 57.3±10.6 and 81% were men. The 6-month data set for myocardial perfusion, ventricular function and clinical events will be presented at AHA. Conclusions: PreSERVE-AMI represents the largest study of cell-based therapy for STEMI completed in US and will determine endpoints, sample size and suitability of autologous CD34+ cell therapy for upcoming Phase 3 study in patients with LVD post STEMI who are at risk for death and major morbidity