Discordance among assays for monitoring? Anticoagulation during extracorporeal life support.

OBJECTIVES: The optimal method for monitoring of anticoagulation in patients on extracorporeal life support (ECLS) is unknown. The objective of this study was to assess the relationship between anti-factor Xa level (anti-Xa; IU/mL) and activated partial thromboplastin time (aPTT; seconds) for monitoring intravenous unfractionated heparin anticoagulation in adult ECLS patients. METHODS: Charts of all adult patients cannulated for ECLS from 2015 through 2017 were reviewed and laboratory and heparin infusion data were extracted for analysis. Time matched pairs of anti-Xa and aPTT were considered concordant if both laboratory values were within the same clinically utilized range. A hierarchical logistic regression model was used to determine factors associated with discordance while accounting for patient level effects. RESULTS: A total of 1016 paired anti-Xa and aPTT values from 65 patients were evaluated. 500 (49.2%) paired samples were discordant with a degree of variability on linear regression (r2 = 0.315). The aPTT fell into a higher therapeutic range compared to the anti-Xa in 31.6% and lower in 17.3%. Logistic regression demonstrated that discordance was independently associated with time from initiation of ECLS (OR 1.17 per day, p < 0.001), average heparin infusion rate (OR 1.25 per U/kg/hr, p < 0.001), and INR (OR 3.22, p < 0.001). CONCLUSIONS: Nearly half of all aPTT and anti-Xa values were in discordant ranges and discordance is more likely as the time on ECLS and the INR level increase. The use of either assay in isolation to guide heparin anticoagulation may lead to misestimation of the degree of anticoagulation in complex ECLS patients.

Socio-economic status and COVID-19-related cases and fatalities.

OBJECTIVES: The United States has the highest number of coronavirus disease 2019 (COVID-19) in the world, with high variability in cases and mortality between communities. We aimed to quantify the associations between socio-economic status and COVID-19-related cases and mortality in the U.S. STUDY DESIGN: The study design includes nationwide COVID-19 data at the county level that were paired with the Distressed Communities Index (DCI) and its component metrics of socio-economic status. METHODS: Severely distressed communities were classified by DCI>75 for univariate analyses. Adjusted rate ratios were calculated for cases and fatalities per 100,000 persons using hierarchical linear mixed models. RESULTS: This cohort included 1,089,999 cases and 62,298 deaths in 3127 counties for a case fatality rate of 5.7%. Severely distressed counties had significantly fewer deaths from COVID-19 but higher number of deaths per 100,000 persons. In risk-adjusted analysis, the two socio-economic determinants of health with the strongest association with both higher cases per 100,000 persons and higher fatalities per 100,000 persons were the percentage of adults without a high school degree (cases: RR 1.10; fatalities: RR 1.08) and proportion of black residents (cases and fatalities: Relative risk(RR) 1.03). The percentage of the population aged older than 65 years was also highly predictive for fatalities per 100,000 persons (RR 1.07). CONCLUSION: Lower education levels and greater percentages of black residents are strongly associated with higher rates of both COVID-19 cases and fatalities. Socio-economic factors should be considered when implementing public health interventions to ameliorate the disparities in the impact of COVID-19 on distressed communities.

Adenosine A2A receptor agonist (regadenoson) in human lung transplantation.

BACKGROUND: Currently, there are no clinically approved treatments for ischemia-reperfusion injury after lung transplantation. Pre-clinical animal models have demonstrated a promising efficacy of adenosine 2A receptor (A2AR) agonists as a treatment option for reducing ischemia-reperfusion injury. The purpose of this human study, is to conduct a Phase I clinical trial for evaluating the safety of continuous infusion of an A2AR agonist in lung transplant recipients. METHODS: An adaptive, two-stage continual reassessment trial was designed to evaluate the safety of regadenoson (A2AR agonist) in the setting of lung transplantation. Continuous infusion of regadenoson was administered to lung transplant recipients that was started at the time of skin incision. Adverse events and dose-limiting toxicities, as pre-determined by a study team and assessed by a clinical team and an independent safety monitor, were the primary end-points for safety in this trial. RESULTS: Between January 2018 and March 2019, 14 recipients were enrolled in the trial. Of these, 10 received the maximum infused dose of 1.44 µg/kg/min for 12 hours. No dose-limiting toxicities were observed. The steady-state plasma regadenoson levels sampled before the reperfusion of the first lung were 0.98 ± 0.46 ng/ml. There were no mortalities within 30 days. CONCLUSIONS: Regadenoson, an A2AR agonist, can be safely infused in the setting of lung transplantation with no dose-limiting toxicities or drug-related mortality. Although not powered for the evaluation of secondary end-points, the results of this trial and the outcome of pre-clinical studies warrant further investigation with a Phase II randomized controlled trial.

Smoking Cessation Counseling Improves Quality of Care and Surgical Outcomes with Financial Gain for a Vascular Practice.

BACKGROUND: Cigarette smoking is strongly associated with atherosclerotic disease. It is incumbent on vascular surgeons to provide smoking cessation counseling (SCC) to their patients. The objective of this study was to determine the association of SCC and improvement in quality of care. METHODS: As a quality project using retrospective data, the study received institutional review board exemption status. A retrospective review of prospectively maintained database from April 2014 through March 2015 of outpatient encounters in a vascular surgery clinic was performed of current smokers. Through the quality support team, providers were encouraged to counsel smokers to quit, document the discussion, and bill specific Evaluate and Management codes (99406 and 99407). The number of outpatients by smoking status, documentation and billing of SCC, demographics of current smokers, and monetary collections were collected. Data were compared using a correlation coefficient calculated and tested for statistical significant using two-tailed t-test. RESULTS: A sample of 1,077 visits by 612 currently smoking patients accounted for 24% of all outpatient vascular surgery visits. The average age was 61 years, and 64% were male. Comorbidities included 77% with hypertension, 32% with diabetes mellitus, and 14% with chronic kidney disease. Medically, 72% were on aspirin, 71% on statin, and 48% on beta blocker. A total of 208 (34%) never underwent a vascular intervention, and 183 (30%) had an intervention during the study period (44% for peripheral artery disease, 10% for carotid stenosis, 14% amputations, and 10% abdominal aortic aneurysm). Documentation improved from 65% of encounters during the first month to 89% in the peak month and 79% of total encounters. All-cause mortality rate was 2%, and this cohort demonstrated 75% SCC for 28 encounters. Fifty-five patients (9%) quit smoking for more than 30 days at the end of the study period, and this cohort had 69% of their 97 encounters with documented SCC. Increased SCC was correlated with decreased 30-day readmissions during the concurrent month (r = -0.711, P = 0.009) and the following month (r = -0.719, P = 0.008). There was a weak correlation with decreased amputations the following month (r = -0.5, P = 0.08). From a financial perspective, $1,373 was collected for 33 patients with a potential for collection of $7,460 predicted for minimum Medicare payment of 1 visit per patient. CONCLUSIONS: Advising vascular patients in the arduous process of smoking cessation benefits both the patient and the health system. Proper documentation and billing decreases costs of early readmissions and increases departmental revenue.