A randomized study of the safety and efficacy of fondaparinux versus placebo in the prevention of venous thromboembolism after coronary artery bypass graft surgery.

UNLABELLED: Venous thromboembolism (VTE) after coronary artery bypass graft (CABG) surgery may increase the postoperative morbidity and mortality. Therefore, we examined the current postoperative need for prophylactic antithrombotic therapy after CABG surgery. METHODS: This randomized, placebo-controlled, double-blind study was designed to compare the safety and efficacy of fondaparinux versus placebo in the prevention of VTE after CABG surgery. Between March 2010 and January 2013, 78 patients free from preoperative deep vein thrombosis (DVT) were enrolled, of whom 37 were randomly assigned to placebo and 41 to treatment with fondaparinux. The primary study end point was a composite, up to day 11, of (a) cumulative incidence of all VTE events, defined as symptomatic and asymptomatic DVT, and fatal and nonfatal pulmonary embolisms (efficacy end point), and (b) cumulative incidence of major hemorrhages (safety end point). RESULTS: A single asymptomatic DVT of a lower extremity was detected by duplex ultrasound at the time of discharge from the hospital in the placebo-treated group, and a single major postoperative hemorrhage occurred in the fondaparinux-treated group. CONCLUSIONS: The incidence of postprocedural asymptomatic DVT in this sample of patients undergoing CABG surgery was low. The overall incidence of DVT in the control and investigational treatment groups was similar. Our results showed no benefit of prophylactic postoperative fondaparinux in this population. These findings are congruent with other published studies and provide additional support for recent recommendations not to routinely use anticoagulant prophylaxis after cardiac surgery.

Electrocardiographic manifestations of COVID-19: Effect on cardiac activation and repolarization.

BACKGROUND: Prolonged QT intervals are reported in patients with COVID-19. Additionally, virus particles in heart tissue and abnormal troponin levels have been reported. Consequently, we hypothesize that cardiac electrophysiologic abnormalities may be associated with COVID-19. METHODS: This is a retrospective study between March 15th, 2020 and May 30th, 2020 of 828 patients with COVID-19 and baseline ECG. Corrected QT (QTc) and QRS intervals were measured from ECGs performed prior to intervention or administration of QT prolonging drugs. QTc and QRS intervals were evaluated as a function of disease severity (patients admitted versus discharged; inpatients admitted to medical unit vs ICU) and cardiac involvement (troponin elevation >0.03 ng/ml, elevated B-natriuretic peptide (BNP) or NT pro-BNP >500 pg/ml). Multivariable analysis was used to test for significance. Odds ratios for predictors of disease severity and mortality were generated. FINDINGS: Baseline QTc of inpatients was prolonged compared to patients discharged (450.1±30.2 versus 423.4±21.7  msec, p<0.0001) and relative to a control group of patients with influenza (p=0.006). Inpatients with abnormal cardiac biomarkers had prolonged QTc and QRS compared to those with normal levels (troponin - QTc: 460.9±34.6 versus 445.3±26.6  msec, p<0.0001, QRS: 98.7±24.6 vs 90.5±16.9  msec, p<0.0001; BNP - QTc: 465.9±33.0 versus 446.0±26.2  msec, p<0.0001, QRS: 103.6±25.3 versus 90.6±17.6 msec, p<0.0001). Findings were confirmed with multivariable analysis (all p<0.05). QTc prolongation independently predicted mortality (8.3% increase in mortality for every 10  msec increase in QTc; OR 1.083, CI [1.002, 1.171], p=0.04). INTERPRETATION: QRS and QTc intervals are early markers for COVID-19 disease progression and mortality. ECG, a readily accessible tool, identifies cardiac involvement and may be used to predict disease course. FUNDING: St. Francis Foundation.

Reduced cardiac function is associated with cardiac injury and mortality risk in hospitalized COVID-19 Patients.

BACKGROUND: Cardiac injury is common in COVID-19 patients and is associated with increased mortality. However, it remains unclear if reduced cardiac function is associated with cardiac injury, and additionally if mortality risk is increased among those with reduced cardiac function in COVID-19 patients. HYPOTHESIS: The aim of this study was to assess cardiac function among COVID-19 patients with and without biomarkers of cardiac injury and to determine the mortality risk associated with reduced cardiac function. METHODS/RESULTS: This retrospective cohort study analyzed 143 consecutive COVID-19 patients who had an echocardiogram during hospitalization between March 1, 2020 and May 5, 2020. The mean age was 67 ± 16 years. Cardiac troponin-I was available in 131 patients and an increased value (>0.03 ng/dL) was found in 59 patients (45%). Reduced cardiac function, which included reduced left or right ventricular systolic function, was found in 40 patients (28%). Reduced cardiac function was found in 18% of patients without troponin-I elevation, 42% with mild troponin increase (0.04-5.00 ng/dL) and 67% with significant troponin increase (>5 ng/dL). Reduced cardiac function was also present in more than half of the patients on mechanical ventilation or those deceased. The in-hospital mortality of this cohort was 28% (N = 40). Using logistic regression analysis, we found that reduced cardiac function was associated with increased mortality with adjusted odds ratio (95% confidence interval) of 2.65 (1.18 to 5.96). CONCLUSIONS: Reduced cardiac function is highly prevalent among hospitalized COVID-19 patients with biomarkers of myocardial injury and is independently associated with mortality.

Rural interhospital transfer of ST-elevation myocardial infarction patients for percutaneous coronary revascularization: the Stat Heart Program.

BACKGROUND: In Europe, interhospital transfer of ST-elevation myocardial infarction (STEMI) patients for primary percutaneous coronary intervention (PCI) from non-PCI-capable (STEMI-referral) to PCI-capable (STEMI-accepting) facilities has been shown to be a superior reperfusion strategy compared with on-site fibrinolysis. The feasibility of such programs in the United States remains poorly defined. METHODS AND RESULTS: We describe an observational cohort of 230 consecutive presumed STEMI patients who underwent interhospital transfer between January 2005 and March 2007 among 6 STEMI-referral and 2 STEMI-accepting hospitals in rural central Illinois. A standard treatment protocol using rapid interhospital transfer for primary PCI or rescue PCI after full-dose intravenous fibrinolysis (in event of unanticipated transfer delays) was initiated by the STEMI-referral emergency department physician. Three time intervals were evaluated: STEMI-referral care (door 1 to departure), transport time (door 1 departure to STEMI-accepting hospital arrival [door 2]), and STEMI-accepting hospital care (door 2 to balloon). Primary PCI was performed in 165 STEMI-confirmed patients (87.7%), whereas fibrinolysis was required in 16 patients (8.5%), with 56% undergoing rescue PCI. The median door 1-to-departure time was 46 minutes (25th and 75th percentiles, 32 and 62 minutes); approximately two thirds of this delay was attributable to the wait for transport arrival and departure. The transport and door 2-to-balloon times were 29 minutes (25th and 75th percentiles, 25 and 35 minutes) and 35 minutes (25th and 75th percentiles, 32 and 46 minutes), respectively. The door 1-to-balloon time was 117 minutes (25th and 75th percentiles, 98 and 137 minutes), with 12.2% and 58% of patients achieving a time of < or = 90 and < or = 120 minutes, respectively. No adverse clinical events occurred during interhospital transport. CONCLUSIONS: In rural US communities, emergency department physician-initiated interhospital transfer of STEMI patients for primary or rescue PCI is feasible and was safely executed with achievement of timely reperfusion when performed within coordinated healthcare networks.