Wesley McMillian

Hemopericardium in a Patient Treated with Dabigatran Etexilate

Dabigatran etexilate is a new oral anticoagulant used for the prevention of systemic thromboembolism in patients with atrial fibrillation. Acute bleeding episodes are known to occur with dabigatran etexilate therapy; however, only a few case reports in the literature describe such events. We describe a 70‐year‐old man treated with dabigatran etexilate for newly diagnosed, nonvalvular atrial fibrillation who developed a large hemopericardium that appeared to be temporally related to dabigatran etexilate administration. One month after starting the drug, an incidental finding of a small pericardial effusion was found on echocardiography. One month later, the patient came to his pulmonologists office complaining of shortness of breath; a large pericardial effusion was found on a noncontrast computed tomographic scan, and the patient was admitted to the hospital. Laboratory monitoring of his coagulation status was limited due to the lack of assays available to directly monitor the therapeutic effects of dabigatran. The internal laboratory was able to perform a dilute thrombin time (DTT) test as part of a quality improvement project aiming to validate an assay for monitoring patients receiving dabigatran therapy. A DTT was therefore performed in conjunction with routine coagulation assays to evaluate the patients coagulation status. After pericardiocentesis, the patient recovered without incident and was discharged without anticoagulant therapy. Although the Naranjo adverse reaction probability scale only indicated a possible relationship (score of 1) between the patients development of hemopericardium and dabigatran etexilate therapy, investigation into the patients clinical course, comorbidities, and laboratory results led us to conclude that dabigatran etexilate was responsible for the hemopericardium. To our knowledge, this report is the first to describe a case of potentially life‐threatening pericardial bleeding that was temporally related to starting dabigatran etexilate therapy. Although we found that the DTT was a viable method of monitoring coagulation status in a patient receiving dabigatran etexilate therapy, the assay lacks approval by the United States Food and Drug Administration, which limits its clinical utility and widespread use at this time. Clinicians should be aware of the potential for life‐threatening bleeding with use of this agent and the difficulty associated with monitoring and reversing this therapy in the setting of acute bleeding.

Compliance with the Eastern Association for the Surgery of Trauma guidelines for prophylactic antibiotics after open extremity fracture

Context: Prophylactic antibiotics, paired with wound care and surgical intervention, is considered the standard of care for patients with open fracture. Guidelines from the Eastern Association for the Surgery of Trauma (EAST) recommend specific prophylactic antimicrobial therapy based on the type of open fracture. Aims: We quantified adherence to EAST guideline recommendations and documented the incidence of infection in patients with open fracture. Settings and Design: A retrospective, observational study of all patients with open fracture admitted to our facility from January 2004 to December 2008 was conducted. Materials and Methods: Patients were divided into compliant and noncompliant groups according to the EAST guideline recommendations. Compliance was defined as an appropriate spectrum of therapy for guideline suggested duration. We assessed for surgical and non-surgical site infections, and morbidity outcomes. Statistical Analysis: Nominal data were explored using summary measures. Continuous variables were compared using the Student t-test or the Mann–Whitney U-test. Dichotomous data were compared using χ2 statistic or Fishers exact test. Results: The final analysis included 214 patients. Prophylactic antibiotics were guideline compliant in 28.5% of patients, and ranged from 10.0% in type 3b fractures to 52.7% in type 1 fractures. The most common reason for non-compliance was the use of guideline recommended coverage that exceeded the suggested duration (71.2%). Patients who received non-compliant therapy required prolonged hospital lengths of stay (6 vs. 3 days, P = 0.0001). The overall incidence of infection was similar regardless of guideline compliance (17.0% vs. 11.5%, P = 0.313). Conclusions: Prophylactic antibiotics for open fracture frequently exceeded guideline recommendations in duration and spectrum of coverage, especially in more severe fracture types. Non-compliance with EAST recommendations was associated with increased in-hospital morbidity.

Original ContributionRisk of thromboembolic events after protocolized warfarin reversal with 3-factor PCC and factor VIIa☆☆☆

Bleeding events and life-threatening hemorrhage are the most feared complications of warfarin therapy. Prompt anticoagulant reversal aimed at replacement of vitamin K-dependent clotting factors is essential to promote hemostasis. A retrospective cohort study of warfarin-treated patients experiencing a life-threatening hemorrhage treated with an institution-specific warfarin reversal protocol (postimplementation group) and those who received the prior standard of care (preimplementation group) was performed. The reversal protocol included vitamin K, 3-factor prothrombin complex concentrate, and recombinant factor VIIa. Demographic and clinical information, anticoagulant reversal information, and all adverse events attributed to warfarin reversal were recorded. A total of 227 patients were included in final analysis, 109 in the preimplementation group and 118 in the postimplementation group. Baseline patient characteristics were similar in both groups, with the exception of higher average Sequential Organ Failure Assessment scores in the postimplementation group (P = .0005). The most common indication for anticoagulation reversal was intraparenchymal hemorrhage. Prereversal international normalized ratios (INRs) were similar in both groups. Attainment of INR normalization to less than 1.4 was higher, and rebound INR was lower in the postimplementation group (P < .0001; P = .0013). Thromboembolic complications were significantly higher in the postimplementation group (P = .003). Elevated baseline Sequential Organ Failure Assessment score and mechanical valve as an indication for anticoagulation were independently associated with thrombotic complications (P = .005). A warfarin reversal protocol consisting of 3-factor prothrombin complex concentrate, recombinant factor VIIa, and vitamin K more consistently normalized INR values to less than 1.4 as compared to the prior standard of care in a diverse patient population. This success came at the cost of a 2-fold increase in risk of thromboembolic complications.

Anticoagulation management around percutaneous bedside procedures: is adjustment required?

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) and percutaneous dilatational tracheostomy (PDT) are frequently performed bedside in the intensive care unit. Critically ill patients frequently require anticoagulant (AC) and antiplatelet (AP) therapies for myriad indications. There are no societal guidelines proffering strategies to manage AC/AP therapies periprocedurally for bedside PEG or PDT. The aim of this study is to evaluate the management of AC/AP therapies around PEG/PDT, assess periprocedural bleeding complications, and identify risk factors associated with bleeding. METHODS: A retrospective, observational study of all adult patients admitted from October 2004 to December 2009 receiving a bedside PEG or PDT was conducted. Patients were identified by procedure codes via an in-hospital database. A medical record review was performed for each included patient. RESULTS: Four hundred fifteen patients were included, with 187 PEGs and 352 PDTs being performed. Prophylactic anticoagulation was held for approximately one dose before and two doses or less after the procedure. There was wide variation in patterns of holding therapy in patients receiving anticoagulation via continuous infusion. There were 19 recorded minor bleeding events, 1 (0.5%) with PEG and 18 (5.1%) with PDT, with no hemorrhagic events. No association was found between international normalized ratio, prothrombin time, or activated partial thromboplastin time values and bleed risk (p = 0.853, 0.689, and 0.440, respectively). Platelet count was significantly lower in patients with a bleeding event (p = 0.006). CONCLUSIONS: We found that while practice patterns were quite consistent in regard to the management of prophylactic anticoagulation, it varied widely in patients receiving therapeutic anticoagulation. It seems that prophylactic anticoagulation use did not affect bleed risk with PEG/PDT. LEVEL OF EVIDENCE: II, therapeutic study.

Antimicrobial prophylaxis during Hirudo medicinalis therapy: a multicenter study.

BACKGROUND Medicinal leeches (Hirudo medicinalis) are indicated for salvage of tissue flaps, grafts, or replants when venous congestion threatens tissue viability. The purpose of this study was to evaluate the efficacy of prophylactic antimicrobial agents in patients who received medicinal leech therapy. MATERIALS AND METHODS A multicenter retrospective cohort study of all adult patients between January 1, 2010, and February 28, 2013, who received medicinal leech therapy was conducted. RESULTS Antimicrobial prophylaxis was documented in 54 (91.5%) of the included patients, ciprofloxacin, trimethoprim-sulfamethoxazole, piperacillin-tazobactam, and ceftriaxone in 33 (61.1%), 18 (33.3%), 2 (3.7%), and 2 (3.7%) patients, respectively. Surgical site infection (SSI) was found in seven (11.9%) patients, all of whom received antimicrobial prophylaxis. Aeromonas spp. was isolated in four infections, and all isolates were resistant to the chosen prophylactic agent. The SSI incidence was similar between antimicrobial prophylaxis agents. CONCLUSION Trimethoprim-sulfamethoxazole and ciprofloxacin appear equally effective at preventing leech-associated infections.

Surgical Site Infections in Patients With Type 3 Open Fractures: Comparing Antibiotic Prophylaxis With Cefazolin Plus Gentamicin Versus Piperacillin/Tazobactam.

Objectives: The purpose of this study was to compare rates of surgical site infection (SSI) in patients with type 3 open fractures who had received cefazolin plus gentamicin versus piperacillin/tazobactam for antibiotic prophylaxis. Design: Retrospective cohort study. Setting: Level 1 trauma center. Patients: Seven hundred sixty-six patients admitted between January 1, 2004, and December 31, 2012, with open fractures were identified using the National Trauma Data Bank by searching International Classification of Diseases, Ninth Revision (ICD-9) codes. Electronic medical record review revealed 134 patients with type 3 open fractures, of which 72 were included in the final analysis. Intervention: Administration of cefazolin plus gentamicin or piperacillin/tazobactam for type 3 open fracture antibiotic prophylaxis. Main Outcome Measurements: SSI, nonunion, death, and rehospitalization rates at 1 year. Results: Surgical site infection at 1 year occurred in 12 of 37 patients (32.4%) in the cefazolin plus gentamicin group and 11 of 35 patients (31.4%) in the piperacillin/tazobactam group (P = 1.000). Nonunion, death, and rehospitalization rates at 1 year were similar between the 2 groups. Although there was no statistically significant difference in SSI at 30 days between groups, the rate was higher in the cefazolin plus gentamicin group (21.6% vs. 11.4%; P = 0.246). Conclusions: At our institution, use of piperacillin/tazobactam as compared with cefazolin plus gentamicin for antibiotic prophylaxis in patients with type 3 open fractures showed similar rates of SSI, nonunion, mortality, and rehospitalization at 1 year after injury. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Utility of ampicillin-sulbactam for empiric treatment of ventilator-associated pneumonia in a trauma population.

BACKGROUND Ampicillin-sulbactam is guideline-recommended treatment for early-onset ventilator-associated pneumonia (VAP). However, intensive care unit clinicians are encountering increasing resistance to ampicillin-sulbactam. We sought to analyze the time period for early-onset VAP in our trauma population by using daily evaluation of resistance to ampicillin-sulbactam. METHODS A retrospective cohort study was completed on all mechanically ventilated trauma patients admitted to a rural level-1 trauma center from January 2003 to December 2008 who were diagnosed with VAP. Daily bacterial resistance to ampicillin-sulbactam > 15% was defined as the threshold for early empiric antibiotic failure for the first episode of VAP. A univariate analysis of risk factors for multi-drug resistant pathogens (MDRPs) and comorbidities was completed to assess for predisposing factors for ampicillin-sulbactam resistance. RESULTS One hundred sixty-three pathogens were identified in 121 trauma patients diagnosed with VAP. Of these isolates, 71% were gram-negative, 28% were gram-positive, and 1% was fungal. Methicillin-susceptible Staphylococcus aureus (23.9%), H aemophilus influenzae (20.9%), and Pseudomonas aeruginosa (11.7%) were the most common infecting organisms. Daily ampicillin-sulbactam resistance was 40%, 26%, 32%, 43%, 50%, and 60% on days 3 to 7 and ≥ 8 days, respectively. Only the presence of MDRP risk factors (89% vs. 65%, p < 0.01) and hospital LOS (36.8 [22.8-49.0] vs. 25.7 days [19.0-32.5], p < 0.01) was different between ampicillin- sulbactam resistant and ampicillin-sulbactam susceptible VAP groups. On univariate analysis, hospital length of stay >4 days and antibiotic use within 90 days were associated with ampicillin-sulbactam resistant VAP (p < 0.01). CONCLUSIONS Ampicillin-sulbactam is not an effective empiric therapy for early-onset VAP in our rural trauma population. The utility of ampicillin-sulbactam should be reviewed at other institutions to assess for appropriate empiricism.