Bleeding with direct oral anticoagulants vs warfarin: clinical experience.

The risk of bleeding in the setting of anticoagulant therapy continues to be re-evaluated following the introduction of a new generation of direct oral anticoagulants (DOACs). Interruption of DOAC therapy and supportive care may be sufficient for the management of patients who present with mild or moderate bleeding, but in those with life-threatening bleeding, a specific reversal agent is desirable. We review the phase 3 clinical studies of dabigatran, rivaroxaban, apixaban, and edoxaban in patients with nonvalvular atrial fibrillation, in the context of bleeding risk and management

Grand Rounds: What\u27s in It for You?

No abstract available

Jefferson Medical College and CME: New Challenges, New Opportunities

No abstract available

Is Interchangeability Possible? Understanding and Evaluating the Evidence Base-Implications for Quality and Safety

Geno Merli, a board-certified specialist in internal medicine and physical medicine and rehabilitation, is Director of the Jefferson Center for Vascular Disease at Jefferson Medical College and Senior Vice President and Chief Medical Officer at Thomas Jefferson University Hospital. Dr. Merli received his medical degree from Jefferson Medical College and completed his residency in rehabilitation medicine and internal medicine at Thomas Jefferson University Hospital. Dr. Merli is a nationally recognized expert in the areas of prophylaxis for and management of deep-vein thrombosis and pulmonary embolism (DVT/PE), as well as for the medical consultation of surgical patients. His research interests have focused on prophylaxis for DVT/PE and the management of DVT in acute spinal cord injury, total joint replacement, trauma, and high-risk cancer patients. Former editor-in-chief of Internal Medicine, Dr. Merli currently serves on the editorial board of Patient Care, Journal of the Society of Hospital Medicine, and The Hospitalist. He is also a reviewer for the Archives of Internal Medicine, Annals of Internal Medicine, Chest, Journal of Thrombosis and Thrombolysis, Journal of Thrombosis and Hemostasis and JAMA. He is co-editor of the book Medical Management of the Surgical Patient and co-chairs for a national course on the perioperative care of the surgical patient with medical problems. Dr. Merli is a fellow of the American College of Physicians and a member of American Venous Forum, the Society of Hospital Medicine, American Medical Association, Society of Vascular Medicine and Biology, and the International Society of Thrombosis and Hemostasis

Management of intracranial bleeding associated with dabigatran use in a neuroscience hospital

Dabigatran, an alternative to warfarin for prevention of stroke with non-valvular atrial fibrillation (AF), offers advantages of a fixed dosage, minimal laboratory monitoring and limited medication interactions. Dabigatran requires dosage adjustment in renal dysfunction and is contraindicated if severe dysfunction. No identified dabigatran reversal agent exists. Methods: As part of an ongoing quality initiative, novel anticoagulant associated adverse events (AE) are monitored at a dedicated neuroscience hospital. Results: 5 cases of intracranial bleeding associated with dabigatran occurred from 12/2011-4/2012. All patients were on anticoagulation for AF, the most common dose of dabigatran was 150 mg BID. Mean admission values were as follows: age 83.2 yrs (range 79-90), serum creatinine 1.48 mg/dL (range 0.9- 3.5), creatinine clearance 45.6 mL/min (18-59) and aPTT 49 seconds (range 32- 60). Strategies for the management of bleeding included withholding dabigatran, supportive care, administration of blood products and hemodialysis, when required. Dialysis was initiated on 3 patients. One patient had 3 dialysis sessions in an effort to normalize coagulation assays and had transfusions with 10 units of platelets and 4 units of fresh frozen plasma in an effort to stabilize bleeding. One patient died. Mean time for aPTT to normalize when abnormal on admission was 30.8 hours (range 21-37). Conclusions: Appropriate patient selection is required to prevent dabigatran associated AE, especially in the setting of advanced age and kidney dysfunction. aPTT values may remain prolonged for extended periods, despite efforts to normalize. Hospitals need a defined management plan for major bleeding associated with novel anticoagulants

How good are we at determining risk? Quantifying the accuracy of clinician determined risk for VTE prophylaxis

Objectives: Create and validate a simple tool for concurrent audits of risk stratification, compliance and documentation Evaluate accuracy of clinician risk stratification and prophylatic ordering practice compared with a standardized Caprini RAM across different assigned risk categories Provide recommendations for EPIC VTE Prophylaxis CDS Developmenthttps://jdc.jefferson.edu/patientsafetyposters/1050/thumbnail.jp

Quantifying Patient Reported and Documented Compliance with Adjuncts to Venous Thromboembolism Prophylaxis

Objectives: 1. Measure patient compliance with pharmacologic, mechanical and ambulatory prophylactic measures. 2. Evaluate for agreement between nursing documentation and patient reported compliance with mechanical and ambulatory prophylactic measures.https://jdc.jefferson.edu/patientsafetyposters/1042/thumbnail.jp

The incidence of deep vein thrombosis detected by routine surveillance ultrasound in neurosurgery patients receiving dual modality prophylaxis.

The optimal method of thromboprophylaxis and the value of screening ultrasonography for detection of deep venous thrombosis (DVT) in neurosurgery patients remains unclear. The goal of this study was to determine the incidence of DVT in neurosurgical patients who, by hospital protocol, receive surveillance ultrasonography of the lower extremities twice weekly, in addition to prophylaxis with unfractionated heparin and external pneumatic compression sleeves. A retrospective review of 7,298 ultrasound studies carried out on 2,593 patients over 4 years at a university neurosurgical hospital was conducted. There was a 7.4% incidence of proximal lower extremity DVT and a 9.7% total incidence including distal DVT. A greater number of distal DVTs were detected with the implementation of whole-leg ultrasonography in the last 2 years of observation. Chart review of 237 patients diagnosed with DVT demonstrated an admitting diagnosis of subarachnoid hemorrhage in nearly half of the patients. The median hospital length of stay for DVT patients was 18 days. Institutional control data demonstrated non-ruptured aneurysm and cerebrovascular anomalies to be the leading reason for admission, followed closely by subarachnoid hemorrhage. The hospital protocol of biweekly screening ultrasound and dual modality prophylaxis for neurosurgery patients resulted in a proximal DVT incidence consistent with that demonstrated by previous studies of standardized dual modality prophylaxis, and higher than that demonstrated in previous studies that employed ultrasound screening protocols

Efficacy, Safety, and Timing of Anticoagulant Thromboprophylaxis for the Prevention of Venous Thromboembolism in Patients With Acute Spinal Cord Injury: A Systematic Review

Study Design: Systematic review. Objectives: The objective of this study was to answer 5 key questions: What is the comparative effectiveness and safety of (1a) anticoagulant thromboprophylaxis compared to no prophylaxis, placebo, or another anticoagulant strategy for preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after acute spinal cord injury (SCI)? (1b) Mechanical prophylaxis strategies alone or in combination with other strategies for preventing DVT and PE after acute SCI? (1c) Prophylactic inferior vena cava filter insertion alone or in combination with other strategies for preventing DVT and PE after acute SCI? (2) What is the optimal timing to initiate and/or discontinue anticoagulant, mechanical, and/or prophylactic inferior vena cava filter following acute SCI? (3) What is the cost-effectiveness of these treatment options? Methods: A systematic literature search was conducted to identify studies published through February 28, 2015. We sought randomized controlled trials evaluating efficacy and safety of antithrombotic strategies. Strength of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Results: Nine studies satisfied inclusion criteria. We found a trend toward lower risk of DVT in patients treated with enoxaparin. There were no significant differences in rates of DVT, PE, bleeding, and mortality between patients treated with different types of low-molecular-weight heparin or between low-molecular-weight heparin and unfractionated heparin. Combined anticoagulant and mechanical prophylaxis initiated within 72 hours of SCI resulted in lower risk of DVT than treatment commenced after 72 hours of injury. Conclusion: Prophylactic treatments can be used to lower the risk of venous thromboembolic events in patients with acute SCI, without significant increase in risk of bleeding and mortality and should be initiated within 72 hours. © 2017, © The Author(s) 2017

Thromboembolism After Intramedullary Nailing for Metastatic Bone Lesions.

BACKGROUND: The risk of venous thromboembolism (VTE) in patients undergoing intramedullary nailing for skeletal metastatic disease is currently undefined. The purpose of our study was to determine the risk of thromboembolic events, to define the risk factors for VTE, and to define the rate of wound complications in this population. METHODS: A retrospective review of surgical databases at three National Cancer Institute (NCI)-designated cancer centers identified 287 patients with a total of 336 impending or pathologic long-bone fractures that were stabilized with intramedullary nailing between February 2001 and April 2013. Statistical analysis was performed utilizing multivariable logistic regression and Fisher exact tests. RESULTS: The overall rate of VTE was twenty-four (7.1%) of the 336; thirteen (3.9%) were pulmonary embolism (PE), and eleven (3.3%), deep venous thrombosis (DVT). In two patients, adequate anticoagulation data were not available. We found no significant relationship between the type of anticoagulant used and VTE. There was a significant positive correlation found between lung-cancer histology and the development of VTE (p \u3c 0.001) or PE (p \u3c 0.001). The absence of radiation therapy approached significance (p = 0.06) with respect to decreased overall VTE risk. Wound complications were documented for 11 (3.3%) of the operations. CONCLUSIONS: There is a high rate of VTE among those with skeletal metastatic disease who undergo intramedullary nailing, even while receiving postoperative thromboembolic prophylaxis. Current anticoagulation protocols may be inadequate. Wound-complication risk with anticoagulant use in this population is low and should not be a deterrent to adequate anticoagulant use for this population