Browsing by Subject "Anticoagulation"
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Item Bone Density in Children with Single Ventricle Physiology(Springer, 2015-04) Bendaly, Edgard A.; DiMeglio, Linda A.; Fadel, William F.; Hurwitz, Roger A.; Department of Pediatrics, Indiana University School of MedicineBackground Children with chronic diseases are at risk for low bone mineral density (BMD). There are no studies of BMD in children with congenital heart disease and particularly SV. Children with this defect are often treated with warfarin, suspected to negatively impact BMD in adults. We assessed BMD in patients with single ventricle (SV) physiology and compared the BMD of subjects taking warfarin to those who were not. Methods Subjects 5-12 years with SV were included. BMD z-scores by dual-energy X-ray absorptiometry (DXA) of the spine and total body less head (TBLH) were obtained. Calcium intake, activity level, height, and Tanner stage were assessed. Linear regression models and t-tests were used to investigate differences between participants and normative data as well as between subjects' subgroups. Results Twenty six subjects were included; 16 took warfarin. Mean BMD z-score at the spine was significantly lower than expected at -1.0±0.2 (p<0.0001), as was the BMD z-score for TBLH at - 0.8±0.2 (p<0.0001). Those results remained significant after adjusting for height. Subjects who were on warfarin tended to have lower BMD at both the spine and TBLH than those who were not, with a z-score difference of 0.6±0.46 at the spine (p=0.106) and a difference of 0.4±0.34 at TBLH (p=0.132). Conclusions BMD is significantly reduced in children with SV. Warfarin appears to lower BMD but the effect is less conclusive. Continued evaluation is recommended for these patients at risk for reduced bone density. Evaluation of other cardiac patients on warfarin therapy should also be considered.Item Clinical and Laboratory characteristics of patients with COVID-19 Infection and Deep Venous Thrombosis(Elsevier, 2020-10-22) Motaganahalli, Raghu L.; Kapoor, Rajat; Timsina, Lava R.; Gutwein, Ashley R.; Ingram, Michael D.; Raman, Subha; Roberts, Scott D.; Rahman, Omar; Rollins, David; Dalsing, Michael C.; Surgery, School of MedicineObjective: Early reports suggest that patients with novel coronavirus disease-2019 (COVID-19) infection carry a significant risk of altered coagulation with an increased risk for venous thromboembolic events. This report investigates the relationship of significant COVID-19 infection and deep venous thrombosis (DVT) as reflected in the patient clinical and laboratory characteristics. Methods: We reviewed the demographics, clinical presentation, laboratory and radiologic evaluations, results of venous duplex imaging and mortality of COVID-19-positive patients (18-89 years) admitted to the Indiana University Academic Health Center. Using oxygen saturation, radiologic findings, and need for advanced respiratory therapies, patients were classified into mild, moderate, or severe categories of COVID-19 infection. A descriptive analysis was performed using univariate and bivariate Fisher's exact and Wilcoxon rank-sum tests to examine the distribution of patient characteristics and compare the DVT outcomes. A multivariable logistic regression model was used to estimate the adjusted odds ratio of experiencing DVT and a receiver operating curve analysis to identify the optimal cutoff for d-dimer to predict DVT in this COVID-19 cohort. Time to the diagnosis of DVT from admission was analyzed using log-rank test and Kaplan-Meier plots. Results: Our study included 71 unique COVID-19-positive patients (mean age, 61 years) categorized as having 3% mild, 14% moderate, and 83% severe infection and evaluated with 107 venous duplex studies. DVT was identified in 47.8% of patients (37% of examinations) at an average of 5.9 days after admission. Patients with DVT were predominantly male (67%; P = .032) with proximal venous involvement (29% upper and 39% in the lower extremities with 55% of the latter demonstrating bilateral involvement). Patients with DVT had a significantly higher mean d-dimer of 5447 ± 7032 ng/mL (P = .0101), and alkaline phosphatase of 110 IU/L (P = .0095) than those without DVT. On multivariable analysis, elevated d-dimer (P = .038) and alkaline phosphatase (P = .021) were associated with risk for DVT, whereas age, sex, elevated C-reactive protein, and ferritin levels were not. A receiver operating curve analysis suggests an optimal d-dimer value of 2450 ng/mL cutoff with 70% sensitivity, 59.5% specificity, and 61% positive predictive value, and 68.8% negative predictive value. Conclusions: This study suggests that males with severe COVID-19 infection requiring hospitalization are at highest risk for developing DVT. Elevated d-dimers and alkaline phosphatase along with our multivariable model can alert the clinician to the increased risk of DVT requiring early evaluation and aggressive treatmentItem Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial(American Heart Association, 2022) Noseworthy, Peter A.; Branda, Megan E.; Kunneman, Marleen; Hargraves, Ian G.; Sivly, Angela L.; Brito, Juan P.; Burnett, Bruce; Zeballos-Palacios, Claudia; Linzer, Mark; Suzuki, Takeki; Lee, Alexander T.; Gorr, Haeshik; Jackson, Elizabeth A.; Hess, Erik; Brand-McCarthy, Sarah R.; Shah, Nilay D.; Montori, Victor M.; SDM4AFib (Shared Decision-Making for Atrial Fibrillation) Trial Investigators; Medicine, School of MedicineBackground: Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results: We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions: In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes.Item Getting Out of a PCCL: Percutaneous Cholecystolithotomy as a Salvage Treatment Option for Gallstone Removal in Patients Deemed Unfit for Standard Surgical Approaches(Mary Ann Liebert, Inc., 2016-02-01) Calaway, Adam C.; Borofsky, Michael S.; Dauw, Casey A.; Lingeman, James E.; Department of Urology, IU School of MedicineDefinitive management of acute cholecystitis or symptomatic cholelithiasis in exceedingly high-risk patients remains a clinical dilemma. In certain cases, treatment through a percutaneous approach following standard techniques and principles similar to those of percutaneous nephrolithotomy may be considered. However, one potential challenge, particularly among a high-risk population, is the possible necessity to stay on obligate anticoagulation for pre-existing medical reasons. To date, there have been no prior reports documenting the role of this procedure in patients on systemic anticoagulation, particularly clopidogrel. Here we report a case of a percutaneous cholecystolithotomy performed on an elderly patient unable to stop dual antiplatelet therapy (aspirin and clopidogrel) secondary to recent drug eluting stent placement for myocardial infarction.Item Incidence of Venous Thromboembolism and Hematoma Following Placement of Inflatable Penile Prosthetic: Safety of Perioperative Subcutaneous Heparin(2023-07-28) Good, Jacob; Bernie, HelenBACKGROUND/OBJECTIVE: Patients undergoing inflatable penile prosthetic (IPP) surgery are at an increased risk for cardiovascular complications such as venous thromboembolism (VTE) following surgery due to pre-existing comorbidities associated with erectile dysfunction. The use of perioperative subcutaneous heparin (SqH) along with a surgical drain has been shown to be effective in preventing VTE in IPP patients, without increasing hematoma formation. Not all prosthetic surgeons utilize surgical drains postoperatively. In this study we aim to assess the safety and efficacy of perioperative SqH in preventing VTE in IPP patients without the use of a surgical drain. METHODS: This was a retrospective review from January 2021-July 2023 of patients who underwent IPP placement or explant and replacement at a single institution. Patient demographics, comorbidities, Caprini risk factor scores, VTE risk factors, and 90-day post-operative complications, including hematoma formation, were reviewed. Statistical analyses were performed comparing these variables in men who received SqH and those who did not. RESULTS: We reviewed data for 240 patients; 53% (n=127) received perioperative SqH. The incidence of VTE was 0.9% (1/113) in the non-SqH group, and no VTE was recorded in the group receiving SqH. There was no statistical significance in hematoma formation between groups (SqH 5.5% vs. non-SqH 6.2% p=.898). Beyond hypertension prevalence (SqH 74.8% vs. non-SqH 62.8% p=.045), there was no difference between comorbidities or Caprini risk factor scores (SqH 6.79 vs. non-SqH 6.82 p=.474) between groups (Table 1). 94% of the patients in this study were considered high risk for VTE. CONCLUSIONS: Perioperative SqH use without placement of a surgical drain was found to be safe and effective in preventing VTE in patients undergoing IPP surgery. There was no increased risk of hematoma formation or post-operative complications between the groups. Perioperative SqH should be considered in all patients undergoing IPP surgery.Item Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial(American Heart Association, 2021) Kline, Jeffrey A.; Adler, David H.; Alanis, Naomi; Bledsoe, Joseph R.; Courtney, Daniel M.; d’Etienne, James P.; Diercks, Deborah B.; Garrett, John S.; Jones, Alan E.; Mackenzie, David C.; Madsen, Troy; Matuskowitz, Andrew J.; Mumma, Bryn E.; Nordenholz, Kristen E.; Pagenhardt, Justine; Runyon, Michael S.; Stubblefield, William B.; Willoughby, Christopher B.; Emergency Medicine, School of MedicineBackground: The objective was to test if low-risk emergency department patients with vitamin K antagonist (venous thromboembolism [VTE]; including venous thrombosis and pulmonary embolism [PE]) can be safely and effectively treated at home with direct acting oral (monotherapy) anticoagulation in a large-scale, real-world pragmatic effectiveness trial. Methods: This was a single-arm trial, conducted from 2016 to 2019 in accordance with the Standards for Reporting Implementation Studies guideline in 33 emergency departments in the United States. Participants had newly diagnosed VTE with low risk of death based upon either the modified Hestia criteria, or physician judgment plus the simplified PE severity index score of zero, together with nonhigh bleeding risk were eligible. Patients had to be discharged within 24 hours of triage and treated with either apixaban or rivaroxaban. Effectiveness was defined by the primary efficacy and safety outcomes, image-proven recurrent VTE and bleeding requiring hospitalization >24 hours, respectively, with an upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0% for both outcomes. Results: We enrolled 1421 patients with complete outcomes data, including 903 with venous thrombosis and 518 with PE. The recurrent VTE requiring hospitalization occurred in 14/1421 (1.0% [95% CI, 0.5%-1.7%]), and bleeding requiring hospitalization occurred in 12/1421 (0.8% [0.4%-1.5%). The rate of severe bleeding using International Society for Thrombosis and Haemostasis criteria was 2/1421 (0.1% [0%-0.5%]). No patient died, and serious adverse events occurred in 2.5% of venous thrombosis patients and 2.3% of patients with PE. Medication nonadherence was reported by patients in 8.0% (6.6%-9.5%) and was associated with a risk ratio of 6.0 (2.3-15.2) for VTE recurrence. Among all patients diagnosed with VTE in the emergency department during the period of study, 18% of venous thrombosis patients and 10% of patients with PE were enrolled. Conclusions: Monotherapy treatment of low-risk patients with venous thrombosis or PE in the emergency department setting produced a low rate of bleeding and VTE recurrence, but may be underused. Patients with venous thrombosis and PE should undergo risk-stratification before home treatment. Improved patient adherence may reduce rate of recurrent VTE.Item The Heparin-Antithrombin Product: A Novel Value for Pediatric Extracorporeal Anticoagulation(EDP Sciences, 2022) Rogerson, Colin M.; Hobson, Michael J.; Pediatrics, School of MedicineHematologic complications are a source of morbidity and mortality for patients receiving extracorporeal membrane oxygenation (ECMO) support. There is no consensus strategy for monitoring anticoagulation for children supported with ECMO. This study evaluated a novel measurement of anticoagulation for children on ECMO. This was a single-center observational study of children supported with ECMO from 2015 to 2020. Each patient’s current unfractionated heparin dose was multiplied by the current antithrombin III (AT) level to obtain a novel anticoagulation value, the heparin-antithrombin product (HAP). This value was compared with the heparin dose, AT, and activated clotting time (ACT) to predict anti-Xa value using linear correlation and decision tree methods. Data were obtained from 128 patients supported with ECMO. The HAP value was more highly correlated with anti-Xa level than heparin dose, AT level, and ACT. This correlation was highest in the neonatal population (r = .7). The variable importance metrics from the regression tree and random forest models both identified the HAP value as the most influential predictor variable for anti-Xa value. The HAP value is more highly correlated with the anti-Xa level than heparin dose, AT level, or ACT. Further research is needed to evaluate the effectiveness of the HAP value as a measurement of anticoagulation for children on ECMO.Item Usage of Direct Acting Oral Anticoagulants in Cirrhotic and Non-Cirrhotic Portal Vein Thrombosis: A Systematic Review(Cureus, 2021-08-05) Gupta, Sachin; Hidalgo, Jessica; Singh, Balraj; Iyer, Aditya; Yang, Yang; Short, Alexandra; Singh, Sandeep; Bhatt, Harshil; Gupta, Sorab; Medicine, School of MedicineThrombosis of the portal vein (PVT) is generally seen in the setting of liver cirrhosis and to a lesser extent in the absence of cirrhosis. There is no clear guidance in relation to approaching treatment with anticoagulation in this condition. The professional societies and guidelines recommend treatment with traditional anticoagulation like low-molecular-weight heparin and vitamin-K antagonists in patients presenting with acute portal vein thrombosis. There is no clarity in relation to treatment in the setting of chronic PVT and in patients with cirrhosis. Also, the role of direct-acting oral anticoagulants (DOACs) that are becoming a preferred choice for anticoagulation for various other indications is not clear in the case of PVT. There are a very few studies in the medical literature that have investigated the role of DOACs in patients with PVT in different settings. Thus, we performed a systematic review of the literature to study the use of DOACs in PVT in patients with and without cirrhosis. The results of the available studies show that DOACS appears to be a promising choice for the treatment of patients with PVT. The availability of more data in the future along with better availability of the approved reversal agents for various DOACs is expected to make DOACS a preferred choice for the clinicians to treat patients with PVT.