Impact of a Venous Thromboembolism Prophylaxis “Smart Orderset”: Improved Compliance, Fewer Events

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 172-172
Author(s):  
Amer M. Zeidan ◽  
Michael B. Streiff ◽  
Syed-Rafay Ahmed ◽  
Peggy S Kraus ◽  
Deborah Hobson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Decision Support ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Vte Prophylaxis ◽  
Patient Demographics ◽  
Medicine Service ◽  
Before And After ◽  
Pharmacologic Prophylaxis ◽  
The Impact

Abstract Abstract 172FN2 Introduction: Venous Thromboembolism affects 900,000 Americans annually. Prophylaxis reduces the risk of VTE by 60% but many patients do not receive risk-appropriate VTE prophylaxis. We developed mandatory computer decision support “smart ordersets” (i.e. electronic menus with DVT prophylaxis recommendations) to improve our institution's VTE prophylaxis performance. The ordersets require providers to respond to 2 questions that assess VTE risk factors and contraindications to pharmacologic prophylaxis. Using these answers along with known patient demographics, the orderset gives providers an evidence-based risk-appropriate VTE prophylaxis recommendation. Methods: To study the impact of Medicine service-specific orderset on compliance with the 2008 American College of Chest Physicians (ACCP) VTE prophylaxis guideline and clinical outcomes, we conducted a retrospective cohort chart review of consecutive patients admitted to the Medicine service during one month immediately prior to (November 2007) and a single month subsequent to (April 2010) orderset launch. Data collection included patient demographics, VTE risk factors, and use and type of VTE prophylaxis. Patient characteristics before and after implementation of the protocol were compared. The primary outcome measures were compliance with thromboprophylaxis guidelines in patients at risk for VTE and the 90-day VTE rate. Secondary outcomes were bleeding events and 30-day mortality. Outcomes were compared by Student's t-test and Fisher's exact test. Results: The before and after cohorts contained 1,025 and 1,057 patients, respectively. Demographic characteristics and contraindications to pharmacologic prophylaxis were similar between groups. (Table 1) Some VTE risk factors were more prevalent in the before group. (Table 1) ACCP compliant prophylaxis increased significantly from 68.3% to 85.9% (p <.0001). Provider choices for prophylaxis changed with an increase in mechanical prophylaxis and twice daily heparin in the post-orderset implementation cohort. (Table 2) Radiographically-documented symptomatic VTE by day 90 post-hospital discharge declined from 2.8% to 0.7% after orderset implementation (p=0.001). There was also a trend toward fewer in-hospital VTE (0.8% versus 0.2%, p=0.06). (Figure 1) Major bleeding remained unchanged (0.3% to 0.1%, p=0.47). Conclusion: A VTE prophylaxis computerized decision support “smart orderset” improves ACCP-compliant VTE prophylaxis and results in lower risk of symptomatic VTE without an increase in major bleeding. Disclosures: Streiff: BristolMyers Squibb: Research Funding; sanofi-aventis: Consultancy; Daiichi-Sankyo: Consultancy; Eisai: Member of study outcome adjudication committee; sanofi-aventis: Honoraria.

Impact of Postoperative Venous Thromboembolism on Postoperative Morbidity, Mortality, and Resource Utilization after Hepatectomy

2015 ◽  
Vol 81 (12) ◽  
pp. 1216-1223 ◽  
Author(s):  
Timothy E. Newhook ◽  
Damien J. Lapar ◽  
Dustin M. Walters ◽  
Shruti Gupta ◽  
Joshua S. Jolissaint ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Fold Increase ◽  
The United States ◽  
Albumin Level ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Resource Usage ◽  
Vte Prophylaxis ◽  
The Impact

The impact of venous thromboembolism (VTE) after hepatectomy on patient morbidity, mortality, and resource usage remains poorly defined. Better understanding of thromboembolic complications is needed to improve perioperative management and overall outcomes. About 3973 patients underwent hepatectomy within NSQIP between 2005 and 2008. Patient characteristics, operative features, and postoperative correlates of VTE were compared with identify risk factors for VTE and to assess its overall impact on postoperative outcomes. Overall incidence of postoperative VTE was 2.4 per cent. Risk factors for postoperative VTE included older age, male gender, compromised functional status, degree of intraoperative blood transfusion, preoperative albumin level (all P < 0.05), and extent of hepatectomy ( P = 0.004). Importantly, major postoperative complications, including acute renal failure, pneumonia, sepsis, septic shock, reintubation, prolonged ventilation, cardiac arrest, and reoperation were all associated with higher rates of VTE (all P < 0.05). Operative mortality was increased among patients with VTE (6.5% vs 2.4%, P = 0.03), and patients with VTE had a 2-fold increase in hospital length of stay (12.0 vs 6.0 days, P < 0.001). Postoperative VTE remains a significant source of morbidity, mortality, and increased resource usage after hepatectomy in the United States. Routine aggressive VTE prophylaxis measures are imperative to avoid development of VTE among patients requiring hepatectomy.

scholarly journals Enoxaparin Dosing for Venous Thromboembolism Prophylaxis in Low Body Weight Patients

2019 ◽  
Vol 12 ◽  
pp. 1179545X1986381 ◽  
Author(s):  
Daniel Dybdahl ◽  
Grant Walliser ◽  
Michelle Pershing ◽  
Christy Collins ◽  
David Robinson
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
The Elderly ◽  
Primary Objective ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Thromboembolism Prophylaxis ◽  
Vte Prophylaxis ◽  
The Impact

Background: The appropriate dose of enoxaparin for venous thromboembolism (VTE) prophylaxis in low body weight patients is unknown. Objective: The aim of this study is to evaluate the impact of enoxaparin dosing on major and minor bleeding events in low body weight patients. Methods: This was a retrospective cohort study of patients weighing less than 45 kg receiving subcutaneous (SC) enoxaparin for VTE prevention. The primary objective was to determine whether enoxaparin dose was associated with major and minor bleeding. The secondary objective was to determine the incidence of VTE by enoxaparin dose. Results: There were 173 patients included in the study, of which 37 patients received 2 different courses of enoxaparin during hospitalization, resulting in 210 enoxaparin courses. Among all enoxaparin courses, 16.2% were associated with major bleeding and 5.2% with minor bleeding. There was no difference in the incidence of major bleeding by dose (enoxaparin 30 mg SC daily, 30 mg SC twice daily, or 40 mg SC daily; P = .409). Patients who experienced major bleeding were older (54.9 ± 16.1 years) than patients who did not (48.4 ± 18.4 years) ( P = .043). There was no difference in the incidence of minor bleeding by dosing schedule ( P = .14). No patients experienced a VTE. Conclusion and Relevance: The risk of bleeding was similar by enoxaparin dose but increased with age in low body weight patients. Given the low incidence of VTE in this study, it is reasonable to consider decreasing the prophylactic enoxaparin dose in low body weight patients, especially in the elderly population.

The Impact Of a Standardized Protocol On Thromboprophylaxis, Venous Thromboembolism and Bleeding Rates In Hospitalized Patients With Hematological Malignancies

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1729-1729
Author(s):  
Erica A. Peterson ◽  
Hayley Merkeley ◽  
Elena Cavazzi ◽  
Leena Chen ◽  
Agnes Y.Y. Lee
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Left Ventricular ◽  
Hospitalized Patients ◽  
Bleeding Complications ◽  
Historical Cohort ◽  
Thrombotic Risk ◽  
Vte Prophylaxis ◽  
Standardized Protocol ◽  
The Impact

Abstract Background Venous thromboembolism (VTE) is a frequent complication in patients with underlying cancer. This risk is higher during hospitalization for acute medical conditions. Consequently, routine thromboprophylaxis is recommended in hospitalized cancer patients. A retrospective review of admissions to the Leukemia/Bone Marrow Transplant (LBMT) unit at our institution between January and June 2010 demonstrated that VTE prophylaxis was prescribed in only 6.6% of admissions. In March 2012, a mandatory VTE risk assessment and thromboprophylaxis protocol was introduced in the LBMT unit as part of a hospital-wide policy to improve thromboprophylaxis compliance for all hospitalized patients. Objectives The primary goal is to assess the impact of the VTE thromboprophylaxis protocol on the use of thromboprophylaxis in the LBMT unit. Secondary aims of this study are to evaluate the incidence of VTE (including catheter-related thrombosis [CRT]) and bleeding after the introduction of the protocol. Methods A retrospective chart review of all admissions to the Vancouver General Hospital LBMT unit between March 1, 2012 and February 28, 2013 was performed (intervention cohort [IC]). Only the first admission for each patient during the study period was included in the analysis. Data were extracted from electronic medical records using standardized forms. The primary outcome, rate of VTE prophylaxis, was compared to historical data from January 2010 to June 2010 (historical cohort [HC]). Results 361 patients were included in the IC and 166 patients were included in the HC. All baseline patient characteristics, thrombotic risk factors and bleeding risk factors were similar between the cohorts with the exception of the presence of thrombocytopenia (82.0% IC vs. 68.7% HC, p=0.001) (Table 1 ). At least one dose of thromboprophylaxis was prescribed in 14.0% of admissions in the IC vs. 6.6% of admissions in the HC. This increase was statistically significant (p=0.01). Despite the low prophylaxis prevalence, VTE was uncommon, occurring in only 1.9% patients in the IC (pulmonary embolism [PE] in 5 patients, CRT in 1 patient and left ventricular thrombus in 1 patient) vs. 2.4% patients in the HC (deep vein thrombosis +/- PE in 3 patients, CRT and PE in 1 patient) (p=0.7). In contrast, bleeding complications were frequent (even in the absence of anticoagulants), with 13.3% of patients in the IC and 19.3% of patients in the HC experiencing at least one bleeding episode (p=0.08). 22 patients (6.1%) in the IC and 8 patients (4.8%) in the HC died during the study period. While fatal bleeding events occurred in 2 patients in each cohort in the absence of anticoagulation, no deaths due to VTE were observed. Conclusions After introduction of a standardized protocol, VTE prophylaxis rate in hospitalized LBMT patients significantly increased by over 2-fold but remains low. No changes in bleeding and VTE rates were observed despite the increase in prophylaxis compliance. Although thrombocytopenia is likely the prime reason for withholding prophylaxis, further review is ongoing to elucidate the reasons why thromboprophylaxis was not prescribed in the majority of patients. Disclosures: No relevant conflicts of interest to declare.

scholarly journals A clinical decision support system for venous thromboembolism prophylaxis at a general hospital in a middle-income country

2013 ◽  
Vol 39 (2) ◽  
pp. 138-146 ◽  
Author(s):  
Fernanda Fuzinatto ◽  
Fernando Starosta de Waldemar ◽  
André Wajner ◽  
Cesar Al Alam Elias ◽  
Juliana Fernándes Fernandez ◽  
...  
Keyword(s):  
Decision Support ◽  
Venous Thromboembolism ◽  
Decision Support System ◽  
General Hospital ◽  
Clinical Decision Support ◽  
Support System ◽  
Clinical Decision Support System ◽  
Clinical Decision ◽  
Vte Prophylaxis ◽  
The Impact

OBJECTIVE: To determine the impact that implementing a combination of a computer-based clinical decision support system and a program of training seminars has on the use of appropriate prophylaxis for venous thromboembolism (VTE). METHODS: We conducted a cross-sectional study in two phases (prior to and after the implementation of the new VTE prophylaxis protocol) in order to evaluate the impact that the combined strategy had on the use of appropriate VTE prophylaxis. The study was conducted at Nossa Senhora da Conceição Hospital, a general hospital in the city of Porto Alegre, Brazil. We included clinical and surgical patients over 18 years of age who were hospitalized for ≥ 48 h. The pre-implementation and post-implementation phase samples comprised 262 and 261 patients, respectively. RESULTS: The baseline characteristics of the two samples were similar, including the distribution of patients by risk level. Comparing the pre-implementation and post-implementation periods, we found that the overall use of appropriate VTE prophylaxis increased from 46.2% to 57.9% (p = 0.01). Looking at specific patient populations, we observed that the use of appropriate VTE prophylaxis increased more dramatically among cancer patients (from 18.1% to 44.1%; p = 0.002) and among patients with three or more risk factors (from 25.0% to 42.9%; p = 0.008), two populations that benefit most from prophylaxis. CONCLUSIONS: It is possible to increase the use of appropriate VTE prophylaxis in economically constrained settings through the use of a computerized protocol adhered to by trained professionals. The underutilization of prophylaxis continues to be a major problem, indicative of the need for ongoing improvement in the quality of inpatient care.

scholarly journals Rate of Venous Thromboembolism in Obese Patients Undergoing General Surgery: A Retrospective Cohort Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4261-4261
Author(s):  
Andrea Meade ◽  
Sudeep Shivakumar ◽  
Susan Bowles ◽  
Mark Walsh ◽  
Michael MacNeil
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Epidural Catheter ◽  
Major Bleeding ◽  
General Surgery ◽  
Fixed Dose ◽  
Specific Recommendation ◽  
Obese Patients ◽  
Pharmacological Prophylaxis ◽  
Vte Prophylaxis

Abstract Background: Implementation of prophylactic drug therapy for venous thromboembolism (VTE) can greatly reduce VTE-associated morbidity and mortality in patients undergoing surgery. Obesity has been demonstrated to be an independent risk factor for fatal pulmonary embolism following surgery; however, there is currently a lack of guidance with regard to the optimal drug regimen for VTE prophylaxis in obese patients. At the QEII Health Sciences Center (QEII HSC), a district-wide pre-printed order form is used to guide risk classification and corresponding VTE prophylactic regimens for a variety of nonorthopedic surgical populations. In the absence of a contraindication, such as heparin-induced thrombocytopenia, dalteparin is the drug of choice for the majority of patients. A standard fixed dose of dalteparin 5000 units given subcutaneously is employed for most patients except for those patients weighing less than 40 kg or over the age of 80, in which a lower fixed dose of 2500 units is recommended. There is no specific recommendation for obese patients with regard to dosing. Objectives: To determine the rate of objectively confirmed VTE during admission or up to six weeks post-discharge in obese patients (Body Mass Index (BMI) ≥ 35 kg/m2), compared to non-obese patients, that undergo general surgery at the QEII HSC. Risk factors associated with the development of VTE and practice patterns with regard to implementation of pharmacologic VTE prophylaxis were also evaluated. Methods:A retrospective chart review of 378 patients,18 years or older, who underwent general surgery (colorectal, surgical oncology, or hepatobiliary) from January 1, 2010 to December 31, 2013 was performed. Patient and procedure-related data was collected and analyzed using summary statistics and multivariate logistic regression. Results: The rate of VTE was not significantly different when comparing obese and non-obese patients (3.3% vs. 2.5%; p = NS). There were no risk factors identified to be significantly associated with VTE in patients undergoing general surgery. Although not included as an endpoint in our research objectives, data collected with regard to bleeding revealed a significant difference between obese and non-obese patients in the rate of major bleeding events (2.8% vs 7.6%; p=0.03). Being non-obese (OR 2.87, 95% CI 1.021 - 8.06; p=0.0456), having a higher dose per total body weight (OR 1.02, 95% CI 1.01 - 1.04; p=0.0346) and per BMI (OR 1.07, 95% CI 1.01 - 1.14; p=0.0330), having cancer (OR 2.65, 95% CI 1.07 - 6.58; p=0.0355), failure to ambulate early after surgery (OR 21.25, 95% CI 2.81 - 160.40; p=0.0030), and having a central venous catheter (OR 4.97, 95% CI 1.65 - 14.96); p=0.0043) and/or epidural catheter in place (OR 4.21, 95% CI 1.29 - 13.78; p=0.0174) increased the risk of a major bleeding event. Ninety-nine percent (374/378) of patients received some form of pharmacological prophylaxis. Of the 374 who received prophylactic therapy, 6 patients received pre-operative prophylaxis only and 368 patients received post-operative prophylaxis. Of the patients that received post-operative prophylaxis, 217 (59%) patients received dalteparin and 145 (39%) patients received unfractionated heparin (UFH), while the remaining 6 (2%) patients had a switch from one agent to the other. Of the 145 patients that received UFH, 24 patients (17%) had a recommended indication for its use as they required an epidural catheter while the remaining 121 (83%) did not. Conclusions: The rate of VTE in patients undergoing general surgery is low and obese patients (BMI ≥ 35 kg/m2) appear to be adequately protected against VTE. There is no need to alter our current VTE prophylaxis dosing strategy; however, in order to maintain a low rate of VTE, continued compliance with the implementation of pharmacological prophylaxis as well as assessment of VTE risk on a case by case basis is recommended. We likely failed to see an association of risk factors with the outcome of VTE as we had a low event rate and would have required a larger sample size to find significance. The rate of bleeding, although significantly different between groups, appears to be consistent with the rate reported in the literature. The percentage of patients receiving UFH outside of the recommended indications was fairly high and therefore further education is needed to ensure selection of the most appropriate pharmacologic agent. Disclosures No relevant conflicts of interest to declare.

scholarly journals Contemporary approach to primary prophylaxis of venous thromboembolism regarding the impact of risk factors on anticoagulation therapy duration

2014 ◽  
Vol 142 (3-4) ◽  
pp. 249-256
Author(s):  
Nebojsa Antonijevic ◽  
Ljubica Jovanovic ◽  
Valentina Djordjevic ◽  
Ivana Zivkovic ◽  
Miodrag Vukcevic ◽  
...  
Keyword(s):  
Risk Factors ◽  
Heart Failure ◽  
Venous Thromboembolism ◽  
Anticoagulation Therapy ◽  
Chronic Obstructive ◽  
Medical Illness ◽  
Medical Patients ◽  
Class Iii ◽  
Vte Prophylaxis ◽  
The Impact

Adequate thromboprophylaxis primarily requires timely detection of reversible and irreversible risk factors of venous thromboembolism (VTE) and their categorization. It is important to note that the highest percentage of VTE episodes occur in non-surgical (medical) patients and that VTE develops in a large number of surgical patients upon hospital discharge; this emphasizes the need for adequate VTE prevention in inflammatory diseases, acute medical illness and other medical diseases as well as for prolonging and optimizing the anticoagulant regimen after surgical intervention in the primary VTE prophylaxis. As almost completely unrecognized and neglected major risk factors of VTE in clinical practice, we particularly point out the chronic obstructive pulmonary disease (COPD) and heart failure, especially in NYHA functional class III and IV patients with significantly reduced left heart ventricle. It is necessary to raise clinicians? awareness of a potential danger from wrongly and one-sidedly interpreted dyspnea and coughing signs in patients with COPD as typical symptoms of basic respiratory disease as well as from ascribing the signs of disease aggravation in heart failure patients exclusively to cardial status worsening, neglecting the possibility of having unrecognized and untreated pulmonary embolism at issue. Contemporary way of life enhances the development of new VTE risk factors such as traveler?s thrombosis, in particular during long-haul flights as well as in individuals sitting at a computer for prolonged periods (e-thrombosis). Determining and recognizing VTE risk factors, especially those formerly neglected nonsurgical ones and simultaneous presence of multiple risk factors within a given period is required for defining an adequate anticoagulant regimen in primary VTE prophylaxis for surgical and non-surgical (medical) patients.

Influence of Perceived Risk Factors for Bleeding on Venous Thromboembolism Prophylaxis Practices in Acutely Ill Medical Patients: Findings from IMPROVE.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 917-917
Author(s):  
Manuel Monreal ◽  
Rainer B. Zotz ◽  
Hervé Decousus ◽  
Beng H. Chong ◽  
Geno Merli ◽  
...  
Keyword(s):  
Risk Factors ◽  
Platelet Count ◽  
Venous Thromboembolism ◽  
Hepatic Failure ◽  
Perceived Risk ◽  
Medical Illness ◽  
Cumulative Number ◽  
Medical Patients ◽  
Vte Prophylaxis ◽  
Pharmacologic Prophylaxis

Abstract Background Acutely ill medical patients at risk for venous thromboembolism (VTE) should receive VTE prophylaxis. However, factors perceived by physicians to increase patients’ risk of bleeding may influence VTE prophylaxis practices. In this analysis from The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE), we examined whether perceived risk factors for bleeding had a significant influence on physicians’ prescribing of in-hospital prophylaxis in acutely ill medical patients. Methods Patients aged ≥18 years and hospitalized ≥3 days with an acute medical illness have been enrolled consecutively since July 2002. Risk factors considered were: severe renal failure, known bleeding disorder, hemorrhagic stroke, thrombocytopenia, bacterial endocarditis, active gastroduodenal ulcer, NSAID use, hepatic failure, age, immobility and alcoholism. Factors associated with different prescription rates of prophylaxis compared with rates in patients without these factors were identified and included in a multiple logistic regression model (significance at p&lt;0.05). Results Up to 31 March 2005, 6946 patients were enrolled in 49 hospitals in 12 countries. Pharmacologic prophylaxis was received by 42%, 25%, 16%, and 14% of patients with a platelet count at admission &gt;100, 50–100, 20–50 and &lt;20x109/L, respectively (p&lt;0.0001), and 43%, 39%, 30% and 32% of patients with none, 1, 2 and 3 risk factors for bleeding (p&lt;0.0001). Factors independently associated with a lower/higher prescription rate of heparin-based prophylaxis compared with the risk in patients without these factors are shown in the Table. Conclusions The likelihood that hospitalized acutely ill medical patients receive in-hospital pharmacologic prophylaxis decreases as their platelet count at admission decreases, or their cumulative number of perceived risk factors for bleeding increases. Further studies are needed to determine whether the changes in prophylaxis practices observed in this study are justified. Table. Factors Independently Associated with a Higher/lower Rate of Heparin-based VTE Prophylaxis Factor Odds Ratio 95% Confidence Interval Age (per 10-year increase) 1.19 1.66–1.22 Immobility (per 10-day increase) 1.03 1.02–1.05 Alcoholism 0.62 0.46–0.83 Thrombocytopenia 0.60 0.48–0.74 Active duodenal ulcer 0.36 0.26–0.52 Hepatic failure 0.34 0.21–0.54

scholarly journals Incidence, Management and Outcomes of Arterial and Venous Thromboembolism after Chimeric Antigen Receptor Modified T Cells for B-Cell Lymphoma and Multiple Myeloma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 7-7
Author(s):  
Anna L. Parks ◽  
Swetha Kambhampati ◽  
Bita Fakhri ◽  
Charalambos Andreadis ◽  
Lissa Gray ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multiple Myeloma ◽  
T Cells ◽  
Venous Thromboembolism ◽  
B Cell ◽  
Research Funding ◽  
Vte Prophylaxis ◽  
Therapeutic Anticoagulation ◽  
Car T ◽  
History Of

Introduction: Chimeric antigen receptor modified T Cell (CAR-T) therapy is a rapidly developing treatment for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). Although this population is at high risk for thrombosis, there are few data about rates of venous thromboembolism (VTE) and arterial thromboembolism (ATE) with CAR-T. Additionally, treatment with anticoagulation is complicated because of the prevalence of thrombocytopenia following CAR-T. Our goal was to determine the incidence, associated risk factors, management and outcomes of VTE and ATE in the 60 days following CAR-T therapy. Methods: We performed a single-center, retrospective cohort study of all patients who received inpatient CAR-T cells at UCSF Medical Center between January 2018 and May 2020 for R/R NHL or MM as standard-of-care or on a clinical trial. The outcomes of incident VTE and ATE were identified by ICD-10 codes and medical record review. Patient characteristics, pre-existing thrombosis risk factors, laboratory results, medications, and major or clinically relevant non-major bleeding or recurrent thrombotic complications were obtained through chart review. We used descriptive statistics to delineate risk factors, incidence, management and outcomes of thrombotic events. Results: Ninety-one patients who underwent CAR-T therapy were included in the analysis, 37 with NHL and 54 with MM. For NHL, mean age was 63 (range 38-82), and 41% were women. For MM, mean age was 62 (range 33-77), and 50% were women. Patients with NHL were treated with either investigational or Federal Drug Administration-approved CD19-directed therapies, and patients with MM were treated with a variety of investigational B-cell maturation antigen-directed (BCMA) therapies. For thrombotic risk factors, 13% of patients with NHL had a history of VTE, 3% had a history of ATE, 27% had a BMI ≥30, 59% had a recent procedure including central venous catheter (CVC) placement, 14% had an intensive care unit (ICU) stay, and 22% had an infectious complication in the 30 days pre- or post-CAR-T. Forty-one percent of patients with NHL had neurotoxicity of any grade, and 59% had CRS of any grade. At 30 days, 57% had a complete response, 41% had a partial response, 3% had stable disease. For MM, 6% of patients had a pre-existing history of VTE, 2% had a history of ATE, 19% had a BMI ≥30, 96% had a recent procedure, 11% had an ICU stay and 19% had an infection. Seventeen percent had neurotoxicity, and 85% had CRS. Thirty-two percent of patients with NHL and 48% with MM received pharmacologic VTE prophylaxis while undergoing CAR-T. For those who did not receive VTE prophylaxis, thrombocytopenia was the reason for holding prophylaxis, which occurred in 51% and 50% of NHL and MM patients, respectively. In the 60 days post-CAR-T, 4 (11%) patients with NHL were diagnosed with VTE-3 pulmonary embolism (PE) and 1 lower extremity deep vein thrombosis (DVT) associated with a previously placed inferior vena cava filter. Four (7%) patients with MM were diagnosed with VTE-1 PE and 3 upper extremity DVTs associated with CVCs. Five out of these 8 (63%) patients had symptomatic VTE, while the remainder were incidental on PETCT. Mean time from CAR-T infusion to VTE diagnosis was 20 days (range 6-39 days). There were no documented ATEs. Six out of 8 (75%) were treated with therapeutic anticoagulation. Of those who were anticoagulated, 4 patients received direct oral anticoagulants and 2 received low-molecular-weight-heparin. Duration was 3 months in 3 patients, 11 days in 1, 150 days in 1, and indefinitely in 1 with atrial fibrillation. Among all 8 patients with VTE, there were no bleeding events or recurrent thromboses regardless of whether or not they received anticoagulation. Discussion: In this cohort of patients with R/R NHL or MM who received either CD19- or BCMA-directed therapies, almost 1 in 10 developed VTE in the 60 days post-CAR-T. This occurred in the context of a high prevalence of risk factors for thrombosis and low rates of pharmacologic prophylaxis. Among those who developed VTE, the majority were treated with therapeutic anticoagulation for at least 3 months, without documented bleeding or recurrent VTE. Our findings provide crucial information on a common complication that can inform patients, clinicians and researchers and should be expanded upon in larger, prospective studies to identify optimal preventive and therapeutic strategies. Disclosures Fakhri: University of California San Francisco: Current Employment. Andreadis:Jazz Pharmaceuticals: Honoraria; Karyopharm: Honoraria; Incyte: Consultancy; Merck: Research Funding; Gilead/Kite: Consultancy; Novartis: Research Funding; BMS/Celgene/Juno: Honoraria, Research Funding; Genentech: Consultancy, Current equity holder in publicly-traded company. Wong:Janssen: Research Funding; Amgen: Consultancy; Roche: Research Funding; Fortis: Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Research Funding; GSK: Research Funding. Shah:BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar: Research Funding; GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm: Consultancy.

Societal costs of venous thromboembolism and subsequent major bleeding events: a national register-based study

2019 ◽  
Vol 6 (2) ◽  
pp. 130-137
Author(s):  
Nina Gustafsson ◽  
Peter Bo Poulsen ◽  
Sandra Elkjær Stallknecht ◽  
Lars Dybro ◽  
Søren Paaske Johnsen
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Home Care Services ◽  
Care Hospital ◽  
Bleeding Events ◽  
Societal Costs ◽  
Vein Thrombosis ◽  
Primary Care Hospital ◽  
Major Bleeding Events ◽  
The Impact

Abstract Aims Detailed evidence on the societal costs of venous thromboembolism (VTE), i.e. deep vein thrombosis (DVT) and pulmonary embolism (PE), and of subsequent major bleeding events, e.g. intracranial and gastrointestinal bleedings, is limited. The objective was to estimate the average 3-year societal event costs attributable to VTE and subsequent major bleedings in Denmark. Methods and results Based on nationwide Danish registers, each incident patient diagnosed with VTE in the period from 2004 to 2016 was identified and matched with four non-VTE patients by nearest-neighbour propensity score matching. For bleeding patients, the reference cohort was VTE patients without bleedings. Event costs in terms of VTE, DVT, PE, and major bleedings in VTE patients were measured by the ‘difference-in-actual-cost’ method within 3 years after the incidence. Societal costs included healthcare costs (primary care, hospital, and prescription medicine), municipality home care services, and production loss. The study population included 74 137 VTE incident patients (DVT: 43 099; PE: 31 038), and 4887 VTE patients with a major bleeding within 3 years from VTE diagnosis. The 3-year attributable societal VTE event costs were 40 024 EUR (DVT: 34 509 EUR; PE: 50 083 EUR) with 53% of these costs appearing in the first incident year. Similar results for major bleedings were 51 168 EUR with 46% of these costs appearing in the first incident year. Conclusion The societal costs of VTE and subsequent major bleedings are substantial and ought to be considered. Estimated costs of events may be informative in evaluating the impact of preventive interventions targeting VTE and subsequent major bleedings.

scholarly journals Pharmacologic thromboprophylaxis in adult patients undergoing neurosurgical interventions for preventing venous thromboembolism

2020 ◽  
Vol 4 (12) ◽  
pp. 2798-2809
Author(s):  
Juan José Yepes-Nuñez ◽  
Anita Rajasekhar ◽  
Maryam Rahman ◽  
Philipp Dahm ◽  
David R. Anderson ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Neurosurgical Procedures ◽  
Assessment Development ◽  
Vein Thrombosis ◽  
Surrogate Outcomes ◽  
Symptomatic Pulmonary Embolism ◽  
Neurosurgical Patients ◽  
Pharmacologic Prophylaxis ◽  
Pharmacologic Thromboprophylaxis ◽  
The Impact

Abstract The impact of pharmacologic prophylaxis for venous thromboembolism in patients undergoing neurosurgical intervention remains uncertain. We reviewed the efficacy and safety of pharmacologic compared with nonpharmacologic thromboprophylaxis in neurosurgical patients. Three databases were searched through April 2018, including those for randomized controlled trials (RCTs) and for nonrandomized controlled studies (NRSs). Independent reviewers assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Seven RCTs and 3 NRSs proved eligible. No studies reported on symptomatic proximal and distal deep vein thrombosis (DVT). Two RCTs reported on screening-detected proximal and distal DVTs. We used the findings of these 2 RCTs as the closest surrogate outcomes to inform the proximal and distal DVT outcomes. These 2 RCTs suggest that pharmacologic thromboprophylaxis may decrease the risk of developing asymptomatic proximal DVT (relative risk [RR], 0.50; 95% confidence interval [CI], 0.30-0.84; low certainty). Findings were uncertain for mortality (RR, 1.27; 95% CI, 0.57-2.86; low certainty), symptomatic pulmonary embolism (PE) (RR, 0.84; 95% CI, 0.03-27.42; very low certainty), asymptomatic distal DVT (RR, 0.54; 95% CI, 0.27-1.08; very low certainty), and reoperation (RR, 0.43; 95% CI, 0.06-2.84; very low certainty) outcomes. NRSs also reported uncertain findings for whether pharmacologic prophylaxis affects mortality (RR, 0.72; 95% CI, 0.46-1.13; low certainty) and PE (RR, 0.18; 95% CI, 0.01-3.76). For risk of bleeding, findings were uncertain in both RCTs (RR, 1.57; 95% CI, 0.70-3.50; low certainty) and NRSs (RR, 1.45; 95% CI, 0.30-7.12; very low certainty). In patients undergoing neurosurgical procedures, low certainty of evidence suggests that pharmacologic thromboprophylaxis confers benefit for preventing asymptomatic (screening-detected) proximal DVT with very low certainty regarding its impact on patient-important outcomes.

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