Symptomatic Venous Thromboembolic Events Research Articles

Safety and Efficacy of Extended Duration of Thromboembolic Prophylaxis Following Radical Cystectomy: An Initial Institutional Experience

IntroductionWe evaluated the safety and efficacy of extended duration of pharmacological prophylaxis for preventing symptomatic venous thromboembolism following radical cystectomy. MethodsWe recorded symptomatic venous thromboembolism and lymphocele events within 30 days of radical cystectomy among patients treated with extended duration of pharmacological prophylaxis (enoxaparin 40 mg subcutaneously daily for 30 days). We compared these outcomes to those in the cohort of patients who underwent radical cystectomy at our institution in the year prior to extended prophylaxis implementation. Unadjusted descriptive statistics and univariate analyses were performed using the Pearson test or the Fisher chi-square test for categorical variables and the Wilcoxon rank sum test for continuous variables. ResultsWe analyzed the records of 52 patients who did and 82 who did not receive extended duration of pharmacological prophylaxis after radical cystectomy. Only 1 patient (1.9%) discharged home on extended prophylaxis was diagnosed with venous thromboembolism within 30 days of RC compared to 5 (6.1%) who had not received extended prophylaxis. In 3 patients symptomatic lymphocele developed within 30 days of radical cystectomy, including 1 (1.9%) who had received extended prophylaxis and 2 (2.4%) who had not. No patient in either cohort was rehospitalized for bleeding complications. ConclusionsOur initial experience suggests that extended duration of pharmacological prophylaxis is associated with a lower rate of venous thromboembolism following radical cystectomy and it does not increase the risk of bleeding or symptomatic lymphocele. These data warrant validation in larger patient cohorts, ideally in the prospective clinical trial setting.

A Prospective Cohort Study of Symptomatic Venous Thromboembolic Events in Foot and Ankle Trauma

Category: Trauma Introduction/Purpose: The incidence of Venous Thromboembolism (VTE) and the balance of risks and benefits associated with chemical thromboprophylaxis in foot and ankle trauma are controversial, and much less investigated than in hip and knee surgery. A recent systematic review showed a low VTE rate in foot and ankle surgery (0-0.55%), but with an increased incidence in foot and ankle trauma, the highest in TA rupture and surgery. This study compares the 90-day VTE rates of 3 cohorts of patients: Group 1: TA ruptures managed in a full weight bearing (FWB), functional, Vacoped™ protocol over an 8 week period; Group 2: Stable ankle fractures managed in NWB below knee casts for 6 weeks; Group 3: Unstable or displaced ankle fractures managed with surgery and NWB below knee casts for 6 weeks. Methods: The data was extracted from two prospectively collected databases, one for the acute TA ruptures between March 2010 and December 2014, and one for ankle fractures from October 2013 to April 2014. These datasets were cross validated with the hospital VTE database. All patients were risk assessed at the time of presentation to the hospital. Selective chemical thromboprophylaxis was prescribed for patients with the previous history of VTE and patients who were deemed high-risk on VTE assessment. 90-day incidence of symptomatic VTE was drawn from the hospital radiology database. Results: Group 1: Overall VTE rate of 4.9% at a mean of 16.1 days. 3 Pulmonary Embolism (PE) and 11 Deep Vein Thrombosis (DVT). Total number of 283 patients. Group 2: Overall VTE rate of 2.2% at a mean of 33.4 days. 5 DVT. Total number of 227 patients Group 3: Overall VTE rate of 3.0% at a mean of 37.2 days. 1 PE and 5 DVT. Total number of 199 patients. Symptomatic VTE presents significantly earlier in acute TA rupture than ankle fracture patients (p=0.002) Conclusion: Although the overall incidence of VTE in foot and ankle trauma is low., there is a relatively higher incidence of VTE in patients with acute TA ruptures. This is, in spite of recent early weight bearing regimens. This study also shows that occurrence of symptomatic VTE in patients with Acute TA rupture happens much sooner compared to the ankle fracture patients. Although the exact reason for this difference in time of presentation of VTE is unknown, it may be due to de-functioning of the calf muscle pump immediately after the acute TA rupture.

Incidence and Risk Factors Related to Symptomatic Venous Thromboembolic Events After Esophagectomy for Cancer

Major oncologic surgery is associated with a high incidence of venous thromboembolic events (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE). However, the incidence and risk factors for symptomatic VTE during curative treatment for patients with esophageal cancer are poorly documented. Data were collected from 30 European centers from 2000 to 2010. The incidence of in-hospital VTE was assessed in 2,944 patients with esophageal cancer having surgery with curative intent, and 50 clinically relevant parameters were assessed as potential risk factors for VTE. Patients received low molecular weight heparin prophylaxis during hospital stay and for 4 weeks after surgery. Eighty-four patients (2.9%) developed a symptomatic VTE; all of them had a DVT and 44 were also diagnosed with a PE. In the VTE group there were 19postoperative deaths recorded, 5 of which (26.3%) weredirectly caused by PE at postoperative days 7, 10, 21, 45, and 48 despite VTE prophylaxis. In-hospital postoperative mortality was significantly higher in VTE patients (23% versus 7%, p < 0.001) and mean hospital stay was also longer in this group (33 ± 24 versus 25 ± 21 days, p < 0.001). Multivariable analysis showed that highAmerican Society of Anesthesiologists (ASA) class (p= 0.008), pneumopathy (p= 0.002), or an acute respiratory distress syndrome (ARDS) (p= 0.015) were significantly associated with VTE. Patients with ASA class III or IV and those who present a postoperative pneumopathy or ARDS seem to be at higher risk for VTE. Thus, current VTE screening and thromboprophylaxis for these patients might be inadequate and needs further investigation.

Prevalence of Symptomatic and Asymptomatic Thrombosis in Pediatric Oncology Patients With Tunneled Central Venous Catheters.

Pediatric oncology patients with tunneled central venous catheters (CVCs) are at increased risk to develop venous thromboembolic events (VTEs), but the true prevalence of (a)symptomatic VTE is unknown. Aim of this study was to evaluate the prevalence of (a)symptomatic VTE in pediatric oncology patients with tunneled CVCs. All patients were included in the Aristocaths study: a randomized controlled multicenter trial investigating the prophylactic effect of 70% ethanol locks on CVC-associated bloodstream infections (CABSIs) were eligible for this study. We assessed the following outcomes: (i) symptomatic VTE and (ii) asymptomatic CVC-related VTE (using ultrasound [US]). Follow-up was 6 months, unless patients developed one of the following events: VTE, CABSI, CVC removal, or death. We included 305 patients (hematologic malignancy, n = 148; solid tumor, n = 157), median age 9 years (range, 1-18 years). Symptomatic VTE was detected in 8 of 305 patients (2.6%; 95% confidence interval [CI]: 1.1-5.1%), which was related to the CVC in three patients. Patients (185/305) were evaluated with US: 11 of 185 (5.9%; 95% CI: 3.0-10.4%) patients had asymptomatic CVC-related VTE. Prevalence of both symptomatic VTE and asymptomatic CVC-related VTE was low compared to other studies, which may be explained by the inclusion of patients with solid tumors, reduction of CABSI by ethanol, use of tunneled CVCs, and use of US.

Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting.

BackgroundThromboprophylaxis is recommended for patients undergoing total hip or total knee replacement (THR, TKR). An international, open-label, prospective, observational, single-arm study in a routine clinical setting was performed to assess the safety and efficacy of dabigatran etexilate 220 mg once daily in patients undergoing THR or TKR, and in subgroups of patients with potentially increased risk of bleeding or venous thromboembolism (VTE).Materials and methodsPatients were ≥18 years and required to be eligible to receive dabigatran 220 mg once daily (first dose 110 mg 1–4 h after THR/TKR surgery) according to the European Summary of Product Characteristics. The primary safety and efficacy outcomes were incidence of major bleeding events (MBEs), and the composite incidence of symptomatic VTE events and all-cause mortality, respectively.ResultsIn total, 5292 patients (median age 64 years) were enrolled and received dabigatran (2734 THR and 2558 TKR). Median drug exposure was 31 days (THR 34 days; TKR 27 days). Overall incidence of MBEs was 0.72 % (95 % confidence interval [CI] 0.51, 0.98), and this rate was comparable between types of surgery and was not significantly affected by protocol-defined risk factors. The overall incidence of symptomatic VTE and all-cause mortality was 1.04 % (95 % CI 0.78, 1.35); the only significant risk factor was history of VTE events (odds ratio 5.59; 95 % CI 2.53, 11.08). A post-hoc analysis showed that the incidence of MBEs in this observational study was similar to or lower than those reported in previous phase 3 trials.ConclusionsResults from this observational study of dabigatran etexilate administered to patients undergoing THR or TKR surgery are reassuring and supportive of those obtained in dabigatran phase 3 trials.Trial registrationClinicalTrials.gov identifier: NCT00846807.Electronic supplementary materialThe online version of this article (doi:10.1186/s12959-016-0082-4) contains supplementary material, which is available to authorized users.

Aspirin Can Be Used as Prophylaxis for Prevention of Venous Thromboembolism After Revision Hip and Knee Arthroplasty

BackgroundThe optimal prophylaxis for prevention of venous thromboembolic events (VTEs) after revision total joint arthroplasty (TJA) remains unknown. The objective of this study was to evaluate whether aspirin, known to be effective for prevention of VTEs after primary arthroplasty, is also effective after revision TJA. MethodsWe studied 2997 consecutive patients who underwent revision TJA between 2005 and 2013 and were treated with intermittent pneumatic compression devices and either aspirin (534 patients) or warfarin (2463 patients) for VTE prophylaxis. Pertinent data including the incidence of symptomatic VTEs, bleeding events, infection, and mortality were retrieved from our prospectively collected database. ResultsThe incidence of symptomatic VTEs was significantly higher in the warfarin group at 1.75% (43 of 2463) compared with 0.56% (3 of 534) in the aspirin group (odds ratio: 3.2; 95% CI: 1.03-16.3; P = .03). There was a higher rate of bleeding events with administration of warfarin (1.5%) compared with aspirin (0.4%; P = .02; odds ratio: 4.1; 95% CI: 1.2-34.0). The rate of surgical site infection was similar between the aspirin group and the warfarin group (1.61% and 1.70%, respectively). ConclusionAdministration of aspirin as prophylaxis against VTEs after revision arthroplasty may be a viable option as it appears to be more effective than warfarin in prevention of symptomatic VTEs and is associated with a lower rate of complications.

The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications.

Hospital-associated venous thromboembolism (VTE) is a leading cause of premature death and disability worldwide. Evidence-based guidelines recommend that anticoagulant thromboprophylaxis be given to hospitalised medical patients at risk of VTE, but suggest against routine use of thromboprophylaxis beyond the hospital stay. The MARINER study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of thromboprophylaxis using rivaroxaban, begun at hospital discharge and continued for 45 days, for preventing symptomatic VTE in high-risk medical patients. Eligible patients are identified using the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE VTE) risk score, combined with a laboratory test, D-dimer. The rivaroxaban regimen is 10 mg once daily for patients with CrCl ≥ 50 ml/min, or 7.5 mg once daily for patients with CrCl ≥ 30 ml/min and < 50 ml/min. The primary efficacy outcome is the composite of symptomatic VTE (lower extremity deep-vein thrombosis and non-fatal pulmonary embolism) and VTE-related death. The principal safety outcome is major bleeding. A blinded clinical events committee adjudicates all suspected outcome events. The sample size is event-driven with an estimated total of 8,000 patients to acquire 161 primary outcome events. Study design features that distinguish MARINER from previous and ongoing thromboprophylaxis trials in medically ill patients are: (i) use of a validated risk assessment model (IMPROVE VTE) and D-dimer determination for identifying eligible patients at high risk of VTE, (ii) randomisation at the time of hospital discharge, (iii) a 45-day treatment period and (iv) restriction of the primary efficacy outcome to symptomatic VTE events.

Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial

Venous thromboembolism (VTE) is the leading cause of mortality and morbidity in women following gynecologic surgery. To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery. We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1:1 ratio into parallel groups to receive either seven daily doses of 3500IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7days and 30days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE. In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI]0.002-0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR]7.1; 95%CI1.3-36.2), varicose veins (OR16.8; 95%CI3.1-76.2), and thrombophilia (OR39.3; 95%CI1.5-1006.7). There were no major bleeding events or side effects related to the use of bemiparin. Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery.

Tranexamic Acid in Hip and Knee Arthroplasty.

Perioperative blood loss is a significant concern for patients undergoing total joint arthroplasty. A growing body of evidence has shown tranexamic acid (TXA) to be effective in decreasing perioperative blood loss and transfusion requirements in both primary and revision hip and knee arthroplasty. TXA is a synthetic drug that limits blood loss through inhibition of fibrinolysis and clot degradation. Both topical and intravenous administration of TXA, in a variety of dosing regimens, has proven effective. Further investigation is required to determine the optimal dose and dosing regimens; however, evidence exists to recommend an initial intravenous dose be given before beginning the procedure, with at least one additional intravenous dose administered postoperatively. Additionally, topical TXA doses >2 g appear to be more efficacious than lower doses. Finally, relatively few adverse reactions have been reported in arthroplasty patients, and no study to date has demonstrated an increased risk of symptomatic venous thromboembolic events in this patient population.

Safety and efficacy of switching from low molecular weight heparin to dabigatran in patients undergoing elective total hip or knee replacement surgery.

BackgroundThe aim of this study was to assess the safety and efficacy of switching therapy from low molecular weight heparin (LMWH; enoxaparin) to dabigatran for prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip or knee replacement surgery (THR/TKR).MethodsThis was a prospective, multicenter, open-label, single-arm, observational, study in patients undergoing THR or TKR who were to receive enoxaparin 40 mg for thromboprophylaxis. Enoxaparin was initiated before or after surgery according to local practice, and was switched to dabigatran 220 mg once daily at a time point chosen by the investigator. The coprimary endpoints were major bleeding events, and the composite of symptomatic VTE and all-cause mortality, from last use of enoxaparin to 24 h after last intake of dabigatran.ResultsAltogether, 168 (81 THR, 87 TKR) patients were enrolled, of whom 161 received both enoxaparin and dabigatran, 2 received dabigatran only and 5 received enoxaparin only. The median time of the first dabigatran tablet was 24.0 h after the last LMWH dosage and the median number of days on dabigatran treatment was 36 days. No symptomatic VTE or death occurred during the study. One major bleeding event was seen at the surgical site and required treatment cessation. Three minor bleeding events were observed.ConclusionsIn the normal clinical setting, switching from LMWH to dabigatran in patients who had undergone THR and TKR was safe and effective in preventing VTE. The reported adverse events and serious adverse events were consistent with the known safety profile for dabigatran. Switching from a subcutaneous to an oral anticoagulant may offer greater convenience in the outpatient setting after discharge.Trial registrationClinicalTrials.gov identifier NCT01153698.

Tranexamic Acid in Hip and Knee Arthroplasty.

Perioperative blood loss is a significant concern for patients undergoing total joint arthroplasty. A growing body of evidence has shown tranexamic acid (TXA) to be effective in decreasing perioperative blood loss and transfusion requirements in both primary and revision hip and knee arthroplasty. TXA is a synthetic drug that limits blood loss through inhibition of fibrinolysis and clot degradation. Both topical and intravenous administration of TXA, in a variety of dosing regimens, has proven effective. Further investigation is required to determine the optimal dose and dosing regimens; however, evidence exists to recommend an initial intravenous dose be given before beginning the procedure, with at least one additional intravenous dose administered postoperatively. Additionally, topical TXA doses >2 g appear to be more efficacious than lower doses. Finally, relatively few adverse reactions have been reported in arthroplasty patients, and no study to date has demonstrated an increased risk of symptomatic venous thromboembolic events in this patient population.

Rivaroxaban for Venous Thromboembolism Prophylaxis in Abdominoplasty: A Multicenter Experience

Abdominoplasty, a commonly performed aesthetic procedure, is considered to have an increased risk of venous thromboembolism (VTE) events. At present, routine VTE chemoprophylaxis following abdominoplasty remains controversial. This study evaluates the authors' experience with rivaroxaban, an oral Factor Xa inhibitor, for VTE prophylaxis in abdominoplasty patients. A retrospective case series was conducted. All patients who underwent abdominoplasty and received rivaroxaban were included. The prophylactic dose was 10 mg daily for 7 days, beginning 12 hours postoperatively. Patient demographics, comorbidities, and type of surgery were recorded. The primary outcome measured was hematologic complication, including VTE, hematoma requiring operative evacuation, and need for blood transfusion. From September 2012 until July 2014, 132 patients (122 women and 10 men) underwent abdominoplasty surgery and received rivaroxaban postoperatively. Mean patient age was 43.7 years, and mean body mass index was 27.1. One hundred twenty-five patients also underwent abdominal muscle plication. Eleven patients underwent a fleur de lis vertical skin resection component. One hundred patients underwent concomitant abdominal liposuction, while 79 patients also had back liposuction. Only 1 patient had a symptomatic VTE event. Three patients had a hematoma requiring operative evacuation, and all went on to heal without sequelae. Two patients received a blood transfusion for anemia during their course of rivaroxaban. Oral rivaroxaban administration for chemoprophylaxis in abdominoplasty patients is safe, with low rates of symptomatic VTE and hematoma formation. The authors continue routine use of the medication for patients at increased risk for VTE events. LEVEL OF EVIDENCE 4: Risk.

Incidence and Risk Factor Analysis of Symptomatic Venous Thromboembolism After Knee Arthroscopy

To (1) determine the incidence of symptomatic venous thromboembolic events (VTEs) after knee arthroscopy and arthroscopy-assisted procedures at a single institution and (2) determine associated risk factors for VTEs in these patients. The records of patients who underwent knee arthroscopy at a single institution between 1988 and 2008 were reviewed. Chemoprophylaxis was not routinely used. Confirmed VTEs occurring within 4 weeks after the index arthroscopy procedure were included. A 2:1 matched control group was generated to include patients in whom knee arthroscopy was performed by the same surgeon either on the same day or immediately before each case resulting in a VTE. Preoperative and perioperative data were collected with respect to demographic data, medical history, medications, and surgical and anesthesia data. Univariate and multivariate analyses were performed. During the study period, 12,595 patients underwent knee arthroscopy. Among these patients, 43 cases of VTEs (35 deep venous thromboses [DVTs], 5 pulmonary embolisms [PEs], and 3 DVTs that progressed to PEs) occurred, resulting in an incidence of 0.30% (95% confidence interval [CI], 0.22% to 0.41%) for DVT, 0.06% (95% CI, 0.03% to 0.12%) for PE, and 0.34% (95% CI, 0.25% to 0.46%) for VTEs overall. Factors associated with an elevated risk of symptomatic postoperative VTEs included a history of malignancy (P= .01; odds ratio [OR], 6.3), a history of VTEs (P= .02; OR, 5.2), or the presence of more than 2 classic risk factors for VTEs (P= .01; OR, 13.6). In this study, symptomatic VTEs were rare and occurred infrequently, with an incidence of 0.34% (95% CI, 0.25% to 0.46%), after knee arthroscopy and arthroscopy-assisted cases in the absence of routine chemoprophylaxis. Patients with a history of VTEs, a history of malignancy, or 2 or more classic risk factors are at increased risk of VTEs after knee arthroscopy, and chemoprophylaxis should be considered in these select patients. Level III, case-control study.

Staged venous thromboemolic events prophylaxis with low-molecular-weight heparin followed by aspirin is safe and effective after arthroplasty.

The rate of fatal pulmonary embolism (PE) following hip and knee arthroplasty has remained unchanged despite the use of low-molecular-weight heparin (LMWH) and oral antithrombotic agents. Concerns regarding bleeding and wound complications resulted in the introduction of a staged chemoprophylaxis protocol at our institution in 2002. We hypothesized that staged chemoprophylaxis using LMWH in hospital followed by aspirin after discharge was safe and effective for the prevention of venous thromboembolic events (VTE). Data were retrospectively collected on all patients undergoing hip and knee arthroplasty between 2002 and 2012. For VTE prophylaxis, LMWH was administered to all patients following surgery until discharge. Aspirin was prescribed from discharge until 6 weeks following surgery. Complications were recorded in a database. Patients suspected of having a VTE were investigated with bilateral lower limb duplex ultrasound and computerized tomography-pulmonary angiogram. The 11-year results of this protocol used in 9035 patients with a mean age 62 years (range 20-95) and follow-up at 6 weeks demonstrate an overall symptomatic VTE rate of 2.55% and overall PE rate of 1.28%. The overall fatal PE rate is 0.03% (unicompartmental knee arthroplasty 0.07-0.96%, total knee arthroplasty 0.19% and total hip arthroplasty 0%) and the all-cause mortality is 0.07%. The wound complication rate is low. Staged chemoprophylaxis using LMWH followed by aspirin is a safe and effective thromboprophylactic regime that is associated with a very low rate of fatal PE and all-cause mortality.

Efficacy of Prophylactic Low-Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial.

Advanced pancreatic cancer (APC), in addition to its high mortality, accounts for the highest rates of venous thromboembolic events (VTEs). Enoxaparin, a low-molecular weight heparin, is effective in prevention and treatment of VTEs. Some small studies have indicated that this benefit might extend to patients with cancer. Patients with histologically proven APC were randomly assigned to ambulant first-line chemotherapy and prophylactic use of enoxaparin or chemotherapy alone to investigate the probable reduction in symptomatic VTEs and the impact on survival. A total of 312 patients were recruited as one of the protocol end points was reached. Within the first 3 months, the numbers of symptomatic VTEs were as follows: 15 of 152 patients in the observation group and two of 160 patients in the enoxaparin group (hazard ratio [HR], 0.12; 95% CI, 0.03 to 0.52; χ(2) P = .001). The numbers of major bleeding events were as follows: five of 152 patients in the observation arm and seven of 160 patients in the enoxaparin arm (HR, 1.4; 95% CI, 0.35 to 3.72; χ(2) P = 1.0). Overall cumulative incidence rates of symptomatic VTEs were 15.1% (observation) and 6.4% (enoxaparin; HR, 0.40; 95% CI, 0.19 to 0.83; P = .01). Progression-free (HR, 1.06; 95% CI, 0.84 to 1.32; P = .64) and overall survival (HR, 1.01; 95% CI, 0.87 to 1.38; P = .44) did not differ between groups. This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic VTEs in outpatients with APC. Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting.

Low incidence of symptomatic thromboembolic events after total ankle arthroplasty without routine use of chemoprophylaxis.

There is little evidence regarding the incidence of symptomatic venous thromboembolism (VTE) following total ankle arthroplasty (TAA) to allow formulation of treatment recommendations. The purpose of this study was to determine the incidence of symptomatic VTE events after TAA without use of chemoprophylaxis and to identify risk factors contributing to the occurrence of VTEs. We conducted a retrospective chart review of 637 patients (664 ankles) who received a TAA between May 2007 and January 2014 and had a minimum follow-up of 3 months. Chemoprophylaxis was prescribed only in the setting of a history of VTE or active coagulopathy. Patients were continued on chemoprophylactic agents if they were taking these medications preoperatively. A VTE event was defined when clinical signs and symptoms of deep venous thrombosis (DVT) were confirmed with use of Doppler ultrasonography or pulmonary embolism was confirmed with the use of a computed tomography scan. Routine screening for VTE was not performed. The overall incidence of clinically detected VTE events was 0.60% (4/664), with 0.45% (3 patients) developing a DVT and 0.15% (1 patient) developing a nonfatal pulmonary embolism. Moreover, we identified a subset of 434 patients without identifiable preoperative risk factors who were not taking chemoprophylaxis preoperatively and were not prescribed chemoprophylaxis postoperatively. Two of these patients developed a DVT postoperatively (0.46%). Given the low incidence of clinically detected VTE, no significant correlation could be identified between the occurrence of VTE events and risk factors. Our results suggest that clinically detectable VTE after TAA is uncommon. Patients without identifiable risk factors do not appear to require chemoprophylaxis following TAA. We recommend continuation of antiplatelet or anticoagulation therapy in patients who are taking these medications preoperatively and the initiation of chemoprophylaxis postoperatively in patients with known risk factors for VTE. Level IV, case series.

Computerised clinical decision support for suspected PE

This study aimed to determine the effect of an evidence-based clinical decision support (CDS) algorithm on the use and yield of CT pulmonary angiography (CTPA) and on outcomes of patients...

Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program.

BackgroundThe global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding. Owing to differences in targeted anticoagulant intensities in Japan, Japanese patients were not enrolled into the global studies. Instead, a separate study of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in Japanese patients was conducted, which compared the Japanese standard of care with a reduced dose of rivaroxaban.MethodsWe conducted an open-label, randomized trial that compared 3, 6, or 12 months of oral rivaroxaban alone (10 mg twice daily or 15 mg twice daily for 3 weeks followed by 15 mg once daily) with activated partial thromboplastin time-adjusted intravenous unfractionated heparin (UFH) followed by warfarin (target international normalized ratio 2.0; range 1.5–2.5) in patients with acute, objectively confirmed symptomatic DVT and/or PE. Patients were assessed for the occurrence of symptomatic recurrent venous thromboembolic events or asymptomatic deterioration and bleeding.ResultsEighty-one patients were assigned to rivaroxaban and 19 patients to UFH/warfarin. Three patients were excluded because of serious non-compliance issues. The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4%) rivaroxaban patient and in 1 (5.3%) UFH/warfarin patient (absolute risk difference, 3.9% [95% confidence interval, -3.4–23.8]). No major bleeding occurred during study treatment. Clinically relevant non-major bleeding occurred in 6 (7.8%) patients in the rivaroxaban group and 1 (5.3%) patient in the UFH/warfarin group.ConclusionsThe findings of this study in Japanese patients with acute DVT and/or PE suggest a similar efficacy and safety profile with rivaroxaban and control treatment, consistent with that of the worldwide EINSTEIN DVT and PE program.Trial registrationClinicaltrials.gov: NCT01516840 and NCT01516814.Electronic supplementary materialThe online version of this article (doi:10.1186/s12959-015-0035-3) contains supplementary material, which is available to authorized users.

Highest risk of symptomatic venous thromboembolic events after radical cystectomy occurs in patients with obesity or nonurothelial cancers.

Context:Venous thromboembolism (VTE) is a common cause of postoperative morbidity and mortality in cystectomy patients.Aims:The aim of this study is to identify variables associated with risk of developing deep venous thrombosis (DVT) or pulmonary embolism (PE) within 90 days after radical cystectomy (RC).Setting and Design:Retrospective chart review of patients undergoing RC from 2004 to 2011 at the University of Wisconsin.Subjects and Methods:Clinical variables collected for all RC patients. All patients received mechanical prophylaxis, and routine heparin prophylaxis began in 2010.Statistical Analysis Used:Univariate and multivariate analyses were used to evaluate VTE association with known risk factors.Results:A total of 241 patients were identified with median age of 67.1 (interquartile range: 57.8-74.3) years. Body mass index (BMI) was ≥30 in 36.8% of patients. Median blood loss was 950 (600-1500) mL and 157/241 (65.2%) patients received a blood transfusion.Conclusions:Patients with BMI ≥30 or nonurothelial cancer are at highest risk for postoperative VTE and should be considered for extended heparin prophylaxis.

Editorial comment.

One Size May Not Fit All Is Extended Pharmacologic Venous Thromboembolism Prophylaxis Uniformly Safe After Radical Cystectomy?UrologyVol. 84Issue 5PreviewTo quantitate the risk of clinically significant renal function deterioration after radical cystectomy (RC), which could result in supratherapeutic levels of low-molecular-weight heparin (LMWH) and increased risk of bleeding events with the use of extended pharmacologic venous thromboembolism prophylaxis (EPVTEP) after hospital discharge. Full-Text PDF ReplyUrologyVol. 84Issue 5PreviewDeep-vein thrombosis and pulmonary thromboembolism are the major and potentially lethal complications of abdominal or pelvic cancer surgery. A noteworthy proportion of symptomatic venous thromboembolic events occur after hospital discharge. Appropriately, national guidelines recommend the use of extended pharmacologic venous thromboembolism prophylaxis (EPVTEP) for 4-week duration after pelvic surgery, including radical cystectomy. Nevertheless, such recommendations may not be appropriate for all patients. Full-Text PDF