Since the introduction of the National Institute
for Health and Care Excellence (NICE) guidelines on thromboprophylaxis
and the use of extended thromboprophylaxis with new oral agents,
there have been reports of complications arising as a result of
their use. We have looked at the incidence of wound complications
after the introduction of dabigatran for thromboprophylaxis in our
unit. We investigated the rate of venous thromboembolism and wound
leakage in 1728 patients undergoing primary joint replacement, both
before and after the introduction of dabigatran, and following its
subsequent withdrawal from our unit. We found that the use of dabigatran led to a significant increase
in post-operative wound leakage (20% with dabigatran, 5% with a
multimodal regimen; p <
0.001), which also resulted in an increased
duration of hospital stay. The rate of thromboembolism in patients
receiving dabigatran was higher (1.3%) than in those receiving the multimodal
thromboprophylaxis regimen, including low molecular weight heparin
as an inpatient and the extended use of aspirin (0.3%, p = 0.047).
We have ceased the use of dabigatran for thromboprophylaxis in these
patients. Cite this article:
Aims.
We performed a meta-analysis of the English literature to assess the efficacy of four common regimes for
Purpose:
Background: Prophylaxis against thromboembolic complications has become routine after major trauma and major orthopaedic surgery. In contrast, it remains an issue for debate whether prophylaxis after minor surgery and immobilization is necessary, even though these treatments are well-known risk factors for deep vein thrombosis (DVT). Objectives: The objective of this study was to evaluate the efficacy of Dalteparin (5,000 U given subcutaneously once daily for six weeks) during lower limb immobilization after surgical treatment of Achilles tendon rupture. Methods: After surgery, 105 consecutive patients were randomized to a placebo-controlled double-blind study to evaluate the efficacy of given thromboprophylaxis. DVT screening using validated color duplex sonography was performed three weeks and six weeks after surgery, and all DVTs were confirmed with phlebography. Results: Primary endpoint analysis was available for 91 patients. DVT was diagnosed in 16/47 patients (34%) in the Dalteparin group and in 16/44 patients (36%) in the placebo group. These figures are not significantly different (p=0.8). Proximal DVT was diagnosed in one patient (2%) in the Dalteparin group and in three patients (6%) in the placebo group (p=0.6). No pulmonary emboli or major bleeding occurred in either of the groups. Conclusions: DVT is common after surgical treatment of Achilles tendon rupture and therefore effective thromboprophylaxis is desirable.
Introduction: After total hip replacement (THR), thromboprophylaxis for at least 10 days and for up to 35 days is recommended – yet a convenient, oral anticoagulant is not currently available. Rivaroxaban – a once-daily, oral, direct Factor Xa inhibitor with a predictable clinical profile – is in advanced clinical development. RECORD1, a multinational, randomized, double-blind, double-dummy, phase III study, compared once-daily oral rivaroxaban with subcutaneous enoxaparin for 5 weeks following THR. Methods: In total, 4541 patients were randomized to receive oral rivaroxaban 10 mg (6–8 hours after surgery and once daily thereafter), or 40 mg enoxaparin (administered subcutaneously the evening before surgery, resumed 6–8 hours after surgery, and continued once daily).
Aim.
Rivaroxaban is a novel, oral, once-daily, direct Factor Xa inhibitor in advanced clinical development. RECORD1 was a multinational, randomized, double-blind, double-dummy, phase III study investigating the efficacy and safety of extended thromboprophylaxis with rivaroxaban compared with subcutaneous enoxaparin following THR. Patients (N=4541) were randomized to receive oral rivaroxaban 10 mg (6–8 hours after surgery and once daily thereafter) or subcutaneous enoxaparin 40 mg (administered the evening before surgery, 6–8 hours after surgery, and once daily thereafter) for 35±4 days. The primary efficacy outcome was the composite of deep vein thrombosis (DVT: symptomatic or detected by mandatory, bilateral venography if asymptomatic), non-fatal pulmonary embolism (PE), and all-cause mortality up to day 36±6. Major venous thromboembolism (VTE), the composite of any DVT, non-fatal PE and VTE-related death, was a secondary outcome. Safety endpoints included major and non-major bleeding while receiving study medication. Rivaroxaban significantly reduced the incidence of the primary efficacy outcome compared with enoxaparin (1.1% vs 3.7%, respectively; p<
0.001; relative risk reduction [RRR] 70%). Rivaroxaban also significantly reduced the incidence of major VTE compared with enoxaparin (0.2% vs 2.0%, respectively; p<
0.001; RRR 88%). There were no significant differences in the incidence of major bleeding (0.3% vs 0.1%; p=0.178) or non-major bleeding (5.8% vs 5.8%; p=1.000) between rivaroxaban and enoxaparin, respectively. There was no evidence of liver safety issues associated with rivaroxaban.
Total Joint Arthroplasty (TJA) is a successful orthopaedic procedure allowing dramatic clinical and functional improvements. Globally, there's been an increase in demand and performed cases associated with an increase in complications. Subsequently, focus on the prevention of complications has become important worldwide. The incidence of venous-thrombolic events (VTE) despite great attention has not diminished despite much investigation. A balance between efficacy and safety from the available agents is essential. Low molecular weight heparin (LMWH) has been commonly used, but oral anti-coagulants have become more popular. The aim of this study was to assess the adherence LMWH and the effectiveness and safety of preventing VTE in post-operative arthroplasty patients in a South African setting. We conducted a prospective cohort study that included hip and knee, primary and revision, arthroplasty patients who received thromboprophylaxis with one daily injection of LMWH for 14 days post discharge. Patients who omitted 1 or more doses during the follow up period were classified as “non adherent”. A questionnaire was used at follow up visits at least 6 weeks post-operatively. 100 consecutive patients were followed up. The mean age of patients was 63.45 years. There were 68 % female patients. There was a 92% compliance rate. 60 % of patients had the injection administered by a family member, 38 % administered it themselves and 2 % had the injection administered by health professionals. Venous thromboembolic events were confirmed in 5 % at 7.86 days after surgery. Three patients had persistent wound drainage after surgery, however, none required reoperation or readmission. Compliance with LMWH is high and is comparable with oral agents. It is effective in preventing VTE and safe with regards to bleeding and wound complications in a South African setting. Patient education regarding medications may improve compliance of the medication.
The use of intramedullary lengthening devices is becoming increasingly popular. There are no published data regarding the incidence of venous thromboembolism following intramedullary lengthening and no reports or guidance for current practices on use of thromboprophylaxis. Following a case of post-operative deep vein thrombosis in our institution, we felt that it is important to assess best practice. We conducted this survey to collect data that would describe current practice and help guide consensus for treatment. We have identified surgeons across the UK that perform intramedullary lengthening through the British Limb Reconstruction Society membership and a Precise Users database. Surgeons were contacted and asked to respond to an online survey (SurveyMonkey - SVMK Inc.). Responses to thromboprophylaxis regimes employed in their practice and cases of venous thromboembolism were collated.Introduction
Materials and Methods
We report preliminary results from the first, multicenter prospective study designed to define the incidence of symptomatic (Venous Thromboembolism) VTE in patients with isolated leg fractures distal to the knee. Eight hundred and twenty-six enrolled patients have completed three months of follow up. By three months, only seven patients had sustained a symptomatic VTE with no fatal PE. Symptomatic and fatal VTE were infrequent complications after isolated leg fractures distal to the knee without thromboprophylaxis. Routine thromboprophylaxis may not be warranted in isolated leg fractures distal to the knee. To report results from the first, multicenter prospective study designed to define the incidence of symptomatic Venous Thromboembolism (VTE) in patients with isolated leg fractures distal to the knee. Symptomatic and fatal VTE are infrequent complications after isolated leg fractures distal to the knee without thromboprophylaxis. Routine thromboprophylaxis may not be warranted in isolated leg fractures distal to the knee. From August 2002 to April 2004, one thousand eight hundred and eight consecutive patients with isolated leg fractures distal to the knee were screened for entry at five hospitals in Ontario. Patients with major trauma, active cancer and previous VTE were excluded.
Venous thromboembolism (VTE) is the second most common complication and pulmonary embolism (PE) is the fourth most common cause of death after a hip fracture. Despite thromboprophylaxis, deep vein thrombosis (DVT) is detected in up to 45% of hip fracture patients. Thrombelastography (TEG) is a whole-blood, point of care test capable of providing clinicians with a global assessment of the clotting process, from fibrin formation to clot lysis. Maximal amplitude (mA) from TEG analysis is a measure of clot strength. Elevated admission mA values of >65mm and >72mm have been determined to be independent predictors of in-hospital PE. The coagulation index (CI) is calculated based on TEG parameters and defines hypercoagulable state as CI >3. This study aimed to use serial TEG analysis to determine the duration of hypercoagulable state after hip fracture. A prospective cohort of hip fracture patients >50 years of age amenable to surgical treatment (AO 31A1–A3 & 31B1–B3) were enrolled at a Level I trauma centre. Serial TEG analysis (TEG 6S) was performed every 24-hours from admission until 5-days post-operatively and at 2- and 6-week follow-up visits. All patients received a minimum of 28 days of thromboprophylaxis. Descriptive statistics and single sample t-tests were used for comparison of mA to the 65mm threshold. Thirty-five patients (26 female) with a median age of 83 (range = 71–86) years were included. On admission, 31.4% and 82.9% of patients were hypercoagulable based on mA >65mm and CI, respectively. At 2 weeks, all patients remained hypercoagulable, however, mA >72mm showed that 16 patients (47.1%) were at even higher risk for VTE. At 6-weeks, 65.7% and 97.1% of patients were hypercoagulable based on mA >65mm and CI, respectively. When compared with the mA >65mm threshold, patients were hypocoagulable at the time of admission (mA = 62.2 (±6.3), p = 0.011), but became significantly more hypercoagulable at 2-weeks (mA = 71.6 (±2.6), p < 0 .001), followed by continued hypercoagulability at 6-weeks, however not significantly elevated above the 65mm threshold (mA = 66.2 (±3.8), p = 0.058). One patient developed a symptomatic DVT at 2-weeks and had a mA = 72.9 and a CI of 5.9. This is the first study to demonstrate that >50% of hip fracture patients remain hypercoagulable 6 weeks post fracture despite thromboprophylaxis, and there are individual hypercoagulable responses. This is critical, as guidelines only recommend 28 to 35 days of thromboprophylaxis in this high-risk population. Previously determined mA thresholds may be a more sensitive test for risk-stratifying patients' VTE risk than the CI threshold. Additionally, assessing ΔmA using serial TEG may better predict VTE risk.
Purpose: We conducted the first, multicentre, prospective cohort study to define the incidence of symptomatic venous thromboembolism (VTE) in patients with tibia and ankle fractures treated conservatively and relatively minor lower leg fractures. The reported incidence of deep vein thrombosis (DVT) using routine venography in patients with lower leg injury requiring cast immobilization is approximately 20–40%, which has lead to the routine use of anticoagulant prophylaxis for several weeks in many such patients. However the vast majority of venographically-detected DVTs are asymptomatic, distal thrombi whose clinical relevance is uncertain. Therefore venography is not the best outcome measure to assess the burden of clinically important VTE. Method: Consecutive patients with tibia and fibula fractures (treated non-operatively) and patella and foot fractures, (treated operatively or conservatively) were assessed for eligibility at 5 Ontario hospitals. Patients were enrolled after informed consent within 96 hours of injury and were followed prospectively, by telephone, at 2, 6 and 12 weeks. Those with major trauma, active cancer, and previous VTE were excluded.
The aims of this study were to compare the efficacy of two agents,
aspirin and warfarin, for the prevention of venous thromboembolism
(VTE) after simultaneous bilateral total knee arthroplasty (SBTKA),
and to elucidate the risk of VTE conferred by this procedure compared
with unilateral TKA (UTKA). A retrospective, multi-institutional study was conducted on 18
951 patients, 3685 who underwent SBTKA and 15 266 who underwent
UTKA, using aspirin or warfarin as VTE prophylaxis. Each patient
was assigned an individualised baseline VTE risk score based on
a system using the Nationwide Inpatient Sample. Symptomatic VTE,
including pulmonary embolism (PE) and deep vein thrombosis (DVT),
were identified in the first 90 days post-operatively. Statistical
analyses were performed with logistic regression accounting for
baseline VTE risk.Aims
Patients and Methods