Aims.
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.
British national guidelines recommend agents which antagonise factor Xa or warfarin as prophylaxis of venous thromboembolism (VTE) in lower limb arthroplasty. However, they discourage the use of aspirin prophylaxis. We conducted a prospective, multi-centre audit between two national centres, Ninewells Hospital in Dundee and the Royal Infirmary in Edinburgh to compare bleeding and VTE risk. Only Edinburgh routinely uses aspirin as VTE prophylaxis. The study comprises a number of cycles from 2013 to 2015. Consecutive groups of patients were identified prospectively using elective theatre data and information extracted from their case-notes on type of VTE prophylaxis, VTE occurrence, wound complications and length of hospital stay for a period of nine weeks post-operatively. 262 Edinburgh patients and 92 Dundee patients were included. Most Edinburgh patients were prescribed aspirin in hospital and on discharge (188/262, 71.8%), in line with local protocol. In Dundee, dalteparin was most commonly prescribed in hospital (68/92, 73.9%) and rivaroxaban on discharge (57/92, 62.0%). The Edinburgh group had a 1.5% incidence of pulmonary embolus (PE) and a 1% rate of deep venous thrombosis (DVT), 2% had problems with wound haematoma and one patient (0.4%) required a transfusion; no wound washouts were required. In Dundee there was 0% PE, 2% DVT, 5% had problems with haematoma, 3% required transfusion and 2% required washout. There was no difference in length of hospital stay, with a mode of 4 days for both centres. Non-fatal PE was prevented in Dundee patients but possibly at the cost of greater incidence of wound complications.
Venous thromboembolism (VTE) is a serious complication after total hip and knee arthroplasty. There is still no consensus regarding the best mode of thromboprophylaxis after lower limb arthroplasty. The aim of this study was to ascertain the efficacy, safety profile and rate of adverse thromboembolic events of aspirin as extended out of hospital pharmacological anticoagulation for elective primary total hip and knee arthroplasty patients and whether these rates were comparable with published data for low molecular weight heparin (LMWH). Data was extracted from a prospective hospital acquired thromboembolism (HAT) database. The period of study was from 1st Jan 2013-31st Dec 2016 and a total of 6078 patients were treated with aspirin as extended thromboprophylaxis after primary total hip and knee arthroplasty. The primary outcome measure of deep vein thrombosis and pulmonary embolism within 90 days postoperatively was 1.11%. The secondary outcome rates of wound infection, bleeding complications, readmission rate and mortality were comparable to published results after LMWH use. The results of this study clearly show that Aspirin, as part of a multimodal thromboprophylactic regime, is an effective and safe regime in preventing VTE with respect to risk of DVT or PE when compared to LMWH. It is a cheaper alternative to LMWH and has associated potential cost savings.
We studied the safety and efficacy of multimodal thromboprophylaxis (MMP) in patients with a history of venous thromboembolism (VTE) undergoing total hip arthroplasty (THA). MMP includes discontinuation of procoagulant medications, VTE risk stratification, regional anesthesia, an intravenous bolus of unfractionated heparin before femoral work, rapid mobilization, the use of pneumatic compression devices, and chemoprophylaxis tailored to the patient's risk. From 2004 to 2018, 257 patients (mean age: 67 years; range: 26–95) with a history of VTE underwent 277 primary, elective THAs procedures (128 right, 100 left, 9 single-stage bilateral, 20 staged bilateral) by two orthopaedic surgeons at a single institution. The patients had a history deep vein thrombosis (DVT) 186 (67%), pulmonary embolism (PE) 43 (15.5%), or both 48 (17.5%). Chemoprophylaxis included aspirin (38 patients) and anticoagulation (239 patients; Coumadin: 182, low-molecular-weight heparin: 3, clopidogrel: 1, rivaroxaban: 3, and a combination: 50). Forty eight patients (17.3%) had a vena cava filter at the time of surgery. Patients were followed for 120 days to detect complications, and for a year to detect mortality.Introduction
Material and methods
Venous Thromboembolism (VTE) is the most common complication following major joint surgery. While attention has focused on VTE following joint arthroplasty their exists a gap in the literature examining the incidence of VTE in spinal surgery; with a shortage of epidemiological data, guidelines for optimal prophylaxis are limited. This survey, undertaken at the 2009 BASS Annual Meeting, sought to examine prevailing trends in VTE thromboprophylaxis in spinal surgery and to compare selections made by Orthopaedic and Neurosurgeons. We developed a questionnaire based around eight clinical scenarios. Participants were asked to supply details on their speciality (orthopaedics or neurosurgery) and level of training (grade) and to select which method(s) of thromboprophylaxis they would employ for each scenario. Thirty-nine participants provided responses to the eight scenarios; complete details, including speciality and grade of those surveyed, were complied for 27 of the 39 questionnaires completed. LMWH was the preferred pharmacological method of thromboprophylaixs selected 31% and 72% of the time by orthopaedic and neurosurgeons respectively. For each of the eight clinical scenarios LMWH and BK TEDS were selected more frequently by neurosurgeons than orthopaedic surgeons who elected to employ early mobilisation and mechanical prophylaxis. Neurosurgeons were more likely to employ more than method of thromboprophylaxis. Thromboprophylactic selections differed between the two groups; Neurosurgeons preferred LMWH and BK TEDS whilst Early Mobilisation and Mechanical prophylaxis were the preferred methods of thromboprophylaxis amongst orthopaedic surgeons. Based on the results of this survey neurosurgeons more closely adhered to guidelines outlined by NICE/BASS.
It is widely recognised that pelvic disruption in association with high-energy trauma is a life-threatening injury. The potential morbidity and mortality associated with acetabular injuries are less well understood. Due to chronic underfunding and the absence of a comprehensive and coordinated national approach to the management of acetabular trauma throughout the UK, patients can incur prolonged recumbency. Prompt and appropriate referral for specialist management, thromboprophylaxis and venous thrombosis surveillance are important issues for the referring centre. We performed a postal questionnaire to establish the current clinical practice in the specialist centres throughout the UK in pelvic and acetabular trauma, with respect to time to surgery, thromboprophylaxis, and surveillance. We identified twenty-one units and thirty-seven surgeons in the NHS who deal with pelvic and acetabular injuries. The mean time to surgery from injury in the UK is 8.5 days (range 2-19 days). The larger units that accept and treat patients from outside their region experience the greatest delay to surgery. Mechanical thromboprophylaxis was used in 67% (14) of the units. 24% (5) use arterio-venous boots, 19% (4) use calf pumps, and 52% (11) use TEDS stockings. No unit routinely use prophylactic IVC filters in acetabular trauma. Chemical thromboprophylaxis is routinely used in 100% (21) of the units. 95% (20) used prophylactic doses of unfractionated heparin or low molecular weight heparin. Clinical surveillance alone for thromboembolism is employed in 90% (19) of the units. Only 2 (10%) units routinely perform radiological surveillance with ultrasound Doppler on its acetabular fracture cases pre-operatively. Currently there is no published directory of dedicated pelvic and acetabular surgeons in the UK. There is no general consensus on the approach to thromboprophylaxis and surveillance in acetabular trauma in the UK. There is no consensus approach to thromboprophylaxis and surveillance in the literature.