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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 15 - 15
1 Jan 2016
Mammoto T Iwabuchi S Hirano A
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Introduction. Patients undergoing total knee arthroplasty (TKA) are at high risk of post operative venous thromboembolism (VTE). Edoxaban, the oral direct and selective factor Xa inhibitor, is available for preventing VTE after TKA. Recently, patients often take antiplatelet drugs including aspirin for their past illness. In our hospital, patients, in general, undergoing TKA receive edoxaban, but patients with aspirin for past illness receive only aspirin for preventing VTE. The aim of this study was to compare edoxaban and aspirin for preventing VTE in patients undergoing TKA. Materials and methods. From April 2012 to March 2014, 137 patients underwent primary TKA under general anesthesia with epidural anesthesia or femoral/ sciatic nerve block. Patients were excluded following; (1) renal dysfunction, (2) have taken anticoagulants such as warfarin for past illness. Finally, a total of 120 patients were enrolled. At the surgery, tourniquet was inflated and mid-vastus approach was used. After prosthesis implantation, tourniquet was deflated and drain tube was inserted. Intra and after operation, an intermittent pneumatic compression device was used. At postoperative day 2, edoxaban or aspirin started after removal of epidural anesthesia or drainage tube. Ninety-seven patients were assigned to receive edoxaban once daily (group E), and the rest of 23 received aspirin again same as before (group A). Edoxaban were scheduled to continue for 10 days. DVT diagnosis. At postoperative day 7, compression and colored Doppler imaging was taken for bilateral common femoral veins, superficial veins, popliteal veins and calf veins by skilled clinical technologist. Augmentation by calf squeezing and by dropped lower leg down were included. Diagnosing DVT criteria was loss of vein compressibility, presence of intraluminal echogenicity and absence of venous flow. D-dimer levels. At preoperative, postoperative days 7 and 14, plasma D-dimer levels were measured. Statistical analysis. Data were compared using independent t-test or the chi-square test. A significant difference was set at p<0.05. Results. Patients’ characteristics were shown in table 1. Age in the group A was significantly higher than in the group E. The total incidence of DVT was 40%. The incidence of DVT was significantly decreased in group E compared to group A at day 7 (group E: 34% versus group A: 65%, p<0.01) (table 2). The D-dimer level in group E was significantly decreased at postoperative day 7 (13.2 ± 6.8 (mean ± SD) vs 17.0 ± 9.1, p<0.05). At day 14, there were no significant differences (Figure 1). Discussion. In this study, edoxaban decreased the incidence of DVT after TKA compared to aspirin. The result of D-dimer supported the efficacy of edoxaban. Results showed that edoxaban is effective for preventing DVT following TKA. Recently, TKA patients often take antiplatelet drugs including aspirin for their past illness. It is still controversial to add an antithrombotic drug for preventing VTE. The incidence of DVT with aspirin was higher than that with edoxaban. Thus, patients received only aspirin might be needed not only to pay attention to VTE, but also to add anticoagulants as edoxaban for preventing VTE


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_13 | Pages 18 - 18
1 Nov 2019
Ghosh A Best AJ Rudge SJ Chatterji U
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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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 39 - 39
1 Jan 2013
Jameson S Baker P Charman S Deehan D Reed M Gregg P van der Meulen J
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Background. The most appropriate form of chemical thromboprophylaxis following knee replacement is a contentious issue. Most national guidelines recommend the use of low molecular weight Heparin (LMWH) whilst opposing the use of aspirin. We compared thromboembolic events, major haemorrhage and death after knee replacement in patients receiving either aspirin or LMWH. Methods. Data from the National Joint Registry for England and Wales was linked to an administrative database of hospital admissions in the English National Health Service. A total of 156 798 patients undergoing knee replacement between April 2003 and September 2008 were included and followed up for 90 days. Multivariable risk modelling was used to estimate odds ratios adjusted for baseline risk factors (AOR). An AOR < 1 indicates that risk rates are lower with LMWH than with aspirin. Results. In all, 23.1% of patients were prescribed aspirin and 76.9% LMWH. We found no statistically significant differences in the rate of pulmonary embolism (aspirin 0.49%, LMWH 0.45%, AOR 0.88; 95% confidence intervals (CI) 0.74 to 1.05), 90-day mortality (0.39% versus 0.45%, AOR 1.13; 95% CI 0.94–1.37) and major haemorrhage (0.37% versus 0.39%, AOR 1.01; 95% CI 0.83–1.22). There was a significantly greater likelihood of requirement for return to theatre in the aspirin group (0.26% versus 0.19%, AOR 0.73; 95% CI 0.58–0.94). Discussion. Between patients receiving LMWH or aspirin, there was no difference in the risk of pulmonary embolus, 90-day mortality and major haemorrhage. These results should be considered when the existing guidelines for thromboprophylaxis after knee replacement are reviewed


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 196 - 196
1 Sep 2012
Akram T Templeton-Ward O Yousaf S Hargrove R
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Following the outcomes of the RECORD trials the protocol of extended thromboprophylaxis in patients undergoing elective primary total hip or knee arthroplasty has been changed in our institution. Between June 2008 and May 2009 patients were offered extended thromboprophylaxis with 150mg of aspirin daily, commencing preoperatively on admission and continuing for a total of six weeks. From June 2009 onwards patients were treated with 10mg of rivaroxaban once daily for two weeks following total knee and five weeks following total hip arthroplasty commencing 4 to 6 hours postoperatively. Our cohorts were 700 patients before and after the introduction of the new regimen. The two groups were matched for age, sex and type of operation. All patients with no contraindication to treatment with aspirin or rivaroxaban respectively undergoing elective primary total hip or knee arthroplasty were included in the study. Patients receiving warfarin on admission were treated with warfarin postoperatively and were excluded. We have compared the two treatment protocols in terms of safety and efficacy. Results focus on 4 safety outcome measures including mortality, haemorrhagic complications, transfusion requirements and infection rates and 2 efficacy outcome measures including thromboembolic complications and length of inpatient stay. Rates of DVT were equal in the two cohorts (P< 0.005) as were the mortality rates. Transfusion requirements post-operatively were not affected by the introduction of the new regimen however there was a significant increase in both return to theatre rates and prolonged wound ooze (P< 0.005). Infection rates were slightly higher in the cohort treated with rivaroxaban but this was not statistically significant. We conclude that further trials need to be done to confirm the suitability of routine use of rivaroxiban


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLII | Pages 4 - 4
1 Sep 2012
Gbejuade HO Kamali H Murray JR
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Thromboprophylaxis is of particular interest to the NHS due to the number of deaths from preventable hospital-acquired venous thrombo-embolism, considerable treatment cost and related long-term morbidities. In compliance with current NICE guidelines, our departmental protocol for chemical thromboprophylaxis changed from aspirin to clexane. We present a review of the use of both these chemical agents in our hip fracture patients; assessing duration of wound ooze, incidence of symptomatic PE and DVT and thrombocytopaenia. Prospective study of surgically treated hip fractures patients on chemical thromboprophylaxis postoperatively over a 7 month period. Of 224 patients reviewed, 110 fitted our inclusion criteria; 78 on Clexane and 32 on aspirin. Mean patient age: 82.6 years(48–100). Mean hospital stay: 30d ays(6–80). Female predominance (3:1). Mean duration of wound ooze: 6.9 days (1–24) for aspirin and 5.6 days (0–15) for clexane. Symptomatic DVTs: 1(3%) for aspirin and 3(3.8%) for clexane. Symptomatic PE: 0 for aspirin and 1(1.3%) for clexane. Thrombocytopenia: 0 for both groups. Mean duration of wound ooze for both groups was approximately 1 week. Low but significant incidence of thrombo-embolism. Thromboembolism-deterrent-stockings were observed to be unreliable mainly due to skin problems and compliance


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 10 - 10
1 Feb 2012
Mackenzie D Muir R Wild S
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Background. Hip fracture in the elderly has high morbidity and mortality. National guidelines have recommended low molecular weight (LMW) heparin or aspirin for thromboprophylaxis in hip fracture. Unlike other types of major surgery, there is a lack of trial evidence for graduated elasticated compression (GEC) stockings in hip fracture patients. Objective. To explore the effect of thromboprophylaxis on survival in hip fracture patients. Participants. 8470 Scottish Hip Fracture Audit (SHFA) participants aged 60 years and over, admitted 1998-2003. Methods. SHFA records were linked to routinely collected hospital discharge and death records occurring within one year of hip fracture admission. Cox proportional hazards regression was used to adjust for age, gender, previous hospital admissions, previous walking ability and residence, American Society of Anesthesiologists grade, fracture type, pressure sores prior to surgery, and delay to surgery. Results. 2531 (30%) patients died within one year of hip fracture admission. GEC stockings appeared to be protective against death (hazard ratio 0.88, 95% confidence interval 0.80-0.97) as did aspirin (HR 0.85, 95% CI 0.76-0.95). However heparin did not appear to protect against death (HR 0.97, 95% CI 0.87-1.08), even when only LMW heparin was included in the analysis. Overall, 3318 (39%) patients were given GEC stockings, 2735 (32%) aspirin, and 4527 (53%) heparin. Patients commonly received more than one type of thromboprophylaxis. Conclusions. This study provides evidence for a protective effect of GEC stockings and aspirin following hip fracture, but not heparin. The study design allowed sophisticated analysis, adjusting for a number of functional, social, surgical, anaesthetic and medical factors. The findings may however be explained by other confounding factors not included in the analysis. These findings suggest that a randomised controlled trial of GEC stockings, aspirin and heparin in hip fracture patients is warranted


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 324 - 324
1 Dec 2013
Ginsel B Crawford R Whitehouse S Taher A
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Aim:. This prospective cohort study investigated whether the use of preoperative anticoagulants is an independent risk factor for the outcomes of surgical treatment of patients with a neck of femur fracture. Methods:. Data was obtained from a prospectively collected database. All patients admitted for a neck of femur fracture between Nov 2010 and Oct 2011 were included. This resulted in three hundred twenty-eight patients with 330 neck of femur fractures. Four groups were defined; patients preoperatively (i) on aspirin (n = 105); (ii) on clopidogrel (n = 28); (iii) on warfarin (n = 30); and (iv) without any anticoagulation history (n = 167, the control group). The non-warfarin group included the aspirin group, clopidogrel group and the control group. Primary outcome was the in-hospital mortality. Secondary outcomes were the postoperative complications, return to theatre and length of stay. Results:. Thirteen in-hospital deaths were identified, 4 deaths in the aspirin group, 1 death in the clopidogrel group, 2 deaths in the warfarin group and 6 deaths in the control group. No significant difference in the mortality rates was found between the different groups. Also in the secondary outcomes, no significant difference was found between the four groups. A trend to a higher wound complication rate for the warfarin group was detected. Conclusion:. The use of clopidrogel or aspirin pre operatively is not an influence on short term patient outcome for patients with a neck of femur fracture. Surgical procedures should not be delayed to reverse their influence


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 60 - 60
1 Jul 2014
Brown G
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The selection of venous thromboembolism (VTE) prophylaxis after total joint arthroplasty (TJA) has been controversial. Although the aspirin controversy is presumably resolved, there is no medical evidence for the “optimal” VTE prophylaxis regime for individual patients. A risk-stratified multi-modal VTE prophylaxis protocol was developed and adopted by consensus. VTE risk factors and bleeding risk factors were categorised into six VTE/bleeding risk levels: (1) pre-operative vitamin K antagonists (VKA) use, (2) bleeding risk factors, (3) hypercoagulable state, (4) pre-operative anti-platelet therapy [clopidogrel use], (5) VTE risk factors, (6) no VTE or bleeding risk factors. The pharmacologic agents used for each risk level were: (1) resume VKA with low molecular weight heparin (LMWH) bridge, (2) pharmacologic agents contra-indicated and mechanical prophylaxis only, (3) VKA for 90 days with LMWH bridge, (4) resume anti-platelet therapy, (5) LMWH in hospital and discharge on aspirin for 90 days, (6) aspirin for 90 days (starting in hospital). In addition to pharmacologic treatment, all patients received multi-modal prophylaxis including early mobilisation, mechanical foot pumps, and neuraxial anesthesia when not contra-indicated. Prior to surgery, a VTE/bleeding risk factor checklist was completed determining the risk level. The intervention cohort included all TJA patients from January 1, 2010 to December 31, 2012. The comparison cohort included all TJA patients from the year prior to implementation of the protocol at the same community hospital. Thirty day all-cause non-elective re-admissions, 30 day same-site re-operations, 90 day VTE events, and protocol compliance were abstracted from the electronic medical record. The intervention group consisted of 2679 patients (1075 hip arthroplasty patients and 1604 knee arthroplasty patients). The comparison group consisted of 1118 patients (323 hip arthroplasty patients and 795 knee arthroplasty patients). The 30 day all cause non-elective re-admission rate was 2.72% (73/2679) in the intervention group and 4.29% (48/1118) in the comparison group (p=0.0148). The 30 day same-site re-operation rate was 1.38% (37/2679) in the intervention group and 1.25% (14/1118) in the comparison group (p=0.8773). The 90 day VTE event rate was 1.57% (42/2679) in the intervention group and 3.40% (38/1118) in the comparison group (p=0.0007). The VTE rate was higher for knee arthroplasty patients 2.00% (32/1604) than for hip arthroplasty patients 0.93% (10/1075) (p=0.0379). The rate of VTE events was higher for patients that deviated from the VTE protocol 5.03% (10/199) than for all risk groups treated per the protocol 1.29% (32/2481) (p=0.0007). The risk-stratified multi-modal VTE prophylaxis protocol simultaneously reduced 30 day all-cause non-elective re-admissions and 90 day VTE events. The possible causes for reducing 30 day re-admissions and reducing 90 day VTE events are: (1) reducing bleeding events by using aspirin for VTE prophylaxis in more than 80% of patients, (2) extending VTE prophylaxis to 90 days, and (3) using multi-modal prophylaxis. The risk-stratified multi-modal VTE prophylaxis protocol for total joint arthroplasty is consistent with 9 of the 10 recommendations in the AAOS Clinical Practice Guideline. The risk-stratification checklist provides a standardised tool to assess risks, discuss risks, and make shared decision with patients. Patient treatment that deviated from the protocol had a significantly higher VTE rate (5.03%). Protocol compliance increased each year from 91.1% in 2010 to 94.2% in 2012


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 111 - 111
1 Jan 2016
Oshima Y Fetto J
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Introduction. Pulmonary emboli (PE) after total hip and knee arthroplasties is an uncommon event. However, once it happens, it may results in sudden death. Thus, the prophylaxis of venous thromboembolism (VTE), including symptomatic deep vein thrombosis (DVT) and PE, is one of the challenging trials for Orthopaedic surgeons. Many procedures have been developed, e.g. early mobilization, compression stocking, intermittent pneumatic compression (IPC) devices, and anticoagulation agents. However, the most effective treatment for prophylaxis against VTE after the arthroplasties remains undecided. Recently, many low molecular weight heparin (LMWH) agents are developing, and these are strongly effective for anticoagulation. However, these agents sometimes lead to bleeding complications, and result in uncontrolled critical bleeding. We are introducing our protocol with conventional aspirin as VTE prophylaxis after the arithroplasties. Patients and methods. All patients prior to the surgeries are evaluated laboratory and duplex venous ultrasonography examinations to exclude thrombophilic or hemophilic conditions, and existence of DVT. Then, the thrombophilic, and also prolonged immobility, obesity, malignant tumors, cardiovascular dysfunction and DVT patients are regarded as high risk for VTE. These are offered a prophylaxis consisting of a removable inferior vena cava (IVC) filter, together with anticoagulant medication. Usually, the filter is removed three months after the surgery. In other patients, the arthroplasties are carried out under the spinal or epidural anesthesia with IPC on both feet. IPC is also applied, except for the periods of ambulation, usually two to three days of hospitalization after surgery. Full weight bearing ambulation with a walker is allowed on post-op day one. Patients receive aspirin (acetylsalicylic acid) 325 mg daily for six weeks starting the night of surgery. Pain is controlled with celecoxib (COX-2 selective nonsteroidal anti-inflammatory drug) 400 mg daily, and oral narcotics for break through pain. Before discharge, usually within three days post surgery, all patients are evaluated DVT by duplex venous ultrasonography. The incidence of blood loss, wound complications, and subcutaneous ecchymosis are recorded. Results and discussion. Although the incidence rate of all DVT (symptomatic and asymptomatic) after the arthroplasties was 2–3%, there was no patient readmitted or reoperated with critical bleeding, wound complications, nor fatal DVT/PE in this time period. The cost for the preoperative screening examinations, i.e. blood test and duplex venous ultrasonography, is approximately 200 US dollars. This is much less expensive than the cost associated with more aggressive anticoagulation agents and our procedures provided an acceptable level of outcomes with minimal risk of severe complications. Conclusions. The efficacy and safety of multimodal prophylaxis which employs aspirin against symptomatic PE in selected patients with hip and knee arthroplasties was demonstrated. Thus our protocol is recommended as a first choice for VTE prophylaxis


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 39 - 39
1 Dec 2016
Nam D
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Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), remain one of the most common complications following total joint arthroplasty. Reported rates of symptomatic VTE following THA and TKA range from 0.83% to 15% and 2% to 10%, respectively. Thus, VTE prophylaxis should be routinely administered following total joint arthroplasty. However, while orthopaedic surgeons have considerable flexibility regarding their VTE prophylaxis regimen, it remains unclear which is optimal. Patients at low risk of VTE may receive excessive anticoagulation and unnecessarily risk further perioperative morbidity (wound complications, bleeding) following total joint arthroplasty. With an evolving health care landscape, emphasis on complications and readmissions, and shorter inpatient hospitalizations, it is imperative that a VTE prophylaxis regimen is simple, effective, easy to monitor, and has high patient compliance. Mobile pneumatic compression devices (MCDs) have been used with greater frequency following total joint arthroplasty, with multiple reports demonstrating their effectiveness in VTE prevention with or without the addition of aspirin for chemical prophylaxis. The use of MCDs allows the avoidance of more aggressive anticoagulation in the majority of patients undergoing total joint arthroplasty, decreases the incidence of wound complications, and achieves a low overall incidence of symptomatic VTE. Future investigations are necessary to determine the necessity and impact of the addition of aspirin to the use of MCDs for VTE prophylaxis


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 40 - 40
1 Apr 2017
Parvizi J
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Venous thromboembolism (VTE) prophylaxis following total joint arthroplasty (TJA) should be individualised in order to maximise the efficacy of prophylactic measures while avoiding the adverse events associated with the use of anticoagulants. At our institution, we have developed a scoring model using the Nationwide Inpatient Sample (NIS) database, which is validated against our institutional data, to stratify patients into low- and high-risk groups for VTE. Low-risk patients are placed on aspirin 81 mg twice daily for four weeks post-operatively, and high-risk patients are placed on either a Vitamin K antagonist (warfarin), low molecular weight heparin, or other oral anticoagulants for four weeks post-operatively. All patients receive sequential pneumatic compression devices post-operatively, and patients are mobilised with physical therapy on the day of surgery. Patients who have a history of peptic ulcer disease or allergy to aspirin are also considered for other types of anticoagulation following surgery. Risk Stratification Criteria. Major comorbid risk factors utilised in our risk stratification model include history of hypercoagulability or previous VTE, active cancer or history of non-cutaneous malignancy, history of stroke, and pulmonary hypertension. We consider patients with any of these risk factors at elevated risk of VTE and therefore candidates for formal anticoagulation. Other minor risk factors include older age, bilateral surgery compared with unilateral, inflammatory bowel disease, varicose veins, obstructive sleep apnea, and history of myocardial infarction, myeloproliferative disorders, and congestive heart failure. Each minor criterion is associated with a score. The cumulative score is compared with a defined threshold and the score that surpasses the threshold indicates that the patient should receive post-operative anticoagulation. To facilitate the use of this scoring system, an iOS mobile application (VTEstimator) has been developed and can be downloaded from the app store


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 195 - 195
1 Sep 2012
Edwards H Yeoh D Dawson-Bowling S Ellens N East D Miles K Butler-Manuel A Apthorp H
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Introduction. Deep vein thrombosis(DVT) and pulmonary embolism(PE) are well-recognised complications following lower limb arthroplasty (Cohen et al, 2001). The National Institute for Clinical Excellence and British Orthopaedic Association recommend the use of both mechanical and chemical prophylaxis. At our institute regimens have changed reflecting new developments in the use of thombo-prophylaxis. Our aim was to assess the efficacy of these methods in preventing complications. Methods. Since moving from Aspirin and compression stockings (TEDS) only, three different treatment methods were prospectively audited. Regimen 1 consisted of Aspirin (150 mg OD) and TEDS for 6 weeks (n=660). Regimen 2 used Clexane 40mg OD (n=448). Regimen 3 used Rivaroxaban (n=100) as licensed and Regimen 4 Dabigatran (n=185) as licensed. We looked at rates of venous thromboembolism (VTE), rates of post op bleeding/haematoma and wound complications. Patients were reviewed prior to discharge, and at a six-week follow-up. Any casualty attendances were also recorded up to 12 weeks post-operatively. Results. Symptomatic VTE rates were as follows 3.78% for Regimen 1, 1.9% for Regimen 2, 0% for Regimen 3 and 1.6% for regimen 4. Haematoma/bleeding rates were as follows 1.06% Regimen 2, 5% Regimen 3, and 2.7% Regimen 4. Rates of serosanguineous exudate were as follows 0.2% Regimen 2, 8% Regimen 3 and 5.4% Regimen 4. Conclusion. Our move from Aspirin was based on local audit, which highlighted a higher than national average PE rate. A change towards oral based prophylaxis was based on ease of administration and potential reduction in costs. Although DVT/PE rates were lower with the oral thrombo-prophylaxis, bleeding and wound complications appear higher. This study highlights the need to monitor both VTE and bleeding rates when adopting any changes in protocol, with a view on individualised treatment on balance of risks


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 88 - 88
1 Nov 2016
Barrack R
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In his classic monograph entitled Low Friction Arthroplasty of the Hip, which was published in 1979, John Charnley dedicated a chapter to thromboembolic complications. The overall incidence of pulmonary embolism (PE) was approximately 8% and the incidence of death from PE approximately 1%. Surveys of orthopaedic surgeons who undertake total joint replacement conducted by The American Association of Hip and Knee Surgeons (AAHKS), 30 years later, showed that there was still no consensus as to the best form of prophylaxis with a wide variation of methods being used. In the past 3 years, for the first time there is uniformity in the recommendations of the American Academy of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP). Both groups have reached an agreement that the rate of DVT formation is not the ideal endpoint to use when assessing the efficacy of thromboprophylaxis after joint replacement, as had been done in previous drug trials. Most of these DVTs are asymptomatic and of questionable clinical significance. At least one recent study brings into question the association between the rate of DVT formation and that of subsequent symptomatic events. Both groups also focus on minimizing iatrogenic bleeding complications, which can lead to compromised clinical results, including limited movement and pain in the case of knee replacement and increased risk of infection in both knee and hip replacement. To further complete the uniformity of approach in the United States, the Center for Medicare and Medicaid Services (CMS), which administers the Surgical Care Improvement Program (SCIP) that monitors hospital compliance with VTE prophylaxis of hospitalised patients, has also changed their policy. Beginning January 2014, either aspirin or a compression device has been considered as acceptable measures for THR, TKR and hip fracture. The remarkable success reported from many centers with the use of aspirin and/or the use of a mobile compression device in patients without major risk factors, such as a prior history of symptomatic VTE, clearly indicate that aggressive pharmacoprophylaxis is not necessary for the vast majority of patients who undergo joint replacement


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_13 | Pages 95 - 95
1 Nov 2015
Barrack R
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Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were 18 years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began peri-operatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months post-operatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, twenty-eight (0.92%) had venous thromboembolism (20 distal deep venous thromboses, 3 proximal deep venous thromboses, and 5 pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provide a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_22 | Pages 84 - 84
1 May 2013
Barrack R
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After decades of clinical experience and hundreds of studies, the ideal method of deep vein thrombosis (DVT) prophylaxis remains controversial. One of the most widely quoted publications on the subject in recent years has been the guidelines published by the American College of Chest Physicians (ACCP). The seventh and eighth ACCP Conference on Antithrombotic Therapy and Prevention of Thrombosis were published in Chest in 2004 and 2008 respectively. The highest level recommendation (1-A) was reserved for Warfarin at a relatively high dose (target international normalised ratio (INR) of 2–3), Low Molecular Weight Heparin (LMWH), or Fondaparinux for a minimum of 10 days for both total hip and total knee replacement. These agents were recommended for all patients, regardless of their relative risk of bleeding or risk of venous thromboembolism (VTE). These recommendations were found to be aggressive by the standards of most orthopaedic surgeons and a number of issues were identified with the methodology and resulting recommendations of the ACCP including: The emphasis on multicentre randomised clinical trials that are enormously expensive and strongly weighted towards pharmaceutical sponsored studies, methodology that prevented inclusion of studies of lower cost, lower tech options such as aspirin or lower dose Warfarin since randomised trials on a large scale are not available due to lack of funding or pharmaceutical company interest in generic low-cost options, lack of consideration of pneumatic compression options such as newly available mobile foot pumps with chips for monitoring compliance, financial conflict of interest of virtually all of the authors of the guidelines and the fundamental problem with utilising asymptomatic DVT as a study endpoint. The concerns with the aggressive nature of these recommendations were confirmed by studies from two academic centres which reported a high incidence of wound and bleeding complications when changing to a 1-A protocol. Recent studies indicate that readmissions following joint replacement are much more likely to be due to wound drainage and bleeding complications than DVT or pulmonary embolism (PE). In response to these concerns, the AAOS released guidelines in 2008 that were updated in 2011. The resulting recommendations represented a dramatic departure from the ACCP guidelines. Clinically crucial endpoints such as PE and death were utilized in the analysis rather than asymptomatic DVT, which was the criteria utilised by the Chest Physicians and the 2011 recommendations also considered symptomatic DVT. The AAOS guidelines consider patient risk category rather than making a uniform recommendation for all patients. Much more discretion is given to surgeons to utilise less aggressive prophylactic strategies including aspirin and foot pumps. In 2012, the ninth edition of the ACCP guidelines was published and many of the concerns previously expressed over prior editions were successfully addressed. Conflict of interest among the authors was much less of an issue, there was more attention placed on symptomatic events and clinically important complications, and a wider scope of literature was considered. The resulting guidelines represented a dramatic departure from previous recommendations. Aspirin and pneumatic compression were elevated to level 1 recommendation status along with potent drug regimens such as injectable drugs (LMWH and Xa inhibitor) as well as the new oral Xa inhibitors and antithrombin agents. When pneumatic compression devices are utilised, the use of a battery powered device capable of recording compliance was recommended. Patient risk status as well as patient preference were also considered. The new ACCP guidelines have successfully addressed many of the concerns previously addressed and are much more in line with the AAOS guidelines. It is anticipated that the federal Surgical Care Improvement Project (SCIP) guidelines for VTE prophylaxis will be released in 2013 and will also embrace the changes recommended by the ACCP. It is further likely that the AAOS and ACCP guidelines are close enough that they may well join forces in the near future and release a single unified document


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 82 - 82
1 Jan 2016
Choi CH Chung KS Lee JK Shin TY
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Introduction. We investigated the incidence of venous thromboembolism (VTE) and pulmonary embolism (PE) after total knee arthroplasty (TKA) and assessed the efficacy and complications of three different chemical prophylactic regimens. Materials and Methods. From May, 2011 to November 2013, 268 patients, 330 knees were randomly allocated to three groups, low molecular weight heparin (LMWH) 5000IU for 2 days followed by aspirin 100mg for 5 days (Group HA, 110 knees), rivaroxaban 10mg for 7 days (Group X7, 110 knees), or for 10 days (Group X10, 110 knees) postoperatively. Intermittent pneumatic compression device was applied on all patients. The multidetector row computed tomography (MDCT) was done at postoperative 10 days to evaluate VTE (PE & DVT separately), and MDCT was rechecked to evaluate the changes of VTE at postoperative 3 months in VTE patients. Additionally, major and minor bleeding complications, amounts of bleeding, and bruise around wound were checked. Results. The incidence of VTE was 42 (38.2%) in Group HA, 22 (20.0%) in Group X7, 11 (10.0%) in Group X10. Deep vein thrombosis (DVT) was revealed 39 (35.5%) in Group HA, 17 (15.5%) in Group X7, 8 (7.3%) in Group X10. Group HA showed statistically higher prevalence in VTE and DVT than rivaroxavan groups. PE was detected 21 (19.1%) in Group HA, 11 (10.0%) in Group X7, 3 (2.7%) in Group X10. Group X10 was statistically significantly lower PE incidence than Group HA (p=0.0001) and Group X7 (p=0.027). Asymptomatic distal DVT was completely resolved in 88.8% with no specific treatment. There was no major or minor bleeding complications and bleeding amounts were not statistically different in 3 groups. Conclusion. Rivaroxaban has better prophylactic efficacy with no increasing bleeding complications than LMWH followed by aspirin. Ten days rivaroxaban was more effective for PE and VTE prevention than 7 days rivaroxavan. However, most of reduced VTEs were asymptomatic and distal DVTs


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_1 | Pages 40 - 40
1 Feb 2015
Barrack R
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Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, 28 (0.92%) had venous thromboembolism (20 distal deep venous thromboses, 3 proximal deep venous thromboses, and 5 pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provide a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 2 - 2
1 Feb 2020
Jenny J De Ladoucette A
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Introduction. Deep venous thrombosis (DVT) is a potentially serious complication after total hip (THA) and knee (TKA) arthroplasty, traditionally justifying aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) at the cost of an increased risk of bleeding. However, fast-track procedures might reduce the DVT risk and decrease the cost-benefit ratio of the current recommendations. The objective of this study was to compare thrombotic and bleeding risk in an unselected population of elective THA and TKA with a fast-track procedure. MATERIAL - METHODS. A series of 1,949 patients were analyzed prospectively. There were 1,136 women and 813 men, with a mean age of 70 years. In particular, 16% were previously treated by antiplatelet agents and 8% by anticoagulants. All patients followed a fast-track procedure including early walking within 24 hours of surgery, and 80% of patients returned home after surgery, with a mean length of stay of 3 days (THA) or 4 days (TKA). The occurrence of a thromboembolic event or hemorrhagic complication has been identified. Results. Out of the 1,110 THAs, 5 thromboembolic events were identified (0.4%): 2 non-fatal pulmonary embolism and 3 DVTs. There was no impact of these complications on the final result. 19 hemorrhagic complications were identified (1.7%): 10 significant haematomas (3 of which were complicated by infection), 9 anemias (with 4 transfusions). Out of the 839 TKAs, 9 thromboembolic events were identified (1.0%): 4 non-fatal pulmonary embolism and 5 DVTs. There was no impact of these complications on the final result. 14 hemorrhagic complications were identified (1.7%): 8 haematomas including 4 reoperations, 6 anemias (with 5 transfusions). Discussion. Thromboembolic complications after elective THA and TKA have virtually disappeared, with a rate of 0.7%. On the other hand, bleeding complications are now more frequent, with a rate of 1.7%. This suggests that the cost-benefit ratio of preventive treatments with LMWH or DOA should be reassessed. Prescribing LMWH or DOA after elective THA and TKA with fast-track procedures exposes the patient to a much higher risk of bleeding than thrombotic risk. The use of aspirin may represent an acceptable compromise in these patients


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 36 - 36
1 Jul 2014
Barrack R
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Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began peri-operatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months post-operatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thromboses, three proximal deep venous thromboses, and five pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provide a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 44 - 44
1 May 2014
Barrack R
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Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thromboses, three proximal deep venous thromboses, and five pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provides a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature