AIM: To investigate the potential role of a novel electrostimulation device in augmenting the femoral vein venous blood flow following total knee replacement surgery.
MATERIAL AND METHODS: A total of 30 consecutive patients undergoing total knee replacement were allocated to receive either peroneal nerve electrostimulation plus low molecular weight heparin and below-knee compression stockings (Group 1, electrostimulation group, n = 15, mean age: 63.40 ± 5.91 years, male: female ratio 9:6) or low molecular weight heparin and below-knee compression stockings alone (Group 2, control group, n = 15, mean age: 63.86 ± 7.47 years, male: female ratio 8:7). Electrostimulation was performed for 1 h in every 4 h after the operation. Peak blood velocity in the femoral vein was evaluated with Duplex ultrasonongraphy in supine position. Presence of leg edema and calf diameter was also taken into consideration as outcome measures, which were recorded both before surgery and at the time of discharge from hospital.
RESULTS: Postoperative peak blood flow velocity in the femoral vein was significantly higher in electrostimulation group compared to control group (17.46 ± 2.86 cm/s vs. 13.84 ± 3.58 cm/s, p < 0.02). Electrostimulation group achieved a significant increase in peak blood flow velocity in the femoral vein after the operation (mean increase 67.48 ± 17.38%, p < 0.001).
CONCLUSION: Electrostimulation of the common peroneal nerve enhanced venous flow in the lower limb and may potentially be of use as a supplementary technique in deep venous prophylaxis following lower limb orthopedic operations.
We conducted a randomized clinical trial to compare the effectiveness of the A-V Impulse System foot pump for reducing the incidence of deep-vein thrombosis (DVT) after total knee arthroplasty (TKA) in patients under edoxaban thromboprophylaxis. Patients undergoing primary TKA at our institution between September 2013 and March 2015 were enrolled after obtaining informed consent. The patients were randomized to use the foot pump (n = 58) and not to use the foot pump (n = 62). Both groups were given prophylactic edoxaban. Primary outcomes were any DVT as detected by bilateral ultrasonography up to postoperative day 10 (POD10) and pulmonary embolism (PE) up to POD28. The safety outcomes were bleeding and death of any cause up to POD28. Plasma D-dimer levels were measured before TKA and on POD10 after TKA. Immunoglobulin G (IgG)-class anti-PF4/heparin antibodies were measured using an IgG-specific enzyme-linked immunosorbent assay. The incidences of any DVT up to POD28 were 31.0% and 17.7% in patients with or without the foot pump, respectively. The incidences of major bleeding up to POD28 were 5.1% and 4.8% in patients with or without the foot pump, respectively. Foot pump use did not significantly reduce the incidence of DVTs in patients undergoing TKA under edoxaban thromboprophylaxis. Although seroconversion of anti-PF4/heparin antibodies was confirmed in one-fourth of patients, the seroconversion rates did not differ between patients with (20.7%) or without (25.8%) foot pump use. This study shows that the A-V Impulse system foot pump did not affect the incidence of DVT under edoxaban thromboprophylaxis in patients undergoing TKA. Seroconversion of anti-PF4/heparin antibodies was detected in a significant number of patients who underwent TKA under antithrombotic prophylaxis using edoxaban.
This prospective study was conducted to report the effect of oral factor Xa inhibitor and low-molecular-weight heparin (LMWH) on surgical complications following total hip arthroplasty (THA). The patients with an age < 60 years were randomly assigned to three groups (rivaroxaban, enoxaparin, and placebo) and the patients with an age ≥ 60 years were assigned to two groups (rivaroxaban and enoxaparin). All drug regimens started at 12 hours postoperatively and continued for two weeks after surgery. Primary measure outcome was major surgical wound complications defined as haematoma requiring any intervention, superficial wound infection, deep periprosthetic infection, and increased wound bleeding. Secondary measured outcome included minor surgical complications (swelling, drainage, erythema, and oozing), organ bleeding, and venous thromboembolic (VTE) events. A total of 184 patients aged < 60 years and 167 patients aged ≥ 60 years were included as the analysis population per group. Up to 14 days after surgery, the overall incidence of major surgical complications associated with thromboprophylaxis was 6.5 % (58/886). There were no significant differences in the rate of major surgical complications among all the three groups of the patients aged < 60 years and between two groups of the patients aged ≥ 60 years. For the patients aged < 60 years, wound oozing continued significantly longer in the pharmacological group than in the placebo group, but wound infection did not occur in any case. The VTE events were similar in all the groups.
BACKGROUND: Deep venous thrombosis (DVT) is a common complication of arthroplasty in old patients. We analyzed risk factors for lower-limb DVT after arthroplasty in patients aged over 70 years to determine controllable risk factors.
METHODS: This was a retrospective study of 1,025 patients aged >70 years treated with knee arthroplasty at our hospital between January 2009 and December 2013. Of 1,025 patients, 175 had postoperative lower-limb DVT. We compared medical history, body mass index (BMI), ambulatory blood pressure, preoperative and postoperative fasting blood glucose (FBG), preoperative blood total cholesterol, triglyceride, high- and low-density lipoprotein cholesterol, and preoperative homocysteine (Hcy) between thrombus and non-thrombus groups. B-mode ultrasonography was used to detect lower-limb DVT before the operation and 7 days after the operation in all patients. Logistic regression analysis was used to determine risk factors for DVT.
RESULTS: Incidence of diabetes (P = 0.014), BMI (P = 0.003), preoperative FBG (P = 0.004), postoperative FBG (P = 0.012), and preoperative Hcy (P < 0.001) were significantly higher in the thrombus group. A significantly greater proportion of patients in the non-thrombus group had early postoperative activity (P < 0.001) and used a foot pump (P < 0.001). Operative duration was significantly longer in the thrombus group (P = 0.012). Within the thrombus group, significantly more patients had bilateral than unilateral knee arthroplasty (P < 0.01). Multivariate logistic analysis revealed BMI, preoperative Hcy, postoperative FBG, long operative duration, bilateral knee arthroplasty, and time to the activity after the operation to be predictive factors of DVT. At 6-month follow-up of the thrombus group, 4.7% of patients had pulmonary embolism and 18.8% had recurrent DVT; there were no deaths.
CONCLUSIONS: Obesity, inactivity after operation, elevated preoperative Hcy and postoperative FBG, long operative duration, and bilateral knee arthroplasty were risk factors for DVT in patients aged over 70 years.
Journal»中国组织工程研究与临床康复 (Chinese Journal of Tissue Engineering Research)
Year»2015
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BACKGROUND: After knee joint replacement, patients are often treated with Rivaroxaban and Enoxaparin Sodium for postoperative anticoagulation, avoiding the formation of deep vein thrombosis in lower limbs. OBJECTIVE: To explore the application effects of different anticoagulant drugs in patients with knee joint replacement. METHODS: Ninety patients underwent knee joint replacement in Xiangya Second Hospital of Central South University from July 2011 to July 2014, were randomly divided into two groups, with 45 patients in each group. The experimental group was treated with Rivaroxaban, while the control group was treated with Enoxaparin. RESULTS AND CONCLUSION: Postoperative drainage volume, total blood transfusion, bleeding index, quantity of blood platelet, activated partial thromboplastin time, thrombin reduction time, whole blood viscosity, plasma viscosity, D-dimer coagulation index, HSS score at postoperative 2 weeks, average ecchymosis area, average thigh circumference, and average leg circumference were significantly better in the experimental group, than in the control group(P 0.05). The incidence of deep vein thrombosis of lower limbs in the experimental group was lower than that in the control group(P 0.05). Experimental findings indicate that, both Rivaroxaban and Enoxaparin can exert anticoagulation effect during the knee joint replacement, and Rivaroxaban is better.
BACKGROUND: Experimental data indicate that reducing factor XI levels attenuates thrombosis without causing bleeding, but the role of factor XI in the prevention of postoperative venous thrombosis in humans is unknown. FXI-ASO (ISIS 416858) is a second-generation antisense oligonucleotide that specifically reduces factor XI levels. We compared the efficacy and safety of FXI-ASO with those of enoxaparin in patients undergoing total knee arthroplasty.
METHODS: In this open-label, parallel-group study, we randomly assigned 300 patients who were undergoing elective primary unilateral total knee arthroplasty to receive one of two doses of FXI-ASO (200 mg or 300 mg) or 40 mg of enoxaparin once daily. The primary efficacy outcome was the incidence of venous thromboembolism (assessed by mandatory bilateral venography or report of symptomatic events). The principal safety outcome was major or clinically relevant nonmajor bleeding.
RESULTS: Around the time of surgery, the mean (±SE) factor XI levels were 0.38±0.01 units per milliliter in the 200-mg FXI-ASO group, 0.20±0.01 units per milliliter in the 300-mg FXI-ASO group, and 0.93±0.02 units per milliliter in the enoxaparin group. The primary efficacy outcome occurred in 36 of 134 patients (27%) who received the 200-mg dose of FXI-ASO and in 3 of 71 patients (4%) who received the 300-mg dose of FXI-ASO, as compared with 21 of 69 patients (30%) who received enoxaparin. The 200-mg regimen was noninferior, and the 300-mg regimen was superior, to enoxaparin (P<0.001). Bleeding occurred in 3%, 3%, and 8% of the patients in the three study groups, respectively.
CONCLUSIONS: This study showed that factor XI contributes to postoperative venous thromboembolism; reducing factor XI levels in patients undergoing elective primary unilateral total knee arthroplasty was an effective method for its prevention and appeared to be safe with respect to the risk of bleeding. (Funded by Isis Pharmaceuticals; FXI-ASO TKA ClinicalTrials.gov number, NCT01713361.).
INTRODUCTION: Clinical trials have provided evidence about efficacy and safety of extended thromboprophylaxis among total hip replacement (THR) patients. There is a lack of evidence on effectiveness and safety of extended treatment in unselected patients from routine clinical practice. We examined the effectiveness and safety of short (1-6 days) and standard (7-27 days) compared with extended (≥28 days) thromboprophylaxis using population-based design.
MATERIAL AND METHODS: Among all primary THR procedures performed in Denmark from 2010 through 2012 (n=16,865), we calculated adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for risk of symptomatic venous thromboembolism (VTE) and major bleeding, in addition to net clinical benefit, defined as the number of VTE avoided minus the number of excess bleeding events occurring among patients prescribed short-term and standard versus extended treatment.
RESULTS: The 90-day risks of VTE were 1.1% (short), 1.4% (standard), and 1.0% (extended), yielding aHRs of 0.83 (95% CI: 0.52-1.31) and 0.82 (95% CI: 0.50-1.33) for short and standard versus extended treatment. The risk of major bleeding was 1.1% (short), 1.0% (standard), and 0.7% (extended), resulting in aHRs of 1.64 (95% CI: 0.83-3.21) and 1.24 (95%CI: 0.61-2.51) for short and standard versus extended thromboprophylaxis. Direct comparison between benefits and harms using net clinical benefit analyses did not favor any of the three treatment durations. The same results were found for VTE or death.
CONCLUSIONS: In a real-word observational cohort of unselected THR patients, we observed no difference in the risks of symptomatic VTE, VTE/ death or bleeding with respect to thromboprophylaxis duration.
Background: In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan. Methods: This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n = 307) or enoxaparin 2000 IU (equivalent to 20 mg) twice daily (n = 303) for 11 to 14 days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding. Results: The incidence of VTE, based on venography and clinical surveillance, was 2.4 % in the edoxaban group and 6.9 % in the enoxaparin group (P <0.001). The absolute difference in the incidence of VTE was -4.5 % (95 % confidence interval [CI]: -8.6, -0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (P = 0.475). Conclusions: Oral edoxaban 30 mg once daily was superior to subcutaneous enoxaparin 2000 IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding.
The efficacy and safety of the new oral anticoagulants (NOAC) and the benefits of extended duration thromboprophylaxis following hip and knee replacements remain uncertain. This observational study describes the relations between thromboprophylaxis policies following hip and knee replacements across England's NHS and patient outcomes between January 2008 and December 2011. From the national administrative database, we analyzed mortality, thromboembolic complications, emergency readmission, and bleeding rates for 201,418 hip and 230,282 knee replacements. There were no differences in outcomes for either LMWH or NOAC. We found no advantage in favor of any single anticoagulation policy or in changing policy. This study supports the American Academy of Orthopaedic Surgeons' recommendation that the choice and duration of thromboprophylaxis prophylaxis be decided by the treating surgeon.
In this randomized trial, we compared the hemodynamic effects of 2 different methods of bilateral sequential pneumatic compression (Simultaneous compression with Fixed cycling rate [SF] vs Alternate compression with Adjusted cycling rate [AA]) and investigated whether venous flow augmentation influenced deep vein thrombosis (DVT) development in patients undergoing total knee arthroplasty. Pneumatic compression was started on the operation day and applied to discharge. A total of 108 limbs was evaluated by computed tomographic angiography and duplex ultrasound. Augmented peak volume flow (P = .008), expelled total volume (P < .001), and expelled peak volume (P < .001) were significantly larger in group SF. The DVT developed in 35 (32.4%) limbs, and they were neither symptomatic nor ileofemoral in location. The enhanced hemodynamic parameters did not influence the DVT development. In conclusion, group SF showed superior hemodynamic efficacy, but this superiority may not be a surrogate for better thromboprophylaxis.
To investigate the potential role of a novel electrostimulation device in augmenting the femoral vein venous blood flow following total knee replacement surgery.
MATERIAL AND METHODS:
A total of 30 consecutive patients undergoing total knee replacement were allocated to receive either peroneal nerve electrostimulation plus low molecular weight heparin and below-knee compression stockings (Group 1, electrostimulation group, n = 15, mean age: 63.40 ± 5.91 years, male: female ratio 9:6) or low molecular weight heparin and below-knee compression stockings alone (Group 2, control group, n = 15, mean age: 63.86 ± 7.47 years, male: female ratio 8:7). Electrostimulation was performed for 1 h in every 4 h after the operation. Peak blood velocity in the femoral vein was evaluated with Duplex ultrasonongraphy in supine position. Presence of leg edema and calf diameter was also taken into consideration as outcome measures, which were recorded both before surgery and at the time of discharge from hospital.
RESULTS:
Postoperative peak blood flow velocity in the femoral vein was significantly higher in electrostimulation group compared to control group (17.46 ± 2.86 cm/s vs. 13.84 ± 3.58 cm/s, p < 0.02). Electrostimulation group achieved a significant increase in peak blood flow velocity in the femoral vein after the operation (mean increase 67.48 ± 17.38%, p < 0.001).
CONCLUSION:
Electrostimulation of the common peroneal nerve enhanced venous flow in the lower limb and may potentially be of use as a supplementary technique in deep venous prophylaxis following lower limb orthopedic operations.
