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.
BACKGROUND: Whereas routine prophylaxis for venous thromboembolism (VTE) is frequently utilized in the West, Asian physicians employ it much less often, based on its recorded rarity amongst their patients. This study was designed to examine the incidence of VTE and to determine the optimal method of thromboembolic prophylaxis following gastrectomy for cancer.
METHODS: In this prospective, randomized trial, patients were assigned to either an intermittent pneumatic compression (IPC) only or an IPC plus enoxaparin. The primary end point of this study was to determine the VTE incidence rate within 30 days of surgery. A history with physical examinations for VTE and a serum d-dimer test was scheduled on postoperative days (POD) 0, 1, 4, and 7. Duplex ultrasonography (DUS) was performed as an objective test for deep vein thrombosis at POD 4. An interim analysis was performed to determine if it was ethical to continue the study. This clinical trial was registered at www.clinicaltrials.gov (NCT01448746).
RESULTS: Among the 220 patients, 3 (all from the IPC group) were diagnosed with VTE; these cases were asymptomatic, having been detected only on DUS 4 days after surgery. Postoperative bleeding occurred in 12 cases, among which 11 patients were in the IPC plus enoxaparin group.
CONCLUSIONS: This interim analysis showed a higher incidence of VTE in the IPC group but a higher bleeding rate in the IPC plus enoxaparin group. We expect that this study, once completed, will provide information key to the determination of the optimal method for preventing VTE in Korean gastric cancer patients.
BACKGROUND/AIMS: The advantages of combined pharmacological and physical methods for venous thromboembolism (VTE) prophylaxis after colorectal surgery have not been clearly determined. The aim of this study is to compare the efficacy and safety of fondaparinux combined with intermittent pneumatic compression (IPC) with IPC alone for VTE prophylaxis after resection for colorectal cancer.
METHODOLOGY: Between June 2008 and March 2010, 137 consecutive patients with colorectal cancer (CRC) who underwent colorectal resection in our surgical unit were enrolled in the study. Patients were divided into 2 groups. The IPC group was treated with IPC alone as controls. The fondaparinux group was treated with IPC and received subcutaneous injections of fondaparinux once daily. The aim of this study was to compare the efficacy and safety of fondaparinux combined with IPC with IPC alone for VTE prophylaxis.
RESULTS: The demographic variables and risk factors, operating time, blood loss and length of the postoperative hospital stay were similar in the two groups. No clinically evident VTE, critical bleeding, and postoperative death occurred during the study period. No adverse reactions due to fondaparinux were observed.
CONCLUSIONS: In patients undergoing resection of colorectal cancer, receiving fondaparinux and IPC thromboprophylaxis was highly effective, well tolerated and safe. The use of combined modalities for VTE prophylaxis is justified in patients at high risk of VTE.
Deep-vein thrombosis (DVT) and pulmonary embolism (PE) represent life-threatening postoperative complications frequently responsible for in-hospital mortality following total knee arthroplasty (TKA). Mechanical prophylaxis in the form of a foot pump offers an alternative to pharmacological and physical therapy. The aim of this prospective and randomised study was to examine the clinical efficacy of the A-V Impulse (AVI) system in reduction of soft-tissue swelling of the lower limb following a TKA. A total of 80 patients undergoing cemented TKA between September 2005 and December 2006 were randomised into two groups of 40 patients (n¹ = 40, n² = 40) during the 16-month study period. All patients received a subcutaneous dose of low molecular weight heparin (LMWH) (Enoxaparin/Clexane® 40 mg) once daily beginning 24 hours prior to the operation. The mean age for the groups n¹ and n² were 68.93 and 68.15 years, respectively. The reduction of soft-tissue swelling in the n¹ group was significantly higher (p < 0.05) compared with n². Evaluation of body mass index (BMI) with regard to the average reduction of soft-tissue swelling showed no significant influence (p < 0.05). The better function of the operated knee in group AVI was a significant predictor for improved agility and mobility (p < 0.01). No complications were reported for the application of the AVI. No ultrasonographic evidence of DVT or PE was found in any of the 80 patients during the investigative time period of eight days. After three months, there was no evidence of a symptomatic DVT.
Prophylaxis against venous thromboembolism after elective total hip replacement is routinely recommended. Our preference has been to use mechanical prophylaxis without anticoagulant drugs. A randomised controlled trial was performed to evaluate whether the incidence of post-operative venous thromboembolism was reduced by using pharmacological anticoagulation with either fondaparinux or enoxaparin in addition to our prophylactic mechanical regimen. A total of 255 Japanese patients who underwent primary unilateral cementless total hip replacement were randomly assigned to one of three postoperative regimens, namely injection of placebo (saline), fondaparinux or enoxaparin. There were 85 patients in each group. All also received the same mechanical prophylaxis during and after the operation, regardless of their assigned group. The primary measurement of efficacy was the presence of a venous thromboembolic event by day 11, defined as deep-vein thrombosis detected by ultrasonography, documented symptomatic deep-vein thrombosis or documented symptomatic pulmonary embolism. The duration of follow-up was 12 weeks. The rate of venous thromboembolism was 7.2% with the placebo, 7.1% with fondaparinux and 6.0% with enoxaparin (p = 0.95 for the comparison of all three groups). Our study confirmed the effectiveness and safety of mechanical thromboprophylaxis without the use of anticoagulant drugs after total hip replacement in Japanese patients.
This preliminary prospective study to determine the rate of deep venous thrombosis (DVT) examined 277 patients undergoing total knee or total hip arthroplasty (TKA or THA) who were randomized to use a portable, continuous enhanced circulation therapy (CECT) compression device and low-molecular-weight heparin (LMWH) or to receive LMWH alone. Patients were screened for DVT using duplex ultrasound at hospital discharge and followed clinically for 3 months. In TKA, 5 DVTs (6.6%) occurred in the CECT + LMWH group compared with one pulmonary embolism and 14 DVTs (19.5%) in the LMWH group (P = .018). In THA, 1 DVT (1.5%) occurred in the CECT + LMWH group and 2 DVTs (3.4%) occurred in the LMWH group. This preliminary study demonstrated significant reduction in rate of DVT after TKA when the CECT device was combined with LMWH.
Conférence»1st Joint Congress, European Association for Trauma and Emergency Surgery–EATES and European Trauma Society–ETS
Year»2007
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INTRODUCTION: La thromboembolie veineuse (TEV) la cause de morbidité et de mortalité dans les lésions traumatiques. L'objectif de cette étude était d'évaluer l'efficacité et la sécurité des dispositifs de compression pneumatique intermittente (CPI) avec ou sans héparine de bas poids moléculaire (HBPM) dans la prévention de la thromboembolie veineuse chez les patients victimes de traumatismes. MÉTHODES: de Janvier 2000 à Novembre 2002, les 120 patients atteints de traumatismes ont été inclus dans l'étude. Groupe A, B et C ont été traités avec des dispositifs seulement CIB, dispositifs IPC ainsi HBPM (40 mg par jour) et seulement HBPM (40 mg par jour), respectivement, et chaque groupe était constituée de 40 patients. duplex de flux de couleur (CFD) des membres inférieurs a été obtenu le septième jour d'hospitalisation et avant la décharge.
Mollet et la cuisse circonférences ont également été mesurées quotidiennement et D-dimères ont été obtenues en cas de signes cliniques suspects de TVP. RÉSULTATS: thrombose veineuse profonde développé sur 4 (10%), 2 (5%), 2 (5%) des patients du groupe A, B, et C respectivement. Deux patients (5%) dans le groupe A et C et un patient (2,5%) dans le groupe B présentaient des signes cliniques d'embolie pulmonaire et SCT a révélé EP massive. Aucun des patients avec PE a survécu. Onze (27,5%), huit (20%) et treize (32,5%) patients ont été perdus à cause de plusieurs raisons autres que le PE. CONCLUSION: IPC peut être utilisé en toute sécurité en combinaison avec ou sans HBPM dans la prophylaxie TVP. IPC peut être considéré comme prophylaxie contre la TVP chez les patients qui ont eu de contre-indication pour l'anticoagulation. Aucun effet addictif de l'IPC à HBPM est apparent.
CONTEXTE: Les régimes thérapeutiques actuels qui sont conçus pour prévenir la thrombose veineuse profonde chez les patients subissant des interventions orthopédiques comptent surtout sur la prophylaxie médicamenteuse seule. Le but de cette étude clinique randomisée était d'évaluer l'efficacité d'un complément à la chimioprophylaxie mécanique qui implique une compression intermittente des jambes. MÉTHODES: Au cours d'une période de vingt-deux mois, 1803 patients subissant une variété de procédures orthopédiques ont été prospectivement randomisés pour recevoir soit la chimioprophylaxie seul ou une combinaison de la chimioprophylaxie et la prophylaxie mécanique. Neuf cent deux patients ont été gérées à bas poids moléculaire héparine seule, et 901 ont été gérées à bas poids moléculaire et l'héparine de compression pneumatique intermittente des veaux pour différentes périodes. Vingt-quatre pour cent des patients ont subi une prothèse totale de hanche ou de genou. Le dépistage de la thrombose veineuse profonde a été réalisée sur le jour de sortie en duplex-code couleur échographie. RÉSULTATS: Dans le groupe chimioprophylaxie seule, quinze patients (1,7%) ont été diagnostiqués avec une thrombose veineuse profonde; trois thromboses étaient symptomatiques. Dans la chimioprophylaxie, plus intermittente groupe de compression pneumatique, quatre patients (0,4%) ont été diagnostiqués avec une thrombose veineuse profonde; une thrombose était symptomatique. La différence entre les groupes en ce qui concerne la prévalence de la thrombose veineuse profonde était significative (p = 0,007). Dans la chimioprophylaxie, plus intermittente groupe de compression pneumatique, aucun thromboses veineuses profondes ont été trouvés chez les patients qui ont reçu plus de six heures de la compression pneumatique intermittente quotidienne. CONCLUSIONS: prophylaxie thrombose veineuse à faible poids moléculaire héparine complétée par un dispositif qui offre rapide de l'inflation compression pneumatique intermittente aux veaux a été jugé significativement plus efficace pour prévenir la thrombose veineuse profonde par rapport à une régime de traitement qui a impliqué de bas poids moléculaire -poids l'héparine seule.
CONTEXTE: L'avantage de combinés méthodes mécaniques et pharmacologiques pour la prévention thrombo-embolie veineuse après une chirurgie abdominale n'a pas été clairement établi. OBJECTIFS: Pour comparer l'efficacité et l'innocuité du fondaparinux en conjonction avec la compression pneumatique intermittente vs compression pneumatique intermittente seul dans ce contexte. PATIENTS ET MÉTHODES: Il s'agissait d'une étude randomisée, en double aveugle, essai de supériorité contre placebo. Les patients âgés d'au moins 40 ans subissant une chirurgie abdominale ont été randomisés pour recevoir soit du fondaparinux 2,5 mg ou un placebo pendant sc 5-9 jours, en commençant 6-8 h après l'opération. Tous les patients ont reçu la compression pneumatique intermittente. Le critère principal d'efficacité a été la thromboembolie veineuse jusqu'à 10 jours. Les résultats principaux étaient la sécurité des saignements majeurs et la mortalité toutes causes. Suivi a duré 32 jours. RÉSULTATS: Parmi les 1309 patients randomisés, 842 (64,3%) étaient évaluables pour l'efficacité. Le taux de thrombo-embolie veineuse était de 1,7% (7/424) chez les patients traités par fondaparinux-et de 5,3% (22/418) chez les patients traités par placebo (odds ratio de réduction de 69,8%, intervalle de confiance de 95% de 27,9 à 87,3; P = 0,004 ). Le fondaparinux a réduit significativement le taux de profonde proximale thrombose veineuse de 1,7% (7/417) à 0,2% (1/424; P = 0,037). Saignements majeurs sont survenus chez 1,6% (10/635) et 0,2% (1/650) du fondaparinux traités et les patients sous placebo, respectivement (P = 0,006), aucun n'étant fatal ou impliquant un organe critique. En 32 jours, huit patients (1,3%) recevant le fondaparinux et cinq (0,8%) recevant le placebo était mort. CONCLUSIONS: Chez les patients subissant une chirurgie abdominale et la réception de la compression pneumatique intermittente, fondaparinux 2,5 mg a réduit le taux de thrombo-embolie veineuse de 69,8% par rapport à la compression pneumatique seul, avec un risque de saignement faible par rapport au placebo.
Deux cent soixante-cinq patients subissant une arthroplastie totale du genou unilatérale ont été prospectivement randomisés pour recevoir une anesthésie rachidienne péridurale (SEA), un dispositif de compression VenaFlow veau, et de l'énoxaparine (groupe A) ou de l'EES, VenaFlow, et de l'aspirine (groupe B). L'aspirine a été commencé le jour de la chirurgie, alors que l'énoxaparine a été commencé 48 heures après la chirurgie. Les anticoagulants ont été poursuivi pendant 4 semaines après la chirurgie. Tous les patients avaient un test à l'hôpital échographie de dépistage sur les jours post-opératoires de 3 à 5 et un suivi de la deuxième échographie de 4 à 6 semaines après la chirurgie. Les généraux profondes taux de thrombose veineuse dans les groupes A et B étaient de 14,1% et 17,8% (P = non significatif), respectivement. Lorsqu'il est utilisé en combinaison avec des dispositifs de compression pneumatique et la mer, l'énoxaparine n'était pas supérieure à l'aspirine dans la prévention de la thrombose veineuse profonde après une arthroplastie totale du genou.
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.
