Abstract
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.
