A device designed to prevent blood clots following joint replacement surgery received a boost of support last week from data presented at the American Academy of Orthopedic Surgeons (AAOS; Rosemont, Illinois) annual meeting in Las Vegas.
Medical Compression Systems (MCS; West Hills, California and Or Akiva, Israel) reported new data supporting the use of its ActiveCare DVT prophylaxis compression system following total joint replacement procedures. The study was selected as the best poster in the adult reconstruction category at AAOS.
"These encouraging results demonstrate that using a mobile compression device offers comparable efficacy for preventing thromboemboli, while introducing a significantly lower risk of associated complications," said Ryan Nunley, associate professor of orthopedic surgery at the University of Washington School of Medicine (St. Louis). "Furthermore, issues associated with drainage, bleeding events and wound problems were significantly lower in the standard risk patient group, which are critical factors that contribute to an overall higher level of patient satisfaction and reduced hospital readmissions."
VTE is a condition that includes both deep vein thrombosis (DVT), a blood clot in a deep vein in the lower extremities, and pulmonary embolism (PE), where the blood clot becomes dislodged and migrates to the lungs.
While doctors have always known that blood clots were a major issue after orthopedic surgery, Nunley told Medical Device Daily that the concern has received more attention lately as a number of professional athletes have had life-threatening encounters with DVT or PE. These high-profile cases have encouraged healthcare providers to take extra precautions to protect active patients from developing clots after surgery, Nunley said.
The study was designed to prospectively evaluate the safety and efficacy of the ActiveCare mobile compression device and warfarin for preventing venous thromboembolism (VTE) post-operatively, and to monitor patient satisfaction following each treatment regimen. Among 2,722 participants, 1,888 received standard-risk therapy and 834 received high-risk therapy. Standard risk patients wore ActiveCare for 10 days following elective total joint replacement of the hip or knee and took aspirin 325 mg twice daily for six weeks post-operatively. High-risk patients received adjusted-dose warfarin for four weeks and wore compression stockings for six weeks post-operatively.
Nunley said patients start using the device while they are still in the hospital and continue using it at home for about a week after discharge, for a total of 10 days.
Patients were followed prospectively for six months and monitored for bleeding complications, symptomatic VTEs, hospital readmissions and patient satisfaction with the two VTE prophylaxis treatment approaches. The rate of VTEs at four to six weeks were nearly identical in the standard risk and high risk groups (0.6% and 0.4% respectively) and no differences were found based on the type of joint replacement procedure. Drainage of greater than or equal to four days, rate of major bleeding events, and rate of wound problems were significantly higher in the high-risk group than in the standard group (21% vs. 14%), 2.0 vs. 0.3% and 1.3% vs. 0.2% respectively). Patients who were treated with ActiveCare were consistently more satisfied at two weeks and at four to six weeks vs. those who received high-risk anticoagulation therapy.
"These study results add to a growing body of evidence demonstrating that ActiveCare is clinically equivalent to anticoagulant therapy for preventing VTE post-operatively, with a significant decrease in complications and a high degree of patient satisfaction," said Timothy McCarthy, CEO of MCS. "As part of our ongoing efforts to support the needs of the orthopedic surgery community to deliver outstanding clinical results in the most cost-effective manner possible, we are actively working with scientific investigators to conduct additional research to not only reinforce the outstanding DVT prophylaxis ActiveCare delivers, but also to further demonstrate the value our offering brings to the entire healthcare system."
Nunley said that by reducing post-op complications, the ActiveCare device benefits the entire healthcare system by reducing readmission rates and unnecessary surgeries while at the same time keeping the patients satisfied.
"I think it will help to change clinical practice," Nunley said.