Abstract
OBJECTIVE: Intermittent pneumatic compression (IPC) is considered the standard of care for preventing venous thromboembolism (VTE) in the hospital setting. However, its widespread adoption after hospitalization has been limited due to its shortcomings in obstruction of venous valves and blood reflux. The objective of this study is to compare the effects of continuous graduated pneumatic compression (CGPC), a new device with a novel mechanism, and IPC on lower hemodynamics and the incidence of VTE in patients undergoing arthroplasty. METHODS: We randomized 123 participants undergoing knee arthroplasty to receive either IPC or CGPC from June 2022 through August 2023. An experienced sonographer used a Doppler ultrasound scanner to obtain hemodynamic indicators of venous blood. The primary outcome was the blood velocity of the femoral vein measured by a Doppler scanner. Secondary outcomes included the hemodynamic of the femoral vein and popliteal vein, quality of life at discharge and 30 days after surgery, symptomatic and asymptomatic VTE up to 30 days, and adverse events related to the IPC and CGPC device. For statistical analyses, Student's t-test, analysis of covariance, and the Mann-Whitney U test were used. Statistical significance was indicated with p < 0.05. RESULTS: There was no significant difference in femoral vein velocity between the IPC and CGPC groups. However, CGPC demonstrated a significant increase in femoral vein flow compared to the IPC group, with a median (interquartile) increasing from 158.9 (122.9, 204.3) to 265.6 (203.3, 326.8) mL/min in the CGPC group and from 139.0 (103.3, 175.9) to 189.6 (161.4, 270.8) mL/min in the IPC group (p < 0.001). Similar trends were observed in popliteal vein measurements. The differences between the two groups were similar in terms of quality of life, incidence of VTE, and adverse events. CONCLUSION: The CGPC device provides a substantial increase in blood flow compared to the IPC device. Its safety and effectiveness have been preliminarily validated. The CGPC device presents a promising alternative for VTE prophylaxis in arthroplasty. TRIAL REGISTRATION: Chinese Clinical Trial Registry (registration number: ChiCTR2300078201).