Patient-centered outcomes of a dual action pneumatic compression device in comparison to compression stockings for patients with chronic venous disease.

Abstract

The ACTitouch (AT) device (Tactile Medical, Minneapolis, Minn) represents a new generation of pneumatic compression devices by combining sustained compression with intermittent pneumatic compression. The sustained compression mode provides automatic pressure adjustment every 30minutes, ensuring pressure consistency regardless of leg volume changes and environmental influences. Designed for mobile patients, this device has not been studied in comparison to standard compression stockings (CS). A two-arm, randomized, multicenter pilot study was conducted. Patients with primary chronic venous disease (C3-C6) and a documented history of low adherence to compression therapy were randomized at 10 centers to use the AT device or 30 to 40mm Hg graduated CS. Primary end points were patient-reported comfort and ease of use. Secondary end points included compliance (measured by a device meter and patient diaries), limb volume change (by water displacement and circumferences), and change in disease severity (using Venous Clinical Severity Score, Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms, and EuroQol-5 Dimension 3-Level). Patients were assessed at 15 and 30days after randomization. Eighty-nine patients (136 limbs) received either AT (66 limbs) or CS (70 limbs). Patients in the AT group found the device easy to apply (71% compared with 37.5% in the CS group; P= .0001), easy to remove (89% compared with 59% in the CS group; P= .0001), and comfortable to wear (71% compared with 58% in the CS group; P= .125). Compliance with compression was not significantly different between the groups (100% vs 88%, AT and CS groups, respectively, at 15days; 87% vs 85% at the end of the study; P= .97). Daily use was not different either (10.7hours in the AT group, 11.7± 2.7hours in the CS group). In the AT group, in addition to self-reporting, the patient's compliance was objectively measured by a usage meter built into the device. The average time of compression use reported by patients was 2.5hours higher than measured by the device, and the limits of agreement were-6hours to+11hours. These findings indicate that self-reported time of use is highly unreliable and tends to overestimate the actual use. This is the first trial comparing an adaptive pneumatic compression device with CS in previously noncompliant patients with C3 to C6 chronic venous disease. The study demonstrated that even within limitations of a pilot project, use of the AT device is comparable to CS in the patient's acceptance and compliance and likely to have equal or better clinical outcomes.