Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP): A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of using wearable activity monitors (WAMs) in patients with intermittent claudication (IC) within a single-center randomized controlled trial. BACKGROUND: WAMs allow users to set daily activity targets and monitor their progress. They may offer an alternative treatment to supervised exercise programs (SEPs) for patients with IC. METHODS: Thirty-seven patients with IC were recruited and randomized into intervention or control group. The intervention consisted of a feedback-enabled, wrist-worn activity monitor (WAM) in addition to access to SEP. The control group was given access to SEP only. The outcome measures were maximum walking distance (MWD), claudication distance (CD), and quality of life as measured by the VascuQol questionnaire. Participants were assessed upon recruitment, and at 3, 6, and 12 months. RESULTS: Patients in the WAM group showed significant improvement in MWD at 3 and 6 months (80-112 m, to 178 m; P < 0.001), which was sustained at 12 months. The WAM group also increased CD (40 vs 110 m; P < 0.001) and VascuQol score (4.7 vs 5.8; P = 0.004). The control group saw a temporary increase in VascuQol score at 6 months (4.5 vs 4.7; P = 0.028), but no other improvements in MWD or CD were observed. Significantly higher improvements in MWD were seen in the WAM group compared with that in the control group at 6 months (82 vs -5 m; P = 0.009, r = 0.47) and 12 months (69 vs 7.5 m; P = 0.011, r = 0.52). CONCLUSIONS: The study demonstrates the significant, sustained benefit of WAM-led technologies for patients with IC. This potentially resource-sparing intervention is likely to provide a valuable adjunct or alternative to SEP.

Improved catheter navigation with 3D electromagnetic guidance.

PURPOSE: To evaluate the in vitro performance of an electromagnetic navigation system (ENS) in aortic arch branch cannulation and describe its role for fenestrated endograft deployment. METHODS: Reconstructed multidetector computed tomography images of silicone phantoms representing the aortic arch and a thoracoabdominal aortic aneurysm were uploaded onto the StealthStation workstation, which provided 3-dimensional visualization of a guidewire by tracking sensors on its tip. For the evaluation of aortic arch branch cannulation, 9 operators were asked to cannulate the phantom's common carotid and left subclavian arteries using the (1) ENS, (2) a 2-dimensional (2D) screen setting simulating fluoroscopy, and (3) both imaging modalities. Analysis included procedure times, number of wall hits, and the Imperial College Complex Cannulation Scoring Tool (IC3ST) qualitative performance score. To evaluate the ability of the ENS during positioning of a fenestrated stent-graft over the visceral segment, a custom-made 4-vessel fenestrated stent-graft with sensors on the fenestrations was deployed 5 consecutive times using the ENS as the exclusive imaging technique. RESULTS: In the aortic arch model, cannulation times were significantly longer in the ENS group. However, compared with the 2D version, using both imaging modalities reduced fluoroscopic times [median 26.5 seconds (IQR 19.7-30.7) vs. 87 seconds (IQR 64-128), p<0.0001] and wall hits [median 8.5 (IQR 16-38) vs. 14 (IQR 11-160, p<0.05), while improving IC3ST performance scores [31/35 (IQR 30-31.2) vs. 25/35 (IQR 24-27), p<0.05]. Following deployment of the endograft with tracked fenestrations, the 4 visceral vessels were cannulated in all cases using only the ENS. CONCLUSION: The use of the ENS as a complementary imaging modality might be beneficial in terms of radiation exposure, cannulation performance, and positioning of intravascular devices.