Are wearables passe? The use of an implantable Micro-Oxygen Sensor (MOXYs)

Our team at SALSA have been partnering with the clever folks at PROFUSA. We think this area is enormously promising. Perhaps “what are you wearing?” will soon be less important than “what’s on the inside?”.

The Use of Micro-Oxygen Sensors (MOXYs) to Determine Dynamic Relative Oxygen Indices in the Foot of Patients with Critical Limb Ischemia (CLI) During an Endovascular Therapy: The First-in-Man ‘Si Se Puede’ Study – Journal of Vascular Surgery.

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Article Outline

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Objective
Methods
Results
Conclusions

Objective

Critical limb ischemia (CLI) patients exhibit uneven patterns of perfusion in the foot, which makes it challenging to determine adequate topographic needs by angiography alone. This study assessed the feasibility of reporting dynamic relative oxygen indices from multiple locations on the foot during endovascular therapy, using a novel micro-oxygen sensor (MOXYs) approach.

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Objective
Methods
Results
Conclusions

Methods

A prospective, 28-day, single-arm, observational study was performed on 10 patients who underwent endovascular therapy for CLI. At least 24 hours before therapy, four MOXYs were injected in each patient, one in the arm and three in the treated foot. The optical signal from the MOXYs corresponds to relative oxygen concentration. A custom detector on the surface of the skin was used to continuously and noninvasively measure the sensors. The ability to locate and read the signal from each injected MOXY was characterized. Oxygen data from the MOXYs were collected throughout the revascularization procedure. The timing of therapy deployment was recorded during the procedure to assess its relationship with the oxygen data from the MOXYs. Moreover, oxygen data collection and clinical evaluation were performed immediately postoperatively as well as on postoperative days 7, 14, 21, and 28. The study protocol was approved by the CEATE Research Foundation IRB of Costa Rica; informed consent was obtained from patients before study procedures.

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Objective
Methods
Results
Conclusions

Results

Ten CLI patients (50% male) were enrolled (30% class 4, 70% class 5), and the mean age was 70.7 years (range, 46-90 years). All patients were Hispanic of varying origins (European and indigenous origins). MOXYs were successfully read 209 of 212 times (98.6%) in all patients during the course of the study. Sensors were compatible with intraoperative use in the catheterization laboratory and postoperative use in an office setting. In nine of 10 revascularization procedures, at least one of the three MOXYs showed immediate change in dynamic relative oxygen indices, correlating to deployed therapy (Fig). There were no adverse events related to the microsensor materials.

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Objective
Methods
Results
Conclusions

Conclusions

The study results show that use of MOXYs in CLI merits further testing to determine its potential effect on clinical decision making that ultimately can lead to improved healing and limb salvage rates.

Fig

An Example of Dynamic Relative Oxygen Indices (DROIDS) versus Time during endovascular therapy showing the effect of delivered therapy on local perfusion on the foot.

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