The First-in-Man “Si Se Puede” Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients.

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Presentation transcript:

The First-in-Man “Si Se Puede” Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy Miguel F. Montero-Baker, MD, Kit Yee Au-Yeung, PhD, Natalie A. Wisniewski, PhD, Soya Gamsey, PhD, Luis Morelli-Alvarez, MD, Joseph L. Mills, MD, Marianella Campos, MD, Kristen L. Helton, PhD Journal of Vascular Surgery Volume 61, Issue 6, Pages 1501-1510.e1 (June 2015) DOI: 10.1016/j.jvs.2014.12.060 Copyright © 2015 Society for Vascular Surgery Terms and Conditions

Fig 1 A case study of dynamic relative oxygen indices (DROIDS) vs time during endovascular therapy shows the relationship of delivered therapy on local tissue oxygen in the foot. On the far right side of the image is a topographic descriptor of where the sensors were placed in the patient's foot. The Supplementary Fig (online only) demonstrates quick changes in tissue oxygen levels after delivery of therapy in patients with popliteal-tibial disease. Journal of Vascular Surgery 2015 61, 1501-1510.e1DOI: (10.1016/j.jvs.2014.12.060) Copyright © 2015 Society for Vascular Surgery Terms and Conditions

Fig 2 Box and whisker plot shows the dynamic relative oxygen index (DROID). DROID is calculated as the micro-oxygen sensor (MOXY) value from the arm/MOXY value from the foot. The horizontal lines in the middle of each box represent the median value of the sensors at each time of measurement included in the study protocol. The top and bottom borders of the box mark the 75th and 25th percentiles, respectively, the whiskers mark the lowest and highest datum within 1.5 of the interquartile range of the lower and upper quartile, respectively (Tukey boxplot), and the circles indicate outliers. Stdev, Standard deviation. Journal of Vascular Surgery 2015 61, 1501-1510.e1DOI: (10.1016/j.jvs.2014.12.060) Copyright © 2015 Society for Vascular Surgery Terms and Conditions

Fig 3 Comparison of arm and foot sensors' oxygen concentration (μM) before (pre) and after (post) revascularization. The horizontal lines in the middle of each box represent the median value, the top and bottom borders of the box mark the 75th and 25th percentiles, respectively, the whiskers mark the lowest and highest datum within 1.5 of the interquartile range of the lower and upper quartile, respectively (Tukey boxplot), and the circles indicate outliers. Stdev, Standard deviation. Journal of Vascular Surgery 2015 61, 1501-1510.e1DOI: (10.1016/j.jvs.2014.12.060) Copyright © 2015 Society for Vascular Surgery Terms and Conditions

Fig 4 Graphic comparison of current modalities for clinical and nonclinical oxygen (O2) evaluation in tissue. Micro-oxygen sensor (MOXY) sensor (as depicted in the tissue by the light gray bar) measures the tissue oxygen concentration (Pto2) directly from the tissue. HB, Hemoglobin; HbO2, oxyhemoglobin; NIR, near-infrared. Journal of Vascular Surgery 2015 61, 1501-1510.e1DOI: (10.1016/j.jvs.2014.12.060) Copyright © 2015 Society for Vascular Surgery Terms and Conditions

Supplementary Fig (online only) A, A.second case study (patient 3) of dynamic relative oxygen indices (DROIDSs) vs time during endovascular therapy in a patient with popliteal-tibial disease. The image at the right is a topographic descriptor of sensor locations in the patient's foot. Traces demonstrate increase in tissue oxygen levels resulting from therapy delivery. B, A third case study (patient 9) of DROIDS during endovascular therapy in a patient with proximal iliac disease. In this example, the magnitude and responsiveness of sensors is not as pronounced as in A and in Fig 1. The sensors exhibit changes, but whether they are significant in response to deployed therapies is less clear. Journal of Vascular Surgery 2015 61, 1501-1510.e1DOI: (10.1016/j.jvs.2014.12.060) Copyright © 2015 Society for Vascular Surgery Terms and Conditions