title: 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.
abstract: OBJECTIVE
  Patients with limb-threatening ischemia exhibit uneven patterns of perfusion in the foot, which makes it challenging to determine adequate topographic perfusion by angiography alone. This study assessed the feasibility of reporting dynamic relative oxygen indices and tissue oxygen concentration from multiple locations on the foot during endovascular therapy using a novel micro-oxygen sensor (MOXY; PROFUSA, Inc, South San Francisco, Calif) approach.
  
  
  METHODS
  A prospective, 28-day, single-arm, observational study was performed in 10 patients who underwent endovascular therapy for limb-threatening ischemia. At least 24 hours before therapy, four microsensors were injected in each patient (one in the arm, three in the treated foot). The optical signal from the microsensors corresponded to tissue oxygen concentration. A custom detector on the surface of the skin was used to continuously and noninvasively measure the signals from the microsensors. The ability to locate and read the signal from each injected microsensor was characterized. Oxygen data from the microsensors were collected throughout the revascularization procedure. The timing of therapy deployment was recorded during the procedure to assess its relationship with the microsensor oxygen data. Oxygen data collection and clinical evaluation were performed immediately postoperatively as well as postoperatively on days 7, 14, 21, and 28.
  
  
  RESULTS
  The study enrolled 10 patients (50% male) with ischemia (30% Rutherford class 4, 70% Rutherford class 5). Patients were a mean age of 70.7 years (range, 46-90 years), and all were Hispanic of varying origin. Microsensors were successfully read 206 of 212 times (97.2%) in all patients during the course of the study. Microsensors were compatible with intraoperative use in the interventional suite and postoperatively in an office setting. In nine of 10 revascularization procedures, at least one of the three MOXYs showed an immediate change in the dynamic relative oxygen index, correlating to deployed therapy. Moreover, there was a statistically significant increase in the concentration of oxygen in the foot in preoperative levels compared with postoperative levels. No adverse events occurred related to the microsensor materials.
  
  
  CONCLUSIONS
  This MOXY approach appears to be safe when implanted in patients with limb-threatening ischemia undergoing endovascular recanalization and is effective in reporting local tissue oxygen concentrations over a course of 28 days. Further testing is needed to determine its potential effect on clinical decision making, both acutely on-table and chronically as a surveillance modality, which ultimately can lead to improved healing and limb salvage.
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Arizona, Tucson, Ariz; Pima Vascular Group, Tucson, Ariz. Electronic address: montero.bkr@gmail.com.
authors.forename: Miguel F
authors.initials: MF
authors.lastname: Montero-Baker
authors.affiliation: Product Development Division, PROFUSA, Inc, South San Francisco, Calif.
authors.forename: Kit Yee
authors.initials: KY
authors.lastname: Au-Yeung
authors.affiliation: Research & Development Division, PROFUSA, Inc, South San Francisco, Calif.
authors.forename: Natalie A
authors.initials: NA
authors.lastname: Wisniewski
authors.affiliation: Research & Development Division, PROFUSA, Inc, South San Francisco, Calif.
authors.forename: Soya
authors.initials: S
authors.lastname: Gamsey
authors.affiliation: Center of Academic Excellence in Endovascular Therapy (CEATE) Foundation, San José, Costa Rica.
authors.forename: Luis
authors.initials: L
authors.lastname: Morelli-Alvarez
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Arizona, Tucson, Ariz.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Mills
authors.affiliation: Center of Academic Excellence in Endovascular Therapy (CEATE) Foundation, San José, Costa Rica.
authors.forename: Marianella
authors.initials: M
authors.lastname: Campos
authors.affiliation: Product Development Division, PROFUSA, Inc, South San Francisco, Calif.
authors.forename: Kristen L
authors.initials: KL
authors.lastname: Helton
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015415:Biomarkers / Q000097:blood; D003364:Costa Rica; D057510:Endovascular Procedures / Q000009:adverse effects; D004867:Equipment Design; D005240:Feasibility Studies; D005528:Foot / Q000098:blood supply; D007511:Ischemia / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D023821:Limb Salvage; D008904:Miniaturization; D010092:Oximetry / Q000295:instrumentation; D010100:Oxygen / Q000097:blood; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012039:Regional Blood Flow; D012815:Signal Processing, Computer-Assisted; D013997:Time Factors; D014159:Transducers; D016896:Treatment Outcome; D017321:Clinical Trials, Phase I as Topic
chemical_list: D015415:Biomarkers; D010100:Oxygen