Colleen M Kiernan1, Giju Thomas2,3, Naira Baregamian1, Carmen C Solόrzano1. 1. Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA. 2. Vanderbilt Biophotonics Center, Vanderbilt University, Nashville, Tennessee, USA. 3. Department of Biomedical Engineering, Vanderbilt University, Nashville, Tennessee, USA.
Abstract
BACKGROUND AND OBJECTIVE: The Food and Drug Administration has cleared a probe-based near-infrared autofluorescence (NIRAF) detection system called PTeye™ as an adjunct tool for label-free intraoperative parathyroid gland (PG) identification. Since PTeye™ has been investigated only in a "blinded" manner to date, this study describes the preliminary impressions of PTeye™ when used by surgeons without being blinded to the device output. METHODS: Patients undergoing thyroid and parathyroid procedures were prospectively recruited. Target tissues were intraoperatively assessed with PTeye™. The surgeon's confidence in PG identification was recorded concomitantly with NIRAF parameters that were output in real-time from PTeye™. RESULTS: A retrospective review of prospectively collected data on 83 patients was performed. PTeye™ was used for interrogating 336 target tissues in 46 parathyroid and 37 thyroid procedures. PTeye™ yielded an overall accuracy of 94.3% with a positive predictive value of 93.0% and a negative predictive value of 100%. An increase in confidence for intraoperative PG identification with PTeye™ was observed by all three participating high-volume surgeons, irrespective of their level of accrued surgical experience. CONCLUSIONS: Probe-based NIRAF detection with PTeye™ can be a valuable adjunct device to intraoperatively identify PGs for surgeons of varied training and experience.
BACKGROUND AND OBJECTIVE: The Food and Drug Administration has cleared a probe-based near-infrared autofluorescence (NIRAF) detection system called PTeye™ as an adjunct tool for label-free intraoperative parathyroid gland (PG) identification. Since PTeye™ has been investigated only in a "blinded" manner to date, this study describes the preliminary impressions of PTeye™ when used by surgeons without being blinded to the device output. METHODS: Patients undergoing thyroid and parathyroid procedures were prospectively recruited. Target tissues were intraoperatively assessed with PTeye™. The surgeon's confidence in PG identification was recorded concomitantly with NIRAF parameters that were output in real-time from PTeye™. RESULTS: A retrospective review of prospectively collected data on 83 patients was performed. PTeye™ was used for interrogating 336 target tissues in 46 parathyroid and 37 thyroid procedures. PTeye™ yielded an overall accuracy of 94.3% with a positive predictive value of 93.0% and a negative predictive value of 100%. An increase in confidence for intraoperative PG identification with PTeye™ was observed by all three participating high-volume surgeons, irrespective of their level of accrued surgical experience. CONCLUSIONS: Probe-based NIRAF detection with PTeye™ can be a valuable adjunct device to intraoperatively identify PGs for surgeons of varied training and experience.
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