Initial clinical experiences using the intraoperative probe-based parathyroid autofluorescence identification system-PTeye™ during thyroid and parathyroid procedures.

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.