Pervasive wearable device for free tissue transfer monitoring based on advanced data analysis: clinical study report

Melissa Berthelot,Daniel Leff,Navid Jallali,Elizabeth Dex,Francis Patrick Henry,Guang-Zhong Yang,Benny Lo,Ladislava Lysakova,Simon Wood,Judith Hunter

doi:10.1117/1.jbo.24.6.067001

Abstract

.Free tissue transfer (FTT) surgery for breast reconstruction following mastectomy has become a routine operation with high success rates. Although failure is low, it can have a devastating impact on patient recovery, prognosis, and psychological well-being. Continuous and objective monitoring of tissue oxygen saturation () has been shown to reduce failure rates through rapid detection time of postoperative vascular complications. We have developed a pervasive wearable wireless device that employs near-infrared spectroscopy (NIRS) to continuously monitor FTT via measurement. Previously tested on different models, the results of a clinical study are introduced. Our goal for the study is to demonstrate that the developed device can reliably detect variations in a clinical setting: 14 patients were recruited. Advanced data analysis was performed on the variations, the relative gradient change, and the classification of the within different clusters of blood occlusion level (from 0% to 100% at 25% step) based on previous studies made on a vascular phantom and animals. The outcomes of the clinical study concur with previous experimental results and the expected biological responses. This suggests that the device is able to correctly detect perfusion changes and provide real-time assessment on the viability of the FTT in a clinical setting.

Highlights

Free tissue transfer (FTT) surgery is commonly performed following trauma or cancer to reconstruct defects
Focusing on breast reconstruction after mastectomy, the autologous FTT consists in harvesting soft tissue, including blood vessels, from a distant body region, and anastomosis to the recipient area for reconstruction
Validated with phantom, animal, and healthy human studies, the results show that the device can distinguish venous from arterial blood and different levels of venous occlusion for detection of FTT vascular complications (VCs).[17,18] his paper introduces the results of the clinical study for postoperative FTT monitoring in the case of breast reconstruction using our developed near-infrared spectroscopy (NIRS) device

Summary

Introduction

Free tissue transfer (FTT) surgery is commonly performed following trauma or cancer to reconstruct defects. The lack of detailed and large studies investigating their sensitivity and efficiency over different surgery types; patients’ demographics; and potential risks, costs, and practical usability or limitations reduce its acceptability.[4,5] The long setup time and recalibration with chemical solutions can limit its routine use.[4,5] The Doppler effect has been used to monitor blood perfusion changes It has been embodied within different modalities: as an implantable probe and as a handheld device. Spectroscopy has been used with near-infrared wavelengths to continuously monitor the concentration variations of different hemoglobin compounds to deduce the relative oxygen saturation in an area

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Results

Discussion

Conclusion