Evaluation of a Wearable in-Ear Sensor for Temperature and Heart Rate Monitoring: A Pilot Study.

In the context of the COVID-19 pandemic, wearable sensors are important for early detection of critical illness especially in COVID-19 outpatients. We sought to determine in this pilot study whether a wearable in-ear sensor for continuous body temperature and heart rate monitoring (Cosinuss company, Munich) is sufficiently accurate for body temperature and heart rate monitoring. Comparing with several anesthesiologic standard of care monitoring devices (urinary bladder and zero-heat flux thermometer and ECG), we evaluated the in-ear sensor during non-cardiac surgery (German Clinical Trials Register Reg.-No: DRKS00012848). Limits of Agreement (LoA) based on Bland-Altman analysis were used to study the agreement between the in-ear sensor and the reference methods. The estimated LoA of the Cosinuss One and bladder temperature monitoring were [-0.79, 0.49] °C (95% confidence intervals [-1.03, -0.65] (lower LoA) and [0.35, 0.73] (upper LoA)), and [-0.78, 0.34] °C (95% confidence intervals [-1.18, -0.59] (lower LoA) and [0.16, 0.74] (upper LoA)) of the Cosinuss One and zero-heat flux temperature monitoring. 89% and 79% of Cosinuss One temperature monitoring were within ± 0.5 °C limit of bladder and zero-heat flux monitoring, respectively. The estimated LoA of Cosinuss One and ECG heart rate monitoring were [-4.81, 4.27] BPM (95% confidence intervals [-5.09, -4.56] (lower LoA) and [4.01, 4.54] (upper LoA)). The proportion of detection differences within ± 2BPM was 84%. Body temperature and heart rate were reliably measured by the wearable in-ear sensor.

Endoscopic confocal laser-microscopy for the intraoperative nerve recognition: is it feasible?

Surgeons lose most of their tactile tissue information during minimal invasive surgery and need an additional tool of intraoperative tissue recognition. Confocal laser microscopy (CLM) is a well-established method of tissue investigation. The objective of this study was to analyze the feasibility and diagnostic accuracy of CLM nervous tissue recognition. Images taken with an endoscopic CLM system of sympathetic ganglions, nerve fibers and pleural tissue were characterized in terms of specific signal-patterns ex-vivo. No fluorescent dye was used. Diagnostic accuracy of tissue classification was evaluated by newly trained observers (sensitivity, specificity, PPV, NPV and interobserver variability). Although CLM images showed low CLM image contrast, assessment of nerve tissue was feasible without any fluorescent dye. Sensitivity and specificity ranged between 0.73 and 0.9 and 0.55-1.0, respectively. PPVs were 0.71-1.0 and the NPV range was between 0.58 and 0.86. The overall interobserver variability was 0.36. The eCLM enables to evaluate nervous tissue and to distinguish between nerve fibers, ganglions and pleural tissue based on backscattered light. However, the low image contrast and the heterogeneity in correct tissue diagnosis and a fair interobserver variability indicate the limit of CLM imaging without any fluorescent dye.

Confocal laser microscopy without fluorescent dye in minimal-invasive thoracic surgery: an ex-vivo pilot study in lung cancer.

Cancer will be the leading cause of death in a few decades. In line with minimal invasive lung cancer surgery, surgeons loose most of their tactile tissue information and need an additional tool of intraoperative tissue navigation during surgery. Confocal laser microscopy is a well-established method of tissue investigation. In this ex-vivo pilot study, we evaluated an endoscopic confocal laser microscope (eCLM) that does not need any fluorescent dye as a diagnostic tool in non-malignant and malignant pulmonary tissue and distal stapler resection margins, respectively. In seven cases, an eCLM was used for examining pulmonary tissue ex-vivo. Images of non-malignant and non-small cell lung cancer tissue and distal stapler resection margins were characterized in terms of specific signal-patterns. No fluorescent dye was used. Correlations to findings in conventional histology were systematically recorded and described. Healthy lung tissue showed hyperreflectoric alveolar walls with dark alveolar spaces. Hyperreflective nets indicated the tumor stroma; whereas the hyperreflective areas indicated the tumor cell clusters. Compared to adenocarcinoma tissue, tissue from squamous cell carcinoma showed more distinctive hyperreflective stroma nets. eCLM characteristics seen in non-malignant and malignant tissue were also visible in distal stapler resection margins and so therefore it was feasible to distinguish between healthy lung tissue and lung cancer. This pilot study shows that the assessment of pulmonary tissue with this eCLM for minimally invasive surgical approach without any fluorescent dye is feasible. It enables to differentiate between benign and malignant tissue in pulmonary specimen by easy to evaluate and reproducible parameters.

Confocal Laser Microscopy for in vivo Intraoperative Application: Diagnostic Accuracy of Investigator and Machine Learning Strategies.

BACKGROUND: Confocal laser microscopy (CLM) is one of the optical techniques that are promising methods of intraoperative in vivo real-time tissue examination based on tissue fluorescence. However, surgeons might struggle interpreting CLM images intraoperatively due to different tissue characteristics of different tissue pathologies in clinical reality. Deep learning techniques enable fast and consistent image analysis and might support intraoperative image interpretation. The objective of this study was to analyze the diagnostic accuracy of newly trained observers in the evaluation of normal colon and peritoneal tissue and colon cancer and metastasis, respectively, and to compare it with that of convolutional neural networks (CNNs). METHODS: Two hundred representative CLM images of the normal and malignant colon and peritoneal tissue were evaluated by newly trained observers (surgeons and pathologists) and CNNs (VGG-16 and Densenet121), respectively, based on tissue dignity. The primary endpoint was the correct detection of the normal and cancer/metastasis tissue measured by sensitivity and specificity of both groups. Additionally, positive predictive values (PPVs) and negative predictive values (NPVs) were calculated for the newly trained observer group. The interobserver variability of dignity evaluation was calculated using kappa statistic. The F1-score and area under the curve (AUC) were used to evaluate the performance of image recognition of the CNNs' training scenarios. RESULTS: Sensitivity and specificity ranged between 0.55 and 1.0 (pathologists: 0.66-0.97; surgeons: 0.55-1.0) and between 0.65 and 0.96 (pathologists: 0.68-0.93; surgeons: 0.65-0.96), respectively. PPVs were 0.75 and 0.90 in the pathologists' group and 0.73-0.96 in the surgeons' group, respectively. NPVs were 0.73 and 0.96 for pathologists' and between 0.66 and 1.00 for surgeons' tissue analysis. The overall interobserver variability was 0.54. Depending on the training scenario, cancer/metastasis tissue was classified with an AUC of 0.77-0.88 by VGG-16 and 0.85-0.89 by Densenet121. Transfer learning improved performance over training from scratch. CONCLUSIONS: Newly trained investigators are able to learn CLM images features and interpretation rapidly, regardless of their clinical experience. Heterogeneity in tissue diagnosis and a moderate interobserver variability reflect the clinical reality more realistic. CNNs provide comparable diagnostic results as clinical observers and could improve surgeons' intraoperative tissue assessment.

Towards an Optical Biopsy during Visceral Surgical Interventions.

BACKGROUND: Cancer will replace cardiovascular diseases as the most frequent cause of death. Therefore, the goals of cancer treatment are prevention strategies and early detection by cancer screening and ideal stage therapy. From an oncological point of view, complete tumor resection is a significant prognostic factor. Optical coherence tomography (OCT) and confocal laser microscopy (CLM) are two techniques that have the potential to complement intraoperative frozen section analysis as in vivo and real-time optical biopsies. SUMMARY: In this review we present both procedures and review the progress of evaluation for intraoperative application in visceral surgery. For visceral surgery, there are promising studies evaluating OCT and CLM; however, application during routine visceral surgical interventions is still lacking. KEY MESSAGE: OCT and CLM are not competing but complementary approaches of tissue analysis to intraoperative frozen section analysis. Although intraoperative application of OCT and CLM is at an early stage, they are two promising techniques of intraoperative in vivo and real-time tissue examination. Additionally, deep learning strategies provide a significant supplement for automated tissue detection.

[Quantitative Intraoperative Measurement of Tissue Perfusion of Transplanted Kidneys by Indocyanine Green Angiography]. / Quantitative intraoperative Messung der Gewebeperfusion von Nierentransplantaten mittels Indocyaningrün-Angiografie.

Postoperative delayed graft function (DGF) after kidney transplantation is a risk factor for kidney failure and reduced kidney allograft survival after transplantation. The aim of this study was to measure the quantitative perfusion of kidney transplants during kidney transplantation and to investigate whether differences in perfusion predict the development of DGF. Over a period of one year, intraoperative quantitative ICG perfusion measurements were performed with the IC-View camera (Pulsion®) in 36 patients for whom informed consent for ICG perfusion measurement had been obtained. The groups were divided into donation after brain death and living donors and into the occurrence or absence of a DGF. An area with sufficient and low ICG perfusion was determined intraoperatively. The maximum perfusion was significantly decreased in the DGF group compared to living donors in areas with sufficient ICG perfusion and the slope of perfusion in these areas was documented. In addition, the maximum perfusion ratio was investigated. Evaluation was carried out by IC-Calc software (Pulsion). A total of 36 patients were included in this study. DGF occurred in 10 of the patients. No DGF was found in the group of living donors. The maximum perfusion and the slope of perfusion in the defined areas were fewer, but not significant in the group with BDB donor. The less perfused areas showed significant differences between DGF and living donors in maximum perfusion, absolute slope of perfusion and ratio to the standard area. A difference between BDB donor without DGF and the DGF group could not be predicted. This study shows that quantitative perfusion of kidney transplants can be evaluated safely during kidney transplantation. DGF being defined as one or more dialyses after kidney transplantation can only be detected postoperatively, however, it may be predicted intraoperatively.

[Laparoscopic Treatment of Splenic Artery Aneurysm]. / Laparoskopisches Ausschalten eines Aneurysmas der A. lienalis.

OBJECTIVE: Visceral artery aneurysms are a rare but dangerous vascular pathology. The branches of the coeliac trunc are most frequently affected, especially the splenic artery. A visceral aneurysm is usually diagnosed only when a bleeding complication occurs due to rupture. It is therefore recommended to treat this pathology at an early stage after diagnosis. Endovascular elimination is the preferred procedure. However, if endovascular elimination is not suitable, the visceral aneurysm can be successfully treated by minimally invasive surgery. INDICATIONS: Splenic artery aneurysms are located at the splenic hilum, and are therefore considered to be at high risk of splenic ischemia and secondary complications following endovascular coiling. PROCEDURE: Laparoscopic treatment of splenic artery aneurysm. CONCLUSION: In the case of complex vascular pathologies unsuitable for an endovascular approach, laparoscopic treatment of splenic artery aneurysm is a safe and effective minimally invasive option and alternative.

Confocal laser microscopy as novel approach for real-time and in-vivo tissue examination during minimal-invasive surgery in colon cancer.

BACKGROUND: Histological analysis of surgical specimen is the gold standard for cancer classification. In particular, frozen histological diagnosis of vague peritoneal spots or uncertain excision of tumors plays a crucial role in the decision to proceed with or abandon an operation. Confocal laser microscopy (CLM) enables in-vivo and real-time high-resolution tissue analysis. This method has already been used during endoscopic assessments analyzing transformation of esophageal or colon mucosa. We examined whether a CLM device enables to distinguish between non-malignant and malignant tissue in vivo and real time and enables to assign peritoneal carcinomatosis spots to their primary tumor. In addition, we investigated whether the newly developed CLM camera device causes any tissue damage. METHODS: CC531 colon carcinoma cells were implanted on the serosa side of the colon and intraperitoneally in Wag/Rija rats via laparotomy. After 7 days of tumor growth, confocal laser microscopy in vivo was performed by re-laparotomy. Images of non-malignant and malignant tissue were characterized in terms of specific signal pattern. No fluorescent dye was used. Correlations to findings in conventional histology were systematically recorded and described. Potential tissue damage was examined by conventional histology. RESULTS: All animals survived the operative procedure and could be evaluated 7 days following surgery. No unexpected death occurred after surgery. Non-malignant colon is defined by small cycles of the microvilli of the colon. There is repetitive deregulated structure in colon carcinoma. Peritoneal carcinomatosis showed the same structural pattern as in primary colon carcinoma. In all examined cases, it was possible to differentiate between peritoneal carcinomatosis spots and non-malignant peritoneum. The CLM device did not cause any tissue damage. CONCLUSIONS: The CLM camera device reported here is feasible to identify peritoneal carcinomatosis spots, assign these spots to the primary tumor, as well as distinguish between non-malignant and malignant tissue in without using any fluorescent dye.

Analysis of laparoscopic laser liver resection in standardized porcine model.

BACKGROUND: Hepatocellular carcinoma is a highly prevalent and lethal primary neoplasia of the liver and metastases of other malignancies affect most frequently the liver. Minimally invasive surgical approach for liver resections is advancing. Dissection of liver parenchyma by laparoscopic technique remains challenging and new technologies are in need. Therefore, we asked whether it is feasible to dissect liver tissue comparably in terms of speed and hemostasis with a non-contact 1.9-µm cw-laser device and whether there are differences in the postoperative healing process compared to a gold standard device (ultrasound aspirator) in an experimental model. METHODS: Laparoscopic laser and ultrasound aspirator standardized partial liver resections were performed in seven pigs. Resection time, hemostasis time, and blood loss were evaluated. After at least 10 days, representative specimen of the resection areas was collected via re-laparoscopy and biopsy and side effects like hematoma, abscess, or bilioma were noted. Histologically, coagulation necrosis margin, granulation tissue zone, tissue fibrosis, and giant cell count were analyzed. RESULTS: Laparoscopic laser liver resection was three times faster compared to the laparoscopic ultrasound aspirator. Blood loss was equal in both groups. No side effects like hematoma or bilioma occurred. Histologically, specimen showed the same expansion of coagulation necrosis zone and granulation tissue. Fibrotic scar could be determined in three cases in both groups, respectively. However, giant cell count was significant higher in the laser resection group. CONCLUSIONS: The 1.9-µm cw-laser device enables a safe and fast liver resection in an experimental pig model compared to a gold standard (ultrasound aspirator) laparoscopic liver resection method. Wound healing is not interfered by laser liver resection.