Utilization of the Histolog® Scanner intraoperatively, clinical and economic perspectives
18th March 2021
Dr. Viktoria Hofmann, Prof. Dr. Michael P Lux, MD – OBGYN Department and Breast Center St. Louise, Paderborn, Germany
Technology Review
Confocal microscopy is a recognized imaging method that provides high resolution images of fresh tissue in a timely manner. The Histolog® Scanner integrates this approach in a new medical imaging modality enabling real-time visualization of fresh specimens ranging from biopsies to large surgical excisions. The whole specimen surface is imaged in a few minutes to obtain morphological information up to subcellular details, allowing the visualization of cancerous lesions immediately after sampling or excision.
Case Report
In November 2020, a non-palpable lesion in the right breast of a 63-year-old woman was detected during standard mammography screening. Suspicious microcalcifications were located at the 9 o’clock position, suspected ductal carcinoma in situ (DCIS), BIRADS IV (Fig. 1). Vacuum suction core biopsy confirmed the presence of poorly differentiated DCIS with associated microcalcifications.
In consensus with the patient and the certified breast center’s tumor board, the decision was taken to realize a breast conserving surgery with preoperative radiological wire marking of the lesion (Fig. 2). The patient was offered the possibility to participate in a non-interventional study, Polarhis, which analyzes the intraoperative use of the Histolog Scanner compared to the standard-of-care. After appropriate preparation and consent, the surgery was performed in December 2020.
During the surgery, the preoperatively marked segment was excised in accordance with guidelines (Fig. 3).
Immediately following the excision, the specimen was dipped in a contrast agent, the Histolog Dip, and scanned with the Histolog Scanner prior to preservation in formalin for histopathology (Fig. 4).
All excision margins were examined (ventral, dorsal, cranial, caudal, lateral, and medial). Epithelial cells detached from the dressing was observed at the cranial and lateral margins, indicating DCIS localized on the margin (Fig. 5).
The remaining resection margins were considered as tumor-free. No re-excision was taken intraoperatively, as DCIS present in the margin was not detected by intraoprative standard-of-care.
Postoperative histopathology confirmed that cranial and lateral lumpectomy margins included poorly differentiated DCIS measuring approximately 50mm, whereas remaining resection margins were tumor-free. The patient was scheduled for a re-operation, which was performed 10 days after primary surgery, without complications. The hospital scheduled a re-operation as early as possible to ensure maximum patient benefit. As a consequence, the time window between primary surgery and the re-operation was too short to get a second G-DRG reimbursement. The re-operation represented thus a cost of approx. €2’000 for the hospital, lower range estimated on outpatient setting, including medical procedure, staff present during the surgery, and additional length of stay.
Conclusion
Assessments of cancer-positive and -negative Histolog Scanner images were in agreement with final pathological assessment. The intraoperative information generated by the Histolog Scanner could reduce re-operation rate, as illustrated in this case. It could have a significant impact for the patients, in particular less psychological and physical stress, a more optimal cosmetic as well as a higher oncological safety. In addition, the Histolog Scanner carries the promise to decrease the cost burden for the service provider. With a median of 200 breast conserving surgeries performed each year and an average re-operation rate of 20%, certified breast centers in Germany (278 centers) could save up to €80’000 minimum every single year with the Histolog Scanner.