Wire-free breast tumor localization improves quality, efficiency, capacity

2020 02 04 19 10 5417 Merit Medical Thumbnail 20200204191758

For many patients, the most dreaded aspect of breast surgery is the needle localization prior to the procedure. This requires patients, who are on a "nothing by mouth" protocol, to have uncomfortable wires placed two hours prior to scheduled surgery. Fortunately, developments in wire-free breast localization have not only improved our ability to detect and diagnose early stage breast cancer, but have also relieved patients of the discomfort and stress associated with wire localization.

However, despite these advances, many hospitals continue to rely on wire localization to guide surgeons to breast lesions on the day of surgery.

Mills-Peninsula Medical Center in Burlingame, CA, is an example of an institution that is taking a more progressive and patient-friendly approach by making the most of these wire-free localization advances. At Mills-Peninsula, we see wire-free localization for surgical guidance of small, nonpalpable, malignant, or high-risk breast lesions as an opportunity to elevate quality of care and the patient experience, while improving efficiency and capacity for these services and procedures.

Dr. Andrea Metkus, medical director of the breast cancer program, and myself championed the adoption and implementation of wire-free localization technology. We started by reviewing available wire-free localization technologies, and then selected the SCOUT Radar Localization system by Merit Medical for a 15-patient feasibility study.

Our main objective in conducting the study was to assess reflector placement and retrieval, as well as complications, patient tolerance, and satisfaction. Furthermore, we wanted to determine ease and accuracy of reflector placements and complications for the full gamut of mammographic, tomographic, and ultrasound detected lesions, including lesions requiring bracketing, and we also wanted to ensure successful intraoperative removal of all reflectors and index lesions.

Another goal was to evaluate improvements in overall efficiency and capacity of radiology and operating room services, as well as the positive impact on margin status. We would then compare these findings with traditional wire localization procedures.

The lead radiologist was trained in reflector placement and deployment, and the lead surgeon was trained in intraoperative reflector retrieval procedures. All patients diagnosed via tomographic, stereotactic, ultrasound, or MRI-guided core-needle biopsies and with high-risk lesions requiring surgical excision (or malignant lesions amenable to breast conservation surgery with lumpectomy) were referred for surgical consultation. The surgeon then referred appropriate patients for reflector placement prior to their scheduled surgery. The first 15 cases were performed and reviewed for successful reflector placement and retrieval, complications, and patient tolerance and satisfaction.

SCOUT console (above) and reflector (below). All images courtesy of Merit Medical.SCOUT console (above) and reflector (below). All images courtesy of Merit Medical.

The results of the feasibility study were officially presented to the Mills-Peninsula New Procedure and Technology Evaluation Committee, which is comprised of our chief executive officer, chief financial officer, chief of staff, vice chief of staff, our nursing supervisor, managers of the radiology and surgical departments, and our foundation president. The wire-free localization procedures proved to be easily and conveniently scheduled, well tolerated by all patients, and complication-free. All index lesions, including those requiring bracketing, were able to be accurately localized.

After careful consideration, the Radar Localization System was approved for implementation. The Mills-Peninsula Medical Center Foundation funded the technology, and information about it was then shared with hospital staff and physicians through department meetings and a written article in Mid-Peninsula's professional medical staff newsletter.

Achieving a successful wire-free program required the creation of new protocols and workflows for wire-free localization scheduling, procedure performance, image access, and specimen radiography and documentation on the day of the procedure. This customized plan was a collaborative effort between radiology scheduling personnel and operating room staff that demanded cooperation and a commitment to changing decades-old habits. This was the first collaborative project conducted between the breast center and the outpatient operating room teams. Fortunately, we found that all key stakeholders were up to the challenge. We had several meetings of lead physicians, staff, and administration to discuss the project and address concerns and training, as well as to ensure seamless workflow and patient safety.

The project and feasibility study on wire-free localization procedures confirmed a positive impact on patient experience, improvements in efficiency and capacity for the radiology and operating room departments (by decoupling the surgery and radiology schedules), successful localization and surgical excision of reflectors and index lesions in all cases, and elimination of surgical mishaps related to wires and wire localization procedures.

For the operating room schedule, wire-free localization increased our ability to start procedures early in the morning and eliminated unexpected delays due to vasovagal events or complication/transportation issues related to wire localizations on the day of surgery. For the radiology/breast imaging department, the technology eliminated the need to place wires on the day of surgery and avoided procedure and capacity conflicts.

While we are still refining our processes for wire-free localizations, we are encouraged by the positive impact it has so far had on overall patient experience and quality of care, including easing patient anxiety and procedure time on the day of surgery, while simultaneously improving workflow and overall capacity. Our experience confirmed this procedure to be easily learned, quickly performed, and incorporated into the breast imaging center's workflow for all localizations, including bracketing of complex lesions, with high accuracy.

This case and other information are for the practitioner's convenience and general information purposes only. This information does not constitute medical or legal advice, nor is it meant to endorse or guarantee the suitability of any of the referenced products or methods for any specific patient or procedure. Before using any product, refer to the instructions for use (IFU) for indications, contraindications, warnings, precautions, and directions for use.

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