Pilot Study of a New Nonradioactive Surgical Guidance Technology for Locating Nonpalpable Breast Lesions

Cox, Charles E.; Garcia-Henriquez, Norbert; Glancy, M. Jordan; Whitworth, Pat W.; Cox, John M.; Themar-Geck, Melissa; Prati, R; Jung, Michelle; Russell, Stephen R.; Appleton, Kristie; King, Jeff; Shivers, Steven C.

doi:10.1245/s10434-015-5079-x

Cited by 82 publications

(67 citation statements)

References 24 publications

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“…The Savi Scout surgical guidance system (Cianna Medical, Aliso Viejo, Calif) is an alternative method to localize and excise nonpalpable breast lesions (15,16). Savi Scout helps the radiologist to implant an infrared-activated, electromagnetic wave reflector device (referred to as a reflector) into the breast with image guidance, which can then be percutaneously detected by using a handpiece-and-console system.…”

Section: Methodsmentioning

confidence: 99%

“…Placement of the Savi Scout reflector deeper than 4.5 cm may interfere with detection according to the manufacturer; the initial pilot study reported difficulty with detection of two reflectors at 4.5-and 6-cm deep (16). This is a potential limitation of the system.…”

Section: Breast Imaging: Reflector-guided Breast Lesion Localization mentioning

confidence: 99%

“…The initial Savi Scout pilot study (16) reported that radiologists cancer (ie, ink on tumor) that required re-excision and 10 of 54 malignancies (18.5%; 95% CI: 10.2%, 31.1%) demonstrated a close margin of less than 1 mm. This is similar to Cox et al (16) who reported a 7% positive margin rate and 22% close margins by using Savi Scout. This is comparable to radioactive seed localization and better than reported for wire localization with positive margins in 12%-60% of cases (11).…”

Section: Breast Imaging: Reflector-guided Breast Lesion Localization mentioning

confidence: 99%

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Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision

et al. 2017

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Purpose To evaluate outcomes of Savi Scout (Cianna Medical, Aliso Viejo, Calif) reflector-guided localization and excision of breast lesions by analyzing reflector placement, localization, and removal, along with target excision and rates of repeat excision (referred to as re-excision). Materials and Methods A single-institution retrospective review of 100 women who underwent breast lesion localization and excision by using the Savi Scout surgical guidance system from June 2015 to May 2016 was performed. By using image guidance 0-8 days before surgery, 123 nonradioactive, infrared-activated, electromagnetic wave reflectors were percutaneously inserted adjacent to or within 111 breast targets. Twenty patients had two or three reflectors placed for bracketing or for localizing multiple lesions, and when ipsilateral, they were placed as close as 2.6 cm apart. Target and reflector were localized intraoperatively by one of two breast surgeons who used a handpiece that emitted infrared light and electromagnetic waves. Radiographs of the specimen and pathologic analysis helped verify target and reflector removal. Target to reflector distance was measured on the mammogram and radiograph of the specimen, and reflector depth was measured on the mammogram. Pathologic analysis was reviewed. Re-excision rates and complications were recorded. By using statistics software, descriptive statistics were generated with 95% confidence intervals (CIs) calculated. Results By using sonographic (40 of 123; 32.5%; 95% CI: 24.9%, 41.2%) or mammographic (83 of 123; 67.5%; 95% CI: 58.8% 75.1%) guidance, 123 (100%; 95% CI: 96.4%, 100%) reflectors were placed. Mean mammographic target to reflector distance was 0.3 cm. All 123 (100%; 95% CI: 96.4%, 100%) targets and reflectors were excised. Pathologic analysis yielded 54 of 110 malignancies (49.1%; 95% CI: 39.9%, 58.3%; average, 1.0 cm; range, 0.1-5 cm), 32 high-risk lesions (29.1%; 95% CI: 21.4%, 38.2%), and 24 benign lesions (21.8%; 95% CI: 115.1%, 30.4%). Four of 54 malignant cases (7.4%; 95% CI: 2.4%, 18.1%) demonstrated margins positive for cancer that required re-excision. Five of 110 radiographs of the specimen (4.5%; 95% CI: 1.7%, 10.4%) demonstrated increased distance between the target and reflector distance of greater than 1.0 cm (range, 1.1-2.6 cm) compared with postprocedure mammogram the day of placement, three of five were associated with hematomas, two of five migrated without identifiable cause. No related postoperative complications were identified. Conclusion Savi Scout is an accurate, reliable method to localize and excise breast lesions with acceptable margin positivity and re-excision rates. Bracketing is possible with reflectors as close as 2.6 cm. Savi Scout overcomes many limitations of other localization methods, which warrants further study. RSNA, 2017.

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Section: Methodsmentioning

confidence: 99%

Section: Breast Imaging: Reflector-guided Breast Lesion Localization mentioning

confidence: 99%

Section: Breast Imaging: Reflector-guided Breast Lesion Localization mentioning

confidence: 99%

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Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision

et al. 2017

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“…The audible and numerical signals change with increasing proximity to the lesion, directing precise localization. 10 A pilot study by Cox et al 11 in June 2016 reported the use of the SAVI SCOUT system for preoperative breast localization in 50 patients. This showed that the system was safe and effective, with all of the lesions and reflectors successfully removed and no adverse outcomes.…”

Section: Savi Scoutmentioning

confidence: 99%

Localization for Breast Surgery: The Next Generation

Jeffries¹,

Dossett²,

Jorns³

2017

Archives of Pathology &Amp; Laboratory Medicine

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Context.— Preoperative localization of nonpalpable breast lesions using image-guided wire placement has been a standard of breast imaging, diagnosis, and treatment since its development in the 1970s. With this technique, coordinated, same-day wire placement by the radiologist and surgery are required, which can lead to significant inefficiencies in workflow. Other disadvantages of wire localization (WL) include limitations in surgical incision and dissection route and protruding wires that can be both bothersome for the patient and have risk of displacement. Objective.— To outline several recently developed techniques that could replace traditional WL and eliminate its disadvantages. The first developed was radioactive seed localization (RSL) using I-125, a technique adopted by many institutions during the last few years. The challenge to this method, however, is the strict nuclear regulatory requirements, which can be a significant burden and limitation. The disadvantages of WL and RSL have provided incentive for the development of other types of preoperative localization procedures. Two of these are recently US Food and Drug Administration–cleared, nonradioactive, non-wire location technologies emerging as alternatives to WL and RSL; SAVI SCOUT (Cianna Medical Inc, Aliso Viejo, California), which uses infrared light and a microimpulse radar reflector, and Magseed (Endomagnetics Inc, Austin, Texas), which uses a magnetic seed for localization. Data Sources.— We review the published literature on non-wire location technologies for breast tissue resection. Conclusions.— Non-wire location techniques are beneficial, allowing image-guided placement before the day of surgery and resulting in improved workflows. These techniques also eliminate bothersome protruding wires, risk of dislodging, and allow the incision site to be independent from the localization site.

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“…1 The technique uses a small implantable device placed through a needle via ultrasound or stereotactic guidance, similar to current radiologic localization techniques. Once implanted, the device is activated by infrared light from the handpiece, and an electromagnetic wave is reflected back to the console.…”

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confidence: 99%

The Search Continues for the Ideal Method to Localize Nonpalpable Breast Lesions

Jakub

2016

Ann Surg Oncol

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In this issue of Annals of Surgical Oncology, an alternative method of surgical localization for nonpalpable breast lesions is described.1 The technique uses a small implantable device placed through a needle via ultrasound or stereotactic guidance, similar to current radiologic localization techniques. Once implanted, the device is activated by infrared light from the handpiece, and an electromagnetic wave is reflected back to the console. Similar to radioactive seed-localized (RSL) breast surgery, a handpiece and console are utilized with continuous audible feedback.In this feasibility study, the authors retrieved the seed and the targeted lesion in 100 % of cases and thought that this was subjectively easier than a wire localized approach. This was a single-arm pilot study with specific inclusion/ exclusion criteria, performed by two highly experienced breast surgical teams, and some issues were identified during the pilot that led to refinements in the delivery system.Although all targeted lesions were recovered, in six cases (12 %), the reflector placed in the breast for localization was not able to be identified by the surgeon in the operating room before incision. In five cases it was detected after skin incision. In one case the reflector malfunctioned and could not be localized, and in another case the reflector was deactivated by contact with electrocautery. No other localization devices were used in any cases. The ability to remove the lesion in all cases, despite the technology's shortcomings and failure, speaks to the surgeon's skill and experience, as 2-view postlocalization mammograms and preoperative ultrasounds were adequate for incision planning in their hands.On the basis of these and other issues uncovered during the pilot study, a number of technologic modifications were made to the system, including addressing a reflector malfunction that prevented detection, incorporating an additional component into the reflector to minimize the likelihood of cautery deactivation, incorporating a display screen on the console, and designing shorter, more lightweight localization needles for ease of radiologic placement.It is worth noting the inclusion criteria required that the implantable device be placed a maximum of 3 cm deep into the breast parenchyma. Two of the reflectors that were not detected before skin incision were outside this depth range, placed 4.5 and 6 cm deep. It is not clear, but it would appear that this limitation is related to a combination of breast density and the distance between the reflector and probe. This will, I hope, be further defined in the ongoing prospective multiinstitutional single-arm validation study that is actively accruing.In terms of margin status, the findings are purely descriptive, with 41 patients having ductal carcinoma-insitu or invasive disease. Two of the 41 cases had positive margins, and six were within 1 mm (20 % margin B1 mm). One issue that was not reported in this pilot system was the cost of the device. Unlike a wire or RSL in which no new capital b...

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Pilot Study of a New Nonradioactive Surgical Guidance Technology for Locating Nonpalpable Breast Lesions

Abstract: These data suggest that the SCOUT system is safe and effective for guiding the excision of nonpalpable breast lesions and a viable alternative to standard localization options. A larger prospective, multi-institution trial of SCOUT currently is underway to validate these findings.

Cited by 82 publications

References 24 publications

Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision

Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision

Localization for Breast Surgery: The Next Generation

The Search Continues for the Ideal Method to Localize Nonpalpable Breast Lesions

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