Single-step ultrasound localization of breast lesions and lumpectomy procedure

The American Journal of Surgery 186 (2003) 386 –390

Scientific paper

Single-step ultrasound localization of breast lesions and lumpectomy procedure Mark A. Gittleman, M.D.* Breast Care Specialists, 1240 S. Cedar Crest Blvd., Suite 205, Allentown, PA 18103, USA Manuscript received June 3, 2003; revised manuscript June 21, 2003 Presented at the Fourth Annual Meeting of the American Society of Breast Surgeons, Atlanta, Georgia, April 30 –May 4, 2003

Abstract Background: This review was made to evaluate whether the efficiencies of intraoperative ultrasound-guided localization could be extended to stereotactic biopsy cases by using a marker visible by sonography and mammography. Methods: A retrospective review identified 170 stereotactic directional vacuum-assisted biopsy (DVAB) procedures marked with an ultrasound-visible marker. Localization device, imaging method, lesion retrieval, and margin status were assessed for patients having subsequent lumpectomy or wider excision. Results: Nineteen of 170 patients underwent lumpectomies (12) or wider excision (7) localized by a radiofrequency device or 18G needle up to 7 weeks after stereotactic biopsy. In 15 of 19 procedures, an ultrasound-guided localization was performed intraoperatively, targeting the marker. All targeted lesions were successfully excised. In the 13 malignant lesions (of 19 surgeries), only 1 had a positive margin (8%). Conclusions: Marking stereotactic biopsies with a sonographically visible marker allows ultrasound-guided intraoperative localization, improving efficiencies for the patient, surgeon, and operating room schedule. © 2003 Excerpta Medica, Inc. All rights reserved. Keywords: Stereotactic breast biopsy; Ultrasound-guided breast biopsy; Breast biopsy markers; Wire localization

Percutaneous biopsy has replaced many needle localized open surgical excisional biopsies for diagnosis of mammographically detected nonpalpable lesions [1–3]. Stereotactic is the preferred guidance modality for percutaneous diagnostic biopsy of clusters of microcalcifications, which are rarely visualized by ultrasound (US). These may represent atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), or invasive ductal cancer (IDC), which must be reliably differentiated from benign processes and each other. To improve the accuracy of the biopsy in these types of lesions and reduce the likelihood of diagnostic upgrades at surgery, many authors recommend harvesting a relatively large volume of tissue using directional vacuum-assisted biopsy (DVAB) [4 –7]. Since this is likely to remove most or all of the imaging evidence of microcalcifications or small lesions, placement of a postbiopsy tissue marker as a surrogate for the lesion has become standard of practice [8 –10]. Ultrasongraphy can be used to place localization devices

* Corresponding author.

to guide surgery for nonpalpable masses detected or biopsied with sonography [11]. Ultrasonography guidance for breast interventions such as wire localizations offers advantages over mammographic guidance including patient comfort in the supine position without breast compression, anatomic positioning of the breast, visualization of the lesion by the operating surgeon and therefore, placement of the device from the approach, and position most optimal for surgery [11,12]. Intraoperative US guidance has also been advocated as an adjunct to surgery for masses visible on US [13,14]. Ultrasonography can also be used to confirm the presence of the lesion or a surrogate marker in the excised specimen [11,15]. However, these procedures have not been extended to lesions that are not ultrasound visible, requiring stereotactic guidance for biopsy. Ultrasound-guided surgery has been advocated using only the postbiopsy hematoma, rather than a biopsy marker and localization device, as the target lesion to guide excision [15,16]. However, this may not be possible in many cases, as the hematoma that is present after stereotactic biopsy may only be present for a short period of time.

0002-9610/03/$ – see front matter © 2003 Excerpta Medica, Inc. All rights reserved. doi:10.1016/S0002-9610(03)00277-0

M.A. Gittleman / The American Journal of Surgery 186 (2003) 386 –390

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The original markers placed following stereotactic biopsy, in use since 1995, consist of a 1- to 2-mm stainless steel metal clip (MicroMark; Ethicon Endo-Surgery, Cincinnati, Ohio), which is only visible by radiography. This necessitates mammographic guidance for placement of a preoperative localization device, should additional surgery be indicated [17,18]. The recent availability of biopsy markers that are visible sonographically as well as mammographically provides the physician with a choice of either modality as guidance, should preoperative localization and surgery be required [19]. This study retrospectively examined how changes in biopsy marker technology, which were incorporated into a surgical practice over time, resulted in changes in the localization procedure, and associated operating room surgical procedures.

Methods The study design is a retrospective review of computerized billing records and charts in the outpatient office of a surgical practice. Since this examined historical records, there was no prospective change in patient care for this study and therefore, no increase in risk to the patients. This was an office based study, with data queried and reported by ICD-9 and billing codes, so individual patient confidentiality was maintained. For these reasons, oversight by an Institutional Review Board was not deemed necessary. The breast biopsy marker (Gel Mark Ultra; SenoRx, Aliso Viejo, California), which is sonographically and mammographically visible, was first used in this practice on January 14, 2002. This biopsy marker consists of a disposable syringe-type applicator containing 11 synthetic marker pellets in a linear configuration. A medical grade stainless steel wireform embedded in the central pellet permanently marks the biopsy site. The pellets are composed of Poly Lactide co Glycolide (PLA/PGA), a biodegradable material with a favorable biocompatibility profile and a long history of use in implantable clips and anchors as well as in surgical sutures [20 –22]. The pellets provide ultrasound visibility for up to 4 weeks [23] and are essentially resorbed over approximately 12 weeks. The biopsy marker pellets create a characteristic appearance distinct from the usual benign anatomic structures or pathologic processes occurring in the breast. CO2 bubbles embedded in the pellet matrix create a hyperechoic tubular pattern with posterior acoustic shadowing (see Fig. 1). A multicenter study showed that placement accuracy for this type of marker is superior to other markers [24]. When this new marker became available, a short study was conducted in this office, which included a follow-up ultrasound examination at 3 to 5 weeks after placement to evaluate the sonographic signature and visibility over time [25]. After this trial period, the practice effectively con-

Fig. 1. Transverse and sagittal sonographic images of the ultrasoundvisible biopsy marker obtained immediately after stereotactic-guided biopsy and biopsy marker placement.

verted to the US visible marker for marking of all stereotactically guided biopsies. Stereotactic-guided biopsies were performed in the standard manner using an 11G DVAB (Mammotome ST; Ethicon Endo-Surgery, Cincinnati, Ohio) on a dedicated prone biopsy table with digital imaging (MammoTest Fisher Imaging, Denver, Colorado). All stereotactic biopsy patients received a postbiopsy marker at the conclusion of tissue sampling, which has been our routine practice for 7 years. Ultrasound-guided biopsy is used for all lesions visible with US, with stereotactic guidance reserved for microcalcifications and small lesions where the imaging features are more likely to be removed completely at biopsy. Computerized billing records identified all percutaneous DVAB with image guidance (CPT 19103) and marker placement (CPT 19295) between January 14, 2002, and October 15, 2002, the date of review. Computerized records for each biopsy were reviewed to determine follow-up treatment and histologic diagnosis for each biopsied patient based on procedure codes and ICD-9 diagnostic codes. Codes for diagnoses requiring surgical treatment were identified. Billing codes for mastectomy, lumpectomy, and wider excision were identified. A procedure code for ultrasound guidance on the operative date identified those pa-

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M.A. Gittleman / The American Journal of Surgery 186 (2003) 386 –390

Fig. 3. Study population flow chart.

For analysis, study parameters were summarized descriptively. A t test for independent samples was used to compare the interval between biopsy and surgery for preoperative and intraoperative localization.

Results Fig. 2. Transverse sonographic image of the biopsy marker obtained on the operating table, 3 weeks after biopsy. Transverse image of the radiofrequency localization device being placed at the biopsy site immediately prior to surgery.

tients having intraoperative placement of a localization device rather than preoperative placement in the stereotactic suite of the radiology department. Patients having a mastectomy were excluded. For the subset of patients having lumpectomy or surgical wider excision, copies of the operative and pathology reports contained within the office charts were reviewed to confirm the diagnosis and localization imaging method and determine the localization device, success of lesion retrieval and margin status. The interval from diagnostic stereotactic biopsy to surgical treatment was determined. Intraoperative localization was performed using US guidance (SonoSite, Bothell, Washington) and sterile probe covers (see Fig. 2). Based on clinical judgment, the operating surgeon used either an 18G needle or a radiofrequency localization device that may also serve as a surgical retractor (Anchor Guide Localization and Fixation Device; SenoRx, Aliso Viejo, California). This device consists of a calibrated shaft with a radiofrequency cutting tip to facilitate positioning of the device and a set of fixation wires that extend radially to secure the device at the target lesion [26]. Preoperative localizations were performed using stereotactic guidance on the same prone table used for biopsies.

Between January 14, 2002, and October 15, 2002, 173 stereotactically guided 11G DVAB were performed in 169 patients (see Fig. 3). Of these, 3 were excluded from further review: 2 who received a different marker without US visibility and 1 patient diagnosed with ADH who did not have follow-up surgery during the study review period. Review of computerized records for the remaining 166 patients revealed benign biopsies in 141 patients. Of these, 139 patients resumed routine follow-up. Two patients with benign histology had discordant imaging-pathology correlation and went on to surgical wider excision. Of the 27 patients having additional procedures, 8 had mastectomies. The remaining 19 patients requiring localization prior to wider excision (7) or breast conservation procedure (12) comprise the study group. Patients ranged in age from 43 to 83 years (mean 65) at the time of their diagnostic biopsy. The average interval from biopsy to surgery for all patients was 23 days, ranging from 7 to 47 days. The mean for the 4 patients who had preoperative stereotactic-guided localizations was 14 days (range 7 to 21) and 25 days (range 14 to 47) for the 15 patients who had intraoperative US-guided localizations (P ⫽ 0.07). All 4 of the stereotactic-guided cases were within the first 8 surgical cases in the series. The 4 patients whose lesions were localized with stereotactic guidance had the radio-opaque metal wireform of the marker as the target for localization, with the radiofrequency localization device placed in all 4 cases. The pre-

M.A. Gittleman / The American Journal of Surgery 186 (2003) 386 –390

operative diagnosis was invasive cancer (IC) in 2 patients, DCIS in 1, and benign (but discordant) in 1. For the 15 intraoperative US-guided localizations, the operative report stated that the target was the biopsy marker in 10 patients, the prior biopsy site in 1, and the residual lesion in 1. In 3, the target was not specifically identified in the operative report. An 18G needle was placed in 6 cases (1 DICS, 5 ADH) and the radiofrequency localization device in the remaining 9 cases (5 IC, 3 DCIS, 1 benign discordant). The target lesion was excised in all cases. Confirmation of the target within the specimen was done by specimen radiograph in the radiology department in 2 of the 4 stereotactic cases and intraoperative US in 13 of the 15 US-guided cases. Gross examination of the specimen in the operating room and the pathology report confirmed the other 4 cases (2 in each group). The pathology report specifically confirmed excision of the prior biopsy site in 18 of the 19 cases. In the 1 case with no specific comment, the biopsy and surgical histology were the same, reported as infiltrating cancer and infiltrating ductal cancer, respectively. In addition to the primary surgical specimen, additional margins were obtained in 2 of the 4 stereotactic cases: 1 with a preoperative diagnosis of DCIS and 1 with infiltrating cancer. Additional margins were obtained in 2 of the 15 ultrasound cases: the first patient, who had 2 adjacent lesions biopsied, each revealing DCIS, and the last patient in the series with a preoperative diagnosis of ADH. Final margins were positive in only 1 patient who was localized intraoperatively with an 18G needle and upgraded from a preoperative diagnosis of ADH to DCIS on surgical pathology. Comparing preoperative biopsy and operative surgical diagnoses revealed concordance in most cases. There were 3 cases with no residual lesion: 2 cases of ADH, and 1 case of DCIS. There were four upgrades in diagnosis on surgical pathology.

Comments Deployment of the biopsy marker is very intuitive and simpler than other markers [23], allowing the operator to become proficient rapidly. To confidently recognize the US signature of the marker may require a short learning curve. However, like the sonographic signatures of cancers or benign masses, once learned, it can be easily recognized. As the marker signature is nonanatomic and unique, the learning curve may be shorter than for breast abnormalities typically evaluated by breast surgeons. In this practice, the short imaging study and preoperative US in a few patients provided the opportunity to learn and recognize the pattern. It took less than 3 months to develop confidence and 6 months to convert completely to intraoperative US-guided placement of a localization device. The majority of patients had their surgery within 4 weeks of diagnosis, with a small

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percentage still able to have an intraoperative localization procedure up to 7 weeks after their diagnostic biopsy. The option to perform the localization intraoperatively using US guidance rather than preoperatively with radiographic guidance offers advantages in terms of surgical approach, time, and patient comfort. In the operating room, the patient can be anesthetized, prepared, and draped for surgery prior to placing the localization device. Using a sterile probe cover over the US transducer, the marker (tumor surrogate) can be visualized with US, allowing the surgeon to locate it three dimensionally within the breast and plan the most advantageous incision site and surgical approach. The localization device can then be placed to facilitate that approach. Having the same physician perform the localization and surgery at the same time on the operating table simplifies the procedure by insuring the device is optimally positioned and decreasing the potential for movement in the interval between placement and excision. Performing the localization in the operating room under anesthesia saves time for the patient by eliminating a separate procedure in another department and the transport time to the operating room to wait for her surgery. Performing the localization intraoperatively adds only a few minutes to the surgical procedure. An ultrasonogram of the resected specimen, with immediate visible results, takes much less time than a specimen radiograph and allows the surgeon to better visualize any close margins that may benefit from immediate reexcision. This does not remove the option of obtaining a confirmatory specimen radiograph to document the presence of the biopsy marker wireform but decreases the reliance on it as the only means of documenting excision of the target lesion. Conclusions Placement of an ultrasound visible marker at the time of diagnostic stereotactic biopsy provides the surgeon with a reliable and effective means of incorporating an ultrasoundguided localization procedure into the surgical treatment in the operating room. That allows the surgeon to optimize placement of the localization device to facilitate the preferred surgical approach to the lesion. It also simplifies the process for the patient by eliminating a separate localization procedure performed in the radiology suite. Efficiencies are gained for the patient, the surgeon, and the operating room schedule.

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