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by the American Institute of Ultrasound in Medicine J Ultrasound Med 27:65-73 • 0278-4297 Factors Affecting the Efficacy of Ultrasound-Guided Vacuum-Assisted Percutaneous Excision for Removal of Benign Breast LesionsDepartment of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (E.Y.K.); and Departments of Radiology (Y.-A.B., M.-J.K., K.S.L., Y.L.) and Surgery (L.S.K.), Hallym University Hospital, Anyang, Korea. Address correspondence to Eun Young Ko, MD, Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul 135-710, Korea. E-mail: claudel{at}skku.edu
Objective. This study was designed to evaluate the effectiveness of complete removal and factors affecting the presence of a residual mass and complications after ultrasound-guided vacuum-assisted percutaneous removal of benign breast lesions. Methods. We retrospectively evaluated ultrasound images and medical records of 263 breast masses from 199 patients that were removed with an ultrasound-guided vacuum-assisted device. All lesions were assumed as benign on ultrasound imaging or had been confirmed as benign by a previous core needle biopsy. The influence of the size, distance from the nipple, number of lesions removed at a time, and pathologic diagnosis of all of the removed masses on the completeness of the removal and the presence of complications was analyzed. The Mann-Whitney U test was used in the statistical analysis. Results. The complete removal rate for ultrasound imaging immediately after the procedure was 95.8%, and the rate at more than 6 months for follow-up ultrasound imaging was 92.3%. Larger lesions, lesions closer to the nipple, and cases in which multiple lesions were removed at a time showed the presence of more residual lesions. Lesions closer to the nipple and cases in which multiple lesions were removed simultaneously developed more hematomas (P < .05). Conclusions. Ultrasound-guided vacuum-assisted percutaneous excision showed high effectiveness for the removal of benign breast masses. However, more attention should be given to certain lesions to increase the efficacy.
Key Words: benign breast lesion • mammotome • ultrasound Abbreviations: BI-RADS, Breast Imaging Reporting and Data System • DCIS, ductal carcinoma in situ • IDC, invasive ductal carcinoma
Over the past several years, breast cancer has emerged as the most frequent malignancy in Korean women. Detection of breast masses has also been rapidly increasing because of increased interest in screening examinations for early breast cancer and the rapid development of imaging equipment. Most breast lesions that are detected during screening examinations are likely to be benign and need no treatment but only a periodic checkup. Some lesions require a biopsy and follow-up examinations after being diagnosed as benign by a biopsy. Some patients have anxiety with the knowledge of a palpable mass with or without symptoms, even though the mass appears to be a probable benign lesion on ultrasound imaging or mammography. Furthermore, some patients view the follow-up examinations as a burden and do not follow through on proceeding with the follow-up recommendation. In either case, removal of the mass is preferable to a follow-up imaging study. Removal is also indicated for some lesions that are increasing in size or changing in a suspicious direction. Percutaneous vacuum-assisted removal under ultrasound guidance can be performed in the out-patient setting, is less invasive, and has better cosmetic results than surgical removal.1 Because the procedure removes all visible lesions, diagnosis and treatment can be performed together. If one removes all imaginary visible lesions, a short-term follow-up will not be necessary, and the procedural costs will be decreased. However, when the removal is partial, the accuracy and effect of both diagnosis and treatment can be decreased, and an additional follow-up procedure may be needed. To date, only a few reports of small populations have been published concerning the short-term experiences of ultrasound-guided percutaneous vacuum-assisted removal, and relatively little is known about its performance in terms of complete removal or follow-up results and the factors that influence the success of removal or complications.1–5 Accordingly, this study was designed to evaluate the performance of complete removal and the frequency and severity of complications after ultrasound-guided percutaneous vacuum-assisted removal of masses through an analysis of follow-up medical records and ultrasound images. We also analyzed factors affecting the presence of a residual mass and complications, with the goal of increasing the efficacy of ultrasound-guided vacuum-assisted percutaneous removal of benign breast lesions.
The Institutional Review Board approved this study, and informed consent was obtained from all patients. From July 2002 to December 2003, 263 breast masses from 199 patients were removed percutaneously. All of the lesions were category 3 lesions as determined by ultrasound imaging according to the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS)6 (n = 225) or had been confirmed as benign by a previous core needle biopsy (n = 38). Eighty-five patients (42.7%) had palpable masses, and 114 patients (57.3%) had nonpalpable masses. Sixty-eight masses were detected on patient self-examinations, and 69 masses were visualized on mammograms; 126 masses were visible only on ultrasound examinations. Indications for removal included severe anxiety of a patient with a palpable mass, a palpable mass with tenderness or pain (n = 24), a palpable mass with an increasing size (n = 33), a palpable mass with a change in shape in a suspicious direction (n = 10), a palpable mass with a family history of breast cancer (n = 3), a palpable mass causing serous nipple discharge (n = 1), and discomfort caused by the palpable mass (n = 14). Additional indications included a nonpalpable mass with a family history of breast cancer (n = 7) or a self-history of cancer in other sites, including an ovary or a contralateral breast (n = 5), an increased size or changed shape of a nonpalpable mass (n = 59), pain in the area of a nonpalpable mass (n = 28), and difficulty in follow-up examinations (n = 15) because of the patient’s place of residence, travel, or a physical handicap. A board-certified breast radiologist performed the removal of all breast lesions using a vacuum-assisted handheld device (SCM 23 mammotome; Ethicon Endosurgery, Cincinnati, OH) under ultrasound guidance (Acuson Sequoia 512, Siemens Medical Solutions USA, Inc, Mountain View, CA; and LOGIQ 700, GE Healthcare, Milwaukee, WI) with 12- to 15-MHz high-resolution linear probes. Selection of the probe was based on the size and shape of the lesion: an 8-gauge probe for relatively round masses or masses usually larger than 1.2 cm and an 11-gauge probe for flat masses or masses relatively smaller than 1.2 cm. Masses located in the thin breast parenchyma with a thickness of less than 1 cm were also removed with the 11-gauge probe.
We performed a breast ultrasound examination for all lesions before the removal procedure to determine the insertion site for the probe. The approach to the lesion from the insertion site was along the long axis of the lesion, parallel to the muscle plane, and peripheral to the central direction in the same quadrant of the breast. After 2 to 3 mL of a local anesthetic agent mixed with epinephrine (1:200,000) was injected in the cutaneous layer, an additional anesthetic agent mixed with normal saline was injected around the mass and along the estimated course of the probe with an 18-gauge spinal needle for anesthesia along with loosening of the breast tissue. For masses abutting the pectoralis muscle or masses just beneath the skin or near the nipple, saline was administered between the structures and masses to artificially increase the distance for needle passage and to increase safety (Figure 1
We obtained and stored immediate postprocedure ultrasound images in all cases, and follow-up ultrasound images were obtained for 123 breast lesions in 69 patients. We compared the immediate postprocedure ultrasound and follow-up ultrasound images and analyzed the presence of residual lesions and complications. We also reviewed the medical records of all patients to evaluate the presence and degree of 3 important complications: pain, ecchymosis, and hematomas. The size, distance from the nipple, number of lesions removed at a time, and pathologic diagnosis of all removed masses were analyzed, and the influence of each factor on the completeness of the removal and the presence of complications was evaluated. The Mann-Whitney U test was used in the statistical analysis.
The numbers of lesions removed were 1 for 155 patients, 2 for 30 patients, 3 for 12 patients, and 4 for 2 patients. The mean size ± SD of all lesions was 1.37 ± 0.56 cm, and the mean sizes of the lesions removed with the 8-guage probe (n = 188) and the 11-guage probe (n = 75) were 1.49 ± 0.56 cm (range, 0.4–3.5 cm) and 1.06 ± 0.31 cm (0.3–1.7 cm), respectively. Twenty masses (8.6%) were located within 1 cm from the nipple, and the mean distance of all masses from the nipple was 2.93 ± 1.63 cm (0.5–8 cm). The depth of a mass was divided into anterior, middle, and posterior sections, according to the location of the mass within the total thickness of breast tissue: 76 masses were in the anterior breast; 151 masses were in the middle breast; and 36 masses were in the posterior breast. The most common location was the upper outer quadrant (48 cases [18%]), and more lesions were located in the upper breast than in the lower breast.
The pathologic diagnoses of removed masses were predominantly benign (259/263 [98.5%]). Fibroadenoma was the most common diagnosis (n = 185), followed by fibrocystic changes, stromal fibrosis, sclerosing adenosis, benign intra-ductal papilloma, and ductectasia. One case was diagnosed as a benign phyllodes tumor (Figure 2
At the end of percutaneous removal after the 15 minutes of compression, postprocedure ultrasound images showed residual lesions in 3 of 263 masses. Complete removal was suggested for 252 (95.8%) of 263 masses, and lesions were difficult to access in 8 cases.
Follow-up ultrasound examinations were performed for 93 of 199 patients. A total of 123 follow-up ultrasound examinations were performed between 7 and 10 days for 45 cases, within 6 months for 13 cases, within 1 year for 36 cases, and after 1 year for 29 cases. One patient underwent follow-up ultrasound examinations 4 times; 8 patients underwent follow-up examinations 3 times; 11 patients underwent follow-up examinations 2 times; and 73 patients had only 1 follow-up examination. Forty-two of the 73 patients that had only 1 follow-up ultrasound examination were evaluated after more than 6 months. In all cases, the board-certified breast radiologist, with the knowledge of previous percutaneous removal, performed a bilateral whole-breast ultrasound examination, and the exact site of the previous mass removal was shown well on the follow-up ultrasound images. In the 65 cases that were followed after more than 6 months, residual lesions were observed in 5 cases, and the complete removal rate was 92.3% (Table 2
The average size of the 5 masses that had residual lesions on the follow-up ultrasound examinations was 1.47 cm; the mean distance from the nipple was 2.43 cm; and the number of lesions removed at a time was 2. Masses without residual lesions had an average size of 1.29 cm; the mean distance from the nipple was 2.56 cm; and the average number of lesions removed at a time was 1.78. Comparing the 2 types, masses with residual lesions were larger and closer to the nipple, and a greater number were removed at a time; however, there was no statistically significant difference between the 2 types (Table 3  ). The sizes of the residual lesions detected on follow-up ultrasound examinations were less than 1 cm, and none of the lesions were palpable. The other patients without a follow-up ultrasound examination had only clinical examinations, mammography, or both when they revisited the hospital, but there were no persistent palpable masses.
Additional surgeries were performed for the 3 cases diagnosed as malignant lesions after percutaneous removal. In 1 malignancy case, the lesion was incompletely removed because of calcifications, and the pathologically residual lesion was present in the surgical specimen. In another case, no residual lesion was seen on the immediate postprocedure ultrasound images, but pathologically malignant lesions were found in the surgical specimen. The third case was diagnosed as DCIS after percutaneous removal, but after additional wide surgical excision, the residual lesion pathologic finding was a fibrocystic change with atypical ductal hyperplasia. This indicates that the DCIS portion of the lesion was eliminated with ultrasound-guided percutaneous removal.
On follow-up ultrasound images, scar changes were noted at the percutaneous removal site in 32 cases (Figure 5
Not all benign or presumably benign breast masses need to be removed. According to the BI-RADS categorization, category 2 and 3 lesions can be tracked with regular routine checks and 6-month periodic follow-up examinations.6 For cases that do require removal, surgical excision causes hospital admission, exposure to general anesthesia, and cosmetic problems. As a result, many patients want a less invasive procedure for removal of breast lesions. Recently, the use of ultrasound-guided vacuum-assisted handheld devices for removal of benign breast masses has been on the increase because the procedure is simple, less time-consuming, and feasible in the outpatient setting with the use of local anesthesia. It also causes minimal scarring and has as high a diagnostic accuracy rate as surgical excision.7–10 In our studies, there were no notable complications with the procedure. There were no limitations in performing the procedure, except for not attempting to pass the probe through the subareolar area, which is susceptible to pain and vulnerable to ductal injury, as is similar to performing a core needle biopsy. In the cases in which the masses were located just above the pectoralis muscle, just below the skin and very close to the nipple, we injected saline mixed with an anesthetic agent between the mass and the adjacent structures to artificially increase the distance and to make it safe to insert the probe. With this step, we could safely remove the breast mass without injuring the muscle fascia or skin. In our study, the complete removal rate based on ultrasound imaging immediately after the procedure was 95.8%, and the rate without evidence of residual lesions at more than 6 months for follow-up ultrasound imaging was 92.3%. These values are higher than results reported by Fine et al,4 which showed 90% and 82% success rates on follow up ultrasound examinations, respectively. This difference may be attributed to case selection and the procedural methods; we confined an indication for removal to BI-RADS category 3 or biopsy-proven benign mass lesions, and all procedures were ultrasound guided under real-time monitoring. However, in the study by Fine et al,4 both masses and suspicious calcifications, including BI-RADS category 4 lesions and percutaneous removals, were removed both stereotactically and via ultrasound guidance. The presence of residual lesions was monitored on the immediate postprocedure ultrasound images after 15 minutes of compression, and the procedure was repeated if there was any suspicion of the presence of residual lesions. Repeated confirmation for the absence of a residual lesion before finishing the procedure and an effort to make the ultrasound field of view clear during and after the procedure have been helpful in reducing the number of residual lesions. The method of saline injection in problematic cases may have also helped the success rate of complete removal. We had 8 cases in which we could not confirm the absence of residual lesions on the immediate postprocedure images because of fluid collections at the removal site, severe edema of the breast parenchyma, or the presence of air or the injected anesthetic agent that obscured the margin of the mass. In these types of cases, we recommend adequate hand compression, squeezing the fluid at the removal site and along the needle tract using the fingers, confirmation of complete removal on ultrasound imaging after compression before dressing, and repeating the procedure if there is any residual lesion. In this study, the mean sizes of 5 masses with residual lesions and 60 masses without residual lesions on follow-up ultrasound imaging were 1.5 and 1.3 cm, respectively. Although the difference was not statistically significant, the masses were larger in the cases with residual lesions. Larger masses probably cause increased fluid collections, with a larger defect obscuring the residual lesions to a greater degree. Lesions closer to the nipple also showed more residual lesions, and more attention should be given to these cases. Lesions closer to the nipple and cases in which multiple lesions were removed simultaneously also developed more hematomas; adequate hand compression for a sufficient amount of time is recommended for these lesions. More residual lesions in multiple masses removed simultaneously are also considered to be associated with the presence of hematomas. A poor ultrasound field of view with a large fluid collection and increased edema of the surrounding tissue or air can disturb the evaluation of residual lesions at the removal site. Therefore, in the case of multiple masses, enough time for compression after removal of a mass is needed to reduce the formation of hematomas and residual lesions. Limitations of this study were its retrospective design and that not all patients had a follow-up ultrasound examination. Evaluations of residual lesions with ultrasound at least 6 months after the procedure were performed in only 65 cases. A prospective study with a large number of patients and homogeneous follow-up ultrasound images for a long period should be conducted to support the usefulness of ultrasound-guided percutaneous vacuum-assisted removal in managing benign breast masses. Another limitation is that we did not use the radiopaque clip for marking the site of removal. However, our study was based on the follow-up ultrasound findings, and it was not difficult to find the exact site of percutaneous removal of the previous masses on ultrasound imaging in all cases. We considered removal complete when there was no ultrasound evidence of a mass, but we do not think that this signifies histologic complete removal. March et al7 reported residual lesions in up to 60% of pathologic surgical specimens, even after all radiologic evidence had been completely removed. We also had 1 case of IDC that showed BI-RADS category 3 features and no residual lesions after percutaneous removal, as seen on ultrasound imaging, but residual tumor infiltrations were found in the pathologic specimen after additional surgical treatment. Therefore, malignant pathologic results after percutaneous removal must be followed with additional surgical treatment, even if there is no radiologic evidence of residual lesions. Limiting the use of ultrasound-guided percutaneous vacuum-assisted removal of masses to benign lesions is the best course of action. Although it is a benign lesion, the proper clinical management of a benign phyllodes tumor is wide surgical excision because of its high possibility of recurrence.11 However, in our case of a benign phyllodes tumor, the possibility of a phyllodes tumor was not considered before removal because the lesion was relatively small (1.8 cm) and had a slow growing pattern for more than 2 years. After percutaneous removal, no residual lesion was detected on ultrasound imaging, and we decided to follow the case with ultrasound rather than perform an immediate additional surgical excision. To date, there has been no evidence of a recurring tumor on follow-up ultrasound examinations. In conclusion, ultrasound-guided vacuum-assisted percutaneous excision for removal of breast masses is a very useful method for benign or presumably benign masses. The complete removal rate was high: 92.3% on follow-up ultrasound imaging after more than 6 months. However, residual lesions frequently occur after removal of larger masses, masses closer to the nipple, and multiple masses, and hematomas are frequent in masses close to the nipple and in simultaneous removal of multiple masses. Therefore, more attention should be given to lesions of these types to improve the success rate of complete removal without complications.
Received March 7, 2007, from the Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (E.Y.K.); and Departments of Radiology (Y.-A.B., M.-J.K., K.S.L., Y.L.) and Surgery (L.S.K.), Hallym University Hospital, Anyang, Korea. Revision requested May 7, 2007. Revised manuscript accepted for publication August 13, 2007.
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Abstract
Introduction
