- Email: [email protected]
Breast Interventions: A Primer for Interventional Radiologists
Breast Interventions: A Primer for Interventional Radiologists Kenneth R. Tomkovich, MD Breast cancer is the second leading cause of cancer related deaths in the United States. The area of breast interventions has benefited from recent advances in devices and imaging quality. Ultrasound, MRI, and stereotactic guided vacuum assisted and mechanical rotating stick freeze biopsy are the preferred methods for histologic diagnosis of breast lesions. Ablation techniques are available for the treatment of benign and malignant breast disease. The MammoSite balloon catheter can be placed percutaneously for delivering high dose short term brachytherapy. Interventional Radiologists can and should perform all of these procedures to improve the quality of women’s health. Tech Vasc Interventional Rad 9:30-35 © 2006 Elsevier Inc. All rights reserved. KEYWORDS breast, intervention, biopsy, ablation, brachytherapy
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n 2006 it is estimated that there will be 212,920 newly diagnosed invasive breast cancer cases and an additional 61,980 cases of carcinoma in situ.1 Breast cancer is the second leading cause of cancer related deaths in women with an estimated 40,970 deaths in 2006. Breast cancer is the most prevalent form of cancer in the female population of the United States.1 The ability to accurately diagnose early breast cancer is important to achieve the best possible outcomes for these patients. The area of breast interventions has benefited greatly from recent developments in imaging. With improvements in ultrasound, magnetic resonance imaging (MRI), and digital mammography, more lesions and smaller lesions in the breasts are being detected. These improvements, in addition to increased levels of patient awareness and education, have increased our ability to find smaller cancers. Finding the lesion, however, is only the beginning. Once the lesion is detected, the challenge is to then appropriately diagnose and treat patients in as minimally invasive a way as possible. During the past 5 years, significant advances have occurred in the area of breast biopsies, including the development of hand held ultrasound-guided mechanical and vacuum assisted devices. The introduction of several MRI compatible biopsy systems has also expanded the capabilities to perform minimally invasive interventions on lesions only seen by MRI. More recently, the focus has been on developing new devices and techniques for treatment, which can be performed percutaneously with imaging guidance for both benign and Department of Radiology, CentraState Medical Center, Freehold, NJ. Address reprint requests to Kenneth R. Tomkovich, MD, Department of Radiology, CentraState Medical Center, 901 West Main Street, Freehold, NJ 07728. E-mail: [email protected].
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1089-2516/06/$-see front matter © 2006 Elsevier Inc. All rights reserved. doi:10.1053/j.tvir.2006.08.007
malignant breast diseases. Radiofrequency ablation, cryoablation, microwave ablation, laser irradiation, and high frequency ultrasound ablation have all been studied for their efficacy to treat benign and malignant breast tumors.2 The MammoSite balloon catheter, used for high dose brachytherapy after lumpectomy for breast cancer, can be placed percutaneously with imaging guidance. In light of these advances and the potential for these patients to undergo minimally invasive image-guided procedures for both diagnosis and treatment, the opportunities for interventional radiologists to increase their involvement in the care of patients with breast diseases are numerous.
Breast Biopsies Patients with newly discovered breast lesions often require image-guided biopsies to obtain the tissue needed for diagnosis.3 Patients presenting for biopsy will have either a palpable or nonpalpable abnormality. Patients with a palpable abnormality will still typically require some form of imaging evaluation before biopsy. More commonly, patients requiring biopsy will have a nonpalpable abnormality that was discovered based on an abnormality on mammography. These patients typically present with BI-RADS category 4 (suspicious) or 5 (highly suggestive of malignancy) abnormalities on mammography, including abnormal calcifications, architectural distortion, and a suspicious mass. As the safety of image-guided biopsies has improved, some patients with BI-RADS category 3 lesions (probably benign) are being considered for biopsy. This includes patients who live in remote areas where access to health care is limited, patients in whom pregnancy is being planned, patients who have breast cancer in the opposite breast for treatment planning purposes, and particularly anxious patients.3
Breast interventions
Figure 1 Echogenic line through the center of the mass seen on breast ultrasound represents a 10 gauge Cassi II biopsy needle (Sanarus Medical). This utilizes a stick freeze technology with a 19-gauge central guiding needle and 10-gauge outer cutting needle.
Typically, fine-needle aspirations and core biopsies are performed with either ultrasound or stereotactic guidance although MRI-guidance for biopsies is growing in popularity as this technique becomes more widely available and accepted. Fine-needle aspirations obtain a suspension of cells with a small gauge needle that are analyzed for cytologic features.4 Cytologic evaluation of breast aspirates remain highly variable between pathologists because the supporting histology is not available to assist with diagnosis.4 Core biopsies use larger needles to obtain tissue samples from the breast and data has shown concordance between stereotactic and ultrasound-guided core biopsies with surgical excision.4-6 Recently, vacuum-assisted biopsy devices have become more commonly used for breast biopsies, both for palpable lesions and nonpalpable lesions using imaging guidance. These devices typically obtain larger specimens than typical core-biopsy needles and only require one cannula insertion.4
Figure 2 Pictured is a Mammotome EX (Ethicon) hand held vacuum assisted biopsy needle utilized for ultrasound guided breast biopsy. This needle can accommodate placement of a marking clip after biopsy through the needle shaft. (Color version of figure is available online.)
31
Figure 3 Pictured is the Visica (Sanarus Medical) cryoablation needle used for treatment of breast fibroadenomas.
This allows the operator to avoid the trauma and inefficiency resulting from multiple needle insertions.4 The probe is positioned within the target lesion, the vacuum is utilized to draw breast tissue through an aperature of the probe into the sampling chamber of the device7 (Fig. 2). A rotating cutting device is then used to obtain a tissue sample. Once introduced, the probe can be rotated 360 degrees, which improves the ability to obtain tissue and allows for the collection of multiple specimens without removing and reinserting the device.7 Because these devices obtain multiple tissue cores in a circumferential manner around the biopsy probe, there is more complete sampling of the lesion, reducing the number of unsatisfactory biopsies.8 Vacuum-assisted biopsy has been shown to accurately diagnose mammary microcalcifications,9 ductal carcinoma in situ,10 and atypical ductal hyperplasia.11 There has been some preliminary work done concerning the use of vacuum-assisted devices in the treatment of benign breast diseases, including gynaecomastia12 and fibroadenomas.13,14 Complications associated with diagnostic proce-
Figure 4 The Visica (Sanarus Medical) needle has been placed through a fibroadenoma. Ultrasound image is obtained documenting placement before cryoablation.
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K.R. Tomkovich
Figure 7 Ultrasound image of the Mammosite balloon catheter deployed in the breast.
Figure 5 Ultrasound image is obtained during cryoablation of a fibroadenoma documenting development of the anechoic shadowing ice ball with an echogenic rim. (Color version of figure is available online.)
dures are usually minor, including bruising and small hematomas.15 These devices are available in 8, 11, and 14 g sizes. The Cassi II biopsy needle (Sanarus Medical, Pleasanton, CA) provides another option for ultrasound guided biopsy. A 19 gauge needle (Fig. 1) is placed through the lesion and, using a CO2 cartridge, stick freezes the needle to the mass. A 10 gauge needle then passes over the 19 gauge needle and produces a circumferential core. Stereotactic guidance for a biopsy is often required when the target lesion cannot be visualized with ultrasound. Instead, these lesions typically present with microcalcifications
Figure 6 Image demonstrates the various shapes of the Mammosite balloon catheter (Cytyc Surgical, Palo Alto, CA) designed to conform to various cavity shapes in the breast following lumpectomy. (Color version of figure is available online.)
or an area of architectural distortion detected on mammography. Lesions that are difficult to biopsy using stereotactic guidance include lesions very deep in the breast, lesions high in the upper outer quadrant, and very small and fine microcalcifications.4 These biopsies require a dedicated biopsy table. With the patient lying prone and the breast extending through a circular opening in the middle of the table, the equipment is able to determine the three-dimensional position of the lesion within the breast by measuring the parallax shift of the targeted areas from defined angles of view.4 By reviewing the mammogram before the procedure, the best approach to the lesion can be determined. This consists of a path that enables the best view of the lesion, is the shortest route, avoids intervening blood vessels, and minimizes the risk for penetrating the posterior skin of the breast.4 Calculations are then made to determine the path and depth to the target area of the breast. For a Stereotactic biopsy, the breast is prepared in sterile fashion and after an infusion of local anesthetic a 3 mm incision is made through which the stereotactic biopsy needle is placed. Pre- and postdeployment images of the needle relative to the target are performed to confirm appropriate positioning and alignment of the needle. Multiple core biopsies are obtained with the use of a vacuum assistance. Following performance of a confirmation specimen mammogram, a localizing marker is placed to document the position of the biopsy site should further surgical excision be required. Lesions that can be visualized with ultrasound can typically be biopsied using ultrasound for imaging guidance. Despite the fact that characteristic appearances for benign and malignant lesions have been described using ultrasound, it has been established that this does not always accurately predict histology and that is why biopsies are typically required for diagnosis. Ultrasound guided breast biopsies can be performed using a fine needle aspiration or core biopsy technique similar to that used for biopsy procedures in other organs. As described, large gauge core biopsies using vacuum-assisted devices can be performed under ultrasound guidance as well. These biopsies can be performed in an outpatient setting using local anesthesia. The benefits of
Breast interventions ultrasound-guided large gauge mechanical biopsy are that it provides real time feedback to ensure accuracy of needle placement in the appropriate area or mass and allows for the placement of a marker at the biopsy site as is done with stereotactic biopsies. An added benefit for large gauge core biopsy is the ability to perform tumor marker analysis on the specimen. Solid masses are usually identified by ultrasound. If a center is performing breast MRI, then the capability should be available to perform an MRI-guided intervention if a lesion is identified that requires a biopsy, especially if the lesion in question can only be visualized on an MRI and not with ultrasound or mammography. Similar to ultrasoundguided biopsy, many vendors have developed MRI compatible biopsy needles and markers including vacuum assisted rotating devices to enable performance of large gauge biopsies.16
Ablation of Breast Tumors The current management of breast cancer has changed significantly in the past 15 to 20 years.17 Today, the focus on treatment is on more conservative management of cancer through lumpectomy and radiation therapy for small nonmetastatic cancers. Interventional radiologists are, as a group, very familiar with the fact that thermal ablation therapies have proven successful in the management of tumors throughout the body (eg, liver, kidney, lung, etc). The goal of any thermal ablation procedure is to heat or cool the tumor cells to a sufficient temperature so as to cause cell death. Studies have been completed to demonstrate the effectiveness of these therapies from a pathologic perspective and clinical trials are now ongoing to test the clinical feasibility of utilizing this technology in patients with limited disease.18 Over 30 articles have evaluated the feasibility of this therapy but the treatments to date remain investigational.19 For radiofrequency ablation, studies have been performed in which patients are ablated before surgery to determine if there is tumor viability within these tumors after ablation. The results for radiofrequency ablation have been somewhat mixed with some studies demonstrating complete necrosis within treated areas and others reporting viable tumor tissue at the time of surgery.20-22 MRI was shown by Burak and co-workers22 to be a valuable tool for the assessment of tumor response to radiofrequency ablation by evaluating enhancement characteristics in the targeted area of the breast after ablation. Studies have been performed on Cryoablation in the same manner with similar outcomes.23-25 Interestingly, Tafra and co-workers have reported their experience with utilizing Cryoablation before planned resection of small (⬍2 cm) breast tumors to provide the surgeons with a spherical template for dissection that includes the lesion within it.26 Similar studies have also been performed to evaluate the feasibility of interstitial laser thermal ablation therapy under ultrasound and MRI guidance.27,28 Finally, the use of MRguided high-frequency ultrasound may be promising for these patients29-31 and is exciting because of the potential to treat these lesions in a precisely targeted manner without the need for a skin incision.19 All of these studies appear promising but more research in the form of well-designed clinical trials is needed before ablative therapies are accepted as alternatives for surgery in appropriate patients.
33 Fibroadenomas are common benign breast lesions that have the potential to be symptomatic by causing pain and discomfort.32 Therefore, many patients will be interested in treating these symptomatic fibroadenomas once a histologic diagnosis has been made. Percutaneous image-guided cryoablation can now be considered a minimally invasive alternative to the open surgical removal of benign fibroadenomas. Cryoablation can be performed in an outpatient office setting using a 13 g cryoprobe (Fig. 3) (Visica system, Sanarus Medical, Inc., Pleasanton, CA), which is Food and Drug Administration (FDA) approved for this indication. This procedure is typically performed under ultrasound guidance, which allows for visualization of the cryoprobe as it is advanced through the center of the target fibroadenoma (Fig. 4). A freeze-thaw-freeze treatment cycle is performed under direct visualization with ultrasound (Fig. 5). A multicenter trial of 32 patients and 37 fibroadenomas in 32 patients reported a median volume reduction in fibroadenoma of 89% at 1 year and 99% reduction, or essentially complete resorption, at 2.6 years. Mammographic findings included calcifications, an asymmetric density and no artifact as compared with architectural distortion, skin thickening and asymmetric densities commonly seen after surgical excision. The safety profile and satisfaction with outcomes for this cryoablation procedure were both reported as being very good.33 The advantages of cryoablation compared with open surgery include a smaller incision similar to that of a core biopsy, and no requirement for an operating room, recovery room or anesthesia. The advantages of cryoablation as compared with hand-held vacuum-assisted ultrasound-guided fibroadenoma excision is destruction of the fibroadenoma cells as compared with possible incomplete removal with the vacuum assisted procedure in up to 27% of patients.34,35 Another larger multicenter trial of 444 treated fibroadenomas reported palpability of 46% and 35% at 6 and 12 months, respectively, for all lesions with improved outcomes for lesions less than 2 cm. For lesions less than 2 cm, visibility by ultrasound was 27% at 12 months and for lesions greater than 2 cm visibility by ultrasound was 32%.36 Percutaneous cryoablation of biopsy proven benign fibroadenomas should be considered as a primary option for symptomatic patients desiring treatment and one that falls well within the skill set of an interventional radiologist.
Mammosite Procedure After lumpectomy of a malignant breast lesion, patients often undergo radiation therapy. For years, whole breast irradiation was the standard means by which this was delivered. More recently, accelerated partial breast irradiation using interstitital brachytherapy has been proven effective for postlumpectomy breast cancer treatment in low-risk patients. The Mammosite system (Cytyc Surgical, Palo Alto, CA), introduced in 2002, has been touted as a simpler way to perform postoperative partial breast brachytherapy.37 This device is a dual lumen balloon catheter with one lumen allowing for balloon inflation and one lumen for administration of the high-dose iridium-192 source.37 The major advantage of this device is that only one applicator is necessary for the delivery of fractionated radiotherapy.38 Placement of the Mammosite balloon catheter can be per-
34 formed after lumpectomy on an outpatient basis using ultrasound guidance or can be placed inside the cavity at surgery using an open technique (Fig. 6). If placed percutaneously, the lumpectomy site is typically localized using ultrasound for guidance. A small incision is made through which an introducer trocar is placed into the lumpectomy site. The trocar is removed and the Mammosite balloon is placed into the lumpectomy site and the balloon inflated within the cavity created by the lumpectomy (Fig. 7). Patients then receive high dose brachytherapy through this catheter with treatment lasting up to 7 days. The balloon catheter is then removed. Complications that have been reported include wound complications including infection, skin toxicity (erythema, hyperpigmentation, telangiectasias), seroma formation, and catheter failure.39 This device is currently FDA approved but a multi-center trial is now underway to compare the outcomes after this therapy to the outcomes after traditionally accepted partial breast irradiation in the appropriate patient population.
Conclusion The model for cancer care provided by interventional radiologists is currently in place. Interventional Radiologists in office-based and hospital-based practices routinely evaluate the imaging findings for patients with a variety of abnormalities in many different organs and then proceed to perform percutaneous biopsies using imaging guidance. In addition, many patients with subsequently diagnosed cancer are evaluated and considered candidates for a variety of local tumor therapy options for both palliative and curative indications. This same model can and should be applied to diseases of the breast. Breast interventions can be performed safely in an office setting with the use of only local anesthesia. Interventional Radiologists have the background to evaluate the images used for diagnosis and can then utilize their skill set to perform image-guided percutaneous biopsies similar to those performed for abnormalities in other organs. Based on the biopsy results and extent of disease, the future possibility exists that local, thermal-ablation therapies may be options to offer these patients as we have seen in patients with tumors in other locations. Even now, percutaneous cryoablation is one option to offer patients with symptomatic benign fibroadenomas of the breast. Both patients and referring physicians can benefit from having a physician trained in complex minimally invasive image guided interventions performing image-guided breast interventions. Many Interventional Radiologists now perform these procedures as part of a comprehensive cancer care and women’s health program. Caring for women with diseases of the breast should become part of our standard practice and incorporated into our training programs. There are many opportunities to participate in research in this field along with our colleagues in Surgery and Diagnostic Radiology. Perhaps the most important reason for our participation in the area of breast interventions is to improve the quality of care for women’s health.40
References 1. Estimated new cancer cases and deaths by sex for all sites, US, 2006. American Cancer Society, Inc., Surveillance Research; http:// americancancersociety.org
K.R. Tomkovich 2. Agnese DM, Burak WE Jr: Ablative approaches to the minimally invasive treatment of breast cancer. Cancer J 11:77-82, 2005 3. Sickles EA: Periodic mammographic follow-up of probably benign lesions result of 3,184 consecutive cases. Radiology 179:463-468, 1991 4. Nurko J, Edwards MJ: Image-guided breast surgery. Am J Surg 190: 221-227, 2005 5. Parker SH, Jobe WE, Dennis MA, et al: US-guided automated large core breast biopsy. Radiology 187:507-511, 1993 6. Parker SH, Burbank F, Jackman RL, et al: Percutaneous large-bore breast biopsy: A multi-institutional study. Radiology 193:359-364, 1994 7. Iwuagwu O, Drew P: Vacuum-assisted biopsy device: Diagnostic and therapeutic applications in breast surgery. Breast 13:483-487, 2004 8. Cangiarella J, Waisman J, Symmans WF, et al: Mammotome core biopsy for mammary microcalcifications analysis of 160 biopsies from 142 women with surgical and radiologic follow-up. Cancer 91:173177, 2001 9. Meloni GB, Dessole S, Becchere MP, et al: Ultrasound-guided mammotome vacuum biopsy for the diagnosis of impalpable breast lesions. Ultrasound Obstet Gynecol 18:520-524, 2001 10. Won B, Reynolds HE, Lazaridis CL, Jackson VP: Stereotactic biopsy of ductal carcinoma in-situ of the breast using an 11-gauge vacuum-assisted device: Persistent underestimation of disease. AJR 173:227-229, 1999 11. Joshi M, Duva-Frissora A, Padmanabhan R, et al: Atypical ductal hyperplasia in stereotactic breast biopsies: Enhanced accuracy of diagnosis with the mammotome. Breast J 7:207-213, 2001 12. Iwuagwu O, Calvey TA, Ilsley D, Drew P: Ultrasound guided minimally invasive breast surgery (UMIBS): A superior technique for gynecomastia. Ann Plast Surg 52:131-133, 2004 13. Iwuagwu OC, Drew PJ: Ultrasound guided minimally invasive surgery for fibroadenomas. Arch Surg 139:564, 2004 14. Fine RE, Boyd BA, Whitworth PW, et al: Percutaneous removal of benign breast masses using a vacuum-assisted hand-held device with ultrasound guidance. Am J Surg 184:332-336, 2002 15. Diebold T, Jacobi V, Krapfl EV, et al: The role of stereotactic 11g vacuum biopsy for clarification of BI-RADS trade mark IV findings in mammography. Fortschr Rontg 175:489-494, 2003 16. Van Den Bosch MA, Daniel BL: MR-guided interventions of the breast. Magn Reson Imag Clin N Am 13:505-517, 2005 17. Burak WE Jr, Agnese DM, Povoski SP, et al: Radiofrequence ablation of invasive breast carcinoma followed by delayed surgical excision. Cancer 98:1369-76, 2003 18. Fornage BD, Sneige N, Ross MI, et al: Small (ⱕ2-cm) breast cancer treated with US-guided radiofrequency ablation: feasibility study. Radiology 231:215-224, 2004 19. Huston TL, Simmons RM: Ablative therapies for the treatment of malignant diseases of the breast. Am J Surg 189:694-701, 2005 20. Hayashi AH, Silver SF, van der Westhuizen NG, et al: Treatment of invasive breast carcinoma with ultrasound-guided radiofrequency ablaqtion. Am J Surg 185:429-435, 2003 21. Izzo F, Thomas R, Delrio P, et al: Radioferquency ablation in patients with primary breast carcinoma: A pilot study in 2 patients. Cancer 92:2036-2044, 2001 22. Burak WE, Agnese DM, Povoski SP, et al: Radiofrequency ablation of invasive breast carcinoma followed by delayed surgical excision. Cancer 98:1369-1376, 2003 23. Stocks LH, Chang HR, Kaufman CS, et al: Pilot study of minimally invasive ultrasound-guided Cryoablation in breast cancer. 2002. Presented at the American Society of Breast Surgeons Meeting, Boston, MA 24. Pfleiderer SO, Freesmeyer MG, Marx C, et al: Cryotherapy of breast cancer under ultrasound-guidance: Initial results and limitations. Eur Radiol 12:3009-3014, 2002 25. Sabel MS, Kaufman CS, Whitworth PW, et al: Cryoablation of early stage breast cancer: Work in progress report of a multi-institutional trial. Ann Surg Oncol 11:542-549, 2004 26. Tafra L, Smith SJ, Woodward JE, et al: Pilot trial of cryoprobe-assisted breast-conserving surgery for small ultrasound-visible cancers. Ann Surg Oncol 10:1018-1024, 2004 27. Daniel BL: Intraprocedural magnetic resonance imaging-guided interventions in the breast. Top Magn Reson Imaging 11:184-190, 2000 28. Mumatz H, Hall-Craggs MA, Wotherspoon A, et al: Laser therapy for breast cancer: MR imaging and histopathologic correlation. Radiology 200:651-658, 1996
Breast interventions 29. Gianfelice D, Khiat A, Amara M, et al: MR imaging-guided focused US ablation of breast cancer: Histopathologic assessment of effectiveness— initial experience. Radiology 227:849-855, 2003 30. Huber PE, Jenne JW, Rastert R, et al: A new noninvasive approach in breast cancer therapy using magnetic resonance imaging-guidance focused ultrasound surgery. Cancer Res 61:8441-8447, 2001 31. Wu F, Wang ZB, Cao YD, et al: A randomized clinical trial of highintensity focused ultrasound ablation for the treatment of patients with localized breast cancer. Br J Cancer 89:2227-2233, 2004 32. Isaacs JH: Benign neoplasms. In: Marchant DJ, ed. Breast Disease. Philadelphia: WB Saunders, 1997, pp 66-67 33. Kaufman CS, Littrup PJ, Freeman-Gibb LA, et al: Office-based cryoablation of breast fibroadenomas with long-term follow-up. Breast J 11: 344-350, 2005 34. Sperber F, Blank A, Metser U, et al: Diagnosis and treatment of breast fibroadenomas by ultrasound-guided vacuum-assisted biopsy. Arch Surg 138:796-800, 2003 35. Fine RE, Whitworth PW, Kim JA, et al: Low-risk palpable breast masses
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36. 37.
38.
39.
40.
removed using a vacuum-assisted hand-held device. Am J Surg 186:362-367, 2003 Nurko J, Mabry CD, Whitworth P, et al: Interim results from the fibroadenoma cryoablation treatment registry. Am J Surg 190:647-652, 2005 Niefhoff P, Ballardini B, Polgar C, et al: Early European experience with the MammoSite radiation therapy system for partial breast brachytherapy following breast conservation operation in low-risk breast cancer. Breast 15:319-325, 2006 Niehoff P, Polgar C, Ostertag H, et al: Clinical experience with the MammoSite radiation therapy system for brachytherapy of breast cancer: Results from an international phase II trial. Radiother Oncol 79: 316-320, 2006; Epub Jun 13 Herper JL, Jenrette JM, Vanek KN, et al: Acute complications of MammoSite brachytherapy: A single institution’s initial clinical experience. Int J Rad Oncol Biol Phys 61:169-174, 2005 Silverstein MJ, Lagios MD, Recht A, et al: Image-detected breast cancer: State of the art diagnosis and treatment. International Breast Cancer Consensus Conference II. J Am Coll of Surg 201:586-597, 2005
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n 2006 it is estimated that there will be 212,920 newly diagnosed invasive breast cancer cases and an additional 61,980 cases of carcinoma in situ.1 Breast cancer is the second leading cause of cancer related deaths in women with an estimated 40,970 deaths in 2006. Breast cancer is the most prevalent form of cancer in the female population of the United States.1 The ability to accurately diagnose early breast cancer is important to achieve the best possible outcomes for these patients. The area of breast interventions has benefited greatly from recent developments in imaging. With improvements in ultrasound, magnetic resonance imaging (MRI), and digital mammography, more lesions and smaller lesions in the breasts are being detected. These improvements, in addition to increased levels of patient awareness and education, have increased our ability to find smaller cancers. Finding the lesion, however, is only the beginning. Once the lesion is detected, the challenge is to then appropriately diagnose and treat patients in as minimally invasive a way as possible. During the past 5 years, significant advances have occurred in the area of breast biopsies, including the development of hand held ultrasound-guided mechanical and vacuum assisted devices. The introduction of several MRI compatible biopsy systems has also expanded the capabilities to perform minimally invasive interventions on lesions only seen by MRI. More recently, the focus has been on developing new devices and techniques for treatment, which can be performed percutaneously with imaging guidance for both benign and Department of Radiology, CentraState Medical Center, Freehold, NJ. Address reprint requests to Kenneth R. Tomkovich, MD, Department of Radiology, CentraState Medical Center, 901 West Main Street, Freehold, NJ 07728. E-mail: [email protected].
30
1089-2516/06/$-see front matter © 2006 Elsevier Inc. All rights reserved. doi:10.1053/j.tvir.2006.08.007
malignant breast diseases. Radiofrequency ablation, cryoablation, microwave ablation, laser irradiation, and high frequency ultrasound ablation have all been studied for their efficacy to treat benign and malignant breast tumors.2 The MammoSite balloon catheter, used for high dose brachytherapy after lumpectomy for breast cancer, can be placed percutaneously with imaging guidance. In light of these advances and the potential for these patients to undergo minimally invasive image-guided procedures for both diagnosis and treatment, the opportunities for interventional radiologists to increase their involvement in the care of patients with breast diseases are numerous.
Breast Biopsies Patients with newly discovered breast lesions often require image-guided biopsies to obtain the tissue needed for diagnosis.3 Patients presenting for biopsy will have either a palpable or nonpalpable abnormality. Patients with a palpable abnormality will still typically require some form of imaging evaluation before biopsy. More commonly, patients requiring biopsy will have a nonpalpable abnormality that was discovered based on an abnormality on mammography. These patients typically present with BI-RADS category 4 (suspicious) or 5 (highly suggestive of malignancy) abnormalities on mammography, including abnormal calcifications, architectural distortion, and a suspicious mass. As the safety of image-guided biopsies has improved, some patients with BI-RADS category 3 lesions (probably benign) are being considered for biopsy. This includes patients who live in remote areas where access to health care is limited, patients in whom pregnancy is being planned, patients who have breast cancer in the opposite breast for treatment planning purposes, and particularly anxious patients.3
Breast interventions
Figure 1 Echogenic line through the center of the mass seen on breast ultrasound represents a 10 gauge Cassi II biopsy needle (Sanarus Medical). This utilizes a stick freeze technology with a 19-gauge central guiding needle and 10-gauge outer cutting needle.
Typically, fine-needle aspirations and core biopsies are performed with either ultrasound or stereotactic guidance although MRI-guidance for biopsies is growing in popularity as this technique becomes more widely available and accepted. Fine-needle aspirations obtain a suspension of cells with a small gauge needle that are analyzed for cytologic features.4 Cytologic evaluation of breast aspirates remain highly variable between pathologists because the supporting histology is not available to assist with diagnosis.4 Core biopsies use larger needles to obtain tissue samples from the breast and data has shown concordance between stereotactic and ultrasound-guided core biopsies with surgical excision.4-6 Recently, vacuum-assisted biopsy devices have become more commonly used for breast biopsies, both for palpable lesions and nonpalpable lesions using imaging guidance. These devices typically obtain larger specimens than typical core-biopsy needles and only require one cannula insertion.4
Figure 2 Pictured is a Mammotome EX (Ethicon) hand held vacuum assisted biopsy needle utilized for ultrasound guided breast biopsy. This needle can accommodate placement of a marking clip after biopsy through the needle shaft. (Color version of figure is available online.)
31
Figure 3 Pictured is the Visica (Sanarus Medical) cryoablation needle used for treatment of breast fibroadenomas.
This allows the operator to avoid the trauma and inefficiency resulting from multiple needle insertions.4 The probe is positioned within the target lesion, the vacuum is utilized to draw breast tissue through an aperature of the probe into the sampling chamber of the device7 (Fig. 2). A rotating cutting device is then used to obtain a tissue sample. Once introduced, the probe can be rotated 360 degrees, which improves the ability to obtain tissue and allows for the collection of multiple specimens without removing and reinserting the device.7 Because these devices obtain multiple tissue cores in a circumferential manner around the biopsy probe, there is more complete sampling of the lesion, reducing the number of unsatisfactory biopsies.8 Vacuum-assisted biopsy has been shown to accurately diagnose mammary microcalcifications,9 ductal carcinoma in situ,10 and atypical ductal hyperplasia.11 There has been some preliminary work done concerning the use of vacuum-assisted devices in the treatment of benign breast diseases, including gynaecomastia12 and fibroadenomas.13,14 Complications associated with diagnostic proce-
Figure 4 The Visica (Sanarus Medical) needle has been placed through a fibroadenoma. Ultrasound image is obtained documenting placement before cryoablation.
32
K.R. Tomkovich
Figure 7 Ultrasound image of the Mammosite balloon catheter deployed in the breast.
Figure 5 Ultrasound image is obtained during cryoablation of a fibroadenoma documenting development of the anechoic shadowing ice ball with an echogenic rim. (Color version of figure is available online.)
dures are usually minor, including bruising and small hematomas.15 These devices are available in 8, 11, and 14 g sizes. The Cassi II biopsy needle (Sanarus Medical, Pleasanton, CA) provides another option for ultrasound guided biopsy. A 19 gauge needle (Fig. 1) is placed through the lesion and, using a CO2 cartridge, stick freezes the needle to the mass. A 10 gauge needle then passes over the 19 gauge needle and produces a circumferential core. Stereotactic guidance for a biopsy is often required when the target lesion cannot be visualized with ultrasound. Instead, these lesions typically present with microcalcifications
Figure 6 Image demonstrates the various shapes of the Mammosite balloon catheter (Cytyc Surgical, Palo Alto, CA) designed to conform to various cavity shapes in the breast following lumpectomy. (Color version of figure is available online.)
or an area of architectural distortion detected on mammography. Lesions that are difficult to biopsy using stereotactic guidance include lesions very deep in the breast, lesions high in the upper outer quadrant, and very small and fine microcalcifications.4 These biopsies require a dedicated biopsy table. With the patient lying prone and the breast extending through a circular opening in the middle of the table, the equipment is able to determine the three-dimensional position of the lesion within the breast by measuring the parallax shift of the targeted areas from defined angles of view.4 By reviewing the mammogram before the procedure, the best approach to the lesion can be determined. This consists of a path that enables the best view of the lesion, is the shortest route, avoids intervening blood vessels, and minimizes the risk for penetrating the posterior skin of the breast.4 Calculations are then made to determine the path and depth to the target area of the breast. For a Stereotactic biopsy, the breast is prepared in sterile fashion and after an infusion of local anesthetic a 3 mm incision is made through which the stereotactic biopsy needle is placed. Pre- and postdeployment images of the needle relative to the target are performed to confirm appropriate positioning and alignment of the needle. Multiple core biopsies are obtained with the use of a vacuum assistance. Following performance of a confirmation specimen mammogram, a localizing marker is placed to document the position of the biopsy site should further surgical excision be required. Lesions that can be visualized with ultrasound can typically be biopsied using ultrasound for imaging guidance. Despite the fact that characteristic appearances for benign and malignant lesions have been described using ultrasound, it has been established that this does not always accurately predict histology and that is why biopsies are typically required for diagnosis. Ultrasound guided breast biopsies can be performed using a fine needle aspiration or core biopsy technique similar to that used for biopsy procedures in other organs. As described, large gauge core biopsies using vacuum-assisted devices can be performed under ultrasound guidance as well. These biopsies can be performed in an outpatient setting using local anesthesia. The benefits of
Breast interventions ultrasound-guided large gauge mechanical biopsy are that it provides real time feedback to ensure accuracy of needle placement in the appropriate area or mass and allows for the placement of a marker at the biopsy site as is done with stereotactic biopsies. An added benefit for large gauge core biopsy is the ability to perform tumor marker analysis on the specimen. Solid masses are usually identified by ultrasound. If a center is performing breast MRI, then the capability should be available to perform an MRI-guided intervention if a lesion is identified that requires a biopsy, especially if the lesion in question can only be visualized on an MRI and not with ultrasound or mammography. Similar to ultrasoundguided biopsy, many vendors have developed MRI compatible biopsy needles and markers including vacuum assisted rotating devices to enable performance of large gauge biopsies.16
Ablation of Breast Tumors The current management of breast cancer has changed significantly in the past 15 to 20 years.17 Today, the focus on treatment is on more conservative management of cancer through lumpectomy and radiation therapy for small nonmetastatic cancers. Interventional radiologists are, as a group, very familiar with the fact that thermal ablation therapies have proven successful in the management of tumors throughout the body (eg, liver, kidney, lung, etc). The goal of any thermal ablation procedure is to heat or cool the tumor cells to a sufficient temperature so as to cause cell death. Studies have been completed to demonstrate the effectiveness of these therapies from a pathologic perspective and clinical trials are now ongoing to test the clinical feasibility of utilizing this technology in patients with limited disease.18 Over 30 articles have evaluated the feasibility of this therapy but the treatments to date remain investigational.19 For radiofrequency ablation, studies have been performed in which patients are ablated before surgery to determine if there is tumor viability within these tumors after ablation. The results for radiofrequency ablation have been somewhat mixed with some studies demonstrating complete necrosis within treated areas and others reporting viable tumor tissue at the time of surgery.20-22 MRI was shown by Burak and co-workers22 to be a valuable tool for the assessment of tumor response to radiofrequency ablation by evaluating enhancement characteristics in the targeted area of the breast after ablation. Studies have been performed on Cryoablation in the same manner with similar outcomes.23-25 Interestingly, Tafra and co-workers have reported their experience with utilizing Cryoablation before planned resection of small (⬍2 cm) breast tumors to provide the surgeons with a spherical template for dissection that includes the lesion within it.26 Similar studies have also been performed to evaluate the feasibility of interstitial laser thermal ablation therapy under ultrasound and MRI guidance.27,28 Finally, the use of MRguided high-frequency ultrasound may be promising for these patients29-31 and is exciting because of the potential to treat these lesions in a precisely targeted manner without the need for a skin incision.19 All of these studies appear promising but more research in the form of well-designed clinical trials is needed before ablative therapies are accepted as alternatives for surgery in appropriate patients.
33 Fibroadenomas are common benign breast lesions that have the potential to be symptomatic by causing pain and discomfort.32 Therefore, many patients will be interested in treating these symptomatic fibroadenomas once a histologic diagnosis has been made. Percutaneous image-guided cryoablation can now be considered a minimally invasive alternative to the open surgical removal of benign fibroadenomas. Cryoablation can be performed in an outpatient office setting using a 13 g cryoprobe (Fig. 3) (Visica system, Sanarus Medical, Inc., Pleasanton, CA), which is Food and Drug Administration (FDA) approved for this indication. This procedure is typically performed under ultrasound guidance, which allows for visualization of the cryoprobe as it is advanced through the center of the target fibroadenoma (Fig. 4). A freeze-thaw-freeze treatment cycle is performed under direct visualization with ultrasound (Fig. 5). A multicenter trial of 32 patients and 37 fibroadenomas in 32 patients reported a median volume reduction in fibroadenoma of 89% at 1 year and 99% reduction, or essentially complete resorption, at 2.6 years. Mammographic findings included calcifications, an asymmetric density and no artifact as compared with architectural distortion, skin thickening and asymmetric densities commonly seen after surgical excision. The safety profile and satisfaction with outcomes for this cryoablation procedure were both reported as being very good.33 The advantages of cryoablation compared with open surgery include a smaller incision similar to that of a core biopsy, and no requirement for an operating room, recovery room or anesthesia. The advantages of cryoablation as compared with hand-held vacuum-assisted ultrasound-guided fibroadenoma excision is destruction of the fibroadenoma cells as compared with possible incomplete removal with the vacuum assisted procedure in up to 27% of patients.34,35 Another larger multicenter trial of 444 treated fibroadenomas reported palpability of 46% and 35% at 6 and 12 months, respectively, for all lesions with improved outcomes for lesions less than 2 cm. For lesions less than 2 cm, visibility by ultrasound was 27% at 12 months and for lesions greater than 2 cm visibility by ultrasound was 32%.36 Percutaneous cryoablation of biopsy proven benign fibroadenomas should be considered as a primary option for symptomatic patients desiring treatment and one that falls well within the skill set of an interventional radiologist.
Mammosite Procedure After lumpectomy of a malignant breast lesion, patients often undergo radiation therapy. For years, whole breast irradiation was the standard means by which this was delivered. More recently, accelerated partial breast irradiation using interstitital brachytherapy has been proven effective for postlumpectomy breast cancer treatment in low-risk patients. The Mammosite system (Cytyc Surgical, Palo Alto, CA), introduced in 2002, has been touted as a simpler way to perform postoperative partial breast brachytherapy.37 This device is a dual lumen balloon catheter with one lumen allowing for balloon inflation and one lumen for administration of the high-dose iridium-192 source.37 The major advantage of this device is that only one applicator is necessary for the delivery of fractionated radiotherapy.38 Placement of the Mammosite balloon catheter can be per-
34 formed after lumpectomy on an outpatient basis using ultrasound guidance or can be placed inside the cavity at surgery using an open technique (Fig. 6). If placed percutaneously, the lumpectomy site is typically localized using ultrasound for guidance. A small incision is made through which an introducer trocar is placed into the lumpectomy site. The trocar is removed and the Mammosite balloon is placed into the lumpectomy site and the balloon inflated within the cavity created by the lumpectomy (Fig. 7). Patients then receive high dose brachytherapy through this catheter with treatment lasting up to 7 days. The balloon catheter is then removed. Complications that have been reported include wound complications including infection, skin toxicity (erythema, hyperpigmentation, telangiectasias), seroma formation, and catheter failure.39 This device is currently FDA approved but a multi-center trial is now underway to compare the outcomes after this therapy to the outcomes after traditionally accepted partial breast irradiation in the appropriate patient population.
Conclusion The model for cancer care provided by interventional radiologists is currently in place. Interventional Radiologists in office-based and hospital-based practices routinely evaluate the imaging findings for patients with a variety of abnormalities in many different organs and then proceed to perform percutaneous biopsies using imaging guidance. In addition, many patients with subsequently diagnosed cancer are evaluated and considered candidates for a variety of local tumor therapy options for both palliative and curative indications. This same model can and should be applied to diseases of the breast. Breast interventions can be performed safely in an office setting with the use of only local anesthesia. Interventional Radiologists have the background to evaluate the images used for diagnosis and can then utilize their skill set to perform image-guided percutaneous biopsies similar to those performed for abnormalities in other organs. Based on the biopsy results and extent of disease, the future possibility exists that local, thermal-ablation therapies may be options to offer these patients as we have seen in patients with tumors in other locations. Even now, percutaneous cryoablation is one option to offer patients with symptomatic benign fibroadenomas of the breast. Both patients and referring physicians can benefit from having a physician trained in complex minimally invasive image guided interventions performing image-guided breast interventions. Many Interventional Radiologists now perform these procedures as part of a comprehensive cancer care and women’s health program. Caring for women with diseases of the breast should become part of our standard practice and incorporated into our training programs. There are many opportunities to participate in research in this field along with our colleagues in Surgery and Diagnostic Radiology. Perhaps the most important reason for our participation in the area of breast interventions is to improve the quality of care for women’s health.40
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