An Improved Process for Breast Cancer Margin Identification and Orientation

An Improved Process for Breast Cancer Margin Identification and Orientation

An Improved Process for Breast Cancer Margin Identification and Orientation MARY BELAND, RN, MSN, CNOR F or women in the United States, breast cance...

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An Improved Process for Breast Cancer Margin Identification and Orientation MARY BELAND, RN, MSN, CNOR

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or women in the United States, breast cancer is the second most commonly diagnosed cancer.1 More than 182,000 new cases of breast cancer were diagnosed in 2008,2 meaning that nearly one in eight women is affected by this disease.1,2 Despite this occurrence rate, however, there are now approximately 2.4 million US breast cancer survivors.1 Early detection with the use of screening mammography, ultrasound, magnetic resonance imaging, and stereotactic biopsy has considerably improved outcomes for women diagnosed with breast cancer, and breast cancer surgery has advanced significantly during the past 40 years. Previously, surgical options were limited to radical or modified mastectomy, often including axillary node dissection, which contributed to extensive disfigurement and complications such as lymphedema. The emergence of breast conserving surgery (BCS) allows women the option of preserving a cosmetically acceptable breast without sacrificing survival. Breast conserving surgery refers to surgical excision of a known malignancy, with the goal of preserving normal breast tissue.3 Women with early stage I or II ductal carcinoma in situ (DCIS) now have more surgical choices for treatment such as excisional biopsy, lumpectomy, partial mastectomy, and quandrantectomy. Studies have shown no differentiation in survival rates between patients who choose lumpectomy versus mastectomy.4-6 Its benefits notwithstanding, BCS is not without risks and considerations. Conservative surgery can be complicated by incomplete excisions, revealed in © AORN, Inc, 2009

pathologically positive margins, and a higher rate of recurrence.3,7 In fact, the rate of recurrence is directly proportional to the extent of positively involved specimen margins.3,7 Margin width, which is used to assess the entirety of an excision “should be the single most important factor predicting disease recurrence.”8(p23) Current literature lacks consensus as to what constitutes an adequate margin width, and defining those measurements has become an important issue among clinicians and researchers. Some guidelines recommend that margins should be free of tumor, whereas others classify > 1 mm as negative and < 1 mm as positive.9 Others describe a range of 2 mm to 10 mm; however, narrow margins can lead to a need for re-excision and wider margins may compromise cosmetic results.10,11 In addition to cosmetic implications, re-excision for positive margins

ABSTRACT Breast conservation surgery has improved treatment for women faced with a diagnosis of breast cancer. A key factor in breast cancer surgery is the assurance of clear surgical margins. Inadequate or unclear margins prompt the need for re-excision, which can be physically and emotionally stressful for patients. A variety of techniques have been used to indicate margins intraoperatively, but the use of arbitrary methods can contribute to miscommunication between the OR and the radiology and pathology departments. A standardized process to identify surgical margins using radiopaque charms has improved communication and outcomes for patients undergoing breast cancer surgery at one facility. Key words: breast cancer, breast conserving surgery, surgical margin, resection margin. AORN J 90 (October 2009) 525-529. © AORN, Inc, 2009.

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Documenting the purpose of each suture was time-intensive and, on occasion, contributed to imprecise orientation. This process extended the time between excision of the specimen and its delivery to the radiology and pathology departments.

of electrocauterization can diminish image accuracy,17 and the technique requires either a surgeon adept at performing intraoperative ultrasound or the presence of a radiologist, thus increasing procedural resources and cost.18 Sewing suture materials of various colors, numbers, and lengths into specific margins is considered a cost-effective method but the suture color and placement is arbitrary based on the surgeon’s preference and technique. This method can also lead to miscommunication between the OR, the radiology department, and the pathology department.19 One recent study demonstrated a 31.1% disagreement rate between the orientation marked by the surgeon and that identified by the pathologist when this technique was used.20

ONE HOSPITAL’S SOLUTION is histopathologically complicated by reactive tissue indurations as well as residual blood and fluid collections.12 Careful attention to surgical margin status is the most reliable method to control local recurrence. The importance of detecting adequate margins intraoperatively reduces the need for re-excision surgery, sparing patients additional emotional stress and discomfort.13,14

DELINEATING SURGICAL MARGINS A number of techniques to delineate surgical margins intraoperatively and provide orientation have been employed over the years. One method uses tissue inks to demarcate specific margins, although some inks have been found to mimic microcalcifications on radiography, which complicates accurate localization.15 Enhanced intraoperative touch preps identify potential tumor cells using a combination of cytologic and immunofluorescent staining techniques. Though they provide high rates of specificity and sensitivity in detecting cancer cells at tissue margins, the time of preparation varies between 30 and 50 minutes, contributing to prolonged surgical time.16 Intraoperative high-frequency ultrasound yields timely, reliable, and accurate results in identifying nonpalpable breast lesions and confirming surgical margins but has some disadvantages.17,18 For example, the thermal effects

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In one community hospital with several surgeons on staff performing BCS, methods of margin identification were arbitrary. Some surgeons used a combination of black silk, white braided, and blue monofilament nylon sutures. Some used a single type of suture material but varied the number and lengths of the stitches. The circulating nurses were responsible for noting on pathology slips exactly how specimens were to be interpreted. The procedure of documenting the purpose of each suture was time-intensive and, on occasion, contributed to imprecise orientation. This process extended the time between excision of the specimen and its delivery to radiology and pathology. Occasionally, the receiving department’s personnel requested additional communication to clarify that proper orientation and margin status were confirmed. Discussion among the physicians involved revealed that a standardized method of orientation and margin identification would improve communication between the OR, radiology department, and pathology department. The chosen method employs the use of a device called the MarginMap™, which carries six radiopaque “charms” that are individually sewn into place with sutures. Each charm has a unique shape, identifying its intended location: cranial, caudal, lateral, medial, deep, and skin (Figure 1). Designed collaboratively by a

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Figure 1 • The MarginMap device for identifying surgical margins. (Photograph courtesy of Beekley Corp, Bristol, CT)

general surgeon and a radiologist on staff at the hospital, the device is manufactured locally and has served to expedite the process of specimen margin identification and orientation and improved communication among surgeons, nurses, radiologists, and pathologists. It has also decreased the need for re-excision surgeries, because the radiologist and pathologist communicate questionable margins to the surgeon before the surgery is completed. With the present process, the surgeon sews each charm into place before completely excising the specimen; the charms provide unmistakable and uninhibited orientation both radiologically and pathologically (Figure 2). The process conforms to American Society of Breast Disease recommendations that lesions be removed intraoperatively in one piece, with orientation done by the surgeon.21 After excision is complete, the specimen is delivered to either the radiology or pathology department for definitive assessment (Figure 3). The radiological and/or pathological evaluation is performed to confirm margin status and determine any need for re-excision before the patient leaves the OR. No additional documentation or communication regarding orientation is necessary, and surgical margin status is confirmed before closure. A recent surgery demonstrated the effectiveness of this standardized process. A 50-year-old

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Figure 2 • The sewn-in charms provide unmistakable orientation of the excised tissue. (Photograph courtesy of Beekley Corp, Bristol, CT)

Figure 3 • An x-ray shows the radiopaque charms. (Photograph courtesy of Beekley Corp, Bristol, CT)

woman with a known invasive DCIS tumor presented for lumpectomy with needle localization. The mass was excised and each radiopaque charm was sutured into appropriate surgical margins using 3-0 silk stitches. The specimen was then placed into a clear surgical specimen bag for transport and radiological imaging. The circulating nurse documented the essential preoperative history and diagnosis on the surgical pathology record, and the specimen was transported to the radiology department along with aornjournal.org



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the patient’s preoperative mammograms. After specimen radiography, the radiologist communicated to the surgical team that the mass was close to the cranial margin, enabling the surgeon to remove additional tissue. Subsequent evaluation by the pathologist confirmed clear surgical margins.19

A STANDARDIZED PROCESS As illustrated here, the MarginMap has facilitated a standardized process for surgical margin identification and specimen orientation. Its use has decreased the need for re-excision surgeries by facilitating a process of timely margin assessment before the patient leaves the OR suite. According to Molina et al, the need for additional margins is dependent on reliable orientation performed by the surgeon intraoperatively, as well as accurate confirmation of orientation by the pathologist.20 The standardized process has simplified documentation and communication among health care providers, thus improving the diagnosis and surgical treatment for women undergoing breast cancer surgery. Acknowledgement: The author acknowledges James T. Sayre, MD, FACS, senior staff physician, Bristol Hospital, Bristol, CT, for his clinical expertise and consultation in development of this article; Susan H. Diehl, EdD, APRN, associate professor, University of Hartford, West Hartford, CT, for her professional mentorship; and Chelsea Fithian, product manager-breast biopsy, Beekley Corp, Bristol, CT, for her clinical support. Editor’s notes: MarginMap is a trademark of Beekley Corp, Bristol, CT. Publication of this article does not imply AORN endorsement of specific products.

REFERENCES 1. Breast Cancer Facts & Figures 2007-2008. Atlanta, GA: American Cancer Society, Inc; 2007. http:// www.cancer.org/downloads/STT/BCFF-Final.pdf. Accessed August 18, 2009. 2. Breast cancer statistics. November 26, 2008. Breastcancer.org. http://www.breastcancer.org /symptoms/understand_bc/statistics.jsp. Accessed August 28, 2009. 3. Fitzal F, Gnant M. Breast conservation: evolution 528 •

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of surgical strategies. Breast J. 2006;12(5 Suppl 2): S165-S173. 4. Mai KT, Perkins DG, Mirsky D. Location and extent of positive resection margins and ductal carcinoma in situ in lumpectomy specimens of ductal breast carcinoma examined with a microscopic three-dimensional view. Breast J. 2003;9(1):33-38. 5. Veronesi U, Cascinelli N, Mariani L, et al. Twentyyear follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347(16): 1227-1232. 6. Fisher B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-1241. 7. Silverstein MJ, Lagios MD, Groshen S, et al. The influence of margin width on local control of ductal carcinoma in situ of the breast. N Engl J Med. 1999; 340(19):1455-1461. 8. Silverstein MJ. Ductal carcinoma in situ of the breast. Ann Rev Med. 2000;51:17-32. 9. Scarth H, Cantin J, Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: mastectomy or lumpectomy? The choice of operation for clinical stages I and II breast cancer (summary of the 2002 update). CMAJ. 2002;167(2):154-155. 10. Kunos C, Latson L, Overmoyer B, et al. Breast conservation surgery achieving  2 mm tumor-free margins results in decreased local-regional recurrence rates. Breast J. 2006;12(1):28-36. 11. Sahoo S, Recant WM, Jaskowiak N, Tong L, Heimann R. Defining negative margins in DCIS patients treated with breast conservation therapy: the University of Chicago experience. Breast J. 2005; 11(4):242-247. 12. Hanley C, Kessaram R. Quality of diagnosis and surgical management of breast lesions in a community hospital: room for improvement? Can J Surg. 2006;49(3):185-192. 13. Horst K, Smitt M, Goffinet D. Predictors of re-excision findings and ipsilateral breast tumor recurrence after breast conservation therapy. Current Medical Literature: Breast Cancer. 2004;16(4): 73-81. 14. Balch GC, Mithani SK, Simpson JF, Kelley MC. Accuracy of intraoperative gross examination of surgical margin status in women undergoing partial mastectomy for breast malignancy. American Surgeon. 2005;71(1):22-28. 15. Wong JW, Bai H, Abdul-Karim FW, MacLennan GT. Simulation of microcalcifications on specimen radiographs of breast biopsies by inks used in marking the surgical resection margins. Breast J. 2004;10(5):423-426. 16. Blair SL, Wang-Rodriguez J, Cortes-Mateos MJ, et al. Enhanced touch preps improve the ease of

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interpretation of intraoperative breast cancer margins. Am Surg. 2007;73(10):973-976. 17. Buman SJ, Clark DA. Breast intraoperative ultrasound: prospective study in 112 patients with impalpable lesions. ANZ J Surg. 2005;75(3):124-127. 18. Bennett IC, Greenslade J, Chiam H. Intraoperative ultrasound-guided excision of nonpalpable breast lesions. World J Surg. 2005;29(3):369-374. 19. Sayre JT, Bober SE. Making your mark: Beekley device standardizes surgical specimen margin orientation. ADVANCE for Imaging and Oncology Administrators. September 2004:85. 20. Molina MA, Snell S, Franceschi D, et al. Breast specimen orientation. Ann Surg Oncol. 2009;16(2):

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285-288. Epub December 3, 2008. 21. Policy statement on routine orientation of excised breast specimens. June 6, 2005. American Society of Breast Disease. https://www.netforumon demand.com/eWeb/DynamicPage.aspx?Site=asbd &WebCode=ArticleDetail&faq_key=16e23540-c3354eb9-865c-a594a34ddf57. Accessed August 28, 2009.

Mary Beland, RN, MSN, CNOR, is an RN first assistant, Perioperative Services, at Bristol Hospital, Bristol CT.

Computerized Rx Entry Still Poses Slight Safety Risk

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nconsistent information within the same prescription entry in a computerized provider order entry (CPOE) system is a patient safety risk, according to a prospective study reported in the May 25, 2009, Archives of Internal Medicine. The researchers enrolled pharmacists to report prescriptions entered during a four-month period that contained inconsistent information between structured fields and freetext fields in the system. They also received the prescriptions electronically with any comments written in the free-text field and then randomly selected 500 for manual review. Results of the study indicated that of nearly

56,000 prescriptions, 532 (.95%) contained inconsistent communication, and medication dosage was the most common inconsistent element. The researchers stated that about 20% of these errors could have resulted in moderate to severe harm to a patient. They concluded that improving the usability of the CPOE interface and integrating it with workflow may reduce the risk. Singh H, Mani S, Espadas D, Petersen N, Franklin V, Petersen LA. Prescription errors and outcomes related to inconsistent information transmitted through computerized order entry. Arch Int Med. 2009;169(10):982-989.

National Survey Reveals Decline in Drug Misuse

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he 2008 National Survey on Drug Use and Health (NSDUH) revealed that the misuse of prescription medications declined significantly between 2007 and 2008 among those aged 12 years and older, according to a September 10, 2009, news release from the Substance Abuse and Mental Health Services Administration. Survey findings also revealed, however, that the overall rate of illicit drug use has remained level at approximately 8%. Progress has been made to curb the use of some drugs. For example, past-month use of methamphetamine among those 12 years of age and older declined significantly, from 529,000 respondents in 2007 to 314,000 respondents in 2008. Current cocaine use in the same age group also decreased from 1% in 2006 to 0.7% in 2008. Survey results also showed promising reductions in drug use among young people between 12 and 17

years of age. Within this population, overall pastmonth illicit drug use declined from 11.6% in 2002 to 9.3% in 2008, and nonmedical use of prescription medication declined from 3.3% in 2007 to 2.9% in 2008. The rate of heavy alcohol use among full-time college students steadily decreased during the past three years from 19.5% in 2005 to 16.3% in 2008. The NSDUH is a scientifically conducted annual survey of approximately 67,500 people throughout the United States. According to the survey, 23.1 million Americans should receive specialized substance abuse treatment; however, only 2.3 million (ie, about 10%) receive it. New national survey reveals significant decline in the misuse of prescription drugs [news release]. Rockville, MD: Substance Abuse and Mental Health Services Administration; September 10, 2009. aornjournal.org



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