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Original Research |
1 All authors: The Elizabeth Wende Breast Clinic, 170 Sawgrass Dr., Rochester, NY 14620.
Received December 12, 2007;
accepted after revision April 10, 2008.
Address correspondence to P. Somerville
(psomerville{at}ewbc.com).
Abstract
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MATERIALS AND METHODS. Core needle biopsy was performed at 1,144 sites in 1,055 women from August 2004 to May 2007. A retrospective study of these cases was performed. The patient group was composed of 200 women (220 biopsy sites) who were taking anticoagulant therapy daily (180 patients, aspirin; 16 patients, warfarin; and four patients, Excedrin), and the control group was composed of 855 women (924 biopsy sites) who were not receiving daily anticoagulant therapy. Any adverse reactions after core needle biopsy, including the presence and size of bruises or lumps (hematomas), were recorded.
RESULTS. There was a statistically significant difference (p = 0.035) in the percentage of bruises between patients receiving anticoagulation therapy and those who were not. Bruising occurred in 68 of the 200 (34%) women in the patient group (anticoagulated), whereas bruising occurred in 227 of the 855 (26.5%) women in the control group (nonanticoagulated). The differences were not statistically significant for hematoma formation (p = 0.274) or bruising with hematoma formation (p = 0.413). Hematoma occurred in 12 of the 200 (6%) anticoagulated patients versus 36 of the 855 (4.2%) patients in the control group. Patients reporting a bruise and lump (hematoma) numbered 10 of 200 (5%) for the anticoagulated group and 32 of 855 (3.7%) for the control group.
CONCLUSION. No patients undergoing core needle biopsy reported any clinically important complications. The results of this study confirm that performing core needle biopsy in patients on anticoagulation therapy is safe.
Keywords: breast biopsy • breast cancer • breast mass • mammography • MRI guidance • sonographic guidance • stereotactic guidance
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As the population ages, the number of patients with concurrent medical problems increases, as does the number of patients prescribed daily aspirin for general health concerns. Our community-based private practice clinic has a large referral area, including not only urban but also rural areas, requiring many patients to drive more than 2 hours for an appointment at our clinic. For several reasons, but mainly because of patient preference, the physicians at our clinic prefer to perform core needle biopsy at the time of mammographic consultation. We undertook this study to confirm our clinical suspicion that patients on daily aspirin therapy, as well as patients on warfarin, can safely undergo core needle biopsy.
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Informed consent was obtained from patients before core needle biopsy was performed, and the possible complications were discussed with pa tients including the risk of bleeding, which can result in bruising, hematoma formation, or possible operative therapy. Patients were given the option of returning for biopsy after refraining from taking aspirin for 1 week or, if on warfarin, waiting until the level was subtherapeutic. Patients who chose these options were excluded from the study. The remaining patients composed the study cohort, which was then divided into the control group of patients not on aspirin or warfarin and the anticoagulated group of patients on aspirin or warfarin. In addition, four patients took daily Excedrin (acetaminophen, acetylsalicylic acid, and caffeine, Novartis Consumer Health). Patients on warfarin were required to have a current international normalized ratio (INR) result within the therapeutic range from blood testing.
The method of guidance (stereotactic, sonographic, or MRI), the size of the needle, and the number of samples were recorded for each pa tient. In the control group, 631 patients under went stereotactic biopsy; six, MRI-guided bio psy; and 218, sonographically guided biopsy. An average of 8.1 passes were made per biopsy site. In the anticoagulated group, 155 patients underwent stereotactic biopsy and 45 underwent sono graphically guided biopsy, with an average of 8.1 biopsy samples per site (Table 1). When using stereotactic or sonographic guidance, the operator tried to avoid visible vessels. Color and power Doppler imaging techniques were not used. All biopsies were performed by two dedicated mam mographers, each with more than 10 years' experience.
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The type of abnormality—whether calcifications, masses, architectural distortion, a developing density, or a mass with calcium—was also recorded (Table 2).
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Both radiologists routinely use 2% lidocaine for the skin at the biopsy site as well as up to 2 mL of 1% lidocaine with 1/100,000 epinephrine for deep anesthesia unless contraindicated by patient allergy. In addition, significant localized compression (i.e., compression for at least 5 minutes) is routinely performed after core needle biopsy. If bleeding continues, compression is maintained until bleeding has ceased and an elastic fabric compression wrap and ice are used after the procedure. It is our practice in small lesions to mark the area biopsied with a metallic marker. The following markers are used in our practice: 14-gauge Ultraclip II (InRad), 14-gauge EndaSurgery CorMark (Ethicon), 12- and 14-gauge ATEC Trimark TD 13 (Suros Surgical Systems), and 12-gauge Celero Mark Site Identification (Suros Surgical Systems).
After the procedure, each patient was contacted by the radiologist who performed the biopsy to give the patient her histopathology results from the core needle biopsy. In addition, the patient was questioned regarding adverse reactions, including any bruising or lump formation, that may have developed. Patients were interviewed on the telephone by the radiologist who performed the procedure. The patients were questioned about the size of any bruises and whether a lump was palpable. Bruises were defined as discoloration of the skin (red, purple, green, or otherwise) and the absence of a palpable lump. A hematoma was deemed to be present if the patient could feel a palpable lump. The patient was questioned about the size of the bruise or lump and encouraged to give a specific measurement in either inches or centimeters. In cases in which the patient was not able to directly measure the abnormality, the patient was encouraged to compare the size of the bruise or lump with a dime, quarter, or 50-cent piece. Answers not given in centimeters were then converted to centimeters for statistical analysis. The patients were asked to look at the site and remove bandages or clothing if necessary to answer the questions. Most patients knew the size of the bruise or lump because our postprocedure instructions instructed them to remove the compression wrap before bedtime the previous night and remove all dressings except Steri-Strips (3M) for a shower that morning before the telephone call. If patients had difficulty answering the questions, we encouraged them to use a mirror or ask a family member for assistance. Generally patients were contacted the day after the procedure, although several were contacted after the weekend (72 hours) if the biopsy was performed on a Friday. For patients with two biopsy sites, only the worst bruising or largest lump was recorded, yielding 1,055 recorded results.
These results were collated and statistical analysis performed. Event rates were computed as the percentage of patients having an event among those evaluated. Differences in event rates between groups were assessed using a chi-square test. An alpha level of 0.05 was used to determine statistical significance. The sample size was chosen to have 80% power to detect a difference in event rates of 10 percentage points comparing patients on anticoagulants versus those not on anticoagulants assuming a roughly 1:4 ratio of the two groups in the final sample.
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The control group consisted of 855 patients and a total of 924 biopsy sites. Two hundred twenty-seven patients (26.5%) reported bruises ranging in size from 2.5 to 150 mm. The average size was 27.5 mm. Thirty-six patients (4.2%) reported a lump, ranging from 5 to 75 mm, with an average size of 20.4 mm. Thirty-two patients (3.7%) reported both a bruise and a lump.
The anticoagulation group consisted of 200 patients with a total of 220 biopsy sites. One hundred eighty patients were on daily aspirin; 16, warfarin; and four, Excedrin. Sixty-eight patients (34%) reported bruising that ranged in size from 5 to 150 mm. The average size of the bruises was 33.7 mm. Twelve patients (6%) reported a lump (hematoma) ranging from 5 to 70 mm with an average size of 24.5 mm. Ten patients (5%) reported both a bruise and a lump.
In the subgroup of anticoagulated patients on aspirin, there were 180 patients with a total of 197 biopsy sites. Of those patients, 62 (34.4%) reported bruising ranging in size from 5 to 150 mm, with an average size of 35.2 mm. Ten (5.6%) of these patients had a lump ranging from 5 to 70 mm, with an average size of 27.4 mm. A combination of a bruise and lump was reported by nine (5%) of the patients on aspirin.
The subgroup of anticoagulated patients on warfarin consisted of 16 patients and a total of 17 biopsy sites. Of these 16 patients, six (37.5%) reported bruising ranging from 5 to 30 mm with an average size of 17.3 mm. Two patients (12.5%) reported a lump of 10 mm each. One patient (6.2%) reported a lump and a bruise.
No lumps or bruises were reported by any of the four patients (six biopsy sites) on Excedrin (Table 3).
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The combination of bruising and lump formation was noted in more patients with malignant disease than in those with benign disease (Table 4) whether the patient received anticoagulation therapy or not.
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Neither the patient group nor the control group included patients who required hospit alization or operative intervention for bleeding. We are unaware of any patients who developed hematomas or bruising after the postbiopsy interview. Also, in our experience, subsequent therapy was not affected by hematoma formation. All patients tolerated the procedure well. Many patients, especially elderly patients or those who had traveled a long distance, were exceedingly grateful to be offered the opportunity to undergo biopsy on the same day as imaging.
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With regard to hematoma formation after core needle biopsy, a clinically important hematoma after stereotactic biopsy has been reported in fewer than 1% of biopsies in multiple studies [8, 9]. In addition, in a small preliminary study, Melotti and Berg [10] reported 18 patients on anticoagulant therapy who underwent 14- or 11-gauge biopsy without clinically important complications and a hematoma rate similar to that of the nonanticoagulated control group. In a single study, Deutch and colleagues [11] described a small carcinoma that was obscured by a large hematoma that resulted from biopsy, which delayed surgical excision by 12 weeks.
In our experience, core needle biopsy, whether performed using stereotactic, sonographic, or MRI guidance, with a variety of needle sizes ranging from 14- to 9-gauge can be performed safely on patients taking daily aspirin or therapeutically-in-range warfarin. Overall, patients on anticoagulation therapy experienced more bruising of the skin, but hematoma formation was essentially the same as that in patients not on anticoagulation therapy. In our practice, performing stereotactic biopsy is more time efficient than sonographically guided core biopsy, resulting in 69% of the core needle biopsies being performed under stereotactic guidance. Also, because most lesions are found mammographically, stereotactic bio psy is frequently the preferred method to ensure that the correct area is being biopsied.
Although slightly more bleeding (hematoma and bruising) was seen overall in cases of malignancy (invasive and intraductal cancers) than in cases of benign disease, a high suspicion of malignancy before biopsy should not dissuade one from performing core needle biopsy (Table 4). The routine use of lidocaine with epinephrine may aid in hemostasis as well as the practice of significant (i.e., for at least 5 minutes) localized compression. In addition, if a patient continued bleeding, additional compression was maintained until the bleeding had ceased and an elasticized fabric compression wrap and ice were used. There was no issue with obscured lesions because it is our practice in small lesions and calcifications to mark the area biopsied with a metallic marker.
This study did not assess complete risk profiles of the patients and did not stratify results with regard to patient age, other medications, lesion size, lesion location, needle size, or number of passes. Although there was slightly more bleeding in cases of malignancy, these results were not further stratified by histopathology results. In a larger, more detailed study, one might be able to assess additional risk factors that influence bruising and hematoma formation. Our study is further limited by the fact that it was a retrospective study that relied on patient self-reporting without confirmation of the physical findings by a medical professional. Further areas of study include assessment of risk with clopidogrel bisulfate (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals) because this medication is being used with increasing frequency. At the time of this study, the number of patients on Plavix was too small to be meaningful. The use of color or power Doppler imaging (or both) may also be beneficial in limiting bleeding complications, particularly in a practice in which sonographically guided core needle biopsies predominate.
Performing the core needle biopsy the same day that it is recommended, if at all possible, alleviates patient stress and anxiety. When questioned, patients frequently mention that waiting to undergo the biopsy and to receive the biopsy results are the most stressful parts of the workup. In addition, we have patients who not only are extremely anxious about the procedure, but also are at risk of not returning for the biopsy if it is scheduled at a different time. These patients include those with psychiatric diagnoses or significant travel issues. In the case of MRI-guided core biopsies, many patients are women with a known diagnosis of carcinoma who are awaiting surgery. These patients have an additional lesion that requires biopsy. It is beneficial to perform the additional biopsy as quickly as possible to aid in planning surgical and oncologic therapy.
Although in all cases it is preferable to minimize any complication, there arises occasions when the patient cannot and should not stop anticoagulation therapy because of underlying medical reasons or because there are time constraints that do not permit cessation of anticoagulation therapy. In addition, in a setting where patients travel extensively for or have limited access to medical care or in a setting in which a time delay and a second appointment would be burdensome, performing core needle biopsy in patients taking anticoagulants can be deemed safe.
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