Interventional bleeding, hematoma and scar-formation after vacuum-biopsy under stereotactic guidance: Mammotome®-system 11g/8g vs. ATEC®-system 12g/9g

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Abstract

Purpose

To evaluate prospectively the correlation of scar-formations after vacuum-assisted biopsy with different systems and needle-sizes and interventional bleeding/post-interventional hematoma.

Methods and materials

Between 01/2008 and 12/2009, 479 patients underwent vacuum-assisted biopsy under stereotactic-guidance, using the Mammotome®-system with 11/8-gauge and ATEC®-system with 12/9-gauge, whereas in 178 cases with representative benign histology no surgical-biopsy after vacuum-assisted biopsy was performed and at least a 2-plane-follow-up-mammogram after 6 month post-vacuum-assisted biopsy was available. Bleeding during intervention, hematoma post-intervention and scar-tissue was scored as minimal and moderate/severe. Statistical analysis included Chi-Square-trend-test, p-value <0.05 was considered to be significant.

Results

Significantly more bleedings and post-interventional hematomas for 8-gauge-Mammotome®-system vs. 11-gauge-Mammotome®-system (41.9% vs. 8.4%, p < 0.001/35.5% vs. 16.7%, p = 0.029), no significant-differences for the ATEC®-systems 9-gauge vs. 12-gauge (26.9% vs. 29.7%, p = 0.799/42.3% vs. 43.2%, p = 0.596). 11-gauge-Mammotome®-system vs. ATEC®-12-gauge-system revealed significantly less bleedings/hematomas (8.4% vs. 29.7%, p = 0.015/16.7% vs. 43.2%, p = 0.001), no significant differences for the large-systems (p = 0.135/p = 0.352). Follow-up of Mammotome®-11/8-gauge-system system has shown 13.1/16.1% minimal scar-formation and 1.2/3.2% moderate/severe scars, whereas ATEC®-12/9-gauge-system has shown 10.8/3.8% minimal scar-formation and 0/11.5% moderate/severe scars, no significant differences. No significant difference was found when comparing Mammotome®-11/8-g-systems vs. ATEC®-12/9-g-systems (p = 0.609/p = 0.823). There was also no correlation between risk of scar-formation after occurrence of bleeding or hematoma with any examined VAB-system or any needle size in this study (p = 0.800).

Conclusion

Using larger needle-sizes significantly (Mammotome®)/not significant for ATEC®) more interventional bleedings and post-interventional hematomas were detected, only a tendency concerning scar-formation.

Introduction

In the last decade stereotactic breast biopsy has rapidly gained acceptance as the technique of choice for preoperative histopathologic diagnosis for non-palpable mammographic breast lesions that are not visible on ultrasound. The effectiveness and high accuracy of non-operative diagnosis achieved by this technique has led to reduced numbers of open surgical biopsies [1]. Stereotactically guided vacuum assisted-biopsy (VAB) includes devices ranging from 7- to 14-gauge. Vacuum-biopsy is more accurate than core-needle biopsy in the evaluation of microcalcifications, and a metaanalysis has proved the value of VAB for the diagnosis of breast cancer to be good. VAB provides lower mis- and underestimation rates than core biopsy does [2], [3], [4]. However, concerning complication rates for bleeding or hematoma using different VAB systems, data available in the literature is limited. There are only a few studies showing various results concerning suspicious changes, scar formation or abnormalities on follow-up mammograms after vacuum-biopsy [5], [6]. This may cause problems in the diagnosis of potential malignancy in the breast.

The purpose of our prospective study was to evaluate the performance of different VAB-systems and needle-sizes in VAB in terms of the periinterventional complications bleeding and hematoma and in terms of postinterventional scar formations. The VAB systems of interest were Mammotome® (Ethicon Endosurgery, Cincinatti, USA) implementing 11- and 8-gauge needles and ATEC®-VAB system (Suros, Indianapolis, USA) implementing 12- and 9-gauge needles.

Section snippets

Methods

Between January 2008 and December 2009, 479 patients underwent consecutively VAB under stereotactic guidance, using the Mammotome® system with 11- and 8-gauge needles or the ATEC® system with 12- and 9-gauge needles. Both systems are technically different. Different to the Mammotome® system the ATEC® system has a collecting vessel for the harvested biopsy samples and a lavage function to flush the biopsy cavity with NaCl solution 0.9%.

All biopsies were performed on a digital prone table

Results

Mammotome® 11-gauge and 8-gauge needles were used in 84 and 31 cases, respectively. ATEC® 12-gauge and 9-gauge needles were used in 37 and 26 cases, respectively. In 38 biopsies a craniocaudal approach was chosen (21.3%), in 108 cases a lateromedial approach (60.7%), and in 32 cases a mediolateral approach (18.0%). The mean number of biopsy samples taken was n = 22.71 for the Mammotome® 8-gauge needle (range, 6–24; standard deviation (SD), 4.173), n = 24.48 for the Mammotome® 11-gauge needle

Discussion

Scar formation after open surgical breast biopsy for benign or malignant lesions is well known and described in the literature [7], [8]. Mammographic findings also include architectural distortions with or without concomitant mass, micro- or macrocalcifications, opaque foreign body, asymmetric tissue defect, oil cysts, skin thickening or deformity. Especially scar formation may mimic direct mammographic signs of malignancy. But those findings usually present stable or regressive on follow-up

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