Home Evaluation of 11-Gauge and 9-Gauge Vacuum-Assisted Breast Biopsy Systems in a Breast Parenchymal Model
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Evaluation of 11-Gauge and 9-Gauge Vacuum-Assisted Breast Biopsy Systems in a Breast Parenchymal Model

Rationale and Objectives

To compare three commercially available vacuum-assisted breast biopsy systems for tissue yield, length and fragmentation of specimens.

Materials and Methods

Specimens were acquired from radiolucent (bacon) and radioopaque (turkey breast) tissue using three different commercially available vacuum-assisted breast biopsy devices. Two systems (system 1 and 2) were equipped with 11 G needles, one system (system 3) with a 9 G needle. As for systems 1 and 2 a second chamber for applying the vacuum is attached to the needle, the external maximum diameter was identical for all three systems. 48 specimens were taken out for each tissue type and for each device. Specimens were measured for total weight, individual length, and number of fragments. Differences between groups were analyzed using analysis of variance (ANOVA) and Student’s t-test.

Results

For both tissue types, system 1 and 2 showed similar results, for system 3 tissue weight and length of specimens were larger. Differences in lengths and weight were statistically significant between system 1 and 3 and system 2 and 3 (ANOVA, P < 0.05). Differences between length and weight were statistically significant between tissue 1 and 2 for all devices (t-Test < 0.05).

Conclusion

As for system 3 a larger tissue yield was obtained with the same number of specimens compared to systems 1 and 2, it can be assumed that the same diagnostic accuracy as for systems 1 and 2 may be achieved for system 3 with less passes through tissue.

Many breast lesions depicted by mammography or other imaging modalities have an uncharacteristic appearance. This is why there is a high demand for a reliable minimally invasive diagnostic tool with a high sensitivity and specificity. Various minimal invasive techniques for histologic diagnosis of focal breast lesions depicted by imaging modalities are available today, such as fine-needle aspiration cytology (FNAC), core-needle biopsy, and vacuum-assisted biopsy ( ). While in the past most breast biopsies were performed using FNAC, vacuum-assisted biopsy is increasingly used for confirmation of suspicious breast lesions ( ). This biopsy technique has been available at specialized centers since 1996 ( ). The most important advantage over other biopsy techniques is that larger tissue cores are obtained ( ), which reduces the rate of underestimation of breast lesions (e.g., diagnosis of atypical ductal hyperplasia on the basis of core biopsy versus invasive cancer based on open biopsy) and improves surgical planning ( ). Many publications recommend obtaining at least 12 specimens when vacuum-assisted breast biopsy is performed ( ). Most recommendations are based on 11-gauge biopsy, which is the most widely used technique. However, other vacuum-assisted biopsy devices with different probe systems have since become available. While older systems (Mammotome and Vacora) from Ethicon Endosurgery (Cincinnati, OH) and Bard (C.R. Bard, Murray Hill, NJ) that have been on the market for some time have been tested in various phantom studies ( ), the breast biopsy device from ATEC Suros (Suros Surgical Systems, Indianapolis, IN), to the best of our knowledge, has not been compared with conventional systems previously. Because the double-lumen needle of the Ethicon biopsy device increases the overall outer diameter, we compared the Ethicon device for obtaining an 11-gauge biopsy core with the 9-gauge ATEC Suros biopsy system, in order to compare two systems with identical overall outer diameters. The Bard system uses 10-gauge needles with an outer diameter that differs from that of the Ethicon and Suros biopsy systems; this is why we did not include the Bard system in our comparison. Moreover, the Bard breast biopsy unit is based on a different working principle (use of an insertion guide, withdrawal of the entire probe with each sampling step, vacuum not created externally as with the Ethicon and ATEC Suros systems).

The aim of the study presented here is to compare two Ethicon breast biopsy systems (Ethicon Mammotome Biopsys [system 1] and Ethicon Mammotome ST [system 2]) and a Suros Surgical Systems biopsy device (ATEC [system 3]) in terms of the amount of tissue that is obtained in a breast parenchyma phantom. As the diagnostic accuracy increases when more tissue is available for histology, the preferred system for vacuum-assisted biopsy would be the one with the highest tissue yield for a given number of specimens ( ). The only end point of this study is to determine differences between the three systems with regard to the average weight of biopsy specimens, core length, and degree of fragmentation.

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Materials and methods

Configuration of the Breast Biopsy Systems

Shared features

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Differences

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Figure 1, Diagrams comparing the needle cross sections of systems 1 and 2 (a) and of system 3 (b) . The biopsy channels (There is no fig 1c hatched ) have a diameter of 11 gauge (a) and 9 gauge (b) , respectively. With their additional channels ( open arrow ), the needles of systems 1 and 2 (d) have overall outer diameters corresponding to that of system 3 (d) .

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Tissue Sampling

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Figure 2, For sampling, the breast models (shown here for turkey breast) were fixed in a stereotaxic biopsy system.

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Results

Geometry

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Figure 3, The needles of systems 1 and 2 (a) can be advanced as close as 4 mm to the lower edge of the fenestrated paddle ( white arrow ), whereas the needle of system 3 (b) cannot be advanced closer than 8 mm to the edge due to central needle configuration ( black arrow ).

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Time

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Disadvantages of the Systems

Ethicon Mammotome (system 1)

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Ethicon ST (system 2)

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ATEC Suros (system 3)

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Statistical Analysis

Results in turkey breast

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Figure 4, Specimen lengths for turkey breast. System 2 did not yield significantly longer biopsy specimens than system 1 ( P = .937, ANOVA), while the specimens obtained with system 3 were significantly longer ( P < .001, ANOVA; box-whisker plots: median with 25th and 75th percentiles).

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Figure 5, Comparison of specimen weights obtained with systems 1–3 in turkey breast. Specimen weights were significantly greater for system 3 than for system 1 or 2 ( P < .001, ANOVA; box-whisker plots: median with 25th and 75th percentiles). However, specimens acquired with system 3 had a markedly higher water content, as they are collected in a water bath. To correct for this effect, the specimens were left to dry for 24 hours and weighed again. Drying resulted in a 9% weight decrease from a mean of 133 mg to 120 mg. The difference in weight was still significant.

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Results in bacon

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Figure 6, Specimen lengths in bacon. The difference between system 1 and the two other systems was statistically significant ( P < .001 and P < .027, respectively; ANOVA), while the difference between system 2 and system 3 was not ( P < .131; ANOVA; box-whisker plots: median with 25th and 75th percentiles).

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Figure 7, Comparison of average specimen weights for bacon. The mean specimen weight for system 3 was 60.42 mg, which is significantly higher than the mean weight of specimens obtained with systems 1 and 2 (ANOVA, P < .050; box-whisker plots: median with 25th and 75th percentile).

Figure 8, Comparison of a biopsy specimen (bacon) obtained with system 1 (a) and a specimen obtained with system 3 (b) .

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Comparison between turkey breast and bacon for systems 1–3

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Discussion

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Conclusion

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