ATEC system for vacuum-assisted breast biopsy

Study component

Description

Objectives/hypotheses

The aim of this study was to evaluate the diagnostic reliability, biopsy duration and medical and technical complications of 2 VB systems.

Study design

Prospective, randomised comparative study.

Setting

Single‑centre (Germany). Patients were enrolled during April 2006 to July 2007. There was no follow‑up.

Inclusion/exclusion criteria

Inclusion criteria:

Exclusion criteria:

Primary outcomes

BI‑RADS distribution according to the biopsy method, histological results, mean lesion size, mean operating time and total excision.

Statistical methods

Mann–Whitney U tests were carried out where appropriate. Uni‑ and multivariate logistical regression were used to predict the effect of different parameters on complete lesion excision; uni‑ and multivariate linear regression were used to predict the effect of parameters on biopsy duration.

Patients included

59 patients were enrolled in the study and 62 biopsies were done.

Mammotome 8‑gauge and 11‑gauge biopsies: n=30.

ATEC 9‑gauge and 12‑gauge biopsies: n=32.

Results

BI‑RADS grading

BI‑RADS III, IV and V grading was seen in 18, 13 and 1 instance(s) respectively for the ATEC system, and 19, 10 and 1 instance(s) for the Mammotome system.

Histological results

A range of benign and malignant states was seen in the 62 biopsies: ADH (3.2%), DCIS (3.2%), invasive ductal carcinoma (1.6%), papilloma (6.5%), fibroadenoma (45.2%), scar (8.1%), LCIS (1.6%) and other benign lesions (30.6%).

Total excisions

Total excision was achieved in 64.7% and 60.0% of biopsies using the ATEC system with 9‑gauge and 12‑gauge needles respectively. Total excision was achieved in 85.7% and 88.9% of biopsies using the Mammotome with 8‑gauge and 11‑gauge needles respectively.

Multivariate logistic regression for sonographic

complete resection

The statistically significant influencing variables were BI‑RADS IV lesions (OR 0.10; 0.02 to 0.45; p=0.003) and the mean lesion size (OR 0.81; 0.71 to 0.93; p=0.002).

Multivariate logistic regression for biopsy duration

The statistically significant influencing variables were BI‑RADS IV lesions (OR −2.29; −4.83 to 0.25; p=0.077) and the maximum lesion size (OR 0.25; 0.06 to 0.44; p=0.01).

Conclusions

Both systems are suitable for clinical applications involving diagnostic tissue removal from focal lesions in the breast. Imaging‑guided complete resections can be achieved more often with the Mammotome.

Abbreviations: ADH, atypical ductal hyperplasia; BI‑RADS, breast imaging‑reporting and data system; DCIS, ductal carcinoma in situ; LCIS, lobular carcinoma in situ; OR, odds ratio; SD, standard deviation; VB, vacuum‑biopsy.

n

Mean (mm)

SD (mm)

Mean lesion size

Mammotome 8 gauge

21

14.2

4.6

ns, p=0.685

ATEC 9 gauge

17

14.9

6.4

Mammotome 11 gauge

9

8

3.9

ns, p=0.088

ATEC 12 gauge

15

10.5

3.7

Mean operating time

Mammotome 8 gauge

21

9.7

5.6

ns, p=0.931

ATEC 9 gauge

17

9.6

5.9

Mammotome 11 gauge

9

6.2

3.9

ns, p=0.640

ATEC 12 gauge

15

6.9

3.7

Abbreviations: ns, not significant; n, number.

Study component

Description

Objectives/

hypotheses

To prospectively evaluate the correlation of scar‑formations after vacuum‑assisted breast biopsy with different systems, needle‑sizes and interventional bleeding or post‑interventional haematoma.

Study design

Consecutive, prospective, comparative study.

Setting

Mammary Diagnostic, Gynaecology and Radiology Departments, Kiel, Germany.

Inclusion/exclusion criteria

Inclusion criteria: Patients presenting with suspicious microcalcifications seen on mammography.

Exclusion criteria not stated.

Primary outcomes

Bleeding during intervention, post–interventional haematoma and scar tissue formation. Each metric was scored as small, moderate or severe.

Bleeding or haematoma definitions: small bleeding or haematoma – a maximum of 20 ml blood aspirated or discrete density area of a maximum extension of 1.5×1.5×1.5 cm in projection of the target area in post‑interventional mammography; moderate bleeding or haematoma – a maximum of 20–40 ml blood aspirated or density area of a maximum of 3.0×3.0x3.0 cm; severe bleeding or haematoma – more than 40 ml blood aspirated or density area of more than 3.0×3.0×3.0 cm.

Scar formation definitions: minimal – a very vague density seen only along the z‑axis of the biopsy probe; moderate – a density area or an architectural distortion on one or both projection planes in the target area of the biopsy site; severe – a lesion causing diagnostic problems regardless of the knowledge of previous biopsies and so needing additional mammography, ultrasound, re‑biopsy or MRI imaging.

Statistical methods

The Chi‑square trend test was used for inter‑ and intra‑group analysis of differences between the groups. A p‑value of <0.05 was considered to be significant.

Patients included

479 consecutive patients had VAB under stereotactic guidance, using the Mammotome system with 11‑gauge or 8‑gauge needles or the ATEC system with 12‑gauge or 9‑gauge needles. Out of 479 patients the results for only 178 patients are presented. These patients did not have open surgical biopsy, and had at least a 2‑plane follow‑up mammogram after 6 months post VAB.

Needle size was determined by the size of the lesion: for small lesions (>15 mm diameter) ATEC 9 gauge or Mammotome 8 gauge were used; for larger lesions (<15 mm diameter) ATEC 12 gauge or Mammotome 11 gauge was used.

Mammotome 11‑gauge and 8‑gauge needles were used in 84 and 31 patients, respectively. ATEC 12‑gauge and 9‑gauge needles were used in 37 and 26 patients, respectively.

Results

The mean number of biopsy samples taken was 22.71 for the Mammotome 8‑gauge needle (range, 6–24; standard deviation [SD], 4.173), 24.48 for the Mammotome 11‑gauge needle (range, 7–48; SD, 3.695), 24.46 for the ATEC 9‑gauge needle (range, 24‑36; SD, 2.353), and 24.65 for the ATEC 12‑gauge (range, 12–35; SD, 3.946).

Bleeding

There was no significant difference in the bleeding rates of the Mammotome 8 gauge compared with the ATEC 9 gauge (p=0.135).

There were significantly fewer incidences of bleeding with Mammotome 11 gauge than the ATEC 12 gauge (p=0.015).

Haematoma

No significant differences between the different ATEC needle sizes (p=0.596). No significant differences between Mammotome 8 gauge and ATEC 9 gauge (p=0.352). Haematomas occurred significantly more often with the Mammotome 8 gauge than Mammotome 11 gauge (p=0.029). Significantly fewer haematomas with Mammotome 11 gauge compared with the ATEC 12 gauge (p=0.001).

Scar formation

No significant differences between Mammotome 8 gauge and 11 gauge or ATEC 9 gauge and 12 gauge for scar formation.

No significant differences in scar formation between Mammotome 8 gauge and ATEC 9 gauge (p=0.823) or Mammotome 11 gauge compared with the ATEC 12 gauge (p=0.609).

There was no correlation between the risk of scar formation and the occurrence of bleeding or haematoma (p=0.800).

Conclusions

The larger needle sizes of Mammotome (8 gauge) and ATEC (9 gauge) did not result in statistically significantly different rates of bleeding or haematoma formation. However, the Mammotome 11 gauge showed statistically significantly fewer bleeding events and haematoma formation than the ATEC 12 gauge.

There was no statistically significant difference in scar formation between Mammotome and ATEC systems regardless of needle gauge.

Abbreviations: SD, standard deviation; VAB, vacuum‑assisted biopsy.

Study component

Description

Objectives/hypotheses

To analyse how patients experience stereotactic‑guided vacuum‑assisted breast biopsy (VABB) both physically and mentally.

Study design

Prospective, comparative study with a patient questionnaire element.

Setting

Radiology and Gynaecology & Obstetrics Departments, Erlangen, Germany.

Inclusion/exclusion criteria

Inclusion criteria: patients with breast microcalcifications classified as BI‑RADS 4 or 5 (all were sent questionnaires).

Exclusion criteria not stated.

Primary outcomes

Percentage of benign or malignant lesions identified by histological result.

Results from a questionnaire on the patients' experience of the biopsy; Q1 and Q2 were rated excellent, very good, good, fair or poor):

Q1: Your condition during biopsy.

Q2: Your condition the week after the biopsy.

Q3: Complications (yes or no).

Q4: Evaluate your cosmetic result after biopsy. (satisfactory or non‑satisfactory).

Q5: Retrospectively, would you prefer a vacuum‑assisted biopsy to an open surgical biopsy? (yes or no).

Statistical methods

Pearson's Chi‑square‑test.

Patients included

211 patients; 189 responded to questionnaire or phone call.

Median age 61 years (range 32–87).

VABB was done in 150 patients with ATEC (9 gauge), 39 with Mammotome (11 gauge). Post‑interventional mammograms were available for 179/189 (95%) patients (Mammotome 34/39, 87%; ATEC. 145/150, 97%). For the remainder, the images were given to the patients and so were not available for analysis.

Results

The 2 different devices did not show significant differences for biopsy accuracy.

Complications (n=69):

15 patients did not regard haematoma or pain as a complication.

Post‑operative mammograms were done in 179/189 people. Haematomas were seen in 74/179 mammograms: 62/145 (43%) patients with ATEC; 12/34 (35%) patients with Mammotome. However, 58/189 (31%) patients biopsied thought they had a haematoma.

There was no significant difference between the 2 devices for patient condition while having the biopsy or 1 week after the biopsy (Q1, p=0.25; Q2, p=0.2).

In Q3, the ATEC system was significantly more frequently associated with complications (ATEC: 62/150; Mammotome: 7/39; p=0.005). The authors note that the smaller diameter of the ATEC needle (9 gauge) may have higher traumatic potential than the 11 gauge Mammotome needle.

Conclusions

Most patients preferred VABB to surgical biopsy. ATEC was not statistically significantly different to Mammotome for biopsy accuracy, but was statistically significantly worse for complication rates including haematomas. Younger patients more readily reported complications than older patients, and were more sensitive to the cosmetic results post‑biopsy.

Abbreviations: BI‑RADS, breast imaging‑reporting and data system; Q, question; VABB, vacuum‑assisted breast biopsy.

Study component

Description

Objectives/hypotheses

To compare 2 stereotactically‑guided vacuum‑assisted biopsy systems, measuring time effectiveness and harvested sample quality.

Study design

Randomised, part‑blinded, comparative study

Setting

Mammary Diagnostic, Gynaecology and Radiology Departments, Kiel, Germany.

Inclusion/exclusion criteria

Inclusion criteria: patients presenting with suspicious microcalcifications seen on mammography.

Exclusion criteria not stated.

Primary outcomes

Time taken to collect histological samples. Four time slots: system set‑up; the biopsy itself starting with the first skin incision and ending with the last sample gathered; preparation of tissue samples to be sent to pathologist; cleaning the site for the next patient.

Quality of samples for histology was judged by a blinded pathologist. Tissue fragmentation was judged as: 0 (having no tissue); 1 (multiple fragments, none >5 mm in length); 2 (multiple fragment, at least one ≥5 mm); 3 (at least 1 fragment, ≥10 mm). Crush artefacts were graded as: 0 (no tissue); 1 (severe crush, destroying most of the sample); 2 (some crush, does not impair interpretation of biopsy), 3 (limited or no crush artefacts). Adequacy of tissue for diagnosis was graded: 0 (no tissue); 1 (tissue, but provides non‑diagnostic samples); 2 (allows sufficient diagnosis); 3 (specimen with textbook quality).

Statistical methods

Means and standard deviations reported for sample collection time, evaluated biopsy quality compared using Mann–Whitney U test and Chi‑squared. P value set at <0.05 for significance.

Patients included

146 people presenting with suspicious microcalcifications seen on mammography. Calcifications were classified as BI‑RADS 4 or 5. Mammography was used to further subdivide the patients into those with small lesions (<15 mm, small‑gauge biopsy needles were used – ATEC 12 gauge or Mammotome 11 gauge), or large lesions (>15 mm, ATEC 9 gauge or Mammotome 8 gauge).

Large lesions: 34 people biopsied with Mammotome 8 gauge and 37 people with ATEC 9 gauge

Small lesions: 37 people biopsied with Mammotome 11 gauge and 38 people with ATEC 12‑gauge needles.

Results

Sampling time

The ATEC 9 gauge was 244.84 seconds faster than the Mammotome 8 gauge (p<0.001). The ATEC 12 gauge was 267.58 seconds faster than the Mammotome 11 gauge (p<0.001).

Significant time differences were only seen in the biopsy performance stage itself, not for the system setup, sending to the pathologist or clean‑up for the next patient.

Sample quality

Highest‑quality samples:

Medium‑quality samples:

Lowest‑quality samples:

Mammotome (of both sizes) provided significantly better sample quality than the ATEC system (of both sizes) (p<0.001).

In 3/68 (4.4%) of patients with malignant lesions, a histological underestimation was found with vacuum‑assisted biopsies, when a DCIS was diagnosed, but the histology of the surgical specimen had shown micro‑invasive cancer. One of these was collected with the 8 gauge Mammotome, and the other 2 with ATEC 12 gauge and 9 gauge respectively. The small number of these patients means that statistical analysis cannot be performed for significance.

Conclusions

The ATEC system provides statistically significantly faster sample collection, and Mammotome system provides statistically significantly higher‑quality histological samples for analysis.

Abbreviation: BI‑RADS. breast imaging‑reporting and data system.

Study component

Description

Objectives/hypotheses

To determine the frequency and upgrade rate for atypical ductal hyperplasia diagnosed with stereotactic 9 gauge vacuum‑assisted breast biopsy and to compare the frequencies and upgrade rates of atypical ductal hyperplasia between 9 gauge and 11 gauge vacuum‑assisted breast biopsy.

Study design

Retrospective, consecutive, comparative data study.

Setting

Radiology Department, University of Washington Medical Centre, USA.

Inclusion/exclusion criteria

Inclusion criteria – specimens were included if:

Exclusion criteria – specimens were excluded from the upgrade analysis if:

Primary outcomes

Frequency of ADH, rates of upgrade (from benign to malignant), and the number of VABB samples between 9‑ and 11‑gauge procedures.

Statistical methods

Chi‑square, Fischer's Exact and Student's t tests used. p<0.05 was considered significant.

Patients included

Retrospective database analysis: Patients with BI‑RADS category 4 or 5 who had stereotactic VABB procedures. 991 patients: 391 consecutive Mammotome 11‑gauge biopsies, 600 consecutive ATEC 9‑gauge biopsies.

Results

Mammotome 11 gauge versus ATEC 9 gauge:

The frequency of ADH was similar for ATEC 9 gauge

(13.8%) and Mammotome 11 gauge (14.8%) VABB (p=0.66).

The difference in upgrade rate between ATEC 9 gauge (21.6%) and Mammotome 11 gauge (20.4%) was not significant (p=0.87).

The difference between the mean number of samples taken with ATEC 9 gauge (9.9) and Mammotome 11 gauge (10.5) was not significant (p=0.4).

Conclusions

No statistically significant differences between ATEC 9‑gauge and Mammotome 11‑gauge sizes were found for the frequency of ADH identified, the number of biopsy samples taken, or the upgrade rate.

Abbreviations: ADH, atypical ductal hyperplasia; ALH, atypical lobular hyperplasia; BI‑RADS, breast imaging‑reporting and data system; VABB, vacuum‑assisted breast biopsy.

Study component

Description

Objectives/hypotheses

The purpose of this study was to evaluate a new method of doing MRI‑guided vacuum‑assisted breast biopsy in a study of lesions that had subsequent surgical excision.

Study design

Prospective, consecutive, comparative study.

Setting

Single‑centre (Germany).

Inclusion/exclusion criteria

Inclusion criteria:

Patients scheduled for MRI‑guided needle localisation of a non‑palpable mammographically occult lesion. The patients must have had an MRI at the study‑site institution as part of screening of patients at high risk for breast cancer or for assessing the extent of disease, if logistics allowed the biopsy to be done on the day of her surgery, and if her surgeon approved her participation.

Exclusion criteria: not stated.

Primary outcomes

Technical success, lesion characteristics, lesion biopsy procedure, number of biopsy specimens collected, clip deployment and positioning, time to do the biopsy, review of mammograms taken after biopsy, final histology and correlation of histology from VABB specimens with surgical samples.

Statistical methods

Summary statistics have been presented.

Patients included

20 patients, median age 51 years (range 19–64 years). 27 lesions from 19 patients were biopsied in total.

Results

Technical success

The biopsy was technically successful in 19 (95%) of 20 patients. In 1 woman, the biopsy device could not be inserted and the lesion needed surgical excision.

Lesion characteristics

27 lesions were biopsied in 19 patients. There were single lesions in 11 of the patients and 2 lesions in 8 of the patients who had a biopsy. The median size of these 27 lesions was 1.0 cm (range, 0.4–6.4 cm). A separate skin incision was made for each lesion that was biopsied.

Number of biopsy specimens collected

The median number of specimens obtained per lesion was 8 (range 6–14). In 23 lesions, only a single round of tissue collection was needed. Four required repeat acquisition.

MRI clip deployment and positioning

Clip placement was successful in 25/26 (96%) lesions. The first attempt at clip placement was successful in 20/26 (77%) lesions, and a second attempt was successful in 5/26 (19%) lesions. One placement failed despite 2 attempts.

Median time to do the biopsy

(From the original axial localising images to the final images obtained after clip deployment).

Single lesion: 35 min (mean, 35 min; range, 24–48 min) 2 lesions: 65 min (mean, 69 min; range, 62– 86 min).

Tissue collection time: 38 sec (mean, 41 sec; range, 29–87 sec).

Mammograms

Haematoma with air in 14/26 lesions (54%),

Air without haematoma in 10/26 lesions (38%).

No changes (biopsy site was not visible on the mammogram) in 2 (8%) lesions.

Complication in 1/27 (4%) lesions (1/19 patients, 5%): a clinical haematoma, which resolved with compression and did not delay subsequent surgery.

Correlation of VABB with surgical histology

24/27 agreement of VABB samples with surgical histology.

2/20 VABB benign lesions were diagnosed malignant by surgical histology.

1/5 VABB invasive cancers was diagnosed benign by surgical histology.

Conclusions

MRI‑guided VABB is an alternative to surgery and to existing MRI‑guided needle biopsy methods in clinical use for the histologic diagnosis of MRI‑detected lesions. Further work with more patients is needed, including optimisation of equipment and techniques for biopsy and clip placement, potential use of long‑acting contrast agents, imaging–histologic correlation, and long‑term follow‑up.

Abbreviations: ADH, atypical ductal hyperplasia; DCIS, ductal carcinoma in situ; MRI, magnetic resonance imaging; VABB, vacuum‑assisted breast biopsy.

VABB histology

Surgical histology

Benign

ADH

DCIS

Invasive cancer

Benign

18 (67%)

1 (4%)

1 (4%)

0 (0)

ADH

0 (0)

0 (0)

1 (4%)

0 (0)

DCIS

0 (0)

0 (0)

1 (4%)

0 (0)

Invasive cancer

1 (4%)

0 (0)

0 (0)

4 (15%)

Abbreviations: ADH, atypical ductal carcinoma; DCIS, ductal carcinoma in situ; VABB, vacuum‑assisted breast biopsy.

Study component

Description

Objectives/

hypotheses

The purpose of this study was to evaluate 2 systems of MRI‑guided vacuum‑assisted breast biopsy and to investigate the influence of the choice of system in the care of patients with lesions found only at MRI.

Study design

Retrospective, comparative study.

Setting

Single‑centre (German), patients were recruited between January 2005 and December 2007.

Inclusion/

exclusion criteria

No inclusion or exclusion criteria were stated.

Primary outcomes

Number of patients and lesions having handheld (Vacora), console (ATEC) or needle localisation; lesion characteristics; procedure time; histological results.

Statistical methods

The Student's t‑test and Wilcoxon's signed rank test were used to compare the biopsied lesion size and biopsy time. A value of p=0.05 was accepted as indicating statistical significance.

Patients included

349 patients (mean age, 52.5 years; range, 28–76 years) had MRI‑guided intervention (needle localisation or VABB). 475 lesions were seen on MRI. 149 patients (159 lesions) had needle localisation, and 200 patients (316 lesions) had VABB.

Two study periods with different devices were compared:

Results

Patient demographics, clinical indications

There was no statistically significant difference between the number of patients or lesions that had vacuum biopsy or needle localisation using the Vacora or ATEC devices (p>0.05) for mean age and distribution of clinical indications for breast MRI.

Number of patients and lesions having handheld (Vacora), console (ATEC) or needle localisation

Total: 349 patients, 475 lesions.

Vacora 10‑gauge localisation: 115 patients, 121 lesions.

Vacora 10‑gauge VABB: 42 patients, 49 lesions.

ATEC 9‑gauge localisation: 34 patients, 38 lesions.

ATEC 9‑gauge VABB: 158 patients, 267 lesions.

Mean time to do single‑ and multiple‑site vacuum biopsy

Mean number of biopsy specimens: Vacora 8 (range, 4–16); ATEC 12 (range, 6–25).

Mean single‑site biopsy time: Vacora 69 minutes (range, 35–95); ATEC 36 minutes (range, 23–64); p<0.005.

Mean biopsy time for 2 lesions: Vacora 90 minutes (range, 62–134); ATEC 70 minutes (range, 40–112); p< 0.005.

Pain tolerance and procedural complications

16/42 patients (38%) biopsied with the Vacora had notable pain during stylet placement and during biopsy.

16/267 (6%) biopsied with ATEC had notable pain during needle placement, none during actual tissue sampling. This difference was statistically significant (p<0.012).

No major complications or infections were seen during or after vacuum biopsy. 1 ATEC‑biopsied patient had continuous venous bleeding after manual compression lasting >90 minutes. 60 minutes of further manual compression stopped the bleeding. 1 Vacora patient had a 3 cm haematoma at the biopsy site.

Conclusions

Smaller lesions were biopsied in less time and with higher operator confidence with ATEC because of the procedural advantages of using the console‑based system. As a result, there was a major shift in the care of patients with lesions identified by MRI alone, away from lesion localisation to increased use of MRI‑guided VABB.

Abbreviations: SD, standard deviation; VABB, vacuum‑assisted breast biopsy.

Procedure

Vacora

Non‑malignant (n)

Malignant (n)

Positive predictive value (%)

Needle localisation

55

66

55 (66/121)

Vacuum biopsy

35

14

29 (14/49)

Total

90

80

47 (80/170)

Procedure

ATEC

Non‑malignant (n)

Malignant (n)

Positive predictive value (%)

Needle localisation

18

20

53 (20/38)

Vacuum biopsy

151

116

43 (116/267)

Total

169

136

45 (136/305)

Abbreviation: n, number.

Component

Quantity supplied

Price

ATEC Sapphire console

1 (can be used for all 3 imaging modalities)

£15,000

9‑gauge (3.7 mm) needle, 9/12 cm length with 12/20 mm aperture size for ultrasound and stereotactic imaging

5

£1170

9‑gauge (3.7 mm) needle, 14 cm length with 20 mm aperture size for ultrasound and stereotactic imaging

5

£1170

12‑gauge (2.7 mm) needle, 9/12 cm length with 20 mm aperture size for ultrasound and stereotactic imaging

5

£1170

9‑gauge (3.7 mm) needle, 14 cm length with 12/20 mm aperture size and MRI compatibility

5

£1550

Range of 9‑gauge and 12‑gauge needle guides for compatibility with Fischer, GE, Siemens, Instrumentarium and Lorad prone/upright stereotactic systems

5

£32

ATEC 400 cc canister with lid

10

£50

Stereotactic adapters for use with upright systems or prone table

1 (reusable)

£3500

9‑gauge introducer localisation set for MRI

5

£720

Component

Quantity

Price

ATEC tissue filter

5

£30

ATEC remote tissue filter adapter

5

£45

SecurMark biopsy site marker

10

£734

TriMark biopsy site marker

10

£678

Note: Markers are available in different configurations to match the needle length and gauge used during the procedure.