Advice
Evidence review
Evidence review
Clinical and technical evidence
Regulatory bodies
A search of the Medicines and Healthcare Products Regulatory Agency website revealed no manufacturer Field Safety Notices or Medical Device Alerts for this device. Twenty two reports of adverse events related to the ATEC device were identified from a search of the US Food and Drug Administration (FDA) database: Manufacturer and User Device Facility Experience (MAUDE). Table 1 lists the events and outcomes that were noted.
Table 1 Summary of adverse events and outcomes relating to the ATEC device on the FDA MAUDE database
|
Event |
n=22 |
Outcome |
n=22 |
|
Lesion pushed away |
1 |
Hologic enhanced quality checks |
1 |
|
Biopsy too small |
1 |
Repeat procedure |
1 |
|
Component missing |
5 |
Procedure repeated |
1 |
|
Component replaced |
1 |
||
|
Not stated |
3 |
||
|
Device continued taking biopsies |
2 |
Patient unharmed |
2 |
|
Device stopped during biopsy |
1 |
Not stated |
1 |
|
Difficulty removing device from the breast |
1 |
Not stated |
1 |
|
Device failed pre‑procedure quality assurance checks |
1 |
Not stated |
1 |
|
Haematoma |
1 |
Patient hospitalised |
1 |
|
Inner/outer cannula broke off |
2 |
Cannula still in patient |
1 |
|
Patient unharmed |
1 |
||
|
Operator needle stick injury |
1 |
Not stated |
1 |
|
Suresight tip disengaged |
1 |
Patient unharmed |
1 |
|
Needle tip broke off/bent/lodged |
5 |
Needle tip still in patient |
2 |
|
Occurred before procedure |
1 |
||
|
Patient unharmed |
2 |
Clinical evidence
Thirty-three potentially relevant studies were identified, from which the following were excluded: 2 German‑language publications, 2 reports that did not separate ATEC results from other vacuum‑assisted breast biopsy devices, 1 abstract with no results, 2 posters with limited information, and 1 poster of a study also available as a full paper. The remaining 26 studies used the ATEC system with either ultrasound‑, stereotactic‑ or MRI‑guided imaging. Studies were selected for further assessment and prioritised according to design (from highest to lowest) as follows: prospective comparative, prospective non‑comparative, retrospective comparative and retrospective non‑comparative. No randomised controlled trials were identified. This resulted in 7 studies: 1 for ultrasound‑guided, 2 for MRI‑guided and 4 for stereotactic‑guided. A detailed summary of included studies is in the appendix; key outcomes are summarised in table 2.
Table 2 Key study outcomes
|
Study |
Comparator(s) and imaging technique |
Outcomes and safety |
Summary of findings |
|
Hahn et al. 2010 |
Mammotome |
Operating time: ATEC 9 gauge 9.6 minutes, Mammotome 8 gauge 9.7 minutes (p=0.931). ATEC 12 gauge 6.9 minutes, Mammotome 11 gauge 6.2 minutes (p=0.640). Total excision of lesions: ATEC 9 gauge 64.7%, Mammotome 8 gauge 85.7%. ATEC 12 gauge 60.0%, Mammotome 11 gauge 88.9%. Two ATEC 9‑gauge procedures stopped because of needle clogging due to the canister not being secure. One needle deviation with Mammotome 8 gauge that needed a second needle. |
Study results favour the Mammotome for total excision only. |
|
Schaefer et al. 2012 |
Mammotome |
Fewer incidences of bleeding with Mammotome 11 gauge versus ATEC 12 gauge (p=0.015). No significant differences in bleeding with ATEC 9 gauge versus Mammotome 8 gauge. Fewer post‑interventional haematomas with Mammotome 11 gauge versus ATEC 12 gauge (p=0.001). There were no significant differences in scar formation at any needle size. No correlation between scar formation and bleeding or haematoma (p=0.8). |
Study results favour the Mammotome 11 gauge for fewer incidences of bleeding and post‑interventional bleeding. |
|
Eller et al. 2014 |
Mammotome |
Patient questionnaire: no significant difference for patient condition during procedure (p=0.25) or 1 week after biopsy (p=0.2). Haematomas (n=179) identified using mammography, in 62/145 (43%) of ATEC 9 gauge procedures and 12/34 (35%) of Mammotome 11 gauge procedures. Questionnaire reporting complications: ATEC 9 gauge 62/150 (41%), Mammotome 11 gauge 7/39 (18%) (p=0.005). |
The study results favour the Mammotome for fewer incidences of haematoma. |
|
Order et al. 2013 |
Mammotome |
Sampling time: ATEC 9 gauge was 244.84 s faster than the Mammotome 8 gauge, and the ATEC 12 gauge was 267.58 s faster than the Mammotome 11 gauge (p<0.001). Sample quality (judged by a blinded pathologist): both Mammotome needle sizes produced significantly higher‑quality samples than both ATEC needle sizes (p<0.001). Underestimation of micro‑invasive cancer was seen in both the Mammotome and ATEC sizes. |
The study results favour the ATEC system for shorter biopsy time and the Mammotome system (both needle sizes) for higher sample quality. |
|
Eby et al. 2009 |
Mammotome |
No significant difference between the rate of tumour upgrade (from benign to malignant) between ATEC 9 gauge and Mammotome 11 gauge (21.6% and 20.4% respectively, p=0.87). The number of samples taken by each system was not statistically significantly different, with the ATEC 9 gauge taking an average of 9.9 samples and the Mammotome 11 gauge taking an average of 10.5 samples (p=0.4). |
The study results did not favour either system for upgrade frequency or the mean number of samples taken. |
|
Liberman et al. 2003 |
ATEC versus surgical histology |
The procedure was a technical success in 95% of the patients. Complications: In mammograms taken after VABB (26 lesions), haematoma and air were seen in 54% of lesions whereas air without haematoma was seen in 28% of lesions. Clinical haematoma that was resolved was seen in 1/19 patients. Disagreements between comparators: ATEC diagnosis agreed with surgical histology in 89% of cases. ATEC falsely diagnosed benign lesions in 10% of patients (these were positive under surgical histology. 1/5 lesions diagnosed as invasive cancers using ATEC was diagnosed as benign by surgical histology. |
The study results did not favour either procedure. However, the study showed that there was a high level of agreement between the ATEC system and surgical histology. |
|
Schrading et al. 2010 |
Vacora |
More needle localisations for open biopsy needed with Vacora 10 gauge (115 patients, 121 lesions) compared with ATEC 9 gauge (34 patients, 38 lesions). More biopsies were possible with ATEC 9 gauge (158 patients, 267 lesions) versus Vacora 10 gauge (42 patients, 49 lesions). ATEC produced more biopsy samples (mean=12) than the Vacora system (mean=8). ATEC was statistically significantly faster (mean 36 minutes) versus Vacora (mean 69 minutes) for a single biopsy site (p=<0.005) and for 2 lesions (ATEC mean=70 minutes, Vacora=90 minutes, p<0.005). The ATEC system had a higher positive predictive value for malignant lesions than the Vacora system (43% and 29% respectively). Pain was noted statistically significantly less frequently with the ATEC system (6%) than with the Vacora system (38%; p<0.012). Prolonged bleeding after ATEC biopsy was seen in 1 patient, needing compression for 150 minutes. A 3 cm haematoma was seen in 1 patient after Vacora biopsy. |
The study results favour the ATEC system for being able to do more procedures with the device over needle localisations for open biopsy, more biopsy samples, faster procedure time, higher positive predictive value for malignant lesions, and less pain during the procedure. |
|
Abbreviations: VABB, vacuum‑assisted breast biopsy. |
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Costs and resource consequences
In 2013–2014, there were 3170 finished consultant episodes of breast biopsies in England; 3118 of these were in women. Of these, 1625 were done using vacuum‑assisted breast biopsy (VABB) or needle core biopsy, 977 were open (surgical) biopsies, 434 were wire‑guided open (surgical) biopsies, 95 were breast biopsies specified as 'other' and 39 were unspecified breast biopsies ( Health and Social Care Information Centre 2015).
The payment by results tariffs (Department of Health 2013) for outpatient attendance, leading to consultant‑led breast surgery (service code 103), are as follows:
-
first attendance, single‑professional and multi‑professional: £150 (WF01B and WF02B respectively)
-
follow‑up attendance, single professional and multi‑professional: £86 (WF01A) and £99 (WF02A) respectively.
The NHS costs for combined day case or ordinary elective spells for breast excision (Payment by results tariff, Department of Health 2013) are:
-
unilateral major breast procedures category 2 with intermediate complications and co‑morbidities (CC): £2163 (HRG code, JA07E)
-
unilateral major breast procedures category 2 without CC: £2020 (HRG code, JA07F)
-
unilateral intermediate breast procedures without CC: £1128 (HRG code, JA09G).
VABB is widely used in the NHS and, according to the manufacturer, the ATEC system is currently in use in 22 NHS hospitals across the UK. The system uses 1 console coupled to different accessories for use under ultrasound, stereotactic and MRI guidance, so there is no need for a dedicated biopsy system for each imaging modality. For MRI guidance, the ATEC system works successfully with both 1.5T and 3T MRI systems (Dogan et al. 2012).
Strengths and limitations of the evidence
Hahn et al. (2010) prospectively evaluated 2 VABB systems in a randomised study with statistical analyses included. The authors described the inclusion and exclusion criteria. The number of patients assigned to either ATEC or Mammotome was relatively even, as was the distribution of patients with BI‑RADS III, IV and V. In table 4 of the paper, the operating times of the Mammotome and ATEC systems are presented in mm; these are presented in minutes elsewhere in the paper.
Schaefer et al. (2012) compared biopsies taken with ATEC and Mammotome, using a range of needle‑gauge sizes. The study is quite large, with 178 patients, but is based upon retrospective data. The outcomes are important complication factors including bleeding, haematoma and scar formation, but the study did not assess histological sample quality produced by either system. The evaluation of scar formation was subjective. In addition, haematoma is a common complication with VABB regardless of the device used.
Eller et al. (2014) was mainly a questionnaire‑based patient‑reported study. This is the only study that deals with patient experience during the biopsy procedure, and compares ATEC with Mammotome. It was a well‑sized study, surveying 189 patients. However, the 2 treatment groups were highly unbalanced with 145 patients in the ATEC group and 34 patients in the Mammotome group. This study does not contain comparative data on the clinical effectiveness of the ATEC device, or histological sample quality produced by the device. The study compares 11‑gauge with 9‑gauge needles, which are very different in size; the 11‑gauge needle is smaller than the 9‑gauge needle. A better comparison would have been 11 gauge with 12 gauge or 8 gauge with 9 gauge. In the study, question 5 asked whether participants preferred VABB over open surgical biopsy. However, the authors did not state whether the participants had previously had open surgical biopsy and so may have had no experience to compare with VABB. Although the authors present the incidence of haematoma, this is a common complication with VABB regardless of the device used.
Order et al. (2013) compared biopsies taken using ATEC and Mammotome, with a range of needle‑gauge sizes. The outcomes were important comparative factors, such as biopsy time and histological sample quality. This study was also prospective, which reduces bias. Histological quality was a multi‑factorial judgement made by a blinded pathologist, which reduces the bias in the study. Pathologists are highly likely to regard histological sample quality as more important than biopsy time.
Eby et al. (2009) compared the ATEC and Mammotome systems in a retrospective study in which patients had stereotactic‑guided VABB and were consecutively allocated to the 2 study groups. Inclusion and exclusion criteria were noted by the authors, and the study had a large sample size of 991 patients. Statistical analysis methods have been described and applied. However, there is a large discrepancy in the size of the 2 groups, with 391 patients in the Mammotome arm and 600 patients in the ATEC arm. VABB can underestimate the incidence of atypical ductal hyperplasia and ductal carcinoma in situ as can core needle biopsy because of sampling error. VABB allows more samples to be collected, or even complete excision in some instances, and so reduces sampling error in an effort to decrease histological underestimation. However, it must be noted that the ATEC device is not intended to be used for complete excision of the suspicious lesion. This study shows that both the ATEC and Mammotome systems have similar atypical ductal hyperplasia diagnosis and upgrade frequencies.
Liberman et al. (2003) evaluated the ATEC system under MRI‑guidance and compared the diagnosis made using the ATEC biopsied lesions with the diagnosis made after surgical biopsy, to validate the method. The authors have stated inclusion criteria but not exclusion criteria, and it is not clear if the people in the study were enrolled consecutively. The patient numbers were low (n=20) and this was reduced to 19 people after a technical failure. The authors of the study did not carry out any inferential statistical analysis of the data; this is probably because of the low patient numbers. The authors present data on haematoma incidence, but this is a common complication with VABB regardless of the device used.
Schrading et al. (2010) did a comparative study of the ATEC and Vacora systems. This study had a large number of patients (n=349) and compared outcomes from the 2 systems. However, no inclusion or exclusion criteria were stated and it is unclear whether the study participants were consecutively enrolled. The authors concluded that operator confidence with the ATEC system led to a change in patient care compared with needle localisation. However, the devices were not compared simultaneously, with the ATEC phase (July 2006 to December 2007) following 18 months of using the Vacora VABB device (January 2005 and June 2006).