Key points
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The Breast Lesion Excision System is designed to excise and retrieve a single intact tissue specimen.
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Reported underestimation rates of atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) ranged from 0 to 14.3% and from 0 to 22.2%, respectively.
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Complete excision rates for IDC and DCIS ranged from 5.3 to 76.3%.
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Complications are infrequent and comparable with vacuum-assisted biopsy (VAB).
Introduction
Methods
Search strategy
Study selection
Data extraction, statistics, and quality assessment
Results
Studies
Authors, publication year and country | Study type; Study period | Number of lesionsa | Entry criteria | Age (years)b | Basket size (mm) | Lesion size (mm)b | Guidance type |
---|---|---|---|---|---|---|---|
Sie et al. 2006, USA (4) | Retrospective; 2002–2004 | 742 | Breast lesions with microcalcifications | NA | 10, 15 | NA | Stereotactic |
Killebrew et al. 2006, USA (9) | Retrospective; 2003–2004 | 800 | Mammographic lesions presenting as microcalcifications | NA | 10, 15 | NA | Stereotactic |
Allen et al. 2011, UK (5) | Prospective; 2007-NA | 76 | Sub-centimeter breast lesions | NA | 15, 20 | 7.1 (2–10) | Ultrasound + stereotactic |
Seror et al. 2011, France (10) | Prospective; 2008–2009 | 166 | Microcalcifications | 55.7 (31–93) | 12, 15, 20 | 8.1 (2–25) | Ultrasound + stereotactic |
Diepstraten et al. 2011, Netherlands (11) | Prospective; 2010 | 19 | Mammographic lesions presenting as microcalcifications | 59 (37–74) | 15, 20 | 8 (2–76) | Stereotactic |
Whitworth et al. 2011, USA (6) | Prospective; 2006–2010 | 1170 | Mammographic lesion recommended for image-guided core-needle breast biopsy | NA | 15, 20 | NA | Stereotactic |
Razek et al. 2013, Egypt (12) | Prospective; 2012 | 80 | Small breast lesions with unclassified microcalcifications | NA (21–55) | 15, 20 | 9 (4–16) | Ultrasound + stereotactic |
Medjhoul et al. 2013, France (13) | Retrospective; 2010–2012 | 31 | Mammographic lesions presenting as calcifications or masses | 61.2 (NA) | 12, 15, 20 | 10 (3–38) | Stereotactic |
Al-Harethee et al. 2013, Greece (7) | Prospective; 2008–2010 | 134 | Mammographic lesions presenting as microcalcifications, solid lesions or asymmetric density | 51.3 ± 10.3 | 12, 15, 20 | NA | Stereotactic |
Allen et al. 2014, UK (14) | Prospective; 2007–2009 | 41 | Sub-centimeter breast lesions | NA | 15, 20 | 5.7 (1–10) | Ultrasound + stereotactic |
Al-Harethee et al. 2015, Greece (15) | Prospective; 2009–2012 | 273 | Suspicious, non-palpable mammographic lesions | 54.4 ± 10.4 | 12, 15, 20 | NA | Stereotactic |
Scaperrotta et al. 2016, Italy (16) | Retrospective; 2010–2014 | 105 | Mammographic lesions presenting as microcalcifications measuring up to 1 cm | 55 (38–81) | 15, 20 | ≤ 10 (NA) | Stereotactic |
Graham, 2017, USA (17) | Prospective; 2007–2014 | 461 | US visualized lesions measuring up to 2 cm | NA (23–88) | 12, 15, 20 | < 20 (NA) | Ultrasound |
Milos et al. 2017, Austria (20) | Retrospective; 2011–2015 | 34 | Microcalcifications | 55 (31–75) | 12, 15, 20 | 8 (4–15) | Stereotactic |
Sklair-Levy et al. 2017, Israel (21) | Prospective; 2012–2016 | 111 | Benign or atypical high-risk lesions | 50.5 (21–91) | 12, 15, 20 | < 20 (NA) | Ultrasound + stereotactic |
Papapanagiotou et al. 2017, Greece (22) | Retrospective; 2010–2014 | 50 | Pathological diagnosis of a carcinoma lesion | 61.8 (43–80) | 12, 15, 20 | 12.7 (1.5–30) | Stereotactic |
Niinikoski et al. 2018, Finland (23) | Retrospective; 2011–2016 | 80 | Histological or cytological and radiological suspicion of an intraductal papilloma | 60 (25–84) | 12, 15, 20 | 7 (3–16) | Ultrasound + stereotactic |
Quality assessment
Diagnostic accuracy
First author | ADH underestimation rate n/N (%) | DCIS underestimation rate n/N (%) |
---|---|---|
Sie et al. (4) | 3/32 (9.4) | 6/115 (5.2) |
Killebrew et al. (9) | NA | 1/31 (3.2) |
Allen et al. (5) | NA | NA |
Seror et al. (10) | 0/4 (0) | 6/27 (22.2) |
Diepstraten et al. (11) | NA | 0/3 (0) |
Whitworth et al. (6) | 3/32 (9.4)a | NA |
Razek et al. (12) | 0/14 (0) | 0/8 (0) |
Medjhoul et al. (13) | 0/4 (0)b | 1/9 (11.1) |
Al-Harethee et al. (7) | NA | NA |
Allen et al. (14) | 0/6 (0) | 0/11 (0) |
Al-Harethee et al. (15) | NA | NA |
Scaperrotta et al. (16) | NA | 5/32 (15.6) |
Graham (17) | 1/38 (2.6)b | 0/8 (0) |
Milos et al. (20) | 2/14 (14.3)b | 0/10 (0) |
Sklair-Levy et al. (21) | NA | NA |
Papapanagiotou et al. (22) | NA | 0/5 (0) |
Niinikoski et al. (23) | NA | NA |
Therapeutic accuracy
First author | Definition complete excision | Benign complete excision rate n/N (%) | ADH complete excision rate n/N (%) | DCIS complete excision rate n/N (%) | IDC complete excision rate n/N (%) | Total complete excision rate n/N (%) |
---|---|---|---|---|---|---|
Sie et al. (4) | No residual disease at surgical specimen | NA | 21/32 (65.6) | 1/115 (0.9) | NA | 22/147 (15) |
Killebrew et al. (9) | BLES produced a diagnosis of DCIS or ADH and surgical biopsy resulted in a benign diagnosis with no evidence of IDC, DCIS, or ADH | NA | NA | 12/31 (38.7) | NA | 12/31 (38.7) |
Allen et al. (5) | No residual disease at surgical specimen | 5/6 (83.3) | NA | 4/6 (66.7)a | 3/6 (50)b | 12/18 (66.7) |
Seror et al. (10) | No residual disease at surgical specimen | 0/1 (0) | 2/9 (22.2)c | 11/27 (40.7) | 1/7 (14.3)d 0/2 (0)e | 14/46 (30.4) |
Diepstraten et al. (11) | NA | NA | NA | 1/19 (5.3)f | NA | 1/19 (5.3) |
Whitworth et al. (6) | NA | NA | NA | NA | NA | NA |
Razek et al. (12) | 1 mm free margin after BLES | NA | 20/24 (83.3)g | 6/8 (75) | 3/6 (50) | 29/38 (76.3) |
Medjhoul et al. (13) | No residual disease at surgical specimen | NA | 3/4 (75) | NA | 0/10 (0) | 3/14 (21.4) |
Al-Harethee et al. (7) | NA | NA | NA | NA | NA | NA |
Allen et al. (14) | No residual disease at surgical specimen | NA | 3/6 (50) | 6/11 (54.5) | 5/8 (62.5) | 14/25 (56) |
Al-Harethee et al. (15) | NA | NA | NA | NA | NA | NA |
Scaperrotta et al. (16) | No residual disease at surgical specimen | NA | NA | 16/32 (50) | 1/3 (33.3)d 2/4 (50)h | 19/39 (48.7) |
Graham (17) | NA | NA | NA | NA | NA | NA |
Milos et al. (20) | BLES produced a HRL or malignant lesion and the surgical specimen did not contain any remnants of the initial malignant or high-risk lesion | NA | 8/14 (57.1)i | 3/10 (30) | 4/10 (40) | 15/34 (44.1) |
Sklair-Levy et al. (21) | NA | NA | NA | NA | NA | NA |
Papapanagiotou et al. (22) | No residual disease at surgical specimen | NA | NA | 4/5 (80) | 21/45 (46.7) | 25/50 (50) |
Niinikoski et al. (23) | Complete excision was based on histological margin status of the BLES sample | 19/43 (44.2)j | 6/10 (60)i | 2/3 (66.7) | 0/2 (0) | 27/58 (46.6) |
Complications and procedural problems
First author | Infection n (%) | Bleeding n (%) | Hematoma n (%) | Wound leakage n (%) | Wound healing problems n (%) | Skin burning n (%) | Empty basket n (%) | Wire break n (%) | Incorrect guidance n (%) | Basket failed to deploy n (%) | Thermal artifact mm |
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Sie et al. (4) | 1 (0.1) | 0 (0) | 0 (0) | NA | NA | 0 (0) | NA | NA | NA | NA | 0.1–1 |
Killebrew et al. (9) | NA | NA | 0 (0) | NA | NA | NA | 29 (3.6) | 8 (1.0) | NA | NA | 0.2–1 |
Allen et al. (5) | 0 (0) | NA | 1 (1.3) | NA | NA | NA | NA | NA | NA | NA | < 1 |
Seror et al. (10) | NA | NA | 1 (0.6) | NA | NA | NA | 1 (0.6) | 1 (0.6) | 2 (1.2) | NA | 0.2 |
Diepstraten et al. (11) | 1 (5.3) | 1 (5.3) | NA | 1 (5.3) | NA | NA | NA | NA | NA | NA | 0.4–1.9 |
Whitworth et al. (6) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
Razek et al. (12) | NA | NA | 3 (3.8) | NA | NA | NA | NA | NA | NA | NA | < 1 |
Medjhoul et al. (13) | 0 (0) | NA | 1 (3.1) | NA | NA | NA | NA | NA | NA | NA | NA |
Al-Harethee et al. (7) | 4 (3.0) | 9 (6.7) | 5 (3.7) | NA | 7 (5.2) | 2 (1.5) | NA | NA | NA | 1 (0.7) | NA |
Allen et al. (14) | 0 (0) | NA | 1 (2.4) | NA | NA | NA | NA | NA | NA | NA | < 1 |
Al-Harethee et al. (15) | NA | NA | NA | NA | NA | NA | NA | NA | NA | 3 (1.1) | 1–2 |
Scaperrotta et al. (16) | NA | NA | NA | NA | NA | NA | 1 (1.0) | NA | NA | NA | NA |
Graham (17) | 1 (0.3) | NA | 27 (6.7) | NA | 4 (0.9) | 2 (0.5) | NA | NA | NA | NA | NA |
Milos et al. (20) | 0 (0) | 4 (11.8) | 3 (8.8) | NA | NA | NA | NA | NA | NA | NA | NA |
Sklair-Levy et al. (21) | NA | NA | 4 (3.6) | NA | NA | NA | NA | NA | 1 (0.9) | NA | NA |
Papapanagiotou et al. (22) | 1 (2) | NA | 1 (2) | NA | NA | NA | NA | NA | NA | 1 (2) | NA |
Niinikoski et al. (23) | NA | NA | 1 (1.25) | NA | NA | 1 (1.25) | NA | NA | NA | NA | NA |