A prospective comparative study to evaluate the displacement of four commercially available breast biopsy markers

Pinkney, David M.; Mychajlowycz, Mirek; Shah, Biren A.

doi:10.1259/bjr.20160149

Cited by 31 publications

(22 citation statements)

References 20 publications

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“…Table shows the characteristics of all included studies. Among the final 36 eligible studies, 31 were cohort studies (20 142 cases), 1 was randomised controlled trial (RCT) (74 cases), and 4 non‐randomised controlled trials (NRCTs) (574 cases), describing a total of 20 868 patients (mean age, 36–56 years), derived from China (7), United States (6), Italy (5), Germany (5), Korea (2), Japan (2), Spain (1), Poland (1), France (1), United Arab Emirates (1), Britain (1), Switzerland (1), Israel (1), New Zealand (1), and Canada (1). VABB was performed using US (24) and mammography (12) location modes.…”

Section: Resultsmentioning

confidence: 99%

“…• the pooled data suggested that vacuum-assisted breast biopsy with ultrasonography or X-ray mammography could be promising for diagnosis and treatment of breast disease • the results from the 36 articles with 20 868 cases showed high technical success and low complication risks including haematoma, bleeding, skin ecchymosis, pain, vasovagal reflex, and infection • the combination of VABB with US or mammography could be a promising candidate of the standard biopsy methods for detecting nonpalpable lesions controlled trial (RCT) (74 cases), 40 and 4 non-randomised controlled trials (NRCTs) (574 cases), [41][42][43][44] describing a total of 20 868 patients (mean age, 36-56 years), derived from China (7), United States (6), Italy (5), Germany (5), Korea (2), Japan (2), Spain (1), Poland (1), France (1), United Arab…”

Section: Key Messagesmentioning

confidence: 99%

See 1 more Smart Citation

Feasibility and safety of image‐guided vacuum‐assisted breast biopsy: A PRISMA‐compliant systematic review and meta‐analysis of 20 000 population from 36 longitudinal studies

Fang

Liu

Luo

et al. 2019

International Wound Journal

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Breast cancer is a serious disease in women. We estimated the global technical success rate and complication rates of percutaneous vacuum‐assisted breast biopsy (VABB). PubMed, Embase, Web of Science, and Scopus databases were retrieved up to July 2018 to find studies in which technical success rate and complication rates of VABB were available. Pooled rates were calculated according to location mode (ultrasonography [US] or mammography) and needle type (8‐ or 11‐gauge Mammotome probes). Of the 36 articles with 20 868 cases, we found the pooled technical success rate 0.9999(0.9997, 1.0000) (I2 = 17.1%, P = .187) and low complication risks including haematoma 0.1092(0.0748, 0.1437) (I2 = 98.3%, P < .001), pain 0.0738(0.0334, 0.1141) (I2 = 95.9%, P < .001), vasovagal reflex 0.0281(0.0035, 0.0527) (I2 = 92.5%, P < .001), and infection 0.0027(−0.0019, 0.0073) (I2 = 49.8%, P = .113). In this systematic review and meta‐analysis, the pooled data suggested that VABB with US or mammography could be promising for diagnosis and treatment of breast disease. Further studies were necessary to identify strategies for these findings.

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Section: Resultsmentioning

confidence: 99%

Section: Key Messagesmentioning

confidence: 99%

Feasibility and safety of image‐guided vacuum‐assisted breast biopsy: A PRISMA‐compliant systematic review and meta‐analysis of 20 000 population from 36 longitudinal studies

Fang

Liu

Luo

et al. 2019

International Wound Journal

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“…This could result in a decrease in surgery time, re-excision rates, resection volume, and overall cost [17][18][19]. While we did not compare the Tumark Vision clip to other commercially available clips, comparisons between clips have shown that newer self-expanding clips show a lower displacement rate compared with bare metal clips [20].…”

Section: Discussionmentioning

confidence: 99%

Using a New Marker Clip System in Breast Cancer: Tumark Vision® Clip - Feasibility Testing in Everyday Clinical Practice

Rüland¹,

Hagemann²,

Reinisch³

et al. 2018

Breast Care

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Background: This study presents first feasibility experiences with a new 3-dimensional (3D) marker clip system in clinical practice. The rate of clinical complete responses in the treatment of breast cancer patients is increasing; additionally, a change to targeted axillary dissection is being considered after neoadjuvant chemotherapy (NACT). Consequently, marker clips are needed which are reliable and easy to handle even in the axillary lymph node system. Methods: A total of 50 patients from the Breast Care Unit of the Kliniken Essen Mitte were included. Clip marking of all 50 primary breast cancer lesions as well as 23 lymph nodes was performed using the Tumark Vision® clip. Following application, the position and visibility of the marker clip were monitored and documented in 2 axes. Results: The feasibility of the Tumark Vision clip was excellent in everyday clinical practice as none of the markers dislocated. After clip marking of the tumor region and/or suspicious lymph nodes, all Tumark Vision clips could be detected in both axes. The 3D shape could be observed in all cases after application. Conclusion: The new 3D-shaped marker clip seems to be a promising tool for marking breast cancer lesions and even lymph nodes before NACT. As there are many studies ongoing to prove the feasibility of a shift from standard axillary dissection after NACT towards targeted axillary dissection, the Tumark Vision clip seems to provide good visibility even in lymph nodes after NACT. Further studies are warranted.

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“…This was not a likely cause of any DD or AE in this study as all recorded events occurred with ultrasound-guided biopsies which are not performed with the breast in compression. Other hypothesized causes of displacement include errors related to deploying the marker, either from partial deployment of the plug or deploying the plug beyond the biopsy cavity [26,27]. Lastly, marker displacement may result when there is hematoma formation or excess air in the biopsy site.…”

Section: Discussionmentioning

confidence: 99%

Long-term safety and efficacy of breast biopsy markers in clinical practice

Smith

Taylor

Kanevsky³

et al. 2020

Expert Review of Medical Devices

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Objective: Percutaneous breast and axillary core biopsy followed by marker placement are integral parts of a breast imager's practice benefiting both patients and clinicians. Marker placement is the standard to facilitate future care. The purpose of this study is to characterize the safety and performance of MammoMARK, CorMARK, and HydroMARK biopsy markers by evaluating device-related adverse events, device deficiencies, and long-term safety. Methods: A retrospective review of three radiology practices identified patients who underwent imageguided breast or axillary biopsies followed by marker placement between 1 January 2012 and 1 January 2017. Medical records were reviewed with adverse events related to marker placement and use recorded. Results: 768 markers were placed with three (0.4%) events recorded. Two device deficiencies and one non-serious adverse event occurred in three patients. Device deficiency events involved user errors deploying the markers, one to inability to locate the marker on post-biopsy imaging, and the second to misplacement relative to biopsy target. One non-serious adverse event involved inability to locate/ retain the marker in a surgically resected specimen. No serious adverse events were reported. Conclusion: Placement of breast biopsy markers is safe with minimal associated risks. Issues related to device malfunction, durability, reliability, safety, or performance were not reported.

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A prospective comparative study to evaluate the displacement of four commercially available breast biopsy markers

Cited by 31 publications

References 20 publications

Feasibility and safety of image‐guided vacuum‐assisted breast biopsy: A PRISMA‐compliant systematic review and meta‐analysis of 20 000 population from 36 longitudinal studies

Feasibility and safety of image‐guided vacuum‐assisted breast biopsy: A PRISMA‐compliant systematic review and meta‐analysis of 20 000 population from 36 longitudinal studies

Using a New Marker Clip System in Breast Cancer: Tumark Vision® Clip - Feasibility Testing in Everyday Clinical Practice

Long-term safety and efficacy of breast biopsy markers in clinical practice

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