Vacuum-assisted Breast Biopsy Procedures Research Articles

Vacuum-assisted Evacuation (VAEv) of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries and Percutaneous Procedures.

Among postoperative complications in breast surgery, postoperative hematoma is the most common occurrence. While mostly self-limited, in some cases surgical revision is mandatory. Among percutaneous procedures, preliminary studies demonstrated the efficacy of vacuum-assisted breast biopsy (VAB) in evacuating postprocedural breast hematomas. However, no data are available regarding VAB evacuating postoperative breast hematomas. Therefore, the present study aimed to investigate the efficacy of the VAB system in evacuating postoperative and postprocedural hematoma, symptom resolution, and avoidance of surgery. From January 2016 to January 2020, patients with ≥25 mm symptomatic breast hematomas developed after breast-conserving surgery (BCS) and percutaneous procedures were retrospectively enrolled from a perspective-maintained database. Hematoma maximum diameter, estimated hematoma volume, total procedure time, and visual analog scale (VAS) score before ultrasound (US) vacuum-assisted evacuation (VAEv) were recorded. At one-week VAS score, residual hematoma volume, and complications were recorded. Among 932 BCSs and 618 VAB procedures, a total of 15 late postoperative hematomas were recorded (9 after BCS and 6 after VAB). Preoperative median diameter was 43.00 (35.50-52.50) mm and median volume 12.60 (7.35-18.30) mm3 Regarding VAEv, median time recorded was 25.92 (21.89-36.81) min. At one week, the median hematoma reduction was 83.00% (78.00%-87.5%) with a statistically significant VAS reduction (5.00 vs. 2.00; p>0.001). No surgical treatment was needed and only one case of seroma occurred. VAEv represents a promising safe, time and resource-sparing treatment modality for the evacuation of breast hematomas, potentially decreasing the rate of reoperation after surgery.

Is 9-G DBT-Guided Vacuum-Assisted Breast Biopsy Sufficient to Completely Remove T1 Breast Cancers (below 20 mm)? Analysis of 146 Patients with Histology as Reference Standard

Objectives: Vacuum-assisted breast biopsy (VABB) is a safe procedure comparable to surgical biopsy for the characterization of distortions, microcalcifications, and mass lesions. Vacuum-assisted excision of T1 breast tumors could be on potential management in alternative to surgery. The primary objective of this work was to assess the therapeutic success of the stereotaxic vacuum breast biopsy in small breast cancer (T1N0M0) lesions excision. Methods: From our electronic database, all the vacuum breast biopsies performed from January 1, 2015, to December 1, 2019, have been retrospectively reevaluated. N = 2,200 cases were identified and n = 145 ensured “mammographic complete removal” at the end of vacuum-assisted excision treatment and were considered for analysis. Surgical gold standard was used. Results: N = 143 procedures were successfully completed with complete removal of mammographic calcifications. The mean size of the lesions completely excised with VABB was 8.9 ± 3.6 mm (range, 3–23 mm). Lesions below 10 mm were n = 118 and lesion with diameter >10 mm were n = 28. N = 3/146 cases (4.4%), relapses were observed in follow-up (at 12–24 up to a maximum of 60 months): the mean size of relapsed lesions completely excised was 3.6 ± 2.1 mm (range, 2–6 mm). No relapse before 12 months were observed. The mean size of the lesions in these patients with relapse at the time of the first VABB procedures was 13 ± 6.5 mm (range, 7–12 mm). N = 117/118 (99%) lesions excised using VABB without relapse after 1 year of follow-up had a diameter below 10 mm. Conclusions: Vacuum breast biopsy could safely remove small breast cancers (T1N0M0) with few relapses.

Clinicopathological Analysis of Ultrasound-guided Vacuum-assisted Breast Biopsy for the Diagnosis and Treatment of Breast Disease.

To evaluate the usefulness and safety of vacuum-assisted breast biopsy (VABB) for breast lesion diagnosis and treatment. Clinical and histopathological data of 8,748 patients, who underwent 11,221 VABB procedures were analyzed. Most patients (58.2%) were <40 years old. Most lesions (39.6%) were 0.6-1.0 cm in diameter while 3.2% were ≥3.0 cm; fibroadenomas were the most common (46.6%). Eight (14% of 57) cases of atypical ductal hyperplasia were underestimated. The positive predictive values (PPVs) of breast imaging reporting and data system (BI-RADS) ultrasound category were 0.6%, 3.4%, 34.8%, 66.2%, and 93.8% for category 3, 4a, 4b, 4c, and 5 lesions, respectively. The mean number of core specimens was 9.5±8.8; the mean procedure time was 3.4±2.7 min. No residual lesions were found in 94.4% of the 7,480 patients. VABB could replace ultrasound-guided core biopsy and surgical excisional biopsy for the diagnosis of breast disease and the treatment of benign breast lesions.

Effectiveness of hemostasis with Foley catheter after vacuum-assisted breast biopsy.

Interventional bleeding and post-interventional hematoma are the most common complications following vacuum-assisted breast biopsy (VABB). The aim of the current study was to evaluate the effectiveness of Foley catheter-induced hemostasis in VABB. A randomized prospective controlled trial was conducted using a total of 437 consecutive 8-gauge ultrasound-guided VABB procedures that were performed in 282 patients from June 2012 to October 2013. In each procedure, hemostasis was induced with either a Foley catheter or with external compression. Bleeding during intervention, hematoma post-intervention and the time of procedure were recorded. Statistical analysis included a Chi-Square test and an independent-samples t-test, and P value <0.05 was considered to be significant. Significantly less bleeding and post-interventional hematoma resulted when hemostasis was induced using a Foley catheter vs. compression (7.6% vs. 17.4%, P=0.002; 8.9% vs. 27.9%, P<0.001). The mean time of breast biopsy was significantly less when using a Foley catheter vs. compression (33.6 vs. 45.5 min, P<0.001). No post-procedural infectious was encountered. In stratification analysis, there were no significantly different bleeding rates between the Foley catheter and compression methods in cases of single lesions (6.7% vs. 14.1%, P=0.346). In cases of multiple lesions, the Foley catheter method produced less bleeding/hematoma than compression (10.4% vs. 47.4%, P=0.018; 16.7% vs. 52.6%, P=0.020). Whether using a Foley catheter or compression to induce hemostasis, no significant difference was found in the rate of bleeding or hematoma when lesions <15 mm were removed (3.8% vs. 6.1%, P=0.531; 6.1% vs. 11.4%, P=0.340). When lesions ≥15 mm were excised, the rates of interventional bleeding and post-interventional hematoma were significantly lower in the Foley catheter study group than the compression control group (12.5% vs. 32.2%, P=0.034; 12.5% vs. 49.4%, P<0.001). There was significantly less bleeding (P=0.004) and hematoma (P<0.001) in the upper external quadrant when using a Foley catheter compared with compression (4.5% vs. 15.7%, P=0.004; 9.8% vs. 40.2%, P<0.001), but no significant differences for other quadrants. Inducing hemostasis with a Foley catheter after VABB is a very effective and safe alternative to hemostasis with compression.

Flat Epithelial Atypia: Comparison Between 9-Gauge and 11-Gauge Devices

BackgroundThis study aimed to establish if women with a diagnosis of flat epithelial atypia (FEA) without residual microcalcifications at stereotactic vacuum-assisted breast biopsy (VABB) could be managed with mammographic follow-up (FU) instead of surgery and to compare 9-gauge and 11-gauge devices. Patients and MethodsFrom October 2003 to January 2011, 2382 VABB procedures were performed (1373 with 11-gauge and 1009 with 9-gauge). We found 121 cases of pure FEA that were surgically treated: 57 with a 9-gauge device (group 1) and 64 with an 11-gauge device (group 2). The underestimation rate (UR) of malignancy for patients without and those with residual microcalcifications for each VABB device was calculated. Differences between groups were analyzed with the Fischer exact test. ResultsThe overall UR of FEA was 4% (2 of 57) with the 9-gauge device and 8% (5 of 64) with the 11-gauge device. With a 9-gauge device, the UR for patients without residual microcalcifications was 0% (0 of 46), and the UR for patients with residual microcalcifications was 18% (2 of 11). With an 11-gauge device, the UR for patients without residual microcalcifications was 0% (0 of 39), the UR for patients with residual microcalcifications at post-biopsy mammograms was 16% (5 of 25). With a 9-gauge device, 80% (46 of 57) of patients did not have residual microcalcifications after VABB. With an 11-gauge device, 60% (39 of 64) of patients had no residual microcalcifications after VABB. Differences between the 9-gauge and 11-gauge devices were statistically significant (P < .05). ConclusionWomen with FEA without residual microcalcifications after VABB can be managed conservatively. Nine-gauge VABB is associated with a lower percentage of residual microcalcifications compared with an 11-gauge device, but it is safe to follow patients with FEA if all calcifications are removed with the core biopsy.

Mammotome® biopsy system for the resection of breast lesions: Clinical experience in two high-volume teaching hospitals

Ultrasound-guided vacuum-assisted breast biopsy (VABB) is regarded as a feasible, effective, minimally invasive and safe method for the removal of benign breast lesions, without the occurrence of serious complications. The aim of this study was to evaluate the feasibility, efficacy and safety of ultrasound-guided VABB using the Mammotome® biopsy system in the treatment of breast lesions. The clinical outcomes of 3,681 patients with breast lesions were evaluated following excisions by ultrasound-guided VABB in two high-volume teaching hospitals. From January 2008 to December 2012, a total of 4,867 ultrasound-guided VABB procedures were performed in the 3,681 patients, who had a mean age of 37.8 years (range, 16–73 years). The parameters examined in this analysis included lesion size, lesion location in the inner breast, Breast Imaging Reporting and Data System (BI-RADS) ultrasound category and histopathological diagnosis. Ultrasonography follow-up was performed at 3–6 month intervals in order to assess recurrence. The size of the investigated lesions ranged between 6 and 62 mm and a histopathological diagnosis was made in 100% of cases. The results indicated that the majority of specimens (98.89%) were benign. On average, the ultrasound-guided VABB was performed in 10.3 min (range, 7.5–43 min) and the mean number of cores removed in the procedure was 8.1 (range, 3–32). A complete excision was achieved in the majority of cases (99.7%). The presence of a hematoma was the most common complication following the biopsy, and was observed in 27.5% of patients. The mean follow-up period was 25.5 months (range, 1–60 months), during which the rate of recurrence was 4.4%. The results indicated that ultrasound-guided VABB using the Mammotome biopsy system is an effective and safe procedure that is able to rapidly remove the majority of benign breast lesions using a small incision and without the occurrence of scarring or complications.

Thermal damage of the specimen during breast biopsy with the use of the Breast Lesion Excision System: does it affect diagnosis?

Stereotactic vacuum assisted breast biopsy (VABB) procedures remain of key importance in the diagnostic evaluation of suspicious non-palpable mammographic lesions. The Breast Lesion Excision System(®) (BLES) is an image-guided percutaneous biopsy method that utilizes radiofrequency (RF) in order to retrieve an intact-tissue biopsy specimen. The purpose of this study is to determine the effects of RF application on the tissue specimen and the possible interference with the histopathologic results. In this study we included 265 patients with suspicious non-palpable mammographic lesions who underwent 273 stereotactic VABB procedures using the BLES. All biopsies were performed by the same surgical-radiology team under local anesthesia. The specimen thermal damage was classified according to the pathology report in 3 categories: Severe (extensive thermal damage or inability to diagnose), medium (ability to diagnose but either circumferential damage >1.5mm or diffuse areas of thermal damage) and mild (circumferential thermal damage <1.5mm but >0.5mm). Radiofrequency-associated thermal damage of the specimen was observed in 14 cases (5.13%), and was classified as severe in 5, medium in 5, and mild in 4 specimens. Within the group of RF damaged specimens, we found a significant (p<0.05) positive correlation between fat cell content and classification of thermal damage. Although thermal damage is of concern during BLES breast biopsy, the incidence is low, and the outcome of the histopathologic assessment is not affected even in severely damaged specimens. Increased thermal damage seems to correlate with higher fat cell content of the specimen.

Stereotactic Vacuum-Assisted Breast Biopsy Is Not a Therapeutic Procedure Even When All Mammographically Found Calcifications Are Removed: Analysis of 4,086 Procedures

The purpose of our study was to assess whether in case of total removal of microcalcifications there is still residual tumor on the surgical specimen and, secondarily, to assess whether complete rather than partial excision of the imaging target with microcalcifications may result in increased diagnostic accuracy. We retrospectively reviewed 4,086 stereotactic vacuum-assisted breast biopsy (VABB) procedures for microcalcifications and histologic findings to determine the frequency of malignancy, histologic underestimation, and complete removal of cancer. No residual microcalcifications on postbiopsy mammograms were seen in 1,594 of 4,047 (39.4%) procedures successfully completed: 351 of 1,594 lesions were malignant, 1,109 benign and 134 atypical. After partial removal of microcalcifications at VABB, the postsurgical specimen had infiltrating carcinoma in 130 of 566 cases (23%), whereas in case of total removal of microcalcifications, the underestimation occurred in 13 of 234 (5.5%) cases. The atypical ductal hyperplasia underestimation rate was 6.6% when the mammography target was completely removed and 38.7% when the target was only sampled. The percentage of lobular carcinoma in situ underestimation was the same for the two groups with partial and total removal of microcalcifications (21.2%). Among 1,016 VABB procedures with pathologic result of malignancy, 882 (86.6%) had residual cancer at surgery. In the group with complete removal of microcalcifications at VABB, residual cancer was found in 70% of cases. VABB may not be considered a therapeutic procedure, even in the case of complete removal of microcalcifications. However, a complete removal of microcalcifications may result in low rates of underestimation of malignancy and may consequently increase the diagnostic accuracy of the diagnostic procedure.

Is Surgical Excision Necessary for Focal Atypical Ductal Hyperplasia Found at Stereotactic Vacuum-Assisted Breast Biopsy?

Our goal was to determine the upgrade rate for lesions described as focal atypical ductal hyperplasia (ADH) after 9- or 11-gauge stereotactic vacuum-assisted breast biopsy (VABB) to determine whether surgical excision is indicated in this setting. We retrospectively reviewed the results of 991 consecutive 9- or 11-gauge stereotactic core VABB procedures from February 2001 through June 2006 and identified lesions diagnosed as ADH. On the basis of the descriptions in pathology reports each lesion was placed in one of three categories: (1) focal ADH, (2) ADH suspicious for ductal carcinoma-in-situ, or (3) ADH not otherwise specified. The final diagnosis after surgical excisional biopsy was determined from medical records. The frequencies and upgrade rates to carcinoma were calculated and compared for all lesions and for each ADH category. A total of 141 (14.2%) of 991 lesions yielded ADH at stereotactic core VABB, and 123 (87.2%) of 141 underwent surgical excisional biopsy of the stereotactic core VABB site. A total of 56 (45.5%) of 123 were categorized as focal ADH, and 7 (12.5%) of 56 were upgraded to carcinoma. A total of 49 (39.8%) of 123 were categorized as ADH not otherwise specified, and 11 (22.4%) of 49 were upgraded. Eighteen (14.6%) of 123 were categorized as suspicious for ductal carcinoma-in-situ, and 8 (44.4%) of 18 were upgraded. Neither the frequency of ADH (P = .66) nor the upgrade rates (P = .87) were significantly different between 9- and 11-gauge VABB. Surgical excisional biopsy is indicated to exclude carcinoma in cases of focal ADH discovered at 9- or 11-gauge VABB.

Ultrasound-guided vacuum-assisted core breast biopsy: experience with 406 cases

The aim of this study was to determine the indications, accuracy and complications of vacuum-assisted breast biopsy (VABB) performed using ultrasonographic (US) guidance for non-palpable lesions. This was a prospective study in which results from consecutive US-guided VABB performed between January 1999 and April 2003 were subsequently compared to those from excisional biopsy or to long-term follow-up imaging. Four hundred and six lesions were submitted to VABB procedures. Out of those, 78.9% were benign, 18.8% were malignant, 1.7% was lobular neoplasia, and 0.4% was atypical duct hyperplasia. Underestimation occurred in 2.6% of the cases and false negative results in 0.6%. Sensitivity to VABB was 97%, specificity went up to 100%, negative predictive value was 99%, positive predictive value was 100%, and accuracy was 99%. Complications occurred in 9% of the patients. US-guided VABB is an accurate and safe procedure. The main indication is the non-palpable suspicious breast lesions (category 4). This new technique could be a good alternative for percutaneous and surgery biopsy.

Stereotactic vacuum‐assisted breast biopsy in 2874 patients: A multicenter study

I read with interest the article by Kettritz et al.1 regarding the accuracy of stereotactic 11-gauge vacuum-assisted breast biopsy (VAB) for diagnosing breast cancer in nonpalpable breast lesions. Of the 2893 VAB procedures performed, 19 (0.7%) yielded findings that were not representative, whereas 2874 were performed successfully. Atypical ductal hyperplasia (ADH), which was diagnosed in 141 lesions, was upgraded to cancer in 32 of 135 lesions that underwent surgical excision. No follow-up information was available for lobular carcinoma in situ (LCIS), which was diagnosed in 18 cases. Benign histology was diagnosed in 2090 lesions, with cancer going undetected in 1 of 24 lesions that underwent surgical excision. The false-negative rate was defined as the percentage of lesions diagnosed as being benign on VAB that later proved to be malignant. This rate, which was calculated excluding nonrepresentative lesions and including benign lesions with (n = 1438) or without (n = 628) follow-up imaging data, was 0.05% (1 of 2090). Although the reported results are impressive, I believe that the analysis may overstate the accuracy of this technique. I prefer an alternative false-negative rate, defined as the percentage of pathologically confirmed malignant lesions that yielded benign stereotactic biopsy findings without findings of atypia or high-risk lesions.2 This approach requires delineation of atypical and high-risk lesions (including ADH and, variably, LCIS, atypical lobular hyperplasia, radial scar, papilloma, and/or benign phyllodes tumor), knowledge of the total number of cancers found in the study group at any time, and knowledge of how many of those cancers yielded benign (including discordant or nonrepresentative) findings on original biopsy. False-negative rates calculated in this manner have been reported for stereotactic 11-gauge VAB2, 3 and automated 14-gauge large-core needle biopsy.2, 4, 5 To calculate this alternative false-negative rate for the study conducted by Kettritz et al.,1 more data are needed. For the 19 nonrepresentative lesions and the 18 lesions diagnosed as LCIS, we must know how many of each were rebiopsied and how many cancers subsequently were identified. The total number of cancers among the 2893 lesions evaluated with VAB equals the number of cancers detected on rebiopsy of nonrepresentative lesions and rebiopsy of lesions diagnosed as LCIS plus the number of cancers detected on VAB (n = 625), rebiopsy of lesions diagnosed as ADH (n = 32), and rebiopsy of lesions found to be benign (n = 1). The total number of false-negative lesions equals the number of cancers found on rebiopsy of nonrepresentative lesions plus the one cancer detected on rebiopsy of a lesion that initially was found to be benign.