Multicenter evaluation of a new ultrasound-guided biopsy device: Improved ergonomics, sampling and rebiopsy rates.

The purpose of this study was to evaluate performance, ergonomics, and immediate rebiopsy rate of a new vacuum-assisted biopsy (VAB) device for ultrasound-guided breast biopsies. Between December 2002 and April 2003, 113 patients meeting study criteria were biopsied at four centers using the new 9 gauge VAB device. The device has a radiofrequency-tipped probe, 360 degrees vacuum, a circumferential cutter, and a coaxial cannula for multiple sampling. Patient and procedural data included breast composition, lesion characteristics, number of samples, procedure time, and complications. Quality of samples, lesion access, and ergonomic features were assessed qualitatively and compared with prior experience with other biopsy devices. Immediate rebiopsy rate included high-risk lesions requiring surgical excision (obligate rebiopsy) and lesions requiring rebiopsy due to discordance or insufficient samples yielding nondiagnostic material. Data were analyzed using the Wilcoxon signed-rank test. One hundred thirteen patients aged 20-83 years (mean 52) were successfully biopsied with dense/fibrous breast tissue in 60% and dense/fibrous lesions in 49%. Lesions measured 6-63 mm (mean 17); 97% were masses. Five circumferential specimens (range 2-19) were obtained in 6 minutes (range 2-20). Operators rated safety and comfort comparable with existing devices and rated sample quality, breast/lesion penetration, and positioning ease/accuracy superior (p < 0.01). Diagnoses included 37 cancers, 70 benign, and six high-risk lesions with one upgrade from atypical ductal hyperplasia to ductal carcinoma in situ at surgery. Excluding obligate excision in high-risk diagnoses, the immediate rebiopsy rate was 2%. No complications required intervention. The new VAB device provides diagnostic samples and reduces sampling error defined by immediate rebiopsy rate. Compared with other devices, it is more ergonomic to target and position for sampling, particularly in dense breast tissue or lesions.

Breast biopsy: multicenter study of radiofrequency introducer with US-guided handheld system--initial experience.

PURPOSE: To evaluate the utility of a radiofrequency (RF) introducer in placement and use of a handheld breast biopsy system during ultrasonography (US)-guided breast biopsy. MATERIALS AND METHODS: In three institutions from September 2000 through June 2001, 99 patients were scheduled for US-guided breast biopsy with the handheld system. Patients were randomly assigned to undergo biopsy with the handheld system alone (control group, 50 patients) or with the RF introducer and the handheld system (treatment group, 49 patients). Investigators compared the ability of the radiologist and pathologist to obtain a histologic diagnosis, ease of tissue penetration, procedure time, and pain. Patients assessed their pain level after the procedure and at 1, 7, and 30 days after biopsy. RESULTS: The RF introducer provided easier penetration (treatment group mean score, 1.6; control group, 2.4), particularly in patients with dense breasts (treatment group, 1.0; control group, 2.9) on the basis of a five-point scale (1 = very easy, 5 = extremely difficult). A histologic diagnosis was obtained in all cases, and no RF-induced artifact was reported. Average biopsy procedure time for treatment and control groups was not significantly different. Average patient pain levels were comparable between groups for each evaluation interval. Clinical complications in four treatment patients and three control patients were minor and resolved spontaneously. CONCLUSION: The RF introducer may serve as a useful adjunct to the handheld biopsy system by facilitating penetration of breast tissue without causing any deleterious effects for the patient or the biopsy specimen.

Percutaneous core needle biopsy of radial scars of the breast: when is excision necessary?

OBJECTIVE: . This study was conducted to evaluate the outcome of cases of radial scar diagnosed by percutaneous core needle biopsy. MATERIALS AND METHODS: Of 198 nonpalpable lesions diagnosed with radial scars found at core needle biopsy, 157 lesions constituting the study group had undergone surgical excision (n = 102) or mammographic surveillance after biopsy for at least 24 months (median, 38 months; n = 55). Mammographic lesion type, lesion size, biopsy guidance method, biopsy device, number of specimens per lesion, and presence of atypical hyperplasia at percutaneous biopsy were retrospectively analyzed. Results were compared with histologic findings at surgery or mammographic findings during surveillance. RESULTS: . Carcinoma was found at excision in 28% (8/29) of lesions with associated atypical hyperplasia at percutaneous biopsy and 4% (5/128) of lesions without associated atypia (p < 0.0001). In the latter group, carcinoma was found at excision in 3% (2/60) of masses, 8% (3/40) of architectural distortions, and 0% (0/28) of microcalcification lesions. Malignancy was missed in 9% (5/58) of lesions biopsied with a spring-loaded device and in 0% (0/70) of lesions biopsied with a directional vacuum-assisted device (p = 0.01); and in 8% (5/60) of lesions sampled with less than 12 specimens per lesion and 0% (0/68) sampled with 12 or more specimens (p = 0.015). Lesion type, maximal lesion diameter, and type of imaging guidance (stereotactic or sonographic) were not significant factors in determining the presence of malignancy. CONCLUSION: . Diagnosis of radial scar based on core needle biopsy is likely to be reliable when there is no associated atypical hyperplasia at percutaneous biopsy, when the biopsy includes at least 12 specimens, and when mammographic findings are reconciled with histologic findings. When the lesion diagnosed by core needle biopsy as radial scar does not meet these criteria, excisional biopsy is indicated.

Risk of needle-track seeding after diagnostic image-guided core needle biopsy in breast cancer.

OBJECTIVE: Image-guided core needle biopsy (IGCNB) is an accepted technique for sampling nonpalpable mammographically detected suspicious breast lesions. However, the concern for needle-track seeding in malignant lesions remains. An alternative to IGCNB is needle-localization breast biopsy (NLBB). No study has been done to compare the local recurrence rate of breast cancer after IGCNB versus NLBB. METHODS: We have retrospectively reviewed the local recurrence of breast cancer in patients diagnosed by either IGCNB or NLBB who underwent breast-preserving treatment for their cancer between May 1990 and June 1995. The length of follow-up averaged 29.7 months. RESULTS: Three hundred ninety-eight patients were diagnosed with breast cancer by IGCNB (297 patients) or NLBB (101 patients). All patients underwent breast-conserving surgery. Fifteen (3.77%) patients had a local recurrence: 11(3.70%) in the IGCNB group and 4 (3.96%) in the NLBB group. These recurrence rates are not statistically different. CONCLUSION: Concerns for seeding of the needle track with cancer cells have made some surgeons wary of IGCNB. However, we did not find an increased rate of recurrence due to needle-track seeding, and IGCNB remains our procedure of choice for diagnosing mammographically detected suspicious breast lesions.