High velocity pulse biopsy device enables controllable and precise needle insertion and high yield tissue acquisition.

Minimally invasive biopsies are a cornerstone of breast cancer management with ultrasound being the preferred guidance modality. New developments in breast cancer management and advances in imaging technologies bring new challenges to current biopsy methodologies. A new biopsy device (NeoNavia® biopsy system, 14 G) was developed. It incorporates a pneumatic needle insertion mechanism that is intended to provide better control of needle progression and enable stepwise insertion without noticeable deformation or displacement of surrounding tissue as visualized under ultrasound. A new method of tissue acquisition was designed to achieve a sampling yield higher than standard methodologies. Needle dynamics was assessed on a specifically designed test bed and sampling performance was compared to a Magnum® biopsy instrument (Bard, Covington, GA, USA) in representative tissue models. The histological quality of samples obtained ex-vivo was evaluated. A pneumatic pulse was measured to accelerate the needle to a maximum velocity of 21.2 ±â€¯2.5 m/s on a stroke length of 2.5 mm, achieving significantly higher acceleration, maximum velocity and power than current biopsy devices. Mean weight of samples obtained by the NeoNavia device were 3.5, 4.6, and 4.3 times higher when sampling was performed in turkey breast, calf thymus and swine pancreas, respectively, as compared to samples obtained with the Magnum instrument. Ex-vivo analysis indicates that the method of tissue acquisition has no apparent negative impact on the histopathologic quality of obtained samples.

A new method to gently place biopsy needles or treatment electrodes into tissues with high target precision.

We present a new core needle biopsy and treatment electrode precision placement technique which, regardless of needle size, target lesion hardness and elasticity, makes it possible to precisely place an image guided device inside the abnormal tissue. Once inside the abnormal lesion, multiple tissue samples can be collected using a dedicated trocar and collecting system. Our unique "Fourier" driver substitutes the commonly used spring-loaded device or complements the jerky insertion technique used by experienced interventional physicians. It enables the physician to precisely and with extreme tactility maneuver even large diameter core needles or treatment-electrodes into the lesion using only a diminutive external force. This is achieved by applying supporting servo-controlled mechanical high-acceleration micro-pulses, proportional to the average vector directed by the physician. The Fourier-needle or Fourier-electrode stands completely non-moving when the system automatically goes into full idling. This means that the angle of attack successively and arbitrary can be aligned to hit the target, becoming successively symmetrically inserted into even small tumors to be treated as well as exactly hit any point outlined by real time ultrasound guiding. This kind of biopsy needle or treatment electrode placement results in a uniquely accurate and less traumatic procedure. Due to the risk of disseminating viable tumor cells the precision placement device can be combined with a computer controlled anti-seeding system, denaturizing tumor cells detached during penetration of the biopsy needle or treatment electrode.

Minimally-invasive treatment of early stage breast cancer: a feasibility study using radiofrequency ablation under local anesthesia.

The objective of this study was to assess efficacy and safety of percutaneous ultrasound (US) guided preferential radiofrequency ablation (PRFA) in early breast carcinoma under local anesthesia and to evaluate a new assessment protocol. Eighteen breast cancer patients were enrolled in order to receive PRFA treatment three weeks prior to resection. Pain assessment was performed using the visual analoge scale. Analysis of treatment success was performed using magnetic resonance imaging (MRI) as well as histological assays for hematoxylin & eosin (H&E) and cytokeratine 8 (CK8). In a subset of patients contrast enhanced ultrasound (CEUS) was performed before and after treatment. MRI showed no residual tumor growth in 100% (18/18) of cases. Complete tumor devitalization was indicated in 83% (15/18) of patients as judged by H&E staining and in 89% (16/18) as judged by immunostaining for CK8. In 100% (18/18) at least one histologic method showed devitalization in the entire tumor. Treatment was well tolerated. Pain experienced during the procedure was mild. US-guided PRFA of small breast carcinoma is feasible under local anesthesia. MRI and CK8 have proven valuable additions to the RF breast tumor ablation protocol. CEUS shows potential as a modality for radiological follow-up.

Breast cancer and clinical outcome among women over 60 years of age: a plead for more screening and alternative treatments.

OBJECTIVE: To study elderly women > or = 60 years of age diagnosed with breast cancer and analyze this cohort according to death from breast cancer and death due to comorbidities. Patients aged 60-69 years of age were included in routine mammography screening, but not women aged > or = 70 years. This enabled a comparison between the 2 groups regarding screening effect, tumor size and survival in breast cancer. STUDY DESIGN: A consecutive sample of 311 breast cancer patients > or = 60 years of age from 1991 were analyzed according to tumor size at diagnosis, frequencies of lymph node metastasis, tumor histological grade and stage, ploidy, proliferation index, stem-line-scatter index and survival rate in breast cancer and other causes of death. Tumor size was compared to a patient group aged 60-69 from 1987, before the introduction of mammography screening in Sweden. RESULTS: In the screening group a significant reduction in tumor size was found at diagnosis compared to the sample from 1987 (p < 0.001) and to the older group > or = 70 years (p < 0.02). In the latter group a higher death rate appeared for breast cancer. CONCLUSION: Older women would have a better outcome if included in the mammography screening program.

Axillary lymph node metastasis and survival in breast cancer patients with concurrent cardio-cerebral-vascular disease.

OBJECTIVES: Dissemination of tumour cells occurring both spontaneously or caused by diagnostic biopsy procedures is the most serious complication of solid malignancies. In the present work we focus on local tumour spread and how this complication of cancer disease can be counteracted. DESIGN: From a cohort of 864 breast cancer patients we selected those who died of their primary cancer and those who died because of a simultaneously existing cardio-cerebral-vascular disease (CCVD) and were exposed to anticoagulants. SETTING: The study was based on breast cancer patients diagnosed at Karolinska University Hospital during 1991 (n = 519) and 1997-1998 (n = 345). MAIN OUTCOME MEASURES: Axillary lymph node metastasis (ALNM) and survival of breast cancer patients with concurrent CCVD. RESULTS: Breast cancer patients belonging to the group that died of CCVD showed ALNM at the time of tumour diagnosis in 27% of the cases compared with 68% diagnosed in the group that died of their breast cancer (p < 0.0001). Likewise we observed a highly significant (p < 0.0001) difference in mean survival time with an average of 102 months in the group of breast cancer patients who died of CCVD and an average of 61 months in the group who died of breast cancer. CONCLUSION: The data presented herein indicate that breast cancer patients regularly involved in treatment with anticoagulants because of simultaneously existing CCVD develop ALNM significantly less frequently and have an increased average survival time compared with breast cancer patients not suffering from CCVD.

Feasibility study on the treatment of small breast carcinoma using percutaneous US-guided preferential radiofrequency ablation (PRFA).

The purpose of this study was to determine the safety and efficacy of percutaneous ultrasound (US) guided preferential radiofrequency ablation (PRFA) of unifocal human invasive breast carcinoma with largest radiological diameters of up to 16 mm. Thirty-three patients were enrolled in a study to be treated prior to scheduled partial mastectomy. A needle-shaped treatment electrode, successively developed in two different sizes, was placed into the center of the lesions using ultrasound guidance. A temperature of 85 degrees C was maintained for 10 min. The analysis of the resected specimen was performed using conventional histopathological methods with the aim to determine the size of the lesion as well as the potential viability of tumor cells. Of the 33 patients enrolled 31 were treated. In 26 (84%) patients a complete ablation of the tumor was achieved. Ultrasound guided preferential radiofrequency ablation of small breast carcinoma is feasible and patient friendly. The success rate depends on accurate preoperative diagnostic imaging as well as an exact position of the needle electrode.