Is radiology replacing the scalpel Advances in minimally

Is radiology replacing the scalpel: Advances in minimally invasive techniques Dr Steven Allen Consultant Breast Radiologist Breast Imaging Lead, Royal Marsden Hospital, Sutton Specialist Advisor to NICE on breast interventional procedures

Radiological Breast Intervention n n Diagnosis (biopsies) Therapy

Fine Needle Aspiration n Insufficient material retrieved for definitive diagnosis n Interpretation is highly dependent on skill of cytopathologist n Cannot distinguish in situ versus invasive carcinomas n Difficult to distinguish atypical ductal hyperplasia from low-grade DCIS or low-grade invasive ductal carcinoma n New “Best practice diagnostic guidelines for patients presenting with breast symptoms”* *Willett et al. Best practice diagnostic guidelines for patients presenting with breast symptoms. Nov 2010. www. rcrbreast group. com/Documents/BBCDiagnostic. Guidelines. pdf

Fine Needle Aspiration-Uses n n n Where core biopsy not technically possible Lymph nodes Complex cysts Radiologically benign, young women Clotting issues Local anaesthetic allergy

Why do we need breast needle biopsy? n n Definitive benign diagnosis avoids unnecessary surgery Knowledge of the type and extent of malignancy influences choice of treatment n ADH or Ductal carcinoma in situ? n Ductal carcinoma in situ or invasive disease? n Invasive tumour type - eg lobular n Invasive tumour grade n Oestrogen receptor status n Other tumour markers n Tumour genetics

Problems with core biopsy n n n False negatives on core (2 -10%, mainly calcifications) Trend to increasing size of biopsy sample to minimize this BUT cheap ( approx £ 15 per needle, £ 50 per case versus £ 150 per needle, £ 500 per case)

Automated 14 g core biopsy deals with more than 90% of cases Very large core biopsy techniques have been developed to deal with the rest and also to help solve diagnostic problems

Tissue volume Method Average weight 14 g core 17 mg 11 g VAB 100 mg 7 g VAB 300 mg Liberman L. AJR 2000; 174: 1191 -1199

Vacuum Assisted Biopsy n n n In USA probably overperformed Increasing in Europe where probably still underperformed The role is extending (MRI, therapy? )

When should vacuum assisted biopsy be used? Indications : n Very small mass lesions n Equivocal or failed core biopsy n Architectural distortions n Microcalcifications n Papillary and mucocele like lesions n Diffuse non-specific abnormality n Complex cysts and abscesses n Excision of benign lesions n Malignant disease ? ?

VAB effects n n Will detect more ADH *, LCIS Will detect more DCIS, Invasive cancer* * cancer Reduced surgical biopsy rate Better preoperative surgical and medical treatment planning * Winchester * *Kettritz et al. Arch Surg 2003: 138(6); 619 -22 et al. Cancer 2004: 100(2); 245 -51

VAB - risks n Haematoma rates are actually low*, and not significantly different to core biopsy n Pain? ** n Clip migration *Lai, et al. Vacuum-assisted large-core breast biopsy: complications and their incidence. Can Assoc Radiol J. 2000 Aug; 51(4): 232 -6. **Szynglarewicz, et al. Pain experienced by patients during minimal-invasive ultrasound-guided breast biopsy: Vacuum-assisted vs core-needle procedure. EJSO, . 2011 Feb 28, Epub

VAB - technique

™) En. Cor (Seno. Rx

En. Cor n Built in headlights illuminate the biopsy area n Choice of sample patterns that continuously repeat

En. Cor

ATEC (Suros surgical)

Vacora

VAB systems - comparison of attributes Attribute Vacora Mammotome Suros Atec Encor X-ray and US MRI Directional Sample Single Multiple Method Cutting Scissor Sharpness + +++ Retrieval Open Closed Vacuum control X Programmable X X Lavage X X Anaesthetic X Sample size Volume in 1 min + ++ +++ Probe offset X

Vacuum assisted excision n n Increasing use to excise benign lesions in a “piecemeal” fashion as an alternative to surgery Cannot give margin status on excision Newer devices are very automated allowing most procedures to be performed in <30 minutes Significant time, cost, morbidity benefits

Vacuum assisted excision § § § Benign lesions such as fibroadenomas * Recurrence rate may be higher for lesions >2 cm Papillary lesions All B 3 lesions without atypia* * Lymph nodes? Cancers? * Grady et al, Breast J 2008, 14(3): 275 -8 * * Tennant et al, Breast 2008, 17(6): 546 -9

™ Breast Lesion Excision The Intact System (BLES) Handle & Disposable Wand Controller & Vacuum Source

The Intact BLES n Developed in USA in 2001, the INTACT breast lesion excision system (BLES) has a unique capability of obtaining a single large biopsy sample using radiofrequency cauterisation n It has been used extensively in the USA as an equivalent large biopsy device to current vacuum assisted systems (>40, 000 cases!). n At least equivalent diagnostically to VAB devices* *Sie et al, 2006. Multicenter Evaluation of the Breast Lesion Excision System, a Percutaneous, Vacuum-Assisted, Intact-Specimen Breast Biopsy Device. Cancer 107: 5

Intact BLES Excision

Goal using The Intact BLES • Excision of lesion in one piece • Best possibility of clear margins

The Intact BLES

Specimen radiograph

The Intact BLES n RMH have had this since 2007 and are the second centre outside the USA n Approved as a biopsy device by appropriate committees n However due to its of obtaining a single large sample, we have almost exclusively used this in an attempt at whole lesion excision n Most of our patient group have been referred from the NHSBSP, and we have attempted to perform complete excision biopsy in removing small breast lesions with a margin * *Allen SD, Nerurkar A, Della Rovere GU. The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? Eur Radiol. 2011 Jan 15.

The Intact BLES n Many borderline (high risk) lesions can be completely excised without surgery in a short well tolerated outpatient procedure * n The results very much represent what can be achieved during the early stages of using this new technique n Complementary to VAB as an alternative therapy to surgery for small breast lesions *Whitworth PW. Intact Percutaneous Excision (IPEX) for Definitive Diagnosis of High-Risk Breast Lesions. Ann Surg Oncol. 2011 Oct; 18(11): 3095. Epub 2011 Sep 9

The Intact BLES n NICE have now approved this as a large biopsy device n The potential of this technique may grow further as wand technology/unit experience improves n Current wand sizes/yield limit excision of many lesions n A 30 mm wand has been in use in selected centres >6/12 n ? whole cancer excision

30 mm wand

Thermal Ablation n n n Radiofrequency ablation Cryoablation Laser therapy High Intensity focused ultrasound (HIFU) All require a probe to be inserted into the tumour under image guidance (usually ultrasound) Margins, margins

Thermal Ablation

RF Ablation n n RF ablation most fashionable Small, centrally sited, low grade tumours, elderly patients Low level of evidence Almost invariably combined with surgery* *Imoto S, et al. Breast. 2009 Apr; 18(2): 130 -4

RF Ablation ? neoadjuvant n n RFA combined with immunologically active cytokines (IL-7 and IL-15) in mice induced immune responses to tumors, inhibited tumor development and lung metastasis * RFA combined with other treatment deliveries? *Habibi M, et al. Breast Cancer Res Treat. 2009 Apr; 114(3): 423 -31.

Conclusions n Biopsies are getting larger! n Core biopsy and even FNA still maintain a role n As with other fields of interventional radiology, the breast interventionalist is finding a role extension in therapy of benign and now malignant breast disease