Is radiology replacing the Is radiology replacing the scalpel:scalpel:

Advances in minimally Advances in minimally invasive techniquesinvasive techniques

Dr Steven AllenDr Steven AllenConsultant Breast RadiologistConsultant Breast Radiologist

Breast Imaging Lead, Royal Marsden Hospital, Breast Imaging Lead, Royal Marsden Hospital, SuttonSutton

Specialist Advisor to NICE on breast Specialist Advisor to NICE on breast interventional proceduresinterventional procedures

Radiological Breast Radiological Breast InterventionIntervention

Diagnosis (biopsies)Diagnosis (biopsies) TherapyTherapy

Fine Needle AspirationFine Needle Aspiration Insufficient material retrieved for definitive Insufficient material retrieved for definitive

diagnosisdiagnosis

Interpretation is highly dependent on skill of Interpretation is highly dependent on skill of cytopathologistcytopathologist

Cannot distinguish Cannot distinguish in situin situ versus invasive versus invasive carcinomascarcinomas

Difficult to distinguish atypical ductal hyperplasia Difficult to distinguish atypical ductal hyperplasia from low-grade DCIS or low-grade invasive ductal from low-grade DCIS or low-grade invasive ductal carcinomacarcinoma

New “Best practice diagnostic guidelines for New “Best practice diagnostic guidelines for patients presenting with breast symptoms”*patients presenting with breast symptoms”**Willett et al. Best practice diagnostic guidelines for patients presenting with breast symptoms . Nov 2010. www.rcrbreastgroup.com/Documents/BBCDiagnosticGuidelines.pdf

Fine Needle Aspiration-Fine Needle Aspiration-UsesUses

Where core biopsy not technically Where core biopsy not technically possiblepossible

Lymph nodesLymph nodes Complex cystsComplex cysts Radiologically benign, young womenRadiologically benign, young women Clotting issuesClotting issues Local anaesthetic allergyLocal anaesthetic allergy

Why do we need Why do we need breast needle biopsy?breast needle biopsy? Definitive benign diagnosis avoids Definitive benign diagnosis avoids

unnecessary surgeryunnecessary surgery Knowledge of the type and extent of Knowledge of the type and extent of

malignancy influences choice of treatmentmalignancy influences choice of treatment ADH or Ductal carcinoma in situ? ADH or Ductal carcinoma in situ? Ductal carcinoma in situ or invasive Ductal carcinoma in situ or invasive

disease?disease? Invasive tumour type - eg lobularInvasive tumour type - eg lobular Invasive tumour gradeInvasive tumour grade Oestrogen receptor statusOestrogen receptor status Other tumour markersOther tumour markers Tumour geneticsTumour genetics

Problems with core Problems with core biopsybiopsy

False negatives on core (2-10%, mainly False negatives on core (2-10%, mainly calcifications)calcifications)

Trend to increasing size of biopsy sample Trend to increasing size of biopsy sample to minimize thisto minimize this

BUT cheap ( approx £15 per needle, £50 BUT cheap ( approx £15 per needle, £50 per case versus £150 per needle, £500 per case versus £150 per needle, £500 per case)per case)

Automated 14g core biopsy deals Automated 14g core biopsy deals with more than 90% of caseswith more than 90% of cases

Very large core biopsy techniques Very large core biopsy techniques have been developed to deal with have been developed to deal with

the rest and also to help solve the rest and also to help solve diagnostic problemsdiagnostic problems

Tissue Tissue volumevolume

MethodMethod Average Average weightweight

14g core14g core 17mg17mg

11g VAB11g VAB 100mg100mg

7g VAB7g VAB300mg300mg

Liberman L. AJR 2000; 174: Liberman L. AJR 2000; 174: 1191-11991191-1199

Vacuum Assisted BiopsyVacuum Assisted Biopsy

In USA probably overperformedIn USA probably overperformed Increasing in Europe where probably still Increasing in Europe where probably still

underperformedunderperformed The role is extending (MRI, therapy?)The role is extending (MRI, therapy?)

When should vacuum When should vacuum assisted biopsy be assisted biopsy be

used?used?Indications :Indications : Very small mass lesionsVery small mass lesions Equivocal or failed core Equivocal or failed core

biopsybiopsy Architectural distortionsArchitectural distortions MicrocalcificationsMicrocalcifications Papillary and mucocele like Papillary and mucocele like

lesionslesions Diffuse non-specific Diffuse non-specific

abnormalityabnormality Complex cysts and Complex cysts and

abscessesabscesses Excision of benign lesionsExcision of benign lesions Malignant disease ??Malignant disease ??

VAB effectsVAB effects

Will detect more ADH Will detect more ADH *, LCIS, LCIS Will detect more DCIS, Invasive cancerWill detect more DCIS, Invasive cancer* * Reduced surgical biopsy rateReduced surgical biopsy rate Better preoperative surgical and medical Better preoperative surgical and medical

treatment planningtreatment planning

* Winchester et al. Arch Surg 2003: 138(6); 619-22

* *Kettritz et al. Cancer 2004: 100(2); 245-51

VAB - risksVAB - risks

Haematoma rates are actually low*, and Haematoma rates are actually low*, and not significantly different to core biopsynot significantly different to core biopsy

Pain?**Pain?**

Clip migrationClip 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 - techniqueVAB - technique

EnCor (SenoRxEnCor (SenoRx™) ™)

EnCorEnCor

Built in Built in headlightsheadlights illuminate the biopsy illuminate the biopsy areaarea

Choice of Choice of sample sample patternspatterns that that continuously repeatcontinuously repeat

EnCorEnCor

ATEC (Suros surgicalATEC (Suros surgical))

VacoraVacora

VAB systems - comparison of VAB systems - comparison of attributesattributes

Attribute Vacora Mammotome Suros Atec Encor

X-ray and US

MRI

Directional

Sample Single Multiple Multiple Multiple

Method Cutting Cutting Cutting Scissor

Sharpness + + + +++

Retrieval Open Open Closed Closed

Vacuum control

X

Programmable

X X

Lavage X X

Anaesthetic X

Sample size

Volume in 1min

+ ++ +++ +++

Probe offset X

Vacuum assisted excisionVacuum assisted excision

Increasing use to excise benign lesions in Increasing use to excise benign lesions in a “piecemeal” fashion as an alternative to a “piecemeal” fashion as an alternative to surgerysurgery

Cannot give margin status on excisionCannot give margin status on excision Newer devices are very automated Newer devices are very automated

allowing most procedures to be performed allowing most procedures to be performed in <30 minutesin <30 minutes

Significant time, cost, morbidity benefitsSignificant time, cost, morbidity benefits

Vacuum assisted excisionVacuum assisted excision

Benign lesions such as fibroadenomas Benign lesions such as fibroadenomas ** Recurrence rate may be higher for lesions Recurrence rate may be higher for lesions

>2cm>2cm Papillary lesionsPapillary lesions All B3 lesions without atypiaAll B3 lesions without atypia* ** * Lymph nodes?Lymph nodes? Cancers?Cancers?

** Grady et al, Breast J 2008, Grady et al, Breast J 2008, 14(3): 275-8 14(3): 275-8

* * Tennant et al, Breast 2008, * * Tennant et al, Breast 2008, 17(6):546-917(6):546-9

TheThe Intact Intact™ ™ Breast Lesion Breast Lesion Excision System (BLES)Excision System (BLES)

Controller & Vacuum Source

Handle & Disposable Wand

The Intact BLESThe Intact BLES Developed in USA in 2001, the INTACT breast Developed in USA in 2001, the INTACT breast

lesion excision system (BLES) has a unique lesion excision system (BLES) has a unique capability of obtaining a single large biopsy capability of obtaining a single large biopsy sample using radiofrequency cauterisationsample using radiofrequency cauterisation

It has been used extensively in the USA as an It has been used extensively in the USA as an equivalent large biopsy device to current vacuum equivalent large biopsy device to current vacuum assisted systems (>40,000 cases!).assisted systems (>40,000 cases!).

At least equivalent diagnostically to VAB devices*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 ExcisionIntact BLES Excision

Goal using The Intact Goal using The Intact BLESBLES

• Excision of lesion in one piece

• Best possibility of clear margins

The Intact BLESThe Intact BLES

Specimen radiographSpecimen radiograph

The Intact BLESThe Intact BLES RMH have had this since 2007 and are the second RMH have had this since 2007 and are the second

centre outside the USAcentre outside the USA

Approved as a biopsy device by appropriate Approved as a biopsy device by appropriate committeescommittees

However due to its of obtaining a single large However due to its of obtaining a single large sample, we have almost exclusively used this in an sample, we have almost exclusively used this in an attempt at whole lesion excisionattempt at whole lesion excision

Most of our patient group have been referred from Most of our patient group have been referred from the NHSBSP, and we have attempted to perform the NHSBSP, and we have attempted to perform complete excision biopsy in removing small breast complete excision biopsy in removing small breast lesions with a margin *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 BLESThe Intact BLES

Many borderline (high risk) lesions can be Many borderline (high risk) lesions can be completely excised without surgery in a short completely excised without surgery in a short well tolerated outpatient procedure *well tolerated outpatient procedure *

The results very much represent what can be The results very much represent what can be achieved during the early stages of using this achieved during the early stages of using this new technique new technique

Complementary to VAB as an alternative therapy Complementary to VAB as an alternative therapy to surgery for small breast lesionsto 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 BLESThe Intact BLES NICE have now approved this as a large biopsy deviceNICE have now approved this as a large biopsy device

The potential of this technique may grow further as The potential of this technique may grow further as wand technology/unit experience improves wand technology/unit experience improves

Current wand sizes/yield limit excision of many lesions Current wand sizes/yield limit excision of many lesions

A 30mm wand has been in use in selected centres A 30mm wand has been in use in selected centres >6/12>6/12

?whole cancer excision?whole cancer excision

30mm wand30mm wand

Thermal AblationThermal Ablation

Radiofrequency ablationRadiofrequency ablation CryoablationCryoablation Laser therapyLaser therapy High Intensity focused ultrasound (HIFU)High Intensity focused ultrasound (HIFU)

All require a probe to be inserted into the All require a probe to be inserted into the tumour under image guidance (usually tumour under image guidance (usually ultrasound)ultrasound)

Margins, margins, marginsMargins, margins, margins

Thermal AblationThermal Ablation

RF AblationRF Ablation

RF ablation most fashionableRF ablation most fashionable Small, centrally sited, low grade tumours, Small, centrally sited, low grade tumours,

elderly patients elderly patients Low level of evidenceLow level of evidence Almost invariably combined with surgery*Almost invariably combined with surgery*

*Imoto S, et al. Breast. 2009 Apr;18(2):130-4

RF Ablation ?RF Ablation ?neoadjuvantneoadjuvant

RFA combined with immunologically RFA combined with immunologically active cytokines (IL-7 and IL-15) in mice active cytokines (IL-7 and IL-15) in mice induced immune responses to tumors, induced immune responses to tumors, inhibited tumor development and lung inhibited tumor development and lung metastasis *metastasis *

RFA combined with other treatment RFA combined with other treatment deliveries?deliveries?

*Habibi M, et al. Breast Cancer Res Treat. 2009 Apr;114(3):423-31.

ConclusionsConclusions

Biopsies are getting larger!Biopsies are getting larger!

Core biopsy and even FNA still maintain a Core biopsy and even FNA still maintain a role role

As with other fields of interventional As with other fields of interventional radiology, the breast interventionalist is radiology, the breast interventionalist is finding a role extension in the therapy of finding a role extension in the therapy of benign and now malignant breast diseasebenign and now malignant breast disease