Luc Rotenberg : US guided vacuum breast biopsy and minimal Invasive Interventional procedures

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Minimal Invasive Interventional procedures in breast lesion

Luc Rotenberg, Grégory Lenczner, Jean Guigui, Catherine Bèges, Henri Ouazan

RPO – ISHH Clinique Hartmann-CMC Ambroise Paré

26-27 bd Victor Hugo 92200 Neuilly Sur Seine - France

dr.rotenberg@radiologieparisouest.com

US guided Breast interventional procedures:

What possible, what feasible ?

Minimal invasive diagnosis Minimal invasive treatment ?

•  Benign lesion • Malignant lesion ?

Local Treatment Surgery / Minimaly treatment US procedures

Breast Intervention: How I Do It Mary C. Mahoney, Mary S. Newell, Cincinnati, Altlanta

Radiology, 2013, Vol.268: 12-24, 10.1148/radiol.13120985

S  Written informed consent is required before all breast interventions

S  The risks explained to the patient include bleeding and infection

S  Anticoagulation is a relative contraindication to all biopsies

S  patients are usually asked to discontinue therapy for a short time prior to the biopsy

S  The patient should be informed of the potential benefits of the biopsy

S  including avoidance of surgery with benign results

S  preoperative confirmation of malignancy, which allows definitive surgical treatment in one surgical setting

S  Tailored prebiopsy counseling may better prepare women for percutaneous breast biopsy and improve their overall experience.

Minimal Invasive Interventions

Methods - Overview

Methods - Comparison

Risk and complications Tumor cells after

Intervention

Reimbursement pricing

Preconditions for Minimal Invasive Interventions

Preconditions for Minimal Invasive Interventions: Complementary Breast Diagnostic

Clinical Examination Mammography Sonography

Radiological Special X-Rays

Color Doppler Sonography MRI

Breast Biopsy : Ultrasound

Why Ultrasound Guidance? •  Real-time imaging of the breast •  Patient is lying on their back •  Ultrasound has excellent contrast resolution •  Cost effective •  Non-ionizing •  Portable

S  Side

S  Size S  h x L x l

S  Location S  Quadrant

S  Radius zone

S  Distance to the nipple

Balistic target tracking •  US •  RX •  MRI

•  Side •  Size

•  h x L x l

•  Location •  Quadrant •  Radius zone •  Distance to the

nipple

S  Deep / cutaneous plane

US balistic target tracking

S  Vacuum assisted devices

S  Mammotome S  1995, 11 et 8 g

S  Vacora (Bard) S  2003, 10 g S  2007, 14 g

S  Atec (Suros - Hologic) S  2007, 12 g 9 g

S  Seno RX (Bard) S  2009, 10 g, 7 g

S  Intact 2009

S  Large core devices

S  16 g

S  14 g

S  Single use devices +++

S  Other biopsy devices S  Spirotome & Coramate

(Medinvents) S  2007, 14 et 9 g

S  Celero (Hologic) S  2008 12 g

S  Finesse (Bard) S  2010 14 g

Choice of the Needle

Possibilities of Assessment Vacuum Assisted Breast Biopsy

Interventional Methods VABB Directional Vacuum - Assisted Breast Biopsy

§  local anesthesia §  external procedure §  Explanation +++ §  Time 15 to 40 mn

Breast biopsy

14 G 11 G 10 G 8 G 17 mg 95 mg 160 mg 300 mg

Indications for diagnostic representative or ablative Vacuum - Biopsy (VABB) /US

1.  After Large Core Needle Biopsy (LCNB) and suspicion of breast cancer (BI-RADS®

4c / 5, missmatch / discordance of the results of diagnostic imaging and histology)

2.  Suspicious lesions (BI-RADS® 4 / 5) diameter ~ 5 mm

3.  Resection of definitely benign, but symptomatic findings or High risk patients

1.  symptomatic Fibroadenoma

2.  recurrent symptomatic cysts

4.  Intraductal / intracystical proliferations : singulary Papilloma, complex cyst

5.  Neoadjuvant Chemotherapy

6.  Suspiscious of local recurrence

7.  Hazardous or dangerous location : deep, superficial, implants…

Indications for diagnostic representative or ablative Vacuum - Biopsy (VABB) /US

1.  After Large Core Needle Biopsy (LCNB) and suspicion of breast cancer (BI-RADS®

4c / 5, missmatch / discordance of the results of diagnostic imaging and histology)

2.  Suspicious lesions (BI-RADS® 4 / 5) diameter ~ 5 mm

3.  Resection of definitely benign, but symptomatic findings or High risk patients

1.  symptomatic Fibroadenoma

2.  recurrent symptomatic cysts

4.  Intraductal / intracystical proliferations : singulary Papilloma, complex cyst

5.  Neoadjuvant Chemotherapy

6.  Suspiscious of local recurrence

7.  Hazardous or dangerous location : deep, superficial, implants…

ENCOR SENO RX 7G

Specimens XRays

Superficial lesion

implants

VABB (Suros 9g, Seno Rx 7 ou 10g)

Post Minimal Invasive Therapy assessment

J8-J15

At an histopathological benign result there should be

performed an imaging control after 6 months

Interactive Case Review of Radiologic and Pathologic Findings from Breast Biopsy: Are They Concordant? How Do I Manage the Results?

Christopher P. Ho, MD, Jennifer E. Gillis, MD, Kristen A. Atkins, MD, Jennifer A. Harvey, MD, and , Brandi T. Nicholson, MD

University of Virginia Heath System, Chalottesville, Va. Radiographics, Volume 33-4 , 2013

S  To successfully perform a minimally invasive breast biopsy S  it is important to not only be familiar with the technique

S  but also with how to determine radiologic-pathologic concordance

S  and the appropriate treatments for patients after the procedure

S  When reviewing pathologic results for concordance S  it is important to ensure that microcalcifications are identified in the

histologic specimen

S  and the specific pathologic diagnosis is consistent S  with the morphologic characteristics seen at mammography

S  and the pretest probability of malignancy.

Interactive Case Review of Radiologic and Pathologic Findings from Breast Biopsy: Are They Concordant? How Do I Manage the Results?

Christopher P. Ho, MD, Jennifer E. Gillis, MD, Kristen A. Atkins, MD, Jennifer A. Harvey, MD, and , Brandi T. Nicholson, MD

University of Virginia Heath System, Chalottesville, Va. Radiographics, Volume 33-4 , 2013

S  At the follow-up examination S  both the histologic and imaging findings should be revisited

S  and the mass should be assessed at mammography or US to ensure that it is stable

S  If it has grown in size or its morphologic characteristics have changed

S  If calcifications increase in number or extent or the mass changes

S  Increases in size or its features become more suspicious

S  appropriate action should be taken

S  Excision is typically recommended

S  If the lesion is stable at follow-up examination

S  the patient may return to the general screening population

Discussion

S  Underestimation rate

ADH, DCIS, LCIS

S  Not eliminated with VABB

S  >> PPV : malignant

S  >> NPV : benign

S  Surgical indication

Roger J. Jackman & al, Radiology February 2001 218:497-502

Stereotactic Breast Biopsy of Nonpalpable Lesions: Determinants of Ductal

Carcinoma in Situ Underestimation Rates

S  DCIS underestimation rates by biopsy device were S  20.4% (76 of 373) at large-core biopsy

S  11.2% (107 of 953) at vacuum-assisted biopsy (P < .001)

S  24.3% (35 of 144) of masses

S  12.5% (148 of 1,182) of microcalcifications (P < .001)

S  and by number of specimens per lesion S  17.5% (88 of 502) with 10 or fewer specimens

S  11.5% (92 of 799) with greater than 10 (P < .02).

S  DCIS underestimations increased with lesion size

1.9 times more frequent with masses than with calcifications

1.8 times more frequent with LCB than with VAB

1.5 times more frequent with 10 or fewer specimens per lesion than with more than 10 specimens per lesion.

Projektpartner

1.  Fraunhofer-Institut für Integrierte Schaltungen IIS, Erlangen,

Kohr et al. Radiology 255: 723 - 730 (2010) N = 991; N = 147 cases of atypia The upgrade rate is significantly higher when ADH involves at least three foci. Surgical excision is recommended even when ADH involves fewer than three foci and all mammographic calcifications have been removed, because the upgrade rate is 12%.

Minimal Invasive Interventions

Wagoner et al. Am J Clin Pathol 131: 112 - 121 (2009) N = 123; Patients with ADH restricted to fewer than 3 foci may not need surgical excision, especially when the mammographic abnormality is completely removed by VAB.

Atypical Lobular Hyperplasia and Lobular Carcinoma in Situ at Core Breast Biopsy: Use of Careful Radiologic-Pathologic Correlation to Recommend Excision or

Observation

Kristen A. Atkins, Michael A. Cohen, Brandi Nicholson, Sandra Rao. Northwestern Memorial Hospital, Prentice Women’s Hospital, Chicago.

S  By consensus of the physicians involved in the diagnosis and treatment of breast disease at the University of Virginia, all cases of ALH or LCIS diagnosed at core needle biopsy receive a recommendation for surgical excision of the biopsy site.

S  with careful pathologic-radiologic correlation, noninvasive ALH and LCIS were not independent risk factors for worse pathology on excision

S  None of the 43 (95% CI: 0%, 8%) benign concordant cases determined with careful radiologic-pathologic correlation were upgraded at subsequent surgical excision or extended imaging follow-up

S  which suggests that arbitrary excision in all cases of ALH or LCIS may not be necessary.

S  In essence, we have reaffirmed the work of Liberman et al , AJR Am J Roentgenol 1999;173(2):291–299

S  LCIS (and we have added ALH) with concordant imaging-histologic analysis need not undergo surgical biopsy

S  comprehensive communication between the radiologist and pathologist, triaging of the biopsy results works well and may save many patients from undergoing surgical excision

Atypical Lobular Hyperplasia and Lobular Carcinoma in Situ at Core Breast Biopsy: Use of Careful Radiologic-Pathologic Correlation to Recommend Excision or

Observation

Kristen A. Atkins, Michael A. Cohen, Brandi Nicholson, Sandra Rao. Northwestern Memorial Hospital, Prentice Women’s Hospital, Chicago.

S  Advance in Knowledge S  When careful radiologic-pathologic correlation is conducted in the setting of a

breast core biopsy with atypical lobular hyperplasia or lobular carcinoma in situ

S  some women can be safely triaged to observation

S  of the 43 benign concordant cases, none were upgraded at surgery or extended follow-up (95% confidence interval: 0%, 8%)

S  Implication for Patient Care S  Focused and complete radiologic-pathologic correlation may obviate

excisional biopsy in patients with benign concordant biopsy findings.

S  Additional validation of this is required before this approach can be universally applied

Discussion

to excise or to sample ?

�  Excision for probably benign lesion + clip

S  Birads 3 S  Birads 4a

�  Sample for suspicious or malignant lesion

S  Birads 4 b & c S  Birads 5 & 6

big lesion

Intact system

intact

Radiofrequency ablation

Alterning electrical current (420-500 kHz)

= Minimally invasive procedure using a thin electrode needle

Ø  Ionic agitation

Ø  heating of the surrounding tissue

Ø  T> 60°C, Necrosis

Breast is RF friendly

Volume of ablation for a given quantity of RF energy

S  Lung (13 ± 3.5 mm)

Breast (11.8 ± 3.5 mm)

S  Soft tissue (9.8 ± 1.0 mm)

S  Kidney (7.3 ± 0.6 mm)

Specificity of the breast tissue - Electric conductivity

- Thermal diffusion - Low vascularity

Manenti G et al. Radiology 2009 Ahmed M, Radiology 2004

Drawing illustrates the RF ablation device correctly placed so as to produce a thermal lesion volume (black outline) that is concentric to the tumor and that encompasses the

tumor and a sufficient margin of noncancerous tissue.

Fornage B D et al. Radiology 2004;231:215-224

US monitoring to ensure accurate placement of the RF device in the Geometric center of the tumor to be ablated.

MR images show visualization and segmentation of the RF ablation–induced lesion in three perpendicular planes (left to right: axial, sagittal, coronal).

Manenti G et al. Radiology 2009;251:339-346

Close-up view of the specimen in a shows the well-defined tumor in the center of the ablation zone

a negative reaction to NADH-diaphorase stain, which confirmed the absence of viable tumor cells after RF ablation

Axial MR images show successful RF ablation in 55-year-old woman with breasts with a

dense glandular pattern.

Manenti G et al. Radiology 2009;251:339-346

Images show residual enhancement in 66-year-old patient with breasts with a fatty

glandular pattern.

Cryotherapie

S  nonoperable liver metastases from colorectal cancers

S  Cryotherapy uses coldness to achieve tumor destruction

S  Local anesthesia

S  Energy is produced by an external generator composed of an argon or nitrogen freezing system and a helium heating system

S  Several probes can be used simultaneously for larger tumors

S  The probe is inserted in the center of the tumor under imaging guidance (US or MRI) through a tiny incision

S  Iceball is created at the needle tip destroying the tumor as well as 5–10 mm of additional breast tissue surrounding the lesion

Littrup P J et al. Radiology 2005;234:63-72

Iceball

Cryotherapie

S  During each freeze cycle, temperatures from –185°C to -70°C

S  Tumor destruction in real time under US or MRI.

S  Tumor destruction is the result of cell damage from membrane

rupture during the successive freeze-thaw cycles

S  In the center of the tumor, cells are completely destroyed

S  in the periphery, a necrotic zone of some millimeters with viable cells is observed

S  cryotherapy ablation zone needs to be larger than the tumor size to be effective.

S  T < 2 cm

Implications for breast cancer management

S  The aim of breast conservation surgery S  to remove the entire tumor

S  achieve negative surgical margins

S  preserve the breast and patient’s body self-image

S  Minimally invasive approaches

S  must offer at least the same advantages as surgery

S  should be at least equivalent to tumor excision with proven negative surgical margins

S  Minimally invasive ablation techniques may replace surgical resection in the future

S  If they do, having imaging modalities that can detect tumor destruction would be essential.

Patient categories may benefit more from these techniques

S  Elderly breast cancer patients

S  often undertreated

S  worse outcome compared with younger patient

S  minimally invasive approaches may allow these patients with

multiple comorbid conditions to be suitable for local treatments

and be cured

S  neoadjuvant chemotherapy

S  challenge to be overcome in the future by novel and less invasive approaches

S  Residual disease can potentially be ablated without the need for surgery in an outpatient setting and can increase quality of life

S  USBP are essential tools in the diagnosis of nonpalpable lesions

S  devices used for biopsy have limitations, which lead to increased failure and underestimation rates for diagnosing of various breast lesions S  USBB must be handled cautiously

S  careful interpretation of some histopathologic results is ensured

S  Complications are rare (<2%) and include hematomas, persistent bleeding, vasovagal episodes, and wound infection

USBB can be a useful tool for both the diagnosis and optimal patient management

S  Percutaneous image-guided biopsy techniques have replaced open surgical biopsies S  considered to be the standard procedure for the diagnosis of

breast cancer

S  None of the ablative techniques described are used alone in

current clinical practice for the treatment of breast cancer and are used only in study settings.

S  Surgery remains the standard local treatment of breast cancer, with radiation therapy if needed clinically

S  The value of these treatments compared with traditional open surgery needs to be confirmed by large prospective studies.

S  In addition, cost-effectiveness and long-term effect on cosmetic outcomes still need to be investigated.

S  Balistic consultation S  Faisability

S  Explanation

S  Concordance +++

S  Device and guidance

S  Success rate : 95 à 98 %

S  Under-estimation : S  ≈ 10 % VABB , less with Intact

S  ≈ 20 % LCNB

S  = Surgery if boarder line lesion

S  Present & Next Futur : S  Minimal invasive therapy

S  Benign

S  Malignant ?

Take home

Luc Rotenberg : US guided vacuum breast biopsy and minimal Invasive Interventional procedures

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