Assessment of breast microcalcification with

stereotactic guidance using the Spirotome Biopsy Needle.

Comparison with other biopsy devices

Dr Richard HarriesConsultant Radiologist

Diana, Princess of Wales HospitalGrimsby

Breast tissue sampling

Aspiration cytologyCore biopsy (14 -18G, Tru-Cut etc)Mammotome (11G, 8G)Spirotome (11G)

Macro-biopsies - advantages

More reliable – fewer failuresLarger samples – better histological

assessment Tumour markers Molecular biology Genetic expression

Angiogenesis IGFR Notch signaling pathway

BCL2 Oncoprotein Ki-67 antigen P53 protein

DNA Methylation Mammaglobin PI3K pathway

EGFR pathway miRNA Proliferation and mitotic index

Gross Cystic Disease Fluid Protein

Multigene testing S100

Hedgehog Signaling Pathway

Molecular subtyping Smooth Muscle Actin

HER-2 Muscle Actin Estrogen Receptor/Progesterone Receptor

Histology Myosin Heavy Chain WNT signaling cascades

Macro-biopsies - disadvantages

Larger samples – more tissue removalDifficulty assessing margins at surgery –

more extensive surgical removalClip migrationTumour cell migration?More haematoma complicationsReduces breast conserving surgery

Ideal Biopsy Needle Characteristics

Accurate targeting of lesionsLarge samplesMinimum tissue damageQuick and easy to useGood patient acceptanceMinimum complicationsCheap!

What was I using?

Mammotome VAB – until about 2001Spirotome needle subsequently

So why not compare them?

Spirotome system

Spirotome system

Sample population

46 patients with microcalcification on mammography

22 months (October 2007 – August 2009)

148 samples (mean 3 samples per patient)

Clip placement – 14 patients

Procedure

Siemens Mammomat Upright stereotaxisSpirotome 11GLidocaine & adrenalineFaxatron specimen radiology

Data Collection

Date Operator Start/Finish Times Number of Cores + Cores with Calcification Clip Marker Histology Further Management Complications

Patient Questionnaire

Scale of 1 – 5FEARPAINOVERALL REACTION TO PROCEDURE No pain at all 1 2 3 4 5 Very painful

Results - Length of proceduresLength of Procedure

0 20 40 60 80 100 120

1

5

9

13

17

21

25

29

33

37

41

45

Time

Length of Procedure

Average length of procedure = 48 minutes

60% of procedures (27/45) took less than 45 minutes

Results - Microcalcification

45/46 patients’ samples (98%) contained microcalcification

107/148 samples yielded calcification (73%)

Number of microcalcification containing cores/total cores

1 CORE TOTAL

2 CORES TOTAL

3 CORES TOTAL

4 CORES TOTAL

5 CORES TOTAL

6 CORES TOTAL

0 with microcalcification 1

1 with microcalcification 2 2 1 1

2 with microcalcification 11 10 2 1

3 with microcalcification 4 2 2

4 with microcalcification 4 2

5 with microcalcification 1

6 with microcalcification

Totals 2 13 15 8 5 3

Number of microcalcification-containing cores per total number of cores

Samples with calcification

The number of expected specimen with microcalcification (solid line) is related to the total number of cores (horizontal axis). The upper and lower 95 % confidence intervals are depicted as dotted lines. Beyond 4 cores there is no increase in expected specimen with microcalcification.

Number of Cores per patient

Number of cores <5 83% (38/46) Mean number of cores = 3.2 per patient VAB – minimum 6 cores recommended

Many practitioners routinely take 20+

VAB vs. Spirotome Stereotactic biopsies

VAB* SPIROTOME

Mean No of samples

14 3

Success 95% 98%

*Ambrogetti et al 2003; Pfleidere et al 2009

B1 Normal 3

B2 Benign 38

B3 Indeterminate 1

B4 Suspicious of malignancy 0

B5 Malignant 4

TOTAL 46

Results - Histology

43/46 examinations yielded positive histology

Further Management

3 patients (B1/B3) → VAB3 patients with invasive cancer →

mastectomy1 patient with invasive cancer → WLE

Results - Complications

None know of (1 patient fainted but procedure was completed)

Complications – VAB

Simon et al (1999) 71 lesions U/S guided

5 (7%) bled beyond 10 minutes 1 (1%) vasovagal episode

Harries …purely anecdotal ≈ 5 years experience, ≈ 250 patients

Several haematomata requiring surgical treatment Many vasovagal attacks requiring interruption of

procedure

Score Fear Pain Overall

5 4 1 2

4 2 2 5

3 11 12 22

2 8 12 8

1 13 11 1

38 38 38

Average 2,4 2,2 2,9

Patient acceptability

Results – Acceptability Scores

Results – Acceptability Scores

Acceptability scores <4Fear - 84% (32/38)

Pain - 92% (35/38)

Overall - 83% (31/38)

Spirotome - Summary

Simpler and cheaper than VAB systemsHigh positive yield with fewer samplesLess traumaticMore acceptable to patientsCan reach lesions VAB cannot