1. Assessment of breast microcalcification with stereotactic guidance using the Spirotome Biopsy Needle. Comparison with other biopsy devices Dr Richard Harries Consultant Radiologist Diana, Princess of Wales Hospital Grimsby

2. Breast tissue sampling Aspiration cytology Core biopsy (14 -18G, Tru-Cut etc) Mammotome (11G, 8G) Spirotome (11G)

3. Macro-biopsies - advantages More reliable – fewer failures Larger samples – better histological assessment  Tumour markers  Molecular biology  Genetic expression

4. AngiogenesisIGFR Notch signaling pathway BCL2 Oncoprotein Ki-67 antigen P53 protein DNA MethylationMammaglobin PI3K pathway EGFR pathwaymiRNA Proliferation and mitotic index Gross Cystic Disease Fluid Protein Multigene testing S100 Hedgehog Signaling Pathway Molecular subtyping Smooth Muscle Actin HER-2Muscle Actin Estrogen Receptor/Progesterone Receptor HistologyMyosin Heavy Chain WNT signaling cascades

5. Macro-biopsies - disadvantages Larger samples – more tissue removal Difficulty assessing margins at surgery – more extensive surgical removal Clip migration Tumour cell migration? More haematoma complications Reduces breast conserving surgery

6. Ideal Biopsy Needle Characteristics Accurate targeting of lesions Large samples Minimum tissue damage Quick and easy to use Good patient acceptance Minimum complications Cheap!

7. What was I using? Mammotome VAB – until about 2001 Spirotome needle subsequently So why not compare them?

9. Spirotome system

15. 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

16. Procedure Siemens Mammomat Upright stereotaxis Spirotome 11G Lidocaine & adrenaline Faxatron specimen radiology

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

21. Patient Questionnaire Scale of 1 – 5 FEAR PAIN OVERALL REACTION TO PROCEDURE No pain at all 12345Very painful

22. Results - Length of procedures Average length of procedure = 48 minutes 60% of procedures (27/45) took less than 45 minutes

23. Results - Microcalcification 45/46 patients’ samples (98%) contained microcalcification 107/148 samples yielded calcification(73%)

24. 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 microcalcification1 1 with microcalcification2211 2 with microcalcification111021 3 with microcalcification422 4 with microcalcification42 5 with microcalcification1 6 with microcalcification Totals21315853 Number of microcalcification-containing cores per total number of cores Samples with calcification

25. 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.

26. Number of Cores per patient Number of cores <583% (38/46) Mean number of cores = 3.2 per patient VAB – minimum 6 cores recommended Many practitioners routinely take 20+

27. VAB vs. Spirotome Stereotactic biopsies VAB * SPIROTOME Mean No of samples 143 Success95%98% *Ambrogetti et al 2003; Pfleidere et al 2009

28. B1 Normal 3 B2 Benign 38 B3 Indeterminate 1 B4 Suspicious of malignancy 0 B5 Malignant 4 TOTAL46 Results - Histology 43/46 examinations yielded positive histology

29. Further Management 3 patients (B1/B3) → VAB 3 patients with invasive cancer → mastectomy 1 patient with invasive cancer → WLE

30. Results - Complications None know of (1 patient fainted but procedure was completed)

31. 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

32. ScoreFearPainOverall 5412 4225 3111222 28128 113111 38 Average2,42,22,9 Patient acceptability Results – Acceptability Scores

33. Acceptability scores <4 Fear - 84% (32/38) Pain - 92% (35/38) Overall - 83% (31/38)

34. Spirotome - Summary Simpler and cheaper than VAB systems High positive yield with fewer samples Less traumatic More acceptable to patients Can reach lesions VAB cannot