1 Infarction End Point in Bland Embolisation and Drug-Eluting Beads UFE treatment: long term follow up of Bead Block registry Dr Thomas J Kroencke Department of Radiology, Charité Berlin, Germany ET/ECIO Satellite Symposium, Thursday 10 April 2008

2 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Bead Block for UFE: 3-year Clinical Follow-up Two centre registry* Bead Block PVA microspheres for UAE Initial Results published in JVIR 2008 Long-term clinical data from one centre *Department of Radiology, Charité Medical School, Berlin, Germany Department of Radiology and Gynecology, St. Elisabeth Ziekenhuis, Tilburg, The Netherlands (Drs. Lohle, Lampman, Boekkoi)

3 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Material and Methods Protocol A („limited“) - start with µm APVA - upsize if endpoint not reached after 6 ml - size range: µm - endpoint: limited embolization Protocol A („stasis“) - start with µm APVA - upsize if endpoint not reached after 6 ml - size range: µm - endpoint: (near) stasis

4 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Data evaluation Quality of Life Changes (UFS-QoL®) –changes in symptom severity score – changes in quality of life score Patient satisfaction Re-interventions / failures

5 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Symptom Severity & QoL per protocol Significant (p < 0.001) for both protocols JVIR 2008; 19:47-57

6 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Symptom Severity & QoL per protocol JVIR 2008; 19:47-57 Significant (p < 0.001) for both protocols

7 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Imaging Results Kroencke et al., J Vasc Interv Radiol 2008; 19:47-57

8 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Limitations limited protocol N= 13/18 N=4/13 N=6/14 stasis protocol N=14/20 35 months Menorrhagia: 3/4 Dominant symptom Menorrhagia: 3/6

9 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Clinical Results limited protocol N=18 N=13 N=14* stasis protocol N=20 36 months Symtom Severity Score: 42 >> 13 HRQL Score 66 >> 98 UFS-QOL Score re-intervention N=2 hysterectomy (N=1 hyster.resec. & myomectomy) re-intervention N = 4 Re-UAE N = 1 HE Symtom Severity Score: 53 >> 19 HRQL Score 59 >> 87 Within 2Y follow-up; None thereafter! * N = 3 lost to follow-up UFS-QOL: uterine fibroid symptom and quality of life questionaire UAE: uterine artery embolisation

10 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Patient Satisfaction Protocol A („limited“) –very satisfied9/13 –satisfied3/13 –not sure - –not satisfied1/13 Protocol A („stasis“) –very satisfied4/14 –satisfied8/14 –not sure1/14 –not satisfied1/14

11 Infarction End Point in Bland Embolisation and Drug-Eluting Beads Conclusion APVA microspheres, Bead Block®, are an effective embolic agent for UAE with favorable clinical results at 3-year follow-up µm spheres and stasis as the embolisation endpoint resulted in fewer re-interventions as compared to limited embolisation with use of µm spheres