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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

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dsBead 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)

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Material and Methods

• Protocol A („limited“)

- start with 500-700 µm APVA

- upsize if endpoint not reached after 6 ml

- size range: 500-1200 µm

- endpoint: limited embolization

• Protocol A („stasis“)

- start with 700-900 µm APVA

- upsize if endpoint not reached after 6 ml

- size range: 500-1200 µm

- endpoint: (near) stasis

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Data evaluation

• Quality of Life Changes (UFS-QoL®)

– changes in symptom severity score

– changes in quality of life score

• Patient satisfaction

• Re-interventions / failures

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Symptom Severity & QoL per protocol

Significant (p < 0.001) for both protocols JVIR 2008; 19:47-57

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Symptom Severity & QoL per protocol

JVIR 2008; 19:47-57 Significant (p < 0.001) for both protocols

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Imaging Results

Kroencke et al., J Vasc Interv Radiol 2008; 19:47-57

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Limitations

limited protocol

N= 13/18

N=4/13

N=6/14

stasis protocol

N=14/20

Menopausal @ 35 months

Menorrhagia:3/4

Dominant symptom

Menorrhagia:3/6

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Clinical Results

limited protocol

N=18

N=13

N=14*

stasis protocol

N=20

Available@

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-UAEN = 1 HE

Symtom Severity Score:

53 >> 19 HRQL Score

59 >> 87

Within 2Yfollow-up;

None thereafter!

* N = 3 lost to follow-up

UFS-QOL: uterine fibroid symptom and quality of life questionaire

UAE: uterine artery embolisation

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Patient Satisfaction

• Protocol A („limited“)

– very satisfied 9/13

– satisfied 3/13

– not sure -

– not satisfied 1/13

• Protocol A („stasis“)

– very satisfied 4/14

– satisfied 8/14

– not sure 1/14

– not satisfied 1/14

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Conclusion

• APVA microspheres, Bead Block®, are an effective embolic agent for UAE with favorable clinical results at 3-year follow-up

• 700-900 µm spheres and stasis as the embolisation endpoint resulted in fewer re-interventions as compared to limited embolisation with use of 500-700 µm spheres