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Table 3 Treatment results and follow-up data

From: Lessons learned during implementation of MR-guided High-Intensity Focused Ultrasound treatment of uterine fibroids

Treatment outcomes

N (%), median [range]

NPV% directly after treatment

66.5% [0–120.6]

 First 25 treatments: 21 fibroids

44.6% [0–99.7]*

 Remaining treatments: 81 fibroids

74.7% [0–120.6]**

Adverse events per woman

 

 Grade 1 adverse event on treatment day

17/70 (24.2%) pain/nausea

 Grade 3b adverse event on treatment day

1/70 (1.4%) 3th degree skin burn

 Grade 1 adverse event follow-up

22/70 (31.4%) pain/ bleeding

 Grade 2 adverse event follow-up

2/70 (2.9%) urinary tract infection

 Adverse events needing treatment

3/70 (4.3%) antibiotics/operation

Volume decrease in fibroids with an available MRI scan at 6-month follow-up

42.4% [− 173.2 to 100]

 First 25 treatments: 14 fibroids

31.7% [7.1–62.2]

 Remaining treatments: 70 fibroids

48.3% [− 173.2 to 100]

Reintervention rate per woman

19/70 (27.1%)

 Hysterectomy

10/19 (52.6%)

 Myosure

2/19 (10.5%)

 UAE

4/19 (21.1%)

 MR-HIFU

4/19 (21.1%)

 First 22 women

10/22 (45.5%)

Remaining 48 women

9/48 (18.8%)

Moment of reintervention

8 months [1–27]

Follow-up duration

24 months [14–44]

Failure of treatment

19/76 (25.0%)

 First 25 treatments

12/25 (48.0%)

Remaining 48 treatments

7/51 (13.7%)

Kind of failures

 

 Treatment

13/19 (68.4%)

 Heating

6/19 (31.6%)

  1. *p =  < 0.05 between the first 25 and remaining 51 treatments
  2. **An NPV% of > 100% could be found when the measured NPV volume exceeded the measured volume of the fibroid at screening MRI scan. This could be caused by either fibroid growth, measurement accuracies or increase in the fibroid directly after treatment due to treatment effect