Table 13B:
Retreatment After MRgHIFU With Complete or Near-Complete Ablation Protocols for Uterine Fibroids
| Country, Author, Year | NPV, % Mean ± SD, (range) | Follow-Up Period | Retreatment Rates, % (N/Eligible [Original Cohort] | Alternative Treatments | Comment |
|---|---|---|---|---|---|
| Australia, Dobrotwir A et al, 2012 (94) | 67 ± 25 (0–100) | 12 months | 13.7 (7/ 51) [100] | 2 HY + 4 MY + 1 UAE | Of the 51 patients due for their 12-month follow-up, 1 withdrew from the study and 7 elected not to have an MRI scan but reported no further intervention. 5 of the 7 who had additional treatments had NPV < 50%. The hysterectomies were both at 8 months, the myomectomies were at 4, 5, 8, and 11 months, and the UAE was at 12 months after HIFU. |
| Japan, Kobe, Funaki K et al, 2009 (73) | 39 ± 24 (0–91) | 12 months 24 months | 3.8 (12/ 65) 11.1 (5/45) [91] | 1 HY + 5 MY + 1TR + 5 rHIFU | 12 patients underwent additional treatments: 2 within 12 months, 5 between 12 and 24 months, and 5 after 24 months. None of the hysterectomies were emergent. The additional treatment rate was higher for type 3 tumours (highly vascular) (2/11) compared to type 1, and for 2 less vascular tumours (12/80). 19 were lost to 12-month follow-up; 12 were lost between 12- and 24-month follow-up. |
| Japan, Tokyo, Morita Y et al, 2008 (96) | 60 ± 18 (22–100) | 12 months | 8.3 (4/48) [48] | 1 MY + 1 UAE + 2 DT | 7 women were not satisfied with treatment and 3 did not seek additional therapy; of these 3, 1 resumed pain killers, 1 continued anemia treatment, and the third was not prescribed therapy. The other 4 underwent additional treatment: 2 had surgical intervention and 2 underwent drug therapy involving GnRHa until onset of natural menopause. |
| Japan, Osaka, Mikami K et al, 2008 (90) | 47 (25–72) | 12 months | 50 (16/32) [48] | NR | 32 of the 48 were evaluated as technical success and, at 6-month follow-up, all 32 women were followed. Alternative treatments (hysterectomy, myomectomy, or UAE) were recommended for 16 women not having symptom relief. |
| United States, Mayo Clinic, Gorny K et al, 2011, 2014 (97;115) | 45 ± 23 (0–100) | 12 months | 5.9 (8/136) [150] | 7 HY + 1 EA | 14 of the original 150 women completing treatment denied use of their data for research. Treatment was not completed in 6 patients and completed in 130 patients: 71 women in 1 session, 59 women in 2 sessions on consecutive days. 8 patients had additional treatments within 12 months, and 3 had surgeries for other indications: hysterectomy during ovarian cyst surgery, myomectomy during surgery for a pancreatic tumour, and hysterectomy when Pap test was unsuccessful. Cumulative additional treatment rates were estimated with Kaplan-Meir analysis and were 0% at 6 months, 2.6% at 9 months, and 7.4% at 12 months. |
| United States, LeBlang S et al, 2010 (43) | 55 ± 25 | 12 months | 10 (8/80) [80] | 8 HY | HIFU was performed in more than 1 session for 20 of the 80 women: 2 sessions for 18 women, 3 sessions for 1 woman, and 4 sessions for 1 woman. The NPV ratio was < 15% for 6 of the women having hysterectomy. 1 woman underwent surgery for bladder prolapse and had a concurrent hysterectomy. Among the 49 women having an NPV > 50%, only 1 needed a hysterectomy for inadequate symptom relief. |
Abbreviations: DT, drug therapy; EA, endometrial ablation; GnRHa; gonadotropin-releasing hormone analogue; HY, hysterectomy; MRgHIFU, magnetic resonance–guided high-intensity focused ultrasound; MY, myomectomy; NPV, non-perfused volume; NR, not reported; rHIFU, repeat high-intensity focused ultrasound; SD, standard deviation; UAE, uterine artery embolization.