Table 9B:
Adverse Events Reported in Clinical Studies of MRgHIFU With Complete or Near-Complete Ablation Protocols for Uterine Fibroids
| Country, Author, Year | Study Size, Follow-Up | NPV, % Mean ± SD, (range) | Minor Complications | Major Complications |
|---|---|---|---|---|
| Australia, Dobrotwir A et al, 2012 (94) | 100 women 2 years | 67 ± 25 (0–100) | N (unspecified) Pain 1 to 2 weeks following HIFU, minor vaginal bleeding or spotting | None reported (no overnight admissions required) |
| Germany, Trumm C et al, 2013 (91) | 115 women 6 months | 88 ± 15 (38–100) | N = 2 First-degree skin burn, skin erythema and blistering, with 4,600 joules, well under 7,100 joules maximum limit (n = 2) | None reported |
| India, Desai S et al, 2012 (95) | 50 women 6 months | 88 ± 6 | N = 14 Leg pain (n = 10, 9 resolving and 1 unresolved at 6 month follow-up), urinary tract infection (n = 1), urine retention (n = 1), skin blister (n = 1), abdominal pain (n = 1) | None reported |
| India, Himabindu Y et al, 2014 (105) | 32 women 6 months | 70 | N = 5 Blisters in abdominal wall subsiding within a week (n = 1), leukorrhea (vaginal discharge) subsiding within 2 weeks (n = 4) | None reported |
| Korea, Park MJ et al, 2014 (82) | 79 women 3 months | 63 ± 26 (1–100) | N = 45 Non-target ablation as indicated by abnormally increased contrast enhancement of abdominal wall muscle or subcutaneous fat layer (n = 9), abnormal vaginal discharge and abdominal bloating (n = 2), nausea lasting for < 1 hour (n = 1), mild pelvic pain resolving within 3 days (n = 19), constitutional symptoms (low-grade fevers, chills and/or malaise) regarded as post-ablation syndrome (n = 12), first-degree skin burns (n = 2), Foley catheterization-related cystitis (n = 1) | N = 1 Sciatic nerve-related leg numbness resolving within 30 days |
| Korea, Kim Y-S et al, 2014 (88) | 71 women 3 months | 68 ± 26 (2–100) | N = 7 Abdominal wall thermal injury (n = 5), cystitis (n = 1), transient gross hematuria (n = 1) | N = 1 Second-degree burn in right inguinal area |
| Japan, Okada A et al, 2009 (106) | 144 women (early protocol) | 39 ± 24 (1–91) | N = 55 Abdominal pain (n = 17), lower back or leg pain (n = 9), vaginal discharge or bleeding (n = 12), fever (n = 7), skin burns (n = 10) | None reported |
| 143 women (later protocol) | 54 ± 19 (4–100) | N = 49 Abdominal pain (n = 16), lower back or leg pain (n = 11), vaginal discharge or bleeding (n = 11), fever (n = 9), skin burns (n = 2) | None reported | |
| Japan, Tokyo, Morita Y et al, 2008 (96) | 48 women 12 months | 60 ± 18 (22–100) | N = 8 Skin redness (n = 4), transient sciatica neuralgia related to underlying disc herniation at L4-L5 and L5-S1 resolving within a month (n = 1), procedural pain (n = 3) | None reported |
| Japan, Osaka, Mikami K et al, 2008 (90) | 48 women 12 months | 47 (25–72) | N = 6 Skin burns: first-degree (n=3), second-degree (n = 3) | None reported |
| United States, Mayo Clinic, Gorny K et al, 2011 (97) | 150 women 12 months | 45 ± 23 (0–100) | N = 22 (17 women) Edema in various regions in 11 women (mild abdominal edema [n = 11], subcutaneous fat edema [n = 8], subcutaneous and abdominal muscle edema [n = 2], subcutaneous fat edema and skin erythema [n = 1]), lower back discomfort (n = 5) with 3 reporting pain and 2 reporting sciatica involving numbness and temporary decrease in strength | N = 1 DVT treated with anti-coagulation therapy |
| United States, University Imaging-Guidance Center, Florida, LeBlang S et al, 2010 (43) | 80 women 6 months | 55 ± 25 | N = 3 First-degree skin burns (n = 2), mild sciatica (n = 1), all resolving within 6 weeks | N = 1 Endometritis and yeast infection 6 weeks following HIFU, managed by hysterectomy |
Abbreviations: DVT, deep venous thrombosis; HIFU, high-intensity focused ultrasound; MRgHIFU, magnetic resonance–guided high-intensity focused ultrasound; NPV, non-perfused volume; SD, standard deviation.