Table 6:
Technical Success of MRgHIFU Treatment for Uterine Fibroids
| Country, Institute, Author, Year | NPV, % Mean ± SD,(range) | Mitigation Strategies | Technical Success, % (n) | Reasons for Technical Failure |
|---|---|---|---|---|
| Restricted Ablation Protocols | ||||
| Israel, Sheba Medical Center, Machtinger R et al, 2012 (92) | 41 ± 21 (10–100) | None reported | 92 (80/87) | Bowel obstructing sonications (n = 2); patient discomfort (n = 2); menopausal: treated but excluded (n = 1) |
| Israel, Sheba Medical Center, Rabinovici J et al, 2007 (87) | 31 ± 23 (2–92) | None reported | 89 (31/35) | Early cessation of treatment (n = 4) |
| Korea, Samsung Medical Center, Park MJ et al, 2013 (89) | 57 ± 26 (0.6–100) | Bladder filling (saline) to avoid scars or small bowel loops (n = 7), bladder and rectal filling (ultrasound gel) to move small bowel loops out of sonication field (n = 1) | 98 (42/43) | Early cessation due to unexpected and severe pelvic pain (n = 1) |
| Netherlands, University Medical Center Utrecht, Voogt M et al, 2012 (42) | 22 (0–66) | None reported | 94 (31/33) | Insufficient heating of fibroid and underwent UAE within 1 week (n=1); underwent surgical removal of fibroid for unknown reason (n = 1) |
| United States, Mayo Clinic, Hesley G et al, 2006 (93) | NR | None reported | 95 (40/42) | Inadequate number of sonications due to discomfort (n=2) |
| Multinational, 5 sites (United States, Germany, United Kingdom, Israel), Stewart E et al, 2003 (84) | 25 | None reported | 76 (42/55) | Presence of bowel in sonication pathway (n=3); less energy delivered than intended, due to inability to visualize the low energy test pulse, resulting in no sonication (related to tissue aberrations of abdominal wall such as surgical scars or inhomogeneous fat and muscle deposition in abdominal wall) (n = 10) |
| Near-Complete Ablation Protocols | ||||
| Australia, Royal Women's Hospital, Dobrotwir A and Pun E, 2012 (94) | 67 ± 25 (0–100) | Patients pretreated with GnRHa (n = 7) | 100 (100/100) | No failures |
| Germany, Klinikum der Ludwig-Maximilians, Trumm C et al, 2013 (91) | 88 ± 15 (38–100) | Patient positioning: rectal filling (ultrasound gel) (n = 64), temporary filling of bladder (sterile water) (n = 51), or both (n = 48), scar patch or tilting transducer to avoid abdominal scars | 93 (115/123) | Bowel in beam pathway (could not be mitigated by modifying the transducer or patient positioning either by bladder and/or rectal filling (n = 6); continuous patient movement (n = 1); system malfunction (n = 1) |
| India, Jaslok Hospital and Research Center, Desai S et al, 2012 (95) | 88 ± 6 | None used; patients with bowel in beam excluded | 100 (50/50) | No failures, excluded risk cases; noted that 20 patients had a second treatment and 1 patient had 3 treatments. |
| Korea, Samsung Medical Center, Kim YS et al, 2014 (88) | 68 ± 26 | Prior GnRHa administration (n = 6), bladder filling (n = 15), rectal filling (n = 14), or both bladder and rectal filling | 94 (67/71) | Inability to achieve high temperature even with highest acoustic power (n = 3); complication (n = 1) |
| Japan, Tokyo, Itabashi Chuo Medical Center, Morita Y et al, 2008 (96) | 60 ± 18 (22–100) | None reported | 100 (48/48) | Required a second procedure because of large fibroids (n = 5) |
| Japan, Osaka, Osaka Kinki University School of Medicine Mikami K et al, 2008 (90) | 47 (25–72) | None reported | 67 (32/48) | Incomplete ablation due to severe pain during sonication (n = 16) |
| United States, Mayo Clinic, Gorny K et al, 2011 (97) | 45 ± 23 (0–100) | None reported | 96 (130/136) | 6 failures: 3 failed in the first procedure (incomplete due to pain) and 3 failed in the second treatment (could not tolerate another 3-hour prone position); 59 patients had 2 sessions on consecutive days |
Abbreviations: GnRHa, gonadotropin-releasing hormone analogue; MRgHIFU, magnetic resonance–guided high-intensity focused ultrasound; NPV, non-perfused volume; UAE, uterine artery embolization.