Laparoscopic Radiofrequency Fibroid Ablation: Phase II and Phase III Results

Abstract

Background and Objectives:To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA).Methods:We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied.Results:From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P < .001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P < .001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P = .008) (n = 58). Patients missed a median of 4 days of work (range, 2–10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1–29 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment.Conclusions:RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies

“…Lim et al 5 reported that laparoscopic Bongers et al 15 39 -23 -4.4 -3.1 -Brölmann et al 16 Garza-Leal 17 ----Braun et al 18 114 -60 6.8 -3.2 --Brucker et al 19 66 -24 10.0 -5.5 20.5 (5, 103) a 10.0 (2, 86) a Hahn et al 20 Krämer et al 21 Carrafiello et al 22 20 (15, 25) b ---Cho et al 23 -(10, 40) ---Cho et al 24 ----Chudnoff et al 25 126 -60 -9.0 (2, 60) a 5.0 (0, 29) a Galen et al 26 Guido et al 27 Berman et al 28 Chudnoff et al 29 47 -30 2. 30 Galen et al 31 140 (42, 290) a -4.5 (1, 11) b 4.0 (2, 10) a Garza-Leal et al 32 Robles et al 33 Ghezzi et al 34 25 (20, 45) a 18 c --Bergamini et al 35 Iversen and Dueholm 36 ----Iversen et al 37 Jiang et al 38 25 (20, 30) b ---Kim et al 39 18 -5 ---Lee et al 40 ----Marcos et al 41 36 -11 12.0 (8, 24) b --Meng et al 42 ----Rattray et al 43 73 -26 6.7 -3.0 -11.1 -7.6 Rey et al 44 17 (11, 44) b ---Turtulici et al 45 28 (16, 43) b ---Wu et al 46 -(20, 40) 2.5 c --…”

Nonresective treatments for uterine fibroids: a systematic review of uterine and fibroid volume reductions

“…Two papers compared two groups. Galen et al [14] presented multi-center, multi-study data of patients from pilot studies of a commercial laparoscopic RFA system. Yin et al [15] split their patient group into premenopausal and menopausal cohorts.…”

Thermal ablative treatment of uterine fibroids

“…A prospective study of 69 women following volumetric radiofrequency laparoscopic ablation of fibroids found a mean decrease in fibroid volume at 12 months of 28.7%, with one major adverse event -the development of a haematoma that resolved spontaneously post-operatively [32]. Overall, the rate of adverse events was 10%, including abdominal pain and urinary tract infections.…”

“…The initial multicentre prospective study by Stewart et al (n ¼ 155) found no deaths, life-threatening events or hysterectomies following MRgFUS [32]. There have been no recorded deaths, or hysterectomies following MRgFUS in any of the current literature.…”

“…Overall, the rate of adverse events was 10%, including abdominal pain and urinary tract infections. Four pregnancies were reported in the first 12 months following ablation; these resulted in two caesarean sections at term, one vaginal delivery at term and one 10-week miscarriage [32]. There have been no reported cases of bladder or bowel perforation following laparoscopic radiofrequency ablation; however, there has been a case of recto-uterine fistula in a patient with co-existing endometriosis [33].…”