FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery

Laughlin-Tommaso, Shannon K.; Barnard, Emily P.; Abdelmagied, Ahmed M.; Vaughan, Lisa E.; Weaver, Amy L.; Hesley, Gina K.; Woodrum, David A.; Jacoby, Vanessa L.; Kohi, Maureen P.; Price, Thomas M.; Nieves, Angel; Miller, Michael J.; Borah, Bijan J.; Moriarty, James P.; Gorny, Krzysztof R.; Leppert, Phyllis C.; Severson, Amanda L.; Lemens, Maureen A.; Stewart, Elizabeth A.

doi:10.1016/j.ajog.2018.10.032

Cited by 65 publications

(41 citation statements)

References 30 publications

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“…The number of patients desiring pregnancy in this study was too small to determine the pregnancy rate, because a desire for future childbearing was an exclusion criterion until 2013 [18]. However, similar to previous cohort studies, the pregnancy outcomes after MR-HIFU treatment in this study were reassuring [34], contrary to UAE, which can compromise ovarian reserve, and thereby fertility, as suggested by the significantly decrease in anti-Mullerian hormone levels compared to HIFU in the FIRSTT study [31]. Moreover, MR-HIFU also has the benefit of no waiting period before attempting to conceive.…”

Section: Discussionsupporting

confidence: 68%

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The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy

et al. 2020

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Objectives Since 2004, uterine fibroids have been treated with MR-HIFU, but there are persevering doubts on long-term efficacy to date. In the Focused Ultrasound Myoma Outcome Study (FUMOS), we evaluated long-term outcomes after MR-HIFU therapy, primarily to assess the reintervention rate. Methods Data was retrospectively collected from 123 patients treated with MR-HIFU at our hospital from 2010 to 2017. Followup duration and baseline (MRI) characteristics were retrieved from medical records. Treatment failures, adverse events, and the nonperfused volume percentage (NPV%) were determined. Patients received a questionnaire about reinterventions, recovery time, satisfaction, and pregnancy outcomes. Restrictive treatment protocols were compared with unrestrictive (aiming for complete ablation) treatments. Subgroups were analyzed based on the achieved NPV < 50 or ≥ 50%. Results Treatment failures occurred in 12.1% and the number of adverse events was 13.7%. Implementation of an unrestrictive treatment protocol significantly (p = 0.006) increased the mean NPV% from 37.4% [24.3-53.0] to 57.4% [33.5-76.5]. At 63.5 ± 29.0 months follow-up, the overall reintervention rate was 33.3% (n = 87). All reinterventions were performed within 34 months follow-up, but within 21 months in the unrestrictive group. The reintervention rate significantly (p = 0.002) decreased from 48.8% in the restrictive group (n = 43; follow-up 87.5 ± 7.3 months) to 18.2% in the unrestrictive group (n = 44; follow-up 40.0 ± 22.1 months). The median recovery time was 2.0 [1.0-7.0] days. Treatment satisfaction rate was 72.4% and 4/11 women completed family planning after MR-HIFU. Conclusions The unrestrictive treatment protocol significantly increased the NPV%. Unrestrictive MR-HIFU treatments led to acceptable reintervention rates comparable to other reimbursed uterine-sparing treatments, and no reinterventions were reported beyond 21 months follow-up.

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Section: Discussionsupporting

confidence: 68%

“…Two studies compared MR-HIFU to UAE [17,31], and they reported lower reintervention rates and greater improvement in symptoms after UAE. However, the mean NPV% in both trials was below 50% [32].…”

Section: Discussionmentioning

confidence: 99%

The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy

et al. 2020

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“…The incidence of minor complications of patients receiving HIFU was lower than that of patients underwent surgery within 1 year after treatment with no significant difference (Table 4). The inconsistency was due to the conflicts between (12)(13)(14)22), the incidence of minor complications of patients in the HIFU group (OR =1.91, 95% CI: 0.75, 4.83, P>0.05) could be higher than that of patients in the UAE group within 1 year after treatment, which was in conflict with the results of the network metaanalysis. Thus, it could not be concluded that there was difference among the three treatment methods.…”

Section: Minor Complicationsmentioning

confidence: 81%

“…After initial search, 2,210 articles were collected and 11 studies [22 articles (12-33)] were finally included following the process of selection. Except for one prospective cohort study (15) and one comprehensive study (12)(13)(14)22) covering RCTs and prospective cohort study, nine other studies remained RCTs, which included one doctoral dissertation (28). Eleven studies were eligible for metaanalysis regarding the inclusion and exclusion criteria, in which a total of 3,646 patients were evaluated.…”

Section: Process and Results Of Literature Selectionmentioning

confidence: 99%

“…The further intervention rate within 1 year after treatment was mentioned in eight studies (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(29)(30)(31), and the total cases of further interventions for UAE, surgery and HIFU were 111 (22.3%), 30 (18.7%), 27 (17.5%). A high heterogeneity was observed in the UAE group and the surgery group through heterogeneity analysis (P=0.068, I 2 =51.2%).…”

Section: Further Intervention Rate After Treatmentmentioning

confidence: 99%

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Uterine artery embolization, surgery and high intensity focused ultrasound in the treatment of uterine fibroids: a network meta-analysis

Gao

Li²,

et al. 2021

Quant Imaging Med Surg

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Background: To systematic review the safety and effectiveness between uterine artery embolization (UAE), surgery and high intensity focused ultrasound (HIFU) in the treatment of uterine fibroids. Methods:The PubMed, EMbase, The Cochrane Library, Web of Science, Wanfang Data, and CNKI were electronically searched to collect relevant studies on comparing the safety and effectiveness of UAE, surgery and HIFU in the treatment of uterine fibroids from January 2000 to August 2019. After two reviewers independently screened the literature, extracted the data and evaluated the risk of bias of included studies, network meta-analysis was performed by ADDIS 1.16.8 and Stata 14 software.Results: A total of 11 studies (22 articles) involving 3,646 patients were included. Compared with surgery, UAE and HIFU patients had higher quality of life (1-year follow-up) improvement, and UAE was higher than HIFU. Network meta-analysis show that patients treated with HIFU had the lowest incidence of major complications within 1 year, followed by UAE, and the highest surgery. Patients treated with HIFU and UAE have shorter hospital stays and quicker recovery time than surgery. The rate of further intervention after surgery treatment might be lower than that of UAE and HIFU.Conclusions: UAE has the highest quality of life improvement (1-year follow-up) for uterine fibroids.HIFU and UAE are safer with shorter hospital stays and quicker recovery time compared with surgery. However, both UAE and HIFU have the risks of re-treatment. However, limited by the number and quality of included studies, the above conclusions need to be verified through more high-quality studies.

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The Role of Transvaginal Two‐Dimensional Ultrasound Combined With Color Doppler in the Evaluation of Ovarian Function and Fertility After Uterine Artery Embolization

Shi¹,

Ge²,

et al. 2021

J of Ultrasound Medicine

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Objective Our study seeks to assess the value of transvaginal two‐dimensional ultrasound combined with color Doppler in evaluating ovarian function and reproductive function after uterine artery embolization (UAE). Methods Totally 64 cases with cesarean scar pregnancy (CSP) were collected. Their information was recorded, including baseline information, intraoperative and postoperative information, preoperative and postoperative uterine receptivity, and preoperative and postoperative levels of sex hormones in serum. Finally, the patients were followed up to observe whether they were pregnant after treatment. Results In comparison with 24 hours after UAE, decreases were found in endometrial blood flow pulsatility index (PI), endometrial thickness, ovarian artery peak end‐systolic velocity (Vs), ovarian artery resistance index (RI), and the ratio of Vs to peak end‐diastolic velocity (S/D) 1 and 3 months after embolization, while Vd increased markedly 3 months after embolization. In addition, in terms of sex hormones, a significant increase was revealed in the level of follicle‐stimulating hormone, while the reduction in the levels of luteinizing hormone (LH), estrogen (E2), prolactin (PRL), and progesterone (P) in the first month and the third month of menstrual resumption compared with those before treatment. From the follow‐up data, there were 50 cases of pregnancy, including 45 cases of intrauterine pregnancy, 2 cases of tubal pregnancy, and 3 cases of recurrent CSP. Conclusion UAE is a safe and effective method to prevent massive hemorrhage of CSP. Transvaginal two‐dimensional ultrasound combined with color Doppler can more accurately evaluate its therapeutic effect and provide a basis for effective treatment.

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FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery

Cited by 65 publications

References 30 publications

The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy

The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy

Uterine artery embolization, surgery and high intensity focused ultrasound in the treatment of uterine fibroids: a network meta-analysis

The Role of Transvaginal Two‐Dimensional Ultrasound Combined With Color Doppler in the Evaluation of Ovarian Function and Fertility After Uterine Artery Embolization

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