Magnetic resonance-high intensity focused ultrasound (MR-HIFU) therapy of symptomatic uterine fibroids with unrestrictive treatment protocols: A systematic review and meta-analysis

Verpalen, Inez M; Anneveldt, Kimberley J.; Nijholt, Ingrid M.; Schutte, Joke M.; Dijkstra, Jeroen R.; Franx, Arie; Bartels, Lambertus W.; Moonen, Chrit; Edens, Mireille A.; Boomsma, Martijn F.

doi:10.1016/j.ejrad.2019.108700

Cited by 72 publications

(54 citation statements)

References 47 publications

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“…Unfortunately, many patients in our department did not have MRI or ultrasonography imagings to evaluate the volume changes of the treated fibroids, so we could not show the volume reduction of the fibroids one year after HIFU treatment. Previous studies [13] have demonstrated that the NPV ratio of fibroids is closely related to long-term symptom relief. Zou et al [2] presented an 83.5% NPV ratio average; at 6 months after treatment, the rate of volume reduction of the fibroids exceeded 50% in 84% patients.…”

Section: Discussionmentioning

confidence: 94%

A comparative analysis of pregnancy outcomes of patients with uterine fibroids after high intensity focused ultrasound ablation and laparoscopic myomectomy: a retrospective study

Jiang

et al. 2021

International Journal of Hyperthermia

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Purpose: The aim of this study was to retrospectively compare and analyze pregnancy outcomes of patients with uterine fibroids after high intensity focused ultrasound (HIFU) ablation and laparoscopic myomectomy (LM). Materials and methods: The study group consisted of 346 patients with uterine fibroids who wished to conceive, in which 152 patients received HIFU ablation treatment (HIFU group) and 194 patients received LM treatment (LM group). The parents' baseline characters were recorded and the pregnancy outcomes were evaluated in a median follow-up time of 42 months (range: 16 81) after the treatment, and the differences of the two groups were compared. Results: Patients with uterine fibroids in HIFU group had a significant shorter pregnancy interval than that in LM group (10 months VS. 13 months, p < .05). No significant differences were observed in pregnancy rate, miscarriage rate, live birth rate, natural pregnancy rate, cesarean section rate, and perinatal complications rate between the HIFU group and the LM group (p > .05). When stratified by age, infertility history, fibroid types, fibroid numbers, and fibroid sizes, there was no statistically significant difference in pregnancy rate between the HIFU group and the LM group (p > .05). Conclusions: Based on the results from this study, both HIFU and LM can be safely used to treat patients who wish to conceive. The pregnancy outcomes of post-HIFU are similar to that of post-LM.

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Section: Discussionmentioning

confidence: 94%

A comparative analysis of pregnancy outcomes of patients with uterine fibroids after high intensity focused ultrasound ablation and laparoscopic myomectomy: a retrospective study

Jiang

et al. 2021

International Journal of Hyperthermia

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“…1), e.g., the nonperfused volume (NPV). A higher NPV% results in greater fibroid shrinkage, improved relief of symptoms, and lower retreatment rates [12][13][14]. Technological improvements and treatment protocol modifications are nowadays leading to increased NPV% [15,16].…”

Section: Introductionmentioning

confidence: 99%

“…Technological improvements and treatment protocol modifications are nowadays leading to increased NPV% [15,16]. Importantly, data beyond 24 months follow-up of MR-HIFU treatments with protocols aiming for complete fibroid ablation is scarce [14].…”

Section: Introductionmentioning

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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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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“…After implementing our 3-step modified manipulation protocol, the location of the uterine fibroid on screening MR images was no longer a reason for ineligibility which drastically improved our eligibility percentage. An eligibility percentage of 75% is one of the highest reported to date [1,2]. Although Zaher et al reported that 74% of the patients in their study was suitable for MR-HIFU, patients in their study with large or multiple fibroids were not excluded and 38% required two MR-HIFU sessions [7].…”

Section: Discussionmentioning

confidence: 98%

“…Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) has been a treatment option for uterine fibroids since 2004. MR-HIFU has been proven to be safe and effective in reducing fibroid-related symptoms and fibroid size [1,2]. Although the treatment has emerged as the only non-invasive interventional therapy, MR-HIFU has not been widely adopted into regular care up to now.…”

Section: Introductionmentioning

confidence: 99%

Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids

et al. 2020

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Objectives The clinical applicability of magnetic resonance image−guided high-intensity focused ultrasound (MR-HIFU) treatment of uterine fibroids is often limited due to inaccessible fibroids or bowel interference. The aim of this study was to implement a newly developed 3-step modified manipulation protocol and to evaluate its influence on the number of eligible women and treatment failure rate. Methods From June 2016 to June 2018, 165 women underwent a screening MRI examination, 67 women of whom were consecutively treated with MR-HIFU at our institution. Group 1 (n = 20) was treated with the BRB manipulation protocol which consisted of sequential applications of urinary bladder filling, rectal filling, and urinary bladder emptying. Group 2 (n = 47) was treated using the 3-step modified manipulation protocol which included (1) the BRB maneuver with adjusted rectal filling by adding psyllium fibers to the solution; (2) Trendelenburg position combined with bowel massage; (3) the manual uterine manipulation (MUM) method for uterine repositioning. A comparison was made between the two manipulation protocols to evaluate differences in safety, the eligibility percentage, and treatment failure rate due to unsuccessful manipulation. Results After implementing the 3-step modified manipulation protocol, our ineligibility rate due to bowel interference or inaccessible fibroids decreased from 18% (16/88) to 0% (0/77). Our treatment failure rate due to unsuccessful manipulation decreased from 20% (4/20) to 2% (1/47). There were no thermal complications to the bowel or uterus. Conclusions Implementation of the 3-step modified manipulation protocol during MR-HIFU therapy of uterine fibroids improved the eligibility percentage and reduced the treatment failure rate. Trial registration Registry number NL56182.075.16 Key Points • A newly developed 3-step modified manipulation protocol was successfully implemented without the occurrence of thermal complication to the bowel or uterus. • The 3-step modified manipulation protocol increased our eligibility percentage for MR-HIFU treatment of uterine fibroids. • The 3-step modified manipulation protocol reduced our treatment failure rate for MR-HIFU treatment of uterine fibroids.

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Magnetic resonance-high intensity focused ultrasound (MR-HIFU) therapy of symptomatic uterine fibroids with unrestrictive treatment protocols: A systematic review and meta-analysis

Cited by 72 publications

References 47 publications

A comparative analysis of pregnancy outcomes of patients with uterine fibroids after high intensity focused ultrasound ablation and laparoscopic myomectomy: a retrospective study

A comparative analysis of pregnancy outcomes of patients with uterine fibroids after high intensity focused ultrasound ablation and laparoscopic myomectomy: a retrospective study

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

Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids

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