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2015 ; 15
(4
): 1-86
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gab.com Text
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Magnetic Resonance-Guided High-Intensity Focused Ultrasound (MRgHIFU) Treatment
of Symptomatic Uterine Fibroids: An Evidence-Based Analysis
#MMPMID26357530
Pron G
Ont Health Technol Assess Ser
2015[]; 15
(4
): 1-86
PMID26357530
show ga
BACKGROUND: Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU)
is a noninvasive uterine-preserving treatment alternative to hysterectomy for
women with symptomatic uterine leiomyomas (fibroids). Uterine fibroids commonly
occur, have a broad impact on women's health and lifestyle, continue to be the
main indication for hysterectomy, and represent a costly public health burden.
OBJECTIVES: The objectives of the analysis were to evaluate patients' eligibility
for MRgHIFU treatment of symptomatic uterine fibroids and the technical success,
safety, effectiveness, and durability of this treatment. The review also compared
the safety and effectiveness of MRgHIFU with other minimally invasive
uterine-preserving treatments and surgeries for uterine fibroids. METHODS: A
literature search was performed on March 27, 2014, using Ovid MEDLINE, Ovid
MEDLINE In-Process and Other Non-Indexed Citations, Ovid EMBASE, EBSCO Cumulative
Index to Nursing & Allied Health Literature (CINAHL), and EBM Reviews, for
studies published from January 1, 2000, to March 27, 2014. RESULTS: The evidence
review identified 2 systematic reviews, 2 RCTs, 45 cohort study reports, and 19
case reports involving HIFU treatment of symptomatic uterine fibroids.
Eligibility for MRgHIFU treatment was variable, ranging from 14% to 74%. In
clinical cohort studies involving 1,594 patients, 26 major complications (1.6%)
were reported. MRgHIFU resulted in statistically and clinically significant
reductions in fibroid-related symptoms in studies conducted in 10 countries,
although few involved follow-up longer than 1 year. Retreatment rates following
MRgHIFU were higher in early clinical studies involving regulated restrictions in
the extent of fibroid ablation than in later reports involving near-complete
ablation. Emergent interventions, however, were rare. Although a desire for
fertility was an exclusion criteria for treatment, spontaneous term pregnancies
did occur following HIFU. There were no randomized trials comparing MRgHIFU and
other guidance methods, other minimally invasive treatments, or surgeries for
symptomatic uterine fibroids. Limitations with MRgHIFU included restricted
eligibility, requirement for a dedicated MR device to guide the treatment,
lengthy procedure time, and loss of MR opportunity time. CONCLUSIONS: For women
failing medical therapy and seeking alternatives to hysterectomy for symptomatic
uterine fibroids, MRgHIFU provides a safe and effective, noninvasive,
uterine-preserving treatment from which they rapidly recover. The treatment
advantages of MRgHIFU are potentially offset by restrictive eligibility, lengthy
procedure time, and dependence on availability of an MR device. The lack of
comparative evidence between MRgHIFU and other, more established
uterine-preserving treatments limits informed decision making among treatment
options.