Medical Policy

Policy Num:       04.001.009
Policy Name:     Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids
Policy ID:           [04.001.009]  [Ac / B / M+ / P-]  [4.01.19]

Last Review:       March 19, 2025
Next Review:      March 20, 2026
 

Related Policies: 

07.001.166 - Uterus Transplantation for Absolute Uterine Factor Infertility
07.001.096 - Magnetic Resonance-Guided Focused Ultrasound

Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids

Summary

Description

Various minimally invasive treatments for uterine fibroids have been proposed as alternatives to surgery. Among these approaches are laparoscopic ,percutaneous, and transcervical techniques to induce myolysis, which includes radiofrequency ablation (RFA), laser and bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation.

Summary of Evidence

For individuals who have symptomatic uterine fibroids who receive RFA, the evidence includes prospective cohorts, RCTs, and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The meta-analysis found low rates of reintervention with RFA and quality of life outcomes that were similar to uterine artery embolization and myomectomy at 12 months. Data on reintervention rates at 36 months were limited to 1 RCT and 1 cohort study with high loss to follow-up. No studies reported reintervention rates at 60 months. Two RCTs found that RFA was noninferior to laparoscopic myomectomy on the primary outcome: length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months in 1 RCT, including symptoms and quality of life. None of the secondary outcomes demonstrated significant between-group differences in a subgroup analysis of 43 patients. The procedure has faster recovery than myomectomy, and provides a reduction in symptoms and improvement in quality of life in the short term. Recurrence and reintervention rates at longer follow-up are unknown. Well-designed comparative trials with longer follow-up are needed to determine the effect of RFA on health outcomes compared with other treatment options such as myomectomy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptomatic uterine fibroids who receive laser or bipolar needles, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The case series were published in the 1990s, and the procedures used then may not reflect current practice. RCTs comparing laser or bipolar needles with alternative treatments for uterine fibroids are needed to evaluate the safety and efficacy of this technology adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptomatic uterine fibroids who receive cryomyolysis, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. Among the few case series, sample sizes were small (≤20 patients). RCTs comparing cryomyolysis with alternative treatments for uterine fibroids are needed to evaluate the safety and efficacy of this technology adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptomatic uterine fibroids who receive magnetic resonance imaging-guided laser ablation, the evidence includes a study with historical controls. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. A single study with historical controls is not sufficiently robust to evaluate this technology. RCTs comparing magnetic resonance imaging-guided laser ablation with alternative treatments for uterine fibroids are needed to evaluate safety and efficacy adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

2021 Input

Clinical input was sought to help determine whether the use of laparoscopic or RFA for individuals with symptomatic uterine fibroids would provide a clinically meaningful improvement in the net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input on the use of RFA was received from 3 respondents: 1 society-level response including input from physicians affiliated with academic medical centers and 2 physician-level responses with academic affiliations.

For individuals with symptomatic uterine fibroids, clinical input provides consistent support that the use of laparoscopic or transcervical RFA provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

Based on the evidence and independent clinical input, the clinical input supports that the following indication provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

Women 18 and older when ALL of the following conditions are met:

• Evidence of uterine fibroids via ultrasound that are less than 10 cm in diameter for laparoscopic RFA with Acessa or 7 cm for transcervical RFA with Sonata; AND

• Patient desires a uterine-sparing treatment approach or is ineligible for hysterectomy or other uterine-sparing alternatives to RFA (e.g., laparoscopic myomectomy, uterine artery embolization [UAE]); AND

• Patient has experienced at least 1 of the following symptoms that are a direct result of the fibroid(s):

  • Menorrhagia or other abnormal uterine bleeding that interferes with daily activities or causes anemia;

  • Pelvic pain or pressure;

  • Urinary symptoms (e.g., urinary frequency, urgency) related to bulk compression of the bladder;

  • Gastrointestinal symptoms related to bulk compression of the bowel (e.g., constipation, bloating);

  • Dyspareunia (painful or difficult sexual relations).

Respondents noted that choice of laparoscopic versus transcervical RFA treatment is dependent on fibroid number, type and location, and patient preferences. For example, predominantly lower uterine segment or cervical leiomyomata, or those with a predominant submucosal location or intramural International Federation of Gynecology and Obstetrics (FIGO) type 2 or 3 fibroids (see Table PG1), may suggest a transcervical approach, whereas fibroids with largely fundal or extramural components may suggest a laparoscopic approach.

Further details from clinical input are included in the Appendix.

Objective

The objective of this evidence review is to determine whether laparoscopic, percutaneous, and/or transcervical techniques to induce myolysis improve the net health outcome in individuals with uterine fibroids.

Policy Statements

Laparoscopic or transcervical radiofrequency ablation (RFA) as a treatment of symptomatic uterine fibroids is considered medically necessary in women 18 years and older when ALL of the following conditions are met:

• Evidence of uterine fibroids via ultrasound that are less than 10 cm in diameter for laparoscopic RFA with Acessa or 7 cm for transcervical RFA with Sonata; AND

• Patient desires a uterine-sparing treatment approach or is ineligible for hysterectomy or other uterine-sparing alternatives to RFA (e.g., laparoscopic myomectomy, uterine artery embolization [UAE]) (see Policy Guidelines); AND

• Patient has experienced at least 1 of the following symptoms that are a direct result of the fibroid(s):

  • Menorrhagia or other abnormal uterine bleeding that interferes with daily activities or causes anemia (see Policy Guidelines);

  • Pelvic pain or pressure;

  • Urinary symptoms (e.g., urinary frequency, urgency) related to bulk compression of the bladder;

  • Gastrointestinal symptoms related to bulk compression of the bowel (e.g., constipation, bloating);

  • Dyspareunia (painful or difficult sexual relations).

Other laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids, including use of laser or bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation, are considered investigational.

Policy Guidelines

Eligibility Considerations

Abnormal uterine bleeding refers to uterine bleeding of abnormal frequency, duration, and volume that interferes with a patient’s quality of life. Patients with abnormal uterine bleeding with an inadequate response to appropriately selected medical therapy may be considered for alternate uterine-sparing interventions. In patients >45 years of age with menorrhagia or other abnormal bleeding, endometrial biopsy is recommended prior to treatment to rule out endometrial malignancy and/or additional assessment to rule out a risk for uterine leiomyosarcoma.

Clinical trial experience with radiofrequency ablation (RFA) has been limited to patients with overall uterine size ≤16 gestational weeks size based on pelvic examination. In patients where fibroids cannot be distinguished from adenomyosis on ultrasound, advanced imaging (e.g., magnetic resonance imaging [MRI]) may be required. For patients with pelvic pain, alternative causes such as endometritis and active pelvic inflammatory disease should be excluded prior to treatment with RFA.

Treatment Approach Considerations for Radiofrequency Ablation

Uterine fibroids are categorized according to the International Federation of Gynaecology and Obstetrics (FIGO) leiomyoma subclassification system (see Table PG1). Choice of laparoscopic versus transcervical RFA treatment is dependent on fibroid number, size, type and location, and patient preferences. For example, predominantly lower uterine segment or cervical leiomyomata, or those with a predominant submucosal location or intramural FIGO type 2 or 3 fibroids, may suggest a transcervical approach, whereas fibroids with largely fundal or extramural components may suggest a laparoscopic approach. Patients aiming to avoid future deliveries via obligate cesarean section may prefer a transcervical approach. Select women with numerous fibroids may benefit from combined laparoscopic RFA and laparoscopic myomectomy. Patients with intramural fibroids, intra-abdominal adhesions, or medical contraindications may not be candidates for alternative uterine-sparing interventions.

Table PG1. FIGO Leiomyoma Subclassification System

    FIGO: International Federation of Gynaecology and Obstetrics. Table adapted from Gomez et al (2021). MRI-based pictorial review of the FIGO classification system for uterine fibroids. Abdom Radiol. 46(5): 2146-2155. PMID: 33385249.

Reinterventions

Reintervention with RFA may be considered for patients meeting policy criteria with documentation of new or recurrent fibroid development following a partial response with the initial procedure. However, data on reinterventions for new or recurrent fibroids is limited and documentation procedures for repeat anatomic mapping of fibroids are not standardized.

Coding

See the Codes table for details.

In November 2014, the U.S. Food and Drug Administration published a safety communication on laparoscopic power morcellators used for myomectomy and hysterectomy in most women. (Morcellators are not otherwise addressed herein). The Administration recommended that manufacturers of these devices include in their product labels a boxed safety warning and wording on contraindications (see https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM424123.pdf).

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Some of the lysis procedures are specialized and not widely disseminated; therefore, requests for out-of-network referral may occur.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Uterine Fibroids

Uterine fibroids, also known as leiomyomas, are among the most common conditions affecting women in their reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. It is estimated that uterine fibroids occur in up to 70% of women by menopause, with approximately 25% of these being clinically significant and requiring intervention.^1, The prevalence rate of uterine fibroids is 2 to 3 times higher among Black women compared with White women, and there are higher rates of hysterectomy and myomectomy compared with non-surgical therapy, potentially demonstrating a disparity in access to uterine-sparing interventions.^2,3,

Treatment

Surgery, including hysterectomy and various myomectomy procedures, is considered the criterion standard for symptom resolution. However, there is the potential for surgical complications and, in the case of a hysterectomy, the uterus is not preserved. In addition, multiple myomectomies may be associated with longer operating time, postoperative febrile morbidity, and development of pelvic adhesions. There has been long-standing research interest in developing minimally invasive alternatives for treating uterine fibroids, including procedures that retain the uterus and permit future childbearing. Treatment options include uterine artery embolization and transcutaneous magnetic resonance imaging-guided focused ultrasound therapy (see evidence review 7.01.109). Various techniques to induce myolysis have also been studied including Nd:YAG lasers, bipolar electrodes, cryomyolysis, and radiofrequency ablation. With these techniques, an energy source is used to create areas of necrosis within uterine fibroids, reducing their volume and thus relieving symptoms. Early methods involved multiple insertions of probes into the fibroid, performed without imaging guidance. There were concerns about serosal injury and abdominopelvic adhesions with these techniques, possibly due to the multiple passes through the serosa needed to treat a single fibroid.^4, Newer systems using radiofrequency energy do not require repetitive insertions of needle electrodes. Ultrasonography is used laparoscopically or transcervically to determine the size and location of fibroids, to guide the probe, and to ensure the probe is in the correct location so that optimal energy is applied to the fibroid. Percutaneous approaches using magnetic resonance imaging guidance have also been reported.

Regulatory Status

In 2012, the Acessa™ System (Acessa Health, formerly Halt Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance (K121858). The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. In 2014, the ultrasound guidance system received marketing clearance from the FDA (K132744). FDA product code: GEI. In 2018, the third-generation Acessa™ ProVu System® was cleared for marketing by the FDA through the 510(k) process for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. (K181124). Hologic acquired Accessa Health in 2020. FDA product code: HFG.

In 2018, the Sonata® Sonography-Guided Transcervical Fibroid Ablation System (Gynesonics) was cleared for marketing by the FDA through the 510(k) process for diagnostic intrauterine imaging and transcervical radiofrequency ablation as treatment of symptomatic uterine fibroids (K173703). The Sonata System 2.1 received marketing clearance in 2020 (K193516) and the Sonata System 2.2 received marketing clearance in 2021 (K211535). The Sonata system was previously known as Vizablate. FDA product codes: KNF, ITX, and IYO.

Cryoablation is a surgical procedure that uses previously approved and available cryoablation systems; and as a surgical procedure, it is not subject to regulation by the FDA. Other products addressed in this review (eg, Nd:YAG lasers, bipolar electrodes) have long-standing FDA approval, and there are no products specifically approved for the treatment of uterine fibroids.

Rationale

This evidence review was created in July 2004 and has been updated regularly with searches of the PubMed database until it was archived in December 2009. In July 2013, the review returned to active status. The most recent literature update was performed through December 17, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 

Radiofrequency Ablation

Clinical Context and Therapy Purpose

The purpose of radiofrequency ablation (RFA) in women who have uterine fibroids is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of RFA improve the net health outcome in women with uterine fibroids?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is women with symptomatic uterine fibroids.

Interventions

The therapy being considered is laparoscopic or transcervical RFA of fibroids under ultrasonic guidance.

Comparators

The following therapies are currently being used to manage symptomatic uterine fibroids: medical management, uterine artery embolization (UAE), myomectomy, and hysterectomy. Surgery, including hysterectomy and myomectomy, is considered the criterion standard for symptom resolution. However, there is the need to recover from surgery, and in the case of a hysterectomy, the uterus is not preserved. UAE is associated with poor pregnancy outcomes and is not advised in patients who desire to become pregnant.

A retrospective cohort from claims data of over 35,000 women found that of the less invasive procedures, myomectomy had the lowest 12-month reintervention rate (4.2%), followed by UAE (7.0%), and endometrial ablation (12.4%).^5,

Outcomes

The outcomes of interest are complications, postoperative pain and recovery time, symptom resolution, fibroid regrowth or recurrence and need for reintervention at 3 to 5 years, and health-related quality of life. The symptom severity score (SSS) is a 0 to 100 scale where higher SSSs indicate more severe symptoms. The EuroQol 5-Dimension (EQ-5D) is a 0 to 100 scale where lower scores indicate worse quality of life. Reinterventions may involve retreatment with RFA or other uterine-sparing techniques or definitive treatment with hysterectomy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

• Studies identify the relevant commercially-available technology.

Review of Evidence

Systematic Reviews

A systematic review and meta-analysis by Sandberg et al (2018) evaluated the risk of reintervention and quality of life after uterine-sparing interventions for fibroids (see Tables 1 and 2).^6,Reintervention was defined as any additional treatment required at ≥1 year after initial treatment owing to symptomatic recurrence of fibroids. Reinterventions directly related to procedure complications and studies enrolling women with a prior history of fibroid interventions were excluded. Risk of reintervention at 12 months was 0.3% for laparoscopic RFA compared with 3.6% for UAE and 1.1% for myomectomy. Symptom severity and quality of life scores were similar for the 3 treatments. Only 1 RFA study was identified on reintervention risk at 36 months (10.4%)which was comparable to UAE (7.4%; 95% Confidence Interval [CI], 0.9 to 10.7%); no RFA studies were identified on reintervention risk at 60 months. At 36 months, the reintervention risk for hysterectomy varied from 0.6% (95% CI, 0 to 2.3%; I² = 60.2%; 4 studies) for myomectomy to 8.1% for laparoscopic RFA (1 study). A systematic review by Havryliuk et al (2017) that did not separate outcomes by the length of follow-up found a reintervention rate of 5.2% after RFA (4 studies, 12 to 36 mo follow-up) compared to 4.2% after myomectomy (6 studies, 12 to 52 mo follow-up).^7, There was no significant difference in complication rates between RFA (6.3%) and myomectomy (7.9%). The length of stay after myomectomy was 2 days (range 0.5 to 6.0). No data were provided on the length of stay after RFA.

Lin et al (2019) conducted a meta-analysis of improvement in symptom severity, quality of life, and reintervention after RFA.^8, The review included 1 RCT (interim analysis only with high loss to follow-up) and 7 non-comparative trials. The reintervention risk at a weighted mean follow-up of 24.65 months (range, 3 to 36 months) was 4.4% (95% CI, 1.6 to 8.45%; I²=65.0%; 7 studies). Improvements in symptoms and quality of life were maintained out to 24 months in 3 studies and out to 36 months in 1 study. No studies were identified that had follow-up longer than 36 months.

Bradley et al (2019) conducted a systematic review of 32 prospective studies on laparoscopic, transvaginal, or transcervical RFA.^9, Most were conducted outside of the U.S. with devices that are not cleared or approved by the U.S. Food and Drug Administration. The overall reintervention risk was 4.2% at 12 months, 8.2% at 24 months, and 11.5% at 36 months. Reintervention rates at 12 months did not differ significantly for the laparoscopic, transvaginal, or transcervical RFA procedures. Because many of the devices are not available in the U.S., relevance for the current review is limited.

Transcervical RFA was evaluated in a qualitative systematic review by Arnreiter and Oppelt (2021).^10, They included 10 studies that reported on myoma volume, patient-reported outcomes, surgical reinterventions, side effects, or safety during pregnancy and delivery. No RCTs were available to perform a meta-analysis. Single-arm studies (n=7, 5 prospective) and case reports (n=3) were evaluated with quality assessment tools; all the single-arm studies were considered to be of fair quality with a high risk of selection bias. Four studies reported on myoma volume, patient-reported symptoms, and reinterventions, 3 studies investigated the effect on surrounding tissue, and 3 articles were case reports on pregnancies after treatment with the transcervical system. Myoma volume, measured by contrast-enhanced magnetic resonance imaging (MRI), was reduced by an average 63.2% in total volume (n=157) and 64.5% (n=156) in perfused volume at 12 months. The symptom severity score was reduced by 55% at 12 months and similar improvement was maintained at 24 and 64 months. Health-related quality of life improved from 38.8 points before treatment to 83.3 points at 12 months (n=183). Reported re-intervention rates ranged from 0.7% to 8% at 12 months, 5.2% at 24 months, and 11.8% at 64 months after ablation, but loss to follow-up was high limiting confidence in these results. Reporting of adverse events was incomplete; of 227 patients, 47.6% of patients experienced adverse events. Although most adverse events were mild, 4 patients required inpatient treatment. There was no reported evidence of wall thinning or scars, no significant change in uterine wall thickness, and no intrauterine adhesions (n=19 to 34). The authors identified case reports of 3 pregnancies after transcervical RFA with no complications. This systematic review is limited by the lack of available RCTs and high risk of bias in the published literature.

Table 1. Characteristics of Systematic Reviews on RFA

    RFA: radiofrequency ablation; UAE: uterine artery embolization; SONATA: sonography-guided transcervical ablation of uterine fibroids

Table 2. Results of Systematic Reviews on RFA

    CI: confidence interval; QOL: quality of life; RFA: radiofrequency volumetric thermal ablation; SD: standard deviation; UAE: uterine artery embolization.

Randomized Controlled Trials of Laparoscopic Radiofrequency Ablation

Studies of laparoscopic RFA include RCTs.

One RCT evaluating laparoscopic RFA (Brucker et al, 2014)^11, was included in the Sandberg et al (2018) systematic review;^6, Tables 3 and 4 describe key RCT trial characteristics and results.

The Treatment Results of Uterine Sparing Technologies (TRUST) Canada post-market RCT compared laparoscopic RFA with laparoscopic myomectomy for the treatment of symptomatic fibroids. A 2018 publication by Rattray et al of TRUST included 45 patients (23 RFA, 22 myomectomy) and reported primarily on short-term resource utilization and return to work.^12, RFA was found to be noninferior to laparoscopic myomectomy in the length of stay. Clinical outcomes at 3 months were improved by a similar percentage in both groups (-44.8%) and women treated with RFA required less time to return to work (11.1 vs 18.5 days, p=.019). A post-market, prospective, single-arm analysis of the ongoing TRUST study reported by Yu et al (2020) surveyed 26 surgeons who performed 105 procedures with 100 per-protocol patients to capture surgical experiences and safety outcomes.^13, Surgeons received proctored training during study run-in and provided self-assessments after performing ≥ 2 procedures at 4 to 8 weeks follow-up. No acute serious adverse events (≤ 48 hours) were reported compared with 2 (1.46%) in the premarket study. Both studies reported 1 (<1%) serious adverse event within 30 days of the procedure. No efficacy outcomes were reported.

Table 3. Summary of Key Randomized Controlled Trial Characteristics for Laparoscopic RFA

    LM: laparoscopic myomectomy; RFA: radiofrequency volumetric thermal ablation. a Key eligibility criteria.

Table 4. Summary of Key Randomized Controlled Trial Outcomes for Laparoscopic RFA

    HRQOL: health-related quality of life; LOS: length of stay; NS: not significant; RFA: radiofrequency volumetric thermal ablation; SSS: Symptom Severity Score. a Analyses at 12 and 24 months were per protocol and included 84% of randomized participants. b Met criteria for noninferiority: hospital LOS after RFA no more than 10% longer than after laparoscopic myomectomy. c Exact between-group p values were not reported.  

In the Brucker et al (2014) trial,^11, all patients in the myomectomy group were hospitalized overnight; although not explicitly stated, this appeared to be the standard procedure at the study hospital. In the laparoscopic RFA (Acessa) group, there was an unplanned hospitalization due to unexplained vertigo and 4 hospitalizations as a standard procedure because the patients also underwent adhesiolysis. It is unclear whether these abdominal adhesions were due to prior surgical interventions for uterine fibroid myolysis; however, patients with significant intra-abdominal adhesions and known or suspected endometriosis or adenomyosis were excluded from the study.

Secondary outcomes of the RCT were reported by Hahn et al (2015)^14, (12-month outcomes) and by Kramer et al (2016)^15, (12-month and 24-month outcomes). In addition to summary symptom and quality of life measures, the publications reported on 11 symptoms: heavy menstrual bleeding, increased abdominal girth, dyspareunia, pelvic discomfort/pain, dysmenorrhea, urinary frequency, urinary retention, sleep disturbance, backache, localized pain, and "other symptoms" (not specified).

Limitations of the 12- and 24-month analyses, shown in Tables 5 and 6, included lack of intent-to-treat analysis and failure to describe secondary study hypotheses and statistical analyses clearly. The RCT had a small sample size and thus might have been underpowered to detect clinically meaningful differences in secondary outcomes, so these results do not rule out potential differences between treatments.

Table 5. Study Relevance Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4. Enrolled populations do not reflect relevant diversity; 5. Other. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 6. Study Design and Conduct Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Prospective Single Arm Studies of Laparoscopic Radiofrequency Ablation

Jacoby et al (2020) surveyed gynecologist experience and health outcomes following adoption of laparoscopic RFA into clinical practice for 26 patients across 5 academic medical centers in California in the Uterine Leiomyoma Treatment with Radiofrequency Ablation (ULTRA) trial.^16, Eligibility criteria included women ≥21 years of age seeking uterine-sparing surgical treatment of leiomyomas for heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia. Women seeking future fertility were informed that there are insufficient data to determine the impact of treatment on fertility outcomes. No intraoperative complications or major adverse events were reported. Significant improvements in menstrual bleeding, sexual function, and quality of life were reported from baseline to 12 weeks, with a 47% decrease in the Leiomyoma Symptom Severity Score. Self-rated mean procedure difficulty score decreased from 6 to 4.25 following the fourth procedure among general gynecologists new to the technology. The authors concluded that laparoscopic RFA can be introduced into clinical practice with good clinical outcomes.

Prospective Single Arm Studies of Transcervical Radiofrequency Ablation

Studies of transcervical RFA are limited to prospective single-arm studies (see Tables 7 and 8).

The pivotal study for the Sonata transcervical RFA system (sonography-guided transcervical ablation of uterine fibroids [SONATA]) was a prospective single-arm study with 147 premenopausal women who had symptomatic uterine fibroids with heavy menstrual bleeding.^17, Patients were excluded if they desired to become pregnant. There were 2 (1.4%) procedure-related adverse events during the first year of follow-up and no additional device-related adverse events between the 1- and 2- year follow-up. At the 24 month follow-up, patients reported significantly improved symptom severity scores, HRQL, and EQ-5D. The cumulative rate of surgical intervention for heavy menstrual bleeding was 5.2% (95% CI 2.5% to 10.6%). Follow-up at 3 years showed a reintervention rate of 8.2%.^18, In patients who did not undergo reintervention, menopause, or withdrawal (not last observation-carried-forward), the gains observed at the 2-year follow-up were maintained at 3 years. In the 105 patients (71%) who remained in the trial, significant improvements in the SSS (P<.001), HR-QoL (P<.001), quality of life (P<.001) work absenteeism (P<.001), and impairment for work (P<.001) and physical activity (P<.001) were maintained. These results are limited by the loss to follow-up in the 3-year results.

The Fibroid Ablation Study EU (FAST-EU) was a prospective single-arm trial with the previously named VizAblate transcervical RFA. ^19, Fifty women who had heavy menstrual bleeding were included in the study. Patients were excluded if they desired to become pregnant. The primary outcome measure, that at least 50% of patients with >30% reduction in perfused fibroid volume, was achieved at the 3-month follow-up. Twelve-month follow-up was not in the original study design, and only 28 (58.3%) of participants agreed to return for an MRI at this time point. Symptom Severity Scores were obtained in all patients except for 1 patient due to pregnancy. A clinically significant minimum 10 point reduction in the SSS was obtained in 82% of patients at 3 months, 86% at 6 months, and 78% at 12 months. There were 34 adverse events deemed possibly, probably, or definitely related to the procedure. Four patients (8%) underwent surgical reintervention between 6 and 12 months post-ablation.

Shifrin et al (2021) conducted a subgroup analysis of patients with submucous (type 1, 2, or 2-5) or large fibroids (> 5 cm) from patients in the FAST-EU and SONATA clinical trials.^20, In total, 72.5% of the 534 treated fibroids were not amenable to hysteroscopic resection because they were intramural, transmural, or subserous. At 3 month follow-up, 86% of women with only submucous fibroids and 81% of women with large fibroids experienced bleeding reduction. At 12 month follow-up, a reduction in menstrual bleeding was found in 92% to 96% of women with submucous fibroids and 86% to 100% of women with large fibroids (although fibroids >5 cm was an exclusion in SONATA, 2.5% (n=11) of patients were in this category). Improvement in the SSS, HR-QoL, and EQ-5D were also noted in these subgroups. Rates of surgical reintervention for women with submucous fibroids was less than 3.7%.

The Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE) will enroll 500 patients treated with transcervical RFA at up to 50 sites in Europe (NCT03118037). Participation in the registry requires willingness to return for follow-up visits through 5 years, with no restrictions for participation based on patient age (>18), fibroid type and size, prior surgical history, or desire for future fertility. Characteristics and adverse events from the first 160 women in the registry were reported by Christoffel et al (2021).^21, A total of 241 fibroids were treated with another 271 identified by sonography but not ablated. Patients will be followed for 5 years.

Table 7. Summary of Single-Arm Study Characteristics for Transcervical RFA

    FAST-EU: Fibroid Ablation Study EU; RFA: radiofrequency ablation; SAGE: Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry; SONATA: sonography-guided transcervical ablation of uterine fibroids

Table 8. Summary of Single Arm Study Results for Transcervical RFA

    EQ-5D Euroqol 5-dimension; HRQL: Health-related quality of life; FAST-EU: Fibroid Ablation Study EU; RFA: radiofrequency ablation; SAGE: TransScervical Radiofrequency Ablation of Uterine Fibroids Global Registry; SD: standard deviation; SONATA: sonography-guided transcervical ablation of uterine fibroids

Pregnancy Outcomes After Radiofrequency Ablation

Keltz et al (2017) published a systematic review of published literature on pregnancy outcomes after thermal ablation of uterine fibroids.^22, For laparoscopic RFA, reviewers identified 20 pregnancies reported in 4 case series; the denominator (ie, the number of patients treated in these series) was not reported. Of the 20 pregnancies, 7 were undesired and were electively terminated. For the remaining 13 pregnancies, there was 1 spontaneous abortion and 12 full-term births. Nine of the 12 live births were delivered by cesarean section.

Berman et al (2020) conducted a retrospective review of pregnancy delivery and safety after laparoscopic RFA of uterine fibroids.^23, The review included results from 2 RCTs, 6 cohort studies, and commercial cases (total N=28) that evaluated rates of spontaneous abortion, preterm delivery, postpartum hemorrhage, placental abnormalities, intrauterine growth restriction, and rates of cesarean delivery. Thirty pregnancies resulted in 26 full-term births (86.7%), with an equal distribution of vaginal and cesarean deliveries, and the spontaneous abortion rate (13.3%) was within the range for the general population. There were no cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction. One patient experienced severe postpartum hemorrhage. While these retrospective results did not identify any safety signals for pregnancy, ongoing prospective studies that are evaluating pregnancy outcomes will provide more confidence in pregnancy outcomes after laparoscopic RFA.

Section Summary: Radiofrequency Ablation

Prospective case series, systematic reviews, and RCTs comparing RFA with laparoscopic myomectomy have been published. The meta-analyses found low rates of reintervention with RFA and quality of life outcomes that were similar to myomectomy and UAE at 12 months. Data on reintervention rates is limited, including reinterventions for hysterectomy. Two RCTs found that RFA was noninferior to laparoscopic myomectomy on the primary outcome (length of hospitalization). A number of secondary outcomes of 1 RCT were reported at 12 and 24 months, including symptoms and quality of life outcomes; none differed significantly between groups. The RCT only had 43 patients in subgroup analyses at 12 and 24 months, and may have had insufficient power for the secondary outcomes. The procedure is associated with a reduction in symptoms and improvement in quality of life in the short-term. The reintervention rate at longer follow-up is unknown. Because most trials excluded women who desired to become pregnant, the impact of RFA on pregnancy outcomes is uncertain. Additional well-designed comparative trials with longer follow-up are needed to determine the effect of RFA on health outcomes compared with other treatment options, including myomectomy.

Summary of Evidence

For individuals who have symptomatic uterine fibroids who receive RFA, the evidence includes prospective cohorts, RCTs, and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The meta-analysis found low rates of reintervention with RFA and quality of life outcomes that were similar to uterine artery embolization and myomectomy at 12 months. Data on reintervention rates at 36 months were limited to 1 RCT and 1 cohort study with high loss to follow-up. No studies reported reintervention rates at 60 months. Two RCTs found that RFA was noninferior to laparoscopic myomectomy on the primary outcome: length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months in 1 RCT, including symptoms and quality of life. None of the secondary outcomes demonstrated significant between-group differences in a subgroup analysis of 43 patients. The procedure has faster recovery than myomectomy, and provides a reduction in symptoms and improvement in quality of life in the short term. Recurrence and reintervention rates at longer follow-up are unknown. Well-designed comparative trials with longer follow-up are needed to determine the effect of RFA on health outcomes compared with other treatment options such as myomectomy. Clinical input provides consistent support that the use of laparoscopic or transcervical RFA provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.Based on the evidence and independent clinical input, the clinical input supports that the following indication provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

Population Reference No. 2 

Laser or Bipolar Needles

Clinical Context and Therapy Purpose

The purpose of therapy with laser or bipolar needles in patients who have uterine fibroids is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of laser or bipolar needles improve the net health outcome in women with uterine fibroids?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is women with symptomatic uterine fibroids.

Interventions

The therapy being considered is laser or bipolar needles.

Comparators

The following therapies are currently being used to manage symptomatic uterine fibroids: medical management, UAE , myomectomy, and hysterectomy. Surgery, including hysterectomy and myomectomy, is considered the criterion standard for symptom resolution. However, there is the need to recover from surgery, and in the case of a hysterectomy, the uterus is not preserved. UAE is associated with poor pregnancy outcomes and is not advised in patients who desire to become pregnant.

A retrospective cohort from claims data of over 35,000 women found that of the less invasive procedures, myomectomy had the lowest 12-month reintervention rate (4.2%), followed by UAE (7.0%), and endometrial ablation (12.4%).^5,

Outcomes

The outcomes of interest are, complications, postoperative pain and recovery time, symptom resolution, need for reintervention, and health-related quality of life. The immediate follow-up would be a week for postoperative pain and recovery, and 3 to 5 years of follow-up would be needed to monitor for fibroid recurrence and retreatment.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Case Series

Several case series were identified, most published in the 1990s. For example, Goldfarb (1995) reported on outcomes for 300 women with symptomatic fibroids no larger than 10 cm who underwent myolysis using either Nd:YAG or bipolar needles. ^24,The author reported that the coagulating effect of the bipolar needle devascularized the fibroids, and the resulting shrinkage was comparable to that produced by Nd:YAG laser. An earlier study by Goldfarb (1992), included 75 patients who presented with symptomatic fibroids 5 to 10 cm in diameter.^25, Symptoms included pelvic pain, pressure, dyspareunia, and recurrent menorrhagia. The Nd:YAG laser was inserted into the fibroid multiple times (eg, 75 to 100 punctures to coagulate a 5-cm fibroid). Based on an assessment by endovaginal ultrasound, the fibroids regressed in size and, after 6 to 14 months of follow-up, the size remained stable. No patient experienced significant complications. Nisolle et al (1993) reported on a case series of 48 women offered myolysis instead of myomectomy if they had completed childbearing.^26, The authors reported that maximal decrease in fibroid size had occurred by 6 months, however, as reported, it is unclear among the 28 of 48 patients with more than 2 fibroids whether all fibroids were treated in each patient, and, if not, how treated fibroids were selected. Additionally, no associated patient symptoms were reported.

Several authors have reported pelvic adhesions as a complication of the Nd:YAG laser procedure, presumably due to thermal damage to the serosal surface. In addition, the Nd:YAG laser produces a significant amount of smoke, which can obscure visibility.^27,28,

Section Summary: Laser or Bipolar Needles

The evidence base on the use of lasers or bipolar needles only includes case series, small in size, and published in the 1990s. RCTs comparing laser and bipolar needles with alternative treatments for uterine fibroids and reporting health outcomes are needed.

Summary of Evidence

For individuals who have symptomatic uterine fibroids who receive laser or bipolar needles, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The case series were published in the 1990s, and the procedures used then may not reflect current practice. RCTs comparing laser or bipolar needles with alternative treatments for uterine fibroids are needed to evaluate the safety and efficacy of this technology adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 3 

Cryomyolysis

Clinical Context and Therapy Purpose

The purpose of cryomyolysis in patients who have uterine fibroids is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does cryomyolysis improve the net health outcome in women with uterine fibroids?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is women with symptomatic uterine fibroids.

Interventions

The therapy being considered is cryomyolysis. Cryomyolysis entails inserting a -180°C cryoprobe into the center of a fibroid, which creates an "iceball" within the fibroid. Several freeze-thaw cycles are typically used, and the process may not be standardized.

Comparators

The following therapies are currently being used to manage symptomatic uterine fibroids: medical management, UAE , myomectomy, and hysterectomy. Surgery, including hysterectomy and myomectomy,is considered the criterion standard for symptom resolution. However, there is the need to recover from surgery, and in the case of a hysterectomy, the uterus is not preserved. UAE is associated with poor pregnancy outcomes and is not advised in patients who desire to become pregnant.

A retrospective cohort from claims data of over 35,000 women found that of the less invasive procedures, myomectomy had the lowest 12-month reintervention rate (4.2%), followed by UAE (7.0%), and endometrial ablation (12.4%).^5,

Outcomes

The outcomes of interest are, complications, postoperative pain and recovery time, symptom resolution, need for reintervention, and health-related quality of life. The immediate follow-up would be a week for postoperative pain and recovery, and 3 to 5 years of follow-up would be needed to monitor for fibroid recurrence and retreatment.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Case Series

No controlled studies evaluating cryomyolysis were identified.

Two case series have been identified. Zreik et al (1998)^29, published a prospective pilot study with 14 patients, and Zupi et al (2004)^30, presented their experience with 20 patients.^29,30, In both case series, the authors reported that patients had symptom resolution. In the Zreik et al (1998) series, cryomyolysis maintained or slightly reduced the myoma volume by 6%. In the Zupi et al (2004) study, cryomyolysis was associated with a 25% reduction in fibroid size. Zupi et al (2005) reported on the 1-year follow-up of these patients.^31, Mean shrinkage in fibroid size continued until 9 months after surgery, to a mean volume reduction of 60%. In the Sandberg et al (2018) systematic review (discussed above), the risk of reintervention was 15%.^6, Interpretation of these studies is limited due to their small sample sizes and lack of comparison groups.

Section Summary: Cryomyolysis

The literature on cryomyolysis includes small case series, with no literature identified in the last decade. Controlled studies comparing cryomyolysis with alternative treatments for uterine fibroids and differentiating between outcomes related to fibroid treatment and outcomes related to the treatment of abnormal bleeding are needed.

Summary of Evidence

For individuals who have symptomatic uterine fibroids who receive cryomyolysis, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. Among the few case series, sample sizes were small (≤20 patients). RCTs comparing cryomyolysis with alternative treatments for uterine fibroids are needed to evaluate the safety and efficacy of this technology adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 4 

Magnetic Resonance Imaging-Guided Laser Ablation

Clinical Context and Therapy Purpose

The purpose of MRI-guided laser ablation in patients who have uterine fibroids is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does MRI-guided laser ablation improve the net health outcome in women with uterine fibroids?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is women with symptomatic uterine fibroids.

Interventions

The therapy being considered is MRI-guided laser ablation.

Comparators

The following therapies are currently being used to manage symptomatic uterine fibroids: medical management, UAE , myomectomy, and hysterectomy. Surgery, including hysterectomy and myomectomy, is considered the criterion standard for symptom resolution. However, there is the need to recover from surgery, and in the case of a hysterectomy, the uterus is not preserved. UAE is associated with poor pregnancy outcomes and is not advised in patients who desire to become pregnant.

A retrospective cohort from claims data of over 35,000 women found that of the less invasive procedures, myomectomy had the lowest 12-month reintervention rate (4.2%), followed by UAE (7.0%), and endometrial ablation (12.4%).^5,

Outcomes

The outcomes of interest are, complications, postoperative pain and recovery time, resolution of symptoms, need for reintervention, and health-related quality of life. The immediate follow-up would be a week for postoperative pain and recovery, and 3 to 5 years of follow-up would be needed to monitor for fibroid recurrence and retreatment

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Nonrandomized Studies

No RCTs evaluating MRI-guided laser ablation were identified. A nonrandomized study by Hindley et al (2002) was identified (see Tables 9 and 10).^32, Results from the women treated with MRI-guided laser ablation were compared with a historical control group of 43 women who underwent a hysterectomy. Compared with the historical control group, the total score on the Menorrhagia Outcomes Questionnaire was significantly lower (ie, worse outcomes) in those undergoing percutaneous myolysis. The quality of life subscores did not differ statistically.

Table 9. Summary of Key Nonrandomized Trial Characteristics

    FU: follow-up; MRI: magnetic resonance imaging.

Table 10. Summary of Key Nonrandomized Trial Results

    MRI: magnetic resonance imaging; MOQ: Menorrhagia Outcomes Questionnaire; NR: not reported; QOL: Quality of Life.

The purpose of the limitations tables (see Tables 11 and 12) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 11. Study Relevance Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 12. Study Design and Conduct Limitations

    The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: MRI-Guided Laser Ablation

A single nonrandomized study with historical controls was identified. Data reporting was incomplete, and self-reported outcomes were worse compared with a historical control group of women undergoing a hysterectomy. RCTs comparing MRI-guided laser ablation with alternative treatments for uterine fibroids and reporting health outcomes are needed.

Summary of Evidence

For individuals who have symptomatic uterine fibroids who receive magnetic resonance imaging-guided laser ablation, the evidence includes a study with historical controls. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. A single study with historical controls is not sufficiently robust to evaluate this technology. RCTs comparing magnetic resonance imaging-guided laser ablation with alternative treatments for uterine fibroids are needed to evaluate safety and efficacy adequately. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2021 Input

Clinical input was sought to help determine whether the use of laparoscopic or transcervical radiofrequency ablation (RFA) for individuals with symptomatic uterine fibroids would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input on the use of RFA was received from 3 respondents, including: 1 society-level response including input from physicians affiliated with academic medical centers and 2 physician-level responses with academic affiliations.

For individuals with symptomatic uterine fibroids, clinical input provides consistent support that the use of laparoscopic or transcervical RFA provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice for the following indication:

Women 18 years and older when ALL of the following conditions are met:

• Evidence of uterine fibroids via ultrasound that are less than 10 cm in diameter for laparoscopic RFA with Acessa or 7 cm for transcervical RFA with Sonata; AND

• Patient desires a uterine-sparing treatment approach or is contraindicated for hysterectomy or other uterine-sparing alternatives to RFA (e.g., laparoscopic myomectomy, uterine artery embolization [UAE]); AND

• Patient has experienced at least 1 of the following symptoms that are a direct result of the fibroid(s):

  • Menorrhagia or other abnormal uterine bleeding that interferes with daily activities or causes anemia;

  • Pelvic pain or pressure;

  • Urinary symptoms (e.g., urinary frequency, urgency) related to bulk compression of the bladder;

  • Gastrointestinal symptoms related to bulk compression of the bowel (e.g., constipation, bloating);

  • Dyspareunia (painful or difficult sexual relations).

Respondents noted that choice of laparoscopic versus transcervical RFA treatment is dependent on fibroid number, type and location, and patient preferences. For example, predominantly lower uterine segment or cervical leiomyomata, or those with a predominant submucosal location or intramural International Federation of Gynecology and Obstetrics (FIGO) type 2 or 3 fibroids (see Table PG1), may suggest a transcervical approach, whereas fibroids with largely fundal or extramural components may suggest a laparoscopic approach.

Further details from clinical input are included in the Appendix.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Obstetricians and Gynecologists

In 2021, the American College of Obstetricians and Gynecologists updated its practice bulletin on the management of symptomatic leiomyomas.^1, Recommendations based on a review of evidence included the following:

• Radiofrequency ablation can be considered as a minimally invasive treatment option in patients who desire to retain their uterus, provided they are counseled about the limited data on reproductive outcomes. Laparoscopic, transvaginal, or transcervical approaches using ultrasound guidance are considered similarly effective.

• Focused ultrasound is associated with a reduction in leiomyoma and uterine size, but is associated with less improvement in symptoms and quality of life and a higher risk of reintervention compared with uterine artery embolization.

• Myomectomy was recommended as an option in patients who desire uterine preservation or future pregnancy and are counseled about the risk of recurrence. The laparoscopic approach is associated with shorter hospitalization, less postoperative pain, faster return to work, and earlier return to normal activities.

• Hysterectomy is recommended as a definitive surgical management option in patients who do not desire future childbearing or do not wish to retain their uterus.

National Institute for Health and Care Excellence

In 2021, NICE published an interventional procedures guidance on the use of transcervical ultrasound-guided RFA for symptomatic uterine fibroids.^42, The NICE guidance noted that while evidence on the safety of transcervical RFA raises no major safety concerns, evidence on the efficacy of the procedure is limited in quality. Therefore, NICE recommends that the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this evidence review are listed in Table 13.

Table 13. Summary of Key Trials

   NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.

References

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Codes

Policy History

APPENDIX

2021 Clinical Input

Objective

Clinical input was sought to help determine whether the use of laparoscopic or transcervical radiofrequency ablation (RFA) for individuals with symptomatic uterine fibroids would provide an improvement in the net health outcome and whether the use is consistent with generally accepted medical practice.

Respondents

Clinical input was provided by the following specialty societies and physician members identified by a specialty society or clinical health system:

• American College of Obstetrics and Gynecology (ACOG)

• Alison F. Jacoby, MD; Professor of Gynecology and Minimally Invasive Gynecologic Surgery; Director of Gynecologic Surgery and the Comprehensive Fibroid Center at the University of California, San Francisco (UCSF) Medical Center

• Anonymous, MD; Advanced Gynecology and Minimally Invasive Gynecologic Surgery; affiliated with an academic medical center

Clinical input provided by the specialty society at an aggregate level is attributed to the specialty society. Clinical input provided by a physician member designated by a specialty society or health system is attributed to the individual physician and is not a statement from the specialty society or health system. Specialty society and physician respondents participating in the Evidence Street® clinical input process provide review, input, and feedback on topics being evaluated by Evidence Street. However, participation in the clinical input process by a specialty society and/or physician member designated by a specialty society or health system does not imply an endorsement or explicit agreement with the Evidence Opinion published by BCBSA or any Blue Plan.

Ratings

Respondent Profile

Respondent Conflict of Interest Disclosure

    Individual physician respondents answered at individual level. Specialty Society respondents provided aggregate information that may be relevant to the group of clinicians who provided input to the Society-level response.

Responses

Question 1.

We are seeking your opinion on whether using laparoscopic or transcervical radiofrequency ablation (RFA) for individuals with symptomatic uterine fibroids provides a clinically meaningful improvement in net health outcome. Please respond based on the evidence and your clinical experience. Please address these points in your response:

• Relevant clinical scenarios (e.g., a chain of evidence) where the technology is expected to provide a clinically meaningful improvement in net health outcome;

• Specific outcomes that are clinically meaningful;

• Any relevant patient inclusion/exclusion criteria or clinical context important to consider in identifying individuals for this indication; and

• Supporting evidence from the authoritative scientific literature (please include PMID).

Question 2.

Are RFA re-interventions appropriate after an initial RFA of uterine fibroids? If so, what criteria may guide appropriate time interval for RFA re-intervention and what would be the expected durability of this procedure? Please comment on benefits and harms of RFA re-intervention compared to re-intervention with myomectomy or other uterine sparing interventions.

Question 3:

Please provide in the box below any comments you may wish to share about differences between the laparoscopic and transcervical approached to the use of RFA of uterine fibroids with evidence that demonstrates health outcomes you would like to highlight.

Question 4.

Would you agree that the following criteria for identifying individuals with symptomatic uterine fibroids for RFA treatment are clinically appropriate?

Women 18 and older when ALL of the following conditions are met:

• Evidence of uterine fibroids via ultrasound that are less than 10cm in diameter for Acessa or 7cm for Sonata, and

• Patient desires a uterine sparing treatment approach or is contraindicated for hysterectomy, and

• Patient has experienced any one of the following symptoms that are a direct result of the fibroid(s):

• Menorrhagia interferes with daily activities or causes anemia; or

• Pelvic pain or pressure, or

• Lower back pain; or

• Urinary symptoms (e.g., urinary frequency, urgency) related to compression of the bladder; or

• Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating); or

• Dyspareunia (painful or difficult sexual relations)

Question 5.

Please provide in the box below any additional comments about the clinical context or specific clinical pathways for this topic and/or any key citations (including the PMID) with evidence that demonstrates health outcomes you would like to highlight.

Question 6.

Is there any key evidence missing from the attached draft review of evidence that demonstrates clinically meaningful improvement in net health outcome? If YES, please share any relevant scientific citations of missing evidence (including the PMID).