| Coverage Policy Manual | |
| Policy #: | 2004031 |
| Category: | Surgery |
| Initiated: | August 2017 |
| Last Review: | March 2024 |
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| Laparoscopic, Percutaneous, and Transcervical Techniques for Uterine Fibroid Myolysis | |
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| Description: |
Uterine fibroids, also known as leiomyomas, are among the most common conditions affecting women in the 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 (Stewart, 2021).The prevalence rate of uterine fibroids is 2-3 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 (Laughlin-Tommaso, 2017; Stewart, 2013),
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 the transcutaneous magnetic resonance imaging-guided focused ultrasound therapy. 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 (Jones, 2012). 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.
Radiofrequency ablation has been performed as a laparoscopic procedure or percutaneous approach using ultrasound or MRI guidance. In ultrasound-guided radiofrequency ablation, the ultrasound probe is used to determine the location and size of all fibroids present. The radiofrequency probe is then inserted, with ultrasound guidance, into the fibroid and the radiofrequency energy is delivered to destroy the fibroid tissue. The intent of the procedure is to shrink the fibroid to decrease fibroid-related symptoms.
Laparoscopic cryomyolysis has also been used to treat symptomatic uterine fibroids. Cryomyolysis uses gas-cooled cryoprobes in which pressurized gas is expanded through a small hole to produce cooling to a temperature of -90 °C in about 9-10 minutes. The cryoprobe is inserted into the fibroid and an iceball forms around the cryoprobe which becomes lethal to the tissue at -20°C. Ultrasound guidance is used to monitor the insertion of the probe and the formation of the iceball created by the cooling.
Other techniques of myolysis of uterine fibroids include Nd:YAG laser ablation, the use of bipolar needles, interstitial laser photocoagulation, uterine artery embolization and MRI-guided focused ultrasound ablation. Uterine artery embolization and MRI-guided focused ultrasound ablation are addressed in separate policies.
Surgeons also use laparoscopic power morcellation during minimally invasive myomectomy procedures, in which they remove uterine fibroids. Power morcellation allows surgeons to make incisions of less than 2 centimeters in size and be able to remove fibroids and other tissue. The morcellators, tiny devices with rotating blades, break large tissue masses into small fragments which are then vacuumed away and out of the body.
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 (Gynsonics) 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.
Coding
Effective in 2017, there is a category I CPT code for radiofrequency ablation of uterine fibroids:
58674: Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance
and monitoring, radiofrequency.
For percutaneous procedures, the following code would likely be used to describe the MRI imaging component of the procedure
77022: Magnetic resonance guidance for, and monitoring of, visceral tissue ablation
For ultrasound guidance, one of the following codes might be used:
76940: Ultrasound guidance for and monitoring of, parenchymal tissue ablation
76998: Ultrasonic guidance, intraoperative.
In November 2014, the U.S. Food and Drug Administration (FDA) published a safety communication on laparoscopic power morcellators used for myomectomy and hysterectomy in most women. (Morcellators are not otherwise addressed in this policy). FDA recommended that manufacturers of these devices include in their product labels a boxed safety warning and wording on contraindications (see http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm39
3809.htm).
Related policies:
MR Guided Ultrasound Ablation-Uterine Fibroids and Other Tumors #2004026.
Uterine Artery Embolization for the Treatment of Leiomyomas or Abnormal Uterine Bleeding #2000014
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Policy/ Coverage: |
Effective June 2022
Meets Primary Coverage Criteria or Is Covered For Contracts Without Primary Coverage Criteria
Laparoscopic or transcervical radiofrequency ablation (RFA) as a treatment of symptomatic uterine fibroids meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for women 18 years and older when ALL of the following conditions are met:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids for any indication not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids for any indication not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Other laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids use of laser or bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, other laparoscopic, transcervical or percutaneous techniques for myolysis of uterine fibroids using laser or bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective May 2013 through May 14, 2022
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids, including, but not limited to, ultrasound-guided radiofrequency ablation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids, including, but not limited to, ultrasound-guided radiofrequency ablation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to May 2013
Laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids is not covered based on benefit certificate primary coverage criteria that there by scientific evidence of effectiveness.
For contracts without primary coverage criteria, laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
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| Rationale: |
Laser and Bipolar Needles
The largest experience using Nd:YAG laser myolysis has been reported by Goldfarb, who published the results of a case series of 75 patients. All the patients presented with symptomatic fibroids 5-10 cm in diameter. Symptoms included pelvic pain, pressure, dyspareunia and recurrent menorrhagia. The Nd:YAG laser was inserted into the fibroid multiple times; for example, 75 to 100 punctures were used to coagulate a 5 cm fibroid. Based on assessment by endovaginal ultrasound, the fibroids regressed in size and after 8 to 14 months of follow up, the size remained stable. No patient experienced significant complications. Nisolle and colleagues reported on a case series of 48 women who were apparently offered myolysis instead of myomectomy if they had completed childbearing. Although the report states that 28 of the 48 had more than two fibroids, it is not clear if all fibroids were treated in each patient, and if not, how the treated fibroids were selected. The authors reported that maximal decrease in fibroid size had occurred by 6 months. However, there is no report of associated patient symptoms. Several authors have reported pelvic adhesions as a complication, presumably due to thermal damage to the serosal surface. Additionally, the Nd:YAG laser produces a significant amount of smoke, which can obscure visibility. Interest shifted to using bipolar electrodes. In a case series, Goldfarb reported the outcomes of 300 women with symptomatic fibroids no larger than 10 cm who underwent either myolysis using either Nd:YAG or bipolar needles. The authors reported that the coagulating effect of the bipolar needle devascularized the fibroids, and the resulting shrinkage was comparable with that produced by Nd:YAG laser.
Chapman reported on a case series of 300 patients who underwent myolysis using a low power energy source, a procedure referred to as interstitial laser photocoagulation. Some patients underwent combined laparoscopic and hysteroscopic procedures. The author reported that the procedure was associated with an improvement in menorrhagia, abdominal pain and bladder discomfort, but there is no description of how these outcomes were assessed and at what length of duration. Visvanathan and colleagues reported on a small case series of 24 symptomatic patients who were treated with low power laser energy. Shrinkage was reported in 23 of 24 lesions, with clinical benefit reported in 13 patients. The authors concluded that fibroids greater than 6 cm in diameter responded poorly to treatment.
Cryomyolysis
Cryomyolysis is a technique in which a cryoprobe is inserted into the center of a fibroid. Freezing temperatures of -180 degrees centigrade create an "iceball" within the fibroid. Several freeze/thaw cycles are typically used. Zreik and colleagues presented their preliminary experience with 14 patients, while Zupi and colleagues presented their initial experience with 20 patients. In both of these small case series, the authors reported that patients had symptom resolution. In the Zreik study, patients were given GnRH agonist before the procedure; cryomyolysis maintained or slightly reduced the post-GnRH uterine size. In contrast, in the Zupi study, GnRH was not used, and cryomyolysis was associated with a 25% reduction in fibroid size. Zupi subsequently reported the one year follow-up of these patients. Mean shrinkage in fibroid size continued until 9 months after surgery to a mean volume reduction of 60%. Patients reported absence of symptoms. Interpretation of these studies is limited due to their small size.
Radiofrequency Ablation
There are no controlled trials comparing radiofrequency ablation to the gold standard treatments of hysterectomy or myomectomy.
Several small prospective case studies with short-term follow-up were identified (Carafiello, 2010; Garza, 2011; Iversen, 2012; Robles, 2013).
Two small studies of laparoscopic radiofrequency ablation (i.e., the HALT procedure) were identified. Milic and colleagues reported on a case series of 4 patients (Milic, 2006), while Bergamini and colleagues reported on a case series of 18 patients (Bergamini, 2005). Both studies reported improvement in patient symptoms from 1 to 12 months after the procedure. Interpretation of these studies is limited due to their small size.
In 2010, Carafiello and colleagues reported on 11 consecutive premenopausal women with symptomatic uterine fibroids who underwent ultrasound-guided radiofrequency ablation (Carafiello, 2010). Mean follow-up of the eleven patients was 9 months (range of 3-12 months). Total or partial regression of symptoms was experienced by 10 of 11 patients. Nine of 11 patients experienced a fibroid shrinkage rate of greater than 65%.
In 2011, Garza and colleagues reported results of a trial of 31 women with symptomatic uterine fibroids who underwent laparoscopic, ultrasound-guided radiofrequency ablation using the HALT 2000 System (Garza, 2011). Follow-up assessments occurred at 3, 6, and 12 months. Primary outcomes were safety, frequency of adverse events, repeat intervention rate and QOL questionnaire. At 3, 6 and 12 months mean symptom severity scores improved significantly compared with baseline. Mean uterine volume decreased from 194.4(105.9cm3) to 113.2 (53.5cm3) at 12 months. The author states, “Additional larger multicenter studies are needed to confirm these results” (Garza, 2011).
Ongoing Clinical Trials
A search of the clinicaltrials.gov website identified the following clinical trials assessing the use of laparoscopic ultrasound-guided radiofrequency ablation of uterine fibroids:
NCT00874029- Laparoscopic Radiofrequency Ablation of Symptomatic Uterine Fibroids (HALT Lap RF). The purpose of this single-arm multicenter study is to assess the safety and effectiveness of radiofrequency ablation using the HALT System for the treatment of patients with symptomatic uterine fibroids. The study is estimated to enroll 150 patients. The estimated completion date is February 2014.
NCT01750008- Laparoscopic Ultrasound Sparing Techniques Outcomes and Reinterventions (LUSTOR). This study is a single blind, randomized trial comparing the outcomes of laparoscopic ultrasound-guided radiofrequency ablation (HALT System) versus laparoscopic myomectomy. The study is estimated to enroll 50 patients with an estimated completion date of September 2018.
NCT01840124- Uterine Leiomyoma Treatment with Radiofrequency Ablation (ULTRA). This study is a single-arm trial of an estimated 100 patients undergoing laparoscopic ultrasound-guided radiofrequency ablation with the Acessa device. According to the clinical trials.gov website, this study has not begun recruitment.
NCT01842789- Post Market Evaluation of Acessa With TAG. This study compares the use of the Acessa System with the Acessa System with Targeting Animation Guidance (TAG) for the treatment of uterine fibroids. The intent of the TAG system is to assist the gynecologist in getting the tip of the Acessa Handpiece to the fibroid by creating an animated image overlay of the movements and placement. The study is estimated to enroll 50 patients with an estimated completion date of December 2014.
Summary:
In summary, there is inadequate data to permit scientific conclusions regarding various laparoscopic or percutaneous myolysis techniques. Larger, longer-term studies comparing laparoscopic myolysis techniques to gold standard treatments are needed. Laparoscopic ultrasound-guided radiofrequency ablation is currently being studied in clinical trials. One randomized trial is currently recruiting patients.
2015 Update
A literature search conducted through October 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A large retrospective case series was published by Yin and colleagues; the study was conducted in China and used Chinese gynecologic RFA devices (Yen, 2015). It included 1216 consecutive patients treated at a single hospital over a 10-year period. All fibroids were less than 6 cm in size and mean diameter was 4.5 cm (range, 3.1-6.0 cm). Mean follow-up time was 36.5 months. Among the 476 premenopausal women, the mean reduction in myoma diameter was 2.7 cm at 6 months, 2.4 cm at 12 months, and 2.2 cm at 24 months. Among the 740 peri- or postmenopausal women, mean reduction was 3.3 cm at 6 months, 2.3 cm at 12 months, and 2.3 cm at 24 months. Myoma diameter was significantly lower at each of these times points posttreatment compared with pretreatment. In the premenopausal subgroup, the proportion of women with dysmenorrhea decreased from 43.7% at baseline to 7.6% at 12 months and to 6.7% at 24 months; rates were significantly lower after treatment.
Practice Guidelines and Position Statements
In 2015, the Society of Obstetricians and Gynecologists of Canada published a clinical practice guideline on management of uterine leiomyomas (Vilos, 2015). The guideline included the summary following statements:
2016 Update
A literature search conducted through November 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Secondary outcomes of the RCT were reported in a 2015 publication by Hahn and colleagues (12-month outcomes) (Hahn, 2015) and a 2016 publication by Kramer and colleagues (24-month outcomes) (Kramer, 2016). Analysis was per protocol and 43 (84%) of 51 randomized participants were available for both the 12- and 24-month analyses. Each publication reported on 12 symptoms: heavy menstrual bleeding, increased abdominal gait, dyspareunia, pelvic discomfort/pain, dysmenorrhea, urinary frequency, urinary retention, sleep disturbance, backache, localized pain and “other symptoms” (not specified). At 12 months, no participants reported 4 of the symptoms (dyspareunia, urinary retention, sleep disturbance, uterine pain) and there were no statistically significant between-group differences in the frequency of any of the remaining 8 symptoms (at the p<0.05) level. The most commonly reported symptom at 12 months, heavy menstrual bleeding, occurred in 7 (33%) of women in the RFVTA group and 2 (9%) of women in the laparoscopic myomectomy group (p=0.069) after controlling for baseline bleeding. At 24 months, no participants reported urinary retention or “other” symptoms and there were no statistically significant between group differences in any of the 10 reported symptoms. The most commonly reported symptom at 24 months, dysmenorrhea, occurred I 8 (38%) in the RFVTA group and 78 (32%) in the laparoscopic myomectomy group (p=0.67). Patients were also assessed using several validated questionnaires eg, the Uterine Fibroid Symptom Severity scale. There were no statistically significant between-group differences on any of these questionnaires at either 12 or 24 months. In addition, the authors described pregnancy outcomes. Three patients in the RF VTA group conceived and these all resulted in delivery of a healthy neonate; the number of women who desired to become pregnant was not reported. Limitations of the 12- and 24-month analyses include that they were not done by intention to treat and that secondary study hypotheses and statistical analyses were not clearly described. The RCT had a relatively small sample size and thus may have been underpowered to detect clinically meaningful differences in secondary outcomes, so these results do not rule out potential differences between the treatments.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this evidence review are listed below:
Ongoing
(NCT01563783) an industry-sponsored or cosponsored trial. The Trust (Treatment Results of Uterine Sparing Technologies) Study; planned enrollment 260; projected completion date December 2020.
Summary of Evidence
For individuals who have uterine fibroids who receive RFVTA, the evidence includes 1 randomized controlled trial (RCT). Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The RCT found that RFVTA was non-inferior to laparoscopic myomectomy on the study’s primary outcome, length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months and there were no significant between-group differences on any of these. There were methodological limitations to this study eg, lack of intention-to-treat analysis, and the statistical hypotheses and analyses were not well-described. As a result, the validity of the reported results is decreased and no definitive conclusions can be made. Additional high-quality RCTs are needed to determine the effect of RFVTA on long-term health outcomes. Moreover, future studies should have a greater focus on fertility outcome following RFVTA. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have 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 utilized may not reflect current practice. RCTs comparing laser or bipolar needles to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have uterine fibroids who receive cryomyolysis, the evidence includes case series. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. There were a small number of case series and sample sizes were small (≤20 patients). RCTs comparing cryomyolysis to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.
2018 Update
A literature search conducted using the MEDLINE database through December 2018 did not reveal any new literature that would prompt a change to the coverage statement. There were no randomized trials identified on any of the laparoscopic and percutaneous techniques of myolysis for the treatment of uterine fibroids.
One systematic review of published literature on pregnancy outcomes after thermal ablation of uterine fibroids was identified (Keltz, 2017). For RFVTA, 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, seven were undesired and were electively terminated. For the remaining 13 pregnancies, there was one spontaneous abortion and 12 full-term births. Nine of the 12 live births were delivered by cesarean section.
American College of Obstetricians and Gynecologists
In 2016, the American College of Obstetricians and Gynecologists reaffirmed its 2008 Practice Bulletin on
alternatives to hysterectomy in the management of leiomyomas (ACOG, 2008; ACOG, 2016). Recommendations based on good and consistent scientific evidence were that abdominal myomectomy is a safe and effective treatment for women with symptomatic leiomyomas and that uterine artery embolization is a safe and effective option for appropriately selected women who want to retain their uteri. The bulletin contained no recommendations on myolysis using laparoscopic or percutaneous techniques.
2019 Update
A literature search was conducted through December 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Systematic Reviews
A systematic review and meta-analysis by Sandberg et al (2018) evaluated the risk of reintervention for hysterectomy and quality of life after uterine-sparing interventions for fibroids (Sandberg, 2018). Risk of reintervention at 12 months was 0.3% for RFVTA 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 RFVTA study was identified on reintervention risk at 36 months; none was identified on reintervention risk at 60 months.
2020 Update
A literature search was conducted through December 2019. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
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 are 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%) (Davis, 2018).
Bradley et al conducted a systematic review of 32 prospective studies on laparoscopic, transvaginal, or transcervical RFA (Bradley, 2019). 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.
The pivotal study for the SONATA transcervical RFA system was a prospective single arm study with 147 premenopausal women who had symptomatic uterine fibroids with heavy menstrual bleeding (Miller, 2019). 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% confidence interval [CI] 2.5% to 10.6%). Follow-up is continuing through 3 years.
The Fibroid Ablation Study EU (FAST-EU) was a prospective single-arm trial with the previously named VizAblate transcervical RFA (Brolmann, 2016). 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. The Symptom Severity Score was obtained in all patients except for 1 patient due to pregnancy. A clinically significant minimum 10-point reduction in the Symptom Severity Score 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.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Transcervical RFA was evaluated in a qualitative systematic review by Arnreiter and Oppelt (Amreiter, 2021). 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.
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 of TRUST included 45 patients (23 RFA, 22 myomectomy) and reported primarily on short-term resource utilization and return to work (Rattray, 2018). RFA was found to be not inferior 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).
Follow-up of the SONATA study is continuing through at 3 years showed a reintervention rate of 8.2% (Lukes, 2020). 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), HRoL (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.
Shifrin et al 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 (Shifrin, 2021). 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 improved in these subgroups. Rates of surgical reintervention for women with submucous fibroids was less than 3.7%.
The TransScervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE) will enroll 500 patients treated with transcervical RFA at up to 50 sites in Europe (NCT03118037). Participants 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 (Christoffel, 2021). A total of 241 fibroids were treated with another 271 identified by sonography but not ablated. Patients will be followed for 5 years.
Berman et al conducted a retrospective review of pregnancy delivery and safety after laparoscopic RFA of uterine fibroids (Berman, 2020). 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.
2022 Update (February 2022)
Key identified literature is summarized below.
Radiofrequency Ablation
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 (Sandberg, 2018). 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 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) (Havryliuk, 2017). 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.
Bradley et al conducted a systematic review of 32 prospective studies on laparoscopic, transvaginal, or transcervical RFA (Bradley, 2019). 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.
Laparoscopic Radiofrequency Ablation
One RCT evaluating laparoscopic RFA was included in the 2018 Sandberg et al systematic review ((Brucker, 2014); Sandberg, 2018).
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 (Rattray, 2018). 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 (Yu, 2020). 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.
In the Brucker et al trial, all patients in the myomectomy group were hospitalized overnight; although not explicitly stated, this appeared to be the standard procedure at the study hospital (Brucker, 2014). 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 (12-month outcomes) and by Kramer et al (12-month and 24-month outcomes) (Hahn, 2015; Kramer, 2016). 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, 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.
Jacoby et al 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 (Jacoby, 2020). Eligibility criteria included women 21 years of age and older 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.
Transcervical Radiofrequency Ablation
Studies of transcervical RFA are limited to prospective single-arm studies.
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 (Miller, 2019). 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 is continuing through at 3 years showed a reintervention rate of 8.2% (Lukes, 2020). 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 (Brolmann, 2016). 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 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 (Shifrin, 2021). 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%.
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.
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:
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 may suggest a transcervical approach, whereas fibroids with largely fundal or extramural components may suggest a laparoscopic approach.
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 practice bulletin on the management of symptomatic leiomyomas (ACOG, 2021). Recommendations based on a review of evidence included the following:
National Institute for Health and Care Excellence
In 2021, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance on the use of transcervical ultrasound-guided radiofrequency ablation (RFA) for symptomatic uterine fibroids (NICE, 2021). The NICE 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, the NICE recommends that the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this evidence review are listed below.
Ongoing
NCT01563783a The Trust (Treatment Results of Uterine Sparing Technologies) Study
Planned Enrollment: 260 Completion Date: Sep 2022
NCT03219385a Directed Ablation of Uterine Fibroids Using a Noninvasive Approach (DIANA)
Planned Enrollment: 180 Completion Date:Sep 2022
NCT03118037a Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
Planned Enrollment: 100 Completion Date: Dec 20232025
NCT02163525a Post Market TRUST - U.S.A. Study
Planned Enrollment: 114 Completion Date: Jun 2024
NCT02100904 Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)
Planned Enrollment: 400 800 Completion Date: Jan 2025
Unpublished
NCT02260752 Patient-Centered Results for Uterine Fibroids (COMPARE-UF)
Planned Enrollment: 3,094 Completion Date: Sep 2020
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Zhang et al conducted a systematic review of minimally invasive interventions for uterine fibroid-related bleeding (Zhang, 2022). A total of 15 studies for RFA were included (2 RCTs, 13 nonrandomized). Meta-analysis was not performed. The authors descriptively summarized that bleeding significantly decreased in severity in all studies after RFA (up to 12 months follow-up). In 3 studies that compared RFA to myomectomy (2 randomized, 1 nonrandomized), all patients experienced a decrease in fibroid-related bleeding with no difference between treatments (p>.05 in all cases).
Yu et al published a preliminary analysis of the ongoing TRUST United States trial, which is an RCT comparing laparoscopic RFA or myomectomy in patients with uterine myoma with a planned follow-up of 5 years (Yu, 2022). The preliminary analysis after 12 months of follow-up included 29 patients who underwent laparoscopic RFA and 27 patients who underwent myomectomy. At baseline, the mean myoma size was 3.1 cm in the RFA group and 3.5 cm in the myomectomy group and about 95% of patients had symptoms. The primary outcome of the TRUST United States trial is length of hospital stay, which was significantly shorter in the laparoscopic RFA group (8.0 ± 5.7 hours) than the myomectomy group (18.8 ± 14.6 hours; p<.05). The outcomes of interest for the preliminary analysis were symptoms and patient reported quality of life outcomes at 12 months. Symptoms improved in both groups at both 3 and 12 months after the procedure with no statistical difference between groups. Symptom severity and health-related quality of life were significantly better in the myomectomy group at 12 months. Major complications occurred in 2 patients who underwent myomectomy and 1 patient who underwent laparoscopic RFA. One reintervention was needed (in the laparoscopic RFA group).
Berman et al reported long-term results of the LAP-RFA trial (also known as the HALT trial), which prospectively evaluated the Acessa system for laparoscopic RFA in premenopausal patients (n=135) with uterine myomas and heavy menstrual bleeding (Berman, 2014). Myoma size ranged from 0.7 to 9.7 cm. After 36 months of follow-up (n=104), mean symptom severity decreased by 32.6 points (p<.001) and health-related quality of life was significantly improved (p<.001). Reintervention was needed in 11% (14 of 135) of patients in the full cohort. Berman et al reported on a subgroup analysis of the HALT trial and found a higher disease burden among Black women (n=46) at baseline compared to White women (n=28) based on both symptom score (p≤.001) and health-related quality of life (p=.005) (Berman, 2022).At 36 months, there were no significant differences in symptom scores or health-related quality of life between groups.
Polin et al conducted a systematic review of published reports of pregnancy outcomes following RFA for uterine myomas (Polin, 2022). Ten publications reported the outcome of 40 pregnancies that occurred after laparoscopic RFA and 10 pregnancies that occurred after transcervical RFA. Outcomes included 44 full-term deliveries (24 vaginal, 20 cesarean) and 6 spontaneous abortions. Two delivery complications occurred (1 placenta previa, 1 delayed postpartum hemorrhage). No cases of uterine rupture or fetal complications occurred.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2024. No new literature was identified that would prompt a change in the coverage statement.
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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