{"paper_id":"36490713-4f6a-4667-8d39-c3d95eb54570","body_text":"UPDATE Minimally invasive gynecologic surgery\nIN THIS  \nARTICLE\nRadiofrequency ablation may address the treatment gap for women with \nfibroids who want a uterine-sparing option and future fertility\nUterine-sparing \ntreatments\npage 38\nRFA technique\npage 39\nRFA unique \nbenefits\npage 40\nMelanie Polin, MD\nDr. Polin is a Resident in Obstetrics and \nGynecology, Columbia University Irving \nMedical Center and New York-Presbyterian \nHospital, New York, New York.\nArnold P. Advincula, MD\nDr. Advincula is Levine Family Professor of \nWomen’s Health; Vice-Chair, Department of \nObstetrics and Gynecology, Sloane Hospital \nfor Women; and Medical Director, Mary \nand Michael Jaharis Simulation Center, \nColumbia University Irving Medical Center, \nNew York-Presbyterian Hospital. He serves \non the OBG Management Board of Editors.\nHye-Chun Hur, MD, MPH\nDr. Hur is an Associate Professor of \nObstetrics and Gynecology, Columbia \nUniversity Irving Medical Center and  \nNew York-Presbyterian Hospital.\nDr. Advincula reports that he serves as a consultant for AbbVie, Baxter, ConMed, CooperSurgical, Eximis Surgical, Intuitive Surgical, and Titan Medical,  \nand that he receives royalties from CooperSurgical. Dr. Hur reports serving as an author for UpToDate, Inc. Dr. Polin reports no financial relationships relevant \nto this article.\ndoi: 10.12788/obgm.0147\nU\nterine fibroids are a common condi -\ntion that affects up to 80% of repro -\nductive-age women. 1 Many women \nwith fibroids are asymptomatic, but some \nexperience symptoms that profoundly dis -\nrupt their lives, such as abnormal uterine \nble\neding, pelvic pain, and bulk symptoms \nincluding bladder and bowel dysfunction. 2 \nAlthough hysterectomy remains the defini -\ntive treatment for symptomatic fibroids, many \nw\nomen seek more conservative management. \nHormonal treatment, such as contraceptive \npills, levonorgestrel intrauterine devices, and \ngonadotropin-releasing \nhormone analogs, \ncan improve heavy menstrual bleeding and \nanemia.\n3 Additionally, uterine artery emboli -\nzation is a nonsurgical uterine-sparing option. \nH\nowever, these treatments are not ideal \noptions for women who want to conceive.4 For \nreproductive-age women who desire future \nfertility, myomectomy has been the standard \nof care. Unfortunately, by the time patients \nbecome symptomatic from their fibroids and \nseek care, they may have numerous and/or \nsizable fibroids that result in high blood loss, \nsurgical scarring, and the probable need for \ncesarean delivery (\nFIGURES 1 AND 2).5\nFor patients who desire future conception, \ntreatment of uterine fibroids poses a challenge \nin which optimizing symptomatic improve -\nment must be balanced with protecting fertil-\nity and improving reproductive outcomes. In \nr\necent years, high-intensity focused ultrasound \n(FUS) and radiofrequency ablation (RFA) have \n36  OBG Management  |   November 2021  |   Vol. 33  No. 11  mdedge.com/obgyn\nFIGURE 1   Large multifibroid uterus \nrequiring extensive uterine incisions for \ncomplete removal\nFIGURE 2   Multifibroid uterus with 60 fibroids removed\n\n\nFAST  \nTRACK\nmdedge.com/obgyn  V ol. 33  No. 11  |   November 2021   |   OBG Management   37\nMyomectomy \ncan be performed \nvia laparotomy, \nlaparoscopy, robot-\nassisted surgery, \nand hysteroscopy\n©KIMBERLY MARTENS FOR OBG MANAGEMENT\nbeen presented as less invasive, uterine-spar-\ning alternatives for fibroid treatment that could \np\notentially provide that balance.\nIn this article, we briefly review the avail-\nable uterine-sparing fibroid treatments and \ntheir o\nutcomes and then focus \nspecifically on RFA as a possible \noption to address the fibroid treat-\nment gap for reproductive-age \nw\nomen who desire future fertility.\nOverview of uterine-sparing treatments\nT\nwo approaches can be pursued for \nconservative fibroid treatment: fibroid \nremoval and fibroid necrosis (\nTABLE 1).  \nWe focus this review on outcomes for the \nmos\nt widely available of these treatments.\nMyomectomy\nFor reproductive-age women who wish to \nconceive, surgical removal of fibroids has \nbeen the standard of care for symptomatic \npatients. Myomectomy can be performed via \nlaparotomy, laparoscopy, robot-assisted sur-\ngery, and hysteroscopy. The mode of surgery \ndep\nends on the fibroid characteristics (size, \nnumber, and location) and the surgeon’s skill \nset. Although some variation in the data exists, \noverall surgical outcomes, including blood \nloss, postoperative pain, and length of stay, are \ngenerally more favorable for minimally inva -\nsive approaches compared with laparotomy, \nw\nith no significant differences in fibroid recur-\nrence or reproductive outcomes (live birth \nr\nate, miscarriage rate, and cesarean delivery \nrate).6 This comes at the expense of longer \noperating time compared with laparotomy.7\nWhile improvement in abnormal uterine \nbleeding and pelvic pain is reliable and usually \nsignificant after myomectomy,\n8 reproductive \nimplications also warrant consideration. Myo-\nmectomy is associated with subsequent uterine \nadhes\nion formation, with some studies find -\ning rates up to 83% to 94% depending on the \ns\nurgical approach and the number of fibroids \nremoved.9 These adhesions can impair fertil -\nity success.10 Myomectomy also is associated \nwith high rates of cesarean delivery,5 invasive \nplacentation (including placenta accreta spec-\ntrum),11 and uterine rupture.12 While the latter \n2 complications are rare, they potentially can be \ncatastrophic and should be kept in mind.\nUterine artery embolization\nAs a nonsurgical alternative to myomec -\ntomy, uterine artery embolization (UAE) has \ng\nained popularity as a conservative fibroid \ntreatment since it was introduced in 1995. It \nis less invasive than myomectomy, a benefit \nfor patients who decline surgery or are not \nideal candidates for surgery.\n13 Evidence sug -\ngests that UAE produces overall comparable  \nsymptomatic improvement compared with \nm\nyomectomy. One study showed no signifi -\ncant differences between UAE and myomec-\ntomy in terms of decreased uterine volume and \nmens\ntrual bleeding at 6-month follow-up. 14  \nIn terms of long-term outcomes, a large multi-\ncenter study showed no significant difference \nin r\neintervention rates at 7 years posttreat -\nment between UAE and myomectomy (8.9% \nvs 11.2%, r\nespectively), and a significantly \nhigher rate of improved menstrual bleeding \nwith UAE (79.4% vs 49.5%), with no significant \ndifference in bulk symptoms.\n15 The evidence \nTABLE 1   Available uterine-sparing fibroid  \ntreatment options\nFibroid removal Fibroid necrosis\nMyomectomy\n•\n Hyster\noscopic myomectomy\n•\n Lapar\noscopic myomectomy\n•\n Robot-assisted lapar\noscopic \nmyomectomy\n•\n Abdominal myomectomy\nUterine artery embolization\nFocused ultrasound ablation\n•\n Magnetic r\nesonance guided\n•\n Ultrasound guided\nRadiofr\nequency ablation \n•\n Lapar\noscopic\n•\n T\nranscervical\n\nUPDATE Minimally invasive gynecologic surgery\nFAST  \nTRACK\n38  OBG Management  |   November 2021  |   Vol. 33  No. 11  mdedge.com/obgyn\nEvidence suggests \nthat UAE produces \noverall comparable \nsymptomatic \nimprovement \ncompared with \nmyomectomy\nis not entirely consistent, as other studies have \nshown increased rates of reintervention with \nUAE,\n8,16 but overall UAE can be considered \na reasonable alternative to myomectomy in \nterms of symptomatic improvement.\nPregnancy outcomes data, however, are \nmixed, and UAE often is not recommended \nfor patients with future fertility plans. In a \nlarge review article that compared minimally \ninvasive fibroid treatments, UAE was associ -\nated with a lower live birth rate compared with \nm\nyomectomy and ablation techniques (60.6% \nfor UAE, 75.6% for myomectomy, and 70.5% for \nablation), and it also had the highest rate of mis-\ncarriage (27.4% for UAE vs 19.0% for myomec-\ntomy and 11.9% for ablation) and abnormal \npl\nacentation.12 While UAE remains an effective \noption for conservative treatment of symptom-\natic fibroids, it appears to have a worse impact \non r\neproductive outcomes compared with \nmyomectomy or ablative treatments.\nMagnetic resonance–guided \nfocused ultrasound\nEmerging as a noninvasive ablation treat -\nment for fibroids, magnetic resonance–\ng\nuided focused ultrasound (MRgFUS) uses \ntargeted high-intensity ultrasound pulses to \ncause thermal and mechanical fibroid tissue \ndisruption.\n17 Data on this treatment are less \nrobust given that it is newer than myomec -\ntomy or UAE. One study showed a decrease \nin fibr\noid volume by 12% at 1 month and  \n15% at 6 months, with 37.1% of patients report-\ning marked improvement in symptoms and an \naddition\nal 31.4% reporting partial improve -\nment; these are modest numbers compared \nw\nith other treatment approaches. 18 Another \nstudy showed more favorable outcomes, with \n74% of patients reporting clinically significant \nimprovement in bleeding and pain, and a \n12.7% reintervention rate, comparable to rates \nreported for UAE and myomectomy.\n19\nBecause MRgFUS is newer than UAE or \nmyomectomy, data are limited in terms of preg-\nnancy outcomes, particularly because initial tri-\nals excluded women with future fertility plans \ndue t\no lack of knowledge regarding pregnancy \nsafety. A follow-up case series from one of the \ninitial studies showed a decreased miscar -\nriage rate compared with UAE, a term delivery \nr\nate of 93%, and a similar rate of abnormal pla-\ncentation.20 A more recent systematic review \nconcluded that reproductive outcomes were \nnoninferior to myomectomy; however, the out-\ncomes data for MRgFUS were heterogenous and \nm\nany studies did not report pregnancy rates.21\nOverall, MRgFUS appears to be an effec-\ntive alternative approach for symptomatic \nfibr\noids, but the long-term data are not yet \nconclusive and information on pregnancy \nsafety and outcomes largely is lacking. Recent \nreviews have not made definitive statements \non whether MRgFUS should be offered to \npatients desiring future fertility.\nRFA is a promising option \nR\nFA is another noninvasive fibroid \nablation technique that has become \nmore widely adopted in recent years. \nHere, we describe the basics of RFA and  \nits impact on fibroid symptoms and repro -\nductive outcomes.\nThe RFA technique\nRFA uses hyperthermic energy from a \nhandpiece and real-time ultrasound for \ntargeted coagulative necrosis via a laparo -\nscopic (L-RFA) or transcervical (TC-RFA) \na\npproach.22 A comparison between the  \n2 devices available on the market in the United \nS\ntates is shown in TABLE 2. Ultrasound guidance \nallows placement of radiofrequency needles \ndirectly into the fibroid to target local treatment \nto the fibroid tissue only. Once the fibroid under-\ngoes coagulative necrosis, the process of fibroid \nr\nesorption and volume reduction occurs over \nweeks to months, depending on the fibroid size.\n\nmdedge.com/obgyn  V ol. 33  No. 11  |   November 2021   |   OBG Management   39\nTABLE 2   Comparison between radiofrequency ablation approaches\nLaparoscopic RFA Transcervical RFA \nAvailable technology in the \nUnited States\nAcessa (Hologic) Sonata system (Gynesonics)\nYear of FDA approval 2012 2018\nMode of surgery Laparoscopic Vaginal\nAccess Need 3 small incisions  \n(for laparoscope, US probe, and RF device)\nIncisionless procedure \n(1 device for US probe and RF device)\nHandpiece design Percutaneous device with  \n7 deployable needle electrodes \nTransvaginal device with  \n7 deployable needle electrodes\nUltrasound Separate laparoscopic ultrasound device Built-in intrauterine ultrasound probe\nEnergy source Radiofrequency Radiofrequency\nTissue effect Coagulative necrosis Coagulative necrosis\nPivotal clinical trial Guido et al, 2013\n26 \nTwo-year follow-up results:\nMiller et al, 201924 \nTwo-year follow-up results:\nReintervention rate 4.8% 5.5%\nPatient satisfaction 98% of patients reported satisfaction 94% of patients reported satisfaction\nHealth-related quality-of-life \nmean score\n37.3 (pre-RFA) to 79.3 (2 years after L-RFA) 40 (pre-RFA) to 83 (2 years after TC-RFA)\nAdverse outcomes 1 serious AE (postpartum hemorrhage involving \nfibroid tissue expulsion)\n2 (1.4%) serious AEs (deep vein thrombosis)\nAbbreviations: AE, adverse event; FDA, Food and Drug Administration; L-RFA: laparoscopic radiofrequency ablation; RF , radiofrequency; TC-RFA: transcervical \nradiofrequency ablation; US, ultrasound.\nImpact on fibroid symptoms\nBoth laparoscopic and transcervical RFA \napproaches have shown significant decreases in \npelvic pain and heavy menstrual bleeding asso-\nciated with fibroids and a low reintervention rate \nth\nat emphasizes the durability of their impact. \nA feasibility and safety study of a TC-RFA \ndevice prior to the primary clinical trials found \nonly a 4.3% reintervention rate in the first 18 \nmonths postprocedure.\n23 The pivotal clinical trial \nof a TC-RFA device that followed also reported a \nlow 5.5% reintervention rate in the first 24 months \npostprocedure, with significant improvement in \nhealth-related quality of life and high patient sat-\nisfaction\n24 (results shown in TABLE 2, along with \ntrial results for an L-RFA device). A subsequent \nstudy of TC-RFA reported that symptomatic \nimprovement persisted at 3-year follow-up, with \na 9.2% reintervention rate comparable to exist-\ning fibroid treatments such as myomectomy and \nUA\nE.25 The original L-RFA trial also has shown \nsimilar positive results at 2-year follow-up, with \na low reintervention rate of 4.8% after treatment, \nand similar patient satisfaction and quality-of-\nlife improvements as TC-RFA.\n26 While long-\nterm data are limited by only recent approval \nby the Food and Drug Administration (FDA) \nof a TC-RFA device in 2018, one study followed \nclinical trial patients for a mean duration of 64 \nmonths. This study found no surgical reinter-\nventions in the first 3.5 years posttreatment and \na p\nersistent reduction in fibroid symptoms from \nbaseline 64.9 points to 27.6 points, as assessed \nby a validated symptom severity scale (out of \n100 points).\n27 Similar improvements in health-\nrelated quality of life were also found to persist \nfor years posttreatment.\n4\nIn a large systematic review that compared \nL-RFA, MRgFUS, UAE, and myomectomy, \nL-RFA had similar improvement rates in quality \nof life and symptom severity scores compared \nwith myomectomy, with no significant differ -\nence in reintervention rates.\n28 This review also \nnoted minimal heterogeneity among RFA meta-\nanalyses data in contrast to significant heteroge-\nneity among UAE and myomectomy data.\nCONTINUED ON PAGE 40\n\nUPDATE Minimally invasive gynecologic surgery\n40  OBG Management  |   November 2021  |   Vol. 33  No. 11  mdedge.com/obgyn\nReproductive outcomes\nSimilar to MRgFUS, the initial studies of RFA \ndevices largely excluded women with future \nfertility plans, as data on safety were lacking. \nHowever, many RFA devices are now on the \nmarket across the globe, and subsequent \npregnancies have been tracked and reported.\nA large case series that included clini -\ncal trials and commercial settings reported a \nmis\ncarriage rate (13.3%) similar to that of the \ngeneral obstetric population and no cases \nof uterine rupture, invasive placentation, \npreterm delivery, or placental abruption.\n29 \nOther case series have reported live birth \nrates similar those with myomectomy, and \nsafe and favorable pregnancy outcomes with \nRFA have been supported by larger system -\natic reviews of all ablation techniques.\n12\nUterine impact\nOne study of TC-RFA patients showed a greater \nthan 65% reduction in fibroid volume (with a 90% \nreduction in fibroid volume for fibroids larger \nthan 6 cm prior to RFA), and 54% of patients \nreported complete resolution of symptoms, \nwith another 36% reporting decreased symp -\ntoms.\n30 Similar decreases in fibroid volume, \nranging from 65% to 84%, have been reported \nin numerous follow-up studies, with significant \ndecreases in bleeding and pain in 78% to 88% of \npatients.\n23,31-33 Additionally, a large secondary \nanalysis of a TC-RFA clinical trial showed that \npatients did not have any significant decrease \nin uterine wall thickness or integrity on follow-\nup with magnetic resonance imaging compared \nwith baseline measurements, and they did not \nhave any new myometrial scars (assessed as \nnonperfused linear areas).\n22\nAs with other ablation techniques, most \ndata on RFA pregnancy outcomes come from \ncase series, and further research and evaluation \nare needed. Existing studies, however, have dem-\nonstrated promising aspects of RFA that argue its \nus\nefulness in women with fertility plans.\nA prospective trial that evaluated intrauter-\nine adhesion formation with use of a TC-RFA \nde\nvice found no new adhesions on 6-week fol-\nlow-up hysteroscopy compared with baseline \npr\ne-RFA hysteroscopy.34 Because intrauterine \nadhesion formation and uterine rupture are \nboth significant concerns with other uterine-\nsparing fibroid treatment approaches such as \nmyomectomy, these findings suggest that RFA \nmay be a better alternative for women who are \nplanning future pregnancies, as they may have \nincreased fertility success and decreased cata-\nstrophic complications.\nThe cons\nensus is growing that RFA is a \nsafe and effective option for women who \ndesire minimally invasive fibroid treatment \nand want to preserve fertility.\nUnique benefits of RFA\nIn this article, we highlight RFA as an emerging \ntreatment option for fibroid management, par-\nticularly for women who desire a uterine-spar-\ning approach to preserve their reproductive \noptions\n. Although myomectomy has been the \nstandard of care for many years, with UAE as \nthe alternative nonsurgical treatment, neither \napproach provides the best balance between \nsymptomatic improvement and reproductive \noutcomes, and neither is without pregnancy \nrisks. In addition, many women with symp -\ntomatic fibroids do not desire future concep-\ntion but decline fibroid removal for religious or \np\nersonal reasons. RFA offers these women an \nalternative minimally invasive option for uter-\nine-sparing fibroid treatment.\nRF\nA presents a unique “incision-free” \nfibroid treatment that is truly minimally \ninvasive. This technique minimizes the \nrisks associated with myomectomy, such \nas intra-abdominal adhesions, intrauterine \nadhesions (Asherman syndrome), need for \ncesarean delivery, and pregnancy compli -\ncations such as uterine rupture or invasive \nWHAT THIS EVIDENCE MEANS FOR PRACTICE\nThe RFA data suggest that both laparoscopic and transcervical RFA \noffer a safe and effective alternative treatment option for patients \nwith symptomatic fibroids who seek uterine-sparing treatment, and \ntranscervical RFA offers the least invasive treatment option. Women \nwith fibroids who wish to conceive currently face a challenging \ntreatment gap in clinical medicine, and future research is needed to \naddress this concern in these patients. RFA is promising and appears \nto be a better fertility-enabling conservative fibroid treatment than the \ncurrent options of myomectomy or UAE.\nCONTINUED FROM PAGE 39\n\nmdedge.com/obgyn  V ol. 33  No. 11  |   November 2021   |   OBG Management   41\nplacentation. Furthermore, the evolution of \nan RFA transcervical approach has enabled \ntreatment with no abdominal or uterine inci-\nsions, thus offering all the above reproduc -\ntive benefits as well as the operative benefits \nof a fas\nter recovery, less pain, and less risk of \nintraperitoneal surgical complications.\nWhile many women desire uterine-sparing \nfibroid treatment even without future fertility \nplans, the larger question is whether we should \ntreat fibroids more strategically for women who \ndesire future fertility. Myomectomy and UAE are \neffective and reliable in terms of fibroid symp-\ntomatic improvement, but RFA promises more \nb\neneficial reproductive outcomes. The ability \nto avoid uterine myometrial incisions and still \nattain significant symptomatic improvement \nshould be prioritized in these patients.\nCurrently, RFA is not approved by the \nFDA as a fertility-enabling treatment, and \nthese patients have been largely excluded \nfrom RFA studies. However, the reproductive-\nage patient who desires future conception \nmay benefit most from RFA. Furthermore, \nRFA technology also could address the gap in \nuterine-sparing treatment for reproductive-\nage women with adenomyosis. Although a \ncomplete review of adenomyosis treatment is \nbeyond the scope of this article, recent stud -\nies show that RFA produces similar improve-\nment in both uterine volume and symptom \ns\neverity in women with adenomyosis.35-37 ●\nReferences\n1. B aird DD, Dunson DB, Hill MC, et al. High cumulative inci-\ndence of uterine leiomyoma in black and white women: ultra-\nsound evidence. Am J Obstet Gynecol. 2003;188:100-107.\n2.\n S\ntewart EA. Clinical practice. Uterine fibroids. N Engl J Med. \n2015;372:1646-1655.\n3. Amer ican College of Obstetricians and Gynecologists. ACOG \npractice bulletin no. 96: alternatives to hysterectomy in the man-\nagement of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.\n4. G upta JK, Sinha A, Lumsden MA, et al. Uterine artery embo-\nlization for symptomatic uterine fibroids. Cochrane Database \nSyst Rev. 2014;CD005073.\n5.\n P\naul GP , Naik SA, Madhu KN, et al. Complications of laparo-\nscopic myomectomy: a single surgeon’s series of 1001 cases. \nAust N Z J Obstet Gynaecol. 2010;50:385-390.\n6.\n F\nlyckt R, Coyne K, Falcone T . Minimally invasive myomec -\ntomy. Clin Obstet Gynecol. 2017;60:252-272.\n7.\n B\nean EM, Cutner A, Holland T , et al. Laparoscopic myomec-\ntomy: a single-center retrospective review of 514 patients.  \nJ Minim Invasive Gynecol. 2017;24:485-493.\n8.\n Br\noder MS, Goodwin S, Chen G, et al. 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J Minim Invasive Gynecol.  \n2020;27:639-645.\n30.\n J\nones S, O’Donovan P , Toub D. Radiofrequency ablation for \ntreatment of symptomatic uterine fibroids. Obstet Gynecol Int. \n2012;2012:194839.\n31.\n B\nergamini V , Ghezzi F , Cromi A, et al. Laparoscopic radiofre-\nquency thermal ablation: a new approach to symptomatic \nuterine myomas. Am J Obstet Gynecol. 2005;192:768-773.\n32.\n G\nhezzi F , Cromi A, Bergamini V , et al. Midterm outcome of \nradiofrequency thermal ablation for symptomatic uterine \nmyomas. Surg Endosc. 2007;21:2081-2085.\n33.\n S\nzydłowska I, Starczewski A. Laparoscopic coagulation of \nuterine myomas with the use of a unipolar electrode. Surg \nLaparosc Endosc Percutan Tech. 2007;17:99-103.\n34.\n B\nongers M, Quinn SD, Mueller MD et al. Evaluation of uterine \npatency following transcervical uterine fibroid ablation with \nthe Sonata system (the OPEN clinical trial). Eur J Obstet Gyne-\ncol Reprod Biol. 2019;242:122-125.\n35.\n H\nai N, Hou Q, Ding X, et al. Ultrasound-guided transcervical \nradiofrequency ablation for symptomatic uterine adenomyo-\nsis. Br J Radiol. 2017;90:201601132. \n36.\n P\nolin M, Krenitsky N, Hur HC. Transcervical radiofrequency \nablation for symptomatic adenomyosis: a case report.  \nJ Minim Invasive Gyn. 2021;28:S152-S153.\n37.\n S\ncarperi S, Pontrelli G, Campana C, et al. Laparoscopic radio-\nfrequency thermal ablation for uterine adenomyosis. JSLS . \n2015;19:e2015.00071.","source_license":"CC0","license_restricted":false}