2021 Update on minimally invasive gynecologic surgery

UPDATE Minimally invasive gynecologic surgery IN THIS ARTICLE Radiofrequency ablation may address the treatment gap for women with fibroids who want a uterine-sparing option and future fertility Uterine-sparing treatments page 38 RFA technique page 39 RFA unique benefits page 40 Melanie Polin, MD Dr. Polin is a Resident in Obstetrics and Gynecology, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York. Arnold P. Advincula, MD Dr. Advincula is Levine Family Professor of Women’s Health; Vice-Chair, Department of Obstetrics and Gynecology, Sloane Hospital for Women; and Medical Director, Mary and Michael Jaharis Simulation Center, Columbia University Irving Medical Center, New York-Presbyterian Hospital. He serves on the OBG Management Board of Editors. Hye-Chun Hur, MD, MPH Dr. Hur is an Associate Professor of Obstetrics and Gynecology, Columbia University Irving Medical Center and New York-Presbyterian Hospital. Dr. Advincula reports that he serves as a consultant for AbbVie, Baxter, ConMed, CooperSurgical, Eximis Surgical, Intuitive Surgical, and Titan Medical, and that he receives royalties from CooperSurgical. Dr. Hur reports serving as an author for UpToDate, Inc. Dr. Polin reports no financial relationships relevant to this article. doi: 10.12788/obgm.0147 U terine fibroids are a common condi - tion that affects up to 80% of repro - ductive-age women. 1 Many women with fibroids are asymptomatic, but some experience symptoms that profoundly dis - rupt their lives, such as abnormal uterine ble eding, pelvic pain, and bulk symptoms including bladder and bowel dysfunction. 2 Although hysterectomy remains the defini - tive treatment for symptomatic fibroids, many w omen seek more conservative management. Hormonal treatment, such as contraceptive pills, levonorgestrel intrauterine devices, and gonadotropin-releasing hormone analogs, can improve heavy menstrual bleeding and anemia. 3 Additionally, uterine artery emboli - zation is a nonsurgical uterine-sparing option. H owever, these treatments are not ideal options for women who want to conceive.4 For reproductive-age women who desire future fertility, myomectomy has been the standard of care. Unfortunately, by the time patients become symptomatic from their fibroids and seek care, they may have numerous and/or sizable fibroids that result in high blood loss, surgical scarring, and the probable need for cesarean delivery ( FIGURES 1 AND 2).5 For patients who desire future conception, treatment of uterine fibroids poses a challenge in which optimizing symptomatic improve - ment must be balanced with protecting fertil- ity and improving reproductive outcomes. In r ecent years, high-intensity focused ultrasound (FUS) and radiofrequency ablation (RFA) have 36 OBG Management | November 2021 | Vol. 33 No. 11 mdedge.com/obgyn FIGURE 1 Large multifibroid uterus requiring extensive uterine incisions for complete removal FIGURE 2 Multifibroid uterus with 60 fibroids removed FAST TRACK mdedge.com/obgyn V ol. 33 No. 11 | November 2021 | OBG Management 37 Myomectomy can be performed via laparotomy, laparoscopy, robot- assisted surgery, and hysteroscopy ©KIMBERLY MARTENS FOR OBG MANAGEMENT been presented as less invasive, uterine-spar- ing alternatives for fibroid treatment that could p otentially provide that balance. In this article, we briefly review the avail- able uterine-sparing fibroid treatments and their o utcomes and then focus specifically on RFA as a possible option to address the fibroid treat- ment gap for reproductive-age w omen who desire future fertility. Overview of uterine-sparing treatments T wo approaches can be pursued for conservative fibroid treatment: fibroid removal and fibroid necrosis ( TABLE 1). We focus this review on outcomes for the mos t widely available of these treatments. Myomectomy For reproductive-age women who wish to conceive, surgical removal of fibroids has been the standard of care for symptomatic patients. Myomectomy can be performed via laparotomy, laparoscopy, robot-assisted sur- gery, and hysteroscopy. The mode of surgery dep ends on the fibroid characteristics (size, number, and location) and the surgeon’s skill set. Although some variation in the data exists, overall surgical outcomes, including blood loss, postoperative pain, and length of stay, are generally more favorable for minimally inva - sive approaches compared with laparotomy, w ith no significant differences in fibroid recur- rence or reproductive outcomes (live birth r ate, miscarriage rate, and cesarean delivery rate).6 This comes at the expense of longer operating time compared with laparotomy.7 While improvement in abnormal uterine bleeding and pelvic pain is reliable and usually significant after myomectomy, 8 reproductive implications also warrant consideration. Myo- mectomy is associated with subsequent uterine adhes ion formation, with some studies find - ing rates up to 83% to 94% depending on the s urgical approach and the number of fibroids removed.9 These adhesions can impair fertil - ity success.10 Myomectomy also is associated with high rates of cesarean delivery,5 invasive placentation (including placenta accreta spec- trum),11 and uterine rupture.12 While the latter 2 complications are rare, they potentially can be catastrophic and should be kept in mind. Uterine artery embolization As a nonsurgical alternative to myomec - tomy, uterine artery embolization (UAE) has g ained popularity as a conservative fibroid treatment since it was introduced in 1995. It is less invasive than myomectomy, a benefit for patients who decline surgery or are not ideal candidates for surgery. 13 Evidence sug - gests that UAE produces overall comparable symptomatic improvement compared with m yomectomy. One study showed no signifi - cant differences between UAE and myomec- tomy in terms of decreased uterine volume and mens trual bleeding at 6-month follow-up. 14 In terms of long-term outcomes, a large multi- center study showed no significant difference in r eintervention rates at 7 years posttreat - ment between UAE and myomectomy (8.9% vs 11.2%, r espectively), and a significantly higher rate of improved menstrual bleeding with UAE (79.4% vs 49.5%), with no significant difference in bulk symptoms. 15 The evidence TABLE 1 Available uterine-sparing fibroid treatment options Fibroid removal Fibroid necrosis Myomectomy • Hyster oscopic myomectomy • Lapar oscopic myomectomy • Robot-assisted lapar oscopic myomectomy • Abdominal myomectomy Uterine artery embolization Focused ultrasound ablation • Magnetic r esonance guided • Ultrasound guided Radiofr equency ablation • Lapar oscopic • T ranscervical UPDATE Minimally invasive gynecologic surgery FAST TRACK 38 OBG Management | November 2021 | Vol. 33 No. 11 mdedge.com/obgyn Evidence suggests that UAE produces overall comparable symptomatic improvement compared with myomectomy is not entirely consistent, as other studies have shown increased rates of reintervention with UAE, 8,16 but overall UAE can be considered a reasonable alternative to myomectomy in terms of symptomatic improvement. Pregnancy outcomes data, however, are mixed, and UAE often is not recommended for patients with future fertility plans. In a large review article that compared minimally invasive fibroid treatments, UAE was associ - ated with a lower live birth rate compared with m yomectomy and ablation techniques (60.6% for UAE, 75.6% for myomectomy, and 70.5% for ablation), and it also had the highest rate of mis- carriage (27.4% for UAE vs 19.0% for myomec- tomy and 11.9% for ablation) and abnormal pl acentation.12 While UAE remains an effective option for conservative treatment of symptom- atic fibroids, it appears to have a worse impact on r eproductive outcomes compared with myomectomy or ablative treatments. Magnetic resonance–guided focused ultrasound Emerging as a noninvasive ablation treat - ment for fibroids, magnetic resonance– g uided focused ultrasound (MRgFUS) uses targeted high-intensity ultrasound pulses to cause thermal and mechanical fibroid tissue disruption. 17 Data on this treatment are less robust given that it is newer than myomec - tomy or UAE. One study showed a decrease in fibr oid volume by 12% at 1 month and 15% at 6 months, with 37.1% of patients report- ing marked improvement in symptoms and an addition al 31.4% reporting partial improve - ment; these are modest numbers compared w ith other treatment approaches. 18 Another study showed more favorable outcomes, with 74% of patients reporting clinically significant improvement in bleeding and pain, and a 12.7% reintervention rate, comparable to rates reported for UAE and myomectomy. 19 Because MRgFUS is newer than UAE or myomectomy, data are limited in terms of preg- nancy outcomes, particularly because initial tri- als excluded women with future fertility plans due t o lack of knowledge regarding pregnancy safety. A follow-up case series from one of the initial studies showed a decreased miscar - riage rate compared with UAE, a term delivery r ate of 93%, and a similar rate of abnormal pla- centation.20 A more recent systematic review concluded that reproductive outcomes were noninferior to myomectomy; however, the out- comes data for MRgFUS were heterogenous and m any studies did not report pregnancy rates.21 Overall, MRgFUS appears to be an effec- tive alternative approach for symptomatic fibr oids, but the long-term data are not yet conclusive and information on pregnancy safety and outcomes largely is lacking. Recent reviews have not made definitive statements on whether MRgFUS should be offered to patients desiring future fertility. RFA is a promising option R FA is another noninvasive fibroid ablation technique that has become more widely adopted in recent years. Here, we describe the basics of RFA and its impact on fibroid symptoms and repro - ductive outcomes. The RFA technique RFA uses hyperthermic energy from a handpiece and real-time ultrasound for targeted coagulative necrosis via a laparo - scopic (L-RFA) or transcervical (TC-RFA) a pproach.22 A comparison between the 2 devices available on the market in the United S tates is shown in TABLE 2. Ultrasound guidance allows placement of radiofrequency needles directly into the fibroid to target local treatment to the fibroid tissue only. Once the fibroid under- goes coagulative necrosis, the process of fibroid r esorption and volume reduction occurs over weeks to months, depending on the fibroid size. mdedge.com/obgyn V ol. 33 No. 11 | November 2021 | OBG Management 39 TABLE 2 Comparison between radiofrequency ablation approaches Laparoscopic RFA Transcervical RFA Available technology in the United States Acessa (Hologic) Sonata system (Gynesonics) Year of FDA approval 2012 2018 Mode of surgery Laparoscopic Vaginal Access Need 3 small incisions (for laparoscope, US probe, and RF device) Incisionless procedure (1 device for US probe and RF device) Handpiece design Percutaneous device with 7 deployable needle electrodes Transvaginal device with 7 deployable needle electrodes Ultrasound Separate laparoscopic ultrasound device Built-in intrauterine ultrasound probe Energy source Radiofrequency Radiofrequency Tissue effect Coagulative necrosis Coagulative necrosis Pivotal clinical trial Guido et al, 2013 26 Two-year follow-up results: Miller et al, 201924 Two-year follow-up results: Reintervention rate 4.8% 5.5% Patient satisfaction 98% of patients reported satisfaction 94% of patients reported satisfaction Health-related quality-of-life mean score 37.3 (pre-RFA) to 79.3 (2 years after L-RFA) 40 (pre-RFA) to 83 (2 years after TC-RFA) Adverse outcomes 1 serious AE (postpartum hemorrhage involving fibroid tissue expulsion) 2 (1.4%) serious AEs (deep vein thrombosis) Abbreviations: AE, adverse event; FDA, Food and Drug Administration; L-RFA: laparoscopic radiofrequency ablation; RF , radiofrequency; TC-RFA: transcervical radiofrequency ablation; US, ultrasound. Impact on fibroid symptoms Both laparoscopic and transcervical RFA approaches have shown significant decreases in pelvic pain and heavy menstrual bleeding asso- ciated with fibroids and a low reintervention rate th at emphasizes the durability of their impact. A feasibility and safety study of a TC-RFA device prior to the primary clinical trials found only a 4.3% reintervention rate in the first 18 months postprocedure. 23 The pivotal clinical trial of a TC-RFA device that followed also reported a low 5.5% reintervention rate in the first 24 months postprocedure, with significant improvement in health-related quality of life and high patient sat- isfaction 24 (results shown in TABLE 2, along with trial results for an L-RFA device). A subsequent study of TC-RFA reported that symptomatic improvement persisted at 3-year follow-up, with a 9.2% reintervention rate comparable to exist- ing fibroid treatments such as myomectomy and UA E.25 The original L-RFA trial also has shown similar positive results at 2-year follow-up, with a low reintervention rate of 4.8% after treatment, and similar patient satisfaction and quality-of- life improvements as TC-RFA. 26 While long- term data are limited by only recent approval by the Food and Drug Administration (FDA) of a TC-RFA device in 2018, one study followed clinical trial patients for a mean duration of 64 months. This study found no surgical reinter- ventions in the first 3.5 years posttreatment and a p ersistent reduction in fibroid symptoms from baseline 64.9 points to 27.6 points, as assessed by a validated symptom severity scale (out of 100 points). 27 Similar improvements in health- related quality of life were also found to persist for years posttreatment. 4 In a large systematic review that compared L-RFA, MRgFUS, UAE, and myomectomy, L-RFA had similar improvement rates in quality of life and symptom severity scores compared with myomectomy, with no significant differ - ence in reintervention rates. 28 This review also noted minimal heterogeneity among RFA meta- analyses data in contrast to significant heteroge- neity among UAE and myomectomy data. CONTINUED ON PAGE 40 UPDATE Minimally invasive gynecologic surgery 40 OBG Management | November 2021 | Vol. 33 No. 11 mdedge.com/obgyn Reproductive outcomes Similar to MRgFUS, the initial studies of RFA devices largely excluded women with future fertility plans, as data on safety were lacking. However, many RFA devices are now on the market across the globe, and subsequent pregnancies have been tracked and reported. A large case series that included clini - cal trials and commercial settings reported a mis carriage rate (13.3%) similar to that of the general obstetric population and no cases of uterine rupture, invasive placentation, preterm delivery, or placental abruption. 29 Other case series have reported live birth rates similar those with myomectomy, and safe and favorable pregnancy outcomes with RFA have been supported by larger system - atic reviews of all ablation techniques. 12 Uterine impact One study of TC-RFA patients showed a greater than 65% reduction in fibroid volume (with a 90% reduction in fibroid volume for fibroids larger than 6 cm prior to RFA), and 54% of patients reported complete resolution of symptoms, with another 36% reporting decreased symp - toms. 30 Similar decreases in fibroid volume, ranging from 65% to 84%, have been reported in numerous follow-up studies, with significant decreases in bleeding and pain in 78% to 88% of patients. 23,31-33 Additionally, a large secondary analysis of a TC-RFA clinical trial showed that patients did not have any significant decrease in uterine wall thickness or integrity on follow- up with magnetic resonance imaging compared with baseline measurements, and they did not have any new myometrial scars (assessed as nonperfused linear areas). 22 As with other ablation techniques, most data on RFA pregnancy outcomes come from case series, and further research and evaluation are needed. Existing studies, however, have dem- onstrated promising aspects of RFA that argue its us efulness in women with fertility plans. A prospective trial that evaluated intrauter- ine adhesion formation with use of a TC-RFA de vice found no new adhesions on 6-week fol- low-up hysteroscopy compared with baseline pr e-RFA hysteroscopy.34 Because intrauterine adhesion formation and uterine rupture are both significant concerns with other uterine- sparing fibroid treatment approaches such as myomectomy, these findings suggest that RFA may be a better alternative for women who are planning future pregnancies, as they may have increased fertility success and decreased cata- strophic complications. The cons ensus is growing that RFA is a safe and effective option for women who desire minimally invasive fibroid treatment and want to preserve fertility. Unique benefits of RFA In this article, we highlight RFA as an emerging treatment option for fibroid management, par- ticularly for women who desire a uterine-spar- ing approach to preserve their reproductive options . Although myomectomy has been the standard of care for many years, with UAE as the alternative nonsurgical treatment, neither approach provides the best balance between symptomatic improvement and reproductive outcomes, and neither is without pregnancy risks. In addition, many women with symp - tomatic fibroids do not desire future concep- tion but decline fibroid removal for religious or p ersonal reasons. RFA offers these women an alternative minimally invasive option for uter- ine-sparing fibroid treatment. RF A presents a unique “incision-free” fibroid treatment that is truly minimally invasive. This technique minimizes the risks associated with myomectomy, such as intra-abdominal adhesions, intrauterine adhesions (Asherman syndrome), need for cesarean delivery, and pregnancy compli - cations such as uterine rupture or invasive WHAT THIS EVIDENCE MEANS FOR PRACTICE The RFA data suggest that both laparoscopic and transcervical RFA offer a safe and effective alternative treatment option for patients with symptomatic fibroids who seek uterine-sparing treatment, and transcervical RFA offers the least invasive treatment option. Women with fibroids who wish to conceive currently face a challenging treatment gap in clinical medicine, and future research is needed to address this concern in these patients. RFA is promising and appears to be a better fertility-enabling conservative fibroid treatment than the current options of myomectomy or UAE. CONTINUED FROM PAGE 39 mdedge.com/obgyn V ol. 33 No. 11 | November 2021 | OBG Management 41 placentation. Furthermore, the evolution of an RFA transcervical approach has enabled treatment with no abdominal or uterine inci- sions, thus offering all the above reproduc - tive benefits as well as the operative benefits of a fas ter recovery, less pain, and less risk of intraperitoneal surgical complications. While many women desire uterine-sparing fibroid treatment even without future fertility plans, the larger question is whether we should treat fibroids more strategically for women who desire future fertility. Myomectomy and UAE are effective and reliable in terms of fibroid symp- tomatic improvement, but RFA promises more b eneficial reproductive outcomes. The ability to avoid uterine myometrial incisions and still attain significant symptomatic improvement should be prioritized in these patients. Currently, RFA is not approved by the FDA as a fertility-enabling treatment, and these patients have been largely excluded from RFA studies. However, the reproductive- age patient who desires future conception may benefit most from RFA. Furthermore, RFA technology also could address the gap in uterine-sparing treatment for reproductive- age women with adenomyosis. Although a complete review of adenomyosis treatment is beyond the scope of this article, recent stud - ies show that RFA produces similar improve- ment in both uterine volume and symptom s everity in women with adenomyosis.35-37 ● References 1. B aird DD, Dunson DB, Hill MC, et al. High cumulative inci- dence of uterine leiomyoma in black and white women: ultra- sound evidence. Am J Obstet Gynecol. 2003;188:100-107. 2. S tewart EA. Clinical practice. Uterine fibroids. N Engl J Med. 2015;372:1646-1655. 3. Amer ican College of Obstetricians and Gynecologists. ACOG practice bulletin no. 96: alternatives to hysterectomy in the man- agement of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400. 4. G upta JK, Sinha A, Lumsden MA, et al. 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