Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial

Abstract

Aims: Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality – radiofrequency volumetric thermal ablation (RFVTA) – we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided RFVTA or LM. Materials and Methods: Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA to LM for fibroid treatment in women ≥ 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (n = 25) or to LM (n = 25) after laparoscopic ultrasound mapping of the uterus. Results: Post surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1–46) and 7 days (range: 1–83 days) respectively (p = 0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2–86 days) and 17.0 workdays (range: 7–30 days) (p = 0.28), resumed normal activities in 20.5 days (range: 5–103 days) versus 28.0 days (range: 10–42 days) (p = 0.86) respectively. Mean symptom severity scores decreased (improved) by − 7.8 for the ablation subjects and by − 17.9 for the myomectomy subjects (p = 0.16). Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p = 0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants. Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM.

Zusammenfassung

Zielsetzung: Die laparoskopische Enukleation von Myomen (LM) war bislang der Goldstandard bei Frauen mit Wunsch nach Uteruserhalt. Wir evaluieren die ultraschallgesteuerte thermale volumetrische Radiofrequenzablation (RFVTA) als eine neue Therapieoption: die 12-Monats-Ergebnisse von Patientinnen, die aufgrund symptomatischer Uterusmyome in die Therapiearme RFVTA oder LM randomisiert wurden, werden verglichen. Material und Methoden: Es handelt sich um eine 1 : 1 parallele, longitudinale, randomisiert prospektive Single-Center-Vergleichsanalyse zwischen RFVTA und LM bei Frauen ≥ 18 Jahren mit Wunsch nach Uteruserhalt. Nach laparoskopisch gesteuertem Ultraschall-Mapping des Uterus wurden insgesamt 50 Frauen intraoperativ in die beiden Arme RFVTA (n = 25) oder LM (n = 25) randomisiert. Ergebnisse: Nach Ablation und Myomektomie nahmen die Patientinnen für 4 (1–46 d) bzw. 7 Tage (1–83 d) Schmerzmittel ein (p = 0,60), fehlten 10 (2–86 d) bzw. 17 Arbeitstage (7–30 d) (p = 0,28) und kehrten nach 20,5 (5–103 d) vs. 28,0 Tagen (10–42 d) (p = 0,86) wieder zu ihren normalen Aktivitäten zurück. Im Mittel sank der Schweregrad der Symptome um − 7,8 (RFVTA) und um − 17,9 (LM) (p = 0,16). Die gesundheitsbezogene Lebensqualität verbesserte sich um 7,5 bzw 13,1 (p = 0,46). Zwei Schwangerschaften traten nach Myomektomie ein und resultierten in einer Sectio und einer vaginalen Entbindung mit unauffälligen Kindern. Zwei Schwangerschaften im RFVTA-Arm führten zu vaginalen Spontanpartus ebenfalls unauffälliger Neugeborener. Conclusio: Die rasche postoperative Erholungsphase und die 12-Monats-Ergebnisse lassen auf einen ähnlichen klinischen Nutzen der neuen RFVTA-Methode im Vergleich zur LM schließen.

Key words

radiofrequency volumetric thermal ablation - laparoscopic myomectomy - fibroids - laparoscopic ultrasound - Acessa

Schlüsselwörter

Radiofrequenz-volumetrische Thermoablation - laparoskopische Myomektomie - Myome - laparoskopischer Ultraschall - Acessa

^* Joint senior author.

• References

• 1 Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Womenʼs Health 2012; 12: 6 http://www.biomedcentral.com/1472-6874/12/6; Online: http://www.biomedcentral.com/1472-6874/12/6 last access: 07.10.2014
• 2 Taran FA, Tempany CM, Regan L et al. for the MRgFUS Group. Magnetic resonance-guided focused ultrasound (MRgFUS) compared with abdominal hysterectomy for the treatment of uterine leiomyomas. Ultrasound Obstet Gynecol 2009; 34: 572-578
• 3 Twijnstra AR, Kolkman W, Trimbos-Kemper GC et al. Implementation of advanced laparoscopic surgery in gynecology: national overview of trends. J Minim Invasive Gynecol 2010; 17: 487-492
• 4 Munro MG. Uterine leiomyomas, current concepts: pathogenesis, impact on reproductive health, and medical, procedural, and surgical management. Obstet Gynecol Clin North Am 2011; 38: 703-731
• 5 Pritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril 2009; 91: 1215-1223
• 6 Shokeir T, El-Shafei M, Yousef H et al. Submucous myomas and their implications in the pregnancy rates of patients with otherwise unexplained primary infertility undergoing hysteroscopic myomectomy: a randomized matched control study. Fertil Steril 2010; 94: 724-729
• 7 Holzer A, Jirecek ST, Illievich UM et al. Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg 2006; 102: 1480-1484
• 8 Chudnoff SG, Berman JM, Levine DJ et al. Outpatient procedure for the treatment and relief of symptomatic fibroids. Obstet Gynecol 2013; 121: 1075-1082
• 9 Guido RS, Macer JA, Abbott K, Falls JL, Tilley IB, Chudnoff SG. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two yearsʼ outcome from the Halt trial. Health Qual Life Outcomes 2013; 11: 139 http://www.hqlo.com/content/11/1/139; Online: http://www.hqlo.com/content/11/1/139 last access: 07.10.2014
• 10 Berman JM, Guido RS, Garza Leal JG et al. Three yearsʼ outcome from the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol 2014; 21: 767-774
• 11 Brucker SY, Hahn M, Kraemer D et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet 2014; 125: 261-265
• 12 Spies JB, Coyne K, Guaou Guaou N et al. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002; 99: 290-300
• 13 Coyne KS, Margolis MK, Bradley LD et al. Further validation of the uterine fibroid symptom and quality-of-life questionnaire. Value Health 2012; 15: 135-142
• 14 Agency for Healthcare Research and Quality, Rockville MD. U.S. Valuation of the EuroQol EQ-5D Health States. December 2005.. Online: http://www.ahrq.gov/rice/EQ5Dproj.htm last access: 07.10.2014
• 15 Bushnell DM, Martin ML, Moore KA et al. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. CMRO 2010; 26: 2745-2755
• 16 Galen DI, Isaacson KB, Lee BB. Does menstrual bleeding decrease after ablation of intramural myomas? A retrospective study. J Minim Invasive Gynecol 2013; 20: 830-835
• 17 Baird DD, Garrett TA, Laughlin SK et al. Short-term change in growth of uterine leiomyoma: tumor growth spurts. Fertil Steril 2011; 95: 242-246