Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting
Tóm tắt
This was a single-site cohort study to evaluate the safety of a new transcervical device (VizAblate™) combining real-time intrauterine sonography with radiofrequency (RF) ablation for the treatment of fibroids. Nineteen women with uterine fibroids received treatment with the VizAblate System in a closed abdomen setting prior to hysterectomy. Twelve of these subjects underwent an immediate abdominal hysterectomy after radiofrequency ablation (acute group), while the remaining seven underwent hysterectomy on post-ablation days 16 and 17 (subacute group). Uteri were sectioned and stained with the viability stain triphenyltetrazolium chloride (TTC) to quantify fibroid ablation dimensions and assess the serosa for thermal injury. Subjects in the subacute group were treated with the VizAblate System under conscious sedation; they provided pain and tolerability data for the interval from ablation through hysterectomy, and indicated overall procedural satisfaction. Twenty-two ablations ranging from 1.8 to 36.2 cm3 were created among 19 subjects within 20 fibroids and one region of adenomyosis. There were no complications or thermal serosal injury. For subjects in the subacute group receiving one ablation, the mean total procedure time was 25.8 ± 6.0 min (range 18–32 min). All subjects in the subacute group were discharged within 2 h of the VizAblate procedure. For fibroids ≤ 5 cm, 67.2% ± 27.0% of the fibroid volume was ablated (range 15–100%; median 75%). Transcervical RF ablation of fibroids under intrauterine sonographic guidance with the VizAblate system can be accomplished with a high degree of reliability and without adverse events.
Tài liệu tham khảo
Day Baird D, Dunson DB, Hill MC et al (2003) High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol 188(1):100–107
Dembek CJ, Pelletier EM, Isaacson KB et al (2007) Payer costs in patients undergoing uterine artery embolization, hysterectomy, or myomectomy for treatment of uterine fibroids. J Vasc Interv Radiol 18(10):1207–1213
Manyonda I, Sinthamoney E, Belli AM (2004) Controversies and challenges in the modern management of uterine fibroids. BJOG 111(2):95–102
Goldfarb HA (1992) Avoiding hysterectomy: Nd:YAG laser and bipolar coagulating needle. Clin Laser Mon 10(12):191–193
Goldfarb HA (1995) Bipolar laparoscopic needles for myoma coagulation. J Am Assoc Gynecol Laparosc 2(2):175–179
Bergamini V, Ghezzi F, Cromi A et al (2005) Laparoscopic radiofrequency thermal ablation: a new approach to symptomatic uterine myomas. Am J Obstet Gynecol 192(3):768–773
Carrafiello G, Recaldini C, Fontana F et al (2009) Ultrasound-guided radiofrequency thermal ablation of uterine fibroids: medium-term follow-up. Cardiovasc Intervent Radiol 33(1):113–119. doi:10.1007/s00270-009-9707-3
Cho HH, Kim JH, Kim MR (2008) Transvaginal radiofrequency thermal ablation: a day-care approach to symptomatic uterine myomas. Aust N Z J Obstet Gynaecol 48(3):296–301
Ghezzi F, Cromi A, Bergamini V et al (2007) Midterm outcome of radiofrequency thermal ablation for symptomatic uterine myomas. Surg Endosc 21(11):2081–2085
Luo X, Shen Y, Song W et al (2007) Pathologic evaluation of uterine leiomyoma treated with radiofrequency ablation. Int J Gynecol Obstet 99(1):9–13
Iversen H, Lenz S (2008) Percutaneous ultrasound guided radiofrequency thermal ablation for uterine fibroids: a new gynecological approach. Ultrasound Obstet Gynecol 32(3):325
Kooij SM, Hehenkamp WJ, Volkers NA et al (2010) Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial. Am J Obstet Gynecol 203(2):105.e1–105.e13
Spies JB, Bruno J, Czeyda-Pommersheim F et al (2005) Long-term outcome of uterine artery embolization of leiomyomata. Obstet Gynecol 106(5 Pt 1):933–939
Homer H, Saridogan E (2009) Uterine artery embolization for fibroids is associated with an increased risk of miscarriage. Fertil Steril 94(1):324–330
ACOG Committee Opinion (2004) Uterine artery embolization. Obstet Gynecol 103(2):403–404
Usadi RS, Marshburn PB (2007) The impact of uterine artery embolization on fertility and pregnancy outcome. Curr Opin Obstet Gynecol 19(3):279–283
Bradley LD (2009) Uterine fibroid embolization: a viable alternative to hysterectomy. Am J Obstet Gynecol 201(2):127–135
Katsumori T, Kasahara T, Tsuchida Y et al (2008) Amenorrhea and resumption of menstruation after uterine artery embolization for fibroids. Int J Gynaecol Obstet 103(3):217–221
Morita Y, Ito N, Hikida H et al (2007) Non-invasive magnetic resonance imaging-guided focused ultrasound treatment for uterine fibroids—early experience. Eur J Obstet Gynecol Reprod Biol 139(2):199–203
Stewart EA, Gostout B, Rabinovici J et al (2007) Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol 110(2 Pt 1):279–287
Clevenger-Hoeft M, Syrop CH, Stovall DW et al (1999) Sonohysterography in premenopausal women with and without abnormal bleeding. Obstet Gynecol 94(4):516–520
Sulaiman S, Khaund A, McMillan N et al (2004) Uterine fibroids—do size and location determine menstrual blood loss? Eur J Obstet Gynecol Reprod Biol 115(1):85–89
Funaki K, Fukunishi H, Sawada K (2009) Clinical outcomes of magnetic resonance-guided focused ultrasound surgery for uterine myomas: 24-month follow-up. Ultrasound Obstet Gynecol 34(5):584–589
Emanuel MH, Wamsteker K (2005) The intra uterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12(1):62–66