OBJECTIVE: To estimate the safety and efficacy of laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women.
METHODS: A cohort of 135 premenopausal symptomatic women with uterine myomas, uteri 14 weeks of gestation-sized or less with no single myoma exceeding 7 cm, and objectively confirmed heavy menstrual bleeding participated in this prospective, international trial of outpatient laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation. Bleeding outcomes were measured by alkaline hematin analysis at baseline and again at 3, 6, and 12 months posttreatment. Validated quality-of-life and patient satisfaction scales and objective measurements of uterine and myoma volume were conducted at 3, 6, and 12 months.
RESULTS: The mean baseline menstrual blood loss of women in the full analysis set (n=127) was 272.7±82.3 mL. At 3-, 6-, and 12-month follow-ups, mean alkaline hematin and associated menstrual blood loss decreased from baseline levels by 31.8%, 40.7%, and 38.3%, respectively (P<.001, paired t test). Symptom severity decreased from a baseline mean transformed score of 61.1 to 26.6 at 12 months postprocedure (P<.001, paired t test). Health-related quality of life improved from a mean transformed score of 37.3 at baseline to 79.5 at 12 months (P<.001, paired t test). At 12 months postprocedure, total mean myoma volume decreased from baseline by 45.1% (measured by magnetic resonance imaging). There was one serious adverse event (one of 135 [0.7%]) requiring readmission 5 weeks postprocedure and one surgical reintervention for persistent bleeding. Ninety-four percent of the women reported satisfaction with the treatment.
CONCLUSION: Radiofrequency volumetric thermal ablation of myomas is well tolerated and results in rapid recovery, high patient satisfaction, improved quality of life, and effective symptom relief.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874029.
LEVEL OF EVIDENCE: II
Outpatient, laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas is effective in relieving myoma-related symptoms in women with uteri sized less than 14 weeks of gestation.
Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Einstein and Moses Divisions, Albert Einstein College of Medicine, New York, New York; the Department of Obstetrics and Gynecology, Division of Gynecology, Wayne State University School of Medicine, Detroit, Michigan; St John's Mercy Hospital, St. Louis, Missouri; Women's Health Research, Phoenix, Arizona; and the University of Pittsburgh Medical School, Magee-Women's Hospital, Pittsburgh, Pennsylvania.
Corresponding author: Scott G. Chudnoff, MD, MS, Centennial Women's Center, Montefiore Medical Center, 3332 Rochambeau Avenue, New York, NY 10467; e-mail: email@example.com.
Supported by Halt Medical, Brentwood, California. Drs. Chudnoff, Berman, Levine, Harris, Guido, and Banks are investigators in the ongoing study: Laparoscopic Radiofrequency Ablation of Symptomatic Uterine Myomas, which is sponsored by Halt Medical. The authors received only materials and administrative support from the sponsor to conduct the study. For a list of other members of the Halt Study Group, see the Appendix online at http://links.lww.com/AOG/A366.
Financial Disclosure All authors' institutions received clinical research support from Halt Medical. Dr. Berman is on the speaker's bureau for Merck and is a consultant for Halt Medical, receives clinical research support from, and is on the Scientific Advisory Board and speaker's bureau for Boston Scientific. Dr. Levine receives clinical research support from Idoman, Ltd. Dr. Guido receives clinical research support from Dysplasia Research and is a board member of the American Society of Colposcopy and Cervical Pathology.
The authors thank Fredrick S. Whaley, PhD, of Innovative Analytics for statistical analysis and Mimi Wainwright for research and editorial support. Halt Medical paid Innovative Analytics and Wainwright Medical Communications for their work.
Presented at the American Association of Gynecologic Laparoscopists 41st Global Congress of Minimally Invasive Gynecology, November 5-9, 2012, Las Vegas, Nevada.