Between March 2006 and February 2008, 11 consecutive premenopausal women with symptomatic uterine fibroids not responsive to medical therapies (including progestin, oral contraceptives, and anti-inflammatory drugs) were recruited by the gynecologist at our hospital in this study to be submitted to RFA treatment.
Our inclusion criteria were women who had completed childbearing and absolutely declined hysterectomy. Exclusion criteria were the presence of more than three fibroids or of one fibroid >8 cm, a gynecological malignant pathology in the past 5 years, a pelvic inflammatory disease, abnormal coagulation tests, breastfeeding, and current pregnancy. All patients were counseled on the potential risks and benefits of the procedure before giving their own written consent. The Institutional Review Board granted authorization to collect data prospectively and approved the study.
All women were assessed regarding the severity of symptoms and the quality of life (QOL) by use of the Uterine Fibroids Symptom and Quality of Life questionnaire (UFS-QOL). This questionnaire consists of eight questions about the severity of the symptoms and 29 health-related quality of life questions. Two scores are calculated, one assesses the symptoms (SSS) and the other the QOL [20
]. Raw scores were converted to a transformed score using the following formula: transformed score = (raw score − 8)/32 × 100. The transformed score varied from 0 to 100, with 100 being the most severely symptomatic. Such clinical evaluation was also repeated 3 months after treatment, at the same time as the instrumental evaluation.
The pretreatment evaluation was performed with transvaginal and suprapubic ultrasound (US) to determine the number, dimensions, and location of the myomas. The uterine fibroids volume was calculated by the following formula: volume = 0.5233 × D1 × D2 × D3, where D1 is the longitudinal dimension, D2 is the anterior-posterior dimension, and D3 is the transverse one [21
Procedures were performed at the day hospital and patients were under moderate sedation (intravenous administration of 1–3 mg midazolam, 1–3 mg fentanyl, and 50–120 mg propofol) in the presence of the anesthetist. All patients received an antibiotic prophylaxis according to an “ultra-short-term antibiotic prophylaxis” scheme with a preprocedural intravenous injection of 1 g of cefazolin to obtain a hematic peak concentration of the medicine at the moment of necrosis.
We used the Le Veen coaxial needle electrode, 3.5 or 4 cm (Boston Scientific, Natick, MA, USA), with 10–14 hooks at the extremity, which were opened during the procedure. In the two patients with fibroids >6 cm, two needle deployments were performed to obtain a volume of necrosis comparable to the volume of fibroids. The needle electrode was connected to a generator (RF 3000 Generator; Boston Scientific) that operates at a maximum power of 250 W and at temperatures ranging from 15 to 125°C; the generator displays the tissue impedance characteristics as well as the ablation power and time. The selected temperature to reach within the tissue was 85°C and the generator automatically adjusted the power to maintain that temperature (150 W).
Real-time suprapubic US was used to perform the procedure transpelvically. To avoid hemorrhagic complications, cauterization of the needle track was obtained at the end of the procedure by setting the generator at 10 W of power while removing the needle.
We evaluated the presence of both intra- and postprocedural minor and major complications in all patients. Minor complications were defined as temporary and self-limiting symptoms requiring no therapy or normal therapy without any clinical sequelae. Major complications were defined as those requiring further interventions and/or hospitalization.
Technical success was assessed 1 day after the procedure by suprapubic US with the administration of a 2.5-ml bolus of second-generation contrast medium (Sonovue; Bracco, Milan, Italy), followed by 10 ml of physiological solution. Contrast-enhanced ultrasound (CEUS) exams were performed with Technos MPX (Esaote Biomedica, Genoa, Italy) and IU 22 (Philips; Best, The Netherlands) ultrasound equipment. Instrumental evaluation of results at 1, 3, 6, 9, and 12 months after treatment was performed by CEUS and the following criteria were assessed: the presence of a necrotic area—defined as a hyphoechoic area without contrast medium enhancement—and diameter reduction.
Statistical analysis was performed with GraphPad Prism version 3.00 for Windows (GraphPad Software, San Diego, CA, USA). Statistical significance was set at P < 0.05.
The aims of the study were, first, to assess the feasibility of RFA of uterine fibroids up to 8 cm and, second, to assess SSS and QOL improvements and volume shrinkage at midterm follow-up.