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Original Research |
1 Department of Radiology, University of Insubria, Viale Borri 57, 21100 Varese,
Italy.
2 Service of Anesthesiology, University of Insubria, Varese, Italy.
3 Department of Obstetrics and Gynecology, University of Verona, Verona,
Italy.
4 Department of Obstetrics and Gynecology, University of Insubria, Varese,
Italy.
Received March 6, 2007;
accepted after revision June 29, 2007.
Address correspondence to C. Recaldini
(chiarec{at}libero.it).
Abstract
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SUBJECTS AND METHODS. Six premenopausal women with symptomatic submucosal or intramural uterine myomas underwent percutaneous radiofrequency ablation under suprapubic sonographic guidance. Relief of symptoms and reduction in the diameter and volume of the myomas were measured every 3 months.
RESULTS. The location of myomas was anterior and submucosal in one of the six patients and intramural in the other five (one posterior, one anterior, two fundal, and one on the left side). Five of the patients had pelvic pain, and four had menorrhagia. The median baseline diameter was 4.8 cm (range, 4.4–5.2 cm), and the mean volume was 58.57 cm3 (range, 44.58–73.58 cm3). The mean follow-up time was 9 months (range, 3–12 months). At follow-up, the median diameter was 2.3 cm (range, 1.20–3.2 cm), and the median volume was 8.97 cm3 (range, 0.90–18.81 cm3). The median preoperative symptom score was 47.2 (31.8–67.30), and the median health-related quality of life (QOL) score was 63.92 (37.20–86.00). The median symptom score during follow-up was 5.15 (range, 0–26), and the mean QOL score was 96.2 (range, 86.30–100). Four of six patients were symptom-free at the last follow-up visit.
CONCLUSION. Percutaneous sonographically guided radiofrequency ablation alone is a feasible and efficient procedure in the management of medium-sized uterine myomas.
Keywords: radiofrequency thermal ablation • sonography • uterine myoma
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Radiofrequency ablation has become a widespread technique for achieving local control of tumors in various organs [16]. It also has been reported to be a reliable alternative procedure for relief of pain and reduction of size of uterine myomas. The procedure can be performed under laparoscopic guidance [13, 14] and percutaneously, in the latter case in association with uterine artery embolization [15]. We assessed the feasibility and safety of percutaneous radiofrequency ablation under sonographic guidance as a unique procedure in the management of symptomatic uterine myomas.
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r3 where r is the mean radius of the fibroid
calculated from the longitudinal, transverse, and anteroposterior diameters of
the lesion. Follow-up was performed by transvaginal sonography 1, 3, 6, 9, and
12 months after treatment. All patients underwent a thorough clinical
evaluation, which included the symptom severity score of the Uterine Fibroids
Symptom and Quality of Life questionnaire
[17]. The questionnaire
consists of eight questions addressing the frequency and severity of symptoms
and 29 questions on health-related quality of life (QOL). Two distinct scores
were calculated for symptom severity and QOL. Higher symptom scores are
indicative of greater symptom severity, and higher QOL scores indicate a
better health-related QOL. Clinical evaluation was performed every 3 months
after treatment. Percutaneous radiofrequency ablation was performed under moderate sedation with IV midazolam (1–3 mg), fentanyl (1–3 mg), and propofol (50–120 mg), according to the principles of monitored anesthesia care. One gram of cefazolin was administered as a prophylactic antibiotic.
The radiofrequency ablation delivery system (RF 3000 Generator, Boston Scientific) consisted of a radiofrequency generator operating at 460 kHz with maximum power of 250 W and a temperature range of 15–125°C. The generator displayed the tissue impedence, power, and ablation time. The target temperature in the tissue was set at 85°C, and power was set at 150 W. Grounding pads were placed on the anterior portions of both thighs of the patient. A coaxial 3.5- or 4-cm needle electrode (LeVeen Needle Electrode, Boston Scientific) was used. The LeVeen applicator consists of 10–14 expandable electrodes at the distal tip. The tip of the applicator and electrode tips expand fully before ablation. The target temperature in the tissue was set at 85°C. The radiofrequency generator automatically adjusts the power to maintain the selected temperature.
Suprapubic sonography was used as a real-time guide for the procedure performed with the transabdominal approach. The depth of needle insertion was determined with real-time sonographic views in two orthogonal planes. Suprapubic contrast-enhanced sonography with a bolus of 2.5 mL of second-generation contrast agent (aqueous suspension of phospholipid-stabilized microbubbles filled with sulfur hexafluoride, SonoVue, Bracco) followed by 10 mL of saline solution was used to assess complete ablation at the end of the procedure (Figs. 1A, 1B and 2A, 2B). Contrast-enhanced sonographic examinations were performed with a sonographic system (Technos MPX, Esaote Biomedica) with harmonic microbubble-specific imaging (contrast-tuned imaging) with low acoustic sonographic pressure (mechanical index, 0.093–0.157).
To avoid hemorrhagic complications, cauterization of the needle track was performed at the end of the procedure by application of radiofrequency current and by setting the generator at 10 W of power while the needle was withdrawn. Patients were evaluated for minor and major complications during the procedure and immediately afterward. Minor complications were defined as temporary and self-limiting symptoms necessitating no additional therapy and without clinical sequelae. Major complications were defined as those necessitating further interventions or hospitalization. Patients were admitted to the gynecologic day hospital in the morning and discharged in the evening.
The primary study end point was feasibility of radiofrequency ablation as single procedure performed percutaneously under sonographic guidance. Feasibility was assessed as the ability to introduce the needle percutaneously into the target lesion and to fully expand the tip to the maximum diameter. The secondary end point was improvement of symptoms and QOL and reduction in volume of the uterine myomas.
Statistical analysis was performed with the GraphPad Prism program version 3.00 for Windows (GraphPad Software). The Wilcoxon's matched-pairs test was used to compare the volumes and the percentages of volume reduction of the treated myomas and the Uterine Fibroids Symptom and Quality of Life scores. Statistical significance was considered achieved at p < 0.05.
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In all patients, the needle was introduced into the myoma and the tip expanded to full size without difficulty. The operative time varied from 15 to 25 minutes (median, 20 minutes). No intraoperative or postoperative complications occurred. Two patients reported mild abdominal pain necessitating nonsteroidal antiinflammatory drugs. One patient had sonographic evidence of a small fluid collection in the pelvis at the end of the procedure. All patients were discharged in the evening of the day of the procedure. The mean follow-up period was 9 months (range, 3–12 months). At the last follow-up visit, the median fibroid diameter was 2.3 cm (range, 1.20–3.2 cm), and the median fibroid volume was 8.97 cm3 (range, 0.90–18.81 cm3), a significant reduction in size. The median symptom score was 5.15 (range, 0–26), and the QOL score was 96.2 (range, 86.30–100). Four of the six patients were free of symptoms at the last follow-up visit. No repeat interventions were necessary during the follow-up period. The evolution of diameter and volume reduction and the changes in symptom score and in health-related QOL for each patient are shown in Table 1.
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Compared with other thermal ablation techniques (bipolar and monopolar coagulation, laser coagulation, cryotherapy), radiofrequency ablation is a relatively inexpensive, easy, and efficient procedure that can be repeated in the same session or at a later time. Radiofrequency generators are widely available in many hospitals for other tumor ablation therapies, and the equipment is simple to use. Larger areas of necrosis (up to 6 cm in diameter) can be achieved in a single access with radiofrequency ablation than can be achieved with other thermal ablative tools, particularly laser fibers and monopolar and bipolar needles. The advantage of using a single insertion is reduction of the risk of injury and adhesions.
When radiofrequency ablation is performed with a percutaneous approach, the skin access is smaller than with other thermal ablation techniques and there is no need for general anesthesia. As Pelage [18] emphasized, the percutaneous transabdominal approach can be challenging for the deep position of the fibroids and the uterus. An endorectal approach may be suitable for posterior fibroids and myomas in the lower uterine segment, but use of the endorectal route increases the risk of bowel injury. A transcervical approach may even be feasible, although interventional radiologists may be more confident with a suprapubic approach. We believe the difficulties related to choice of approach can be overcome by accurate selection of patients on the basis of location of myomas on preprocedural images and by the experience of the operator, who should be skilled in percutaneous procedures on superficial and deep organs. We believe interventional radiologists are the most suitable professionals to perform the procedure in association with a team of gynecologists.
Patient selection should be accurate and exclude patients with myomas larger than 6 cm or with more than three myomas, because multiple probe positions are necessary to obtain complete ablation. In these circumstances, the risk of visceral injury and recurrence is high, and patients should be referred to undergo other minimally invasive techniques, such as uterine embolization.
Sonography provides real-time guidance for needle deployment within a myoma without damage to other organs. The use of contrast-enhanced sonography has the advantage of precise targeting within highly vascularized areas. Contrast-enhanced sonography depicts changes in tissue echotexture during the procedure and the presence of residual viable tissue, which is useful for assessing the success of the procedure. Contrast-enhanced sonography can be used in follow-up to predict clinical failure or recurrence. In our experience, contrast-enhanced sonography has been a readily available and reliable tool for fast evaluation of residual vascularization. At our hospital we do not perform routine preprocedural imaging or follow-up with MRI as is done elsewhere [19]. It would be interesting to compare the results of contrast-enhanced sonography and MRI in follow-up evaluation of residual vital tissue.
Radiofrequency ablation has a low rate of complications [20]. In our study, we found no major complications, including bleeding. Bleeding can be successfully prevented by the use of a track ablation technique to coagulate perimyoma vessels along the access path. In addition, the risk of peritoneal adhesion in theory is reduced to a minimum compared with the risk associated with laparoscopic and conventional surgical approaches. We were not able to evaluate the rate of adhesion in our study because none of the patients needed second-look laparoscopic or abdominal surgery.
The results of our study should be considered preliminary. Further studies with larger numbers of patients and longer follow-up are necessary to assess the benefits of percutaneous radiofrequency ablation for primary management of uterine myomas. Accurate selection criteria for ablative procedures are mandatory for the success of the procedure.
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