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Safety and Efficacy of High Intensity Focused Ultrasound Ablation Therapy for Adenomyosis

Rationale and Objectives

In patients with adenomyosis, the severity of symptoms correlates roughly with the extent of adenomyosis. Thus, it was hypothesized that the ablation of enough volume of adenomyosis might alleviate symptoms. The aim of this study was to investigate the safety and efficacy of high-intensity focused ultrasound (HIFU) ablation for the treatment of adenomyosis.

Materials and Methods

Phase I HIFU ablation of adenomyosis was performed on 12 patients. Three patients each were treated using four different acoustic intensities (290, 340, 380, and 420 W) step by step. Contrast-enhanced ultrasound was used to evaluate the necrotic region of treated adenomyosis. The efficacy of therapy was evaluated after 3 months of follow-up.

Results

All patients in the four groups tolerated the therapy well, and no severe complications were found during follow-up. After treatment, nonenhanced necrotic regions were shown on contrast-enhanced ultrasound in all treated adenomyosis. The mean volumes of the nonenhanced regions were 72, 75, 68, and 124 cm 3 in the 290-W, 340-W, 380-W, and 420-W groups, respectively. At 3 months after therapy, the mean pain relief in the four groups was 25%, 58.3%, 66.7%, and 83.3%, respectively.

Conclusions

HIFU may be a safe and effective method to treat adenomyosis, and an acoustic intensity of 420 W may be able to produce larger volumes of necrosis and better pain relief.

Adenomyosis is a common gynecologic disorder that affects women during their reproductive lives. It is characterized by the presence of ectopic endometrial glands and stroma in the myometrium . About two thirds of women are symptomatic with menorrhagia and dysmenorrhea. The usual treatment for symptomatic women is hysterectomy, which may be performed in women who are not intent on preserving their uteruses . However, hysterectomy cannot be performed in patients who either have not completed their families or do not wish to lose their uteruses. Conservative surgery such as the local excision of adenomyotic lesions, while preserving fertility, is difficult because of the ill-defined endometrial-myometrial boundaries . Surgery may also result in fibrotic scars and sutures in surrounding healthy tissue, which can negatively affect future fertility. Hysteroscopic resection may be performed in some women with superficial adenomyosis . Deep adenomyotic lesions cannot be removed using this technique, and residual adenomyosis-related symptoms may remain after therapy. Symptoms may reappear after the discontinuation of drug administration in medical therapies . Thus, a new, effective method for the treatment of patients with adenomyosis would be of great value.

High-intensity focused ultrasound (HIFU) ablation has been used to treat patients with a variety of malignancies using an external ultrasound energy source to induce thermal ablation of tumors at depth, through the intact skin . In contrast to other energy sources that have been used to induce coagulation necrosis of target tumors in clinical practice, such as radiofrequency, microwave, cryotherapy, and laser, HIFU does not require the insertion of an applicator into the target tissue, and thus, there is no risk for puncture-related bleeding and seeding of metastases, and the procedure may be performed in patients with poor blood coagulability. The volume of the necrotic region is not limited by the technique itself, and thus, large-volume or irregular lesions can be ablated under real-time imaging guidance. HIFU ablation has been used to treat patients with uterine fibroids, and the results have shown decreases in fibroid size and associated symptoms . As for adenomyosis, there have been several case reports of using magnetic resonance–guided focused ultrasound for focal adenomyosis, with satisfactory results . Fukunishi et al reported their early results of magnetic resonance–guided focused ultrasound surgery of adenomyosis in 20 patients. Although these results indicated the safe and effective ablation of adenomyosis tissue using focused ultrasound, further studies are needed for the determination of its final value. Unlike previous studies using HIFU guided by magnetic resonance imaging, in this study, we used real-time ultrasound to target lesions during HIFU therapy, because until now, all HIFU transducers in China have been integrated with diagnostic ultrasound probes, and real-time ultrasound has proved a useful technique for guiding HIFU therapy . Thus, this study was designed to evaluate the safety and efficacy of ultrasound-guided HIFU ablation using different ultrasound intensity levels for the treatment of patients with adenomyosis.

Materials and methods

Patients

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Equipment

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Figure 1, The high intensity focused ultrasound (HIFU) apparatus (JC, Chongqing Haifu Tech Co, Ltd, Chongqing, China) used in this study.

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Preparation and Ultrasound Examination

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Treatment

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Figure 2, A schematic diagram of the patient positioning used for the high intensity focused ultrasound (HIFU) ablation. The patient's abdominal skin is in contact with the degassed water.

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Post-treatment Contrast-enhanced Imaging

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Post-treatment Follow-up

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Results

Treatment Data

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Table 1

Treatment Data of High Intensity Focused Ultrasound (HIFU) Ablation Therapy for Adenomyosis

Power (W) Therapy Time (s) Total Power (J) 290 1430 ± 1065 431,267 ± 300,731 340 1132 ± 497 384,637 ± 160,329 380 1637 ± 600 618,895 ± 240,504 420 1820 ± 1475 765,571 ± 618,741

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Safety of HIFU Ablation and Symptom Relief

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Imaging Assessment of HIFU Ablation

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Figure 3, A 31-year-old woman treated by high intensity focused ultrasound (HIFU) ablation (340 W) for adenomyosis. ( a ) Before HIFU ablation, MR T2-weighted image showed the posterior myometrial wall was markedly thickened and showed the typtical features of adenomyosis. ( b ) Transabdominal ultrasonography showed the uterus was globular and the posterior myometrial wall was markedly thickened and heterogeneous (arrow). ( c ) On contrast-enhanced ultrasonography, the affected myometrium showed inhomogeneous enhancement (arrow). ( d ) After HIFU ablation, conventional ultrasound showed the echogenicity of posterior myometrial wall was slightly higher and inhomogeneous (cursors). ( e ) CEUS showed a non-enhanced region (arrows) (61 cm 3 ) with a regular border in treated adenomyosis.

Figure 4, A 39-year-old woman treated by high intensity focused ultrasound (HIFU) ablation (380 W) for adenomyosis. ( a ) Before HIFU ablation, MR T2-weighted image showed the low signal intensity in the posterior myometrial wall with foci of increased signal intensity. ( b ) Transabdominal ultrasonography showed the uterus was enlarged and the posterior myometrial wall was markedly thickened and heterogeneous (arrow). ( c ) On contrast-enhanced ultrasonography, the affected myometrium showed inhomogeneous enhancement (arrow). ( d ) After HIFU ablation, conventional ultrasound showed the echogenicity of posterior uterine wall was slightly higher (arrow). ( e ) CEUS showed a non-enhanced region (142 cm 3 ) in the treated adenomyosis. A few small blood flows (arrows) were showed at the peripheral area of the ablated region.

Table 2

Contrast-Enhanced Ultrasonography of Uterus After High Intensity Focused Ultrasound (HIFU) Ablation Therapy

Power (W) Uterine Volume (cm 3 ) Necrotic Volume (cm 3 ) Volume Percentage of Nonenhanced to the Whole Uterus (%) 290 226 ± 161 72 ± 75 25 ± 15 340 251 ± 125 75 ± 62 26 ± 11 380 253 ± 142 68 ± 51 30 ± 19 420 213 ± 149 124 ± 121 51 ± 15

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Discussion

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