Rationale and Objectives
To evaluate the long-term clinical outcomes of magnetic resonance–guided high-intensity focused ultrasound (MR-g HIFU) treatments for symptomatic uterine leiomyomata.
Materials and Methods
Patients were recruited for a prospective study for MR-g HIFU treatments of symptomatic leiomyomata, with up to 3-year follow-up. The study was approved by the institutional review board and was Health Insurance Portability and Accountability Act–compliant. Clinical assessments were obtained at 3 months, 6 months, and 1, 2, and 3 years after MR-g HIFU, as well as uterine fibroid symptom severity scores (SSS) and health-related quality of life questionnaires (UFS-QOL). MR imaging was performed at each follow-up to assess the efficacy of the treatment at 6 months, 1 year, 2 years, and 3 years.
Results
Fifty-one leiomyomata in 40 patients were treated. All patients were treated within the US Food and Drug Administration guidelines with leiomyomata localized on MR and treated with sonication. The mean baseline volume of treated leiomyomata was 336.9 cm 3 . The mean improvement scores for transformed SSS was 47.8 ( P < .001) and for tUFS-QOL was 39.8 ( P < .001) at 3 years. The mean volume decrease in treated leiomyomata was 32.0% ( P < .001), and, in the uterus, the volume decrease was 27.7% ( P < .001) at 3 years. There were no long-term complications.
Conclusions
Long-term follow-up data from MR-g HIFU treatments show sustained symptomatic relief among enrolled patients. Although the results are preliminary, MR-g HIFU for the treatment of uterine leiomyomata may result in acceptable long-term outcomes at 3 years.
Uterine leiomyomata occur in approximately 20%–50% of women of reproductive age . Symptoms are found in less than 50% of women; however, uterine leiomyomata can cause significant morbidity in pre- and perimenopausal women. Traditionally, gold standard therapy has been a hysterectomy. In the United States alone, hysterectomy is performed in more than 600,000 women annually and uterine leiomyomata account for approximately 30%–60% of all hysterectomies performed in middle-age women . More than $1.2 billion is spent each year associated with hysterectomies . The cost is even greater when accounted for the loss of women’s productivity during 6–8 weeks of recovery time after hysterectomy or myomectomy is considered.
Less invasive surgical techniques have been studied. Myomectomy is performed in 35,000–40,000 women for the treatment of uterine leiomyomata . Laparoscopic and hysteroscopic myomectomy have gained popularity as uterus-conserving surgeries . These less invasive techniques are restricted with regard to size and location of leiomyoma and still require general anesthesia. Laparoscopic thermoablative myolysis has shown significant variability in clinical efficacy .
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Materials and methods
Patients
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MR-g HIFU Techniques
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MR Imaging Parameters
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Study Endpoints
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Statistical Analysis
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Results
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Table 1
Clinical Assessment: tSSS and tQOL
tSSS tQOL Time Mean Value (95% CI) Mean Change (95% CI) Mean Value (95% CI) Mean Change (95% CI) Baseline 64.8 (59.1–70.6) 44.1 (37.7–50.6) 3 month 35.3 (29.3, 41.3) −29.5 (−37.8, −21.3) 68.8 (62.1–75.6) 24.6 (15.4–34.1) 6 month 32.2 (26.3–38.2) −32.6 (−40.9 to −24.3) 68.6 (61.9–75.4) 24.5 (15.2–33.9) 1 year 40.5 (32.5–48.7) −24.3 (−34.2 to −14.3) 68.7 (59.6–77.9) 24.6 (13.4–35.8) 2 year 18.0 (8.0–28.1) −46.8 (−58.4 to −35.2) 86.1 (74.8–97.5) 42.0 (28.9–51.2) 3 year 17.0 (8.9, 25.1) −47.8 (−57.7, −37.9) 83.9 (74.5–93.3) 39.8 (28.3–51.2)
QOL, quality of life; tQOL, transformed quality of life; tSSS, transformed symptom severity scale.
Table 2
Subgroup Analysis of Uterine Fibroid Symptom - Quality Of Life Questionnaire
Mean Concern Mean Activities Mean Energy Mean Control Mean Consciousness Mean Sexual Function Baseline 47.8 (39.6–56.0) 44.0 (36.3–51.7) 45.4 (38.0–52.8) 45.1 (36.9–53.3) 29.2 (20.2–38.2) 51.1 (42.3–59.8) 3 month 69.4 (60.9–78.0) 68.1 (60.1–76.1) 69.9 (62.2–77.6) 71.8 (63.3–80.4) 59.7 (50.4–69.1) 72.3 (63.2–81.3) 6 month 72.2 (63.6–80.6) 71.0 (63.1–79.0) 71.2 (63.5–78.9) 72.2 (63.6–80.7) 60.1 (50.8–69.5) 75.7 (66.7–84.8) 1 year 71.3 (59.7–82.8) 68.2 (57.4–79.1) 72.5 (62.1–82.9) 73.8 (62.1–85.4) 48.8 (36.1–61.5) 68.1 (55.7–80.5) 2 year 90.8 (76.4–105.1) 82.3 (75.9–102.7) 89.6 (76.7–102.5) 86.5 (72.1–100.9) 62.8 (47.0–78.6) 85.6 (70.2–100.9) 3 year 87.4 (75.5–99.2) 82.9 (71.8–94.0) 85.3 (74.6–96.1) 87.4 (75.5–99.3) 69.3 (56.2–82.4) 86.8 (74.1–99.5)
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Table 3
Volume Changes in Leiomyomata, Uterus, and Nonperfused Area within the Treatment Zone
Time Leiomyoma Volume (cm 3 ) Uterine Volume (cm 3 ) Nonperfused Leiomyoma Volume (cm 3 ) Mean Value (95% CI) Mean Change (95% CI), % Change Mean Value
(95% CI) Mean Change
(95% CI), % Change Mean Value
(95% CI) Mean Change
(95% CI), % Change Baseline 336.9 (295.2–378.6) 978.7 (925.1–1032.3) 7.1
(−11.6 to 25.8), 2.1% Immediate posttreatment 108.1 (87.5–128.7), 32.1% 101.0 (76.6–125.5),
1422.5% 6 month 273.6 (229.3–318.0) −63.3 (−96.5 to −30.0), −18.7% 875.0 (819.2–930.8) −103.7 (−159.4 to −47.9), −10.5% 45.0 (25.2–64.9), 16.5% 40.0 (14.1–61.9),
563.4% 1 year 249.7 (207.7–291.7) −87.2 (−127.7 to −46.7), −25.8% 835.9 (782.4–889.5) −142.7 (−209.8 to −75.7), −14.5% 39.4 (14.9–63.8), 15.8% 32.3 (3.9–60.7),
454.9% 2 year 243.1 (192.2, 293.9) −93.9 (−142.5 to −45.2), −27.6% 762.9 (687.9–837.9) −215.7 (−296.4 to −135.1), −22.0% 26.6 (−4.2 to 57.5), 10.9% 19.6(−15.2 to 54.4),
276.1% 3 year 228.4 (171.9–284.8) −108.5 (165.5 to −51.4), −32.0% 707.3 (622.2–792.4) −271.4 (−365.1 to −177.7), −27.7% 30.5 (−7.0 to 68.0), 13.4% 23.4 (−17.5 to 64.3),
329.6%
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Discussion
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Conclusion
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