MR-Guided HIFU Treatment of Symptomatic Uterine Fibroids Using Novel Feedback-Regulated Volumetric Ablation: Effectiveness and Clinical Practice

 

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Abstract

Purpose: To evaluate a novel feedback-regulated volumetric sonication method in MR-guided HIFU treatment of symptomatic uterine fibroids.

Materials and Methods: 27 fibroids with an average volume of 124.9 ± 139.8 cc in 18 women with symptomatic uterine fibroids were ablated using the new HIFU system Sonalleve (1.5 T MR system Achieva, Philips). 21 myomas in 13 women were reevaluated 6 months later. Standard (treatment) cells (TC) and feedback-regulated (feedback) cells (FC) with a diameter of 4, 8, 12, and 16 mm were used and compared concerning sonication success, diameter of induced necrosis, and maximum achieved temperature. The non-perfused volume ratio (NPV related to myoma volume) was quantified. The fibroid volume was measured before, 1 month, and 6 months after therapy. Symptoms were quantified using a specific questionnaire (UFS-QoL).

Results: In total, 205 TC and 227 FC were applied. The NPV ratio was 23 ± 15 % (2 – 55). The TC were slightly smaller than intended (–3.9 ± 52 %; range, –100 – 81), while the FC were 20.1 ± 25.3 % bigger (p = 0.02). Feedback mechanism is less diversifying in diameter (p < 0.001). Overall, the FC correlate well with the planned treatment diameter (r = 0.79), other than the TC (r = 0.38). Six months after therapy, the fibroid volume was reduced by 45 ± 21 % (5 – 100) (p = 0.001). The symptoms decreased significantly (p = 0.001). No serious adverse events were recorded.

Conclusion: Use of volumetric sonication leads to homogenous heating and sufficient necrosis. It is a safe and effective therapy for treating symptomatic uterine fibroids. Successful sonication of feedback cells leads to more contiguous necrosis in diameter and a less diversifying temperature.

Key Points:

• MR-guided HIFU ablation of symptomatic uterine fibroids is a valuable treatment option.

• By non-invasive HIFU fibroid volumes can be reduced and symptoms improved.

• The novel feedback-regulated treatment cells offer advantages over standard treatment cells.

Citation Format:

• Ruhnke H, Eckey T, Bohlmann M K et al. MR-Guided HIFU Treatment of Symptomatic Uterine Fibroids Using Novel Feedback-Regulated Volumetric Ablation: Effectiveness and Clinical Practice. Fortschr Röntgenstr 2013; 185: 983-991

Zusammenfassung

Ziel: Evaluation einer neuartigen, volumetrischen Sonifikationsmethode mittels Feedback-Regulation in der MR-gesteuerten HIFU-Therapie symptomatischer Uterusmyome.

Material und Methoden: 27 symptomatische Uterusmyome mit einer Größe von 124,9 ± 139,8 ml bei 18 Patientinnen wurden mit dem neuen HIFU-System Sonalleve (1,5 T MRT Achieva, Philips) behandelt, 21 Myome von 13 Pat. wurden nach 6 Monaten nachuntersucht. Bei der Therapie wurden Standard-Therapiezellen (TC) und Feedback-kontrollierte Therapiezellen (FC) mit den Durchmessern 4, 8, 12 und 16 mm benutzt und hinsichtlich Erfolgsrate, Durchmesser der induzierten Nekrose und Temperaturentwicklung verglichen. Die Ausdehnung der induzierten Nekrose (NPV) wurde bestimmt. Die Myomvolumina wurden vor, 1 und 6 Monate nach Therapie ausgemessen und die Symptomatik mittels eines spezifischen Fragebogens (UFS-QoL) bewertet.

Ergebnisse: Es wurden 205 TC durchgeführt und 227 FC. Dabei wurde ein NPV-Anteil der Myome von 23 ± 15 % (2 – 55) induziert. TC sind im Durchmesser 3,9 ± 52 % (–100 – 81) kleiner als geplant, FC dagegen 20,1 ± 25,3 % (–100 – 70) größer (p = 0,02). Die Größenvarianz der Nekrosen mit Feedback-Mechanismus ist geringer (p < 0,001), FC zeigen insgesamt eine gute Korrelation zum geplanten Zelldurchmesser (r = 0,79), anders als TC (r = 0,38). Nach 6 Monaten war das Myomvolumen um 45 ± 21 % (5 – 100) reduziert (p = 0,001). Die Symptomatik konnte signifikant reduziert werden (p = 0,001) Es traten in der Nachsorge keinerlei unerwünschte Nebenwirkungen auf.

Schlussfolgerung: Die Anwendung der volumetrischen Sonifikation mittels Feedback-regulierter Therapiezellen führt zu kontrollierter Erwärmung und suffizienter Nekrotisierung und stellt damit eine sichere und effektive Therapiemethode dar. Dies bestätigt die MR-gesteuerte HIFU als nicht invasives und attraktives Verfahren bei symptomatischen Uterusmyomen.

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