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. 2015 May;75(5):442-449.
doi: 10.1055/s-0035-1545931.

Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial

M Hahn  1 , S Brucker  1 , D Kraemer  1 , M Wallwiener  2 , F-A Taran  1 , C W Wallwiener  1 , B Krämer  1
Affiliations

Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial

M Hahn et al. Geburtshilfe Frauenheilkd. 2015 May.

Abstract
in English, German

Aims: Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality - radiofrequency volumetric thermal ablation (RFVTA) - we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided RFVTA or LM. Materials and Methods: Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA to LM for fibroid treatment in women ≥ 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (n = 25) or to LM (n = 25) after laparoscopic ultrasound mapping of the uterus. Results: Post surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1-46) and 7 days (range: 1-83 days) respectively (p = 0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days) (p = 0.28), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) (p = 0.86) respectively. Mean symptom severity scores decreased (improved) by - 7.8 for the ablation subjects and by - 17.9 for the myomectomy subjects (p = 0.16). Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p = 0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants. Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM.

Zielsetzung: Die laparoskopische Enukleation von Myomen (LM) war bislang der Goldstandard bei Frauen mit Wunsch nach Uteruserhalt. Wir evaluieren die ultraschallgesteuerte thermale volumetrische Radiofrequenzablation (RFVTA) als eine neue Therapieoption: die 12-Monats-Ergebnisse von Patientinnen, die aufgrund symptomatischer Uterusmyome in die Therapiearme RFVTA oder LM randomisiert wurden, werden verglichen. Material und Methoden: Es handelt sich um eine 1 : 1 parallele, longitudinale, randomisiert prospektive Single-Center-Vergleichsanalyse zwischen RFVTA und LM bei Frauen ≥ 18 Jahren mit Wunsch nach Uteruserhalt. Nach laparoskopisch gesteuertem Ultraschall-Mapping des Uterus wurden insgesamt 50 Frauen intraoperativ in die beiden Arme RFVTA (n = 25) oder LM (n = 25) randomisiert. Ergebnisse: Nach Ablation und Myomektomie nahmen die Patientinnen für 4 (1–46 d) bzw. 7 Tage (1–83 d) Schmerzmittel ein (p = 0,60), fehlten 10 (2–86 d) bzw. 17 Arbeitstage (7–30 d) (p = 0,28) und kehrten nach 20,5 (5–103 d) vs. 28,0 Tagen (10–42 d) (p = 0,86) wieder zu ihren normalen Aktivitäten zurück. Im Mittel sank der Schweregrad der Symptome um − 7,8 (RFVTA) und um − 17,9 (LM) (p = 0,16). Die gesundheitsbezogene Lebensqualität verbesserte sich um 7,5 bzw 13,1 (p = 0,46). Zwei Schwangerschaften traten nach Myomektomie ein und resultierten in einer Sectio und einer vaginalen Entbindung mit unauffälligen Kindern. Zwei Schwangerschaften im RFVTA-Arm führten zu vaginalen Spontanpartus ebenfalls unauffälliger Neugeborener. Conclusio: Die rasche postoperative Erholungsphase und die 12-Monats-Ergebnisse lassen auf einen ähnlichen klinischen Nutzen der neuen RFVTA-Methode im Vergleich zur LM schließen.

Keywords: Acessa; fibroids; laparoscopic myomectomy; laparoscopic ultrasound; radiofrequency volumetric thermal ablation.

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Conflict of interest statement

Conflict of Interest Halt Medical, Inc. (Brentwood, California USA) sponsored the study and provided materials and funding for the described procedures and for independent third-party monitoring, statistical analyses, and writing support. None of the authors have other commercial disclosures.

Figures

Fig. 1
Fig. 1
Disposition of subjects throughout study. Flow of subjects through 12 months of follow-up (modified from Figure 1, reference 11).
Fig. 2 a
Fig. 2 a
and b  a Laparoscopic myomectomy. Intraoperative view of sutured uterus after laparoscopic myomectomy. Hemostasis achieved. b Radiofrequency volumetric thermal ablation (RFVTA). Intraoperative view of uterus during RFVTA of an intramural fibroid with handpiece (left) and transducer (right). Hemostasis via tract coagulation is achieved upon withdrawal of the handpiece.
Fig. 3
Fig. 3
Mean transformed uterine fibroid symptom severity scores. Symptom Severity scores for both radiofrequency volumetric thermal ablation (RFVTA) and laparoscopic myomectomy (LM) subjects. Note: The sample sizes at baseline, 3 months, 6 months, and 12 months are 25, 24, 23, and 18 for the RFVTA group; 25, 25, 22, and 20 for the LM group.
Fig. 4
Fig. 4
Mean transformed uterine fibroid health-related quality-of-life scores. Health-Related Quality of Life scores for both RFVTA and LM subjects. Note: The sample sizes at baseline, 3 month, and 6 months are 25, 24, 23, and 20 for the RFVTA group; 25, 24, 23, and 21 for the LM group.
Fig. 5
Fig. 5
Mean transformed health-related quality-of-life subscale scores. Health-related quality-of-life subscale scores at 12 months of follow-up for RFVTA and LM subjects.
Fig. 6
Fig. 6
Mean health state (EQ-5D) scores. Mean health state (EQ-5D) scores over time for both RFVTA and LM subjects.
See this image and copyright information in PMC

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