BACKGROUND AND PURPOSE:

• Chudnoff et al. (Obstetrics & Gynecology, 2019) assessed the 12-month safety and effectiveness of transcervical ablation as treatment of symptomatic fibroids

METHODS:

• Prospective, multicenter, single-arm interventional trial
• Participants
  • Uterine fibroids (non-pedunculated)
  • Premenopausal women, ages 25-50 years with regular cycles
  • ≤10 leiomyomas with ≥1 leiomyoma altering on the endometrial cavity
  • Range of menstrual blood loss (150 to 500 using pictorial tool) and regular cycles
• Procedure performed under ultrasound guidance, using transcervical radiofrequency ablation
• Transcervical ablation was performed on 1–10 leiomyomas per patient
  • Fibroids ranging from 1 to 5 cm in diameter
• Coprimary endpoints assessed at 12 months were
  • Reduction in menstrual blood loss using a validated pictorial blood loss assessment chart
  • Rate of surgical reintervention due to treatment failure
• Secondary outcomes included
  • Symptom severity | Quality of life | Patient satisfaction | Reductions in uterine and leiomyoma volumes | Safety

RESULTS:

• 147 patients were enrolled and treated
• Primary endpoints
  • 64.8% of patients (95% CI, 56.3–72.6%) experienced 50% or greater reduction in menstrual bleeding
  • 99.3% of patients (95% CI, 95.1–99.9%) did not require surgical reintervention
• The mean pictorial blood loss assessment chart score significantly decreased (P<.001)
  • 3 months: decrease 38.9%
  • 6 months: decrease 48.4%
  • 12 months: decrease 51.1%
  • Overall reduced menstrual bleeding at 12 months: 95.1%
• Symptom severity and health-related quality of life both significantly improved (all P<.001) at 12 months
  • Symptom improvement: 96.3%
  • Satisfaction with the treatment: 97%
• Mean maximal fibroid volume reduction per patient: 62.4% (P<.001)
• Most women returned to normal activity within a day
  • Average return to normal daily activities: 2.2±2.2 days
• There were no reported device-related adverse events

CONCLUSION:

• Transcervical ablation led to a significant reduction in leiomyoma symptoms at 12 months

Learn More – Primary Sources:

Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas

Related ObG Topics:

Uterine Artery Embolization or Hysterectomy for Fibroids?

High-Intensity Ultrasound for Fibroids – What are the Pregnancy Outcomes?

Uterine Artery Embolization or Focused Ultrasound for Uterine Fibroids?