Surgical Techniques

For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation

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References

Complication rates were low
Complications included a postoperative pelvic abscess and four other minor events. The latter were treated at the time of RFVTA or resolved without additional procedures. The reintervention rate was 0.7% (1/135 patients).26

Guido and colleagues reported 24-month outcomes for the 124 women entering the second year of the Halt study and affirmed the findings of Chudnoff’s team.27 The 112 patient-reported UFS-QOL scores at 24 months were virtually identical to those reported at 12 months. Six surgical reinterventions (6 of 124 patients, or 4.8%) for fibroid-related bleeding were reported between 12 and 24 months.

280 women have been treated so far
As of September 2013, 280 women have been treated under five international study protocols using the Halt Acessa System, and approximately two-thirds have been followed for more than 12 months, with excellent results. Two of the five clinical trials are under way in Germany and Canada:

  • The Laparoscopic Uterine-Sparing Techniques Outcomes and Reinterventions (LUSTOR) trial in Germany is a prospective, randomized, single-center study comparing outcomes of RFVTA and laparoscopic myomectomy. Fifty women were enrolled and treated and will be followed for as long as 60 months.
  • The Treatment Results of Uterine-Sparing Technologies (TRUST) trial is a prospective, multicenter, randomized study in Canada that compares direct and indirect costs associated with RFVTA, laparoscopic and abdominal myomectomy, and uterine artery embolization. Some US sites also will participate. As many as 200 women will be treated and followed for as long as 60 months.

RFVTA offers several benefits
Although hysterectomy provides a definitive “cure” to fibroid-related symptoms, it is not preferred by many patients and generally is more costly, with an increased risk of complications, a longer hospital stay, longer recovery (6–8 weeks), longer disability and more time off from work, and potential long-term sequelae.

The Acessa procedure not only is an outpatient, minimally invasive, uterine-sparing fibroid treatment option, it permits access to and ablation of almost all fibroids (with the exception of penduculated or Type 0 myomas). The data to date suggest that RFVTA provides many benefits, including a decline in symptom severity and improved health-related quality of life, as well as good cosmesis, quick recovery, and a rapid return to full activity.

There is a learning curve for ­RFVTA with Acessa—as with any new procedure. If physicians already perform ultrasound imaging, the learning process is shorter. Physicians interested in Acessa and furthering their education and training in laparoscopic RFVTA should consult the manufacturer’s professional education division through the company Web site at http://www.haltmedical.com.

CASE: RESOLVED
After she is counseled about the various uterine-sparing options for treatment, L.W. chooses to undergo laparoscopic, ultrasound-guided RFVTA using the Acessa System. The procedure is performed successfully, with the two fibroids destroyed using the appropriate algorithms, which took into account the size of the fibroids and the deployed needle array. Two additional 1-cm fibroids were found during the procedure and ablated. The patient was discharged home shortly after the procedure, with a nonsteroidal anti-inflammatory drug given for pain relief.

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