Post-Market Safety of Laparoscopic Ultrasound-Guided Radiofrequency Ablation

Steve Yu, Kaylen Silverberg, Bala Bhagavath, S Abbas Shobeiri, Anthony Propst, David Eisenstein, Steve Yu, Kaylen Silverberg, Bala Bhagavath, S Abbas Shobeiri, Anthony Propst, David Eisenstein

Abstract

Background and objectives: Postoperative safety outcomes with laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation, as performed by gynecologic surgeons new to the procedure, were evaluated and compared to the premarket, pivotal study. Post-procedure feedback from surgeons was reported.

Methods: This was a post-market, prospective, single-arm analysis with 4 to 8 weeks follow-up among surgeons (n = 29) with varying levels of laparoscopic surgery experience participating in the ongoing, multinational Treatment Results of Uterine Sparing Technologies randomized clinical trial. Patients were premenopausal adult women (n = 110) desiring uterine-conserving treatment for symptomatic fibroids. During run-in, surgeons received proctored training. Following training, and after performing ≥ 2 procedures, surgeons provided self-assessment and feedback using a standardized form.

Results: Surgeons performed 105 procedures with 100 per-protocol patients. The average number of proctored cases per surgeon was 2.48. No acute (≤ 48 hours) serious adverse events occurred (0/101, 0.0%) compared with 2 acute serious adverse events in the premarket study (2/137, 1.46%). Both studies reported 1 near-term (∼30 days) serious adverse event (< 1% for both). In this study, the near-term complication was fever of unknown origin requiring hospitalization related to uterine entry/manipulation. This was categorized as probably device-related; the patient was treated with antibiotics and discharged. Twenty-six surgeons completed the evaluation form; none reported experiencing problems with the procedure.

Conclusion: Minimally invasive gynecologic surgeons can learn laparoscopic intraabdominal ultrasound-guided radiofrequency ablation and perform it safely (in terms of acute and near-term serious adverse events) after ≥ 2 proctored cases. There were no significant differences in safety outcomes compared to the premarket, pivotal study.

Keywords: Fibroids; Gynecology; Intraabdominal; Myoma; Surgery.

Conflict of interest statement

Conflicts of Interest: SY reports receiving compensation for the Acessa procedures performed only during the conduct of the study from Acessa Health. BB reports grants from Acessa Health during the conduct of the study. AS reports grants from Acessa Health/Halt Medical during the conduct of the study. AP has nothing to disclose. DE reports grants from Acessa Health (previously Halt Medical) during the conduct of the study, and is a consultant for Acessa Health, Inc.

© 2020 by JSLS, Journal of the Society of Laparoscopic & Robotic Surgeons.

Figures

Figure 1.
Figure 1.
The acessa Laparoscopic Intra-abdominal Ultrasound-guided Radiofrequency Ablation Procedure.
Figure 2.
Figure 2.
Graphic demonstrating two methods of producing overlapping ablations in oval or irregular fibroids.
Figure 3.
Figure 3.
Laparoscopic Intra-abdominal Ultrasound-guided Radiofrequency Ablation Procedure, Surgeon Evaluation Form.

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Source: PubMed

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