Post-Market Surgeon Safety Outcomes and Experience Performing Laparoscopic Ultrasound-Guided Radiofrequency Ablation using the Acessa™ System
Yu S, Silverberg K, Bhagavath B, Shobeiri SA, Propst A, and Eisenstein DI. 2521 Post-Market Surgeon Safety Outcomes and Experience Performing Laparoscopic Ultrasound-Guided Radiofrequency Ablation using the Acessa™ System. J Minim Invasive Gynecol 2019; 26(7):S98.
J Minim Invasive Gynecol
Study Objective: 1) Evaluate intraoperative and near-term safety outcomes following laparoscopic radiofrequency ablation of fibroids (Lap-RFA) performed by gynecologic surgeons new to the procedure, using the Acessa™ system (Acessa Health, Austin, TX, USA). 2) Compare observed complication rates with those from the pivotal study. Design: Post-market, prospective, single-arm, multicenter analysis; 4-8 weeks’ follow-up. Setting: Community and university hospitals in the U.S. and Canada. Patients or Participants: Surgeons (N=29) with varying levels of laparoscopic surgery experience participating in the ongoing, multinational Treatment Results of Uterine Sparing Technologies (TRUST) randomized clinical trial. Patients were premenopausal women (N=110), aged ≥18 years, enrolled as either run-in patients or randomized to the TRUST Lap-RFA arm. Interventions: During run-in, surgeons received proctored Lap-RFA training. Following training, and after performing ≥2 procedures, surgeons provided feedback using a standardized form. Measurements and Main Results: The primary endpoints were acute intraoperative and serious near-term postoperative complications, defined as occurring <48 hours and 48 hours to ≤30 days post-procedure, respectively, and to compare these outcomes to pivotal study results. Per protocol, surgeons performed 105 procedures (mean number proctored cases per surgeon, 2.48); 100 of the 105 patients were followed at all time points to 30 days. No intraoperative or acute serious complications were reported in this study, unlike the pivotal study where there were 2 acute serious complications (atelectasis and colon injury, 1.46%). Similar to the pivotal study, 1 near-term complication (0.96%) related to uterine entry/manipulation occurred (fever of unknown origin requiring hospitalization), and was categorized as probably device-related. The patient was treated and discharged. Twenty-six surgeons completed the evaluation form; none reported experiencing any problems with the procedure. Conclusion: There were no significant differences in safety outcomes when comparing the pre- and post-market studies. Minimally invasive gynecologic surgeons can safely learn the Lap-RFA procedure with acceptable outcomes after 2-3 proctored cases.