Novel Approaches to Uterine Artery Embolization: A Clinical Assessment of Safety and Efficacy Using a Pressure-Enabled Drug Delivery Device

Purpose: The purpose of this clinical assessment was to evaluate the safety, efficacy, and procedural efficiency of a novel microcatheter with Pressure-Enabled Drug Delivery (PEDD) technology for uterine artery embolization (UAE) in patients with symptomatic uterine fibroids. The study aimed to determine if this device could lead to reduced embolization times and minimal embolic material consumption without compromising clinical outcomes.

Materials and Methods: A retrospective, single-center analysis was conducted on 23 patients who underwent UAE for symptomatic uterine fibroids. Procedures were performed by 6 interventional radiologists with varying levels of experience. The patient cohort, with a median age of 45 (37-59), presented predominantly with menorrhagia and/or dysmenorrhea. Pre-treatment dominant fibroid volume had a median size of 802 mL (46-25095 mL). All procedures were performed using the PEDD microcatheter with 500-700 µm and 700-900 µm size particles. The procedural endpoint was defined as either Near Stasis or Complete Stasis. Procedural data, including embolization time per uterine artery, number of embolic vials used, and pre- and post-treatment dominant fibroid volumes and VAS were extracted and analyzed.

Results: The study demonstrated 100% technical success and no device-related complications. Clinical success was assessed using a Visual Analog Scale (VAS) (0-10). The mean Heavy Menstrual Bleeding-VAS score decreased from 6.6 pre-procedure to 2.6 at 1 month (p=0.003) and 2.1 at 6 months (p=0.008). Mean Pain-VAS for dysmenorrhea decreased from 5.4 pre-procedure to 3.0 at 1 month (p=0.04) and 1.5 at 6 months (p=0.006). The Composite-VAS score for both symptoms decreased from 7.5 pre-procedure to 4.1 at 1 month (p=0.001) and 2.8 at 6 months (p=0.001). Mean embolization time was 7.5 minutes (left) and 6.1 minutes (right). The mean fluoroscopy time of 19.5 minutes compared favorably to published literature (20.1-21.9 minutes). The mean embolic volume used was 2.1 vials per treated artery. Dominant fibroid volume reduction ranged from 69% to 89%, which compares favorably with previously reported reductions (42%-58%).

Conclusion: The PEDD microcatheter demonstrates a compelling combination of safety, efficacy, and procedural efficiency for symptomatic uterine fibroids. The ability to achieve a robust therapeutic effect with minimal embolic material and short embolization times suggests a more targeted delivery mechanism. This technology has the potential to streamline workflow, decrease procedure and fluoroscopy times, and optimize clinical outcomes.