Safety and Effectiveness of a New Electrical Detachable Microcoil for Embolization of Hemorrhoidal Disease, November 2020-December 2021: Results of a Prospective Study.

ABSTRACT

PURPOSE: The purpose of this study was to prospectively evaluate the efficacy and safety of a new, bare platinum, detachable microcoil as a metallic embolization agent in the treatment of hemorrhoidal disease. MATERIAL AND METHODS: This prospective single-center study evaluated a new, bare platinum, electrical, detachable microcoil (Prestige plus coil (Balt Montmorency France)) for use in vascular embolization in patients with hemorrhoidal disease. Between January 2020 and January 2021, 24 embolization procedures were performed in 21 patients (12 males, 9 females; mean age 44.3 ± 7.3). The inclusion criteria were (a) participants with grade I, II and III hemorrhoidal disease on the Goligher classification; (b) patients older than 18 years of age with a score of greater than 4 on the French bleeding score (FBS) scale; (c) patients with scores greater than 2 on the scale of discomfort proposed by Tradi and Farfallah. (d) patients who underwent treatment that included the use of the new novel coil (Prestige plus coil (Balt)) as an embolic material. The exclusion criteria were participants who failed to provide informed consent and participants diagnosed with rectal bleeding due to other causes (cancer, fissures or others). Participants with severe renal insufficiency, non-correctable coagulation abnormalities and adverse reactions to the contrast medium not correctable with medication were also excluded. The symptoms, technical aspects, the transarterial approach, clinical and technical success complications and short-term outcomes were assessed. RESULTS: Technical success was obtained in 100% of the cases. Seventeen (80.9%) patients experienced improvements in their hemorrhoidal disease. The VAS and QL scores improved by 4 and 1.5 points (81.2% and 87.5%), respectively, after embolization (pV 0001). Three (14.2%) patients underwent a second embolization due to rebleeding. One patient (4.7%) underwent surgery. No major complications were observed. Three patients had minor complications. The assessment of subjective post-treatment symptoms and QL surveys showed significant differences from the baseline survey. Likewise, the measurement of the degree of satisfaction using a telephone survey at 12 months revealed a high degree of patient satisfaction over 10 points (mean 8.3 ± 1.1). CONCLUSIONS: The present study demonstrates that the use of the new, platinum, detachable, electrical microcoil is safe and well-tolerated in the treatment of hemorrhoidal disease. KEY POINTS Catheter-directed hemorrhoidal dearterialization (CDHD) is the procedure of embolization with embolic agents for the treatment of internal hemorrhoids. CDHD is a simple and safe procedure that is accepted by patients and preserves the anal sphincter; it presents few complications when metal devices or microspheres are used as embolic agents. As the recommended embolization agent in treatments, the Prestige electrical, detachable coil is a safe, easy-to-use and effective arterial embolic device.