Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study

Author:

Frandon Julien1ORCID,Loffroy Romaric2ORCID,Marcelin Clement34ORCID,Vernhet-Kovacsik Hélène5,Greffier Joel1ORCID,Dabli Djamel1ORCID,Sammoud Skander1,Marek Pierre6,Chevallier Olivier2ORCID,Beregi Jean-Paul1,Rousseau Hervé6

Affiliation:

1. Department of Medical Imaging, IPI Plateform, Nîmes University Hospital, University of Montpellier, Medical Imaging Group Nîmes, IMAGINE, 30029 Nîmes, France

2. Department of Radiology, CHU Dijon-Bourgogne, 21079 Dijon, France

3. Centre Hospitalier Universitaire de Bordeaux, Service d’Imagerie Diagnostique et Thérapeutique de l’Adulte, Hopital Pellegrin, 33076 Bordeaux, France

4. Bordeaux Institute of Oncology, BRIC U1312, INSERM, Université Bordeaux, 33076 Bordeaux, France

5. Department of Radiology, CHU of Montpellier, Arnaud de Villeneuve Hospital, 34090 Montpellier, France

6. Interventional Radiology Department, Rangueil Hospital, University Hospital of Toulouse, 31400 Toulouse, France

Abstract

A wide variety of coils are available for vascular embolization. This study aimed to evaluate the safety and efficacy of a new Prestige coil. We carried out retrospective analysis of a multicenter’s registry data collected between February 2022 and November 2022. The choice of embolization agent used to treat peripheral vascular anomalies was left to the investigator’s discretion. Patients for whom at least one Prestige coil was used were included in Series 1. All other patients were included in Series 2. Efficacy and safety were evaluated. Patients were followed up for one month. In total, 220 patients were included, 110 in each series. Patients included 149 men (67.7%) and 71 women (32.3%), with a median age of 62.5 years (IQR: 35.8–73). Patient ages were similar in the two series. Complete occlusion of the targeted vessel was reported in 96.4% (n = 106/110) of patients in Series 1 and in 99.7% (n = 109/110) in Series 2. Four patients experienced non-serious adverse events (1.8%, n = 4/220): one experienced back pain and one vomiting in Series 1; one patient had off-target embolization and one a puncture site hematoma in Series 2. Sixteen patients (7.2%, n = 16/220) were lost to follow up. Improvement in the patient’s general state at one month was reported in 79.0% (n = 83/105) of patients in Series 1 and in 74.7% (n = 74/99) in Series 2. Ten deaths occurred, five in Series 1 (4.8%, n = 5/105) and five in Series 2 (5.1%, n = 5/99). These deaths all concerned critically ill patients embolized for emergent arterial bleeding. In conclusion, the 1-month follow-up showed that Prestige coils, alone or in combination, are efficient and safe.

Funder

Balt Extrusion SAS

Publisher

MDPI AG

Subject

Medicine (miscellaneous)

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