Universität zu Köln

Oberhuber, Alexander ORCID: 0000-0002-6322-7152, Deglise, Sebastien, Richter, Olaf, Makaloski, Vladimir ORCID: 0000-0001-8826-3232, Bracale, Umberto ORCID: 0000-0001-9507-9791, Isernia, Giacomo, Tines, Roland, Cappelli, Alessandro, Dorweiler, Bernhard ORCID: 0000-0002-8262-8381, Brunkwall, Jan ORCID: 0000-0003-3082-6009, van Weel, Vincent, Hoksbergen, Arjan, Van Herzeele, Isabelle, Abisi, Said, March Garcia, José Ramón, Tinelli, Giovanni, Schäfer, Jost Phillip, Lakshminarayan, Raghu, Goltz, Jan Peter, Muñoz, Jaume Félix Dilmé, Gómez, Ignacio Agúndez, Dziekiewicz, Miroslaw, Giudice, Rocco, Michelagnoli, Stefano, Loos, Maarten, Calavia, Alvaro Revilla, Vaquero Puerta, Carlos, Fernández Heredero, Alvaro, Aparicio Martínez, Cesar, Szopinski, Piotr, Gizewski, Elke, van der Hem, Lieuwe G. and Mylonas, Spyridon N. (2025). A Prospective, Multicentre Registry on Thirty Day and One Year Outcomes of the E-liac Stent Graft System in Patients with Unilateral or Bilateral Aorto-iliac or Iliac Aneurysms: The PLIANTII Study. European Journal of Vascular and Endovascular Surgery, 69 (6). pp. 847-854. Elsevier. ISSN 10785884

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Abstract

Objective: The aim of this study was to prospectively evaluate the real world outcomes of the E-liac stent graft system used to electively treat common iliac artery aneurysms, either unilaterally or bilaterally. Methods: PLIANTII is a prospective, observational, non-randomised, multicentre study. The E-liac stent graft system was implanted for the treatment of iliac artery aneurysms in 295 patients across 30 European centres between September 2018 and September 2023, with 236 patients also treated for a concomitant infrarenal abdominal aortic aneurysm. The endpoints, including clinical outcomes, are reported up to the twelve month follow up. The primary endpoint was a composite of freedom from type I or III endoleak plus patency of the external (EIA) and internal iliac arteries (IIA) on the E-liac implantation side(s) at the twelve month follow up. Technical success was defined as successful access and deployment of the stent graft without surgical conversion, death, type I or III endoleak, or graft limb occlusion, assessed at discharge or 30 days. Clinical success, evaluated at twelve months, also included the absence of stent graft infection and iliac aneurysm rupture. Results: Two hundred and ninetyfive consecutive patients (95.6% male; mean age 72.7 years) were included. The primary endpoint was achieved in 91.8%. No death was recorded within 30 days of implantation, and seven deaths had occurred at twelve months. The Kaplan–Meier estimated survival rate up to the twelve month follow up visit was 96.7 ± 1.2%. Technical success at discharge or 30 days was achieved in 93.1% of patients, while clinical success at twelve months was achieved in 91.2%. There were 5.4% re-interventions within 30 days and 12.9% within twelve months. The Kaplan–Meier estimated freedom from E-liac related re-intervention up to the twelve month follow up visit was 91.3 ± 1.8%. The primary patency rate at discharge or 30 day visit was 97.6% (284/291) for the EIA and 96.2% (280/291) for the IIA, whereas Kaplan–Meier estimated freedom from occlusion up to twelve months was 94.5 ± 1.6% for the EIA and 94.7 ± 1.5% for the IIA.

Item Type:	Article
Creators:	Creators Email ORCID ORCID Put Code Oberhuber, Alexander UNSPECIFIED https://orcid.org/0000-0002-6322-7152 UNSPECIFIED Deglise, Sebastien UNSPECIFIED UNSPECIFIED UNSPECIFIED Richter, Olaf UNSPECIFIED UNSPECIFIED UNSPECIFIED Makaloski, Vladimir UNSPECIFIED https://orcid.org/0000-0001-8826-3232 UNSPECIFIED Bracale, Umberto UNSPECIFIED https://orcid.org/0000-0001-9507-9791 UNSPECIFIED Isernia, Giacomo UNSPECIFIED UNSPECIFIED UNSPECIFIED Tines, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Cappelli, Alessandro UNSPECIFIED UNSPECIFIED UNSPECIFIED Dorweiler, Bernhard UNSPECIFIED https://orcid.org/0000-0002-8262-8381 UNSPECIFIED Brunkwall, Jan UNSPECIFIED https://orcid.org/0000-0003-3082-6009 UNSPECIFIED van Weel, Vincent UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoksbergen, Arjan UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Herzeele, Isabelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Abisi, Said UNSPECIFIED UNSPECIFIED UNSPECIFIED March Garcia, José Ramón UNSPECIFIED UNSPECIFIED UNSPECIFIED Tinelli, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED Schäfer, Jost Phillip UNSPECIFIED UNSPECIFIED UNSPECIFIED Lakshminarayan, Raghu UNSPECIFIED UNSPECIFIED UNSPECIFIED Goltz, Jan Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Muñoz, Jaume Félix Dilmé UNSPECIFIED UNSPECIFIED UNSPECIFIED Gómez, Ignacio Agúndez UNSPECIFIED UNSPECIFIED UNSPECIFIED Dziekiewicz, Miroslaw UNSPECIFIED UNSPECIFIED UNSPECIFIED Giudice, Rocco UNSPECIFIED UNSPECIFIED UNSPECIFIED Michelagnoli, Stefano UNSPECIFIED UNSPECIFIED UNSPECIFIED Loos, Maarten UNSPECIFIED UNSPECIFIED UNSPECIFIED Calavia, Alvaro Revilla UNSPECIFIED UNSPECIFIED UNSPECIFIED Vaquero Puerta, Carlos UNSPECIFIED UNSPECIFIED UNSPECIFIED Fernández Heredero, Alvaro UNSPECIFIED UNSPECIFIED UNSPECIFIED Aparicio Martínez, Cesar UNSPECIFIED UNSPECIFIED UNSPECIFIED Szopinski, Piotr UNSPECIFIED UNSPECIFIED UNSPECIFIED Gizewski, Elke UNSPECIFIED UNSPECIFIED UNSPECIFIED van der Hem, Lieuwe G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mylonas, Spyridon N. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-802150
Identification Number:	10.1016/j.ejvs.2025.02.029
Journal or Publication Title:	European Journal of Vascular and Endovascular Surgery
Volume:	69
Number:	6
Page Range:	pp. 847-854
Number of Pages:	8
Date:	June 2025
Publisher:	Elsevier
ISSN:	10785884
Language:	English
Faculty:	Faculty of Medicine
Divisions:	Faculty of Medicine > Chirurgie > Klinik und Poliklinik für Gefäßchirurgie
Subjects:	Medical sciences Medicine
Uncontrolled Keywords:	Keywords Language E-liac stent graft system ; Endovascular iliac aneurysm repair ; EVAR ; Iliac ; artery aneurysm ; Iliac branch device English
['eprint_fieldname_oa_funders' not defined]:	Publikationsfonds UzK
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/80215