Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry.

Zenith Alpha Abdominal abdominal aortic aneurysm endograft endovascular aortic aneurysm repair

Journal

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
ISSN: 1545-1550
Titre abrégé: J Endovasc Ther
Pays: United States
ID NLM: 100896915

Informations de publication

Date de publication:
30 Aug 2023
Historique:
pubmed: 30 8 2023
medline: 30 8 2023
entrez: 30 8 2023
Statut: aheadofprint

Résumé

Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan-Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12-43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%-93.1%), 95.8% (95% CI: 92.7%-97.1%), 93.6% (95% CI: 90.2%-96.8%), 87% (95% CI: 83.3%-91.6%), and 97.7% (95% CI: 95.1%-98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%-95.5%] vs ZISL 94.3% [95% CI: 90.1%-95.9%], p=0.342; log-rank 0.903). Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.

Identifiants

pubmed: 37646124
doi: 10.1177/15266028231197151
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

15266028231197151

Investigateurs

Francesco Canovaro (F)
Lorenzo Torri (L)
Carlo Pratesi (C)
Aaron Fargion (A)
Sara Speziali (S)
Rossella Di Domenico (R)
Rachele Petroni (R)
Giancarlo Palasciano (G)
Edoardo Pasqui (E)
Giuseppe Galzerano (G)
Cecilia Molino (C)
Anzaldi Manfredi Giuseppe (AM)
Claudio Invernizzi (C)
Vincenzo Loschiavo (V)
Emiliano Chisci (E)
Patrizia Dalla Caneva (PD)
Leonardo Ercolini (L)
Elisa Lazzeri (E)
Federico Filippi (F)
Claudia Panzano (C)

Auteurs

Nicola Troisi (N)

Vascular Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

Raffaele Pulli (R)

CardioThoracic and Vascular Surgery, Vascular Surgery, Careggi University Teaching Hospital, University of Florence School of Medicine, Florence, Italy.

Gianmarco de Donato (G)

Department of Medicine, Surgery, and Neuroscience, Vascular Surgery Unit, University of Siena, Siena, Italy.

Daniele Adami (D)

Vascular Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

Giulia Bertagna (G)

Vascular Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

Stefano Michelagnoli (S)

Vascular and Endovascular Surgery Unit, San Giovanni di Dio Hospital, Florence, Italy.

Raffaella Berchiolli (R)

Vascular Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

Classifications MeSH