BGPLUS

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

The endovascular repair of thoracoabdominal (TAAA) and complex abdominal aortic pathologies has been increasingly used as alternative to open repair in recent years, becoming the treatment of choice for high-risk patients1. Branched endovascular aortic repair (BEVAR) is considered a safe and effective option for the treatment of these aortic pathologies2-3, whether using off-the-shelf or custom-made devices featuring inner or outer branches. The branched devices consist of directional branches for each of the visceral vessel. They are connected to each target visceral vessels (TVVs) with bridging covered stent graft (BSG) that guarantee vascularization of abdominal organs and exclusion of the aneurysm. The choice among multiple available BSG is guided by their technical properties and outcomes reported in literature. Possible BSG-related complications include occlusion, dislocation, fracture and endoleak; all of which can compromise the durability of BEVAR and require reinterventions during follow-up.
Balloon-expandable covered stents have greater radial force and a more precise deployment compared to self-expandable covered stents. Several studies evaluating balloon-expandable covered stents as BSG in complex endovascular aortic procedures have been reported in literature4-6, but most of them mix fenestrated and branched endovascular aortic repair (F/B-EVAR) outcomes, and different BSG, without specifically focusing on BEVAR.
The present study aims to analyze the mid-term result (period ranging from 3 months to 5 years) of the BeGraft Peripheral Plus (BG+, Bentley InnoMed GmbH, Hechingen, Germany) used as BSG during BEVAR. The BG+ is manufactured with a double layer of cobalt chromium and expanded polytetrafluoroethylene (ePTFE) and is pre-mounted on a noncompliant balloon catheter. It is designed to have high radial force, visibility, kink resistance, and a reliable deployment system. Abisi et al7 reported the early outcomes of BG+ in BEVAR, highlighting an overall estimated TV patency of 98%, freedom from branched-related instability of 98%, without cases of branched kinking, fracture dislodgment or endoleak.

Primary objective
To evaluate the efficacy of BG + balloon-expandable stent used as BSG in BEVAR over the 2018-2024 period in 6 European centres.

Primary outcome
The primary endpoint is to evaluate the BG+ technical success, clinical success, and BG+ patency (divided in primary patency, primary assisted patency, and secondary patency) evaluated with contrast-enhanced computed tomography (CT) scans and/or Doppler ultrasound at follow up.
Technical success requires the following criteria to be met: successful access to the arterial system, successful delivery and deployment of the aortic stent graft and all modular stent-graft, successful side branch catheterization and placement of bridging stents, absence of type I or III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging, patency of all aortic and side branch components;

Secondary outcome
Proportion of:
- unplanned additional stents used during the primary procedure,
- freedom from BG+ related reinterventions,
- freedom from target vessel instability.
Freedom from 30 day/in-hospital mortality and from aortic related death during 5 years follow-up will also be evaluated.