Dataset Information

Fluoroscopy with MRA fusion image guidance in endovascular iliac artery interventions: study protocol for a randomized controlled trial (3DMR-Iliac-roadmapping study).

ABSTRACT:

Background

Endovascular iliac artery interventions rely on the use of two-dimensional digital subtraction angiographies with an iodinated contrast agent and ionizing radiation. The amount of iodinated contrast agent should be limited because of its potentially nephrotoxic effects. Three-dimensional (3D) image fusion requires registration of a preprocedural magnetic resonance angiogram (MRA) or computed tomography (CT) angiogram to a perprocedurally acquired cone-beam CT or two fluoroscopic orthogonal projections. After registration, the 3D angiography images can be overlaid on the fluoroscopy screen and will follow table and C-arm movements. This study will assess the added value of the 3D image fusion technique in iliac artery interventions regarding the amount of the iodinated contrast agent administered.

Methods/design

The study cohort will comprise 106 patients (>?18 years) with symptomatic common and/or external iliac artery stenoses or occlusions and a recent (2). Patient participation in the study will be completed after hospital discharge.

Discussion

This study is a randomized controlled multicenter trial to provide evidence on the effect of the 3D image fusion technique on the amount of administered iodinated contrast during endovascular common and/or external iliac artery interventions.

Trial registration

Nederlands Trial Register, NTR5008 . Registered on 16 December 2014.

SUBMITTER: Goudeketting SR

PROVIDER: S-EPMC6211411 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

Fluoroscopy with MRA fusion image guidance in endovascular iliac artery interventions: study protocol for a randomized controlled trial (3DMR-Iliac-roadmapping study).

Goudeketting Seline R SR Heinen Stefan G H SGH de Haan Michiel W MW Sailer Anna M AM van den Heuvel Daniel A F DAF van Strijen Marco J MJ de Vries Jean-Paul P M JPM

Trials 20181101 1

<h4>Background</h4>Endovascular iliac artery interventions rely on the use of two-dimensional digital subtraction angiographies with an iodinated contrast agent and ionizing radiation. The amount of iodinated contrast agent should be limited because of its potentially nephrotoxic effects. Three-dimensional (3D) image fusion requires registration of a preprocedural magnetic resonance angiogram (MRA) or computed tomography (CT) angiogram to a perprocedurally acquired cone-beam CT or two fluoroscop ...[more]

PMID: 30382900

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Project description:PurposeTo determine outcomes of aneurysmal common iliac arteries (aCIA) used for landing zones (LZs) during endovascular aneurysm repair (EVAR).MethodsThis single-center study retrospectively compared 57 EVAR patients (mean age 72±8 years; 56 men) with 70 aCIAs (diameter ≥20 mm) to 25 control EVAR subjects (mean age 73±7 years; 20 men) with 50 normal (≤15-mm) CIA LZs treated consecutively during the same time interval. The CIA LZ measurements were analyzed using random effects linear mixed models to determine diameter change over time. Life tables were used to estimate freedom from endoleak, reintervention, and all-cause mortality.ResultsThe mean maximum preoperative CIA diameter in the aCIA LZ group was 24.8±4.5 mm (range 20.0-47.3, median 23.9) vs 13.6±1.5 mm (range 9.2-15.0, median 13.9; p<0.001) in the controls. Nineteen aCIA LZs were treated outside the instructions for use of the device. Median follow-up in the aCIAs LZ cohort was 39.2 months [interquartile range (IQR) 15, 61] vs 49.3 months (IQR 36, 61) in the controls (p=0.06). The rate of aCIA LZ change (0.09 mm/mo, 95% CI 0.07 to 0.1) was significantly greater than controls (0.03 mm/mo, 95% CI -0.009 to 0.07; p<0.0001). No type Ib endoleaks developed in either group; however, aCIA LZ patients had 6 (11%) iliac limb-related reinterventions. There were significantly more endograft-related reinterventions in the aCIA LZ patients (n=10, 14%) compared with controls (n=2, 4%; p=0.06). There was no difference in mortality or freedom from any post-hospital discharge endoleak.ConclusionAneurysmal CIA LZs used during EVAR experience greater dilatation compared with normal LZs, but no significant difference in outcome was noted in midterm follow-up. However, an increased incidence of graft limb complications or endograft-related reintervention may be encountered. Use of aCIA LZs appears to be safe; however, greater patient numbers and longer follow-up are needed to understand the clinical implications of morphologic changes in these vessels when used during EVAR.

Dataset Information

Fluoroscopy with MRA fusion image guidance in endovascular iliac artery interventions: study protocol for a randomized controlled trial (3DMR-Iliac-roadmapping study).

Background

Methods/design

Discussion

Trial registration

Publications

Fluoroscopy with MRA fusion image guidance in endovascular iliac artery interventions: study protocol for a randomized controlled trial (3DMR-Iliac-roadmapping study).

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