Use and effectiveness of Pioneer re-entry device for subintimal true lumen re-entry: single-centre data and a review of the literature

INTRODUCTION: During subintimal angioplasty (SIA), it is not always possible to re-enter the vessel lumen due to a variety of factors. Recanalization using hydrophilic wires and catheters alone, apart from its potential technical failure, is also limited by minimal control over the re-entry point. This is frequently well beyond the point of occlusion, thus often compromising important collaterals. In order to bypass the obstruction and attain controlled re-entry into the lumen of the diseased vessel, a re-entry device (RED) may be required. This paper assesses our centre’s experience with the safety and efficacy of the Pioneer re-entry system and systematically reviews the pertinent literature. METHOD: A single centre retrospective study of subintimal angioplasty involving the use of the Pioneer Plus intravascular guided reentry catheter was performed. Patient demographics including age, gender, risk factors, comorbidities clinical indication and complications were recorded. Lesion characteristics, including location and severity of calcification were also assessed. A systematic literature review of all reported studies where the Pioneer RED was used for iliac and lower limb revascularization was conducted by 2 of the authors using the PubMed (MEDLINE) and EMBASE databases. RESULTS: The study comprised 30 cases. Technical success was 97%. A small, quickly resolved extravasation was the only device related complication. These results are in line with the systematic review which identified 16 studies using the Pioneer RED, reporting a technical success rate of 87.4–100% (median = 100%) and complication rate of 0–25.8% (median = 0%). However, due to heterogeneity in definitions of technical success, data was not pooled.