Real-Time Aspiration-Enabled Dual Over-the-Wire Microcatheter Enhances Parallel Wire Technique in Chronic Total Occlusion Recanalization.

BACKGROUND: Suboptimal parallel wire technique (PWT) success rates result primarily from progressive subintimal hematoma expansion during procedural maneuvers in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). OBJECTIVES: The aim of this study was to evaluate the procedural outcomes of a novel dual over-the-wire engineered, subintimal hematoma aspiration-enabled dual-lumen microcatheter (DLMC) assisted PWT in CTO PCI. METHODS: One hundred consecutive CTO PCI cases using the PWT were retrospectively analyzed, comparing outcomes between a conventional DLMC (Conv-DLMC) and a H.STARFISH (real-time [RT] aspiration DLMC) assisted PWT. RESULTS: Reattempt cases constituted 31.0% of all procedures (31 of 100). In the RT aspiration DLMC group, 13 of 50 cases (26.0%) crossed over after Conv-DLMC failure. Hematoma aspiration was performed in 70.0% (35 of 50) of the RT aspiration DLMC group and in 100% of cases (13 of 13) switched from failed Conv-DLMC attempts. PWT success rates were significantly higher with RT aspiration DLMC (98.0% [49 of 50]; 95% CI: 89.4%-99.9%) vs Conv-DLMC (78.0% [39 of 50]; 95% CI: 64.0%-88.5%) (P < 0.001). Although median PWT duration showed no significant difference (RT aspiration DLMC vs Conv-DLMC: 22.0 minutes [Q1-Q3: 10.8-51.0 minutes] vs 23.5 minutes [Q1-Q3: 12.0-36.3 minutes]; P = 0.735), prolonged PWT attempts (>45 minutes) occurred more frequently in the RT aspiration DLMC group than the Conv-DLMC group (30.0% [15 of 50] vs 12.0% [6 of 50]; P = 0.027), with a maximum duration of 147 minutes recorded in the RT aspiration DLMC group. Meanwhile, the Conv-DLMC group required a higher rate of strategy switching to retrograde approach (4.0% [2 of 50] vs 22.0% [11 of 50]; P = 0.007). No major complications occurred in either group. CONCLUSIONS: The RT aspiration DLMC was able to improve PWT success rates in CTO PCI and enable prolonged PWT attempts because of its RT hematoma aspiration capability.