First-in-human experience using the Volcano VIBE-RX vascular imaging balloon catheter system (Volcano IVUS-guided Balloon Evaluation - New Zealand: VIBE-NZ Study).

AIMS

Intravascular ultrasound (IVUS) is a proven and safe imaging modality used to guide percutaneous coronary intervention (PCI). The Volcano VIBE™ RX Vascular Imaging Balloon Catheter is a novel rapid exchange, 0.014" wire-compatible multi-lumen conventional balloon catheter modified with the addition of an IVUS transducer proximal to the balloon, delivered via a standard 6 Fr sheath. We sought to evaluate the safety, balloon performance, and image quality of the VIBE™ RX in patients scheduled for coronary intervention.

METHODS AND RESULTS

Patients aged >21 and <85 years with single or multivessel coronary disease scheduled for PCI due to coronary ischaemic symptoms were included. Those with angiographic features that precluded the safe or informative use of the device were excluded. Twenty-nine patients having angiography because of ischaemic symptoms underwent 44 VIBE RX imaging runs, with balloon dilation in 20. Successful device deployment was achieved in all but one patient. All images were adequate and reproducible. One patient had a non-ST-elevation MI felt to be due to the complexity of the procedure rather than directly related to the VIBE™ RX.

CONCLUSIONS

The study demonstrated the safety and effectiveness of the VIBE™ RX for its intended purpose with minimal failure rate and no directly related complications.