Successful Coronary Interventions with the Ingenious Vector\(\circledR\) Balloon in Chronic Total Occlusion (CTO): A Preliminary Study

Abstract

Aims: To assess the safety and plausibility of successful coronary interventions in Chronic Total Occlusion (CTO) with the innovative Vector\(\circledR\) balloon through balloon-assisted crossing technique. Study Design: Observational, prospective study. Place and Duration of Study: Department of Cardiology, King Edward Memorial Hospital and Seth G. S. Medical College, Mumbai. The study was carried out between the months of March and June, 2024. Methodology: A total of 20 patients were included in the study. All patients with chronic coronary syndrome were being planned for Percutaneous Coronary Intervention (PCI) for CTO. During PCI, the standard protocol of intervening CTO lesions was followed. When the operator was not able to cross the lesion with standard CTO guidewires, Vector\(\circledR\) balloon-assisted crossing was planned. This technique was used in a total of seven (35%) patents. Success was defined as the possibility of advancing the guidewire further to the target lesion and being able to deploy a drug eluting stent. Safety was assessed as reporting complications like kinking or rupture of the balloon shaft, loss of balloon inside the guide or the coronary artery and the balloon burst rate after inflation exceeding the Rated Burst Pressure (RBP) according to the manufacturer’s reference table.  Results: The mean age of the patients was 58.1 ± 3.6 years. The balloon-assisted crossing was successful in all seven patients. The most commonly used diameter of the balloon was 1.25 mm (42.85%). Conclusion: The novel Vector\(\circledR\) balloon catheter showed excellent result when deployed to treat the CTO after the usual strategy of guidewire escalation had failed. The proximal shaft with polytetrafluoroethylene (PTFE) coating brings the flexibility to navigate complex and tortuous vascular pathways with ease due to its laser welded core-wire. A study with a larger sample size and a comparator arm would rather clarify if such a balloon-assisted crossing technique in CTO would decrease the need of costly devices like double lumen microcatheters.