Remote-control percutaneous coronary interventions: concept, validation, and first-in-humans pilot clinical trial.

OBJECTIVES: This study was designed to assess the feasibility and safety of a Remote Navigation System (RNS, NaviCath, Haifa, Israel) in which the angioplasty guidewire, the balloon, and the stent are navigated via a computerized system. BACKGROUND: Percutaneous coronary interventions (PCIs) are manually performed under fluoroscopic guidance, requiring lead protection for the operators. A system in which the operator can remotely, safely, and precisely navigate the procedure during PCI would have clear advantages. METHODS: The RNS involves a computer-controlled wire and delivery system navigator. Following preclinical validation, the system was assessed in patients undergoing single-vessel PCI. RESULTS: The study involved 18 patients (age 55.9 years, 16% women). The RNS successfully crossed lesions with the guidewire in 17 patients. The stent was then advanced by the advance/rotate mode and adequately positioned in 15 of 17 cases. Technical malfunction was encountered in three patients in whom the procedure was successfully completed manually. Direct stenting was employed in 10 of 18 patients, pre-dilation in 7 patients, and after-stent balloon dilation in 5 patients. The total fluoroscopy time for 17 RNS patients was compared with the corresponding time of 20 consecutive patients who underwent standard single-lesion PCI. Fluoroscopy time was similar for both procedures, with 8.8 +/- 4.8 min with the RNS versus 9.1 +/- 3.5 min with the standard techniques (p = NS). Clinical success was 100% and technical success 94% for the guidewire and 83% for the overall procedure. CONCLUSIONS: The use of the RNS for guidewire, balloon, and stent manipulation during PCI appears safe and feasible for the treatment of patients with coronary stenosis. The system offers operator radiation safety and may enhance precision of stent placement and balloon dilation strategies.

Concept, design and pre-clinical studies for remote control percutaneous coronary interventions.

INTRODUCTION: Percutaneous Coronary Interventions (PCI) is conducted manually with the operator standing at the bed side, exposed to continuous X-ray radiation. A system where the operator can remotely navigate the wire and device during PCI may improve operator safety and convenience and can possibly enhance procedural precision. AIM: To develop a remote navigation system (RNS) that will allow computer controlled, remote manipulation of percutaneous coronary interventions.. METHODS AND RESULTS: The remote navigation system (RNS) is designed to handle both coronary guide wire and balloon / stent delivery system and can be loaded either with the coronary wire or with both wire and device in parallel. The RNS is comprised of a bedside unit and a remote manipulation unit. The bed side unit has individual wire and device manipulators, capable of precise maneuvering and positioning of the wires and devices. The system was tested in a wire glass model and was evaluated in a normal coronary sheep model. The wire glass model experiments showed that the wire could be navigated to the required branch and the stent/ balloon adequately positioned, as required. The animal experiments showed that the wire could access any required coronary branch and the stent could be adequately positioned under x-ray fluoroscopy, without causing dissection or other vessel trauma. CONCLUSION: A system that enables remote control percutaneous coronary procedures was developed and tested in vitro and in vivo models. Preclinical studies have demonstrated the feasibility of the concept of remote control PCI and have provided the basis for the pilot clinical study of remote control, stent-assisted PCI.