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


OBJECTIVE
To develop a remote navigation system (RNS) that will allow computer controlled, remote manipulation of percutaneous coronary interventions..


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.


CONCLUSIONS
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.
Beyar
Rafael
R
Division of Invasive Cardiology, Rambam Medical Center and the Technion, Haifa, Israel.
Wenderow
Tal
T
Lindner
Doron
D
Kumar
Ganesh
G
Shofti
Rona
R