Remote-control percutaneous coronary interventions: concept, validation, and first-in-humans pilot clinical trial.
OBJECTIVE
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.
Beyar
Rafael
R
Division of Invasive Cardiology, Rambam Medical Center and the Technion, Haifa, Israel. rafael@tx.technion.ac.il
Gruberg
Luis
L
Deleanu
Dan
D
Roguin
Ariel
A
Almagor
Yaron
Y
Cohen
Silviu
S
Kumar
Ganesh
G
Wenderow
Tal
T
D000328:Adult; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000818:Animals; D003327:Coronary Disease / Q000628:therapy*; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012371:Robotics; D012756:Sheep; D015607:Stents