CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Remote-Control Percutaneous Coronary Interventions
Concept, Validation, and First-in-Humans Pilot Clinical Trial
Rafael Beyar, MD, DSc*,*,1,
Luis Gruberg, MD*,
Dan Deleanu, MD ,
Ariel Roguin, MD, PhD*,
Yaron Almagor, MD ,
Silviu Cohen, RN*,
Ganesh Kumar, MD* and
Tal Wenderow, BSc ,2
* Division of Invasive Cardiology, Rambam Medical Center and the Technion, Haifa, Israel
Cardiovascular Disease Institute "Prof. C. C. Iliescu," Fundeni Hospital, Bucharest, Romania
Department of Cardiology, Shaare’i Zedek Medical Center, Jerusalem, Israel
NaviCath Ltd., Haifa, Israel
Manuscript received May 14, 2005;
revised manuscript received September 2, 2005,
accepted September 12, 2005.
* Reprint requests and correspondence: Dr. Rafael Beyar, Women’s Division/Dr. Phillip and Sarah Gotlieb Chair in Medicine and Biomedical Engineering, Head, Division of Invasive Cardiology, Rambam Medical Center, Haifa, Israel. (Email: rafael{at}tx.technion.ac.il).
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.
|
Abbreviations and Acronyms
| | LAD = left anterior descending coronary artery | | LCX = left circumflex artery | | MACE = major adverse coronary events | | PCI = percutaneous coronary intervention | | RCA = right coronary artery | | RNS = Remote Navigation System | | TFT = total fluoroscopy time |
|
This article has been cited by other articles:
|
|
|
|
 
K. E. Kip, K. Hollabaugh, O. C. Marroquin, and D. O. Williams
The Problem With Composite End Points in Cardiovascular Studies The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention.
J. Am. Coll. Cardiol.,
February 19, 2008;
51(7):
701 - 707.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
