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

Rafael Beyar, Luis Gruberg, Dan Deleanu, Ariel Roguin, Yaron Almagor, Silviu Cohen, Ganesh Kumar, Tal Wenderow

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)296-300
Number of pages5
JournalJournal of the American College of Cardiology
Volume47
Issue number2
DOIs
StatePublished - Jan 17 2006
Externally publishedYes

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Percutaneous Coronary Intervention
Clinical Trials
Stents
Dilatation
Fluoroscopy
Pilots
Safety
Balloon Angioplasty
Coronary Stenosis
Israel
Radiation

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Remote-control percutaneous coronary interventions : Concept, validation, and first-in-humans pilot clinical trial. / Beyar, Rafael; Gruberg, Luis; Deleanu, Dan; Roguin, Ariel; Almagor, Yaron; Cohen, Silviu; Kumar, Ganesh; Wenderow, Tal.

In: Journal of the American College of Cardiology, Vol. 47, No. 2, 17.01.2006, p. 296-300.

Research output: Contribution to journalArticle

Beyar, Rafael ; Gruberg, Luis ; Deleanu, Dan ; Roguin, Ariel ; Almagor, Yaron ; Cohen, Silviu ; Kumar, Ganesh ; Wenderow, Tal. / Remote-control percutaneous coronary interventions : Concept, validation, and first-in-humans pilot clinical trial. In: Journal of the American College of Cardiology. 2006 ; Vol. 47, No. 2. pp. 296-300.
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abstract = "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.",
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AU - Roguin, Ariel

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AU - Cohen, Silviu

AU - Kumar, Ganesh

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