Cassidy Duran1, Alan B Lumsden2, Jean Bismuth2. 1. The Methodist DeBakey Heart & Vascular Center, Houston, TX. Electronic address: caduran@tmhs.org. 2. The Methodist DeBakey Heart & Vascular Center, Houston, TX.
Abstract
BACKGROUND: The success of remotely steerable catheters designed for cardiac ablation procedures in the peripheral vasculature (in the laboratory and in highly select live cases) has led to the development of a vascular robotic system designed specifically for use in the arterial and venous systems. Limited bench-top and animal testing has been successful, but no randomized, controlled study of the system's safety has been performed. METHODS: In a 3-phase study, we performed a randomized, controlled trial comparing standard manual catheterization and balloon angioplasty of visceral, renal, and contralateral lower extremity vessels in a porcine model. We also demonstrated feasibility of standard device deployment through the system. RESULTS: There was 100% technical success in test (robotic) and control (manual) arm cannulation and balloon angioplasty of all target vessels, without complications. Pathologic analysis at 7 days revealed significantly fewer traumatic lesions in the test animal arm as compared with the control arm (P < 0.001) and, by 30 days, all lesions had healed in both groups. There was 100% success in delivery of standard devices (balloons and stents) without complications. CONCLUSIONS: Remotely steerable robotic catheters are at least as safe as manual catheter techniques, and may prove less traumatic to peripheral vessels. Standard devices can be deployed through the system, and the stability of the platform may aid in ease of device delivery in difficult vascular segments.
RCT Entities:
BACKGROUND: The success of remotely steerable catheters designed for cardiac ablation procedures in the peripheral vasculature (in the laboratory and in highly select live cases) has led to the development of a vascular robotic system designed specifically for use in the arterial and venous systems. Limited bench-top and animal testing has been successful, but no randomized, controlled study of the system's safety has been performed. METHODS: In a 3-phase study, we performed a randomized, controlled trial comparing standard manual catheterization and balloon angioplasty of visceral, renal, and contralateral lower extremity vessels in a porcine model. We also demonstrated feasibility of standard device deployment through the system. RESULTS: There was 100% technical success in test (robotic) and control (manual) arm cannulation and balloon angioplasty of all target vessels, without complications. Pathologic analysis at 7 days revealed significantly fewer traumatic lesions in the test animal arm as compared with the control arm (P < 0.001) and, by 30 days, all lesions had healed in both groups. There was 100% success in delivery of standard devices (balloons and stents) without complications. CONCLUSIONS: Remotely steerable robotic catheters are at least as safe as manual catheter techniques, and may prove less traumatic to peripheral vessels. Standard devices can be deployed through the system, and the stability of the platform may aid in ease of device delivery in difficult vascular segments.
Authors: Patrick A Kupczyk; Ulrike I Attenberger; Carsten Meyer; Julian A Luetkens; Daniel Kuetting Journal: Cardiovasc Intervent Radiol Date: 2022-06-28 Impact factor: 2.797