Single-site access robot-assisted epicardial mapping with a snake robot: preparation and first clinical experience

Abstract

CardioARM, a highly flexible "snakelike" medical robotic system (Medrobotics, Raynham, MA), has been developed to allow physicians to view, access, and perform complex procedures intrapericardially on the beating heart through a single-access port. Transthoracic epicardial catheter mapping and ablation has emerged as a strategy to treat arrhythmias, particularly ventricular arrhythmias, originating from the epicardial surface. The aim of our investigation was to determine whether the CardioARM could be used to diagnose and treat ventricular tachycardia (VT) of epicardial origin. Animal and clinical studies of the CardioARM flexible robot were performed in hybrid surgical-electrophysiology settings. In a porcine model study, single-port pericardial access, navigation, mapping, and ablation were performed in nine animals. The device was then used in a small, single-center feasibility clinical study. Three patients, all with drug-refractory VT and multiple failed endocardial ablation attempts, underwent epicardial mapping with the flexible robot. In all nine animals, navigation, mapping, and ablation were successful without hemodynamic compromise. In the human study, all three patients demonstrated a favorable safety profile, with no major adverse events through a 30-day follow-up. Two cases achieved technical success, in which an electroanatomic map of the epicardial ventricle surface was created; in the third case, blood obscured visualization. These results, although based on a limited number of experimental animals and patients, show promise and suggest that further clinical investigation on the use of the flexible robot in patients requiring epicardial mapping of VT is warranted.

Keywords: Catheter ablation; Electroanatomical epicardial mapping; Flexible robot; Minimally invasive surgery; Robotic assisted procedure; Ventricular tachycardia.

Fig. 1

CardioARM medical robotic system. a Distal tip of the robotic system showing the “snakelike” device conforming to a surrogate heart model. Screens displaying fiberscope vision, robotic controls, and additional procedural information are in the background. The physician control device is shown in foreground. b Distal tip of the device, which operates in the intrapericardial space. Optics are covered by a dome, and tools channels are shown below

Fig. 2

Representative necropsy showing opening of the pericardium, the CARTO map with radiofrequency (RF) ablation sites marked during ablation, and corresponding heart following excision

Fig. 3

Monitors used during the clinical trial procedure. Information displayed include intracardiac echocardiogram, CARTO, fiberscope vision, fluoroscopy (2 monitors), vitals, and robotic status information. Images shown have been superimposed on the monitor bank

Fig. 4

Select images during the clinical enrollment. a External view of the setup, b intrapericardial view, c subxiphoid access view, d electroanatomical CARTO map at the completion of the procedure