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

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.

Demonstration of transoral surgery in cadaveric specimens with the medrobotics flex system.

OBJECTIVES/HYPOTHESIS: Using human cadavers, we investigated the feasibility of using a new robotic platform, the Medrobotics Flex System, for laryngeal access and flexible tool delivery to facilitate the performance of pharyngolaryngeal procedures without laryngeal suspension. Our initial trials specifically assess the utility of this experimental robotic system for epiglottectomy and base of tongue resection. STUDY DESIGN: Feasibility; Level of evidence: NA. METHODS: Using standard mouth retractors, the Flex™robot was driven via the physician controller to the supraglottic region. Non-crossing, flexible endoscopic tools were inserted through the robot's external tool channels to retract, cauterize, and remove tissue in each procedure type. Mock surgical procedures were performed on the laryngopharyngeal complex including epiglottectomy, base of tongue resection, and vocal cord excision. Time-to-tissue exposure was noted for each procedure. Each epiglottectomy was timed to determine operation duration. RESULTS: Epiglottectomy, base of tongue resection, and vocal cord excision were successfully performed without suspension laryngoscopy. Individual surgeons improved the procedure time significantly (P = 0.03) between first and second attempts. Epiglottectomies were performed in an average time of 42 minutes (N = 5, σ = 28 minutes). CONCLUSIONS: The Medrobotics Flex System demonstrates great potential as a surgical tool in head and neck oncology. Compared to other surgical robots, the Flex System offers facilitated access, vision, and triangulation of flexible tools for procedures in the endolarynx. LEVEL OF EVIDENCE: N/A.

A transoral highly flexible robot: Novel technology and application.

OBJECTIVES/HYPOTHESIS: Organ preservation surgery is a major focus in head and neck oncology. Current approaches are aimed toward improving quality of life and decreasing treatment-related morbidity. Transoral robotic surgery was developed to overcome the limitations of traditional surgical approaches. The most widely used robotic system is the da Vinci Surgical System. Although the da Vinci offers clear surgical advantages over traditional approaches, its rigid operative arms prevent complex maneuverability in three-dimensional space. The ideal surgical robot would configure to the anatomy of the patient and maneuver in narrow spaces. We present the first cadaveric trials of the use of a highly flexible robot able to traverse the nonlinear upper aerodigestive tract and gain physical and visual access to important anatomical landmarks without laryngeal suspension. STUDY DESIGN: Feasibility. METHODS: Using human cadavers, we investigated the feasibility of visualizing the endolarynx transorally with a highly flexible robot without performing suspension of the larynx. Two fresh and four preserved human specimens were used. RESULTS: Unhampered visualization of the endolarynx was achieved in all specimens without performing laryngeal suspension. Standard mouth retractors facilitated the delivery of the robot into the endolarynx. CONCLUSIONS: The flexible robot technology mitigates laryngeal suspension and the limitations of current robotic surgery with rigid line-of-sight-directed instruments. Having demonstrated the feasibility of physical and visual access to the endolarynx, future work will study the feasibility of using the highly flexible robot in transoral robotic procedures with flexible instrumentation placed in the robot's available working ports.