Robotic telestenting performance in transcontinental and regional pre-clinical models.

OBJECTIVES: This study was conducted to evaluate the association of geographic distance with robotic telestenting performance by comparing performance measures in transcontinental and regional pre-clinical models of telestenting. BACKGROUND: Robotic telestenting, in which percutaneous coronary intervention (PCI) is performed on a remotely located patient, might improve PCI access, but has not been attempted over vast distances likely required to reach many underserved regions. METHODS: Telestenting performance was compared in regional (Boston to New York [206 miles]) and transcontinental (Boston to San Francisco [3,085 miles]) ex vivo models of telestenting, wherein a physician in Boston attempted robotic PCI on endovascular simulators in New York and San Francisco, respectively. PCI was attempted over both wired and fifth generation (5G)-wireless networks. Outcome measures included procedural success, procedural time, and perceived latency. RESULTS: Procedural success was achieved in 20 consecutive target lesions in the regional model and in 16 consecutive target lesions in the transcontinental model. The transcontinental model had a greater latency than the regional model over both wired (121.5 ± 2.4 ms vs. 67.8 ± 0.9 ms; p < .001) and 5G-wireless networks (162.5 ± 1.1 ms vs. 86.6 ± 0.6 ms; p < .001), but perceived latencies were graded "imperceptible" in all cases in both models. Transcontinental and regional models did not have significantly different procedural times over wired (4.1 ± 1.9 min vs. 9.0 ± 7.1 min; p = .051) or 5G-wireless (3.0 ± 0.6 vs. 6.3 ± 1.2; p = .36) networks. CONCLUSIONS: Transcontinental robotic manipulation of coronary devices is now possible and was not associated with adverse performance compared to robotic telestenting conducted regionally.

Impact of network performance on remote robotic-assisted endovascular interventions in porcine model.

Remote robotic-assisted endovascular interventions require real-time control of the robotic system to conduct precise device navigation. The delay (latency) between the input command and the catheter response can be affected by factors such as network speed and distance. This study evaluated the effect of network latency on robotic-assisted endovascular navigation in three vascular beds using in-vivo experimental model. Three operators performed femoral, carotid, and coronary endovascular robotic navigation blinded from the hybrid room with the prototype remote-enabled CorPath GRX system in a porcine model. Navigation was performed to different targets with randomly assigned network latencies from 0 to 1000 ms. Outcome measurements included navigation success, navigation time, perceived lag (1 = imperceptible, 5 = too long), and procedural impact scored by the operators (1 = no impact, 5 = unacceptable). Robotic-assisted remote endovascular navigation was successful in all 65 cases (9 femoral, 38 external carotid, 18 coronary). Guidewire times were not significantly different across the simulated network latency times. Compared to 0 ms added latency, both the procedural impact and perceived lag scores were significantly higher when the added latency was 400 ms or greater (< 0.01). Remote endovascular intervention was feasible in all studied anatomic regions. Network latency of 400 ms or above is perceptible, although acceptable to operators, which suggests that remote robotic-assisted femoral, carotid or coronary arterial interventions should be performed with network latency below 400 ms to provide seamless remote device control.

Robotic-assisted intracranial aneurysm treatment: 1 year follow-up imaging and clinical outcomes.

BACKGROUND: The use of robotics in medicine may enable increased technical accuracy, reduced procedural time and radiation exposure, and remote completion of procedures. We have previously described the first-in-human, robotic-assisted cerebral aneurysm treatment using the CorPath GRX Robotic System. In this report we discuss our early experiences and outcomes using this robotic device for endovascular treatment of intracranial aneurysms using stent-assisted coil embolization and flow diversion. METHODS: The patient and disease characteristics, procedural details, and follow-up imaging and clinical outcomes of consecutive patients undergoing robotically-assisted intracranial aneurysm embolization between November 2019 and February 2020 are presented. RESULTS: Six patients underwent robotically-assisted embolization of intracranial aneurysms. Four of the patients were treated with a neck-bridging stent (with or without coiling) and two patients were treated with a flow-diverting stent. Two patients were treated in the subacute period of subarachnoid hemorrhage and four patients were treated electively. All of the procedures could be completed robotically and there was no need for unplanned manual intervention. The technical success rate of the procedures was 100%. There was no morbidity or mortality associated with the procedures. One year follow-up imaging showed that four aneurysms were completely obliterated (Raymond-Roy Occlusion Classification (RROC) class I) and the remaining two were occluded with a residual neck (RROC class II). CONCLUSIONS: The Corpath GRX Robotic System demonstrated a precise control over the microcatheter, wire and stent during aneurysm treatment. Robotic neuro-procedures seem to be safe and effective and demonstrate stable occlusion results in the midterm follow-up.

Preclinical study testing feasibility and technical requirements for successful telerobotic long distance peripheral vascular intervention.

BACKGROUND: Robotic-assisted endovascular surgery enables us to perform interventions from long distances. This study evaluates the workflow and telecommunication requirements of telerobotic peripheral vascular interventions. METHODS: Ten superficial femoral artery cases were performed by the operator being 44 miles away from the interventional suite, with an endovascular robotic system, on a high-fidelity endovascular simulator. Procedural success, technical success, fluoroscopy time, residual stenosis, contrast dose and network delay were registered. Communication success was assessed after each procedure on a scale from 1 (unacceptable) to 5 (ideal). RESULTS: Procedural success and technical success were 100% and 80%, respectively. The mean residual stenosis, fluoroscopy time and contrast dose were 1.7 ± 5.25%, 6.5 ± 1.8 min and 58.8 ± 14.8 ml. The mean network latency was 38.9 ± 3.5 ms. Median communication success scores were 4.5 (min: 4, max: 5) reported by both the operator and the bedside technician on a scale of 1 (unacceptable) to 5 (ideal). CONCLUSION: With a stable network connection and good communication protocol, a high success rate was achieved for remote robotic-assisted peripheral vascular intervention in an ex vivo model.

Biomodex patient-specific brain aneurysm models: the value of simulation for first in-human experiences using new devices and robotics.

BACKGROUND: With the recent advent of advanced technologies in the field, treatment of neurovascular diseases using endovascular techniques is rapidly evolving. Here we describe our experience with pre-surgical simulation using the Biomodex EVIAS patient-specific 3D-printed models to plan aneurysm treatment using endovascular robotics and novel flow diverter devices. METHODS: Pre-procedural rehearsals with 3D-printed patient-specific models of eight cases harboring brain aneurysms were performed before the first in-human experiences. To assess the reliability of the experimental model, the characteristics of the aneurysms were compared between the patient and 3D models. The rehearsals were used to define the patient treatment plan, including technique, device sizing, and operative working projections. RESULTS: The study included eight patients with their respective EVIAS 3D aneurysm models. Pre-operative simulation was performed for the first in-human robotic-assisted neurovascular interventions (n=2) and new generation flow-diverter stents (n=6). Aneurysms were located in both the anterior (n=5) and posterior (n=3) circulation and were on average 11.0±6.5 mm in size. We found reliable reproduction of the aneurysm features and similar dimensions of the parent vessel anatomy between the 3D models and patient anatomy. Information learned from pre-surgical in vitro simulation are described in detail, including an improved patient treatment plan, which contributed to successful first in-world procedures with no intraprocedural complications. CONCLUSIONS: Pre-procedural rehearsal using patient-specific 3D models provides precise procedure planning, which can potentially lead to greater operator confidence, decreased radiation dose and improvements in patient safety, particularly in first in-human experiences.

First-in-human, robotic-assisted neuroendovascular intervention.

Robotic-assisted technology has been used as a tool to enhance open and minimally invasive surgeries as well as percutaneous coronary and peripheral vascular interventions. It offers many potential benefits, including increased procedural and technical accuracy as well as reduced radiation dose during fluoroscopic procedures. It also offers the potential for truly "remote" procedures. Despite these benefits, robotic technology has not yet been used in the neuroendovascular field, aside from diagnostic cerebral angiography. Here, we report the first robotic-assisted, therapeutic, neuroendovascular intervention performed in a human. This was a stent-assisted coiling procedure to treat a large basilar aneurysm. All intracranial steps, including stent placement and coil deployment, were performed with assistance from the CorPath© GRX Robotic System (Corindus, a Siemens Healthineers Company, Waltham, MA, USA). This represents a major milestone in the treatment of neurovascular disease and opens the doors for the development of remote robotic neuroendovascular procedures.