**4. Clinical experience**

### **4.1 Percutaneous coronary interventions**

The first-in-human study regarding coronary angioplasty was published in 2011. Granada and colleagues reported 8 patients, who underwent PCI with the CorPath 200 system. Their data showed a 97% decrease in radiation exposure to the operator with a 97.9% procedural success rate [4]. The first multicenter study with robotic-assisted coronary interventions was the PRECISE study (percutaneous robotically-enhanced coronary intervention) [12]. The study was conducted with the CorPath 200 system and enrolled 164 patients with simple coronary lesions. The inclusion criteria were coronary artery stenosis above 50%, with the diameter in between 2.5–4 mm and with a length that could be covered by one stent. This prospective trial reported a 95.2% decrease in radiation level and a 97.6% success rate. The improvement of the newer generation devices allowed a wider potential application for the robotic assisted therapy as well. The CORA-PCI (Complex Robotically Assisted Percutaneous Coronary Intervention) trial focused on patients with complex coronary artery lesions. Patients were treated by a single operator and a total of 334 PCI-s were analyzed [13]. The results reported a 91.7% technical success and a 99.1% clinical success with robotic-assisted PCI. The study showed that the approach is a viable alternative to manually conducted PCI-s. Regarding postintervention outcomes [14] Walters and colleagues reported non-inferior results in major adverse (cardiac) events at 6 and 12 months also [15]. In 2020, Patel et all. Published their data showing a significant reduction in radiation exposure to patients and medical staff also [16].

#### **4.2 Peripheral vascular interventions**

The first-in-man study evaluating efficacy of robotic-assisted peripheral arterial lesion cannulation was a prospective, single-armed study by Bismuth et al. [17]. The trial focused on navigating successfully and safely through lesions ranging from simple to complex. The results showed a 100% successful navigation rate

and 19 of the 20 lesions were able to be treated by robotic-assisted means using the Magellan system. This study concluded that the robotic-assisted cannulation and treatment are feasible options even for complex peripheral arterial lesions. **Table 2** summarizes the clinical studies completed with the CorPath 200 system (**Table 2**).

The RAPID (Robotic-Assisted Peripheral Intervention for peripheral arterial Disease) trial was a single-arm prospective non-randomized study with symptomatic PAD patients [18]. The inclusion criteria were life-limiting femoro-popliteal stenoses above 50% or occlusion. Total of 20 patients with 29 lesions were treated, primary endpoints were technical success and safety, secondary endpoints included clinical procedural success, fluoroscopy time, contrast volume, procedure time, and adverse events. The procedures were performed from an antegrade femoral punctures, balloon angioplasty alone was performed in 65.5% and in the rest of the cases manually deployed stenting was required. The study reported 100% technical and clinical success without any significant major adverse event. The study's secondary outcome also demonstrated a reduced fluoroscopy time compared to studies treating similar lesions in a conventional manner. These favourable results provided the CorPath system F.D.A. approval for peripheral vascular interventions.

In 2020, the results of the RAPID II trial were published. This study focused on robotic-assisted drug-eluting balloon deployment in the peripheral vascular system [19]. The data of 20 patients reported technical success in all cases, without any major adverse events associated with the device.

The robotic system was used in the below the knee region also. Successful treatments were presented in the posterior tibial artery, tibio-peroneal trunk and in the proximal peroneal artery also [20].

A case-series of robotic-assisted percutaneous renal artery stenting has also been published with promising results and no major adverse events reported [21, 22].

### **4.3 Endovascular aneurysm repair (EVAR) and robotic assistance**

Complex aneurysm treatments are technically challenging and more time consuming, therefore both the patient and the medical staff are exposed to higher radiation. The optimistic results from robotic-assisted target lesion/vessel cannulations pioneered the use of the system in endovascular aneurysm repairs also [23]. A feasibility study on an aortic model with the Magellan system showed lesser cannulation time, reduced radiation exposure and reduced number of catheter movements [24]. They highlighted also that with the assistance of the robot to overcome complex cannulations it is not necessarily required to have a well-experienced operator. In another arch model they concluded that robotic


**101**

*Catheter Robots in the Cardiovascular System DOI: http://dx.doi.org/10.5772/intechopen.97314*

Corindus robotics in EVAR.

system [27].

**4.4 Carotid and neurointerventions**

malformation by embolization in a pig model [31].

**4.5 Robotic-assisted remote interventions**

**5. Limitation of the CorPath system**

assistance reduced vessel wall contact and reduced navigational time [25]. More precise navigation was seen in human subjects as well. Comparing conventional and robotic catheter placement and retraction in patients undergoing TEVAR [26]. They recorded a significantly reduced cerebral embolization with the system, which was associated with the lesser number of catheter-vessel wall contacts during the procedure. There is no data currently available with the use of

Robotic-assisted carotid artery stenting is the boundary of peripheral and neurointerventions. A recently published prospective feasibility study enrolled 13 patients who underwent this procedure. They reported technical success in all of the 13 cases, without postoperative neurological complications using the Magellan

The CorPath system underwent several modifications to become applicable in the field of neurointerventions. One of these modifications is the additional Y-adapter that enables the use of additional microcatheters, another modification is the active device fixation, which allows the operator to maintain guidewire position during catheter movements. Active guide catheter control also supports vessel cannulation [28]. A preclinical feasibility study on a porcine model was conducted to prove safe robotic navigation in neurovasculature sized vessels of the pig [29]. Based on this trial the use of the CorPath GRX system was authorized in New-Zealand, Australia and the European Union. Although the first-in-human use of the robotic system happened in Canada, when a basilar aneurysm was treated with robotic support [30]. Britz et al. used the GRX system to treat arterio-venous

The upgrade on the CorPath system allowed the GRX model to be controlled remotely. Hence tele-stenting become a possible treatment option and a new aspect of robotic-assisted therapies become available. This approach does not require the operator to be in the operating room or next to the patient, the whole system is capable of being controlled from another hospital or office through telecommunication. The setup is provided by local area network and the two sites are using telepresence systems. This includes patient's vital parameters, live or stored fluoroscopy data displayed on monitors and an additional monitor with an overall view of the suite. Communication between the medical staff can be enhanced through wireless headsets [32]. There are multiple studies discussing the safety and feasibility of remote PCI [33–35]. Key factors of the procedure are the network stability and the communication of the medical team. Studies on simulators and on in-vivo models focusing on network latency reported that signal transmission should be below 250 ms not to influence the procedure outcome. The tele-stenting involved five in-human PCIs with a 53 ms mean command delay from a 20 miles distance [36].

Currently both the CorPath 200 and the GRX model are only compatible with 0.014-inch wires and rapid exchange delivery systems. The upcoming generations of the CorPath systems will be able to manipulate 0.035-inch wires also, which will

#### **Table 2.**

*Robotic-assisted clinical studies.*

*Latest Developments in Medical Robotics Systems*

and 19 of the 20 lesions were able to be treated by robotic-assisted means using the Magellan system. This study concluded that the robotic-assisted cannulation and treatment are feasible options even for complex peripheral arterial lesions. **Table 2** summarizes the clinical studies completed with the CorPath 200 system (**Table 2**). The RAPID (Robotic-Assisted Peripheral Intervention for peripheral arterial Disease) trial was a single-arm prospective non-randomized study with symptomatic PAD patients [18]. The inclusion criteria were life-limiting femoro-popliteal stenoses above 50% or occlusion. Total of 20 patients with 29 lesions were treated, primary endpoints were technical success and safety, secondary endpoints included clinical procedural success, fluoroscopy time, contrast volume, procedure time, and adverse events. The procedures were performed from an antegrade femoral punctures, balloon angioplasty alone was performed in 65.5% and in the rest of the cases manually deployed stenting was required. The study reported 100% technical and clinical success without any significant major adverse event. The study's secondary outcome also demonstrated a reduced fluoroscopy time compared to studies treating similar lesions in a conventional manner. These favourable results provided the

CorPath system F.D.A. approval for peripheral vascular interventions.

major adverse events associated with the device.

proximal peroneal artery also [20].

**Clinical trial Year of** 

Peripheral vascular

*Robotic-assisted clinical studies.*

Coronary

**publication**

In 2020, the results of the RAPID II trial were published. This study focused on robotic-assisted drug-eluting balloon deployment in the peripheral vascular system [19]. The data of 20 patients reported technical success in all cases, without any

The robotic system was used in the below the knee region also. Successful treatments were presented in the posterior tibial artery, tibio-peroneal trunk and in the

A case-series of robotic-assisted percutaneous renal artery stenting has also been

published with promising results and no major adverse events reported [21, 22].

Complex aneurysm treatments are technically challenging and more time consuming, therefore both the patient and the medical staff are exposed to higher radiation. The optimistic results from robotic-assisted target lesion/vessel cannulations pioneered the use of the system in endovascular aneurysm repairs also [23]. A feasibility study on an aortic model with the Magellan system showed lesser cannulation time, reduced radiation exposure and reduced number of catheter movements [24]. They highlighted also that with the assistance of the robot to overcome complex cannulations it is not necessarily required to have a well-experienced operator. In another arch model they concluded that robotic

**Intervention Treated** 

RAPID [18] 2016 R-PVI 20 100 100 RAPID II [19] 2018 R-PVI 24 100 100

PRECISE [12] 2013 R-PCI 164 97.6 98.8 CORA-PCI [13] 2016 R-PCI 157 91.7 99.1 REMOTE PCI [16] 2017 Tele-PCI 22 86.4 N/A

**lesions**

**Technical success rate (%)**

**Clinical success rates (%)**

**4.3 Endovascular aneurysm repair (EVAR) and robotic assistance**

**100**

**Table 2.**

assistance reduced vessel wall contact and reduced navigational time [25]. More precise navigation was seen in human subjects as well. Comparing conventional and robotic catheter placement and retraction in patients undergoing TEVAR [26]. They recorded a significantly reduced cerebral embolization with the system, which was associated with the lesser number of catheter-vessel wall contacts during the procedure. There is no data currently available with the use of Corindus robotics in EVAR.
