PART IV - ROBOTS IN INTERVENTIONAL CARDIOLOGY
PART IV

Robots in interventional cardiology

Paul Jau Lueng Ong1, 2, Fahim Haider Jafary2, Deborah JinHyun Lee2
1Heart Specialist International, Mount Elizabeth Novena Specialist Centre, Singapore
2Tan Tock Seng Hospital, Singapore

Summary

Percutaneous coronary intervention (PCI) has rapidly evolved over the last 4 decades with increasing complexity of PCI cases undertaken safely. Robotic-assisted PCI (R-PCI) represents the next paradigm shift in contemporary PCI practice. This chapter outlines the current position and potential of robotic-assisted PCI.

Introduction

While there have been rapid advances in interventional cardiology in improving the safety and efficacy of the procedure for the patient, little has been invested in improving the safety of the procedure for the physician. A career’s worth of radiation exposure with years of prolonged standing while wearing heavy leaded garments leads to significant occupational hazard including orthopaedic injury [1]. Robotic technology has been adopted in the surgical field for a number of years. The adoption of robotics to the interventional cardiology arena offers operators protection from such hazards and has the potential to improve precision of interventional procedures.

FOCUS BOX 1
  • Operators are subjected to cumulative effects of radiation exposure and orthopaedic injuries.
  • The use of robotic technology not only makes PCI safer but may potentially revolutionize the way PCI is performed.

Evolution of R-PCI

A remote navigation system (RNS, NaviCath, Haifa, Israel), was developed by Beyar and his colleagues and its feasibility was reported in first-in-human trial in 2006 [2]. This became the platform for the incarnation of the first R-PCI system, clinically tested and brought to commercial use - the Corindus CorPath® 200 System (Corindus, A Siemens Healthineers Company, Waltham, MA, USA). This enables control of coronary guide wires, balloons and stents during PCI from a protected workstation situated either in the cardiac catheterization laboratory or outside in the control room. The operator is able to control devices with precision in a comfortable sitting position, and without wearing lead if outside the fluoroscopy suite.

Initial data demonstrated R-PCI to be safe and feasible in simpler lesions. The PRECISE (Percutaneous Robotically Enhanced Coronary Intervention) study, published in 2013, was a non-randomized, single arm, multi-centre registry, that demonstrated an excellent acute success rate with a marked reduction in operator radiation exposure using the CorPath 200 system in coronary lesions of low to moderate complexity [3]. The study enrolled 164 patients with a significant stenosis in a coronary artery 2.5 to 4.0 mm in diameter that could be covered with a single stent. Anatomic complexities such as previous stents, planned atherectomy, intraluminal thrombus, severe tortuosity or calcification proximal to the lesion, ostial, bifurcation or unprotected left main lesions were excluded. Majority of patients (68.3%) had Type A or B1 lesions. Procedural success (without conversion to a conventional manual procedure) was achieved in 98.8% with no adverse clinical events at 30 days of follow-up. Impressively, there was a 95% reduction in radiation exposure for the operator at the R-PCI cockpit compared to dosimetry measured at the operator table (0.98 vs. 20.6 μGy, p < 0.0001).The PRECISE study formed the basis for FDA approval of the Corindus CorPath R-PCI system in July 2012.

Extending the findings of the PRECISE study, Mahmud et al. [4] examined the safety and effectiveness of R-PCI in a more complex “real world” cohort of patients. In the single-centre, non-randomised, Complex Robotically Assisted Percutaneous Coronary Intervention (CORA-PCI) Study, consecutive patients undergoing complex R-PCI were compared to a manual PCI (M-PCI) control group over an 18-month period. Complex lesions were defined as bifurcation disease, chronic total occlusion (CTO), unprotected left main stenosis, multivessel disease, mild to moderate calcification, or left ventricular dysfunction with or without hemodynamic support. Excluded cases were ST-elevation myocardial infarction (STEMI), planned bifurcation stenting, CTO requiring hybrid approach, and calcified lesions requiring atherectomy. 315 patients underwent 334 PCI procedures (108 R-PCIs: 78.3% type B2/C; 226 M-PCIs: 68.8% type B2/C). Technical success was measured as completion of the procedure entirely with robotic assistance or minimal manual assistance, as well as clinical success (< 30% residual stenosis and absence of an adverse outcome). The technical success with R-PCI was 91.7%, with an 11.1% rate of manual assistance and a 7.4% rate of manual conversion and no difference in clinical success compared with M-PCI (99.1% versus 99.1%, respectively; p=1.00). In-hospital major adverse cardiac event (MACE) rates were similar between both groups. However, procedure time was somewhat longer in the R-PCI than the M-PCI group (44 vs. 36min; p=0.002). Of note, this difference was observed in the simpler cases only, with no such difference observed in intermediate and high complexity cases – suggesting, perhaps, that the real utility of R-PCI may lie in its use in longer more challenging cases.

The same group subsequently reported on 6 and 12 months outcomes of the CORA-PCI study [5] and showed no difference in MACE at either time points (5.8% vs. 3.3%, P = 0.51 at 6 months; 7.8% vs. 8.1%, P = 0.92) between R-PCI and M-PCI confirming a robust longer-term efficacy of R-PCI.

Since then, a number of reports on the successful use of R-PCI for more unique patient subsets have been published, including the use in CTO PCI [6], and the hybrid use of R-PCI and M-PCI for complex high-risk cases [7]. Furthermore, Mahmud et al [8] recently reported on resource utilization to be comparable between R-PCI and M-PCI, with a higher upfront expense related to single-use consumables used for each case but similar total hospitalization costs. These findings suggest the financial impact of R-PCI may be relatively modest, albeit the study did not factor in the capital investment required for the CorPath system.

Thus, R-PCI appears to be safe and feasible in simple to more challenging lesion subsets compared to M-PCI based on data using the Corindus CorPath 200 system. Limitations of the dataset include lack of randomization, single centre and single/expert operator experience therefore leaving the question of generalizability unanswered. That said, technological improvements in the design may potentially mitigate this limitation by enhancing the “usability” of the device. The Corindus CorPath GRX is the current iteration, improved from the CorPath 200. It includes the addition of a third joystick with ability to control the guide catheter, allowing remote manipulation to augment support after engagement or prevent the guide from being “sucked in” during retraction of devices. The 40-patient study has demonstrated its clinical safety and feasibility of use in humans. Technical procedural and clinical success were defined in the same manner as in CORA-PCI, and were 90% (36 of 40) and 97.7% (39 of 40), respectively [9].

FOCUS BOX 2
  • In July 2012, the first R-PCI system, Corindus CorPath 200 obtained FDA clearance.
  • CorPath GRX is the most advanced robotic PCI technology to date.
  • Trials using mainly CorPath 200 system have proven R-PCI to be safe and feasible in simple to more challenging lesion subsets as compared to M-PCI.

Description of R-PCI

The R-PCI system allows the operator to remotely control the guide wire, balloons, stents (or other rapid exchange devices) and the guide catheter. The only FDA approved device for R-PCI is the CorPath GRX (Corindus, A Siemens Healthineers Company, Waltham, MA, USA). This is a second-generation device in which some of the shortcomings of the first device have been improved upon (CorPath 200).

There are 2 main components- the interventional workstation ( Figure 1), and the bedside unit ( Figure 2 ) consisting of an articulated robotic arm attached to the catheterisation laboratory table, and a single-use cassette to which the guide catheter is connected and through which the intravascular equipment is loaded and retracted.

At the bedside unit, a technician manually loads a guide catheter, a 0.014”guidewire and a rapid exchange catheter (balloon or stent). Meanwhile, the interventional cardiologist can sit comfortably within the shielded environment (without lead apron). The remote workstation can also be taken to the control room. This workstation entails high-resolution angiographic hemodynamic monitors, standard foot pedal controls and a series of joysticks controlling the guide catheter, balloon/stent and guidewire. The balloon or stent can be guided both in a continuous motion using the joystick and in discrete, highly sensitive small steps at 1mm increment using the touch screen. The latest software upgrade to the CorPath GRX System includes specific algorithms that mimic manual techniques used to facilitate wire crossing of complex lesions in tortuous vessels such as “rotate on retract,” which automatically rotates the wire up to 270° after pulling it back. In recent years, the software has added four new automated movements. This includes Spin (clockwise and counterclockwise guidewire rotations), Wiggle (oscillating movements in guidewire navigation), Dotter (lesion crossing and therapy delivery using rapid linear back-and-forth motions), and Constant Speed (precise measurement of the anatomy by maintaining constant speed on the guidewire or device). This could potentially improve the success rates of complex R-PCI but there is no data as of yet.

In essence, the initial arterial access, coronary angiography and engagement using guide catheter are still achieved manually. The guide catheter is then attached to the cassette, followed by manual loading of guide wire, stent catheter and rapid exchange balloon on the cassette. Once loaded, it allows remote control of advancement and retraction of the devices. Subtle manipulation of the guide catheter is feasible. This allows the operator to keep the guiding catheter co-axial and either deep seating or backing it off as required. It can be used with both radial and femoral access.

FOCUS BOX 3CorPath GRX system
  • Consists of:
    • A mobile interventional workstation consisting of control console with touchscreen buttons and 3 joysticks (which controls the guide catheter, guidewires, and balloon/stent)
    • Bedside unit composed of robotic drive with single use cassette, connected through a sleeve to guide catheter
  • Can be used with both radial and femoral access

Learning curve for R-PCI

For senior interventionists to fellows alike, the learning curve primarily involves hand-eye coordination and translating joystick and touchscreen movements into device control. The only study published to date on R-PCI learning curve is a secondary analysis from the PRECISE trial (involving 164 cases) [10] using the CorPath 200 robotic system. Upon performing first 3 cases, interventionalists were able to perform subsequent R-PCI faster, with less radiation and without compromising safety. This highlights the easy adoption of R-PCI technology but further large studies are required to delineate the true learning curve and to come up with a formal R-PCI learning curriculum.

Potential Advantages of R-PCI

Robotic PCI offers several potential advantages for both the patient and operators.

Increased procedural accuracy

PCI involves the need for accuracy at a number of stages during the procedure. Interventionalists are trained to rely on analog cues via either manual manipulation of devices or a “visual estimate” of length, vessel diameter or stent positioning. Visual angiographic assessment in stent length selection is limited by foreshortening especially in tortuous vessels. R-PCI has a unique measurement feature that can measure the real length with great precision independent of foreshortening and angiographic view. This is performed by advancing a balloon marker to the distal and proximal edges of the lesion of interest. The distal edge is marked as ‘0’ on the touch screen display. By withdrawing the balloon marker to the proximal edge of the lesion in 1mm increments, the distance travelled by the marker would give a precise lesion length.

In a study by Campbell et al. comparing operators’ visual stent length estimate with the robotic quantitative measurement, only 35% of visual estimates were accurate. This paper also showed 8.3% reduction in stent usage as the initial lesions visually assessed as long lesions resulted in fewer stents used [11].

In addition, R-PCI also has the potential benefit of increased precision of stent deployment by reducing incidence of longitudinal geographic miss (LGM). In a multicentre observational registry with >1,500 patients, LGM is associated with increased rates of target vessel revascularisation at 1 year, independent of clinical or anatomical risk factors [12]. In a retrospective, propensity-matched cohort analysis, Bezerra et al. demonstrated that the incidence of LGM was greater in those treated with conventional PCI compared with R-PCI (43.1% versus 12.2%, respectively; p<0.0001) [13]. Overall, precise lesion length assessment would lead to appropriate stent selection and lower LGM incidence.

Finally, with the ability of performing truly “millimetre by millimetre” movement of stents and balloons, there is the possibility of extreme precision in stent positioning at critical locations, for example, ostial locations. This needs to be confirmed by clinical studies.

Remote “telestenting”

Another potential advantage of R-PCI would be the possibility of ‘telestenting’. This could allow R-PCI to be performed in remote geographically distant locations.

The REMOTE-PCI study was the first to explore the feasibility of such approach. In this small study of 20 patients, the operator performed R-PCI in a separate physical location while communicating with the lab personnel via telecommunications devices, with a technical success rate of 86% [14]. More recently, Patel et al [15] successfully performed remote R-PCI using the CorPath GRX system, while physically located 20 miles away from the cardiac catheterization laboratory. Procedural success was 100%. While an on-site team was on standby in the laboratory for these cases, this opens the potential of “long-distance” remote PCI. A recent study [16] conducted on pre-clinical models comparing performance over wired networks in transcontinental was shown to be safe and possible compared to R-PCI performed regionally. This technology could break down geographical barriers to achieve prompt primary PCI in underserved areas.

Potential for incorporating artificial intelligence into PCI

Advances in computing technology have made it possible to utilize artificial intelligence (A.I.) in medicine, mostly in the diagnostic realm (imaging, pattern recognition). Companies such as Verb Surgical, a collaboration between Google and Endo-Surgery, are planning on linking the robot to cloud supercomputer service, through which the surgeon and the robot can access the information on countless similar procedures [17].

In interventional cardiology, R-PCI opens up the possibility of incorporating “expert moves” into PCI procedures. In theory, it is not beyond the realm of possibility to have specific technical “moves” programmed into the system, utilized at the operator’s discretion. These could potentially include a CTO expert’s wire manipulations (previously captured off-line) be applied by an operator to a particular lesion. Or another expert’s “moves” for wiring a tortuous vessel. In theory, hence, R-PCI may level the playing field and allow less skilled operators to capitalize on built in “expertise modules” in the system and perform more complex procedures.

Reduce radiation exposure for the operator

Interventional cardiologists have the highest radiation exposure of all health care workers, with estimated exposures of about 5 mSv per year. This translates to an increased lifetime risk of cancer 1 per 100 exposed individuals [18].

The radiation protection is the key advantage offered by R-PCI. This was observed in the PRECISE trial [3], which assessed 164 patients enrolled at nine sites and determined that radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position.

A recent meta-analysis by Allencherril et al. provides the largest analysis of composite data showing lower operator radiation exposure in R-PCI group compared with M-PCI, with no apparent differences in fluoroscopy time [19].

Another area where radiation protection is a particular concern are the many female interventionists and cath-lab staff who are at childbearing age. The adoption of R-PCI may allow pregnant staff to continue to practice throughout the pregnancy without the added worry of radiation injury.

Reduce orthopaedic injuries

Prolonged standing and wearing leaded garments lead to operator fatigue and orthopaedic injuries. Interventional cardiologists, along with interventional radiologists, have the highest rates of orthopaedic injuries among physicians, with half of interventional cardiologists noting spine problems and had strong correlation with both case load and advancing operator age [1].

Being in the radiation shielded control cockpit, the operator can remain seated, not having to wear the leaded garments and the fluoroscopic images in close proximity.

Application to pandemic situations

The COVID-19 pandemic has challenged the cardiac catheterization laboratory in a number of ways, operator and staff exposure to disease being one of them. A potential advantage of R-PCI is to limit operator and staff exposure to infected (or potentially infected) patients in need for urgent and emergent procedures. While R-PCI still requires a human presence at the procedure table, once the system has been deployed the procedure could be conducted at a safe distance. Lemos et al [20] showed that they were able to perform a 103 minute procedure during which a 4-meter “spread zone” around the patient was kept clear of staff for the majority of the time using R-PCI. Thus, R-PCI may be particularly useful in mitigating operator and staff risk during high-risk infectious situations.

FOCUS BOX 4
  • Potential benefit for the patient:
    • Increased procedural accuracy (accurate stent selection and less longitudinal geographic miss)
    • Possibility of remote PCI in underserved areas
  • Potential benefit for the operator:
    • Improved ergonomics
    • Reduced radiation exposure

Limitations of R-PCI

R-PCI is not without limitations.

First, as mentioned earlier, the current CorPath GRX System is not fully remote. Vascular access, angiography and placement of coronary guide catheter need to be done manually. Thus “robotic” PCI is, in essence, a hybrid procedure from the outset. Furthermore, although remote “tele-PCI” is an attractive concept, so far all such procedures performed have involved an on-site cardiologist present on stand-by. It remains to be seen if remote PCI can be performed with key steps (such as guide catheter engagement) performed by non-cardiologists (catheterization laboratory technicians or nurses).

Second, the current robotic system is incompatible with large number of interventional devices including over-the-wire devices, aspiration catheters and microcatheters. Items required in complex lesions such as guide catheter extensions and atherectomy devices also preclude a complete robotic approach ( Table 1). Furthermore, only certain intravascular ultrasound catheters (i.e Phllips Volcano, Phillips Healthcare, WA, USA), are compatible with R-PCI system.

Third, this platform only allows manipulation of 1 guidewire at a time and positioning of 1 balloon or stent simultaneously. Bifurcation cases with planned kissing stents or kissing balloon angioplasty while possible does require some degree of manual input from the operator in a hybrid fashion. Future iterations of the system may accommodate this demand.

Fourth, another limiting factor is the lack of tactile feedback. In complex lesions, the interaction between wires of different mechanical properties, lesion and operator play an important role in achieving technical success. However, experienced interventional cardiologists involved with trainee supervision routinely forgo this tactile feedback and rely on visual cues, with no compromise in success. That said, the integration of haptics within the robotic system may allow for a more natural interaction between the wire and operator.

Fifth, although there have been reports of R-PCI being used for treatment of STEMI, its use in emergent PCI and unstable patients are yet to be studied extensively. It is conceivable that the time taken for device set up may adversely affect door to balloon time although this set up time is likely to decline as laboratory staff get more adept with the process.

Finally, the current dataset is limited to non-randomized single centre studies with expert operators performing R-PCI. Larger multicentre randomized trials are needed to fully understand the role as well as generalizability of R-PCI.

Despite current limitations of R-PCI, robotic PCI should not be considered ‘all or none’. In long and complex cases where radiation and occupational hazard risk is especially high, one can adopt a ‘hybrid’ approach where M-PCI is performed for certain steps (wiring a CTO lesion or lesion preparation using atherectomy devices) followed by R-PCI for routine balloon and stent portions.

FOCUS BOX 5Limitations of CorPath GRX system
  • Vascular access, diagnostic coronary angiography and engagement of guide catheter have to be performed manually.
  • Limited to rapid exchange devices only.
  • Does not support planned coronary bifurcation stenting with two-stent approach.

Conclusion

R-PCI holds great promise for making interventional procedures safer for operators and potentially improving patient outcomes. Being in the early adoption phase of this technology, limitations of current R-PCI platform need to be addressed. This includes lack of compatibility with over-the wire and micro catheter devices and possibly adding additional active ports for advancing catheters to facilitate complex bifurcation stenting. With further advances and innovation, PCI procedures would be safer and more efficient for both patient and the operator. Furthermore, with improvements in technology “true” remote PCI with an interventional cardiologist miles away may one day become routine and bring PCI to underserved areas.

Personal Perspective – Paul Ong

Robotic PCI has caught the imagination of many of us. The Corindus CorPath system described here is by no means the finished product, but it is the first commercially available system that can be used successfully to complete most of the angioplasty carried out day in day out in modern cathlabs. This is a very promising first attempt in introducing some degree of automation in wire manipulation and a more precise way to position stents in the coronary arteries.

While we may debate the merit of R-PCI in patient care, there is little doubt that the set up will benefit the interventionists and the other co-workers in the lab. The long hours standing in the lab doing complex cases are increasingly taking a toll on our body. The ability to perform PCI in a radiation free environment without wearing the back-straining lead aprons will no doubt extend the practicing life of many of us.

Much has been made of the use of robotic in performing remote angioplasty. Remote PCI may not be necessary in densely populated cities with good healthcare infrastructure, but in some part of the world it may mean receiving good treatment versus no treatment at all. In a world that is still battling the pandemic, remote PCI through robotic use may allow patients in isolation facilities to undergo revascularization without exposing the healthcare professionals to extra risk.

We look forward to further improvement of the set up and the expansion of devices that are compatible with R-PCI. The inability to incorporate over-the-wire devices like micro-catheter and rotablation to the robotic platform is an obvious demand gap. However, the use of OTW devices can still be integrated to the R-PCI procedure in a hybrid fashion with some advance planning.

It took foresight and courage for interventionists to move from femoral access to trans-radial PCI, to overcome the learning curve and the usual frustrations. R-PCI may be viewed in the same way.

Robotic PCI is not about replacing interventionists in performing angioplasty, far from it, it is the beginning of a new chapter of training and possibilities.

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