T-trendz Issue 2 / 2020Explore Robotics in Vascular Interventions with Corindus

Today, many procedures that were once highly invasive are now being performed via minimally invasive techniques, with the added benefit of robotic precision and radiation protection. These procedures have the potential to reduce treatment times, increase precision during treatment, raise standardization levels in clinical procedures and ultimately improve clinical outcomes.

Siemens Healthineers completed the acquisition of Corindus Vascular Robotics, Inc. effective October 29, 2019. Corindus is currently the leading company offering a robotic treatment platform for major endovascular therapy applications.

Even in 2020, many people think that using robots to assist in heart interventions sounds a lot like science fiction. Robotic technology has gained widespread adoption in several surgical areas, but its uptake has been limited in interventional cardiology. The new generation Corindus CorPath® GRX System builds on the benefits of robotic therapy by introducing new and advanced features to provide precision and protection during coronary interventions. It is the first and only CE marked and FDA cleared robotic platform with control of device, guide wire, guide catheter designed for PCI, CAD and Neuro procedures.

During a Corindus CorPath® GRX Robotic-assisted intervention, physicians sit in control room workstation and use a set of joysticks and touchscreen controls that transmit the physician’s movements to the device control inside exam room. Robotic-assisted intervention enables precise measurement of anatomy and device.

Watch the video here

Corindus robotics — Corindus CorPath® CRX system in exam room

This also adds the benefit of radiation protection for the physician and the potential to reduce radiation exposure for staff and patients.

This technology touched new heights by proving coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient. This was a first of its kind study, exploring the feasibility of tele stenting by Dr. Ryan D. Madder submitted on May 01, 2016 and published in Europa Digital & Publishing 2017.

Evolution of Interventional Procedures over the last 40+ years

My tryst with Vascular Robotics

Dr. Tejas Patel

MD, DM, FACC, FESC, FSCAI, FCSI
Chairman and Chief Interventional Cardiologist
Apex Heart Institute
Ahmedabad, India
Email: tejaspatel@apexheart.in

I still remember the time I came to know about Transradial PCI. I heard Prof. Saito of Japan talking about transradial angioplasty and somewhere deep down in my heart, I was convinced that it was “the” approach that would redefine PCI.

The only challenge it brought was the new learning curve which was quite stiff. But what also added to the agony was a lot of criticism and scepticism from the senior colleagues and mentors. I decided to go ahead with this as I saw multi-fold benefits to the patients like less trauma, faster recovery and shorter hospitalization. Of course, now it is very well established that there is a reduction in mortality in complex subset of ACS patients with transradial approach, which is of prime importance in any given therapy. As patient wellbeing has always been my prime focus, I naturally gravitated towards adopting transradial approach in my practise. Today, I am immensely proud of the fact that we have achieved a milestone in introducing this technology on the interventional cardiology landscape and it has become a standard approach of performing PCI around the world. Me and my team have been successfully conducting many training programs through TRICO since year 2005. After performing 75,000 transradial procedures, I was thinking what next? It was this time I was thinking about the Robot. I had an intuition that Robot would play an important role in the future of Vascular Intervention. This feeling was largely based on the overall success of adoption of Robotics in high-precision areas like heavy industries, power and nuclear plants. Also, in the field of medical science where Robotics had become a standard of care in certain complex surgeries. I heard that few of the leading hospitals in the United States had started using Vascular Robot in coronary intervention. I was very keen to learn more about it as I was very sure this would be one breakthrough technology again, both for the physicians as well as the patients. Another prime reason of my interest in this technology was its ability to perform teleintervention. I was sure that in a country like ours this was very much necessary as it would enable quality care even to the remotest of the places which lacked quality medical care. This time again, I felt the same way I had felt about transradial PCI few decades ago.

Click on the image to watch how Corindus CorPath® GRX System works

Simultaneously a new era for interventional cardiologists was emerging. The interventional cardiologists had started to venture into treating overtly complex coronary artery diseases which once were considered bastion of CVT surgeons. The advent of new techniques and technologies had further revolutionized PCIs in complex CAD. Technologies like intra-cardiac imaging, plaque modification devices like rotablation and cutting balloons as well as thinner and safer DES and specialized guide wires had started to become a routine armamentarium in most of the cardiac cath labs.

More complex cases were being handled demanding more precision; having to deal with more complex cases, the hours spent in the cath labs had also increased which in turn led to increased radiation exposure. To deal with these two major challenges, the role of vascular robot has been increasingly accepted in the field of interventional cardiology.

With all these events in the background, I finally decided to acquire vascular robot from Corindus in my cath lab in December 2017. It so happened that our installation was the first vascular robotic installation in the world outside the United States of America. Thus, Apex Heart Institute, Ahmedabad, yet again, emerged on the world map as an early adopter of innovative technologies towards improving patient care.

Our team at Apex underwent the required training with the help of Corindus team over a period of one month. After the first remarkably successful case conducted by us, we eventually reached a milestone of completing 100 cases within a span of six months. In the first year itself Apex Heart Institute emerged as the largest robotic-assisted PCI centres in the world. Till date we have performed around 600 Robotic assisted PCIs.

Procedural characteristics:

Table (Extracted from the study): Patient demographics and procedural characteristics.

Patient	Gender	Age (y)	Height (cm)	Weight (kg)	Access	Lesion Length (mm)	Pre Stenosis (%)	Post Stenosis (%)	Procedure Time* (min)	Indication for PCI
1	M	54	174	80	R Femoral	12	95	0	28	Stable Angina
2	M	53	176	60	L Radial	15	90	0	21	Stable Angina
3	F	52	165	85	R Radial	18	90	0	21	Stable Angina
4	F	84	152	50	R Radial	10	99	0	29	Stress Test ECG
5	M	55	169	62	L Radial	09	90	0	19	Stable Angina

y = years, cm= centimeters, Kg= kilograms, R= right, L= left.

* Time from insertion of sheathed catheter to withdrawal of guide catheter.

First-in-man teleintervention

tejas patel — Dr. Tejas Patel conducting long distance¹ first-in-human telerobotic
procedures

Second milestone achieved by our team was conducting first-in-man teleintervention feasibility study. Mayo Clinic had successfully conducted teleintervention in animals.

With this initial successful experiment, Corindus wanted to conduct first-in-man teleintervention in the world and Apex Heart Institute was chosen for this path breaking clinical study.

The primary endpoint was achieved in 100% of patients. No procedural complications or adverse events occurred, and all patients were discharged the following day without MACE. The operator scores were favourable with the operators rating the procedure as equivalent to an in-lab procedure. We successfully demonstrated feasibility in five human subjects and thereby opened a new possibility in healthcare for the entire world.

This was considered as one of the major breakthroughs in the field of medical science in recent times. Our study was published in the Lancet, the world’s leading medical journal. You can visit the following weblink for viewing the complete transcripts of this study. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30137-3/fulltext

Procedural characteristics:

Table (Extracted from the study): Patient demographics and procedural characteristics.

Patient	Gender	Age (y)	Height (cm)	Weight (kg)	Access	Lesion Length (mm)	Pre Stenosis (%)	Post Stenosis (%)	Procedure Time* (min)	Indication for PCI
1	M	54	174	80	R Femoral	12	95	0	28	Stable Angina
2	M	53	176	60	L Radial	15	90	0	21	Stable Angina
3	F	52	165	85	R Radial	18	90	0	21	Stable Angina
4	F	84	152	50	R Radial	10	99	0	29	Stress Test ECG
5	M	55	169	62	L Radial	09	90	0	19	Stable Angina

y = years, cm= centimeters, Kg= kilograms, R= right, L= left.

* Time from insertion of sheathed catheter to withdrawal of guide catheter.

Radiation exposure study

Our recent milestone was conducting a study to demonstrate the benefits of Robotic PCI in reducing the radiation exposure to the patients.

Robotic percutaneous coronary intervention (R-PCI) had shown to benefit the operator but had not shown any significant benefit to the patient previously. I would like to highlight a significant point here that any technology to be accepted by the insurance companies and the hospital administrators, “patient benefit” has to be established first. Ultimately, the technology can only survive and flourish when it proves to be beneficial to the patient. After our initial experience, we had realized that because of the precision of the robot, we were using less radiation while performing R-PCI and it was necessary that this hypothesis had to be proven by conducting a well-designed scientific study. We sought to compare a large cohort of R-PCI to traditional percutaneous coronary intervention (PCI) procedures performed at a tertiary care centre in the same time frame.

corindus console — Corindus CorPath® GRX Control Console

We successfully demonstrated that R-PCI is associated with a significant decrease in radiation exposure to the patient with no increase in fluoroscopy time, as well as contrast utilization, and a minor increase in procedure duration compared with traditional PCI.

This study was published in Circulation: Cardiovascular Interventions May 2020. You can visit the following weblink for viewing the complete transcripts of this study.

Click here

Results of the study

Result achieved by raising the table and hence the patient away from the radiograph source is one of the maneuvers associated with a lower dose to the patient, although a higher dose to the operator is observed with this maneuver.

Table (Extracted from the study): Coprimary Outcomes in the Propensity Score–Matched Cohort

Characteristics	T-PCI (n=280)	R-PCI (n=280)	P Value
AK, mGy	1110 (699–1498)	884 (537–1398)	0.002
Dose-area product, cGycm2	5746 (3751–7833)	4734 (2695–7746)	0.003
Fluoroscopy time, min	5.51 (3.53–8.31)	5.48 (3.31–9.37)	0.936
Contrast volume, mL	130 (103–170)	140 (100–180)	0.905
Total procedural time, min	27 (21–40)	37 (27–50)	<0.0005

Values are median (interquartile range). All continuous variables were compared using Mann-Whitney U test. AK indicates air kerma; R-PCI, robotic percutaneous coronary intervention; and T-PCI, traditional percutaneous coronary intervention.

Conclusions:

R-PCI is associated with a significant decrease in radiation exposure to the patient with no increase in fluoroscopy time, as well as contrast utilization, and a minor increase in procedure duration compared with traditional PCI.

We think that Robotics in Vascular Interventions would emerge as the standard of care due to the various benefits it offers to all the stakeholders, namely patients, physicians, and paramedics.

We will continue our journey to generate more clinical evidence in the real world to evaluate the safety and efficacy of this novel technology.

Future will tell us how this technology would stand the test of time. At least for now, based on our initial experience, I can conclude that this technology holds immense potential in revolutionizing the healthcare delivery in the world.

For any queries please connect with Dr. Tejas Patel at tejaspatel@apexheart.in

Technological innovations spur new clinical applications. This gives healthcare providers an edge in detection and treatment of diseases at an early stage with minimally invasive techniques. This in turn will help in expanding precision medicine, transforming care delivery and improving patient experience. These are the primary objectives with which we developed T-trendz. We would like to know how we can make this initiative more valuable for your practice and the wellbeing of patients.

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