Robotics and advanced imaging provide protection and precision in PCI

371
CorPath GRX System

This article, part of an educational supplement sponsored by Siemens Healthineers, details the use of the CorPath GRX System, the first robotic platform designed for percutaneous coronary intervention (PCI) that is available in the US market.

Robot-assisted angioplasty offers many benefits. For Jean Fajadet (Clinique Pasteur, Toulouse, France), the premier advantage is “the dramatic reduction in X-ray exposure for the operator”.

“Even though X-ray imaging has evolved and protection methods in the cath lab have developed, radiation has still been a problem,” explains Fajadet, “particularly with more complex procedures, such as chronic total occlusion (CTO) or recanalisation, where a physician might need to spend longer on the same patient, increasing their exposure risk.”

He describes the radiation protection offered by CorPath as “a major step forward for interventional practice”. This was evaluated by the PRECISE trial, 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.1 Additionally, RAPID II showed a significant radiation reduction (>95%) for physicians and staff.2

A single-centre retrospective study published in the Journal of Invasive Cardiology compared 40 patients enrolled in PRECISE who had CorPath PCI with 80 consecutive patients who underwent conventional PCI, demonstrating trends toward reduction in fluoroscopy time, radiation dose, and contrast for the patient.3

Furthermore, robotic PCI can be used in combination with the ARTIS icono imaging system. This uses the imaging chain software “OPTIQ”, which allows operators to choose their imaging quality preference at a low dose. Another tool for reducing radiation exposure while using ARTIS icono is the RaySafe personal dosimetry system. This system provides real-time information to cath lab operators about their levels of radiation exposure, so that they can then use this information to take immediate action to minimise their radiation exposure.

Three joysticks for precision guiding

The physician sits at a radiation-shielded workstation, either within the procedure room or the control room, where three joysticks and touchscreen controls translate their movements into device control. One joystick moves the guiding catheter, one the guidewire, and a third the RX catheter, allowing remote delivery and manipulation during PCI. It permits precise measurement of patient anatomy to the submillimetre, and 1mm device, and stent positioning; a top priority during interventional procedures. Fajadet clarifies: “You can move both your guiding catheter and the guidewire forwards or backwards, and rotate them clockwise or counter clockwise, and the third joystick allows back and forth movement of the RX catheter. With these three joysticks,” he notes, “we can mimic what we have been doing manually for many years.”

Jean Fajadet

Robotic precision in complex lesions was assessed in the CORA-PCI trial, a comparison of consecutive robotic or manual PCI procedures over an 18-month period. This trial demonstrated 99.1% clinical success in complex cases and comparable procedures times with manual PCI.4

Measurement of lesion length is also facilitated. “In long lesions, robotic assistance allows exact measurement of the length of the lesion and allows selection of the correct length of stent. If we are able to select a shorter stent, it may lead to better results,” Fajadet points out.

Measurement of lesions with robotic PCI may reduce measurement errors, need for extra stents, and longitudinal geographic miss (LGM) and stent length selection with those provided by CorPath in 60 consecutive patients undergoing robotic PCI.6 The researchers noted that visual estimates were highly variable, and concluded robotic PCI may reduce measurement errors, the need for extra stents, and LGM.

Procedural automation

Rotate on Retract (RoR) is a feature that automatically rotates the guidewire upon joystick retraction, providing consistent and predictable movement and aiding manipulation. The company is working on adding additional features mimicking the manual techniques of highly-skilled physicians in an effort to standardise interventional medicine. Pace can also be altered: “With the press of a button, you can increase the speed of advance of the wire or the device,” says Fajadet. “This is helpful when removing the device. And when crossing a lesion, by turning the wire clockwise or anticlockwise.”

And, an extended reach arm enables radial access, and allows operators to work from a seated position without the need to wear lead, a factor, he says, that reduces fatigue, particularly in high-volume operators and at the end of a full day performing PCI.

Seeing is believing

The benefits of robotic angioplasty have been married to the image-guided developments of ARTIS icono. ARTIS icono provides excellent images of the moving heart and of challenging cardiac anatomies in any angulation, and at low dose, even during complex procedures. The completely new image chain of ARTIS icono uses algorithms to optimise the image quality. This is a great value addition to the robotic system.

Fajadet urges those who are hesitant of robotic technology not to be wary, but to embrace it. As with all novel techniques, he says, there is a learning curve: “It is true that with robotic-assisted angioplasty we use images on the screen instead. But after 10 to 20 cases, the manual instinct in your fingers transfers into a visual instinct. With manual PCI experience, it is very easy to move to robotic procedures.”

Case Flows

Of note, ARTIS icono has a feature called “Case Flows” that is designed to help to standardise workflows. Case Flows, for example, provides a sequence of system settings that match the diagnostic steps and treatment path—these settings can then be adjusted to match the needs of the situation.

Fajadet has had “really good results” using robotic PCI. “In our centre, we have treated more than 150  patients with a very high rate of success. Initially, the rate of conversion from robotic to manual was <3%; among the last 30 or 40 patients, none have required conversion.” His experience is borne out by a study last year reporting six- and 12-month outcomes following robotic PCI that showed no difference in clinical outcomes or safety measures as compared to manual PCI.6

The next step, according to Fajadet, is a large multicentre registry of >1,000 patients looking at success rates, complications, and risk factors. He predicts a wide range of future applications. A preclinical study established the feasibility of robotic telestenting over long geographic distances.7 The development of tele PCI may help to address barriers to access, although, for now, Fajadet remains cautious: “It is nice to be able to share experience in difficult complex anatomies between high-volume operators and those who have performed fewer procedures. But what is the volume of procedures that could be performed with this strategy? There is also the issue of responsibility if there are complications.”

Looking to the future, one wonders what we can expect from the synergy of using robotic PCI (providing a new-generation of treatment delivery) in combination with ARTIS icono (providing a new generation of image guidance). According to Siemens Healthineers, the value of using the two systems together is protection from the risk of radiation exposure, greater precision of procedures, and standardisation for better results.

References

  1. Weisz G, et al. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE Study. JAAC 2013; 61(15): 1596–1600.
  2. Mahmud E, et al. Robotic peripheral vascular intervention with drug coated balloons is feasible and reduces operator radiation exposure: Results of the Robotic-assisted peripheral intervention for peripheral artery disease (RAPID) Study II. JACC 2018; 72(S13): B178. Disclaimer: The study was performed at a single centre and there can be no guarantee that other customers will achieve the same results.
  3. Smilowitz N, et al. Robotic-enhanced PCI compared to the traditional manual approach. J Invasive Cardiol 2014; 26(7): 318–21.
  4. Mahmud E, et al. Demonstration of the safety and feasibility of robotically assisted percutaneous coronary intervention in complex coronary lesions: Results of the Complex robotically assisted percutaneous coronary intervention (CORA-PCI) Trial. JACC Cardiovasc Interv 2017; 10 (13): 1320–7. Disclaimer: The study was performed at a single centre and there can be no guarantee that other customers will achieve the same results.
  5. Campbell PT, et al. The impact of precise robotic lesion length measurement on stent length selection: Ramification for stent savings. Cardiovasc Revasc Med 2015; 16(6): 348–50.
  6. Mahmud E, et al. Complex robotic compared to manual coronary interventions: Six- and 12-month outcomes. Catheter Cardiovasc Interv 2019; 93(4): 613–7.
  7. Madder RD, et al. Feasibility of robotic telestenting over long geographic distances: a pre-clinical ex vivo and in vivo study. EuroIntervention 2019; 15(6): e510–12.
  8. Patel T, et al. Long distance tele-robotic-assisted percutaneous coronary intervention: A report of first-in-human experience. EClinicalMedicine 2019; 14: 53–58.

LEAVE A REPLY

Please enter your comment!
Please enter your name here