Robotic Systems to Play Greater Role in Cath Lab of the Future
The introduction of robotic systems into the cath lab, accompanied by their integration with other technologies, is expected to benefit both patients and physicians, speakers said during a session devoted to innovation at TCT 2015.
Despite major advances in pharmacotherapy and interventional devices, the actual technique of PCI has changed little since the first stent procedure was performed in 1986, said Ehtisham Mahmud, MD, of the University of California, San Diego, La Jolla, Calif. But now, use of robotic systems — particularly the FDA-approved CorPath 200 (Corindus) — is becoming increasingly common. The CorPath system consists of a console, from which operators control guidewires and the delivery of balloons and stents, and a robotic drive at the tableside that holds a single-use cassette containing spots for guidewires and a stent catheter.
For patients, robotic PCI may enhance safety through potential improvements in appropriate stent sizing and more precise device delivery, limiting longitudinal geographical miss, Mahmud said. For operators, he added, moving away from standing at the table to sitting at the console reduces radiation exposure and allows for a superior ergonomic position during procedures.
Interventions with the CorPath system were shown to be feasible and safe in relatively simple lesions in the 164-patient PRECISE trial, which led to FDA approval in 2012. Most patients (83.2%) had non-type C lesions (average lesion length 12.2 mm). Device and procedural success were both high at 98.8% and 97.6%, respectively. There were no serious adverse events, and four patients had periprocedural MIs. The trial showed that median radiation exposure to the primary operator was reduced by a relative 95.2% with use of the robotic system.
Although PRECISE included patients with simple lesions, Mahmud said the system has also been used successfully for more complex cases. He noted that the CORA-PCI trial, which is evaluating the CorPath system in more complex patients, has just completed enrollment. In the robotic arm of the trial, 75% of patients had type C lesions. Procedures, which included radial, chronic total occlusion, saphenous vein graft, ostial, left main, bifurcation and Impella-supported interventions (Abiomed), were generally completed using the robotic system (82%), with partial manual support in 10% and complete conversion to manual in 8%. Mahmud said few procedural issues were reported; these included one ostial guide catheter dissection of the right coronary artery and four permanent pacemaker implantations.
The 20-patient RAPID study — results of which are being presented at TCT today — has shown that robotic-assisted peripheral interventions for peripheral artery disease are feasible, he noted.
“The data are pretty clear that with robotic PCI you can reduce occupational hazards, predominantly with significant reduction in radiation exposure to the primary operator, as well as the fact that you are able to do the case ergonomically in a much superior position,” Mahmud said. He called the robot a natural extension of an operator’s skill set. “Complex percutaneous coronary interventions as well as peripheral vascular interventions are feasible with the current-generation Corindus system.”
Session moderator Giora Weisz, MD, of Shaare Zedek Medical Center, Jerusalem, Israel, said the cath lab of the future would include technologies that currently exist, including robotic systems, navigation technology that can position devices without radiation or contrast media and coronary CT angiography. Integrating these technologies in the cath lab, he said, will “create a much more robust management of CAD.”
- Mahmud reports relationships with multiple pharmaceutical and device companies.
- Weisz reports serving as a medical advisory board member for AngioSlide, AstraZeneca, Calore, Corindus, Medtronic, Medivisor and M.I. Medical Incentive and receiving grant/research support from AngioSlide and Corindus.