Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study

Area of Science:

• Cardiovascular Interventions
• Medical Robotics
• Radiation Safety

Background:

• The R-One system is a robotic percutaneous coronary intervention (PCI) device designed to minimize operator radiation exposure and enhance procedural accuracy.
• CE marked in 2019, it aims to improve ergonomics and device navigation during PCI procedures.

Purpose of the Study:

• To evaluate the safety and efficacy of the R-One robotic system in performing percutaneous coronary interventions (PCI).

Main Methods:

• A European multicenter prospective study (R-EVOLUTION) included 62 patients with de novo coronary artery stenosis undergoing stent implantation.
• Exclusion criteria included recent STEMI, complex lesions, and severe calcification. Clinical and technical success rates were assessed, alongside radiation exposure measurements for patients and operators.

Main Results:

• Robotic PCI achieved 100% clinical success and 95.2% technical success, with no reported complications at 30 days.
• Operator radiation exposure was reduced by up to 84.5% compared to conventional methods.
• Mean procedure and fluoroscopy times were 19.9 minutes and 10.3 minutes, respectively.

Conclusions:

• Robotic PCI with the R-One system is safe and effective, offering substantial reductions in operator radiation exposure.
• Additional studies involving larger patient cohorts and more complex lesions are warranted to further validate these findings.