Coronary interventions

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

EuroIntervention 2023;18:e1339-e1347. DOI: 10.4244/EIJ-D-22-00642

Eric Durand
Eric Durand1, MD, PhD; Remi Sabatier2, MD; Pieter C. Smits3, MD; Stefan Verheye4, MD, PhD; Bruno Pereira5, MD; Jean Fajadet6, MD
1. Department of Cardiology, Normandie Université, UNIROUEN, U1096, CHU Rouen, Rouen, France; 2. Department of Cardiology, Caen University Hospital, Caen, France; 3. Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands; 4. Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium; 5. Institut de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg; 6. Department of Cardiology, Clinique Pasteur, Toulouse, France

Background: R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI.

Aims: We aimed to evaluate the safety and efficacy of the R-One system for PCI.

Methods: The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured.

Results: Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table.

Conclusions: This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. ( NCT04163393)

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from

coronary artery diseaseclinical researchother techniqueradiation protection
Read next article
Angiography-derived assessment of coronary microcirculatory resistance in patients with suspected myocardial ischaemia and non-obstructive coronary arteries

Latest news