CORONARY INTERVENTIONS

CLINICAL RESEARCH

EuroIntervention 2023;18-online publish-ahead-of-print January 2023

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

KEYWORDS
Abstract
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
• coronary artery
deliver guidewires/devices during PCI.
disease
Aims: We aimed to evaluate the safety and efficacy of the R-One system for PCI.
• clinical research
Methods: The European multicentre prospective R-EVOLUTION study included patients with a de novo
• other technique
coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation.
• radiation
Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation,
protection
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 retrac-
tion 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,
DOI: 10.4244/EIJ-D-22-00642

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 popula-
tions with more complex lesions. (ClinicalTrials.gov: NCT04163393)

*Corresponding author: Department of Cardiology, University Hospital of Rouen, 1 rue Germont, 76000 Rouen, France.
E-mail: [email protected]

© Europa Digital & Publishing 2022. All rights reserved. SUBMITTED ON 22/07/2022 - REVISION RECEIVED ON 26/09/2022 - ACCEPTED ON 27/10/2022

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EuroIntervention 2023;18-online publish-ahead-of-print January 2023

Abbreviations considered for the study, but complex lesions were successfully
CAD coronary artery disease treated in a different procedure prior to undergoing robotic PCI of
MACE major adverse cardiac event the target lesion(s).
PCI percutaneous coronary intervention All patients signed an informed consent form prior to inclusion.
SD standard deviation Patients were included in the intention to treat (ITT) population
STEMI ST-segment elevation myocardial infarction if all eligibility criteria were met, the lesion was deemed treat-
able, and the guiding catheter was in place. The study duration
Introduction was 31 months (extended from the anticipated 17 months due to
Coronary angioplasty for patients with coronary artery disease the COVID-19 pandemic).
(CAD) has undergone many procedural improvements since its The study was approved by the respective ethics committees of
introduction1. However, the current practice of percutaneous coro- the involved countries/hospitals.
nary intervention (PCI) remains largely unchanged for interven-
tionalists, who work in a standing position wearing heavy lead DESCRIPTION OF DEVICE
protective garments viewing fluoroscopic images from across the The R-One robotic system is a fully integrated robotic platform
procedure table. Repeated exposure to fluoroscopic radiation puts for the remote and accurate navigation, positioning, and delivery
interventionalists and staff at risk, with well-known health con- of guidewires, balloons, and stents during PCI. An overall sche-
sequences including DNA damage and cancer2-10. Orthopaedic matic of the device is provided in Figure 1. The system comprises
complications from long-term use of heavy lead aprons are a radio-protected control station and a telemanipulated robotic
also common11-14, resulting in lost workdays and decreased per- unit mounted with a single-use sterile cassette. Devices are loaded
formance15,16. The demand for interventionalists is projected to into the robotic unit, with 1 track dedicated to the guidewire and
increase with an ageing population and an increase in patients 1 track for the stent/balloon. Motorised modules provide transla-
with CAD17. tional and rotational movement to the devices. A standby path is
Robotic PCI addresses these challenges by significantly reduc- also available for a potential additional guidewire and/or stent/
ing radiation exposure to the operator18,19 and improving ergonom- balloon catheter. The interventional cardiologist manipulates the
ics. Additionally, the fluoroscopic monitors are placed in closer device with joysticks (1 for the guidewire and 1 for the stent/bal-
proximity to the operator, providing detailed visual feedback dur- loon) while sitting at the radio-protected control station located
ing the procedure. Robotic PCI is also designed to allow more away from the radiation source in the catheterisation laboratory.
accurate navigation through tortuous vessel anatomy with milli- Fluoroscopy command, haemodynamics, patient table and C-arm
metre precision in manoeuvring wires and devices, with the poten- commands, and live and reference image duplications are pro-
tial to improve procedural and clinical outcomes for patients. vided at the radioprotection control station. The R-One system is
The feasibility, safety, and efficacy of robotic PCI have been compatible with all commercially available 0.014” guidewires and
shown in studies assessing the CorPath 200 and the CorPath GRX rapid exchange stent/balloon catheters.
(Corindus/Siemens)20-22. Clinical studies using these robotic sys-
tems have demonstrated results comparable to manual PCI23, even INTERVENTIONAL PROCEDURE
in complex coronary lesions, while providing the above-men- Robotic-PCI operators were trained in PCI device implantation
tioned advantages to interventional cardiologists21,22. using the R-One. Early experience centres (3/6) were defined as
In 2019, the R-One robotic system (Robocath) for PCI received having performed 5 robotic-PCI procedures with the R-One prior
CE mark (European conformity) approval, with the first patient to patient enrolment for this study, while experienced centres (3/6)
procedure performed in France in September 2019. Here, we had performed more than 5 PCI procedures with the R-One. The
report the results of the R-EVOLUTION (R-One Efficiency for choice of device(s) (stent, balloon, guidewire) was made per cur-
PCI Evolution With Robotic Assistance) study, the first multicen- rent practice guidelines, and the R-One was used according to the
tre study conducted in Europe evaluating the safety and efficacy of manufacturer’s instructions.
the novel R-One robotic system for PCI in de novo coronary artery The procedure starts with standard manual techniques by first
stenosis patients undergoing stent placement. obtaining vascular access, then introducing and positioning the
guide catheter at the ostium of the targeted coronary artery. The Y
Methods connector is then fixed to the cassette and the guidewire is inserted
STUDY DESIGN AND PATIENT POPULATION into the robotic unit, beginning the robotic portion of the proce-
This prospective, multicentre, single-arm clinical study was con- dure. The system allows the operator to switch easily and quickly
ducted at 6 cardiology centres in 4 countries: France, Belgium, to manual operation if needed.
Luxembourg and the Netherlands, from September 2019 to
November 2021. A total of 66 consecutive patients who met the STUDY OUTCOMES
inclusion criteria were initially enrolled. Inclusion and exclusion The primary safety outcome was clinical success, defined as the
criteria are listed in Table 1. Patients with complex CAD were absence of intraprocedural complications, including coronary

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EuroIntervention 2023;18-online publish-ahead-of-print January 2023

Table 1. Patient inclusion and exclusion criteria.
Inclusion criteria:
Age ≥18 years
Candidate for percutaneous coronary intervention (PCI)
Presence of a de novo coronary artery stenosis of ≥50% and <100% in a native coronary artery indicated and suitable for stent placement
Reference vessel diameter (RVD) 2.5-4.0 mm
Target lesion length allows for treatment with a single stent up to 38 mm
Up to 2 target vessels, each with a single target lesion requiring a single stent per lesion and treatable within a single procedure
Written informed consent as approved by the applicable Ethics Committee
Willing to comply with all study requirements including 30 days of follow-up
Exclusion criteria:
Target lesion with Thrombolysis in Myocardial Infarction (TIMI) flow <3
Treatment of in-stent restenosis or prior stent in the target vessel proximal to the target lesion
>1 target lesion per vessel requiring treatment at the time of procedure
Target lesion was: 1) a bifurcation requiring balloon or stent implantation of the side branch (RVD ≥1.5 mm with stenosis
≥50% at or within 5 mm from its origin, or RVD ≥2.0 mm regardless of the presence of side branch
disease)
2) located in left main coronary artery, or any left main stenosis >30%
3) within 5 mm of the ostial left anterior descending artery (LAD), ostial left circumflex artery (LCx) or
ostial right coronary artery (RCA)
Severe vessel tortuosity
Severe vessel calcification
ST-segment elevation myocardial infarction (STEMI), cardiopulmonary resuscitation, or cardiogenic shock ≤48 hours of the procedure
Significant issue detected prior to intervention, such as presence of visible thrombus
Need for any procedure other than balloon angioplasty or stenting (e.g., atherectomy, laser)
Patients under judicial protection, tutorship, or curatorship (for France only)
Participating in another clinical study evaluating a drug or medical device (except registries) for which the primary endpoint was not yet
evaluated
Pregnant, breastfeeding, or intention to become pregnant prior to completion of all follow-up procedures

dissection ≥type D according to the National Heart, Lung, and at hospital discharge; and device-related composite criteria
Blood Institute (NHLBI) classification, coronary perforation, (Academic Research Consortium-2)24, defined as cardiovascular
decreased Thrombolysis In Myocardial Infarction (TIMI) flow to death, myocardial infarction (periprocedural and spontaneous)
≤2, acute vessel occlusion, visible thrombus formation, significant not clearly attributed to a non-target or clinically driven target
air embolus during the procedure, and traumatic aortic or left main lesion, or revascularisation at hospital discharge and at 30-day
dissection by the guiding catheter. follow-up.
The primary efficacy outcome was procedural technical success, Patients were followed up after hospital discharge to 30 days
defined as the successful advancement and retraction of all PCI (±7 days) after the index procedure by telephone to determine
devices (guidewires, balloon catheters, and stents) and the suc- anginal status and adverse events.
cessful treatment of all the target lesions using the R-One system
without total conversion to manual operation. Partial manual assis- RADIATION EXPOSURE SUBANALYSES
tance was defined as temporary manual operation at the robotic Radiation exposure to the patient was obtained from the C-arm.
platform and not using the robot to manipulate PCI devices. Total A simulated manual operator and the robotic-PCI operator were
manual conversion was defined as the inability to advance, retract, measured as shown in Supplementary Figure 1. Radiation meas-
or rotate devices with the robotic unit, or any other situation where urements were monitored by Dosilab (Villeurbanne, France).
manual conversion was required (e.g., required device was not To measure radiation exposure to the simulated manual opera-
compatible with the robot, clinical complication, etc.). tor, dosimeters A and B were located on a pole 1-2 metres from the
Secondary outcomes included the procedure duration, defined patient table; they measured radiation exposure on top of a lead
as the time between introducer sheath placement and removal; apron (A) and underneath a lead apron (B); a piece of lead apron
the robotic procedure duration, defined as the time between the was positioned in front of dosimeter B for the duration of the pro-
first robotic manipulation of the guidewire and the last guidewire cedure. Dosimeter readings were multiplied by 4 or 16 depending
removal; contrast volume; bleeding or vascular complications on the distance from the patient.

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EuroIntervention 2023;18-online publish-ahead-of-print January 2023

Monitors
(duplication)
MOBILE RADIOPROTEGTION
TELEMANIPULATED CONTROL STATION
ROBOTIC UNIT Catheter
(command unit + mobile joystick
(robot + articulated radioprotection screen) Scopy pedal
supported arm) Guidewire (duplication)
joystick
Guidewire
path
Contrast command

Stand-by Table and C-arm

path command (duplication)

Catheter
path

ROBOT Guidewire clamp COMMAND

button
UNIT
Release arm
braking

Figure 1. Schematic of the R-One system. The R-One system includes the telemanipulated robotic unit and the mobile radioprotection control
station. The telemanipulated robotic unit includes the robot and the articulated supported arm. The single-use, sterile cassette includes a
catheter path, standby path, guidewire path, guidewire clamp button, and release arm brake. The mobile radioprotection control station
includes a command unit and the mobile radioprotection screen. The control station houses the monitors, the catheter joystick, the guidewire
joystick, a scopy pedal, contrast command, and table and C-arm command.

To measure radiation exposure to the robotic-PCI operator, – the operator dose during the guiding catheter insertion and posi-
dosimeters E and F were used. tioning (A−C) or (B−D) and,
Dosimeters E and F measured radiation exposure for the opera- – the operator dose received during the robot use until the device
tor during the overall procedure; a piece of lead apron was posi- removal (E) or (F)
tioned in front of dosimeter F. Dosimeters E and F were worn by This means:
the operator on top of and underneath their lead apron, respec- – Operator radiation dose ON TOP of the lead apron received
tively, while sitting at the control station. during the overall procedure=(A−C)+E
– Operator radiation dose ON TOP of the lead apron received – Operator radiation dose UNDER the lead apron received
during the overall procedure=E. during the overall procedure=(B−D)+F
– Operator radiation dose UNDER the lead apron received
during the overall procedure=F. STATISTICAL ANALYSIS
Note: in 2 centres, the operators remained in non-sterile con- The ITT dataset was used for analysis. Descriptive statistics were
ditions behind the cockpit while a fellow performed the guiding calculated and are presented as counts and incidence rates for cat-
catheter insertion manually. To calculate the total operator radia- egorical variables, and as mean, standard deviation, and number of
tion dose, the dose received on the simulated operator during the observations for continuous variables. Statistical significance was
guide catheter insertion was added to the dose on top of/under the accepted when p<0.05. Statistical analysis was performed using
operator’s apron during the procedure. SAS software, version 9.4 (SAS).
To calculate the dose received during the guide catheter inser-
tion, dosimeters C and D were used. Results
Dosimeters C and D measured radiation exposure for the A total of 66 consecutive patients were enrolled in the study, but
operator only once the robotic steps of the procedure had been 4 were excluded because of unmet inclusion criteria (severe tor-
started, which means they were activated only once the guiding tuosity [n=2], lesion length >38 mm [n=1], >1 lesion per vessel
catheter was inserted and positioned; a piece of lead apron was [n=1]). Final enrolment included 62 patients with 64 lesions from
positioned in front of dosimeter D. Dosimeter readings from C 6 sites who met the inclusion criteria and underwent robotic PCI.
and D were multiplied by 4 or 16 (depending on the distance Baseline clinical characteristics of the study population are
from the patient). detailed in Table 2. The mean age was 65.4±10.1 years, and
Thus, the operator radiation dose received during the procedure 80.6% (50/62) were male. Fifteen (24.2%) patients had a history
was calculated as follows: the sum of: of PCI. The majority of patients (49/62, 79.0%) presented with

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EuroIntervention 2023;18-online publish-ahead-of-print January 2023

Table 2. Baseline clinical characteristics. Table 3. Angiographic and procedural characteristics.
Overall Overall
Variables
Variables population population
(N=62) Approach Right radial artery 50 (80.6)
Age, years 65.4±10.1 (N=62 patients)
Left radial artery 10 (16.1)
Male 50 (80.6) Right femoral artery 2 (3.2)
BMI, kg/m² 27.2±4.7 Left femoral artery 0 (0)
Risk factors Current smoker 14 (22.6) Lesion location LAD 22 (34.4)
Diabetes 17 (27.4) (N=64 lesions)
LCx 21 (32.8)
Hypercholesterolaemia 35 (56.4) RCA 17 (26.5)
Hypertension 33 (53.2) Other (Ramus) 4 (6.3)
Family history of CAD 19 (30.7) Lesion class (ACC/ A 11 (17.2)
Medical history 9 (14.5) AHA) (N=64 lesions)
B1 37 (57.8)
Previous myocardial infarction 15 (24.2) B2 13 (20.3)
Previous percutaneous coronary intervention 2 (3.2) C 3 (4.7)
Previous CABG 5 (8.1) Percutaneous Sheath size (6 Fr)
62 (100)
History of cerebrovascular disease 5 (8.1) coronary intervention (N=62 patients)
(N=64 lesions)
Peripheral artery disease 8 (12.9) Predilatation 38 (59.4)
Chronic renal failure 4 (6.5) Stent per lesion, n 1.05±0.28
Clinical Silent ischaemia 23 (37.1) Drug-eluting stent 67 (100)
presentation Stent diameter, mm 3.0±0.4
Stable angina 26 (41.9)
Unstable angina 6 (9.7) Stent length, mm 19.5±6.5
NSTEMI 7 (11.3) Post-dilatation 24 (37.5)
Data are mean±SD or n (%). BMI: body mass index; CABG: coronary Duration, minutes Total 39.9±14.6
artery bypass surgery; CAD: coronary artery disease; NSTEMI: non-ST- (N=62 patients)
Robotic 19.9±9.6
segment elevation myocardial infarction; SD: standard deviation
Fluoroscopy time, minutes (N=62 patients) 10.3±5.3
Contrast volume, mL Total 118.2±47.3
a chronic coronary syndrome, such as silent ischaemia or stable (N=62 patients)
Robotic 87.4±35.5
angina, and 21.0% (13/62) had an acute coronary event, such as Medications (N=62 Aspirin 56 (90.3)
unstable angina or non-ST-segment elevation myocardial infarc- patients)
Clopidogrel 49 (79.0)
tion (NSTEMI). Ticagrelor 8 (12.9)
Angiographic and procedural characteristics are detailed in Prasugrel 5 (8.1)
Table 3. A radial approach was used in 96.8% (60/62) of cases, all
Data are mean±SD or n (%). ACC/AHA: American College of Cardiology/
using 6 Fr guiding catheters. The distribution of lesions among the American Heart Association; LAD: left anterior descending artery;
LCx: left circumflex artery; RCA: right coronary artery
3 coronary arteries was 34.4% (22/64) in the left anterior descend-
ing artery, 32.8% (21/64) in the left circumflex coronary artery,
and 26.5% (17/64) in the right coronary artery; 25% (16/64) of guidewire but was unable to cross the lesion with the balloon,
the lesions were classified as B2 or C according to the American which was related to a lack of guiding catheter support. Total
College of Cardiology/American Heart Association classification. manual conversion required the use of a guiding catheter exten-
Predilatation was performed in 38/64 treated lesions (59.4%) and sion (GuideLiner; Teleflex), and the procedure was completed
post-dilatation in 24/64 (37.5%). Drug-eluting stents were used in successfully with predilatation and stent implantation. The 2
all cases, and 96.7% (60/62) of cases used only 1 stent. The mean remaining total manual conversions were not due to robotic fail-
duration of the robotic procedure was 19.9±9.6 minutes. The mean ure. In the first case, after successful advancement of the guide-
fluoroscopy time was 10.3±5.3 minutes, and the mean total con- wire and balloon predilatation, an incorrect manual adjustment
trast volume was 118.2±47.3 millilitres. of the guidewire into the pads of the robot led to an error detec-
Primary safety and efficacy endpoints are detailed in Table  4 tion and temporary system unavailability, resulting in manual
and the Central illustration. A clinical success rate of 100% was conversion. In the second case, the entire procedure was suc-
achieved with no major intraprocedural or 30-day complica- cessfully completed robotically, but the angiographic control
tions. A technical success rate of 95.2% (59/62) was achieved. revealed a non-occlusive coronary dissection (NHLBI type B)
Total manual conversion was required in 3/62 cases (4.8%), not related to the robot. The operator converted to manual and
and only one was directly related to the robotic system. In this successfully treated the coronary dissection with a second stent.
case, the robotic system successfully crossed the lesion with the An analysis by centre experience level (early vs experienced) is

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Table 4. Safety and efficacy endpoints. robotic-PCI experience prior to this study (22.23±10.99 minutes;
Overall p=0.07) (Supplementary Table 1).
Variables population Patient and operator radiation exposure data are detailed in Table 5.
(N=62 patients) Patient radiation exposure was 540.3±498.4 milligrays (mGy). The
30-day safety endpoint 0 (0) simulated manual operator radiation exposure during the overall pro-
Coronary dissection >NHLBI type D 0 (0) cedure on top of the lead apron was 57.1±61.2 microsieverts (µSv)
Perforation 0 (0) and under the lead apron was 3.2±4.1 µSv. The total calculated
Decrease of TIMI flow (<2) 0 (0) robotic operator radiation exposure on top of the lead apron was
Acute occlusion 0 (0) 7.2±8.7 µSv and under the lead apron was 0.2±0.6 µSv. Robotic PCI
Visible thrombus formation 0 (0) operators experienced a reduction of radiation exposure of 77.1%
on top of the lead apron and 84.5% under the lead apron compared
Significant air embolus 0 (0)
to the simulated manual operator. For centres who had a secondary
Relation to procedure 0 (0)
operator at the patient table (n=2), the mean operator dose was 0 µSv.
Relation to robot 0 (0)
MACE 0 (0)
Discussion
Efficacy Procedural technical success 59 (95.2)
endpoint The R-EVOLUTION study assessed the safety and efficacy
Total manual conversion 3 (4.8)
of robotic PCI using the R-One system in de novo coronary
Data are n (%). MACE: major adverse cardiac event; NHLBI: National
Heart, Lung, and Blood Institute; TIMI: Thrombolysis In Myocardial
lesions and demonstrated high rates of clinical and technical suc-
Infarction cess in a patient population that included 25% complex lesions.
Additionally, operator radiation exposure was dramatically
reduced compared to manual operation. With an expected increase
presented in Supplementary Table  1, and all total manual con- in PCI procedures over the next several years, the R-One system
versions occurred in early experienced centres. Additionally, may enable interventionalists to perform PCI with improved navi-
the duration of the robotic procedure was shorter in experi- gation in tortuous vessel anatomy, while reducing their health risks
enced centres (17.4±78.02 minutes) compared to those without from procedure-related radiation exposure.

EuroIntervention

CENTRAL ILLUSTRATION Safety and efficacy of R-One Robotic System for PCI in patients with a de novo coronary artery
stenosis.

Robotic PCI with R-One: safety & efficacy demonstration

62 patients included - Inability to cross the lesion with

the balloon due to a lack of
CLINICAL SUCCESS TECHNICAL SUCCESS support (1/3)
100% 100% - Software error due to wrong
No MACE 95.2% adjustment of the guidewire into
the pads of the robot (1/3)
at hospital - A non-occlusive coronary
discharge dissection (NHLBI type B)
at 1 month non-related to the robot (1/3)
2/3 of manual conversions were
▲

not related to the robot

−77.1% −84.5% KEY FINDINGS
X-ray X-ray
exposure on top
of the physician’s
exposure
to the physician ① >95% technical success
lead apron under lead apron
② 100% clinical success: no major procedural
or 30-day complications reported

② 84.5% average reduction

in physician radiation exposure

④ 100% technical success

achieved in experienced centres*
* For each experienced centre, more than 5 robotic PCI were
performed before patient enrolment in the study and each
investigator from these centres was involved in preclinical studies

MACE: major adverse coronary events; NHLBI: National Heart, Lung, and Blood Institute; PCI: percutaneous coronary intervention

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Table 5. Radiation exposure. Results from studies of similar robotic systems are detailed
Overall in Table  6. In these studies, the reported clinical success was
Variables population 94.9-100%19,21,22,29, technical success was 82.4-98.8%19,21,22,29, and
(N=62) in-hospital MACE was 0-0.9%.21,22,29. Thus, the clinical and tech-
Patient radiation exposure, mGy 540.3±498.4 nical results from the R-EVOLUTION study are similar to the
Simulated manual Total on lead (procedure) 57.1±61.2 results of previous studies using similar devices. Compared to the
operator radiation R-EVOLUTION study, the PRECISE Study21 had a similar patient
exposure, µSv Total under lead (procedure) 3.2±4.1
population, a comparable prevalence of complex lesions (31.7% in
Robotic operator Total on lead (robotic) 7.2±8.7
radiation exposure, PRECISE; 25.0% in R-EVOLUTION), and a comparable techni-
µSv Total under lead (robotic) 0.2±0.5 cal success rate (98.8%).
Operator radiation Total reduction on lead, % 77.1±26.1 Those results are comparable as CorPath GRX and the R-One
exposure reduction
Total reduction under lead, % 84.5±25.2 are both able to robotically manipulate 1 guidewire and 1 stent
Data are mean±SD. mGy: milligray; SD: standard deviation; balloon and are both fixed to the intervention table.
µSv: microsievert
The CorPath GRX is also able to robotically reposition a guid-
ing catheter through a limited translational distance.
Efforts to reduce radiation exposure to interventionalists perform- The main difference is the architecture of the motorisation of
ing PCI procedures have included guidelines and recommenda- the guidewire. The CorPath GRX has a motor for the rotation
tions from the International Commission on Radiological Protection (rotary drive) and a motor for the translation (translation drive).
(ICPR), new generations of imaging systems, lead-free protective This configuration leads to a different design for the cassette.
gear, and additional forms of lead protection25. Despite these efforts, The R-One has a unique architecture which is able to combine
the catheterisation laboratory remains a high-risk work environ- rotation and translation with a system of pads. This architecture
ment. Over the course of a career, the cumulative radiation exposure enables a quick manual conversion as the wire is locked into pads
to an interventional cardiologist can lead to negative health effects (as it would be manually with hands), whereas with the CorPath
such as cataracts, cancer, and accelerated carotid atherosclerosis13,26. GRX, all the rotary drive needs to be carefully removed when
A study of radiation exposure during invasive cardiology procedures switching to manual operation.
showed that cardiologists’ heads are exposed to 11–16 times more The contrast volume and robotic procedure times are also
radiation compared to that received through ambient exposure26. comparable, though the R-One system had lower procedure
Additionally, orthopaedic complications from the use of heavy lead times overall and notably lower patient radiation exposure.
protective aprons are prevalent11,14 and may adversely affect perfor- Operator radiation exposure was dramatically reduced in both
mance and productivity12-14. studies, with a median operator radiation exposure of 0.98 µGy
One of the advantages of robotic PCI is the radiation shield and a reduction of 95.2% in the PRECISE study21. This reported
protecting interventionalists from exposure during the procedure, median reduction was measured comparing the dose received
eliminating the need for heavy lead protective equipment which by the operator at the control station and the dose measured at
often leads to orthopaedic injuries11-14. Moreover, patients bene- the procedure table without lead protection, which may result
fit from improved navigational precision and accuracy of wires in an overestimation in the reduction of radiation exposure.
and devices through tortuous vessel anatomy, leading to a reduc- Additionally, it is unclear whether the dosimeter was activated
tion in Longitudinal Geographic Miss (LGM) − cases where the once the guiding catheter was inserted and positioned manually
entire length of the injured or stenotic segment is not fully covered at the ostium of the targeted coronary. Following the same meas-
by the length of the stent. Patients with LGM often have worse urement methodology, the radiation exposure reduction with the
clinical outcomes and increased incidences of major adverse car- R-One system would be 99.6% (0.2 µSv to 57.1 µSv at the pro-
diac events (MACE)27. Additionally, with a table position further cedure table). As the guiding catheter is still positioned manu-
from the radiation source, radiation exposure is reduced in patients ally, the dose received during this step must be considered and
undergoing robotic PCI compared to manual PCI as reported by explains the absence of a 100% reduction.
Patel et al (mGy, median [interquartile range]: 884 [537-1,398] vs
1,110 [699-1,498]; p=0.002 and cGy·cm2, 4,734 [2,695-7,746] vs STUDY LIMITATIONS AND PERSPECTIVES
5,746 [3,751-7,833]; p=0.003)23. This study was a prospective, multicentre registry and, as such,
R-One is the new robotic-PCI system on the market. A preclini- included a limited number of patients, and only 25% of the
cal study including 42 porcine coronary stented arteries designed treated lesions were complex. The predominant use of a sin-
to evaluate the safety and efficacy of the system compared to man- gle stent with a low rate of pre- and post-dilatation illustrates
ual PCI was successful and demonstrated 100% technical success, low complexity coronary artery disease. In a real-world set-
no MACE, and no significant differences between the 2 groups28. ting, the technical and clinical success rates may be lower given
R-One received its CE mark in 2019 and first-in-human proce- a more diverse patient population with higher rates of complex
dures were simultaneously performed. lesions. Furthermore, clinical follow-up was limited to 30 days

7
EuroIntervention 2023;18-online publish-ahead-of-print January 2023

Table 6. Results comparison with similar devices.

Smitson et PRECISION
Beyar et al29 PRECISE21 CORA-PCI22 R-EVOLUTION
al19 Registry*
CorPath CorPath CorPath
System used RNS CorPath GRX R-One
200 200 GRX
Number of sites, n 1 9 n/r 1 20 6
Patients, n 18 164 108 40 980 62
Complex lesions, % n/r 31.7 78.3 77.8 68.8 25.0
Technical success, % 83.3 98.8 91.7 90.0 86.5 95.2
Clinical success, % 100 97.6 99.1 97.5 97.8 100
MACE, % (follow-up) 0 0 0.9 0 0
n/r
(in-hospital) (30 days) (in-hospital) (in-hospital) (30 days)
Total procedure time, min 44 n/r 44.5 40.2 54.3 39.9
Total robotic procedure time, min n/r 24.4 n/r n/r n/r 19.9
Mean fluoroscopy time, min 8.8 11.1 18.2 17.4 17.8 10.3
Mean contrast injection volume, mL n/r 144.2 183.4 171 118.2 118.3
Mean patient radiation exposure, mGy n/r 1,5 n/r n/r n/r 540.3
Mean reduction in operator radiation exposure with
n/r n/r n/r n/r n/r 84.5
lead protection, %
Median reduction in operator radiation exposure, % 100 (under
n/r 95.2 n/r n/r n/r lead) 86.07
(on lead)
*(Medranda GA, Waksman R. Safety and Efficacy of the Second-Generation Robotic Assisted Systems for PCI. Society for Cardiovascular
Angiography and Interventions. 2 July 2021; https://scai.org/safety-and-efficacy-second-generation-robotic-assisted-systems-pci-coverage-late-
breaking-science. [Last accessed 7 Dec 2022]). MACE: major adverse cardiac event; mGy: milligray; n/r: not reported

but robotic-induced complications are unlikely to be undetected Impact on daily practice

within the first 30 days as they frequently occur during or imme- The results of our study suggest that R-One is a safe and effective
diately after the procedure. robotic system for performing PCI procedures. With the aid of
a robotic system, interventionalists are able to improve the pre-
Limitations cision and accuracy of guidewire and device navigation through
At present, robotic-PCI systems have a number of limitations. coronary arteries. This system also markedly reduces radiation
Manual vascular access and engagement of the coronary artery exposure to the operator while enabling a more ergonomic posi-
with the guiding catheter are still necessary. Furthermore, these tion, simultaneously reducing the chronic effects of long-term
devices allow manipulation of only 1 coronary guidewire at radiation exposure and the orthopaedic complications associated
a time and positioning of only 1 balloon or stent simultaneously. with heavy lead aprons. With a projected increase in the prevalence
Anatomic or lesion characteristics requiring planned use of any of coronary artery disease, the need for safe and efficient robotic
over-the-wire device (e.g., microcatheter, atherectomy) cannot be systems for PCI procedures will probably continue to increase.
performed robotically. These limitations will likely be addressed
in future generations of robotic-assisted systems.
Acknowledgements
Conclusions The authors acknowledge Superior Medical Experts for their edi-
The R-EVOLUTION study suggests that the R-One system for torial assistance, Dosilab for the radiation measurement monitor-
robotic PCI is safe and effective for the patient while significantly ing, and CERC for the study management as an independent CRO.
lowering radiation exposure to the operator (Central illustration).
Our results indicate that it performs as well as other currently Funding
available robotic systems. Given the benefits of robotic PCI, the This study was funded by Robocath SAS. E. Durand has received
interventional cardiology standard of care may be redefined with- a grant from the GCS G4 (FHU CARNAVAL).
out the constraint of modifying the procedural workflow or the
devices used, as this system can easily be integrated into any cath- Conflict of interest statement
eterisation laboratory. Further studies are required to evaluate the R. Sabatier reports compensation from Robocath for support for
R-One system in a larger patient population that includes more the present manuscript, consulting fees, training workshops, expert
patients with complex lesions. testimony, and participation on a Data Safety Monitoring Board or

8
 Robotic-assisted PCI using the R-One system

EuroIntervention 2023;18-online publish-ahead-of-print January 2023

Advisory Board. E. Durand reports compensation from Robocath 17. Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA,
Goldstein JA. Occupational health hazards in the interventional laboratory: time for
for consulting on the present manuscript and from Edwards
a safer environment. Radiology. 2009;250:538-44.
Lifesciences for consulting on grants and contracts. The other 18. Walters D, Omran J, Patel M, Reeves R, Ang L, Mahmud E. Robotic-Assisted
authors have no conflicts of interest to declare. Percutaneous Coronary Intervention: Concept, Data, and Clinical Application.
Interv Cardiol Clin. 2019;8:149-59.
19. Smitson CC, Ang L, Pourdjabbar A, Reeves R, Patel M, Mahmud E. Safety and
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Supplementary data
ogy. Cardiovasc Revasc Med. 2013;14:223-8. Supplementary Table 1. Analysis by centre experience level.
15. Klein LW, Tra Y, Garratt KN, Powell W, Lopez-Cruz G, Chambers C, Goldstein JA; Supplementary Figure 1. Radiation exposure measurements dur-
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9
Supplementary data
Supplementary Table 1. Analysis by centre experience level.
Variables Experience centre Early experience p-value

(N=34) centre

(N=28)

Manual conversion
Transient 0 (0) 2 (4.2) 0.2
Permanent 0 (0) 3 (10.7) 0.09
Total 0 (0) 5 (17.8) 0.01

Simulated manual operator radiation

exposure, µSv
On lead (procedure) 8.19 ± 8.67 5.97 ± 8.70 0.32
Under lead (procedure) 0.19 ± 0.27 0.27 ± 0.77 0.59
Robotic operator radiation exposure,
µSv
On lead 50.02 ± 58.97 65.52± 63.69 0.33
Under lead 2.95 ± 4.02 3.55 ± 4.31 0.57
Operator radiation exposure
reduction, % (95% CI)
On lead 71.88 (61.91-81.84) 83.37 (74.60-92.14) 0.09
Under lead 83.90 (75.28-92.51) 85.32 (73.89-96.76) 0.84
Robotic contrast volume, mL 85.01 ± 34.8 91.09 ± 37.10 0.54
Procedure contrast volume, mL 129.82 ± 53.85 103.67 ± 25.56 0.03
Robotic duration, min 17.47 ± 8.02 22.23 ± 10.99 0.07
Procedure duration, min 35.50 ± 11 .12 45.25 ± 16.60 0.01
Data are mean ± SD or n (%). CI (confidence interval), mGy (milligray), µSv (microsievert), SD
(standard deviation)
Supplementary Figure 1. Radiation exposure measurements during robotic PCI.

Dosimeters A-D are located on a pole 1–2 meters from the patient table. Dosimeters E and F are located
on the robotic-PCI operator seated behind a radioprotection screen at the control station. Dosimeters A
and B measure simulated manual operator radiation exposure on top of and underneath a lead apron,
respectively, for the entire duration of the procedure. A piece of lead apron is positioned on top of B to
represent the wearing of a lead apron. Dosimeters C and D are identical to A and B except they begin
measuring radiation exposure after the initial manual insertion of the guide catheter. Dosimeter readings
were multiplied by 4 or 16 depending on the distance from the patient. Dosimeters E and F are worn by
the robotic-PCI operator on top of and underneath their lead apron, respectively. Radiation doses are
measured in microSieverts (µSv).