Results

Limitations

Conclusions

Complications

Amigo®REMOTE CATHETER SYSTEM

Purpose

Methods Introduction

FIRST EVALUATIOIN OF CONTACT FORCE DURING ATRIAL FIBRILLATION

ABLATION USING A NOVEL ROBOTIC SYSTEM (Amigo®) COMBINED TO A

FORCE-SENSING CATHETER. A SINGLE CENTRE EXPERIENCE

Antonio Scarà1, Luigi Sciarra1, Ermenegildo De Ruvo1, Marina Mercurio2, Alessio Borrelli1, Marco Rebecchi1, Domenico Grieco1, Lucia De Luca1, Leonardo Calò1 1Policlinico Casilino, Roma, Italy, 2Biosense Webster, Roma, Italy

The Amigo® Remote Catheter

System is a new robotic system

for catheter navigation recently

used for electrophysiological

procedures with promising

results. However no data are

available about the contact

force produced to the cardiac

tissue by the use of this remote

navigation system versus

traditional manual catheter

manipulation.

To evaluate contact force (CF) during atrial fibrillation (AF) ablation using AMIGO robotic system (ARs) as compared to manual combined to Thermocool® SmartTouch® catheter (STc).

The system consists of a robotic arm installed on the patient’s table

and a remote controller connected to the robot through a cable.

The ablation catheter is introduced into the patient’s right femoral

vein through a conventional sheath (7-8 F) and advanced manually

into the cardiac chamber of interest; then, the catheter steering

handle mechanism is attached to Amigo and the operator controls

catheter navigation with the remote controller from the control

room, away from the fluoroscopy field. The remote manipulator

controller imitates the operation of the catheter by the

conventional handle: forward and backward, deflection, and torque

(rotation). At any point during the procedure, the catheter can be

removed from the robotic arm for manual manipulation and can

also be re-attached to the robot without breaking sterility.

Twenty-eight consecutive

patients (pts) (mean age

55.2±6.8 year, 18 males),

referred to our centre for

paroxysmal AF, were

randomized to receive

pulmonary veins (PV) isolation

by either a standard manual

procedure (MP) with STc or a

robotic procedure (RP)

combining STc to ARs. Contact

force data were measured and

stored by CARTO3 system.

Pulmonary vein (PV) isolation was reached in all cases. No clinical

complications occurred. Mean fluoroscopy time: 6.5±2 min for RP;

14.5±9 min for MP (p˂0,001). Mean procedural time: 142±19 min

for RP; 170±36 min for MP (p=0,01). Mean CF data among the PVs:

a) LSPV: 14.3±7.4 g for RP; 12.8±7.8 g for MP (p<0,02) b) RSPV:

14.9±6.5 g for RP; 12.0±5.5 g for MP (p<0,01) c) LIPV: 14.0±8.9 g

for RP; 11.9±9.4 g for MP (p<0,02) d) RIPV: 13.1±6.7 g for RP;

11.8±6.8 g for MP (p<0,02). RP compared to MP consistently

produced a higher percentage of ablation sites achieving ≥ 400 FTI

at all 4 PV: LSPV- 80 vs. 52%, LIPV– 68 vs. 42%, RSPV-90 vs. 62%

and RIPV-71 vs.52% (all p,0.001). AF free-survival during mean

follow-up (1.1±0.3 years) was 100% for RP and 84% for MP.

This study provides a first objective evaluation of CF produced

during AF ablation performed by the use of ARs combined to STc.

The system seems to be safe and effective, providing a greater

likelihood of determine a persistent lesion. RP allowed a reduction

of x-ray exposure and procedural times. More extensive data are

needed to support our acute and midterm preliminary findings.

The Control Handle

Amigo®o

No major complications were observed in either group.

• Single center experience

• Small number of patients

• Limited follow up data

Front view

Back view