P1408Initial experience with a novel contact force sensing system - Results of BIOCONCEPT AlCath Force study

Abstract

Background/Introduction: Contact force (CF) sensing catheters are a recent technical innovation in the field of cardiac radio-frequency (RF) ablation. Their use has been suggested to improve acute and long-term procedural outcome and reduce procedural time as well as fluoroscopy exposure. The steerable, irrigated, quadrupolar AlCath Force catheter with an integrated force sensor and the Qubic Force device provide a novel system for measuring CF. The AlCath Force catheter is built on the established AlCath Flux eXtra Gold catheter with X-shaped irrigated GoldTip technology. It is able to measure force in three dimensions using a single optical fibre. Moreover, use of a liquid crystal polymer foil technology with printed sensing electrodes provides additional distal catheter flexibility and aims to improve application of the required force even at challenging anatomies. Purpose: The prospective, non-randomised, multi-centre BIOκCONCEPT. AlCath Force study was the first clinical study to evaluate safety and performance of the AlCath Force catheter and the Qubic Force. Methods: Patients with symptomatic paroxysmal atrial fibrillation and/or typical atrial flutter underwent RF ablation and were followed until a pre-hospital discharge visit. Study endpoints included both safety and efficacy of the catheter (number of device related serious adverse events (SADEs) and acute procedural success rate). Moreover, data of catheter handling characteristics were collected. Results: 30 patients (23 male, mean age 65±11 years) were enrolled in 6 Australian sites and underwent ablation with the AlCath Force catheter. Procedures performed were pulmonary vein isolation (n=12), cavo-tricuspid isthmus (CTI) ablation (n=16) and a combination of both (n=2). Total skin-to-skin procedure time was 1306 48 min (CTI only: 107±48 min, PVI only: 156±37 min) and fluoroscopy time was 28±20 min (CTI only: 31±24 min, PVI only: 26±15 min). Target force was 20 g in the majority of cases (range 20-40 g). Recommended power setting was 30W and FTI of 450 gs (in some flutter cases higher FTI and power were applied). Acute procedural success, defined as bi-directional block across the CTI and entrance and exit block in all pulmonary veins, could be obtained in all cases. No procedure or device related serious adverse events have occurred. Optical inspection of the catheter after the procedure showed neither charring nor clotting. No popping was observed during ablation. Curve stability, reachability, and torqueability of the AlCath Force catheter was rated adequate or better (good, very good) in 100%, 93%, and 97% of cases, respectively. Performance of the force measurement was rated adequate or better in 100% of cases. Conclusion: The results of the BIOjCONCEPT. AlCath Force study indicate that the AlCath Force catheter together with the Qubic Force device is safe and effective for contact force guided RF ablation.