This is all about how to ensure that catheter ablation for paroxysmal atrial fibrillation(PAF) is successful, sustained and reproducible. A new publication concludes by issuing guidelines for contact force and force-time-integral applied during the procedure.
Contact-force reportedly has a bearing on the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias. Now sensing technology company Endosense has seen the results of its EFFICAS I prospective multi-center study published in the April 2013 issue of the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.
The study results have led to the development of guidelines for target and minimum contact force (CF), as well as minimum Force Time Integral (FTI™), during the catheter ablation treatment of paroxysmal atrial fibrillation (PAF). The CF target is 20 g (and minimum CF of 10 g) and minimum FTI, 400 gs per individual ablation lesion.
The results of EFFICAS I demonstrated the importance of CF in the long-term effectiveness of catheter ablation for treating PAF. The study’s authors also concluded that Endosense’s proprietary FTI parameter, which measures the accumulated energy delivered per ablation, combined with CF over the duration of the ablation, is a strong predictor of ablation success.
EFFICAS I was a 46-patient, single-arm, prospective, multi-center European clinical trial. Investigators performed the procedure with Endosense’s TactiCath, the first force-sensing catheter to give the electrophysiologist a real-time, objective measure of contact force during the catheter ablation procedure. While contact force and FTI was recorded, investigators were blinded to these measurements during the procedures.
“As hypothesized, the results of EFFICAS I clearly showed that pulmonary vein reconnection is contingent on the contact force used during initial catheter ablation treatment,” said the study’s primary author, Prof. Petr Neuzil from the Department of Cardiology at Na Homolce Hospital in Prague, Czech Republic. “The study also confirms the immense value of Endosense’s FTI parameter and offers valuable guidelines that may lead to a new standard of care.”
“EFFICAS I has greatly advanced the scientific understanding of contact force combined with FTI in catheter ablation to treat atrial fibrillation,” said Jan Keltjens, president, chief executive officer and chairman of Endosense. “Publication of the study’s groundbreaking findings in a prestigious American Heart Association journal further demonstrates Endosense’s continued technical and clinical leadership in the field of contact-force sensing.”
Source: Endosense, Inc., Businesswire