Endosense’s EFFICAS I Study Yields New Contact Force Guidelines in AFib Catheter
April 4, 2013 — Endosense has announced that the results of its EFFICAS I prospective multi-center study 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). Published in the April 2013 issue of the American Heart Association journal Circulation: Arrhythmia and Electrophysiology, the newly created guidelines call for a CF target of 20 grams (and minimum CF of 10 grams) and minimum FTI of 400 grams 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. Furthermore, the study illustrated that not only the average, but the most inferior ablation value predicts the long-term effectiveness of the procedure. Therefore, CF guidance using FTI is critical in creating every single ablation lesion.
According to the publication, pulmonary vein (PV) isolation is the most prevalent approach for catheter ablation of PAF. Long-term success of the procedure is diminished by arrhythmia recurrences occurring predominantly due to reconnections in previously isolated PVs. The likelihood of recurrence increases in the presence of gaps in the isolation line. EFFICAS I was undertaken to investigate the exact relationship between CF and FTI parameters measured during ablation and the incidence of isolation gaps in the PV line measured invasively during a three-month follow-up electrophysiologic study.
“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, 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 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.
“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.
The optimal contact force parameters identified at the conclusion of EFFICAS I are currently being evaluated in the company’s EFFICAS II study, which will allow operators to view contact force and FTI in real-time during the catheter ablation procedures. EFFICAS II will measure reduction in PVI gaps as well as procedural improvements as compared to EFFICAS I.
For more information: www.endosense.com