Twelve-month data from the TOCCATA study presented at Heart Rhythm 2010 reinforce the potential of force-sensing catheter ablation to improve clinical outcomes. A new study to compare ablation with and without force sensing, EFFICAS I, has started enrolment.
In the new data presented in Denver, USA, TOCCATA (Touch+ for catheter ablation) abstract authors suggested room for a safer and more effective catheter ablation treatment in the future, as retrospective analysis identified a statistically significant relationship (p<0.05) between the contact force applied at ablation sites and the 12-month success of the procedure. The median contact force applied in the non-recurrent patient group was 20g versus 11g in the recurrent patient group. TOCCATA is a study of the TactiCath force-sensing ablation catheter (Endosense).
Led by principal investigator Karl-Heinz Kuck, Hanseatisches Herzzentrum, Asklepios Klinik St Georg, Hamburg, Germany, with the participation of 21 additional highly experienced investigators, TOCCATA was an eight-centre, prospective study designed to evaluate the safety and effective performance of the TactiCath. Investigators used the TactiCath to perform catheter ablation on 76 patients, including 34 with paroxysmal AF. Primary safety and performance endpoints were met during the course of the study.
TactiCath is the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Granted the CE mark in 2009, the TactiCath and its TactiSys supporting system are indicated for the treatment of AF and supraventricular tachycardia. Biotronik is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the USA.
Another study started recently will compare ablations performed with and without a force sensor. The first patients in EFFICAS I, the first study of the EFFICAS series, were enrolled in Na Homolce Hospital, Prague, Czech Republic, and treated by Petr Neuzil and Vivek Reddy.
EFFICAS is a study series intended to demonstrate that the use of contact force control during cardiac ablation utilising the TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor.
EFFICAS I and EFFICAS II are single-arm, multicentre, prospective pilot studies. In EFFICAS I, physicians will perform the procedure with the TactiCath without having access to contact force measurements; however, the contact forces applied will be recorded. In EFFICAS II, physicians will take full advantage of the TactiCath contact force control features, with the ability to objectively influence their ablation technique during lesion creation. The endpoint for EFFICAS I will be the occurrence of reconduction areas in the pulmonary vein isolation lines, relative to the contact forces applied; endpoints for EFFICAS II will include reduction in pulmonary vein isolation reconduction as compared to EFFICAS I.
Outcomes data from EFFICAS I and II will help in the design of future, larger, EFFICAS studies with clinical endpoints.
“The EFFICAS study series represents a very rigorous and thoughtful approach to evaluating the comparative clinical effectiveness of contact force control in the catheter ablation treatment of cardiac arrhythmias,” said Kuck. “EFFICAS I and II will lay an important foundation for achieving this goal while also yielding valuable incremental insights that can be immediately applied to current clinical practice.”