Medtronic has presented data from the FAST-PVI study at Cardiostim 2010, the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques. The data showed anatomically-designed ablation catheters are more efficient than traditional point-by-point focal ablation procedures in reducing lab time and are more than one-third (35%) faster in achieving pulmonary vein isolation (PVI).
Medtronic said that the anatomically shaped Arctic Front Cardiac CryoAblation Catheter and advanced radiofrequency (RF) Pulmonary Vein Ablation Catheter (PVAC) enabled physicians to efficiently isolate the pulmonary veins than with focal RF catheters.
The Arctic Front and PVAC are approved in Europe to treat paroxysmal atrial fibrillation (AF) and supraventricular tachycardia (SVT), respectively. Both catheters are under investigational use in the US and are under FDA review for paroxysmal AF, and continuous AF treatments, respectively.
The Arctic Front uses cryoablation (freezing technology), in which a coolant released to freeze and ablate the tissue helps the balloon to maintain contact with the tissue.
The Medtronic Ablation Frontiers Cardiac Ablation System, an advancement from currently available RF ablation tools, includes an RF generator (or heated energy source) and three anatomically shaped ablation catheters, including the PVAC.
The retrospective FAST-PVI study compared procedure time using anatomically-designed catheter ablation systems with procedure times of point-by-point focal systems. Results from nine German centers and 444 procedures showed that using anatomical catheters for PVI allows for more efficient procedures, reduced cath lab occupancy time and faster physician procedure time.
Of the 245 procedures using anatomical Arctic Front and PVAC catheters, overall staff time lowered by 36%, fluoroscopy time was reduced by 33% and physician procedure time was reduced by 37%.
Using anatomical catheters achieved an average lab use time of 170 minutes compared to 262 minutes for point-by-point focal ablation, or a 35% time reduction. Results with anatomical catheters were compared to the 199 patients receiving point-by-point focal ablation with an acute PVI success rate of 99%.
Gunnar Klein at Hannover Medical School (Medizinische Hochschule Hannover – MHH) in Hannover, Germany, said: “FAST-PVI is the first study quantifying procedure time efficiency improvements associated with the use of anatomically designed catheter ablation systems. The shorter and more predictable procedure times allows me to better manage lab time and treat more patients.”