RETROSPECTIVE COMPARISON OF THE LEARNING CURVES FOR PVI BETWEEN CARDIOFOCUS LASER BALLOON & PVAC

D.Q. Nguyen*, L. Lichtenberg*, K. Schuettler**, W. Fehske*

1Dept. of Electrophysiology, Clinic III for Internal Medicine and Cardiology, St. Vinzenz-*: Hospital Cologne, Merheimer Str. 221 - 223, 50733 Cologne, Germany. **: CardioFocus, 500 Nickerson Road, Marlborough, MA 01752, USA

Abstract

Introduction: The CardioFocus laser balloon (CFLB) with its 30 degree ablation sector takes an intermediate position between a single shot device for PVI as originally designed, and the conventional point-by-point ablation. Advantages are the direct endoscopic view of the ablation area, and the contact force independent application of laser energy.
Methods: A retrospective comparison with a PVAC ablation approach for the first 50 patients (pt) of each technology, i.e. the learning curves will be presented.
Results: Mean procedure time for CFLB was 221±42.9 min, for PVAC 188±37.4 min; mean fluoroscopy time 38±13.6 min, and 41±10.7 min; Mean procedure time reached the bottom after 20 patients - for CFLB with around 210 min, for PVAC with about 180 min; Mean fluoroscopy time for CFLB is continuously declining beyond the 50th pt. with pt 50 at around 30 min, but for PVAC it is reaching a bottom at about 40 min.
Acute isolation rates were optimal with 99% (CFLB: 196 out of 198 veins; PVAC 194 out of 196 veins) from the beginning on. Mean freedom from AF/AT after 6 months after a single procedure was 81.4% for CFLB and 78.0% for PVAC measured by 7-day ECG recording.
Most importantly, mean clinical recurrence of AF/AT after 6 months improved obviously from 31.2% of the first third, to 17.6% for the second third, down to 0% for the last third of patients treated by CFLB while there was less clear improvement by PVAC.
Conclusions: Two learning curves could be found concerning the time course: one finished after 20 pt. for procedure time (CFLB & PVAC) and fluoro time (PVAC), another longer lasting for CFLB’s fluoro time and superior outcome.