Expandable Lattice Electrode Ablation Catheter: A Novel Radiofrequency Platform Allowing High Current at Low Density for Rapid, Titratable, and Durable Lesions.

BACKGROUND

High-current short-duration radiofrequency energy delivery has potential advantages for cardiac ablation. However, this strategy is limited by high current density and narrow safety-to-efficacy window. The objective of this study was to examine a novel strategy for radiofrequency energy delivery using a new electrode design capable of delivering high power at a low current density to increase the therapeutic range of radiofrequency ablation.

METHODS

The Sphere9 is an expandable spheroid-shaped lattice electrode design with an effective surface area 10-fold larger than standard irrigated electrodes (lattice catheter). It incorporates 9 surface temperature sensors with ablation performed in a temperature-controlled mode. Phase I: in 6 thigh muscle preparations, 2 energy settings for atrial ablation were compared between the lattice and irrigated-tip catheters (low-energy: T75°C/5 s versus 25 W/20 s; high-energy: T75°C/7 s versus 30 W/20 s). Phase II: in 8 swine, right atrial lines were created in the posterior and lateral walls using low- and high-energy settings, respectively. Phase III: the safety, efficacy, and durability at 30 days were evaluated by electroanatomical mapping and histopathologic analysis.

RESULTS

In the thigh model, the lattice catheter resulted in wider lesions at both low- and high-energy settings (18.7±3.3 versus 12.2±1.7 mm, P<0.0001; 19.4±2.4 versus 12.3±1.7 mm, P<0.0001). Atrial lines created with the lattice were wider (posterior: 14.7±3.4 versus 9.2±4.0 mm, P<0.0001; lateral: 15.8±4.2 versus 5.7±4.2 mm, P<0.0001) and required 85% shorter ablation time (12.4 versus 79.8 s/cm-line). While current squared (I) was higher with Sphere9 (7.0±0.04 versus 0.2±0.002 A; P<0.0001), the current density was lower (9.6±0.9 versus 16.9±0.09 mA/mm; P<0.0001). At 30 days, 100% of ablation lines created with the lattice catheter remained contiguous compared with only 14.3% lines created with a standard irrigated catheter. This was achieved without steam pops or collateral tissue damage.

CONCLUSIONS

In this preclinical model, a novel, high-current low-density radiofrequency ablation strategy created contiguous and durable ablation lines in significantly less ablation time and a comparable safety profile.