Abstract 3318: A Prospective, Randomized Trial of Remote Magnetic versus Manual Catheter Navigation for Ablation of Supraventricular Tachycardia (SVT): The Stereotaxis Heart Trial
The remote magnetic catheter navigation system (MNS) has been used to treat a variety of arrhythmias. However, MNS has not been directly compared with conventional (CONV) manual navigation for catheter ablation.
Purpose: To directly compare radiofrequency (RF) ablation of common SVTs by MNS and CONV navigation.
Methods: The Heart Trial was a prospective, randomized, multicenter trial comparing the Niobe MNS (Stereotaxis, Inc. St Louis, MO) with CONV manual catheter navigation for RF ablation of AV nodal reentry (AVNRT), accessory pathways (AP) or AV junctional ablation (AVJ). Randomization was 3:1 for MNS:CONV navigation at 13 centers in the USA. Each center completed 5–20 “skill building” cases (SKILL) to become familiar with the new MNS before randomizing patients (pt). The study primary endpoint was total fluoroscopy (fluoro) time. 45 SKILL cases were performed (52±18 yr, 55% male, 69% AVNRT, 22% AP, 9% AVJ) and 67 pt were randomized; 15 CONV pt (43±17 yr, 27% male, 67% AVNRT, 33% AP, 0 AVJ) and 52 MNS pt (51±20 yr, 43% male, 69% AVNRT, 25% AP, 6% AVJ, p ≥ 0.15 all comparisons). Hypertension or structural heart disease was present in 36% SKILL pt, 7% CONV pt and 31% MNS pt (p = 0.48).
Results: Results are shown in the table⇓. * p < 0.05 versus CONV pt. Fluoro time and number RF lesions were both significantly less for MNS vs CONV and SKILL vs CONV. Serious complications within 7 days after procedure were statistically similar among groups: chest pain 1 pt MNS, 0 complications CONV and 1 pt each heart block and pulmonary embolism SKILL (p = 0.60).
Conclusions: Compared to CONV manual catheter navigation for ablation of common SVTs, MNS 1) provides a comparable acute success rate, 2) reduces total fluoro time even during initial use, 3) reduces number RF lesions for success even during initial use and 4) has a comparable complication rate.