A Randomized Controlled Trial Comparing the TruSteer and FXD Double Curve Delivery Systems for Left Atrial Appendage Occlusion With the Watchman FLX Pro Device-The GUIDE-LAAO Study.

BACKGROUND

Deflectable delivery systems have been introduced to enhance coaxial alignment and procedural efficacy during left atrial appendage occlusion (LAAO), yet randomized comparisons with conventional fixed-curve systems are lacking.

AIMS: The GUIDE-LAAO trial evaluated whether the TruSteer deflectable delivery system is non-inferior to the FXD Double Curve (FXD DC) delivery system for procedural success in patients undergoing LAAO with the Watchman FLX Pro device.

METHODS

In this prospective, randomized, all-comers trial, 50 patients with non-valvular atrial fibrillation undergoing LAAO were assigned 1:1 to TruSteer (n = 25) or FXD DC (n = 25). The primary endpoint was procedural success, defined as successful device implantation without major procedural or periprocedural complications. Secondary endpoints included technical success, device success, procedural efficiency, and safety outcomes.

RESULTS

Procedural success occurred in 100% of TruSteer-treated patients and 84% of FXD DC-treated patients (risk difference 16%; 95% confidence interval -6.9% to 34.7%), meeting criteria for non-inferiority; superiority was not demonstrated (p = 0.11). Technical and device success were 100% with TruSteer and 92% with FXD DC. Procedural time (34.6 ± 7.1 vs. 36.5 ± 13.0 min), fluoroscopy time (22.3 ± 4.4 vs. 22.1 ± 7.2 min), and contrast volume (34.5 ± 12.1 vs. 36.8 ± 13.5 mL) were similar. Periprocedural complications occurred in 4% and 16%, respectively, with no deaths or strokes.

CONCLUSIONS

In this first randomized comparison of LAAO delivery systems, TruSteer was non-inferior to a standard fixed-curve system, with comparable efficiency and safety in an unselected population. These findings provide randomized evidence supporting deflectable delivery technology in contemporary LAAO practice and inform future studies in anatomically complex subsets.