ABSTRACT
OBJECTIVE: Postoperative atrial fibrillation (AF) affects 20-30% of patients undergoing open-heart surgery, delays mobilization and impairs hemodynamics. Implantation of TADpole Heart Wires offers a new method of applying internal low-energy-shocks to terminate AF. The safety and efficacy of the TADpole system to treat postoperative AF was evaluated in this multicenter trial. METHODS: Two atrial wires, configured with a highly flexible 11.5 cm distal shocking and a 0.5 cm proximal pacing electrode were sutured onto the right and left atrium. Upon detection of AF, R-wave synchronized low-energy-shocks were administered via an energy attenuating External Defibrillator Interface Module or ICD programmer. RESULTS: A total of 296 patients (65+/-9.2 years, 74.7% male) have been enrolled to date in six European centers. The wire placement time was 4.2+/-2.2 min, 65 patients had a total of 83 episodes of AF treated by the TADpole Heart Wire system with a conversion rate of 88.5% (approximate energy of 6+/-2 J), early recurrence of AF was observed in ten patients (12.8%). No clinical complications were reported. The shocks were well tolerated with slight sedation. The ease of withdrawal was 2.3+/-1.2 on a graded scale of 0 (easy) to 10 (difficult). CONCLUSIONS: These multicenter results indicate that postoperative atrial cardioversion using TADpole Heart Wires is both safe and efficient. It is expected that hospital length of stay and its associated economic impact can be reduced with this therapy.
