| 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.
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