Multicenter results of TADpole (TM) heart wire system used to treat postoperative atrial fibrillation

Objective: Postoperative atrial fibrillation (AF) affects 20-30% of patient s undergoing open-heart surgery, delays mobilization and impairs hemodynami cs. Implantation of TADpole(TM) Heart Wires offers a new method of applying internal low-energy-shocks to terminate AF. The safety and efficacy of the TADpole(TM) system to treat postoperative AF was evaluated in this multice nter 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 o nto the right and left atrium. Upon detection of AF, R-wave synchronized lo w-energy-shocks were administered via an energy attenuating External Defibr illator Interface Module or ICD programmer. Results: A total of 296 patient s (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 to tal of 83 episodes of AF treated by the TADpole(TM) Heart Wire system with a conversion rate of 88.5% (approximate energy of 6 +/- 2 J), early recurre nce of AF was observed in ten patients (12.8%). No clinical complications w ere 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 (difficu lt). Conclusions: These multicenter results indicate that postoperative atr ial cardioversion using TADpole(TM) Heart Wires is both safe and efficient. It is expected that hospital length of stay and its associated economic im pact can be reduced with this therapy. (C) 1999 Elsevier Science B.V. All r ights reserved.