Background: Echo-guided percutaneous procedures have been reported reliable and advantageous. However, the learning curve is difficult for junior doctors. We aimed to evaluate the safety and efficacy of a novel guidewire (Panna wire) in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only.
Methods: The Panna wire is designed for echo-guide procedure with a retractable spindle-shaped tip. A multicenter, randomized, controlled trial was conducted to evaluate the safety and efficacy of the Panna wire versus the conventional guidewire for junior doctors with <100 cases experience. The primary outcome was operative success rate. The secondary outcomes were incidence of major adverse events, operation time, time needed to enter the left atrium, number of arrhythmia episodes, number of misguidance to tricuspid valve, and incidence of peripheral vascular complications.
Results: Between July 2018 and September 2019, 100 patients with atrial septal defect were randomized to either the Panna wire group (n=52) or the conventional wire group (n=48) at 3 centers. The baseline clinical characteristics were similarly distributed. The operative success rate (primary outcome) was 100% in the Panna wire group versus 68.75% in the conventional wire group (P<0.001). No major adverse events occurred in either group. Significant differences in favor of the Panna wire group were found in operation time (P=0.004), time needed to enter the left atrium (P<0.001), number of arrhythmia episodes (P<0.001), and number of misguidance to tricuspid valve (P=0.005).
Conclusions: The Panna wire is safe and effective and reduces the learning curve in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04096924.
Keywords: atrial septal defect; echocardiography; fluoroscopy; incidence; learning curve.