First human use of a novel epicardial access needle embedded with a real time pressure/frequency monitoring of thoracic structures to facilitate epicardial access

Abstract

Introduction: Epicardial (epi) ablation represents an adjunctive strategy for the treatment of challenging arrhythmias. Major complications may occur during epi access since the may inadvertently puncture the right ventricle (RV), the pleural space or the lung. We sought to evaluate if a new access epi reduce the risk for RV puncture and complications. Methods: 7 consecutive pts with epi arrhythmias (6 ventricular, 1 supraventricular) were enrolled. Epi access with a novel needle embedded with a tip sensor able to record beat-to-beat pressure waveform was utilized. Successful epi access was confirmed by fluoroscopy, contrast injection and visualization of the guidewire looping around the epi border of the heart. In 4 cases the epi access was obtained by an expert operator, while in 3 cases the access was obtained by a less experienced operator. Results: Successful epi access was obtained in all cases. No acute and delayed complications occurred. Mean Pericardial pressure/pulsation was 3.5±1.3 mmHg while mean RV pressure was 15±4 mmHg (p=0.001). Pressure monitoring identified pericardial wire access position in 75% of the attempts and was able to identify RV puncture in 100% of the cases. 3 false negative readings were recorded, where the guidewire was within the pericardial space while the tip pressure was indicating differently. Unintended RV puncture occurred in 50% of the cases (always detected). Unintended RV puncture occurred more often in the less experienced operator (6 times vs 2 times, P<0.05). ![Figure][1] Conclusion: Real time pressure monitoring identifies successful pericardial access and RV perforation. This information would be important to facilitate epi access to less experienced operators [1]: pending:yes