Subxyphoid Pericardial Access Using a Novel Blunt-tip Needle Technique

Pericardiocentesis or pericardial tap is a commonly performed procedure for the relief of cardiac tamponade. However the introduction of a standard needle into the pericardial space is associated with a significant risk of complication including cardiac perforation and coronary artery laceration. This becomes especially important when access of the normal pericardium (without significant pericardial fluid) is undertaken for potential therapeutic application with the pericardium acting as a drug delivery reservoir.

This study involves the use of a novel percutaneous subxyphoid pericardial access technique that has the potential to be safer for patients with pericardial effusions, and may potentially be applicable for access of the normal pericardium for drug delivery for therapeutic angiogenesis. The initial phase of this study will involve the use of this technique for patients with cardiac tamponade that need pericardiocentesis. In brief, rather than using a sharp needle for pericardial access, An epidural introducer needle (Tuohy-17) will be advanced gently under fluoroscopic guidance with a continuous positive pressure of 20-30 mmHg (achieved by saline infusion using an intraflow system). The positive pressure is intended to push the right ventricle (with a lower pressure) away from the needle's path. Entry of the pericardial space is suspected after an increase in the saline flow through the intraflow system. Then pericardial fluid is aspirated to relieve the tamponade. A soft floppy-tip 0.025" guidewire is then advanced to the pericardial space and the needle is exchanged for the pericardial drainage catheter used routinely for this application. Patients will undergo a post-procedure echocardiogram to confirm resolution of the pericardial effusion and will be monitored for twenty-four hours after the procedure as routinely done.

The risks of pericardial tap are bleeding, infection, cardiac perforation, pneumothorax, and coronary laceration. These risks should be reduced with this new approach by the use of a blunt tip needle. The potential benefit of this procedure is the lowering of complications since a sharp needle is not used. This study may Make pericardiocentesis a safer procedure. In addition, it is a step towards attempting drug delivery to the pericardial space. The patients are constantly monitored (hemodynamic monitoring and telemetry) during and for 24 hours after the procedure. In addition, they will be contacted 30 days after the procedure for a telephone contact.

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