Development of a Percutaneous Pericardiotomy Tool

Aims

Pericardial therapies that require access to the pericardial space or removal of the pericardium are growing. Animal studies have shown that left ventricular diastolic compliance and cardiac output increase following surgical pericardiectomy. Thus, percutaneous pericardial modulation represents an attractive treatment option for heart failure with preserved ejection fraction. In addition, it may be useful in the treatment of constrictive pericarditis or as an adjunct to epicardial mapping and ablation procedures. We aim to develop a percutaneous-based pericardial modification tool.

Methods and Results

We developed a percutaneous pericardiotomy procedure which involves conventional percutaneous epicardial access. Three novel devices have been developed to enable percutaneous pericardiectomy including a grasper, pericardial slitter and pericardial cutter (figure A). All can be deployed in an over the wire fashion. The grasper permits us to seize the pericardial membrane, providing leverage for incision. The scissors enable anterograde cuts (figure B). The reverse slitter allows retrograde cuts; in addition, it has a deflectable tip which increases the potential cutting area. To optimize safety, the tools contain electrodes to test for phrenic stimulation; also, we can use stimulation to determine the position with respect to myocardium prior to cutting. The base of the scissors and reverse slitter is blunt ensuring that the cutting element is always away from the myocardium.

The tools have successfully permitted incision of the pericardial membrane in acute animal studies in both canine and swine species (figure C). Hemodynamic measurements were assessed post incision and showed no compromise of systolic function or coronary artery damage.

Conclusion

Percutaneous pericardiotomy is feasible and may provide treatment options for heart failure with preserved ejection fraction, constrictive pericarditis and epicardial mapping/ablation procedures.