Thoracoscopic monitoring for pericardial application of local drug or gene therapy

Cardiovascular gene therapy is a promising new approach for a variety of diseases. As far as gene therapy aimed at the myocardium is concerned a new transcutaneous delivery method may be into the pericardial sac. Objective: To evaluate the safety and applicability of the percutaneous pericardial delivery route for drug- or gene-therapy. Methods: A percutaneous pericardial access device called a perducer® was used to deliver either Indian ink or methylene blue to the pericardium of male yorkshire pigs under hemodynamic surveillance. Animals were sacrificed after either 3 h or 3 days. Post mortem distribution of the injectate was evaluated macroscopically and microscopically. Results: With the perducer®, the pericardial cavity was punctured in 10 pigs without hemodynamic complications. Although traces of dye could be seen in the pleural cavity in pigs sacrificed after 3 h, no evidence for dissemination was found in myocardial, lung, mediastinal lymph node and liver tissue in pigs sacrificed after 3 days. In two additional pigs the pericardium was punctured with the same perducer® technique under simultaneous thoracoscopic monitoring. Visualization of the surface of the pericardium facilitated the procedure because pericardial fat could be avoided. Conclusion: Obtaining access to the pericardium with the perducer® technique is safe and feasible. In addition thoracoscopic guidance may improve success rate and offers the possibility of on line surveillance.