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.