Transvenous access to the pericardial space: an approach to epicardial lead implantation for cardiac resynchronization therapy.

BACKGROUND: Percutaneous access to the pericardial space (PS) may be useful for a number of therapeutic modalities including implantation of epicardial pacing leads. We have developed a catheter-based transvenous method to access the PS for implanting chronic medical devices.
METHODS: In eight pigs, a transseptal Mullins sheath and Brockenbrough needle were introduced into the right atrium (RA) from the jugular vein under fluoroscopic guidance. The PS was entered through a controlled puncture of the terminal anterior superior vena cava (SVC) (n = 7) or right atrial appendage (n = 1). A guidewire was advanced through the transseptal sheath, which was then removed leaving the wire in PS. The guidewire was used to direct both passive and active fixation pacing leads into the PS. Pacing was attempted and lead position was confirmed by cine fluoroscopy. Animals were sacrificed acutely and at 2 and 6 weeks.
RESULTS: All animals survived the procedure. Pericardial effusion (PE) during the procedure was hemodynamically significant in four of the eight animals. At necropsy, lead exit sites appeared to heal without complication at 2 and 6 weeks. Volume of pericardial fluid was 10.8 +/- 6.2 mL and appeared normal in four of the six chronic animals. Moderate fibrinous deposition was observed in two animals, which had exhibited significant over-procedural PE.
CONCLUSIONS: Access to the PS via a transvenous approach is feasible. Pacing leads can be negotiated into this region. The puncture site heals with the lead in place. Further development should focus on eliminating PE and performing this technique in appropriate heart failure models.