Preclinical safety testing of percutaneous transatrial access to the normal pericardial space for local cardiac drug delivery and diagnostic sampling

The safety of a percutaneous method and streamlined catheter system to acce ss the normal pericardial space via the right atrial appendage for drug del ivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Acc ess was successfully accomplished in all animals within 3 min of guide cath eter positioning and was documented by fluoroscopic imaging and pericardial fluid sampling. The animals were sacrificed at 24 hr (n = 10) and 2 weeks (n = 10) for histopathologic analysis. Mean pericardial hematocrit was 1.1% +/- 0.3% at initial sampling, 4.3% +/- 1.4% at 24 hr (P = 0.005 vs. baseli ne), and 0.4% +/- 0.2% at 2 weeks (P = 0.13 vs. baseline). Al 24 hr, there was local inflammatory reaction in the atrial wall and a small thrombus at the site of puncture. At 2 weeks, no significant inflammatory changes or pe ricarditis were evident. The technique is well tolerated with no apparent a dverse complications. Advances in intrapericardial therapeutics and diagnos tics will direct the clinical application of this novel approach in human s ubjects. (C) 2000 Wiley-Liss, Inc.