S. Waxman et al., Preclinical safety testing of percutaneous transatrial access to the normal pericardial space for local cardiac drug delivery and diagnostic sampling, CATHET C IN, 49(4), 2000, pp. 472-477
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.