Key result
Arterial wall disruption using a cutting balloon and Fogarty balloon induced a higher incidence of intimal hyperplasia compared to overdistention injury (100% vs 50%, P=0.0059) at 2 weeks.
Why the study?
Does arterial wall disruption with a cutting balloon and Fogarty balloon induce more significant intimal hyperplasia compared to overdistention injury in pig iliac arteries?
Does arterial wall disruption with a cutting balloon and Fogarty balloon induce more significant intimal hyperplasia compared to overdistention injury in pig iliac arteries?
Absolute Event Rate: 100% vs 50%
p-value: p=0.0059
A novel pig model using a cutting balloon and Fogarty balloon induces significant, accelerated intimal hyperplasia without thrombosis, providing a superior model for preclinical testing of peripheral artery interventions.
May enhance preclinical testing of peripheral interventions in pigs; leaves open human translation.
There is no good animal model of large artery injury-induced intimal hyperplasia (IH). Those available are reproducible, providing only a few layers of proliferating cells or have the disadvantage of the presence of a metallic stent that complicates histology evaluation. This study was designed to develop a new, simple model of accelerated IH based on balloon injury in conjunction with disruption of the Internal Elastic Lamina (IEL) in pig external iliac arteries. Iliac artery injury (n = 24) was performed in 12 Yorkshire pigs divided in two groups: Group I (n = 10), overdistention injury induced by an oversized non-compliant balloon; Group II (n = 14), arterial wall disruption by pulling back an isometric cutting balloon (CB) followed by stretching with a compliant Fogarty Balloon (FB). At two weeks, arteries were processed for morphometric analysis and immunohistochemistry (IHC) for smooth muscle cells (SMC) and proliferating cell nuclear antigen (PCNA). When comparing the two groups, at 2 weeks, arteries of group II had a higher incidence of IH (100%vs. 50%, P = 0.0059), increased intimal areas (2.54 ± 0.33 mm(2) vs. 0.93 ± 0.36 mm(2) , P = 0.004), increased intimal area/Media area ratios (0.95 ± 0.1 vs. 0.28 ± 0.05; P < 0.0001) and decreased lumen areas (6.24 ± 0.44 vs. 9.48 ± 1.56, P = 0.026). No thrombosis was noticed in Group II. Neointima was composed by proliferating SMC located with the highest concentration in the area of IEL disruption (IHC). Arterial injury by pulling back CB and FB induces significant IH in pig iliac arteries by two weeks without thrombosis. This model is superior to the classical overdistention non-compliant model and should be useful and cost-effective for preclinical testing of procedures designed to inhibit IH in large peripheral arteries.
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Houbballah et al. (2011) studied Intimal hyperplasia (n=12). Arterial wall disruption using a cutting balloon followed by a Fogarty balloon vs. Overdistention injury induced by an oversized non-compliant balloon was evaluated on Incidence of intimal hyperplasia (p=0.0059). Arterial wall disruption using a cutting balloon and Fogarty balloon induced a higher incidence of intimal hyperplasia compared to overdistention injury (100% vs 50%, P=0.0059) at 2 weeks.
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