A New Paradigm for Endovascular Treatment of Long Peripheral Arteries

Percutaneous revascularization remains fraught with restenosis. To date, bioresorbable scaffolds have failed to achieve sufficient radial strength to support peripheral intervention. The purpose of the present animal experiment was to assess arterial deformation after long-segment treatment with a new device consisting of multiple, short, balloon-expandable, bioresorbable scaffolds. Endovascular devices consisting of closely spaced, polylactide-based, balloon-expandable scaffolds, 10 mm long and crimped on a single delivery balloon were created and deployed into the iliofemoral arteries of female domestic farm swine. Angiographic and optical coherence tomography images were obtained with the hind limb in natural extension and exaggerated flexion. The scaffold arteries were then explanted and analyzed using microcomputed tomography imaging. The results are reported using the mean ± standard deviation. Native porcine iliofemoral arteries become significantly deformed with passive hind limb flexion (bending, 110° ± 20° and compression 20% ± 14%), with preservation of their mean luminal diameter, even with extreme deformation (4.7 ± 0.4 mm vs 5.0 ± 0.2 mm in extension vs flexion; P = .16). A total of 38 resorbable scaffolds were implanted in eight iliofemoral arteries of four swine in the following conFigurations: two scaffolds in two arteries, four scaffolds in two arteries, six scaffolds in three arteries, and eight scaffolds in one artery. The total arterial scaffold length ranged from 32 to 97 mm. After scaffold implantation, supraphysiologic flexion created similar patterns of deformation in the treated artery (bending, 113° ± 19°; compression, 15% ± 15%). The mean luminal diameter remained sTable without kinks or occlusion (4.7 ± 0.7 mm vs 4.7 ± 0.5 mm in extension vs flexion; P = .80). Arterial deformation was borne by shortening of the interscaffold spaces (2.2 ± 08 mm vs 1.9 ± 0.7 mm in extension vs flexion; P < .01) and the scaffolds themselves (10.7 ± 1.4 mm vs 9.9 ± 1.1 mm in extension vs flexion; P < .01). Optical coherence tomography and three-dimensional micro-computed tomography confirmed wall apposition and preserved structural integrity in all scaffolds (Fig). Long, mobile, peripheral arteries can be successfully treated with multiple, short, balloon-expandable, bioresorbable scaffolds.