William J. Drasler

Rheolytic thrombectomy with use of the AngioJet-F105 catheter : Preclinical evaluation of safety

PURPOSE A preclinical evaluation of the safety of the AngioJet-F105 rheolytic thrombectomy catheter. MATERIALS AND METHODS The AngioJet-F105 catheter uses multiple retrograde high-speed fluid jets impinging on a primary aspiration lumen to create a hydrodynamic recirculation vortex that traps and fragments adjacent thrombus, with simultaneous evacuation of the resulting debris through the aspiration lumen. The effect of the AngioJet on treated vessels was evaluated in 10 canines. Vascular integrity on histopathologic examination and endothelial coverage on scanning electron microscopic study were examined in 15 vessel segments treated with the AngioJet-F105 catheter, compared with four vessel segments subjected to the Fogarty balloon maneuver, and 10 untreated vessel segments. The size distribution of particulate debris, upstream and downstream, after thrombectomy was determined in a flow-circuit model simulating the superficial femoral artery. Aliquots from the downstream effluent were then injected into the renal arteries of two healthy canines. RESULTS The device caused only minimal focal endothelial denudation and no significant deep injury. No significant difference in endothelial coverage occurred in AngioJet-treated vessel segments compared to untreated control vessels (mean +/- standard deviation: 88.0% +/- 7.9% vs 89.7% +/- 11.6%, P = .77). Vessels treated with the Fogarty balloon pullback maneuver had significantly less residual endothelial coverage (58.0% +/- 8.0%, P < .03). Particulate microemboli in the effluent of the flow model accounted for 12% of the initial thrombus volume (0% > 100 microm, 99.83% < or = 10 microm). Histopathologic evaluation of the four renal beds injected with the resulting debris demonstrated no signs of necrosis. A moderate transient increase in plasma-free hemoglobin occurred, with a mild corresponding decrease in hematocrit. CONCLUSIONS The AngioJet-F105 catheter resulted in only mild and focal injury to the treated vessels. The vast majority of resulting particulate debris consist of microscopic particles, without significant ischemic effect.

A spun elastomeric graft for dialysis access

A new composite vascular graft was developed using electrostatic spinning technology. The graft is primarily microfibrous polydimethylsiloxane spun onto a mandrel; a small diameter polyester yarn provides additional strength while minimizing wall thickness, and a helical bead provides crush and kink resistance. Eighteen grafts were implanted in a mongrel canine arteriovenous shunt model for 12 months. The grafts were implanted in femoral artery to femoral vein loops and were cannulated using three pairs of 16 gauge dialysis needles per week. Grafts were evaluated during each puncture session, and also followed using angiography. Histologic study of explanted grafts, regional lymph nodes, and lungs was performed. The grafts provided excellent handling and puncture characteristics, with no bleeding through the graft wall at puncture sites. Cumulative patency of these punctured grafts was 8 8% at 6 months and 8 0% at 1 year. Histologic study showed external fibroconnective tissue encapsulation of the grafts, with tissue growth through the interstices of the graft consisting of a microvascular network surrounded predominantly by histiocytes, many multinucleated foreign body giant cells, with some fibroblasts and collagen formation also present. Little luminal thrombus was seen at puncture sites in the patent grafts, and there was no evidence of pulmonary thromboemboli. This new elastomeric graft shows excellent promise for dialysis access; similar grafts under development may also find application for small diameter peripheral vascular reconstruction.