Background. A mechanical system for facilitating vascular anastomosis
(end-to-side, end-to-end) is described that enables the rapid construc
tion of nonpenetrated, compliant junctions. The instrument (United Sta
tes Surgical One-Shot system) simultaneously applies either 10 or 12 n
onpenetrating, arcuate-legged titanium clips to everted vessel or pros
thetic conduit edges. Methods and Results. The instrument has been tes
ted in animals (jugular and femoral vein jump grafts in carotid and fe
moral arteries, interpositional grafts, 20 pigs) and human cadaveric c
onstructs (saphenous veins to left anterior descending coronary arteri
es, 20 cases, 5 brachiocephalic access fistulas) as end-to-side constr
ucts. Clipped constructs have equivalent or superior physical properti
es to control sutured constructs (6-0 polypropylene) as gauged by burs
t and tensile strength. All studies were performed under Food and Drug
Administration Good Laboratory Practice standards, and the device has
been approved for marketing by the Food and Drug Administration. Conc
lusions. The device enables rapid and reproducible vascular anastomoti
c constructs with vessels as small as 1.8 mm outer diameter. The const
ructs are flanged, interrupted, and nonpenetrated.