Purpose: The most common complication of vascular access surgery is thrombosis. This study compared the gold standard Fogarty Thrombectomy Catheter, to the new latis Catheter with an advanced monofilament matrix.
Methods: 30 patients with thrombosed access grafts were randomly assigned to undergo thrombectomy with the Fogarty or latis catheter. An angioscope measured remaining graft thrombi.
Results: Twenty-nine of 30 subjects were successfully thrombectomized. No statistical differences in age, gender, race, or extension graft requirements were found. Catheter use in the latis group was: 1 in 14 procedures, and 2 in 1 procedure; Fogarty group: 1 in 10 procedures, 2 in 3 procedures, and 3 in 2 procedures. The average number of catheter passes was: latis 3.06 (1-6 passes) and Fogarty 4.13 (1-9 passes). A trend in favor of the latis catheter was demonstrated; however, statistical significance was not reached (p = 0.067). The overall 6-month primary patency rates were latis (40%) and Fogarty (30%). The estimated patency at the 50th percentile for latis is 120 days and Fogarty 108 days. Statistical significance was not reached with a p-value of the Log-Rank statistic of 0.68 and a p-value of the Wilcoxon statistic of 0.78.
Conclusions: The latis and Fogarty catheters are very similar. However, the latis balloon is more rugged with fewer catheters used and reduced number of passes. A difference in primary patency could not be demonstrated. The angioscope identified significant residual thrombus despite no returning thrombus from the catheter. Consequently, our protocol is modified to include the angioscope.