Schild A F, Baltodano N M, Elias R, Livingstone J, Raines J K
University of Miami School of Medicine, Miami, Florida.
J Vasc Access. 2003 Jul-Sep;4(3):118-22.
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.
30 patients with thrombosed access grafts were randomly assigned to undergo thrombectomy with the Fogarty or latis catheter. An angioscope measured remaining graft thrombi.
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.
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.
血管通路手术最常见的并发症是血栓形成。本研究将金标准的Fogarty血栓切除术导管与具有先进单丝基质的新型latis导管进行了比较。
30例移植血管血栓形成的患者被随机分配接受使用Fogarty或latis导管进行血栓切除术。通过血管镜测量移植血管残留血栓。
30名受试者中有29名成功进行了血栓切除术。在年龄、性别、种族或延长移植血管需求方面未发现统计学差异。latis组导管使用情况为：14例手术中使用1次，1例手术中使用2次；Fogarty组为：10例手术中使用1次，3例手术中使用2次，2例手术中使用3次。导管平均通过次数为：latis组3.06次（1 - 6次），Fogarty组4.13次（1 - 9次）。显示出对latis导管有利的趋势；然而，未达到统计学显著性（p = 0.067）。总体6个月的初级通畅率latis组为40%，Fogarty组为30%。latis组第50百分位数的估计通畅时间为120天，Fogarty组为108天。对数秩统计量的p值为0.68，Wilcoxon统计量的p值为0.78，未达到统计学显著性。
latis导管和Fogarty导管非常相似。然而，latis球囊更坚固，使用的导管更少，通过次数减少。未能证明初级通畅率存在差异。尽管导管未带回血栓，但血管镜发现了大量残留血栓。因此，我们的方案进行了修改，将血管镜纳入其中。
