Polo Jose R, Ligero Jose M, Diaz-Cartelle Juan, Garcia-Pajares Rosario, Cervera Teresa, Reparaz Luis
Vascular Access Unit, Hospital General Universitario Gregorio Maraņón, Madrid, Spain.
J Vasc Surg. 2004 Aug;40(2):319-24. doi: 10.1016/j.jvs.2004.05.005.
This report presents the results of a prospective randomized study that compared 2 grafts of different diameter: 6 mm, and 8 mm tapered to 6 mm at the arterial site, placed in the upper arm for hemodialysis in a selected population of patients younger than 71 years without diabetes.
Seventy consecutive patients younger than 71 years without diabetes who required an upper arm graft between January 1997 and January 2002 and without previous access in the same limb were randomly allocated to receive either a 6-mm graft or 6- to 8-mm graft. Graft flow was measured every 3 months with the Doppler dilution technique. When access flow was less than 600 mL/min, fistulography was performed, and any stenosis was surgically treated with venous outflow replacement. Thrombectomy and associated stenosis treatment in the same stage was performed in all cases immediately after detection of thrombosis. Complication rate, and primary, assisted primary, and secondary patency rates were compared between the two groups with the Student t test and life table analysis.
Mean access flow was 975 mL/min for 6-mm grafts (range, 600-1500 mL/min; 95% confidence interval [CI], 889-1070), and for 6- to 8-mm grafts was 1397 mL/min (range, 1122-2700 mL/min; 95% CI, 1122-1672). This difference was significant (P <.01). Complication rate was 0.45 episodes per graft-year in 6-mm grafts, and 0.19 episodes per graft-year in 6- to 8-mm grafts (P <.01). At 1, 2, and 3 years, primary patency rates were 62%, 58%, and 44%, respectively, for 6-mm grafts, and 85%, 78%, and 73% for 6- to 8-mm grafts; log-rank comparison between curves was P =.0259. At 1, 2, and 3 years, secondary patency rates were 85%, 85%, and 85%, respectively, for 6-mm grafts, and 90%, 90%, and 90% for 6- to 8-mm grafts; log-rank comparison between curves was not significant, at P =.0603. At 1, 2, and 3 years, assisted primary patency rates were 84%, 79%, and 76%, respectively, for 6-mm grafts, and 90% for 6- to 8-mm grafts; log-rank comparison was P =.0414.
The results of this study show an advantage in terms of primary and assisted primary patency rates, and complication rate for upper arm grafts with diameter 6 mm to 8 mm over grafts with 6-mm diameter in a patient population younger than 70 years without diabetes. The finding of a similar secondary patency rate in both groups is probably due to the surveillance program with sequential measurement of access flow and prompt surgical treatment of stenosis. However, we needed twice the number of rescue procedures in 6-mm grafts to achieve a similar patency rate as with large-bore grafts. These study results must be carefully evaluated, taking into consideration the small number of patients and the selected patient population.
本报告展示了一项前瞻性随机研究的结果，该研究比较了两种不同直径的移植物：6毫米以及动脉端逐渐变细至6毫米的8毫米移植物，将其置于71岁以下无糖尿病的特定患者群体的上臂用于血液透析。
1997年1月至2002年1月期间，70例连续的71岁以下无糖尿病且需要在上臂植入移植物且同一肢体此前未做过通路的患者被随机分配接受6毫米移植物或6至8毫米移植物。每3个月用多普勒稀释技术测量移植物血流量。当通路血流量小于600毫升/分钟时，进行瘘管造影，任何狭窄均通过静脉流出道置换进行手术治疗。在所有病例中，血栓形成一经发现，立即在同一阶段进行血栓切除术及相关狭窄治疗。两组之间的并发症发生率、初次通畅率、辅助初次通畅率和二次通畅率采用学生t检验和生存表分析进行比较。
6毫米移植物的平均通路血流量为975毫升/分钟（范围600 - 1500毫升/分钟；95%置信区间[CI]，889 - 1070），6至8毫米移植物的平均通路血流量为1397毫升/分钟（范围1122 - 2700毫升/分钟；95% CI，1122 - 1672）。这种差异具有统计学意义（P <.01）。6毫米移植物的并发症发生率为每移植物年0.45次，6至8毫米移植物为每移植物年0.19次（P <.01）。在1年、2年和3年时，6毫米移植物的初次通畅率分别为62%、58%和44%，6至8毫米移植物分别为85%、78%和73%；曲线间的对数秩检验P =.0259。在1年、2年和3年时，6毫米移植物的二次通畅率分别为85%、85%和85%，
