Agarwal Anil K, Ash Stephen R
Professor of Medicine, Chief, Section of Nephrology at University Hospiital East, Director, Interventional Nephrology, Director of Clinical Scholarship for FAME, The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, USA.
Nephrology Department, Indiana University Health Arnett, Ash Access Technology, Inc. and HemoCleanse Technologies, LLC, 3601 Sagamore Parkway North, Suite B, Lafayette, Indiana, 47905, USA.
Hemodial Int. 2016 Oct;20(4):501-509. doi: 10.1111/hdi.12443. Epub 2016 Jun 27.
Introduction Chronic central venous catheters (CVC) for dialysis lose patency and deliver lower blood flow over time, often due to fibrous sheathing that covers the lumen tips. The CentrosFLO central venous catheter has a shape that directs the arterial and venous tips away from the walls of the vena cava and right atrium, making sheathing of the tips less likely. Methods A prospective, multicenter, single arm, non-controlled, observational study was conducted at eight sites in the United States. All consenting dialysis patients receiving CentrosFLO catheters through the right or left internal jugular veins were accepted in the study, as long as the catheter was expected to be used for 45 days and was not an over-the-wire replacement for a previous CVC. Data were automatically collected on initial and average dialysis blood flow rate and initial arterial and venous pressures, for up to 26 weeks of dialysis therapy. Findings 75 patients were enrolled. Kaplan-Meier analysis indicated that 87% of patients maintained blood flow rate over 300 mL/min throughout 26 weeks of follow-up. There was no decline in average dialysis blood flow rate and no significant change in hydraulic resistance of the arterial or venous lumens of the catheters during the study. Discussion The CentrosFLO catheter demonstrates long term patency with good flow rates on dialysis, which, by comparison with previous studies, shows a clinically significant improvement in blood flow rate vs. other catheters. Stable hydraulic resistance of the catheter lumens showed no evidence of tip encroachment by fibrous sheaths.
引言 用于透析的慢性中心静脉导管(CVC)会随着时间推移失去通畅性并导致血流量降低,这通常是由于纤维鞘覆盖管腔尖端所致。CentrosFLO中心静脉导管的形状可使动静脉尖端远离腔静脉和右心房壁,从而降低尖端形成鞘的可能性。方法 在美国的八个地点进行了一项前瞻性、多中心、单臂、非对照观察性研究。所有通过右或左颈内静脉接受CentrosFLO导管的同意参与研究的透析患者均被纳入,只要该导管预期使用45天且不是用于替换先前CVC的导丝置换导管。在长达26周的透析治疗期间,自动收集初始和平均透析血流量以及初始动静脉压力的数据。结果 75名患者入组。Kaplan-Meier分析表明,87%的患者在26周的随访期间血流量维持在300 mL/分钟以上。在研究期间,透析平均血流量没有下降,导管动静脉腔的水力阻力也没有显著变化。讨论 CentrosFLO导管在透析时显示出长期通畅性和良好的流速,与先前的研究相比,其血流量在临床上有显著改善。导管腔稳定的水力阻力表明没有纤维鞘侵犯尖端的迹象。