Balloon-assisted over-the-wire technique for placement of the venous outflow component of the Hemodialysis Reliable Outflow (HeRO) device

A modified technique for placement of the venous outflow component (VOC) of the Hemodialysis Reliable Outflow (HeRO) device (Hemosphere Inc, Minneapolis, Minn) is described. The purpose of the technique is to improve the system's trackability and facilitate device insertion in patients with central venous occlusion. Device preparation requires placement of a 6-mm × 4-cm angioplasty balloon within the leading end of the VOC. The leading 2 cm of the balloon are placed just distal to the radiopaque marker of the VOC. The balloon is inflated to profile and locked in this position within the leading end of the VOC. The VOC and balloon combination is advanced over the wire through the 20F peel-away sheath provided by the manufacturer. The described technique was used to successfully implant the HeRO device in 12 patients with central venous occlusion. This technique is recommended for placement of the VOC of the HeRO device in patients with central venous occlusions

Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment

OBJECTIVE: This study explored the long-term outcomes of arteriovenous fistulas treated with vonapanitase (recombinant human elastase) at the time of surgical creation. METHODS: This was a randomized, double-blind, placebo-controlled trial of 151 patients undergoing radiocephalic or brachiocephalic arteriovenous fistula creation who were randomized equally to placebo, vonapanitase 10 mug, or vonapanitase 30 mug. The results after 1 year of follow-up were previously reported. The current analysis occurred when the last patient treated was observed for 3 years. For the current analysis, the primary end point was primary patency; the secondary end points included secondary patency, use of the fistula for hemodialysis, and rate of procedures to restore or to maintain patency. RESULTS: There was no significant difference in the risk of primary patency loss with vonapanitase 10 mug or 30 mug vs placebo. When seven initial patency loss events related to cephalic arch and central vein balloon angioplasty were excluded, the risk of patency loss was reduced with vonapanitase overall (hazard ratio [HR], 0.63; P = .049) and 30 mug (HR, 0.51; P = .03). In patients with radiocephalic fistulas (n = 67), the risks of primary and secondary patency loss were reduced with 30 mug (HR, 0.37 [P = .02] and 0.24 [P = .046], respectively). The rate of procedures to restore or to maintain fistula patency was reduced with 30 mug vs placebo (0.23 vs 0.72 procedure days/patient/year; P = .03) and also reduced in patients with radiocephalic fistulas with 30 mug vs placebo (0.17 vs 0.85 procedure days/patient/year; P = .048). CONCLUSIONS: In this study, vonapanitase did not significantly improve primary patency in the primary analysis but did significantly improve primary patency in an analysis that excluded patency loss due to cephalic arch and central vein balloon angioplasty. In patients with radiocephalic fistulas, 30 mug significantly improved primary and secondary patency. Vonapanitase 30 mug decreased the rate of procedures to restore or to maintain patency in the analysis that included all patients and in the subset with radiocephalic fistulas

Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease

OBJECTIVE: This study explored the safety and efficacy of recombinant type I pancreatic elastase (PRT-201) topically applied once to the external surface of an arteriovenous fistula. METHODS: This was a randomized, double-blind, placebo-controlled trial. Adults with kidney disease undergoing creation of a radiocephalic fistula (RCF) or brachiocephalic fistula were randomized to treatment with placebo (n = 51), PRT-201 at 10 mug (n = 51), or PRT-201 at 30 mug (n = 49). The primary efficacy measure was unassisted primary patency (PP) over 1 year. Secondary efficacy measures were secondary patency (SP), unassisted maturation by ultrasound interrogation, use for hemodialysis, and hemodynamically significant lumen stenosis. RESULTS: Median PP was 224 days for placebo and \u3e 365 days for the PRT-201 groups. At 1 year, 45%, 54%, and 53% of placebo, 10-mug, and 30-mug patients retained PP. The risk of PP loss was nonsignificantly reduced for 10 mug (hazard ratio [HR], 0.69; P = .19) and 30 mug (HR, 0.67; P = .17) vs placebo. In the subset (44% of patients) with a RCF, the median PP was 125 days for placebo and \u3e 365 days for the PRT-201 groups. At 1 year, 31%, 50%, and 63% of placebo, 10-mug, and 30-mug RCFs retained PP. The risk of RCF PP loss was nonsignificantly reduced by 10 mug (HR, 0.59; P = .18) and significantly reduced by 30 mug (HR, 0.37; P = .02) vs placebo. At 1 year, 77%, 81%, and 83% of placebo, 10-mug, and 30-mug patients retained SP. The risk of SP loss was nonsignificantly reduced for 10 mug (HR, 0.79; P = .61) and 30 mug (HR, 0.76; P = .55) vs placebo. In the subset with RCFs, 65%, 82%, and 90% of placebo, 10-mug, and 30-mug patients retained SP at 1 year. The risk of RCF SP loss was nonsignificantly reduced for 10 mug (HR, 0.45; P = .19) and 30 mug (HR, 0.27; P = .08) vs placebo. At month 3, 67%, 87% (P = .03), and 92% (P \u3c .01) of the placebo, 10-mug, and 30-mug group fistulas had unassisted maturation by ultrasound interrogation. At month 3 in the subset with an RCF, 47%, 74% (P = .17), and 93% (P \u3c .01) of placebo, 10-mug, and 30-mug group fistulas had unassisted maturation by ultrasound interrogation. Adverse event reports were not meaningfully different between groups. CONCLUSIONS: PRT-201 appeared safe. The primary efficacy end point was not met. However, both PRT-201 doses were associated with improved unassisted maturation. The 30-mug dose was associated with increased PP in the subset with RCF

Renal function with cyclosporine C 2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/71940/1/j.1399-0012.2006.00622.x.pd