title: Initial clinical experience with a polytetrafluoroethylene vascular dialysis graft reinforced with nitinol at the venous end.
abstract: OBJECTIVE
  The purpose of this study was to examine the outcomes of a vascular hybrid polytetrafluoroethylene (PTFE) graft, provided with a nitinol-reinforced section (NRS) on one end, in hemodialysis vascular access placement.
  
  
  METHODS
  A retrospective study was conducted including all the consecutive patients who underwent Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) implantation for hemodialysis access placement between October 2013 and November 2015. A propensity-matched control group was obtained from consecutive patients who underwent standard PTFE arteriovenous graft implantation between January 2010 and July 2013. The selection criteria were inadequate venous material for autogenous arteriovenous fistula placement, patent deep venous circulation, and vein diameter of 4 to 8.5 mm. The implantation technique involves the insertion of the NRS some centimeters into the target vein. Fluoroscopic guidance helps deploy the device in the desired landing zone (ie, position of the proximal end of the NRS), based on anatomic landmarks. Survival, functional patency rates, and complications were compared with a propensity-matched historical control group. Vein diameter, previous vascular access placement, and diabetes were tested as predictors of reintervention with a logistic regression analysis.
  
  
  RESULTS
  There were 32 patients (14 men; mean age, 69 ± 14 years) who received the GHVG graft. The historical control group included 43 patients. Technical success was 100%. The graft configuration was brachial-axillary (n = 22 [69%]), brachial-basilic loop (n = 5 [16%]), brachial-antecubital loop (n = 3 [9%]), axilloaxillary loop (n = 1 [3%]), and femoral-femoral loop (n = 1 [3%]). Mean NRS oversize was 20% ± 7% (range, 3%-34%; median, 19%). Perioperative complications requiring revision included acute limb ischemia treated with thrombectomy (n = 1 [3%]) and graft infection requiring explantation (n = 2 [6%]). Two patients (6%) died in the hospital of unrelated causes. The mean follow-up was 15 ± 11 months (range, 0-33 months; median, 15.5). The propensity-matched groups included 25 patients each. Survival estimates at 24 months for the GHVG and standard PTFE groups were 91% ± 6% and 82% ± 9% (P > .05), respectively. The 12-month patency estimates were as follows: functional primary patency, 66% ± 10% vs 51% ± 10% (P > .05); functional assisted primary patency, 75% ± 9% vs 51% ± 10% (P > .05); and functional secondary patency, 79% ± 9% vs 67% ± 10% (P > .05). Reduction in vein diameter was associated with reintervention.
  
  
  CONCLUSIONS
  The GHVG is a safe and effective alternative to standard PTFE in hemodialysis access surgery. Careful planning for the landing zone is advisable, especially for small outflow veins. Larger studies and randomized trials are needed to define the role for this device. A study including a greater number of centers experienced with this device is currently under way.
authors.affiliation: Department of Biomedical Sciences and Morphological and Functional Imaging, University of Messina, Messina, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Benedetto
authors.affiliation: Department of Biomedical Sciences and Morphological and Functional Imaging, University of Messina, Messina, Italy. Electronic address: dr.spinelli@me.com.
authors.forename: Domenico
authors.initials: D
authors.lastname: Spinelli
authors.affiliation: Department of Biomedical Sciences and Morphological and Functional Imaging, University of Messina, Messina, Italy.
authors.forename: Narayana
authors.initials: N
authors.lastname: Pipitò
authors.affiliation: Vascular Surgery Unit, Noto-Pasqualino Clinic, Palermo, Italy.
authors.forename: Giambattista
authors.initials: G
authors.lastname: Gagliardo
authors.affiliation: Department of Human Pathology of Adult and Developmental Age "Gaetano Barresi", University of Messina, Messina, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Noto
authors.affiliation: Department of Biomedical Sciences and Morphological and Functional Imaging, University of Messina, Messina, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Villari
authors.affiliation: Department of Human Pathology of Adult and Developmental Age "Gaetano Barresi", University of Messina, Messina, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: David
authors.affiliation: Vascular Surgery Unit, Campus Bio-Medico University, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Spinelli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010690:Phlebography; D011138:Polytetrafluoroethylene; D011183:Postoperative Complications / Q000209:etiology / Q000601:surgery; D057216:Propensity Score; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D006435:Renal Dialysis; D012086:Reoperation; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D014680:Veins / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*
chemical_list: D000497:Alloys; C013616:nitinol; D011138:Polytetrafluoroethylene