A vascular external support for arteriovenous fistula (AVF) creation (VasQ, Laminate Medical, Tel Aviv, Israel) has improved functional success in multiple European studies. Herein is the first complete report of the U.S. Pivotal Comparative Study results with a cost analysis is presented for VasQ over a 24-month period. The U.S. Pivotal study prospectively enrolled 144 patients (90% brachiocephalic and 10% radiocephalic) at 15 sites. A group of 782 patients treated by the same surgeons from the study immediately prior to the VasQ trial enrollment period was developed from the Medicare claims database as a comparative group. Demographic, procedural and postprocedural data were collected for up to 24 months after surgery. To emulate randomized studies, a propensity score weighting method (inverse probability treatment weighting using average treatment effect) was applied to the claims data. Statistical comparisons of primary patency (freedom from intervention), functional success (continuous use for dialysis over a minimum of 30 days), and post-creation intervention rates were made against the matched comparator group as well as calculating payer cost. Descriptive comparisons were made for primary failure rate (abandonment before first use by 6-month follow-up) and 24-month cumulative patency (freedom from abandonment) rates against published meta-analyses. The median diameter of vessels at the VasQ AVF creation site was 4.25 mm (range, 2.0-6.6 mm) arterial and 3.95 mm (range, 2.3-7.8 mm) venous. Incidence of steal (4.2%), infection (0.7%), and (pseudo)aneurysm (0.7%) at 24 months compared favorably with standard AVF creations. Demographic data for the VasQ and Medicare control groups before and after weighting were typical of a U.S. population (Table I). VasQ AVFs demonstrated superior primary patency, functional success and intervention rates compared against the matched cohort (Table II). Primary failure of 7.9% for VasQ AVF patients compared favorably to the 22.0% to 32.2% reported in contemporary U.S. meta-analyses. Cumulative patency of 76.7% (95% confidence interval, 67.7%-83.4%) at 24 months for VasQ was superior to contemporary meta-analyses reporting 53.7% to 63.0% for standard AVFs. No difference in cumulative patency was observed between patients requiring interventions and those that did not, demonstrating VasQ did not inhibit the ability of physicians to maintain patency. The nearly 50% reduction in access interventions with VasQ at 6 months resulted in an annualized cost reduction of $7764.19 per patient-year. The VasQ vascular external support device delivered more functional fistula success, with earlier usability and fewer interventions, reducing overall costs of fistula creation.Table IMatched demographicsCharacteristicsVasQUnmatched controlUnmatched SMDMatched controlMatched SMDMale61.1% (88/144)56.3% (440/782)9.964.9%−7.9Black35.4% (51/144)47.4% (364/768)−24.531.5%8.3White53.5% (77/144)43.1% (331/768)20.957.9%−9.0Other11.1% (16/144)9.5% (73/768)5.310.6%1.8Mean age58.9 ± 11.460.8 ± 12.7−15.758.7 ± 5.63.0Obesity52.1% (75/144)51.2% (400/782)1.948.3%7.6Active dialysis66.0% (95/144)65.3% (511/782)1.365.7%0.6Diabetic69.4% (100/144)79.0% (618/782)−22.069.4%0.1Congestive heart failure21.5% (31/144)41.6% (325/782)−44.122.8%−3.0SMD, Standard mean difference.Values are (proportion) and [range]. Boldface entries indicate statistical significance. Open table in a new tab Table IIVasQ patient outcomes relative to a matched Medicare comparatorEndpoint (n)VasQ vs controlOdds ratioMatched P valuePrimary patency at 6 months64.2% vs 35.5%3.27[2.15-5.17]<.0001Continuous AVF use at 3 months43.4% vs 26.7%2.15[1.32-4.47].0069Continuous AVF use at 6 months72.5% vs 56.3%2.05[1.23-3.75].0059Intervention rate at 6 months0.97 vs 1.91NA<.0001Values are 95% confidence intervals. Boldface entries indicate statistical significance. Open table in a new tab