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VasQ US Clinical Study Outcomes Confirmed in Real World Consecutive Cohort from First Year After FDA De Novo Approval
Ellen D Dillavou
1, David Bjerken
2, Stephen Jensik
3, George Blessios
1 1WakeMed Hospital System, Raleigh, NC;
2McLeod Health, Loris, SC;
3Rush University, Chicago, IL
INTRODUCTION An extravascular support for arteriovenous fistula (AVF) creation (VasQ, Laminate Medical, Tel Aviv) has demonstrated high rates of functional patency in the VasQ US Pivotal Study. Herein is the first report of the real world experience creating extravascular support in U.S. post FDA De Novo Clearance
METHODS A retrospective review from the first consecutive extravascular supported AVF creations at five centers was conducted and compared to the VasQ US Pivotal Study data. Demographic, procedural and post-procedural data was collected up to functional patency or abandonment. Functional patency was defined as the ability of a vascular access to deliver a sufficient blood flow (typically 350 to 400 ml per min) for hemodialysis without recirculation per the Society of Vascular Surgery guidelines. Descriptive comparisons were made for patient characteristics, unassisted and total functional patency as well as intervention rates against the VasQ US Pivotal Study.
RESULTS Outcomes from 119 consecutively created extravascular supported AVFs were collected. The majority of patients were male, diabetic, and hypertensive, similar to the Pivotal study, however an older average age was reported for real world patients (Table 1). The cohort included older patients with more radiocephalic AVFs than the Pivotal study. The increased proportion of radiocephalic AVFs resulted smaller overall median target vessel diameters at 3.7 mm for the arterial outflow and 3.4 mm for the venous outflow. No Incidence of steal or infection were observed. Total and unassisted functional patency was achieved in 89.6% and 63.0% of patients, which was similar to the 88.0% and 63.0% reported in the Pivotal Study, respectively. Intervention rate to achieve functional patency was 0.3 per patient in both cohorts as well.
CONCLUSIONS Extravascular supported AVFs reported equivalent functional patency in the first year of real world use as compared to the US VasQ Pivotal Study, suggesting the observed clinical benefit from the study can be translated in everyday clinical practice. The equivalent outcomes were achieved despite the larger proportion of older patients with radiocephalic fistulas in the real world cohort. However, a more direct comparison with aligned outcomes definitions and statistical analysis are required to validate these findings.
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