SS19. Trends in Use of the Only FDA-Approved Commercially Available Fenestrated EVAR Device in the United States

Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal AAA repair. The Zenith Fenestrated AAA Endovascular graft (ZFEN; Cook Medical), FDA-approved in 2012, remains the only fenestrated device available in the U.S. This transformative technology is among the most technically complex catheter-based procedures and, therefore, inherently associated with serious risk for device-related complications. We sought to define patterns of physician and hospital adoption of ZFEN. A deidentified data set containing numbers of physicians trained, orders by physicians and hospitals, and designs (fenestration/scallop configuration), was provided for 100% of all U.S. ZFEN devices ordered (April 2012-August 2015). We evaluated number of physicians trained, devices ordered, hospital characteristics, and fenestration/scallop design configurations. Cook Medical played no role in study design, analysis, or interpretation of data. Between April 2012 and August 2015, 553 physicians attended ZFEN trainings, 388 (70%) of whom ordered a total of 2669 devices. An increase in orders per month (9 in June 2012 and 91 in August 2015, 911% growth; P < .001) and in number of physicians ordering per month (8 in June 2012 and 62 in August 2015, 675% growth; P < .001) was observed. Teaching hospitals, representing all U.S. regions (Midwest: 927 [35%]; South: 799 [30%]; Northeast: 547 [20%]; West: 396 [15%]), accounted for 1703 (64%) ZFEN orders. Of 553 trained physicians, 165 (30%) ordered no devices, 116 (21%) ordered 1 device, 144 (26%) ordered 2 to 5 devices, 61 (11%) ordered 6 to 10 devices, 39 (7%) ordered 11 to 20, and 28 (5%) ordered >20 devices. For physicians contributing >6 months of data (n = 336), the average number of devices ordered per year was 3 (SD, 4); 272 (81%) ordered ≤5 devices/year, 15 (4.5%) ordered 11 to 20 devices/year, and 3 (0.9%) ordered >20 devices/year. Of devices with design details available (2618 of 2669 [98%]), the most common designs were 2 small fenestrations/1 scallop (1443 [55%]), 2 small fenestrations/1 large fenestration (568 [21%]), 1 small fenestration/1 scallop (173 [6.6%]), and 2 small fenestrations (169 [6.5%]). The average number of target vessels incorporated was 2.7 per device; 2071 (79.1%) incorporated three, and 398 (15.2%) incorporated two. Since 2012, ZFEN has demonstrated a ninefold increase in monthly orders, with 553 physicians trained. Unlike the experience with infrarenal endografts, only 28 (5%) physicians have ordered >20, while 165 (30%) have ordered none, and 272 (81%) ordered ≤devices/year. Assuming that volume, in general, correlates with outcomes, this adoption pattern raises questions whether fenestrated technology should be regionalized to high-volume centers.