title: Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States.
abstract: Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration-approved in 2012, remains the only fenestrated device available in the United States. This 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.
  
  
  
  Deidentified datasets containing numbers of physicians trained, orders by physicians and hospitals, and designs (fenestration/scallop configuration) was provided for U.S. ZFEN devices ordered (April 2012-August 2015). We evaluated the number of physicians trained, the number of devices ordered, hospital characteristics, and fenestration/scallop design configurations. Cook Medical assembled the datasets but played no role in study design, analysis, or interpretation of data.
  
  
  
  Between April 2012 and August 2015, 553 physicians attended formal ZFEN training sessions, 388 (70%) of whom ordered a total of 2669 devices. An increase in orders per month (nine in June 2012 and 91 in August 2015, 911% growth; P < .001) and in number of physicians ordering per month (eight 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 2-5 devices, 61 (11%) ordered 6-10 devices, 39 (7%) ordered 11-20, and 28 (5%) ordered >20 devices. For physicians contributing >6 months of data (n = 336), the average number of devices ordered per year was three (standard deviation, 4); 272 (81%) ordered ≤ 5 devices/year, 15 (4.5%) ordered 11-20 devices/year, and 3 (0.9%) ordered >20 devices/year. Of devices with design details available (2618 of 2669; 98%), most common designs were 2 small fenestrations/1 scallop (1443; 55%), 2 small fenestrations/1 large fenestration (568; 22%), 1 small fenestration/1 scallop (173, 6.6%), and 2 small fenestrations (169; 6.5%). The average number of target vessels incorporated in each design was 2.7/device; 2071 (79%) incorporated three, 398 (15%) incorporated two.
  
  
  
  Since 2012, ZFEN has demonstrated a ninefold increase in monthly orders, with 553 physicians trained. Unlike the experience of rapid dissemination seen with infrarenal endografts, only 28 (5%) physicians have ordered >20, whereas 165 (30%) have ordered none, and 272 (81%) ordered ≤ 5 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.
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
authors.forename: Jessica P
authors.initials: JP
authors.lastname: Simons
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
authors.forename: Bing
authors.initials: B
authors.lastname: Shue
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
authors.forename: Julie M
authors.initials: JM
authors.lastname: Flahive
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
authors.forename: Francesco A
authors.initials: FA
authors.lastname: Aiello
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Steppacher
authors.affiliation: Cook Medical, Bloomington, Ind.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Eaton
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
authors.forename: Louis M
authors.initials: LM
authors.lastname: Messina
authors.affiliation: Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass. Electronic address: andres.schanzer@umassmemorial.org.
authors.forename: Andres
authors.initials: A
authors.lastname: Schanzer
mesh_terms: D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery*; D001807:Blood Vessel Prosthesis / Q000706:statistics & numerical data / Q000639:trends*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000706:statistics & numerical data / Q000639:trends*; D002497:Centralized Hospital Services; D016208:Databases, Factual; D018795:Device Approval; D004502:Education, Medical, Continuing / Q000639:trends; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000706:statistics & numerical data / Q000639:trends*; D061847:Hospitals, High-Volume / Q000639:trends; D061846:Hospitals, Low-Volume / Q000639:trends; D006784:Hospitals, Teaching / Q000639:trends; D006801:Humans; D007318:Inservice Training / Q000639:trends; D010818:Practice Patterns, Physicians' / Q000639:trends*; D017064:Process Assessment, Health Care / Q000639:trends*; D011474:Prosthesis Design; D012040:Regional Health Planning; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration