Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States

Autor: Robert Steppacher, Julie M. Flahive, Louis M. Messina, Jessica P. Simons, Elizabeth A. Eaton, Andres Schanzer, Francesco A. Aiello, Bing Shue
Rok vydání: 2016
Předmět:
medicine.medical_specialty
Hospitals
Low-Volume
Inservice Training
Time Factors
Databases
Factual
medicine.medical_treatment
030204 cardiovascular system & hematology
Prosthesis Design
Endovascular aneurysm repair
Regional Health Planning
Food and drug administration
03 medical and health sciences
Aortic aneurysm
Blood Vessel Prosthesis Implantation
0302 clinical medicine
Device Approval
Medicine
Humans
030212 general & internal medicine
Practice Patterns
Physicians'
Hospitals
Teaching
business.industry
United States Food and Drug Administration
Endovascular Procedures
Process Assessment
Health Care
medicine.disease
Abdominal aortic aneurysm
United States
Surgery
Blood Vessel Prosthesis
Catheter
Treatment Outcome
Regional health planning
Centralized Hospital Services
Education
Medical
Continuing
Cardiology and Cardiovascular Medicine
business
Fenestration
Hospitals
High-Volume
Abdominal surgery
Aortic Aneurysm
Abdominal
Zdroj: Journal of vascular surgery. 65(5)
ISSN: 1097-6809
Popis: 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%) ordered20 devices. For physicians contributing6 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%) ordered20 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 ordered20, 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.
Databáze: OpenAIRE
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