IP133. Type III Endoleaks Are Not Significantly Increasing Over Time

Abstract

Recently, the Food and Drug Administration released a caution regarding an increase in type III endoleaks noted during review of their voluntary reporting surveillance database, Manufacturer and User Facility Device Experience (MAUDE). The goals of this project were to assess the MAUDE database and better characterize the types and incidences of type III endoleaks. The publicly available MAUDE database from January 2012 to October 2017 was queried for type III endoleaks after standard endovascular aneurysm repair. Type IIIA endoleaks represent junctional leaks, whereas IIIB were stent graft fabric defects. The χ2 and Fisher exact tests were used to identify univariate differences, and linear regression was employed to evaluate change in number of endoleak reports during the study period. There were 2093 reports of type III endoleaks identified initially. Restriction to unique reports of infrarenal abdominal aortic aneurysm repairs by modern endovascular aneurysm repair devices (AFX [Endologix, Irvine, Calif], Endurant [Medtronic, Santa Rosa, Calif], Excluder [W. L. Gore & Associates, Flagstaff, Ariz], and Zenith [Cook Medical, Bloomington, Ind]) with confirmed or high suspicion of type III endoleaks resulted in 449 reports included for review. Three groups were defined: type IIIA (n = 212), type IIIB (n = 204), and unknown (n = 33); 329 (73.2%) were identified during follow-up. Type IIIA were more commonly identified after the initial procedure than type IIIB (81% vs 63.2%; P < .01). There was no difference in time from graft implantation to endoleak identification between type IIIA and type IIIB (1.68 years vs 1.73 years; P = .89). Type IIIA endoleaks were less common after placement during rupture (3.3% vs 8.3%; P = .03). There were 221 (53.7%) that were repaired endovascularly, 43 (9.6%) that were explanted, 17 (3.8%) that required aortouni-iliac conversion, and 71 (15.8%) that did not require reintervention (P < .01). When the overall trend of type III endoleaks was examined between 2012 and 2017, there was no major change in total reports (r2 = 0.2045) and in those identified during follow-up (r2 = 0.0002; Fig 1). There was a moderate decrease in type IIIA (r2 = 0.5583) and a small increase in type IIIB (r2 = 0.3783; Fig 2). Overall, the voluntarily reported data available in the MAUDE database demonstrate a decreased trend for type III endoleaks in modern devices. Many are identified during placement of the device, which has unknown significance. Whereas reports of type IIIA endoleaks are decreasing, type IIIB endoleaks appear to be slightly increasing. However, because participation in this database is voluntary, these results may not reflect the complete real-world experience. To further understand the impact of these endoleaks, enhanced and accurate reporting of all device issues as well as robust data validation is essential.Fig 2Trend of type III endoleaks by type.View Large Image Figure ViewerDownload Hi-res image Download (PPT)