Frequence of Follow-up Visits and Outcomes After Fenestrated-Branched Endovascular Aortic Repair (F-BEVAR)
Fernando Motta, Mark A Farber, Martyn Knowles, Luigi Pascarella, William A Marston, Katharine L McGinigle, Elad Ohana, Jacob C Wood, F.Ezequiel Parodi
University of North Carolina - Chapel Hill, Chapel Hill, NC
INTRODUCTION: To evaluate the impact of more frequent follow-up on management of adverse events requiring re-intervention following F-BEVAR in para-renal (PRAA) and Thoraco-Abdominal Aortic aneurysms (TAAA).
METHODS: Patients with PRAA or TAAA were enrolled in a single-center physician-sponsored investigational device exemption, prospective, non-randomized clinical trial and treated with F-BEVAR between July/2012 and August/2021. Patients who required re-intervention had data analyzed including patient demographics and re-interventions. Diagnostic angiograms and aneurysm sac embolization were classified as minor re-intervention. Major re-interventions included any aorto-iliac intervention, treatment of type I or III endoleaks, and severe target vessel stenosis/occlusion. For comparison purposes, patients were grouped as essential (group 1) or optional (group 2) follow-up visits. Essential follow-ups were at 1, 12, 24, 36, 48, and 60 months after the index procedure. Optional follow-ups occurred at 3, 6, 9, and 18 months. Per the study protocol, computed tomography angiography was obtained at all visits except at 3- and 9-months follow-up visits. Reno-mesenteric arterial duplexes were obtained in all clinic visits.
RESULTS: During the study period, a total of 357 patients, 70% male sex were treated with F-BEVAR for TAAA, and 112 were included for the analysis. The mean age was 72 years old. There was a total of 157 adverse events requiring secondary re-interventions, 97 (62%) and 60 (38%) being major and minor re-interventions, respectively. Both groups had similar rates of major and minor re-intervention rates (major RI: 62% (group 1) and 58% (group 2), p=NS; minor RI: 38% [group 1] and 42% [group 2], p=NS]) between groups. Specifically, in group 2, the follow-up visits that had the lower number of adverse events diagnosed requiring secondary re-intervention were 3 months (11 [7%] patients) and 9 months (5 [3%] patients). The follow-up visits at 6 and 18 months represented 12% (52% major RI) and 15% (44% major) of the total re-interventions, respectively.
CONCLUSIONS:This study suggests that close follow-up is crucial for early diagnosis of adverse events requiring re-interventions. The decreased number of adverse events diagnosed at 3- and 9-months follow-up suggest that those visits can potentially be deemed optional. However, follow-up every 6 months during the first 2 years and yearly thereafter are likely valuable in avoiding adverse events and expeditiously diagnosing and treating complications related to F/BEVAR. Larger multicenter studies are necessary to validate our results.
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