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Increasing Clinical Experience And Changes In Practice Protocols Improved Outcomes Of Fenestrated Branched Endovascular Repair Of Complex Aortic Aneurysms
Dora Babocs, MD1, Lucas R. Kanamori, MD
1, Bruno P. Schmid, MD
1, Emanuel R. Tenorio, MD PhD
1, Steven Maximus, MD
1, Bernardo C. Mendes, MD
2, Thanila A. Macedo, MD
1, Ying Huang, MD PhD
1, Gustavo S. Oderich, MD
1.
1Advanced Aortic Research Program, Departments of Cardiothoracic & Vascular Surgery and Diagnostic Imaging and Interventional Radiology, McGovern Medical School, University of Texas Health Houston, Houston, TX, USA,
2Division of Vascular and Endovascular Surgery, Mayo Clinic,, Rochester, MN, USA.
OBJECTIVE: The aim of this study was to evaluate the impact of increasing clinical experience and changes in practice protocols on major adverse events (MAEs) during fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAA) and thoracoabdominal aortic aneurysms (TAAAs).
METHODS: Clinical outcomes of 847 consecutive patients (72% male, median age was 74 [69, 79]) treated by FB-EVAR under the same surgical team were reviewed (2007-2024). Of these, 590 patients were enrolled in a prospective investigational device exemption study. Changes in practice protocols included routine use of fusion/cone beam computed tomography (F/CBCT, 2012), therapeutic instead of prophylactic cerebrospinal fluid drainage (T-CSFD, 2019) and preferential use of total transfemoral access (TTFA, 2020). Primary end-point of any 30-day MAE and/or mortality was assessed usingcumulative sum (CUSUM) analysis per quartiles of experience.
RESULTS: There was a significant increase in the proportion of Extent I-III TAAA (16% to 58%, p<.001), chronic dissections(1.9% to 21%; p<.001), symptomatic aneurysms (5.2% to 10%; p<.001), heritable aortic diseases (0.5% to 4.2%, p=.011) and prior endovascular repair (8.5% to 51%, <.001) in the last quartile of experience. Despite the increased complexity, operating time, fluoroscopy time, cumulative air kerma, and MAEs significantly decreased across quartiles (P<.01). Use of F/CBCT resulted in significant reduction of total operative time, contrast volume and radiation exposure (p<.001). Institution of T-CSFD and TTFA significantly (P<.01) decreased the incidence of MAEs among patients with CAAAs and Extent IV TAAAs, but not for Extent I-III TAAAs which remained stable. Use of TTFA was associated with significant reduction in estimatedblood loss >1000ml, shorter operative time, and lower rates of acute kidney injury (P<.01). CUSUM analysis
(Figure 1) indicates that MAE risk plateaued at 125 cases and significantly improved in the 4th quartile of experience.
CONCLUSIONS: Increasing clinical experience and changes in practice protocol resulted in significantly improved outcomes of FB-EVAR, despite a significant increase in anatomic and patient complexity. Institution of T-CSFD and TTFA had no deleterious effect on outcomes of Extent I-III TAAAs, but improved outcomes in patients with less extensive aneurysms.
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