Increasing clinical experience and changes in practice protocols improved outcomes of fenestrated branched endovascular repair of complex aortic aneurysms.

OBJECTIVE: To evaluate the impact of increased clinical experience and changes in practice protocols on the incidence of early major adverse events (MAEs) during fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs).

METHODS: Clinical outcomes of 847 consecutive patients (72% males; median age, 74 years; interquartile range, 69-79 years) treated by the same operator in two centers were reviewed (2007-2024). Of these, 590 patients were treated under a prospective investigational device exemption study. Changes in practice protocols included routine use of fusion/cone beam computed tomography (2012), therapeutic instead of prophylactic cerebrospinal fluid drainage (CSFD) (2019, Q3) and preferential use of total transfemoral access (2020, Q4). The primary end point was 30-day/in-hospital MAE assessment using learning curve cumulative sum analysis per quartiles of experience. The study period was divided into four quartiles: Q1 (2007-2014), Q2 (2014-2017), Q3 (2017-2020), and Q4 (2020-2024).

RESULTS: There was a significant increase in the proportion of extent I to III TAAA (from 16% to 58%; P < .001), chronic postdissection aneurysms (from 1.9% to 21%; P < .001), symptomatic aneurysms (from 5.2% to 10%; P < .001), heritable thoracic aortic diseases (from 0.5% to 4.2%; P = .011), and prior EVAR (from 8.5% to 51%; P < .001) between Q1 and Q4 experience. Despite the increased aneurysm complexity, MAEs significantly decreased over time and across quartiles (P < .01). The use of fusion/cone beam computed tomography was associated with a significant decrease in total operative time and radiation exposure (P < .001). Overall 30-day mortality was 1.7% (14/847). The incidence of MAEs significantly decreased for CAAAs and extent IV TAAAs (P < .01) and remained stable for extent I to III TAAAs after institution of therapeutic instead of prophylactic CSFD and total transfemoral access. Learning curve cumulative sum analysis indicates that 32 consecutive cases were needed to reach a learning curve and 100 cases to reach plateau, with significantly improved outcomes in the fourth quartile of experience.

CONCLUSIONS: FB-EVAR was performed with low mortality (1.7%) in a large cumulative experience. Increased clinical experience and changes in practice protocol associated with significantly improved outcomes of FB-EVAR, despite a significant increase in anatomical and patient complexity. The institution of therapeutic instead of prophylactic CSFD and total transfemoral access had no deleterious effect on outcomes of extent I to III TAAAs but improved outcomes in patients with less extensive aneurysms. Among CAAA patients, 21.2% had therapeutic instead of prophylactic CSFD, and 10.7% had total transfemoral access. For extent IV aneurysms, 47.3% had therapeutic CSFD, and 22.5% had total transfemoral access.