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

Abstract

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). 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). 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. 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.