Impact of Using Endografts From Multiple Manufacturers on the Mid-term Outcomes of Physician-Modified Fenestrated-Branched Endovascular Aneurysm Repair

Abstract

Complex endovascular aortic repairs can involve interactions of multiple aortic endografts from different device manufacturers. This may be due to the repair of failed previous endografts, intentional staging of extensive thoracoabdominal aortic repairs, and different manufacturers offering distinct device features suitable for specific purposes. However, there are limited data evaluating the interactions between aortic components from different manufacturers and their impact on clinical outcomes. Thus, we evaluated the impact of mixing aortic endografts from multiple manufacturers by comparing the rate of type IIIA endoleaks and clinical outcomes after physician-modified fenestrated-branched endovascular aortic repairs (PM-FBEVAR) using endografts from a single vs multiple manufacturers. A single-institution retrospective review of consecutive patients who underwent PM-FBEVAR between September 2015 and December 2022 was performed. Patients with a single aortic component were excluded. The remaining patients were divided into single- or multimanufacturer groups. Patient demographics, aneurysm extent, and operative details were compared. The primary outcome was type IIIA endoleak. The secondary outcomes included reintervention for type IIIA endoleak, major adverse events, and mortality. These outcomes were compared out to 2 years. Freedom from type IIIA endoleak-related reintervention was estimated using the Kaplan-Meier analysis and compared between the groups using a log-rank test. Data from this cohort include those reported to the Food and Drug Administration in the physician-sponsored investigational device exemption application, and those enrolled in the physician-sponsored investigational device exemption (FDA#: G200159, NCI#:APP-20-04282). Of 232 patients included in this study, 44 patients received a single-manufacturer and 188 patients received multimanufacturer aortic components. Baseline demographics and aneurysm extent were similar between the groups. The majority of concomitant iliac aneurysms repaired with Iliac Branch Endoprosthesis were in the multimanufacturer group (24 of 25). Procedure time, contrast usage, fluoroscopy time, estimated blood loss, and transfusion were significantly lower for the multimanufacturer group (Table). The overall 30-day mortality (2.3% single vs 3.2% multimanufacturer, P = .99) and major adverse events (20.5% vs 20.2%, P = .97) were similar between the groups. At 2-year follow-up, type IIIA endoleak occurred in 3 (6.8%) in the single- and 4 patients (2.1%) in the multimanufacturer groups (P = .128). These endoleaks were repaired in 2 of 3 and 4 of 4 patients in each group (P = .319) (Fig). Two-year mortality was similar between the groups (15.9% vs 13.3%, P = .651). Aortic endografts from multiple manufacturers can be used to facilitate PM-FBEVAR without a significant increase in type IIIA endoleaks, major adverse events, and reinterventions at 2 years. Continued follow-up is planned to assess long-term durability.TableCharacteristics, operative metrics, and outcomes of single vs multimanufacturerTotalSingle manufacturerMultimanufacturerP value23244188Aneurysm characteristics, No. (%) Presentation.113Asymptomatic167 (72.3)27 (61.4)140 (74.9)Symptomatic59 (25.5)15 (34.1)44 (23.5)Ruptured5 (2.2)2 (4.5)3 (1.6) Anatomical classification.160Juxtarenal19 (8.2)3 (6.8)16 (8.5)Pararenal/paravisceral76 (32.8)9 (20.5)67 (35.6)Pseudoaneurysm2 (0.9)0 (0)2 (1.1)TAAA135 (58.2)32 (72.7)103 (54.8)TAAA extent.463Extent I20 (14.8)4 (12.5)16 (15.5)Extent II54 (40.0)11 (34.4)43 (41.7)Extent III23 (17.0)6 (18.8)17 (16.5)Extent IV35 (25.9)9 (28.1)26 (25.2)Extent V3 (2.2)2 (6.3)1 (1.0) Iliac aneurysms requiring IBE25 (10.8)1 (2.3)24 (12.8).055 Aneurysm max diameter68.2 (16.7)66.5 (12.0)68.6 (17.6).336Intraoperative metrics Procedure time, minutes287.9 ± 108.7329.1 ± 115.6278.3 ±105.0.005 Iodinated contrast, cc121.6 ± 58.3154.6 ± 72.9113.9 ± 51.5<.001 Fluoroscopy time, minutes63.9 ± 33.579.5 ± 34.660.3 ± 32.3<.001 Estimated blood loss, cc [median, IQR]150 [262.5]400 [487.5]100 [250]<.00130-day outcomes, No. (%) Mortality7 (3.0)1 (2.3)6 (3.2)1.000 Major adverse events47 (20.3)9 (20.5)38 (20.2).9712-year outcomes, No. (%) All-cause mortality32 (13.8)7 (15.9)25 (13.3).651 Type IIIA endoleak7 (3.0)3 (6.8)4 (2.1).128IBE, Iliac Branch Endoprosthesis; IQR, interquartile range; TAAA, thoracoabdominal aortic aneurysm. Open table in a new tab