Single-Center Experience with the Femoral-to-Brachial Preloaded Delivery System for Fenestrated-Branched Endovascular Repair of Complex Aortic Aneurysms.

PURPOSE: To assess technical aspects and outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using a femoral-to-brachial (FTB) preloaded delivery system (PDS) with two separate configurations. METHODS: Clinical data of all consecutive patients enrolled in a prospective study to evaluate FB-EVAR for complex abdominal and thoracoabdominal aortic aneurysms (CAAAs & TAAA) between 2013 and 2020 were reviewed. Patients treated with FTB-PDS were included. The two configurations included 4 trans-brachial preloaded wires (4BR) or 2 trans-brachial and 2 transfemoral preloaded wires (2BR-2FE). Outcome measures included technical success, procedural metrics, 30-day or in-hospital mortality, major adverse events (MAEs), and target-vessel outcomes. RESULTS: There were 115 patients with a mean age of 73.8 ± 8 years, treated with FTB-PDS. Of these, 62 patients (54%) had 4BR and 53 patients (46%) had 2BR-2FE FTB-PDS. There were 106 TAAA (92%) and 9 CAAAs (8%). Technical success, defined as successful implantation of the stent-graft and all intended target-vessel stents without type I or III endoleak, was 97%, with no differences in total operating time, endovascular time, and radiation dose between groups. There were 3 deaths (3%) at 30 days. MAEs were noticed in 21 patients (18%) with no difference between groups, including new-onset dialysis (2% vs. 4%, P = 0.59), and paraplegia (7% vs. 11%, P = 0.51), for 4BR and 2BR-2FE, respectively. Patient survival and freedom from aortic-related mortality at 2-years were 79 ± 5% and 97 ± 1.7%, respectively, with no difference between groups. CONCLUSION: The use of FTB-PDS for FB-EVAR is safe with high technical success and a reasonable rate of MAEs. Each configuration provides specific benefits based on patient anatomy, while having similar procedural metrics and clinical outcomes.

Outcomes of low- and standard-profile fenestrated and branched stent grafts for treatment of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the outcomes of fenestrated-branched (FB) endovascular abdominal aortic aneurysm repair (EVAR) using low-profile (LP) and standard-profile (SP) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 466 consecutive patients (70% male; mean age, 74 ± 8 years) enrolled in a prospective nonrandomized study to investigate FB-EVAR for the treatment of CAAAs and TAAAs (2013-2021). The endpoints compared between the patients treated with LP (18F-20F) and SP (20F-22F) devices included procedural metrics, access-related complications, major adverse events (MAE), patient survival, freedom from secondary intervention, thromboembolic events, stent graft integrity issues, aneurysm sac enlargement, and the rate of sac shrinkage. RESULTS: Of the 466 aneurysms treated by FB-EVAR, 138 were CAAAs and 141 were extent IV and 187 extent I to III TAAAs, with a mean number of 3.9 ± 0.5 vessels stented per patient. LP devices had been used in 239 patients (51%) and SP devices in 227 patients (49%). LP devices had been used more frequently for chronic dissections (12% vs 7%; P = .041) and with preloaded systems (77% vs 65%; P = .005) and bilateral percutaneous femoral access (83% vs 74%; P = .020) and less frequently with upper extremity access (67% vs 88%; P < .001) and iliac conduits (2% vs 6%; P = .020). The patients treated using LP devices had experienced similar technical success (96% vs 97%; P = .527), with a shorter total operating time (225 ± 81 minutes vs 243 ± 78 minutes; P = .018), lower radiation exposure (median, 0.93 Gy; interquartile range [IQR], 0.94; vs median, 1.01 Gy; IQR, 0.91 Gy; P < .001), and less use of contrast (median, 135 mL; IQR, 68 mL; vs median, 144 mL; IQR, 80 mL; P = .008). No differences were found in the rates of iliofemoral access complications between the LP and SP device groups (1.3% vs 3.5%; P = .107). At 30 days, 5 patients had died (1%) and MAEs had occurred in 89 patients (19%), with no differences between the two groups. The mean follow-up was 28 months (95% confidence interval, 25-30 months). At 4 years, the patients treated with LP devices had had similar freedom from all-cause mortality (69% ± 6% vs 68% ± 4%; P = .199), freedom from aortic-related mortality (97% ± 1% vs 98% ± 1%; P = .488), freedom from any secondary intervention (65% ± 6% vs 70% ± 4%; P = .433), freedom from thromboembolic events (98% ± 1% vs 99% ± 1%; P = .364) and aneurysm sac enlargement (93% ± 3% vs 91% ± 3%; P = .293). However, the LP group had had less freedom from any integrity-related issues (92% ± 5% vs 100%; P < .001). The cumulative risk of sac shrinkage was greater for patients treated with LP devices (adjusted hazard ratio, 2.040; 95% confidence interval, 1.516-2.744; P < .001). CONCLUSIONS: FB-EVAR was performed with low rates of mortality and MAEs, irrespective of the device profile. However, the procedures performed with LP devices had had less need for iliac conduits and had had better procedural metrics. The use of LP devices resulted in higher rates of sac shrinkage. However, the results on stent graft integrity require future investigation.