OBJECTIVE: The objective of this study was to evaluate adverse events occurring during the lead period of custom-made fenestrated/branched endograft for juxtarenal/pararenal abdominal aortic aneurysm (j/p-AAA) and thoracoabdominal aortic aneurysm (TAAA). METHODS: Between 2008 and 2017, patients enrolled for custom-made fenestrated/branched endograft repair were prospectively collected. Anatomic, procedural, and postoperative data were retrospectively analyzed. Lead period was defined as the time between the endograft order to the manufacturer and implantation. Aneurysm diameter, target visceral vessel (TVV) severe stenosis (>75% of ostial lumen), and number of planned TVVs were evaluated at preoperative computed tomography angiography. Patency of TVVs was evaluated intraoperatively. Aneurysm rupture and TVV occlusion during the lead period were assessed. RESULTS: There were 141 custom-made fenestrated/branched endograft repairs planned. Of these, 133 patients (male, 87%; age, 73 ± 6 years) with complete available data were considered for the study. There were 75 (56%) j/p-AAAs and 58 (44%) TAAAs. The mean aneurysm diameter was 58 ± 6 mm (j/p-AAA, 56 ± 6 mm; TAAA, 67 ± 8 mm); 15 cases (11%) had >70-mm diameter. Planned TVVs were 431 (mean, 3 ± 1 TVVs/patient). The mean lead period was 89 ± 25 days, with five (3.8%) aneurysm ruptures (j/p-AAA, one; TAAA, four) occurring, two (1.5%) during manufacture and three (2.3%) with endograft available in the hospital (all three procedures were postponed because of cardiac or pulmonary comorbidities). In one TAAA rupture, the endograft was successfully implanted and the patient survived. Four of five ruptures had >70-mm diameter. On univariate analysis, chronic obstructive pulmonary disease (P = .01; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.1-3.2) and aneurysm diameter >70 mm (P = .001; OR, 42; 95% CI, 4-411) were risk factors for aneurysm rupture during the lead period, with aneurysm diameter >70 mm being confirmed as an independent risk factor on multivariate analysis (P = .005; OR, 29.3; 95% CI, 2.8-308). Overall, eight endografts (6%) were not implanted (refusal, two; aneurysm rupture, four; death not related to aneurysm, two). In the remaining 125 patients (94%), 405 TVVs were planned. Of them, 46 (11%) had severe stenosis at preoperative computed tomography angiography. Twelve (3%) TVVs occluded in the lead period (renal arteries, five; celiac trunks, seven); six were recanalized and six were abandoned. Severe preoperative stenosis was a risk factor for TVV occlusion during the lead period (P = .000; OR, 1.3; 95% CI, 1.1-1.6). CONCLUSIONS: In our series, custom-made design required a mean lead period of 89 days, which was determined by both manufacturing time and clinical reasons. During this delay, there is a high risk of both rupture in aneurysms >70 mm and TVV occlusion in severely stenosed vessels. These factors should be considered in the indication for custom-made fenestrated/branched endograft repair.
OBJECTIVE: The objective of this study was to evaluate adverse events occurring during the lead period of custom-made fenestrated/branched endograft for juxtarenal/pararenal abdominal aortic aneurysm (j/p-AAA) and thoracoabdominal aortic aneurysm (TAAA). METHODS: Between 2008 and 2017, patients enrolled for custom-made fenestrated/branched endograft repair were prospectively collected. Anatomic, procedural, and postoperative data were retrospectively analyzed. Lead period was defined as the time between the endograft order to the manufacturer and implantation. Aneurysm diameter, target visceral vessel (TVV) severe stenosis (>75% of ostial lumen), and number of planned TVVs were evaluated at preoperative computed tomography angiography. Patency of TVVs was evaluated intraoperatively. Aneurysm rupture and TVV occlusion during the lead period were assessed. RESULTS: There were 141 custom-made fenestrated/branched endograft repairs planned. Of these, 133 patients (male, 87%; age, 73 ± 6 years) with complete available data were considered for the study. There were 75 (56%) j/p-AAAs and 58 (44%) TAAAs. The mean aneurysm diameter was 58 ± 6 mm (j/p-AAA, 56 ± 6 mm; TAAA, 67 ± 8 mm); 15 cases (11%) had >70-mm diameter. Planned TVVs were 431 (mean, 3 ± 1 TVVs/patient). The mean lead period was 89 ± 25 days, with five (3.8%) aneurysm ruptures (j/p-AAA, one; TAAA, four) occurring, two (1.5%) during manufacture and three (2.3%) with endograft available in the hospital (all three procedures were postponed because of cardiac or pulmonary comorbidities). In one TAAA rupture, the endograft was successfully implanted and the patient survived. Four of five ruptures had >70-mm diameter. On univariate analysis, chronic obstructive pulmonary disease (P = .01; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.1-3.2) and aneurysm diameter >70 mm (P = .001; OR, 42; 95% CI, 4-411) were risk factors for aneurysm rupture during the lead period, with aneurysm diameter >70 mm being confirmed as an independent risk factor on multivariate analysis (P = .005; OR, 29.3; 95% CI, 2.8-308). Overall, eight endografts (6%) were not implanted (refusal, two; aneurysm rupture, four; death not related to aneurysm, two). In the remaining 125 patients (94%), 405 TVVs were planned. Of them, 46 (11%) had severe stenosis at preoperative computed tomography angiography. Twelve (3%) TVVs occluded in the lead period (renal arteries, five; celiac trunks, seven); six were recanalized and six were abandoned. Severe preoperative stenosis was a risk factor for TVV occlusion during the lead period (P = .000; OR, 1.3; 95% CI, 1.1-1.6). CONCLUSIONS: In our series, custom-made design required a mean lead period of 89 days, which was determined by both manufacturing time and clinical reasons. During this delay, there is a high risk of both rupture in aneurysms >70 mm and TVV occlusion in severely stenosed vessels. These factors should be considered in the indication for custom-made fenestrated/branched endograft repair.