Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, Nonrandomized, Single-center Physician-sponsored Investigational Device Exemption Clinical Study

Objective: To evaluate the outcomes and learning curve of fenestrated and branched endovascular repair (F/BEVAR) of thoracoabdominal aneurysms. Summary of Background Data: Endovascular aneurysm repair has reduced morbidity and mortality compared with open surgical repair. However, application to thoracoabdominal aneurysm repair remains limited by procedural complexity and device availability. Methods: Fifty patients treated in a prospective, nonrandomized, single-center Investigational Device Exemption (IDE) study between January 2014 and July 2017 were analyzed. Patients (mean age 75.6 ± 7.5 years; mean aneurysm diameter 67.3 ± 9.8 mm) underwent F/BEVAR of thoracoabdominal aneurysms (58% type IV; 42% type I-III) using custom-manufactured endografts. The experience was divided into 3 cohorts (Early: 1 to 17; Mid: 18 to 34; Late: 35 to 50) to evaluate learning curve effects on key process measures. Results: F/BEVAR included 194 visceral arteries (average 3.9 per patient). Technical success was 99.5% (193/194 targeted arteries). Thirty-day major adverse events (MAEs) included 3 (6%) deaths, 1 (2%) new-onset dialysis, 3 (6%) paraparesis/paraplegia, and 2 (4%) strokes. One-year survival was 79 ± 7%. Comparing the Early and Late groups revealed reductions in procedure time (452 ± 74 vs 362 ± 53 minutes; P = 0.0001), fluoroscopy time (130 ± 40 vs 99 ± 27 minutes; P = 0.016), contrast administration (157 ± 73 vs 108 ± 38 mL; P = 0.028), and estimated blood loss (EBL; 1003 ± 933 vs 481 ± 317 mL; P = 0.042). Intensive care unit (ICU) and total length of stay (LOS) decreased from 4 ± 3 to 2 ± 1 days and from 7 ± 6 to 5 ± 2 days, respectively, but was not statistically significant. Conclusions: Use of F/BEVAR for treatment of thoracoabdominal aneurysms is safe and effective. During this early experience, there was a significant improvement in key process measures reflecting improvements in technique and physician learning over time.

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