National trends in utilization of surgeon-modified grafts for complex and thoracoabdominal aortic aneurysms.

INTRODUCTION: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. METHODS: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. RESULTS: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. CONCLUSIONS: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.

Long Term Outcomes and Durability of Fenestrated Endovascular Aneurysm Repair: A Meta-analysis of Time to Event Data.

OBJECTIVE: Despite widespread use, long term outcomes for fenestrated endovascular aneurysm repair (FEVAR) are uncertain. This meta-analysis reports long term survival, freedom from re-intervention, target vessel patency, and one year sac regression after FEVAR. DATA SOURCES: Systematic review and meta-analysis to pool time to event data according to PRISMA guidelines. The study was registered with the international prospective register of systematic reviews (PROSPERO) (ID: CRD42023401468). REVIEW METHODS: Medline, Embase, and Cochrane databases were searched from 1992 - 2023; articles were independently screened by two authors. Publication of complete time to event data for any outcome of interest was an inclusion criterion. Raw Kaplan-Meier probabilities were directly extracted from published curves and pooled by random effects. Risk of bias was assessed using ROBINS I and certainty with GRADE. RESULTS: A total of 3 569 records were retrieved, 2 869 screened after duplicate removal, yielding 37 included studies (n = 4 371). The pooled mean age was 73.2 years (interquartile range [IQR] 72.2, 73.7) and 87.4% were male (95% confidence interval [CI] 85.8 - 88.9). Pooled Kaplan-Meier estimated probabilities of survival (n = 34 studies, n = 4 192 patients) at one, three, and five years were 91.6% (95% CI 90.2 - 92.9), 80.8% (95% CI 78.0 - 83.2), and 65.1% (95% CI 60.9 - 69.1). For freedom from re-intervention (n = 24, n = 3 211 patients) at one, three, and five years these were 90.2% (95% CI 87.3 - 92.7), 80.9% (95% CI 76.5 - 84.9), and 73.8% (95% CI 67.1 - 79.6). For target vessel patency (n = 13, n = 5805 target vessels) at one, three, and five years, these were 96.6% (95% CI 94.9 - 98.0), 94.5% (95% CI 91.7 - 96.7), and 93.1% (95% CI 89.3 - 96.0). Pooled estimate of sac regression (n = 8, n = 560) at one year was 40.2% (95% CI 28.9 - 52.7). Risk of bias was judged as moderate in 11 studies and low for the remaining 26. CONCLUSION: There are moderate to low certainty data supporting reasonable long term outcome estimates following fenestrated endovascular aneurysm repair. Beyond five years there is a lack of data in the literature.

Survival and patient-centered outcome in a disease-based observational cohort study of patients with thoracoabdominal aortic aneurysm.

BACKGROUND: Much of the literature describing treatment for thoracoabdominal aortic aneurysm (TAAA) consists of operative series reported by centers of excellence. These studies are limited by referral and selection bias and exclude patients who are not candidates for the reported modality of repair. Little is known about the patients who are not referred or selected for repair. For those undergoing intervention, outcomes such as functional status after surgery are rarely reported. In this study, we address these gaps by reporting two primary end points: 1-year survival and a "good" outcome (defined as successful aneurysm exclusion, freedom from permanent loss of organ system function, and return to preoperative functional status after surgery) in a cohort of TAAA patients, including all nonoperative and operative patients, irrespective of treatment modality. METHODS: A single-institution database was screened by diagnosis codes for TAAA from 2009 to 2017 using the International Classification of Diseases versions 9 and 10. Diagnosis was confirmed by retrospective chart review and computed tomography findings of aneurysmal degeneration ≥3.2 cm of the paravisceral aorta in continuity with aneurysmal aorta meeting standard criteria for repair. Patients <18 years of age and those with mycotic aneurysm were excluded. Patients were either managed nonoperatively or by one of four operative strategies: (i) open; (ii) endovascular with branched endografts; (iii) hybrid, defined as iliovisceral debranching followed by endograft placement; or (iv) partial repair in which the paravisceral segment was intentionally left unaddressed. RESULTS: Among the entire cohort of 432 patients with TAAA, significant comorbidities were seen in 143 (33%). Forty-seven percent of the patients were managed nonoperatively. Of these, 65% survived to 1 year. A survival benefit was seen in the open, endovascular, and partial, but not hybrid, operative groups compared with the nonoperative group during a 3-year period. Overall 1-year survival was 81%, but only 65% had a good outcome (P = .0016). CONCLUSIONS: Nearly half of the patients in this inclusive cohort study did not undergo repair despite access to a variety of operative techniques. Many of these patients die in the short term due to high burden of comorbid disease rather than aneurysm rupture. Among those undergoing operation, a notable difference between survival and good outcome was observed. Operation appears to confer a survival advantage among appropriately selected patients with TAAA, but a large proportion are high risk and may not benefit from operative repair due to limited baseline survival and lower probability of good outcome.

Feasibility and Safety of Percutaneous Axillary Artery Access in a Prospective Series of 100 Complex Aortic and Aortoiliac Interventions.

We aimed to review the feasibility and safe use of the percutaneous axillary artery (AxA, 100 patients) approach for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA, 90 patients) using fenestrated, branched, and chimney stent grafts and other complex endovascular procedures (10 patients) necessitating AxA access. Percutaneous puncture of the AxA in its third segment was performed using sheaths sized between 6 to 14F. For closing puncture sites greater than 8F, two Perclose ProGlide percutaneous vascular closure devices (PVCDs) (Abbott Vascular, Santa Clara, CA, USA) were deployed in the pre-close technique. The median maximum diameter of the AxA in the third segment was 7.27 mm (range 4.50-10.80). Device success, defined as successful hemostasis by PVCD, was reported in 92 patients (92.0%). As recently reported results in the first 40 patients suggested that adverse events, including vessel stenosis or occlusion, occurred only in cases with a diameter of the AxA < 5 mm, in all subsequent 60 cases AxA access was restricted to a vessel diameter ≥ 5 mm. In this late group, no hemodynamic impairment of the AxA occurred except in six early cases below this diameter threshold, all of which could be repaired by endovascular measures. Overall mortality at 30 days was 8%. In conclusion, percutaneous approach of the AxA in its third segment is feasible and represents a safe alternative access to open access for complex endovascular aorto-iliac procedures. Complications are rare, especially if the maximum diameter of the access vessel (AxA) is ≥5 mm.