Fenestrated Endovascular Aneurysm Repair Is A Safe Treatment Option For Infrarenal Abdominal Aortic Aneurysms With Short Necks
Vinamr Rastogi, MD1, Christina L. Marcarccio, MD MPH1, Priya B. Patel, MD MPH1, Livia E.V.M. de Guerre, MD1, Sophie X. Wang, MD1, Sara L. Zettervall, MD MPH2, Ruby C. Lo, MD3, Hence J.M. Verhagen, MD PhD4, Marc L. Schermerhorn, MD1.
1Beth Israel Deaconess Medical Center, Boston, MA, USA, 2University of Washington, Seattle, WA, USA, 3Brown University Medical Center, Providence, RI, USA, 4Erasmus University Medical Center, Rotterdam, Netherlands.
Objectives: Infrarenal AAA patients with short necks are at higher risk of developing type-IA endoleaks and mortality after EVAR. Fenestrated EVAR (FEVAR) may increase durability by creating longer seal. We examined outcomes following standard EVAR (st-EVAR) and FEVAR for the treatment of short-necked infrarenal AAA.
Methods: We identified all patients undergoing primary elective st-EVAR or FEVAR (commercially available and physician-modified endografts, excluding any devices implanted under Investigational Device Exemption studies) for infrarenal AAA with short necks(<15mm) in the VQI between 2014 and 2021. To ensure anatomic compatibility among groups, we excluded angulated and wide necks. St-EVAR patients were stratified by adherence/non-adherence to Instructions for Use(on-label/off-label). The primary outcomes were perioperative mortality and overall survival. Secondary outcomes included completion endoleaks and perioperative complications. We created propensity scores and performed inverse probability-weighted Cox-Regression and Logistic Regression, respectively.
Results: Among 1,804 infrarenal short-necked patients identified, 1298(72%) patients underwent st-EVAR (on-label: 560[31%] vs. off-label: 738[41%]), and 506(28%) underwent FEVAR. Compared with on-label st-EVAR, off-label st-EVAR patients had shorter necks (11mm[IQR 10-13] vs. 10mm[IQR 6.0-12], p<.001). FEVAR patients had an average of 2.7(±0.75) target-vessels/scallops. Following risk-adjustment, between on-label and off-label st-EVAR, there was no difference in type-IA completion endoleaks (Odds Ratio [OR]:0.90 [95%CI 0.57-1.4]), any in-hospital complications (OR:0.67 [95%CI:0.35-1.3]), perioperative mortality (Hazard Ratio [HR]:0.37 [95%CI:0.10-1.3]), or three-year mortality (HR:1.0 [95%CI:0.64-1.6]). However, compared with st-EVAR, FEVAR was associated with lower odds of type-IA
completion endoleaks (OR:0.41 [95%CI:0.24-0.69]), but higher odds of any in-hospital complications (OR:1.7 [95%CI:1.1-2.9]), specifically higher odds of bowel ischemia (OR:3.3 [95%CI:1.1-13]) and acute kidney injury (OR:2.7 [95%CI:1.8-4.2]). Nevertheless, no differences were found in perioperative mortality (HR:1.4 [95%CI:0.55-3.5], p=.49) and three-year mortality (HR:0.75 [95%CI:0.46-1.2], p=.24) following FEVAR compared with st-EVAR.
Conclusion: For treatment of short-neck infrarenal AAAs, no differences in perioperative outcomes or three-year survival are apparent between on-label and off-label st-EVARs. Although FEVAR patients have lower risk of type-IA completion endoleaks and higher risk of perioperative morbidity compared with st-EVAR, there are no differences in perioperative or three-year mortality. Future studies with longer follow-up are necessary to determine whether FEVAR might be a more durable endovascular option for treatment of short-necked infrarenal AAA.
| St-EVAR [on-label]N= 560 | St-EVAR [off-label]N= 738 | St-EVAR [off-label] vs. [on-label] | St-EVAR N= 1298 | FEVAR N= 506 | FEVAR vs. st-EVAR | ||||
| Adjusted Kaplan-Meier estimates | Hazards ratio(95%CI) | p-value | Adjusted Kaplan-Meier estimates | Hazards ratio(95%CI) | p-value | ||||
| Perioperative Mortality | 1.4% | 0.8% | 0.37 (0.10-1.3) | .13 | 1.0% | 2.6% | 1.4 (0.55-3.5) | .49 | |
| 3-year Mortality | 12% | 12% | 1.0 (0.64-1.6) | .99 | 12% | 9.6% | 0.75 (0.46-1.2) | .24 | |
| Unadjusted event rates | Odds ratio(95%CI) | p-value | Unadjusted event rates | Odds ratio(95%CI) | p-value | ||||
| Type-IA completion Endoleak | 36 (6.4%) | 42 (5.7%) | 0.90(0.57-1.4) | .66 | 78 (6.0%) | 13 (2.6%) | 0.41 (0.24-0.69) | .001 | |
| Any Complication | 24 (4.3%) | 20 (2.7%) | 0.67 (0.35-1.3) | 0.21 | 44 (3.4%) | 30 (5.9%) | 1.7(1.1-2.9) | .026 | |
| Pulmonary Complications | 8 (1.4%) | 6 (0.8%) | 0.53 (0.16-1.6) | .28 | 14 (1.1%) | 11 (2.2%) | 1.2 (0.50-2.9) | .70 | |
| Cardiac Complication | 8 (1.4%) | 5 (0.7%) | 0.61 (0.18-1.9) | .39 | 13 (1.0%) | 6 (1.2%) | 1.0(0.37-2.7) | .99 | |
| Bowel Ischemia | 3 (0.5%) | 2 (0.3%) | 0.57 (0.07-3.3) | .53 | 5 (0.3%) | 7 (1.4%) | 3.3(1.1-13) | .005 | |
| Leg Ischemia | 5 (0.9%) | 6 (0.8%) | 1.1 (0.31-4.3) | .85 | 11 (0.8%) | 4 (0.8%) | 0.76 (0.22-2.5) | .64 | |
| AKI | 23 (4.1%) | 27 (3.7%) | 0.88 (0.48-1.6) | .66 | 60 (4.6%) | 55 (10.9%) | 2.7 (1.8-4.2) | <.001 | |
| Postoperative Dialysis | 3 (0.5%) | 2 (0.3%) | 0.21 (0.01-1.5) | .19 | 5 (0.4%) | 1 (0.2%) | 0.73(0.08-5.0) | .74 | |
| Reintervention/Reoperation during index hospitalization | 5 (0.9%) | 8 (1.1%) | 1.1 (0.71-1.7) | .25 | 13 (1.0%) | 17 (3.4%) | 1.4 (1.1-5.4) | .012 | |
| This model was corrected for Age, Sex, Race, AAA Diameter, Hypertension, Diabetes, Myocardial Infarction, Congestive Heart Failure (NYHAI/II / NYHAIII/IV), Smoking Status, Chronic Obstructive Pulmonary Disease, Obesity, Renal Dysfunction, Distal Sealing Zone, Low Physician/Center volume | |||||||||
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