Risk for surgical interventions following endovascular aneurysm repair with Endologix AFX or AFX2 Endovascular AAA Systems compared with other devices.

OBJECTIVE: To evaluate the risk for 90-day returns to care and long-term subsequent surgical interventions after primary endovascular aneurysm repair (EVAR) with an Endologix AFX Endovascular AAA System compared with three other high-volume endograft devices. METHODS: We conducted a matched cohort study using data from Kaiser Permanente's Endovascular Stent Graft Registry. Patients aged ≥18 years who underwent primary EVAR for AAA in the health care system from January 1, 2011, to December 31, 2017, comprised the eligible study sample. The treatment group included patients who received an Endologix AFX or AFX2 device (n = 470). Patients who received one of three other high-volume endograft devices used within the health care system comprised the eligible comparison group (n = 2122). These patients were 2:1 propensity score matched without replacement to patients who received an Endologix device based on a number of patient and procedural characteristics. After the application of matching, conditional logistic regression was used to evaluate the likelihood for 90-day emergency department visit and readmission. Cause-specific Cox regression was used to evaluate the long-term risk of endoleak, graft revision, secondary reintervention (not including revision), conversion to open repair, and rupture during follow-up. Cox proportional hazards regression was used to evaluate the risk of mortality (overall and aneurysm related). RESULTS: The final matched study sample included 470 patients who received an Endologix AFX or AFX2 device and 940 patients who received a different high-volume device. compared with the other devices, AFX/AFX2 had a higher risk for type III endoleak (hazard ratio [HR], 38.79; 95% confidence interval [CI], 14.51-103.67), revision surgery >1 year after the primary EVAR (HR, 4.50; 95% CI, 3.10-6.54), rupture (HR, 6.52; 95% CI, 1.73-24.63), and aneurysm-related mortality (HR, 2.43; 95% CI, 1.32-4.47) was observed with the use of AFX/AFX2. CONCLUSIONS: In our matched cohort study, patients who received an Endologix AFX System during their primary EVAR had a higher risk for several adverse longitudinal outcomes, as well as aneurysm-related mortality, when compared with patients who received other high-volume devices. Patients who have received these devices should be monitored closely after EVAR.

Predictors of infrapopliteal vein bypass graft revision in patients with chronic limb-threatening ischemia.

PURPOSE: Surgical revascularization is the standard treatment for chronic limb-threatening ischemia (CLTI). However, some patients may require reintervention. The Global Anatomic Staging System (GLASS), which evaluates the complexity of infrainguinal lesions, was proposed. This study aimed to identify predictors for graft revision and evaluate whether GLASS impacts vein graft revision. METHODS: Between 2011 and 2018, CLTI patients who underwent de novo infrapopliteal bypass using autogenous veins were retrospectively analyzed. To assess anatomic complexity with GLASS, femoropopliteal, infrapopliteal, and inframalleolar/pedal (IM) disease grades were determined. The outcomes of patients with or without graft revision were compared. Cox regression analysis was performed. RESULTS: Thirty-six of the 80 patients underwent reintervention for graft revision. Compared to the non-graft revision group, the graft revision group exhibited significantly higher rates of GLASS stage III (66% vs 81%, p = 0.046) and grade P2 IM disease (25% vs 58%, p = 0.009). Multivariate analysis revealed that IM grade P2 (hazard ratio [HR], 3.35; 95% confidence interval [CI], 1.66-6.75; p = 0.001) and spliced vein grafts (HR, 3.18; 95% CI, 1.43-7.06; p = 0.005) were significantly associated with graft revision. CONCLUSIONS: This study demonstrated that IM grade P2 and spliced vein grafts were predictors of graft revision. The GLASS stratification of IM disease grade may be useful in optimizing treatment for CLTI.

Drug-eluting stents are associated with improved outcomes for the treatment of infrainguinal bypass graft stenoses.

BACKGROUND: Existing endovascular therapies for failing infrainguinal bypass grafts are associated with modest patency rates. The use of everolimus drug-eluting stents (eDESs) for endovascular bypass graft revision has not yet been reported. The objective of this study was to describe and to compare clinical outcomes of eDESs vs percutaneous cutting balloons (PCBs) vs percutaneous transluminal angioplasty (PTA) for the treatment of infrainguinal bypass graft stenoses. METHODS: A multicenter, single-institution retrospective analysis of patients with infrainguinal bypass graft stenoses treated by endovascular intervention (August 2010-December 2017) was conducted. The primary study outcome was primary patency of the treated lesion. The secondary outcome was limb salvage. Outcomes are described overall and stratified by endovascular treatment modality using Kaplan-Meier curves and log-rank tests. RESULTS: During the 7-year study period, 43 patients with 78 infrainguinal bypass stenoses were treated by endovascular intervention (eDES, 15; PCB, 23; PTA, 40). Mean age was 63.3 ± 1.7 years, 53.5% were male, and 55.8% were black. The majority of patients were diabetic (60.5%) with a history of smoking (74.4%), and nearly all (83.7%) had two or more comorbidities. Half (48.7%) of bypasses treated were femoral-popliteal bypasses, followed by popliteal-distal (25.6%) and femoral-tibial (25.6%) configurations. The location of revision was the proximal anastomosis in 37.2%, midbypass in 25.6%, and distal anastomosis in 37.2%. There were no significant differences in baseline characteristics, bypass configuration, or revision location between treatment groups (P ≥ .19). Technical success for endovascular bypass intervention was 100%. At 2 years after intervention, primary patency was significantly better for patients treated with eDES (81.8%) compared with PCB (54.7%) or PTA (33.2%; log-rank, P = .03). Limb salvage was achieved in 93.6% of patients, including 86.7%, 91.3%, and 97.5% for eDES, PCB, and PTA, respectively (P = .30). CONCLUSIONS: This is the first study reporting the results of eDESs for the treatment of infrainguinal bypass graft stenoses. Use of eDESs for endovascular bypass graft revision not only is feasible but may have better primary patency than other endovascular therapies. These data suggest that eDESs may be considered a safe and efficacious endovascular technique in the armamentarium for treatment of infrainguinal bypass graft stenoses.