Late outcomes of Viabahn self-expandable covered stent for the elective treatment of popliteal artery aneurysms

Objective: In the present study we aim to evaluate in detail the late outcomes of the overall endovascular cohort of the PARADE study, with a focus on factors that could influence such outcomes as these may provide useful insights for patients and clinicians alike. Methods: Between January 2010 and December 2023 patients with non-acute elective PAAs undergoing endovascular exclusion with the Viabahn stent-graft were included in a multicenter retrospective cohort study (40 sites from 10 countries). A cut-off of 15 procedures was used to define a participating center as "high-volume" (>15) or "low-volume" (<15). Results: During the 14-year studied period, 326 patients were treated who met inclusion criteria for the present study. Patients were predominantly male (304, 93.3%) with a mean age of 74.6 ± 9.2 years. Most of patients were asymptomatic (221, 67.8%), whilst 56 (17.2%) had intermittent claudication, and 49 (15%) CLTI. Acute technical success was not obtained in 2 cases (0.6%), due to residual type Ia endoleak (1 case), and residual type Ib endoleak (1 case), Of these, one patient received an open conversion, whereas the other one was followed up because unfit for any type of reintervention. At 30 days, 2 patients died with an overall 30-day mortality rate of 0.6%. Both were not cardiovascular deaths related to interventions. In addition, 30-day rates of MACE, graft occlusion, and procedure-related reinterventions were 1.2%, 3.7%, and 5.2%, respectively. No patient underwent early major amputation. The 5-year Kaplan-Meier estimates of primary patency, secondary patency, freedom from reinterventions(s), and amputation-free survival were 65.8% (95% CI: 61.7% to 71.9%), 84.9% (95% CI: 78.7% to 89.1%), 70.5% (95% CI: 66.2% to 74.8%), and 98.2% (95% CI: 96.4% to 99.6%), respectively. Amputation-free survival was adversely affected by active smoking (p = .011), chronic kidney disease (p < .001), poor run-off status (p = .042), and low number of cases for each center (<15) (p = .011). Multivariate analysis reported an approaching significance for active smoking (HR 3.460, 95% CI 2.6 to 6.1, p = .051), and confirmed the association with chronic kidney disease (HR 7.413, 95% CI 5.4 to 9.3, p = .006). Conclusion: The findings from this study show that endovascular repair using the Viabahn stent-graft may provide a feasible technical option for elective treatment of PAA. Some patient-related and procedure-related factors were identified, including chronic kidney disease, that were associated with higher rates of long-term complications.