Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry ★

Objective: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR). Methods: Retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR procedure were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete/complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at 1-, 6-, and 12-months. Results: From September 2019 to December 2021, a total number of 48 ILO occurred overall and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. Median time from primary EVAR was 24 months (IQR 0, 42 months). Median clot longevity from diagnosis of ILO to PAT was 3 days (IQR 1, 12 days). Ten patients (59%) presented with threatening limb ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and 4 (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 relinings, 1 surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included 1 (6%) distal embolisation, treated successfully. The 30-day mortality was one case (6%) due to pneumonia. At 1, 6, and 12 months, clinical success was 100% without recurrence of ILO. Median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 ± 8% and 90 ± 9%, respectively. Conclusion: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT in the field of application of ILO after EVAR, with promising technical and clinical success up to 1 year.