P-026 - PENUMBRA INDIGO ASPIRATION THROMBO-EMBOLECTOMY SYSTEM IN THE TREATMENT OF AORTIC ENDOGRAFT ILIAC LIMB OCCLUSION: RESULTS FROM AN ITALIAN MULTICENTER REGISTRY.

TOPIC:
Abdominal Aortic Aneurysms
AUTHORS:
Spath P. (Department Vascular Surgery, University of Bologna, DIMES, Bologna, Italy. ~ Bologna ~ Italy) , Pasqui E. (Vascular Surgery, University of Siena, DSMCN, Siena, Italy. ~ Siena ~ Italy) , Leone N. (Department Vascular Surgery of Modena, University of Modena and Reggio Emilia, Modena, Italy. ~ Modena ~ Italy) , Simonte G. (Department of Vascular and Endovascular Surgery, University of Perugia, Perugia, Italy. ~ Perugia ~ Italy) , D'Oria M. (Department of vascular Surgery, University hospital of Trieste, Trieste, Italy. ~ Trieste ~ Italy) , Angiletta D. (Department of Vascular Surgery, University of Bari, Bari, Italy ~ Bari ~ Italy) , Spinazzola A. (Interventional Radiology, Unit of Radiology, ASST-Crema, Crema, Italy. ~ Crema ~ Italy) , Chegai F. (Vascular and Interventional Radiology, Unit of Radiology, Hospital of Viterbo, Viterbo, Italy. ~ Viterbo ~ Italy) , Isernia G. (Department of Vascular and Endovascular Surgery, University of Perugia, Perugia, Italy. ~ Perugia ~ Italy) , Gallitto E. (Department Vascular Surgery, University of Bologna, DIMES, Bologna, Italy. ~ Bologna ~ Italy) , Silingardi R. (Department Vascular Surgery of Modena, University of Modena and Reggio Emilia, Modena, Italy. ~ Modena ~ Italy) , De Donato G. (Vascular Surgery, University of Siena, DSMCN, Siena, Italy. ~ Siena ~ Italy) , Gargiulo M. (Department Vascular Surgery, University of Bologna, DIMES, Bologna, Italy. ~ Bologna ~ Italy)
Introduction:
Aortic Endograft Iliac Limb Occlusion (ILO) is a possible early or late complication of endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAA) ranging from 1.4 to 8%, and requiring re-intervention by surgical, endovascular or hybrid techniques. Extra-anatomical femoro-femoral crossover bypass is hampered by a patency rate of 55-92% at 5-years, risk of infection and inadequate perfusion of donor-limb, standard mechanical thrombectomy give concerns regarding the dislodgment of endografts components, while fibrinolytic agents have many clinical contraindications. Aspiration Thrombo-embolectomy System (ATS) is capable of removing thrombus without any usage of thrombolytic medication and therefore reducing the risk of bleeding. The Penumbra's Indigo system (Penumbra, Alameda, California, USA) is designed for ATS, but no studies have yet described its usage in case of ILO. The aim of this study is to describe the outcomes of the Indigo Aspiration Thrombo-embolectomy System in the clinical presentation of Aortic Endovascular Iliac Limb Occlusion and analyze the results from an Italian multicenter registry.
Methods:
A retrospective observational multicenter study was conducted in eight Italian vascular centers. Patients enrolled presented with claudication, rest pain, or acute limb ischemia after acute, subacute, or chronic ILO after EVAR procedure. The primary outcome was the technical success of Penumbra Indigo ATS, defined as satisfactory revascularization compared to pre-recanalization assessment, and the technical combined success of the revascularization of ATS in association with adjunctive endovascular procedures. Patency was assessed at t1 (before ATS procedure), at t2 (after ATS procedure) and at t3 (after the adjunctive planned endovascular procedure), and was categorized according to Thrombo-aspiration In Peripheral Ischemia (TIPI) classification (score 0-3) [1]. Satisfactory revascularization was considered TIPI 2-3 flow. Secondary outcome was clinical success, defined as the improvement of Rutherford classification compared to the presentation at 1, 6 and 12 months follow-up. Continuous data are expressed as the mean value ± standard deviation or median value with range, where necessary. Categorical data are expressed as absolute values and percentages. Kaplan-Meier's analysis were used for follow-up outcomes. Statistical analyses were performed using SPSS version 24.0 (IBM Corp, Armonk, NY).
Results:
From January 2018 to February 2022, 17 patients (Age 76±7; Male 14 [82%], ASA III-IV 15 [88%], 8 [48%] urgent) were treated with the use of Indigo ATS for ILO after EVAR. Mean time from primary procedure was 24 months (range 0-104 months). Median clot longevity from diagnosis of ILO to ATS was 3 days (interquartile range 2-12 days) and 2 cases (12%) were treated for intra-operative ILO. Ten (60%) patients presented with limb-threatening ischemia and Rutherford stage 1, 2, and 3 was present in 4 (22%), 10 (60%) and 3 (18%) of cases, respectively. The average blood loss by the ATS was 375±170 ml with 2 (12%) intra-operative complications (contralateral limb embolization and one dissection of iliac artery). Fifteen (88%) patients required a planned adjunctive procedure (14 endovascular relining and 1 surgical patch angioplasty). At t1 satisfactory flow (TIPI 2-3) was present in one case (6%) whereas at t2 in 14 (82%) cases with a significant technical success of the ATS procedure (p<.001). At t3 satisfactory flow was present in 16 cases (94%), testifying a higher combined technical success after adjunctive procedure. The increase of flow was statically significant from t2 (mean TIPI at t2 2.18±0.85 vs mean TIPI at t3 2.76±0.7; p=.026) (Figure 1). Perioperative complications included one (6%) death due to pulmonary sepsis (unique case of ATS technical failure); one (6%) acute kidney injury. Among the early reinterventions, one (6%) was related to ATS procedure (distal embolectomy) and one (6%) was a surgical correction of femoral artery pseudoaneurysm. At 1-, 6- and 12-months, clinical success was 100%, without any events related to ATS or recurrence of ILO. Mean follow-up was 25±17 months: survival and freedom from re-intervention at 3-years were 91±9% and 78±13% respectively. One (6%) patient died for myocardial infarction after 15 months and two patients (12%) developed a new ILO after 18 and 22 months, respectively.
Conclusion:
This study reports for the first time the efficacy and safety of Penumbra Indigo Aspiration Thromboembolectomy System in the field of application of iliac leg occlusion after EVAR, with promising technical and clinical success both in short and mid-term follow-up.
References:
1. de Donato G, Pasqui E, Sponza M, Intrieri F, Spinazzola A, Silingardi R, Guzzardi G, Ruffino MA, Palasciano G, Setacci C; INDIAN trial collaborators. Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial. Eur J Vasc Endovasc Surg. 2021 May;61(5):820-828.
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