Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.

BACKGROUND: The purpose of our study is to assess the short-term technical success and the safety of the Indigo System in a series of patients undergoing vacuum-assisted catheter direct thrombus aspiration (IS-CDTA) for acute lower limb ischemia (ALLI) and to evaluate which parameters may affect the outcome. METHODS: All procedures using the IS-CDTA for ALLI, performed in a single-centre Interventional Radiology Unit from February 2016 to March 2020, were retrospectively analysed. Technical success was defined as the achievement of nearly-complete or complete revascularization (TIPI grade 2/3) and considered as a good outcome. Variables potentially correlated with the IS-CDTA outcome were analysed. RESULTS: 33 procedures were performed in 29 patients. Mean age was 69 years old (range 47 - 88), 24 males (83%) and 5 females (18%). The technical success was 70%. Catheter-directed thrombolysis following IS-CDTA was performed in 23 cases and the overall technical success increased from 70% to 90%, afterwards. The median time between symptoms insurgency and IS-CDTA was significantly shorter in patients with good outcome (10 hours; IQR 2.75-48) compared to those with poor outcome (168 hours; IQR 36-336) (P = 0.003). No statistically significant differences were found between the two groups regarding ATK vs. BTK (P = 0.34), native vessel vs. graft (P = 0.25), occlusion nature P = 0.28) or Rutherford score (P = 0.80). CONCLUSION: IS-CDTA is a valid option for a rapid and percutaneous treatment of ALLI. Our experience indicates that the time elapsing from the symptoms insurgency and the endovascular procedure is the best positive predictor of the outcome.

FemoSeal® vascular closure device for antegrade common femoral artery access: Safety and technical notes.

PURPOSE: To retrospectively assess the efficacy and safety of FemoSeal® vascular closure device to achieve hemostasis following antegrade common femoral artery puncture after lower limb revascularization using vascular sheaths from 5 to 8 Fr. METHODS: We reviewed the hemostatic outcome achieved with FemoSeal in 103 consecutive patients (mean age: 69 ± 8 years, 71 males) that undergone to 111 antegrade common femoral artery accesses for percutaneous lower limbs revascularization using 5- to 8-Fr vascular sheaths. We used FemoSeal in an unselected population, without exclusion criteria. The primary outcome was the technical success, meant as achieving complete hemostasis without immediate complications. RESULTS: Hemostasis was achieved in all 111 puncture sites (100% technical success). We observed eight (7%) puncture site minor complications (hematomas), none of which affecting the patients' outcome or requiring further therapies or increasing the hospital stay. There were no statistically significant differences between the variables potentially related to the occurrence of complications (age, international normalized ratio, platelet count, partial thromboplastin time ratio, body mass index, and common femoral arteries calcification grade) in patients with and without complications. Complications group mean body mass index was 26.4 ± 2.8 kg/m2 versus non-complications group 26.6 ± 4.4 kg/m2, p = 0.92. Mean international normalized ratio and partial thromboplastin time ratio were 1.05 ± 0.01 and 1.05 ± 0.14 versus 1.13 ± 0.2 (p = 0.39) and 1.12 ± 0.23 (p = 0.53), respectively. Common femoral arteries calcification grade was the same (mean: 1, p = 1). Platelet count was 202 × 103/mL ± 66.7 versus 226 × 103/mL ± 91.2, p = 0.55. Mean age was 72.3 ± 10 years versus 72.8 ± 8 years, p = 0.86. CONCLUSION: The low rate (7%) and grading of the adverse events, combined with the high technical success rate (100%), in an unselected group of patients treated in daily routine, suggest high safety and efficacy of FemoSeal vascular closure device in antegrade common femoral artery puncture site hemostasis when using vascular sheaths ranging from 5 to 8 Fr. Therefore, FemoSeal could be considered as a first-line hemostasis strategy in such cases.