Abdominal aorta aneurysm with hostile neck: Early outcomes in outside instruction for use in patients using the treovance® stent graft

Purpose: The efficacy and safety of endovascular aneurysm repair (EVAR), in patients outside instruction for use (IFU), is very challenging and widely debated. The aim of this study was to evaluate the placement of the Treovance® abdominal aorta stent-graft in patients with hostile proximal necks considered outside IFU. Materials and Methods: Between May 2013 and August 2014, 5 patients with outside IFU underwent EVAR with the Treovance® stent-graft. Technical and clinical successes were evaluated. All 5 patients underwent clinical and imaging follow-up. Results: Technical and clinical successes were achieved in all 5 patients without adjunctive endovascular procedures or surgical conversion. During the mean follow-up of 21 months, no type I/III endoleaks, stent-graft migration nor kinking/occlusion were observed. In all 5 patients, a reduction of the proximal neck angle was observed. Conclusion: In our small series of selected outside IFU patients, EVAR with the Treovance® stent-graft was technically feasible and safe, with satisfactory short-term follow-up results, when performed by experienced operators. Long-term follow-up will be necessary to confirm the durability of our preliminary promising results

Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial

BACKGROUND: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI.METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 -3. Safety and clinical success rate were collected at one month follow-up.RESULTS: A total of 250 patients were enrolled. The mean age was 72.2 & PLUSMN;13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings

The Indigo System in acute lower-limb malperfusion (INDIAN) registry. Protocol

Background: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis. Objective: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. Methods: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints. Conclusions: These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future