indigo-carmine and Ischemia

Surgical training and evaluation of medical devices require simulation models. The aim of this study was to assess a 3D-printed model as a training model for peripheral endovascular procedures, including thromboaspiration in acute limb ischemia (ALI).. The 3D-simulation model was modeled from an aorta and lower limbs CT scan by segmentation of the arterial light. The 3D simulator was printed in multimaterial with photo-polymerizable resins (Polyjet). The simulator consisted of interchangeable cartridges intended to reproduce the lower limb vasculature. The simulator was connected to a pump to obtain a pulsative flow. A gelled product was positioned in a cartridge just above a stenosis in order to simulate an ALI by in-situ thrombosis. Vascular interventionalists should perform a thrombo-aspiration (Indigo. A total of 6 vascular surgeons performed two training sessions in real-life conditions. Access to the target lesion was achieved by cross-over or antegrade approach with an 8 F - 45 cm introducer. An angiogram was used to localize the thrombus. Due to the flow, a part of the thrombus was migrating from femoropopliteal segment to below the knee level. Thromboaspiration was realized by Indigo (Penumbra Inc.) CAT-8 and -6 with separators. The average score out of 5 was 4.5 (±0.55) regarding anatomical reproducibility, 4.3 (±0.82) for navigation, and 4.5 (±0.84) for aspiration. The didactical evaluation showed a score of 4.3 (±0.52) for improving technical skills. The improvement of the confidence score in the simulator was +1.2 (±1.72).. The 3D-simulation model for peripheral endovascular procedures provides a realistic training for thromboaspiration. This model could mimic different types of peripheral arterial pathologies and participate to the vascular interventionalists training.

Topics: Arterial Occlusive Diseases; Arteries; Humans; Indigo Carmine; Ischemia; Peripheral Vascular Diseases; Printing, Three-Dimensional; Reproducibility of Results; Thrombosis

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.. 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.. A total of 250 patients were enrolled. The mean age was 72.2±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.. 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.

Topics: Aged; Aged, 80 and over; Arterial Occlusive Diseases; Endovascular Procedures; Female; Humans; Indigo Carmine; Ischemia; Limb Salvage; Lower Extremity; Male; Middle Aged; Orlistat; Peripheral Arterial Disease; Retrospective Studies; Thrombectomy; Treatment Outcome; Vascular Patency

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).. A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (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 or 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 one, six, and 12 months.. From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (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 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The 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.. This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year.

Topics: Aged; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Indigo Carmine; Ischemia; Male; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Thrombectomy; Treatment Outcome

Topics: Humans; Indigo Carmine; Ischemia; Peripheral Vascular Diseases; Thrombectomy

Topics: Humans; Indigo Carmine; Ischemia; Thrombectomy

To evaluate the effects of treatment with Indigo Carmine (IC) on rat livers subjected to ischemia-reperfusion injury.. The animals were subdivided into 4 groups: 1.SHAM group(SH) - saline; 2.SHAM group with IC-2mg/Kg(SHIC); 3.IR group - rats submitted to ischemia and reperfusion with saline(IR); 4.IR group with IC-2mg/Kg(IRIC). The IR protocol consists of liver exposure and administration of drug or saline intravenously, followed by 60 minutes of ischemia and 15 of reperfusion. Liver samples were collected for biochemical analysis.. State 3 of mitochondrial respiration showed a significant worsening of the IRIC group in relation to all others. State 4 showed a difference between IRIC and SHIC. The Respiratory Control Ratio showed statistical decrease in IR and IRIC versus Sham. The osmotic swelling showed significant difference between SHxIR; SHICxIRIC and SHxIRIC. There was a significant increase in ALT in the IRIC group in relation to all the others. Concerning the nitrate dosage, there was a decrease in the group treated with IC(IRxIRIC). There was no difference regarding the dosage of Malondialdehyde.. IC was not able to protect mitochondria from IR injury and proved to be a potentiating agent, acting in synergy with the IR injury promoting damage to the hepatocyte membranes.

Topics: Animals; Aspartate Aminotransferases; Indigo Carmine; Ischemia; Male; Rats; Rats, Wistar; Reperfusion Injury

To assess the efficacy of indigo carmine angiography for wound healing after successful below-the-knee intervention in patients with critical limb ischemia (CLI).. A multi-center prospective intervention study was conducted. Fifty-four limbs of 53 patients in Rutherford categories 5 and 6 underwent endovascular therapy (EVT). After successful EVT, 5 mL of indigo carmine was injected through a catheter at the distal popliteal artery and color changes in the foot were evaluated. The results of indigo carmine angiography were divided into three groups: In type I, the color change of the wound was deeper than the surrounding tissue; in type II, the change in wound color was similar to the surrounding tissue; and in type III, no discoloration of the wound was observed by the indigo carmine.. The wound healing rates at 3 months were 78% (25/32) for type I, 70% (7/10) for type II, and 42% (5/12) for type III (P for trend = 0.025). Indigo carmine angiography-related complications were not seen.. Indigo carmine angiography was found to be a safe and useful procedure to provide visual information on foot perfusion. This dye coloring method demonstrated that after successful angioplasty, the perfused area was made visible at the microcirculation level. Indigo carmine angiography can thus be considered an important predictor for wound healing by EVT in patients with CLI.

Topics: Aged; Aged, 80 and over; Angiography; Coloring Agents; Critical Illness; Endovascular Procedures; Female; Foot; Humans; Indigo Carmine; Ischemia; Japan; Male; Perfusion Imaging; Peripheral Arterial Disease; Predictive Value of Tests; Prospective Studies; Regional Blood Flow; Time Factors; Treatment Outcome; Wound Healing

To report a novel technique to visualize the efficacy of revascularization in critical limb ischemia patients with ischemic foot ulcers.. An 80-year-old man was admitted with nonhealing ulcers on his left second toe and lateral border of the foot owing to in-stent restenosis of the left popliteal artery. After dilation of the popliteal in-stent restenosis, below-the-knee angiography revealed that the anterior tibial artery (ATA) was occluded, the posterior tibial artery was hypoplastic, and the peroneal artery was enlarged, with 2 plantar arteries. To evaluate the foot circulation before performing additional procedures, a 4-F multipurpose catheter was advanced into the peroneal artery, and 5 mL of indigo carmine was injected. Immediately, the patient's second toe and lateral border ulcers were dyed blue. We concluded that sufficient blood flow had been obtained to the ulcerated area by balloon angioplasty alone, so the procedure was terminated. The ulcers completely healed at 1 month.. Indigo carmine angiography provides visual information on foot perfusion, yielding new insights into microcirculation and helping to determine the effectiveness of treatment and procedure endpoint.

Topics: Aged, 80 and over; Angioplasty, Balloon; Blood Flow Velocity; Coloring Agents; Critical Illness; Diabetic Foot; Foot; Humans; Indigo Carmine; Injections, Intra-Arterial; Ischemia; Male; Perfusion Imaging; Predictive Value of Tests; Recovery of Function; Regional Blood Flow; Time Factors; Treatment Outcome; Wound Healing