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Objectives: The efficacy and clinical outcomes of a novel technique "HIRANODOME" (Interim hemostatic technique with HIgh pressure for Regional blood flow in the superficial femoral Artery, NOninvasive Distal protection Occlusion MEthod) in preventing distal embolization during endovascular treatment (EVT) of femoropopliteal lesions were evaluated., Background: Distal embolization of femoropopliteal lesions may worsen limb ischemia or cause limb loss. Conventional filter wires are cumbersome and expensive and may cause vessel injury. HIRANODOME can, therefore, be a feasible and noninvasive alternative., Methods: Between April 2007 and August 2018, 94 consecutive patients who underwent EVT for femoropopliteal lesions along with anticipated distal embolization were identified. About 9 out of these 94 patients were excluded due to filter device use and 8 were excluded due to acute limb ischemia. Consequently, 77 patients using HIRANODOME for distal protection were included. HIRANODOME involved wrapping the Tometakun around the knee to enable external compression of the popliteal artery, thereby blocking the blood flow. The evaluation items were 30-day mortality, 30-day major amputation, prevention from distal embolization, and thrombus capture rate., Results: The mean age was 74.4 ± 10.3 years, 53.2% were men, 55.8% were diabetic, and 9.1% were on hemodialysis. The mean lesion length was 199.5 ± 94.4 mm; 79.2% were class C/D lesions (TASC II classification). The 30-day mortality and major amputation rates were 1.9 and 1.0%, respectively. The rate of prevention of distal embolization or no-flow/slow-flow phenomenon was 93.4%. Capture of thrombus was observed in 66 lesions (62.3%)., Conclusions: The HIRANODOME technique was effective in preventing distal embolization during EVT of femoropopliteal lesions., (© 2021 Wiley Periodicals LLC.)

Background: Embolism during percutaneous coronary intervention (PCI) causes microcirculation impairment. The aim of this study was to clarify the relationship between the pathological characteristics of tissue captured by distal protection device (DPD) and amount of tissue accumulated in DPD. Methods and Results: A total of 671 consecutive lesions in PCI using DPD were examined. The amount of necrotic debris, fibrous tissue, calcified particle, platelet thrombus and organized thrombus in the DPD baskets was histologically evaluated. The DPD tissue amount was assessed semi-quantitatively, and the relationship between the captured DPD tissue characteristics and tissue amount was investigated. On pathology, 40.7% of the lesions had necrotic debris, 41.4% had fibrous tissue, and 18.0% had calcified particle. The prevalence of lesions in patients with acute coronary syndrome (ACS) was 62.1%. Tissue amount score distribution was as follows: score 1 (tissue invisible), 3.9%; score 2 (tissue clinging to the basket), 52.0%; score 3 (tissue accumulated at the bottom of the basket), 38.5%; and score 4 (tissue accumulated in more than half of the basket), 5.7%. On multivariate analysis, necrotic debris and fibrous tissue were associated with greater tissue amount as well as clinical presentation of ACS., Conclusions: The presence of atherosclerotic plaque component, such as necrotic debris and fibrous tissue, might be a risk for distal embolism during PCI.

Background: Minimally invasive percutaneous transluminal renal artery stenting (MIPTRS) is a method that prevents complications to the greatest extent possible. The present study aimed to investigate the safety and efficacy of MIPTRS performed in cases of renal artery stenosis with an estimated glomerular filtration rate (eGFR)≤45mL/min., Methods: Cases of patients who underwent MIPTRS at our hospital between December 2010 and June 2015 in whom eGFR was ≤45mL/min were retrospectively analysed. MIPTRS was performed as follows: 1) using a 4Fr sheathless guiding catheter in a trans-radial approach and 2) using a guiding catheter non-touch technique. The amount of contrast agent used was maintained at ≤10mL with 3) carbon dioxide enhancement and 4) intravascular ultrasound guide stenting, and 5) a distal protection device was used., Results: MIPTRS was performed in 22 patients (32 lesions). The pre-MIPTRS creatinine level and eGFR were 2.01±0.88mg/dL and 29.2±9.0mL/min/1.73m 2 , respectively. On postoperative day 2, they were 1.78±0.73mg/dL and 35.1±12.3mL/min/1.73m 2 ; at 1month after the procedure, they were 1.80±0.74mg/dL and 33.3±12.3mL/min/1.73m 2 . Creatinine level did not change significantly, but eGFR was significantly elevated after versus before the procedure, both 2days later (p<0.01) and 1month later (p<0.05)., Conclusion: The results of this study demonstrated the usefulness of MIPTRS for protecting renal function. This method can be safely used in patients with decreased renal function., (Copyright © 2017 Elsevier B.V. All rights reserved.)

To describe an innovative distal protection technique, "sheath rendezvous method", during endovascular treatment for subclavian arterial occlusions. 4.5F and 6F guiding sheath were inserted from left brachial and common femoral artery, respectively. 0.014″ guidewire retrogradely passed through occlusion and into antegrade sheath to establish a pull-through system. 3.0 mm balloon was used to expand occlusion and anchor to deliver retrograde sheath into antegrade one. Both sheaths locked by balloon dilatation crossed occlusion until antegrade sheath passed over lesion. Balloon expandable stent was delivered within antegrade sheath. Sheath was removed, and stent was implanted. We obtained an excellent outcome without complications.

Purpose: Contralateral carotid occlusion (CCO) increases the risk of carotid endarterectomy (CEA). We determined the outcome of carotid angioplasty and stenting (CAS), an alternative to CEA, in the setting of CCO through an independent analysis of imaging and clinical outcome., Materials and Methods: Medical records of 26 consecutive patients with CCO who underwent CAS by a single operator using the same procedural protocol (with distal protection and closed-cell stents) were retrospectively evaluated. National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) scores before and after CAS, periprocedural complications, and the restenosis rate were analyzed by independent stroke neurologists who were not involved in the care of the patients., Results: The median mRS score for the 26 patients was 1 (range 0-5) before and after CAS. All of the patients underwent clinical and imaging follow-up (mean 19.5 ± 14.3 and 11.6 ± 11.2 months, respectively). Thirty-day mortality/permanent morbidity rates were 0 %. One patient had hyperperfusion syndrome and was managed medically without sequelae; however, he had stent occlusion after 30 days, resulting in a decline in his mRS from 4 (preprocedure) to 5. Otherwise, there was no decline in mRS during the post-discharge follow-up., Conclusion: According to an independent analysis of this single-operator series, CAS is safe and effective for the treatment of patients with CCO.

Atherosclerosis is a disease characterized by inflammation in the arterial wall. Atherogenesis is dependent on the innate immune response involving activation of Toll-like receptors (TLRs) and the expression of inflammatory proteins, those may lead to acute coronary syndrome (ACS). We investigated the expression level of TLR-4 in ACS, as compared with TLR-2 and patients with stable angina. Fifty-eight consecutive patients who underwent primary percutaneous coronary intervention (PCI, n = 29) because of ACS and elective PCI (n = 29) because of stable angina using a filter-device distal protection device system were prospectively analyzed. mRNA levels of TLR-2 and TLR-4 in debris containing various inflammatory tissues entrapped in the filter device were altogether analyzed using real-time PCR. There were no significant differences in age, sex distribution, between stable angina and ACS groups. TLR-4 expression levels were higher in patients with ACS than in patients with stable angina. TLR-4 might play a more important role than TLR-2 in atherogenesis, especially in ACS.

Objectives: This study sought to determine whether pre-percutaneous coronary intervention (PCI) plaque characterization using near-infrared spectroscopy identifies lipid-rich plaques at risk of periprocedural myonecrosis and whether these events may be prevented by the use of a distal protection filter during PCI., Background: Lipid-rich plaques may be prone to distal embolization and periprocedural myocardial infarction (MI) in patients undergoing PCI., Methods: Patients undergoing stent implantation of a single native coronary lesion were enrolled in a multicenter, prospective trial. Near-infrared spectroscopy and intravascular ultrasound were performed at baseline, and lesions with a maximal lipid core burden index over any 4-mm length (maxLCBI4mm) ≥600 were randomized to PCI with versus without a distal protection filter. The primary endpoint was periprocedural MI, defined as troponin or a creatine kinase-myocardial band increase to 3 or more times the upper limit of normal., Results: Eighty-five patients were enrolled at 9 U.S. sites. The median (interquartile range) maxLCBI4mm was 448.4 (274.8 to 654.4) pre-PCI and decreased to 156.0 (75.6 to 312.6) post-PCI (p < 0.0001). Periprocedural MI developed in 21 patients (24.7%). The maxLCBI4mm was higher in patients with versus without MI (481.5 [425.6 to 679.6] vs. 371.5 [228.9 to 611.6], p = 0.05). Among 31 randomized lesions with maxLCBI4mm ≥600, there was no difference in the rates of periprocedural MI with versus without the use of a distal protection filter (35.7% vs. 23.5%, respectively; relative risk: 1.52; 95% confidence interval: 0.50 to 4.60, p = 0.69)., Conclusions: Plaque characterization by near-infrared spectroscopy identifies lipid-rich lesions with an increased likelihood of periprocedural MI after stent implantation, presumably due to distal embolization. However, in this pilot randomized trial, the use of a distal protection filter did not prevent myonecrosis after PCI of lipid-rich plaques., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The impact of angiographically visible distal embolization (DE) and distal protection occurring during primary percutaneous coronary intervention (PCI) on long-term outcome has not been studied in a contemporary ST-segment elevation myocardial infarction (STEMI) cohort. To evaluate the association between DE and long-term outcome in STEMI patients treated with primary PCI with or without distal protection., Methods and Results: In this post-hoc analysis of a randomized study, 591 STEMI patients were randomized to conventional primary PCI or primary PCI with distal protection and followed for 5 years. There was no statistically significant difference in MACE rate between patients treated with or wthout distal protection (19% versus 25%; p=0.10). There seemed to be interaction between distal protection and DE in major adverse cardiac events (MACE) (p=0.08), mortality (p=0.02) and reinfarction (p=0.06), but not admission for heart failure (p=0.40). DE was related to increased risk of admission for heart failure independently of distal protection (12.0% versus 5.0; p=0.015). The MACE rate for patients treated with standard PCI with DE was 31.3% compared to 24.8% for patients without DE (p=0.30), and 44.4% for patients treated with distal protection with DE compared to 17.9% for patients without DE (p=0.005). DE was not related to mortality (p=0.52) or reinfarction (p=0.52) among patients treated with standard PCI, but was related to higher rates of mortality (p=0.012) and reinfarction (p=0.008) when distal protection was used., Conclusion: DE occurred in 11% of STEMI patients treated with conventional primary PCI, and was associated with increased risk of development of heart failure. Distal protection did not improve the 5-years MACE rate, and might even aggravate the prognosis following DE, but this should only be considered hypothesis-generating., (© The European Society of Cardiology 2014.)

Objective: Cerebral protection device utilization during carotid artery stenting (CAS) has been shown to decrease risk of perioperative stroke. The two most commonly used devices are distal filters and proximal protection devices, which allow blood flow cessation or flow reversal. The goal of the present study was to examine anatomic and morphologic characteristics of the treated lesions using each type of cerebral protection device and compare clinical 30-day adverse event rates between the two cerebral protection groups., Methods: We conducted a single-center, retrospective review of consecutive CAS cases with proximal protection devices that were matched with CAS cases using distal filter protection devices based on indication (symptomatic vs. asymptomatic), age, and gender. We reviewed clinical, anatomic, and morphologic characteristics of the stented lesions in cases of proximal or distal protection and also studied the rate of major adverse events within the first 30 days after the procedure., Results: We identified a total of 70 patients treated with proximal protection devices who were matched in a blinded fashion to 70 cases with distal protection. There was a significantly higher number of high-risk lesions in patients who had CAS using proximal protection devices (P = 0.009). There was no significant difference in overall frequency of 30-day adverse outcomes (transient ischemic attack/stroke/reperfusion hemorrhage/death) between the two groups (P = 1.0)., Conclusions: Our study is the first attempt (to our knowledge) to review and compare anatomic and morphologic characteristics of the stented lesions in cases of proximal versus distal protection for CAS. Our data indicate that in properly selected patients both approaches could be equally safe and effective., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Primary percutaneous intervention of saphenous vein grafts is associated with a high risk of distal embolization and no reflow. We report a case of acute myocardial infarction with a large intragraft thrombus, successfully treated with a technique combining thrombectomy with a 6 Fr guiding catheter and distal protection with the FilterWire EZ., (Copyright © 2013 Elsevier Inc. All rights reserved.)