The phenomenon of drug-coating embolism during lower extremity endovascular interventions with paclitaxel-coated balloon.

INTRODUCTION: There is a risk of distal embolization lower extremity endovascular interventions. Possibly a drug-coating embolism caused by coating detachment from intravascular devices. METHODS: This review focuses on providing updated information on distal embolism in endovascular revascularization of lower extremity arteries, including the use of drug-coated balloons. RESULTS: Drug-coating embolism is a special case of distal embolization during recanalization of the arteries of the lower extremities. Preclinical studies have demonstrated embolization of drug-coated balloons during angioplasty of lower extremity arteries. However, the clinical role of drug-coating embolism is not completely clear. A 2020 meta-analysis found an increased risk of major lower extremity amputation after drug-coated balloon angioplasty in patients with critical limb ischemia. But long-term research is emerging to support the safety of using these devices. Perhaps a more thorough assessment of the quality of life and the degree of compensation of lower limb ischemia with an intraoperative assessment of the frequency of peripheral embolizations using ultrasound emboli detection, as well as microcirculation with transcutaneous oximetry and laser Doppler flowmetry of the operated lower limb will allow a more detailed study of the phenomenon of drug-coating embolism and its impact on long-term clinical outcomes. CONCLUSION: According to the results of preclinical studies, the use of paclitaxel-coated balloons leads to an increase in the concentration of paclitaxel in distal skeletal muscles. However, paclitaxel concentration in skeletal muscle was significantly higher in first-generation DCBs. The non-target effects of drug-coating balloon are not fully understood and require further study. Understanding the phenomenon of drug-coating embolism can help physicians to better assess the patient risk and to minimize complications.

The Use of Thrombectomy during Primary Percutaneous Coronary Intervention: Resurrecting an Old Concept in Contemporary Practice.

Optimal myocardial reperfusion during primary percutaneous coronary intervention (pPCI) is increasingly recognized to be beyond restoring epicardial coronary flow. Both invasive and non-invasive tools have highlighted the limitation of using this metric, and more efforts are focused towards achieving optimal reperfusion at the level of the microcirculation. Recent data highlighted the close relationship between thrombus burden and impaired microcirculation in patients presenting with ST-segment elevation myocardial infarction (STEMI). Moreover, distal embolization was an independent predictor of mortality in patients with STEMI. Likewise, the development of no-reflow phenomenon has been directly linked with worse clinical outcomes. Adjunctive thrombus aspiration during pPCI is intuitively intended to remove atherothrombotic material to mitigate the risk of distal embolization and the no-reflow phenomenon (NRP). However, prior trials on the use of thrombectomy during pPCI did not support its routine use, with comparable clinical endpoints to patients who underwent PCI alone. This article aims to review the existing literature highlighting the limitation on the use of thrombectomy and provide future insights into trials investigating the role of thrombectomy in contemporary pPCI.

Use of Wallstent device as an embolic protection device during stenting of aortic thrombus.

Blue toe syndrome can occur due to distal embolization from proximal lesions such as an aortic thrombus. We describe the case of a patient who presented with chronic limb threatening ischemia due to a flow-limiting infrarenal aortic thrombus, with gangrene from distal embolization to the left fifth toe, and was successfully treated with endovascular aortic stent graft insertion. Distal embolization during instrumentation was successfully prevented by using a partially deployed Wallstent (Boston Scientific) as an embolic protection device. The reconstrainable Wallstent device can be considered for distal thromboembolic protection during aortic stenting, in particular, when distal embolization is a concern and commercial devices are not readily available.

Correlation between Thrombus Perviousness and Distal Embolization during Mechanical Thrombectomy in Acute Stroke.

PURPOSE: Thrombus permeability has been related to clot composition and treatment outcomes in stroke patients undergoing reperfusion therapies. The aim of this study was to evaluate whether thrombus perviousness, evaluated by multiphase computed tomography angiography (mCTA), is associated with distal embolization risk. METHODS: We interrogated our dataset of acute ischemic stroke (AIS) patients involving the M1 segment of the middle cerebral artery (MCA) who had undergone mechanical thrombectomy, and we calculated thrombus average attenuation measurement (dHU) on non-contrast CT (NCCT) and clot perviousness on mCTA. dHU was calculated as the difference between the thrombus HU average value (tHU) and the HU average value on the contralateral side (cHU), while perviousness was calculated as the difference in mean clot density on mCTA and NCCT both in arterial (Perviousness pre-post-1) and delayed (Perviousness pre-post 2) phases. RESULTS: A total of 100 patients (53 females (53%), mean age 72.74 [± 2.31]) with M1 occlusion were available for analysis. Perviousness, calculated between baseline and arterial phase of mCTA (Perviousness pre-post1), was lower in patients with distal embolization (p = 0.05), revealing an association between reduced perviousness and distal embolization risk. Logistic regression showed that thrombus perviousness calculated on the arterial phase of mCTA (OR, 0.66; 95% CI, 0.44-0.99] (p = 0.04)) and the contact aspiration technique (OR, 0.39; 95% CI, 0.15-1.02] (p = 0.05)) were protecting factors against distal embolization. CONCLUSION: Our study showed an association between reduced perviousness and distal embolization, suggesting that perviousness evaluation may be a useful neuroimaging biomarker in predicting distal embolization risk during mechanical thrombectomy.

Surgical management of primary aortic thrombus in thoracic aorta.

Background: Primary aortic thrombus (PAT) in the absence of underlying aortic pathology such as atherosclerosis or aneurysm is quite rare and presents with various symptoms related to distal embolization. Treatment options include anticoagulation alone, open surgical thrombectomy, endovascular repair, and a combination of these approaches. The optimal management strategy remains controversial. Methods: Between 2016 and 2020, 10 patients (6 females; mean age, 49.1 years) presented to our institution with PAT in the thoracic aorta. All 10 patients were active tobacco users, and 6 patients were found to have an underlying hypercoagulable state. Locations of the PAT included the ascending aorta in 4 patients, the descending thoracic aorta in 3 patients, and the aortic root, aortic arch, and thoracoabdominal aorta in 1 patient each. At presentation, 2 patients had developed myocardial infarction, and 2 others had cerebral infarction. All patients but 1, who was managed medically for PAT, underwent open surgical thrombectomy via either sternotomy or left thoracotomy. Concomitant procedures included coronary artery bypass grafting in 2 patients and pulmonary thromboembolectomy in 1 patient. There were no operative deaths. During a median follow-up of 18 months, 2 patients developed recurrent PAT, owing primarily to poor compliance with anticoagulation. One patient required redo open thrombectomy. Two patients had mesenteric ischemia necessitating small bowel resection. Conclusions: Open surgical thrombectomy of the thoracic aorta can be performed with low mortality and morbidity; however, PAT can recur, especially in patients who have difficulty managing anticoagulation.

Filter-based embolic protection device in saphenous vein graft percutaneous intervention: A case report.

Saphenous vein grafts (SVGs) are commonly used in coronary artery bypass graft (CABG) surgery patients. However, SVGs are prone to degradation and occlusion, resulting in poor long-term patency. Percutaneous coronary intervention (PCI) for SVG has been one of the options to treat SVGs disease despite its challenges. Embolic protection device (EPD) use along with proper stent and medications are considered to minimize complications in this procedure. A 61-year-old man, with 4-vessel coronary artery bypass using SVGs and left internal mammary artery (LIMA) 11 years ago, presented with chest pain for more than 3 months. Coronary angiography showed severe stenosis of the SVG to PDA with two lesions, chronic total occlusion in SVG to OM and LIMA to LAD, with patent SVG to D1. He was admitted for elective PCI using drug-eluting stents and distal embolic filter. There were no problems observed, and the procedure was completed with successful stenting in SVG to PDA without any complications. The patient was discharged on dual-antiplatelet therapy along with his previous medication history. PCI is preferred over repeated CABG in high-risk patients, and EPD should be considered whenever technically possible to minimize the risk of distal embolization and thereby improve outcomes in SVG PCI.

Angiographic outcome in patients treated with deferred stenting after ST-segment elevation myocardial infarction-results from DANAMI-3-DEFER.

AIMS: Stent implantation during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) occasionally results in flow disturbances and distal embolization, which may cause adverse clinical outcomes. Deferred stent implantation seems to reduce the impairment on myocardial function, although the mechanisms have not been clarified. We sought to evaluate whether deferred stenting could reduce flow disturbance in patients treated with primary PCI. METHODS AND RESULTS: Patients with STEMI included in the DANAMI-3-DEFER trial were randomized to deferred versus immediate stent implantation. The primary and secondary outcomes of this substudy were the incidences of slow/no reflow and distal embolization. A total of 1205 patients were included. Deferred stenting (n = 594) resulted in lower incidences of distal embolization [odds ratio (OR) 0.67, 95% confidence interval (CI) 0.46-0.98, P = 0.040] and slow/no reflow (OR 0.60, 95%CI 0.37-0.97, P = 0.039). In high-risk subgroups, the protective effect was greatest in patients >65 years of age (slow/no reflow: OR 0.36, 95% CI 0.17-0.72, P = 0.004 and distal embolization: OR 0.34, 95% CI 0.18-0.63, P = 0.001), in patients presenting with occluded culprit artery at admission (slow/no reflow: OR 0.33, 95% CI 0.16-0.65, P = 0.001 and distal embolization: OR 0.54, 95% CI 0.31-0.96, P = 0.036) and in patients with thrombus grade >3 (slow/no reflow: OR 0.37, 95% CI 0.20-0.67, P = 0.001 and distal embolization: OR 0.39, 95% CI 0.24-0.64, P < 0.001) with a significant P for interaction for all. CONCLUSION: Deferred stent implantation reduces the incidences of slow/no reflow and distal embolization, especially in older patients and in those with total coronary occlusion or high level of thrombus burden.

Association of stress induced hyperglycemia with angiographic findings and clinical outcomes in patients with ST-elevation myocardial infarction.

BACKGROUND: Stress induced hyperglycemia (SIH) is common among patients with ST-elevation myocardial infarction (STEMI), even in patients without diabetes mellitus. However, evidence regarding its role on the angiographic outcomes and the prognosis of patients presenting with STEMI is scarce. METHODS: This study included 309 consecutively enrolled STEMI patients undergoing primary percutaneous coronary intervention (pPCI). Patients were diagnosed with SIH if blood glucose on admission was > 140 mg/dl. Also, patients had to fast for at least 8 hours before blood sampling. The objective was to assess whether SIH was associated with major adverse cardiovascular and cerebrovascular (MACCE) events and explore its relationship with angiographic predictors of worse prognosis such as poor initial TIMI flow, intracoronary thrombus burden, distal embolization, and presence of residual thrombus after pPCI. RESULTS: SIH in diabetic and non-diabetic patients was associated with a higher incidence of LTB (aOR = 2.171, 95% CI 1.27-3.71), distal embolization (aOR = 2.71, 95% CI 1.51-4.86), and pre-procedural TIMI flow grade = 0 (aOR = 2.69, 95% CI 1.43-5.04) after adjusting for relevant clinical variables. Importantly, during a median follow-up of 1.7 years STEMI patients with SIH with or without diabetes experienced increased occurrence of MACCE both in univariate (HR = 1.92, 95% CI 1.19-3.01) and multivariate analysis (aHR = 1.802, 95% CI 1.01-3.21). CONCLUSIONS: SIH in STEMI patients with or without diabetes was independently associated with increased MACCE. This could be attributed to the fact that SIH was strongly correlated with poor pre-procedural TIMI flow, LTB, and distal embolization. Large clinical trials need to validate SIH as an independent predictor of adverse angiographic and clinical outcomes to provide optimal individualized care for patients with STEMI.

Extended Use of Distal Embolic Protection Devices in Treatment of Distal Embolism During Lower Extremity Arterial Endovascular Interventions.

There is no consensus on the best treatment modality for acute distal embolization complications during endovascular interventions for peripheral arterial diseases. We report on 3 patients who underwent mechanical embolectomy using a distal embolic protection device (EPD). All patients showed angiographic evidence of distal embolism, which occurred during lower extremity limb salvage endovascular procedures. After embolectomy, all had complete recanalization of the involved vessel on completion angiogram, and none had any device-related complications or adverse outcomes from the embolization. This initial experience suggests that EPD can be used for both the prevention and treatment of intraoperative distal embolization during endovascular intervention of lower extremity arterial disease.

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study.

BACKGROUND: Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non-flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. MATERIALS AND METHODS: We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). RESULTS: Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, <90° in 13.8%, 90° to 180° in 20.7%, and >180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. CONCLUSION: The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.

Nonculprit Artery Myocardial Infarction and Complex Coronary Lesions in Anterior ST-Elevated Myocardial Infarction Patients: Data from the CIRCUS Study.

AIMS: Periprocedural myocardial infarctions have been reported in the setting of planned percutaneous coronary intervention (PCI). We assessed the prevalence of nonculprit artery acute myocardial infarction (NCAMI) and its relationship with coronary artery characteristics, final infarct size, and 1-year adverse clinical outcomes in a population of anterior ST-elevated myocardial infarction (STEMI) patients. METHODS AND RESULTS: Late gadolinium-enhanced cardiac magnetic resonance (LGE-CMR) studies were performed within 7 days of admission in 129 anterior STEMI patients from the CIRCUS trial treated by primary PCI. Infarct in the noninfarct artery territory (circumflex, right coronary) was assessed on LGE-CMR and T2-weighted images. Eleven (8.5%) patients exhibited NCAMI. The only independent characteristic significantly associated with NCAMI was the presence of multiple complex coronary lesions (odds ratio = 12.9, 95% confidence interval [3.1-53.4]; p < 0.001). There was a significantly increased infarct size in NCAMI patients compared to patients without NCAMI (45.8 ± 20.4% of the left ventricle [LV] vs. 31.0 ± 15.1% of LV, respectively; p = 0.02), with lower LV ejection fraction (46 ± 10% vs. 34 ± 8%, respectively; p < 0.001). CONCLUSION: NCAMIs are present in 8.5% of anterior STEMI patients and are significantly associated with multiple complex coronary lesions without significant relationship to any revascularization procedural technique. NCAMI was associated with a greater infarct size and reduced LVEF but not worse clinical outcomes at 1 year.

Experimental Evaluation of the Risk of Distal Embolization during Endovascular Clot Retrieval Using Various Techniques.

BACKGROUND: This study was conducted to evaluate various devices and techniques for endovascular thrombectomy that can reduce the risk of intraprocedural distal embolism in a preliminary in vitro setting with different types of thrombi. MATERIALS AND METHODS: Endovascular clot retrieval was performed in a vascular model with collateral circulation. White and red thrombi were prepared using whole blood collected from a pig. A Direct Aspiration First Pass Technique (ADAPT), simple stentretrieving with and without proximal flow arrest by a guiding balloon (SR [B+] and SR [B±]), the AspirationRetriever Technique for Stroke (ARTS), and A stentretrieving into an Aspiration catheter with Proximal balloon (ASAP) were performed three times, respectively. The saline samples that were collected at the distal side during each procedure were examined using a particle counter. The particles were counted and categorized into three groups based on size (100 µm). RESULTS: SR (B-) and SR (B+) could not achieve complete retrieval of the clot, especially using the white thrombus. ASAP was the only method that was able to retrieve the clots in all attempts. In both clot types, SR (B-), SR (B+), and ARTS, which involved a temporary flow restoration through stent deployment, demonstrated the migration of a greater number of particles measuring >100 µm in size than that shown by ADAPT and ASAP. CONCLUSIONS: ASAP was the safest method in terms of intraprocedural clot migration among the five methods evaluated in this study. Temporary flow restoration through stent deployment may affect the dangerous distal clot migration.

Proximal splenic embolisation versus distal splenic embolisation for management of focal distal arterial injuries of the spleen.

INTRODUCTION: To compare the outcomes of proximal (pSAE) versus distal (dSAE) splenic artery embolisation for management of focal distal arterial splenic injuries secondary to blunt splenic trauma. METHOD: Ethical approval was granted by the hospital research and ethics committee, Project 389/19. All patients who underwent splenic artery embolisation secondary to blunt abdominal trauma from 1 January 2009 to 1 January 2019 were reviewed. Patients with a tandem embolisation (both proximal and distal embolisations) or those with no acute vascular injury on angiography were excluded. Patient demographics, injury type/ AAST grade (2018 classification), technique of embolisation and outcomes were collected. Complications and splenectomy rates up to 30 days were recorded. RESULTS: 136 out of 232 patients had an embolisation performed for a distal vascular injury including active arterial bleeding, pseudoaneurysm or arteriovenous fistula. Mean age was 41 (range 16-84). Mean AAST grade was 4 (range 3-5). Mean Injury Severity Score was 22. pSAE was performed in 79.4% (n = 108) and dSAE in 20.6% (n = 28). Major complications occurred in 12 patients (pSAE n = 12, 11.1%; dSAE n = 0, P > 0.05); 6 pSAE required splenectomy (n = 6, 5.6%). There was no significant difference in outcomes between the two groups or when based on AAST grading. CONCLUSION: No significant difference was observed between proximal and distal embolisation techniques for blunt trauma patients with a distal vascular injury in terms of technical and clinical success.

Deferring stent optimization in stent thrombosis: A novel approach for STEMI management-Insights from a case series.

Treatment of ST represents a challenge. The presence of large amounts of thrombus combined with stent optimization increase the risk of distal embolization. A two-step strategy of stent implantation and deferred stent optimization might be appropriated. We hereby present three clinical cases of ST successfully treated with a two-step approach.

Efficacy of the novel technique HIRANODOME in preventing distal embolization during endovascular treatment of femoropopliteal lesions.

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.

FairEmbo Concept for Arterial Embolizations: In Vivo Feasibility and Safety Study with Suture-Based Microparticles Compared with Microspheres.

PURPOSE: Microspheres are effective embolic agents, especially for the management of bleeding and oncologic lesions. The first FairEmbo study reported the effectiveness of embolization using suture fragments. The effectiveness and safety of arterial embolization with suture-based microparticles (SBM) were assessed in a swine model. MATERIALS AND METHODS: In this ethical-approved animal study, a polar artery in each kidney was embolized in four swine: one side with hand-cut non-absorbable SBM (Flexocrin 2®) and the contralateral side with Embozene® 900 for comparison. Swine were followed for 3 months (M3) to evaluate the effectiveness and the safety of SBM. Follow-up protocol included clinical monitoring, computed tomography (CT) control and digital subtraction angiography (DSA), followed by histological analyses. The SBM confection parameters were evaluated by automatic microscopic sizer. RStudio software and Mann-Whitney test (significance at P < 0.05) were used for statistics. RESULTS: The average size of SBM was 1002 µm (SD = 258). All targets were effectively embolized by SBM with an angiogram defect estimated at 45.6% (95% CI [35.9-55.2]), compared to 40.5% (95% CI [30.6-55.5]) for Embozene® group (P = 0.342). The average duration of SBM embolization procedure was significantly increased compared to Embozene® embolization (1202 s versus 222 s, P = 0.029). There were no statistical differences in M3 DSA and CT for SBM and Embozene®, with persistence of partial arterial occlusion and atrophic embolized area. No postoperative complications were observed on clinical and CT controls. CONCLUSION: This experimental study suggests that embolization with SBM is feasible, safe and effective in short- and medium-term follow-up as compared to microspheres.

Distal embolization during percutaneous revascularization of the lower extremity arteries.

Background: Percutaneous endovascular therapy is nowadays the leading treatment option for patients with symptomatic peripheral arterial disease, but it can be complicated with distal embolization (DE). Patients and methods: We retrospectively analyzed 2054 endovascular revascularization interventions performed in patients with disabling claudication or chronic critical limb ischemia in the Catheterisation Laboratory of the Department of Vascular Diseases, University Medical Centre Ljubljana between January 2014 and December 2018. Lesions were treated by balloon angioplasty and/or stent implantation, without atherectomy. Results: The overall incidence of DE was 0.9%. DE was more frequent in females than males (1.6% vs 0.5%, p = 0.011), in the absence of antiplatelet treatment prior to intervention compared to previous antiplatelet treatment (2.1% vs 0.6%, p = 0.005) and in femoropopliteal stenting compared to angioplasty without stenting (2.2% vs 0.8%, p = 0.037). DE was successfully managed with percutaneous aspiration, in combination with angioplasty when necessary, in 84% of cases. In remaining 16% of patients, DE was managed with surgical thromboembolectomy. Conclusions: The incidence of DE during endovascular revascularization of chronic atherosclerotic lesions in lower limb arteries without use of atherectomy was low. DE was more frequent in women, in patients without prior antiplatelet treatment and in femoropopliteal stenting. The majority of DE was successfully managed percutaneously.

Successful Treatment of Acute Limb Ischemia Secondary to Iatrogenic Distal Embolization Using Catheter Directed Aspiration Thrombectomy.

Objective: Acute limb ischemia (ALI) due to thromboembolism is a limb- and life-threatening condition regularly encountered by vascular surgeons. Iatrogenic distal embolization is occasionally seen as a complication of various endovascular procedures. We present a series of four patients who developed ALI due to arterial embolization during cardiovascular procedures that were successfully treated via catheter directed aspiration embolectomy. Methods: Retrospective review of demographics, risk factors, and procedural outcomes was completed for 4 patients who presented with ALI due to distal embolization following cardiovascular procedures. All patients were successfully treated with catheter directed aspiration embolectomy using the Penumbra Indigo System (Penumbra Inc., Alameda, California). All patients had high-quality angiography demonstrating successful embolectomy and end-procedure patency. Results: Three patients presented with Rutherford 2A and one with Rutherford 2B ALI secondary to intraoperative distal embolization. Three patients presented with ALI secondary to distal embolization during peripheral vascular interventions, and one following emergent intra-aortic balloon pump (IABP) placement for myocardial infarction. All emboli were located in the infra-inguinal vasculature. Median post-operative ABIs were 0.94 (n = 4). Median length of stay was 2 days. There were no mortalities and no need for adjunctive fasciotomy, amputation, or bypass for limb salvage. All patients improved clinically after intervention, and returned to their reported pre-hospitalization functional status. Conclusion: All procedures achieved technical success with catheter-directed aspiration thrombectomy with or without adjunctive lysis. Catheter-directed aspiration embolectomy with the Penumbra Indigo System for ALI following an iatrogenic embolic event is a safe, less-invasive treatment option. The use of this technology may reduce the need for traditional open thrombectomy or thrombolytic therapy to address ALI.

Delayed Fragmentation and Distal Embolization of Retained Microcatheter Causing Lower Limb Ischemia: Case Report and Review of the Literature.

BACKGROUND: Endovascular microcatheter adherence and retention is an uncommon complication during brain arteriovenous malformation (AVM) embolization with glue or ethylene-vinyl alcohol copolymer that has previously reported, although there are sparse reports of symptomatic complications thereafter. CASE DESCRIPTION: We present a unique complication 6 years after initial embolization of a cerebral AVM. The patient presented with acute lower limb insufficiency with computed tomography angiogram revealing fragmentation of the microcatheter and associated popliteal aneurysm. The patient underwent an emergency grafting and removal of the retained fragment and recovered without deficit postoperatively. CONCLUSIONS: Fragmentation over retained microcatheters remains a concern that may be worth monitoring in the long term, although there are no recommendations for timing.

Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial.

BACKGROUND: B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. METHODS: EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death. RESULTS: A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ±â€¯43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ±â€¯12.2 (femoro-popliteal 85.6 ±â€¯12.8%; tibials 86.0 ±â€¯9.6%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ±â€¯14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ±â€¯0.18), Rutherford category (-1.79 ±â€¯1.22) and WIQ (0.26 ±â€¯0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. CONCLUSION: The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. The device has a high safety profile including a low risk of distal embolization.