Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial.

OBJECTIVE: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. METHODS: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, 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 revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month. RESULTS: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. CONCLUSION: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

Review of pulmonary emboli and techniques for their mechanical removal to inform device design.

Pulmonary emboli present a significant burden of disease, with limited treatment options for some patients. Mechanical devices for pulmonary emboli removal are becoming increasingly prevalent though more work remains to be done. This paper briefly discusses the mechanical properties of pulmonary emboli, the disease state they cause, and the existing embolectomy devices. The goal of this paper is to aid the design of minimally invasive mechanical pulmonary emboli removal devices, by providing a review of this topic as well as some key design specifications.

Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association.

Pulmonary embolism (PE) represents the third leading cause of cardiovascular mortality. The technological landscape for management of acute intermediate- and high-risk PE is rapidly evolving. Two interventional devices using pharmacomechanical means to recanalize the pulmonary arteries have recently been cleared by the US Food and Drug Administration for marketing, and several others are in various stages of development. The purpose of this document is to clarify the current state of endovascular interventional therapy for acute PE and to provide considerations for evidence development for new devices that will define which patients with PE would derive the greatest net benefit from their use in various clinical settings. First, definitions and limitations of commonly used risk stratification tools for PE are reviewed. An adjudication of risks and benefits of available interventional therapies for PE follows. Next, considerations for optimal future evidence development in this field are presented in the context of the current US regulatory framework. Finally, the document concludes with a discussion of the pros and cons of the rapidly expanding PE response team model of care delivery.

Comparison of different types of endovascular mechanical embolectomy in acute ischemic stroke.

BACKGROUND: To compare the treatment efficacy of different types of endovascular mechanical embolectomy in acute ischemic stroke (AIS). MATERIAL AND METHODS: A total of 89 patients with AIS were selected in our hospital from January 2014 to January 2016 and divided into tPA group (n=27), tPA+Trevo group (n=30) and tPA+Solitaire FR group (n=32) for different treatments. Treatment effectiveness was evaluated using NIHSS and mRS system. The NIHSS score, vascular recanalization rate and postoperative complications were compared among groups. RESULTS: The NIHSS score of the tPA group was significantly lower than that of other two groups at 1 d after the operation (p < 0.05), but it was significantly higher than that of other two groups at 3 d and 3 w after the operation (p < 0.05). After the treatment, no significant difference in NIHSS score was found between the tPA+Trevo and tPA Solitaire FR groups. The revascularization rate was significantly higher, but the mortality rate in 90 d was significantly lower in the tPA+Trevo and tPA+Solitaire FR groups than that in the tPA group (p < 0.05), and no significant difference was found between the tPA+Trevo and tPA+Solitaire FR groups. The incidence rate of symptomatic intracranial hemorrhage was significantly lower in the tPA+Solitaire FR group than that in tPA+Trevo group (p < 0.05) or tPA group (p < 0.01). Significantly more patients with mRS no higher than 2 points were found in the tPA+Trevo and tPA+Solitaire FR groups than those in tPA group (p < 0.05), and no significant difference was found between the tPA+Trevo and tPA+Solitaire FR groups. CONCLUSION: TPA+Solitaire FR is a type of thrombectomy that is superior to tPA and tPA+Trevo in the treatment of patients with AIS.

Comparison of different types of endovascular mechanical embolectomy in acute ischemic stroke

SUMMARY Background: To compare the treatment efficacy of different types of endovascular mechanical embolectomy in acute ischemic stroke (AIS). Material and Methods: A total of 89 patients with AIS were selected in our hospital from January 2014 to January 2016 and divided into tPA group (n=27), tPA+Trevo group (n=30) and tPA+Solitaire FR group (n=32) for different treatments. Treatment effectiveness was evaluated using NIHSS and mRS system. The NIHSS score, vascular recanalization rate and postoperative complications were compared among groups. Results: The NIHSS score of the tPA group was significantly lower than that of other two groups at 1 d after the operation (p < 0.05), but it was significantly higher than that of other two groups at 3 d and 3 w after the operation (p < 0.05). After the treatment, no significant difference in NIHSS score was found between the tPA+Trevo and tPA Solitaire FR groups. The revascularization rate was significantly higher, but the mortality rate in 90 d was significantly lower in the tPA+Trevo and tPA+Solitaire FR groups than that in the tPA group (p < 0.05), and no significant difference was found between the tPA+Trevo and tPA+Solitaire FR groups. The incidence rate of symptomatic intracranial hemorrhage was significantly lower in the tPA+Solitaire FR group than that in tPA+Trevo group (p < 0.05) or tPA group (p < 0.01). Significantly more patients with mRS no higher than 2 points were found in the tPA+Trevo and tPA+Solitaire FR groups than those in tPA group (p < 0.05), and no significant difference was found between the tPA+Trevo and tPA+Solitaire FR groups. Conclusion: TPA+Solitaire FR is a type of thrombectomy that is superior to tPA and tPA+Trevo in the treatment of patients with AIS.

RESUMO OBJETIVO Comparar a eficácia do tratamento de diferentes tipos de embolectomia mecânica endovascular em acidente vascular cerebral isquêmico agudo (AIS). MATERIAL E MÉTODOS Um total de 89 pacientes com AIS foi selecionado em nosso hospital de janeiro de 2014 a janeiro de 2016, e os pacientes foram divididos em: grupo tPA (n = 27), tPA + grupo Trevo (n = 30) e grupo tPA + Solitaire FR (n = 32) para diferentes tratamentos. A eficácia do tratamento foi avaliada usando NIHSS e sistema mRS. Escore NIHSS, taxa de recanalização vascular e complicações pós-operatórias foram comparados entre os grupos. RESULTADOS A pontuação NIHSS do grupo tPA foi significativamente menor do que a dos outros dois grupos em um dia após a operação (p < 0,05), mas foi significativamente maior do que nos outros dois grupos em três dias e três semanas após a operação (p < 0,05). Após o tratamento, não houve diferença significativa no escore NIHSS entre o grupo tPA + Trevo e o grupo tPA Solitaire FR. A taxa de revascularização foi significativamente maior, mas a taxa de mortalidade em 90 dias foi significativamente menor nos grupos tPA + Trevo e tPA + Solitaire FR do que no grupo tPA (p < 0,05) e não houve diferença significativa entre os grupos tPA + Trevo e tPA + Solitaire FR. A taxa de incidência de hemorragia intracraniana sintomática foi significativamente menor no grupo tPA + Solitaire FR do que no grupo tPA + Trevo (p < 0,05) ou no grupo tPA (p < 0,01). Significativamente mais pacientes com mRS não maiores que 2 pontos foram encontrados no grupo tPA + Trevo e tPA + Solitaire FR do que no grupo tPA (p < 0,05), e nenhuma diferença significativa foi encontrada entre os grupos tPA + Trevo e tPA + Solitaire FR. Conclusão O tPA + Solitaire FR é um tipo de trombectomia superior ao tPA e tPA + Trevo no tratamento de pacientes com EIA.

Stent retriever placement in embolectomy: the choice of the post-bifurcational trunk influences the first-pass reperfusion result in M1 occlusions.

BACKGROUND: Embolectomy using Stent retriever Assisted Vacuum-locked Extraction (SAVE) is effective in intracranial large vessel occlusion. Which post-bifurcational trunk should be chosen for distal stent retriever placement in M1 occlusions is, however, elusive. METHODS: We conducted a retrospective analysis of prospectively collected data from a comprehensive stroke center between 2015 and 2017. Eighty-nine consecutive patients with M1 occlusions were treated with SAVE. Digital subtraction angiography (DSA) series were studied to determine the anatomy of middle cerebral artery division, the position of the stent retriever, and to measure vessel diameters. The primary endpoint was first-pass complete/near-complete reperfusion, defined as a modified Thrombolysis in Cerebral Infarction (mTICI) score of 2c or 3, after distal stent retriever placement in the inferior trunk. RESULTS: In 76/89 (85%) patients, microcatheter series were documented. A microcatheter was placed within the inferior trunk in 30/76 (40%) cases. First-pass near-complete/complete reperfusion was more likely to be achieved when the inferior trunk was used for stent retriever placement rather than the superior trunk (mTICI ≥2c: 22/30 (73%) vs 22/46 (48%), P=0.034; and mTICI 3: 20/30 (67%) vs 17/46 (37%), P=0.018). Median diameter of the inferior trunk was larger than the superior trunk (1.4 mm (IQR 1.26-1.62) vs 1.18 mm (IQR 0.98-1.43), P=0.011). The inferior trunk was dominant in 56/76 (74%) cases. Successful reperfusion was associated with placement within the dominant trunk (33/40 (83%) vs 22/36 (61%), P=0.044). CONCLUSION: The choice of the inferior trunk for distal stent retriever placement in M1 occlusions is associated with a high rate of first-pass near-complete/complete reperfusion when using SAVE.

Endovascular Renal Artery Stent Retriever Embolectomy in a Young Patient With Cardiac Myxoma: Case Report and Review of the Literature.

PURPOSE: Cardiac myxomas are common tumors of the heart with disproportionate impact on young patients, occasionally with dramatic systemic dissemination of tumor emboli with catastrophic multiorgan system ischemia. The coincident comorbidities can increase the risk of traditional treatments for tumor embolus in each region. CASE REPORT: A young patient with previously unknown cardiac myxoma presented with seizure and was found to have stress cardiomyopathy, multiple cerebral large vessel occlusions with acute ischemic stroke, bilateral lower extremity tumor emboli and rhabdomyolysis, and renal tumor embolus with acute tubular necrosis. We describe a multidisciplinary approach applying cerebrovascular stent retriever devices in tumor embolectomy of the renal artery of a young patient with systemic morbidity, preventing safe laparotomy for open surgical tumor embolectomy. CONCLUSION: We describe 2-month renal function outcomes and the considerations in applying a neuroendovascular mechanical thrombectomy device within the renal artery. This was a radiographically successful technique and her renal function appears to be improving at the 2-month follow-up, although this is complicated by other renal insults and support.

Catheter-Based Embolectomy for Acute Pulmonary Embolism: Devices, Technical Considerations, Risks, and Benefits.

A significant number of patients with high-risk pulmonary embolism have contraindications to thrombolytic therapy. Catheter-based therapy may be helpful and consists of a multitude of catheters and techniques, some old and some new. Although there are few data supporting the use of any of these techniques, there has been a recent rise in interest and use of catheter-based pulmonary embolectomy. This text describes the contemporary devices used in pulmonary embolism treatment, discusses their challenges, and proposes some future directions.

Interventional magnetic resonance imaging guided carotid embolectomy using a novel resonant marker catheter: demonstration of preclinical feasibility.

To assess the visualization and efficacy of a wireless resonant circuit (wRC) catheter system for carotid artery occlusion and embolectomy under real-time MRI guidance in vivo, and to compare MR imaging modality with x-ray for analysis of qualitative physiological measures of blood flow at baseline and after embolectomy. The wRC catheter system was constructed using a MR compatible PEEK fiber braided catheter (Penumbra, Inc, Alameda, CA) with a single insulated longitudinal copper loop soldered to a printed circuit board embedded within the catheter wall. In concordance with IACUC protocol (AN103047), in vivo carotid artery navigation and embolectomy were performed in four farm pigs (40-45 kg) under real-time MRI at 1.5T. Industry standard clots were introduced in incremental amounts until adequate arterial occlusion was noted in a total of n=13 arteries. Baseline vasculature and restoration of blood flow were confirmed via MR and x-ray imaging, and graded by the Thrombolysis in Cerebral Infarction (TICI) scale. Wilcoxon signed-rank tests were used to analyze differences in recanalization status between DSA and MRA imaging. Successful recanalizations (TICI 2b/3) were compared to clinical rates reported in literature via binomial tests. The wRC catheter system was visible both on 5° sagittal bSSFP and coronal GRE sequence. Successful recanalization was demonstrated in 11 of 13 occluded arteries by DSA analysis and 8 of 13 by MRA. Recanalization rates based on DSA (0.85) and MRA (0.62) were not significantly different from the clinical rate of mechanical aspiration thrombectomy reported in literature. Lastly, a Wilcoxon signed rank test indicated no significant difference between TICI scores analyzed by DSA and MRA. With demonstrated compatibility and visualization under MRI, the wRC catheter system is effective for in vivo endovascular embolectomy, suggesting progress towards clinical endovascular interventional MRI.

Retriever first embolectomy (ReFirE): An alternative approach for challenging cervical access.

After endovascular treatment became the standard of care procedure for acute ischaemic stroke with large artery occlusion in 2015 the number of performed interventions has increased dramatically. Especially because age is no exclusion criterion for endovascular treatment, a relevant number of patients with difficult to access carotid arteries has to be treated. In these patients a direct puncture of the carotid is a valuable tool but is associated with severe complications and an initial learning curve. We therefore developed the so called retriever first embolectomy (ReFirE) technique in which a stentretriever is deployed over a 5F diagnostic catheter and a microcatheter to establish a stable anchor prior to accessing the internal carotid artery/intracranial vasculature with an 8F guide catheter and a 5F/6F intermediate catheter. We hereby report the first case in which we performed a thrombectomy applying our novel technique.

[Intracardiac myxoma complicated by acute aortic occlusion (case report)]. / Myxome de l'oreillette gauche compliqué par une occlusion aortique aiguë (À propos d'un cas).

We report the case for a 44-year-old patient without medical history, admitted in our department for bilateral acute limb ischemia (H6). The patient was hemodynamically stable and the physical examination shows limb sever ischemia (no femoral arterial pulses, coldness, cyanosis and paralysis). Abdominal CT angiography showed a complete occlusion of the infra renal abdominal aorta compatible with embolus. An embolectomy with Fogarty catheters was performed. Echocardiography showed a mass in the left atrium. Pathological examination of the material embolic confirmed the diagnosis of the cardiac myxoma. The clinical course was marked by the development of a sever syndrome of revascularization, death occurred the third day of hospitalization. Cardiac myxomas are the most common primary cardiac tumor. The mobility of the tumor and its gelatinous and crumbly consistency generates peripheral emboli.

Use of a Modified Cardiopulmonary Bypass Circuit for Suction Embolectomy with the AngioVac Device.

The AngioVac suction cannula and circuit were designed for the percutaneous removal of soft thrombus and emboli in procedures requiring extracorporeal circulatory support. We describe a modification of the AngioVac suction catheter and cardiopulmonary bypass (CPB) circuit to effectively remove thrombus while maintaining the ability to rapidly initiate full CPBs during a medical crisis. This article will discuss the design concepts of the modified circuit as well as procedural protocols and considerations. The design modifications of incorporating an oxygenator, reservoir, and bridge allow for an increased flexibility that allows adaption to veno-venous extracorporeal membrane oxygenation or full CPB support when required for oxygenation or hemodynamic support.

Surgical Treatment of Acute Massive Pulmonary Embolism.

Massive pulmonary embolism (MPE) is a life-threatening condition. The management of MPE has changed over the course of the last few years. Since the emergence of thrombolytic therapy, only a few patients remain amenable for surgical treatment. Currently, surgical embolectomy is advised only in very specific indications. This chapter will review the background, history, indications, surgical technique and results of surgical pulmonary embolectomy in patients with MPE.

Early Experience with AngioVac Aspiration in the Pulmonary Arteries.

Five consecutive cases in which the AngioVac aspiration cannula was used for the management of pulmonary embolism (PE) were retrospectively reviewed. Four cases (80%) presented with massive PE, and two (40%) were technically successful (reduction in Miller index ≥ 5). Four patients (80%) died at a mean of 7.3 days after the procedure, including one death related to right ventricular free wall perforation. Although the AngioVac aspiration cannula has shown clinical promise in a variety of clinical applications, early experience in the pulmonary arteries has shown limited success, and further study and careful patient selection are required.

The Penumbra System for the Treatment of Acute Ischemic Stroke: Report of Two Cases.

Mortality associated with the occlusion of large vessels in acute ischemic stroke is particularly high despite best available medical therapy. Early and safe revascularization of the primary occlusion is correlated with good clinical result. We report two patients with acute ischemic stroke in whom the mechanical device Penumbra System was used for thrombolysis and embolectomy. The Penumbra System provided the revascularization of the primary occlusion site in the two patients and complete revascularization was obtained. Improvement was observed in both cases on the National Institutes of Health Stroke Scale and on modified Rankin scale scores at 1 and 30 days post-procedure. Neither of the patients had intracranial hemorrhage. The Penumbra System is a valuable device as a treatment for acute ischemic stroke secondary to large vessel occlusion.

Rescue N-butyl-2 cyanoacrylate embolectomy using a Solitaire FR device after venous glue migration during arteriovenous malformation embolization: technical note.

One of the procedural risks in arteriovenous malformation (AVM) embolization is possible migration of the embolic agent into the venous drainage with an incomplete nidus occlusion, which may lead to severe hemorrhagic complications. This report presents the case of a 29-year-old man who presented with a deep intraparenchymal hematoma on the left side secondary to the spontaneous rupture of a claustral AVM. Upon resorption of the hematoma, the patient underwent an initial therapeutic session of N-butyl-2 cyanoacrylate endovascular embolization, with the purpose of reducing the AVM volume and flow before performing Gamma Knife radiosurgery. After glue injection into one of the arterial feeders, the control angiography showed a partial migration of the glue cast into the straight sinus, with most of the nidus still visible. Because of the bleeding risk due to possible venous hypertension, it was decided to try to retrieve the glue from the vein by using a stent retriever via jugular access. This maneuver allowed a nearly complete removal of the glue cast, thereby restoring normal venous flow drainage. The patient showed no clinical worsening after the procedure. To the authors' knowledge, this is the first report of the use of the Solitaire FR device as a rescue glue retriever. This method should be considered by physicians in cases of unintended glue migration into the venous circulation during AVM embolization.

Percutaneous Embolectomy of Serpentine Thrombus from the Right Atrium in a 51-Year-Old Man.

Treatment of large, fresh thrombi in the vascular system can be challenging. AngioVac, a cardiopulmonary pump system, has been used to remove large thrombi and even some tumors by a percutaneous route. We report here a case of a 51-year-old man who presented with a large thrombus (7.5 × 1.5 cm) in his inferior vena cava, extending into his right atrium and right ventricle. Because the surgical risk was high, we attempted percutaneous embolectomy via the AngioVac aspiration system. We also review the literature concerning this emerging technique.