Catheter Interventions for Pulmonary Embolism: Mechanical Thrombectomy Versus Thrombolytics.

Pulmonary embolism is a debilitating and potentially life-threatening disease characterized by high mortality and long-term adverse outcomes. Traditional treatment options are fraught with serious bleeding risks and incomplete thrombus removal, necessitating the development of innovative treatment strategies. While new interventional approaches offer promising potential for improved outcomes with fewer serious complications, their rapid development and need for more comparative clinical evidence makes it challenging for physicians to select the optimal treatment for each patient among the many options. This review summarizes the current published clinical data for both traditional treatments and more recent interventional approaches indicated for pulmonary embolism. While published studies thus far suggest that these newer interventional devices offer safe and effective options, more data is needed to understand their impact relative to the standard of care. The studies in progress that are anticipated to provide needed evidence are reviewed here since they will be critical for helping physicians make informed treatment choices and potentially driving necessary guideline changes.

Assessment of the safety and efficacy of the Zoom 45 and 55 reperfusion catheters for medium and distal mechanical thrombectomies: A multi-institutional study.

INTRODUCTION: The Zoom aspiration catheters harbor novel dimensions and construction to enhance trackability and deliverability. In addition, a beveled tip may improve thrombus interaction and aspiration force for a set inner diameter. This study evaluates their utility in medium and distal vessel occlusions. OBJECTIVE: To evaluate the safety and efficacy of Zoom 45 and 55 aspiration catheters in medium and distal vessel thrombectomy. METHODS: Patients treated for distal vessel occlusions via mechanical thrombectomy utilizing either the Zoom 45/55 catheter or a historical control catheter between 2021-2022 at two institutions were included in this study. Medium and distal occlusions were defined as any anterior or posterior cerebral artery branch as well as the M2-4 segment of the middle cerebral artery (MCA). Preprocedural, procedural, and postprocedural variables were obtained. RESULTS: Thirty-eight patients underwent thrombectomy with Zoom 45 or 55 catheters; four had multiple occluded vessels. Occlusion location included the M2 in 32 cases, M3-4 in 7 cases, A2 in 2 cases and P2 in 1 case. The mean number of passes per occlusion was 1.6 and overall successful reperfusion (TICI 2b or greater) was achieved in 84 % of cases. There were no symptomatic procedure-related complications such as perforation or post-procedural symptomatic ICH. Modified Rankin scores rates of 0-2, 3-5, and 6 at three months post-procedure were 35.7 %, 21.4 %, and 42.9 %, respectively. CONCLUSIONS: The Zoom beveled tip aspiration catheters are safe and effective for more challenging medium and distal vessel occlusions.

Comparison of Balloon Guide Catheters and Standard Guide Catheters for Acute Ischemic Stroke: An Updated Systematic Review and Meta-analysis.

OBJECTIVE: The objective of this study was to update our 2021 systematic review and meta-analysis which reported that balloon guide catheters (BGC) are associated with superior clinical and angiographic outcomes compared to standard guide catheters for treatment of acute ischemic stroke. METHODS: We conducted a systematic review of 7 electronic databases to identify literature published between January 2010 and September 2023 reporting BGC versus non-BGC approaches. Primary outcomes were final modified thrombolysis in cerebral infarction (mTICI) ≥2b, first-pass effect (mTICI ≥2c on first pass), and modified Rankin scale 0-2 at 90 days. The risk of bias was assessed using the Newcastle Ottawa Scale. A separate random effects model was fitted for each outcome. Subgroup analyses by first-line approach were conducted. RESULTS: Twenty-four studies comprising 8583 patients were included (4948 BGC; 3635 non-BGC; 1561 BGC + Stent-retriever; 1297 non-BGC + Stent-retriever). Nine studies had low risk of bias, 3 were moderate risk, and 12 were high risk. Patients treated with BGCs had higher odds of achieving mTICI 2b/3, first-pass effect mTICI 2c/3, and modified Rankin scale 0-2 at 90 days (P < 0.001). The number of patients needed to treat in order to achieve one additional successful recanalization is 17. BGC + Stent-retriever was associated with higher odds of mTICI≥2b, 90-day modified Rankin scale 0-2, and reduced odds of 90-day mortality compared to non-BGC + Stent-retrievers. The main limitation was the absence of randomized trials. CONCLUSIONS: These findings corroborate our previous results suggesting that MT using BGCs is associated with better safety and effectiveness outcomes for acute ischemic stroke, especially BGC + Stent-retrievers.

Economic evaluation of stent retrievers in basilar artery occlusion: An analysis from Chinese healthcare system perspective.

PURPOSE: This study aimed to investigate the cost-effectiveness of stent retriever (SR) versus best medical management (BMM) in patients with basilar artery occlusion (BAO) in China. METHODS: We used a two-step approach to compare the cost-effectiveness of SR plus BMM with that of BMM alone over 20 years. A decision tree was initially constructed for the first 3 months, followed by a Markov model for the subsequent period. Collected data on clinical aspects were extracted from the BAOCHE investigation, while costs-related information was sourced from previously published research. The key metric for evaluating the primary outcome was the incremental cost-effectiveness ratio (ICER), achieved $/QALY. The threshold for identifying SR as highly cost-effective was set at an ICER below $12,551/QALY, SR was deemed cost-effective if the ICER ranged from $12,551 to $37,654 per QALY. Uncertainty was addressed using scenario, one-way sensitivity, and probabilistic sensitivity analyses (PSA). FINDINGS: For Chinese patients with BAO, the 20-year cost per patient was $8678 with BMM alone and $21,988 for SR plus BMM. Effectiveness was 1.45 QALY for BMM alone, and 2.77 QALY for SR plus BMM. The ICER of SR + BMM versus BMM alone was $10,050 per QALY. The scenario and one-way sensitivity analyses revealed that in certain situations the ICER could exceed $12,551 per QALY, but remain below $37,654 per QALY. Results from the PSA suggested that SR was likely to be cost-effective for Chinese patients with BAO, with a probability exceeding 98% when considering a willingness-to-pay (WTP) threshold of $12,551 per QALY. IMPLICATIONS: Our study indicates that SR is an intervention option that is highly likely to be cost-effective for Chinese patients with BAO, with a probability of over 98% under the current WTP threshold of $12,551 per QALY.

Mechanical Thrombectomy for Acute and Subacute Blocked Arteries and Veins in the Lower Limbs: A Health Technology Assessment.

Background: A blockage to the blood vessels in the lower extremities may cause pain and discomfort. If left unmanaged, it may lead to amputation or chronic disability, such as in the form of post-thrombotic syndrome. We conducted a health technology assessment of mechanical thrombectomy (MT) devices, which are proposed to remove a blood clot, which may form in the arteries or veins of the lower legs. This evaluation considered blockages in the veins and arteries separately, and included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MT for lower limb blockages, patient preferences and values, and clinical and health system stakeholders' perspectives. Method: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane tool for randomized controlled trials or the risk of bias among non-randomized studies (RoBANS) tool for nonrandomized studies, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We did not conduct a primary economic evaluation since the clinical evidence is highly uncertain. We also analyzed the budget impact of publicly funding MT treatment for inpatients with arterial acute limb ischemia and acute deep vein thrombosis (DVT) in the lower limb in Ontario. To contextualize the potential value of MT, we spoke with people with acute DVT. To understand the barriers and facilitators of accessing MT, we surveyed clinical and health system stakeholders to gain their perspectives. Results: We included 40 studies (3 randomized controlled trials and 37 observational studies) in the clinical evidence review. For patients who experience arterial acute limb ischemia, compared with catheter-directed thrombolysis (CDT) alone, MT has greater technical success and patency and reduced hospital length of stay, but the evidence for these outcomes is uncertain (GRADE: Very low). Mechanical thrombectomy may reduce the volume of thrombolytic medication required and CDT infusion time (a determinant for intensive care unit [ICU] need) in patients experiencing acute DVT, but it is uncertain if this is to a meaningful degree (GRADE: Moderate to Very low). It may also reduce the proportion of people who experience post-thrombotic syndrome and overall hospital length of stay, but it is uncertain (GRADE: Very low).We estimated that publicly funding MT for people with arterial acute limb ischemia in Ontario would lead to an annual cost savings of $0.17 million in year 1 to $0.14 million in year 5, for a total savings of $0.83 million over 5 years. This cost savings was mainly attributed to reduced ICU stays among people who received MT, but the results had considerable uncertainty. For the population with acute DVT, publicly funding MT would lead to an additional cost of $0.77 million in year 1 to $1.44 million in year 5, for a total additional cost of $5.5 million over 5 years.The people with acute DVT with whom we spoke reported that MT was generally seen as a positive option, and those who had undergone the procedure reported positively on its value as a treatment to quickly remove a clot. Accessing treatment for DVT could be a barrier, especially in more remote areas of Ontario.Clinicians using the technology advised that facilitators to accessing the technology included perceived improvements in patient outcomes, resourcing requirements, addressing unmet needs, and avoidance of ICU stay. The main barrier identified was cost. Clinicians who were not using the technology advised that barriers were low case-use volume, along with costs for the equipment and for health human resources. Conclusions: Mechanical thrombectomy may have greater technical success and patency and reduce hospital length of stay for patients experiencing an arterial acute limb ischemia and, for patients with an acute DVT, it may reduce CDT volume and infusion time, the proportion of people who experience post-thrombotic syndrome, and hospital length of stay. Mechanical thrombectomy may reduce the associated ICU costs, but it has higher equipment costs compared with usual care. Publicly funding MT in Ontario for populations with arterial acute limb ischemia may not lead to a substantial budget increase to the province. Publicly funding MT for acute DVT would lead to an additional cost of $5.5 million over 5 years. For people with acute DVT, MT was seen as a potential positive treatment option to remove the clot quickly. Overall, the majority of clinical stakeholders we engaged with (including both those with and without experience with MT) were supportive of the use of the technology.

Evaluación de la eficacia y seguridad de la trombectomía mecánica con catéter de tromboaspiración en pacientes con ictus isquémico agudo que cumplen con los criterios de trombectomía mecánica pero no son tributarios a tratamiento endovenoso con alteplasa / Evaluation of the efficacy and safety of mechanical thrombectomy with a thromboaspiration catheter in patients with acute ischemic stroke who meet the criteria for mechanical thrombectomy but are not eligible for intravenous treatment with alteplase

ANTECEDENTES: El presente documento expone la evaluación de la eficacia y seguridad de la trombectomia mecánica (TM) con catéter de tromboaspiración (CTA), en pacientes con ictus isquémico agudo (IIA) que cumplen con los criterios de TM, pero no son tributarios al tratamiento endovenoso con alteplasa (TEA)1. A través de la Carta N°4287-GRPAESSALUD-2019, los médicos especialistas del Servicio de Neurorradiología, del Hospital Nacional Guillermo Almenara Irigoyen (HNGAI), a través de la gerencia de la Red Prestacional Almenara, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación de uso del "Catéter para trombo aspiración 6 FR 132 CM de longitud", que para efectos del presente dictamen preliminar será llamado "catéter de tromboaspiración"2, en pacientes con IIA que acuden al hospital luego de las 4.5 horas de iniciado el evento, por lo que descalifican para ser atendidos con TEA, o aquellos con contraindicación para el uso de este medicamento. ASPECTOS GENERALES: Los aspectos relacionados a la epidemiología y consecuencias del IIA han sido abordados en el documento resumen ad hoc del IETSI titulado: "Eficacia y seguridad de la trombectomía mecánica con stent recuperable en pacientes con ictus isquémico agudo que cumplen con los criterios de trombectomía mecánica pero no son tributarios a tratamiento endovenoso con alteplasa". Según las recomendaciones de guías de práctica clínica (GPC) internacionales como de la AHA/ASA (Powers, AA, et al. 2019), los pacientes con IIA, solo pueden recibir TEA de manera eficaz y segura hasta las 4.5 horas de iniciado el evento. Luego de esta ventana el uso de TEA podría incrementar el potencial de daño al paciente. Asimismo, la GPC en mención establece contraindicaciones adicionales para el uso de TEA', por lo que este subgrupo tampoco podría ser tratado con este fármaco incluso si acudieran a emergencia dentro de las 4.5 horas de iniciado el IIA. METODOLOGÍA: Se realizó una búsqueda sistemática de información con el objetivo de identificar la mejor evidencia disponible sobre la eficacia y seguridad de la TM con CTA en comparación con la TE, en pacientes con IIA que cumplen con los criterios de TM, pero que no son tributarios a TEA. Además, se buscó evidencia que compare a los dispositivos CTA vs. SR para procedimientos de TM en la misma población objetivo. La búsqueda bibliográfica' se realizó en las bases de datos de PubMed, The Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan GPC y Evaluaciones de Tecnologías Sanitarias (ETS), incluyendo, el National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Scottish Medicines Consortium (SMC), Scottish Intercollegiate Guidelines Network (SIGN), Institute for Clinical and Economic Review (ICER), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), la Organización Mundial de la Salud (OMS), el Ministerio de Salud del Perú (MINSA) y el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI). Además, se realizó una búsqueda de GPC de las principales sociedades o instituciones especializadas en el manejo terapéutico de pacientes con IIA como: la American Heart Association (AHA), American Stroke Association (ASA), European Stroke Organization (ESO), European Society of Minimally Invasive Neurological Therapy (ESMINT) y la National Stroke Foundations (NSF). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en ClinicalTrials.govy la International Clinical Trial Registry Platform (ICTRP). RESULTADOS: Luego de la búsqueda bibliográfica con fecha 29 de octubre de 2021, se identificaron 7 GPC: NSF8, AHA/ASA9, ESO/ESMINT10, NICE11, IETSI12, CSBP'3, y RCP14(National Stroke Foundation 2021, Powers, Rabinstein, et al. 2019, Turc et al. 2019, National Institute for Health and Care Excellence 2019, Instituto de Evaluación de Tecnologías en Salud e Investigación 2018, Boulanger et al. 2018, Royal College of Physicians 2016); y un ECA (Lapergue et al. 2017) que responden a la pregunta PICO de interés. Todas las GPC incluidas realizaron recomendaciones para el tratamiento con TM en pacientes con IIA, incluyendo a aquellos que acuden para recibir atención luego de las 4.5 horas de ocurrido el evento. Asimismo, solo dos de las GPC (CSBP y RCP) realizaron recomendaciones específicas en pacientes con contraindicaciones para uso de TEA. No se identificaron estudios que comparen la TM con CTA vs. laTE, o que evalúen solamente la TM con CTA en la población de interés. En cuanto a la comparación de la TM con CTA vs. SR en la población de pacientes elegibles para TM no tributarios a TEA, solo el ECA de Lapergue et al. (Lapergue et al. 2017) incluyó un subanálisis preespecificado en dicha población, para la evaluación del desenlace subrogado de tasas de revascularización exitosa. Sin embargo, no se cuenta con información de la eficacia y seguridad proveniente de estudios que comparen directamente estos dispositivos sobre desenlaces de relevancia clínica para esta población. CONCLUSIÓN: Por lo expuesto, el IETSI no aprueba es uso de catéter de tromboaspiración en pacientes con ictus isquémico agudo que cumplen con los criterios de trombectomía mecánica pero no son tributarios a tratamiento endovenoso con alteplasa. Además, se sugiere a los especialistas que, de existir alguna población específica con IIA que consideren como potencial beneficiario del dispositivo CTA, puedan enviar sus solicitudes debidamente justificadas para ser valoradas en una nueva ETS.

Evaluación de la eficacia y seguridad de la trombectomía mecánica con stent recuperable en pacientes con ictus isquémico agudo que cumplen con los criterios de trombectomía mecánica pero no son tributarios a tratamiento endovenoso con alteplasa / Evaluation of the efficacy and safety of mechanical thrombectomy with retrievable stent in patients with acute ischemic stroke who meet the criteria for mechanical thrombectomy but are not eligible for intravenous treatment with alteplase

ANTECEDENTES: El presente documento expone la evaluación de la eficacia y seguridad de la trombectomia mecánica (TM) con catéter de tromboaspiración (CTA), en pacientes con ictus isquémico agudo (IIA) que cumplen con los criterios de TM, pero no son tributarios al tratamiento endovenoso con alteplasa (TEA)1. A través de la Carta N°4287-GRPAESSALUD-2019, los médicos especialistas del Servicio de Neurorradiología, del Hospital Nacional Guillermo Almenara Irigoyen (HNGAI), a través de la gerencia de la Red Prestacional Almenara, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación de uso del "Catéter para trombo aspiración 6 FR 132 CM de longitud", que para efectos del presente dictamen preliminar será llamado "catéter de tromboaspiración"2, en pacientes con IIA que acuden al hospital luego de las 4.5 horas de iniciado el evento, por lo que descalifican para ser atendidos con TEA, o aquellos con contraindicación para el uso de este medicamento. ASPECTOS GENERALES: Los aspectos relacionados a la epidemiología y consecuencias del IIA han sido abordados en el documento resumen ad hoc del IETSI titulado: "Eficacia y seguridad de la trombectomía mecánica con stent recuperable en pacientes con ictus isquémico agudo que cumplen con los criterios de trombectomía mecánica pero no son tributarios a tratamiento endovenoso con alteplasa". Según las recomendaciones de guías de práctica clínica (GPC) internacionales como de la AHA/ASA (Powers, AA, et al. 2019), los pacientes con IIA, solo pueden recibir TEA de manera eficaz y segura hasta las 4.5 horas de iniciado el evento. Luego de esta ventana el uso de TEA podría incrementar el potencial de daño al paciente. Asimismo, la GPC en mención establece contraindicaciones adicionales para el uso de TEA', por lo que este subgrupo tampoco podría ser tratado con este fármaco incluso si acudieran a emergencia dentro de las 4.5 horas de iniciado el IIA. METODOLOGÍA: Se realizó una búsqueda sistemática de información con el objetivo de identificar la mejor evidencia disponible sobre la eficacia y seguridad de la TM con CTA en comparación con la TE, en pacientes con IIA que cumplen con los criterios de TM, pero que no son tributarios a TEA. Además, se buscó evidencia que compare a los dispositivos CTA vs. SR para procedimientos de TM en la misma población objetivo. La búsqueda bibliográfica' se realizó en las bases de datos de PubMed, The Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan GPC y Evaluaciones de Tecnologías Sanitarias (ETS), incluyendo, el National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Scottish Medicines Consortium (SMC), Scottish Intercollegiate Guidelines Network (SIGN), Institute for Clinical and Economic Review (ICER), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), la Organización Mundial de la Salud (OMS), el Ministerio de Salud del Perú (MINSA) y el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI). Además, se realizó una búsqueda de GPC de las principales sociedades o instituciones especializadas en el manejo terapéutico de pacientes con IIA como: la American Heart Association (AHA), American Stroke Association (ASA), European Stroke Organization (ESO), European Society of Minimally Invasive Neurological Therapy (ESMINT) y la National Stroke Foundations (NSF). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en ClinicalTrials.govy la International Clinical Trial Registry Platform (ICTRP). RESULTADOS: Luego de la búsqueda bibliográfica con fecha 29 de octubre de 2021, se identificaron 7 GPC: NSF8, AHA/ASA9, ESO/ESMINT10, NICE11, IETSI12, CSBP'3, y RCP14(National Stroke Foundation 2021, Powers, Rabinstein, et al. 2019, Turc et al. 2019, National Institute for Health and Care Excellence 2019, Instituto de Evaluación de Tecnologías en Salud e Investigación 2018, Boulanger et al. 2018, Royal College of Physicians 2016); y un ECA (Lapergue et al. 2017) que responden a la pregunta PICO de interés. Todas las GPC incluidas realizaron recomendaciones para el tratamiento con TM en pacientes con IIA, incluyendo a aquellos que acuden para recibir atención luego de las 4.5 horas de ocurrido el evento. Asimismo, solo dos de las GPC (CSBP y RCP) realizaron recomendaciones específicas en pacientes con contraindicaciones para uso de TEA. No se identificaron estudios que comparen la TM con CTA vs. laTE, o que evalúen solamente la TM con CTA en la población de interés. En cuanto a la comparación de la TM con CTA vs. SR en la población de pacientes elegibles para TM no tributarios a TEA, solo el ECA de Lapergue et al. (Lapergue et al. 2017) incluyó un subanálisis preespecificado en dicha población, para la evaluación del desenlace subrogado de tasas de revascularización exitosa15. Sin embargo, no se cuenta con información de la eficacia y seguridad proveniente de estudios que comparen directamente estos dispositivos sobre desenlaces de relevancia clínica para esta población. CONCLUSIÓN: Por lo expuesto, el IETSI no aprueba es uso de catéter de tromboaspiración en pacientes con ictus isquémico agudo que cumplen con los criterios de trombectomía mecánica pero no son tributarios a tratamiento endovenoso con alteplasa. Además, se sugiere a los especialistas que, de existir alguna población específica con IIA que consideren como potencial beneficiario del dispositivo CTA, puedan enviar sus solicitudes debidamente justificadas para ser valoradas en una nueva ETS.

Balloon-Assisted Endovascular Thrombectomy for Tibial Thromboembolism.

We present a novel approach to endovascular thrombectomy using the Penumbra Indigo® Aspiration System with balloon assistance for a thromboembolic occlusion to the tibioperoneal trunk and tibial arteries causing acute limb ischemia. This technique allows for effective suction thrombectomy of distal vessels into a shorter, large-diameter aspiration catheter, thereby overcoming the limitations of the longer but smaller aspiration catheters.

Utility of a Mechanical Thrombectomy Device in Treating Calcified Instent Restenosis Post Iliofemoral Venous Stenting.

Instent restenosis (ISR) following iliofemoral venous stenting is quite common with up to three-quarters of patients developing some degree of ISR. However, only around 16% develop recurrent symptoms impairing their quality-of-life meriting reintervention. The first line of treatment for such ISR involves the use of angioplasty balloons to recreate an adequate flow channel. At times such angioplasty alone is inadequate particularly in the presence of calcified ISR. It is in this setting that the authors decided to explore the utility of a mechanical thrombectomy device to debulk the ISR and thereby help create an adequate flow channel. The successful utilization of such a device in a patient presenting with recurrent, disabling, quality of life impairing symptoms due to ISR represents the focus of this report.

Application of the AngioJet Ultra Thrombectomy Device for the Percutaneous Mechanical Treatment (PMT) of Iliac Limb Occlusion after Endovascular Aneurysm Repair (EVAR).

BACKGROUND: To investigate the safety and efficacy of applying the AngioJet Ultra thrombectomy device in treating endograft occlusions in the iliac arteries following endovascular aneurysm repair (EVAR). METHODS: This study utilized a retrospective analysis of 452 patients with infrarenal abdominal aortic aneurysm (AAA). Twelve of the patients experienced iliac limb occlusion during their follow-up period, and the AngioJet Ultra thrombectomy device was used in tandem with iliac angioplasty to treat these patients. The safety of the device was assessed through the amount of blood drawn, the duration of the procedure, and the occurrence of post-operative complications, while its efficacy was assessed through aortic computed tomography angiography (CTA) imaging and post-operative symptomatology results. RESULTS: All 12 patients were male, and they had a mean age of 62.8 ± 11.8 years. Iliac limb occlusion occurred on the left side of 4 patients and on the right side of 8 patients. The AngioJet Ultra thrombectomy device was used together with iliac angioplasty during surgery, with a success rate of 100%. A bifurcated endograft was successfully implanted in 9 patients following AngioJet Ultra thrombectomy and balloon dilation angioplasty, while a unibody endograft was successfully implanted in 3 patients following AngioJet Ultra thrombectomy and balloon dilation angioplasty. The mean surgery duration was 2.4 hrs, and the patients were hospitalized for an average of 4.5 days. After surgery, the patients' intermittent claudication/buttock claudication gradually vanished. Two patients experienced hemoglobinuria, with one of them developing mild renal dysfunction. Currently, the twelve patients have been followed up for an average of 12 months, and none have experienced any lower extremity ischemia. CONCLUSIONS: The use of the AngioJet Ultra thrombectomy device as a supplementary treatment for iliac limb occlusion following abdominal EVAR is safe, effective, and minimally invasive.

Percutaneous Transhepatic AngioJet-assisted Mechanical Thrombectomy for the Treatment of Post-Transplant Portal Vein Thrombosis: A Case Report.

Portal vein thrombosis (PVT) is an uncommon but serious complication after liver transplantation (LT). Treatments for PVT include thrombolysis, surgical treatment or percutaneous intervention. We here report a case of PVT after LT successfully treated by an AngioJet device using the percutaneous transhepatic approach. A 36-year-old male presented with substantial thrombosis of the portal vein/superior mesenteric vein 2 years after a liver transplant. He was managed with an Angiojet thrombectomy and subsequent stent placement. This approach may be a safe and effective treatment for PVT in post-orthotopic LT patients.

Successful IVC thrombus extraction with the AngioVac device following five vessel coronary artery bypass graft: a case report.

BACKGROUND: Inferior vena cava thrombosis is cited to be a complication of inferior vena cava filter placement and post coronary artery bypass surgery. Often only mild symptoms arise from these thrombi; however, due to the chronic nature of some thrombi and the recanalization process, more serious complications can arise. Although anticoagulation remains the gold standard of treatment, some patients are unable to be anticoagulated. In this case, we present a 65-year-old male who underwent IVC filter placement and open-heart surgery who later developed extensive femoral and iliocaval thrombosis leading to right heart failure, which required thrombus extraction with an AngioVac suction device. CASE PRESENTATION: We present a 65-year-old male who presented with bilateral pulmonary emboli with extensive right lower extremity deep vein thrombosis. Upon investigation he had ischemic heart disease and underwent a five-vessel coronary artery bypass for which he had an IVC filter placed preoperatively. On post operative day 3 to 4, he was decompensated and was diagnosed with an IVC thrombus. He progressed to right heart failure and worsening cardiogenic shock despite therapeutic anticoagulation and was taken for a suction thrombectomy using the AngioVac (AngioDynamics, Latham, NY) aspiration thrombectomy device. The thrombectomy was successful and he was able to recover and was discharged from the hospital. CONCLUSION: Despite being a rare complication, IVC thrombosis can have detrimental effects. This case is an example of how IVC thrombus in the post-operative setting can lead to mortality. The gold standard is therapeutic anticoagulation but despite that, this patient continued to have worsening cardiogenic shock. Other therapies have been described but because of its rarity, they are only described in case reports. This case shows that the AngioVac device is a successful treatment option for IVC thrombus and can have the possibility of future use.

AngioVac Aspiration Thrombectomy of Right Atrial Thrombus is Safe and Effective in Cancer Patients.

OBJECTIVES: The aim of this study was to test the hypothesis that endovascular aspiration thrombectomy of right atrial thrombus (RAT) using the AngioVac device is as safe and effective in patients with cancer as those without cancer. BACKGROUND: RAT is a uniquely challenging clinical presentation of venous thromboembolism due to its low incidence and historically high-risk of mortality due to thrombus propagation into the pulmonary arteries. There is a lack of consensus regarding management, particularly in high-risk cancer patients. Endovascular aspiration thrombectomy utilizing the AngioVac device is effective in removal of right atrial thrombus and may be a safer option for patients with cancer in whom avoidance of higher-risk intervention is preferred. METHODS: This was an institutional review board-approved retrospective single-center case control study of patients with RAT who underwent AngioVac aspiration thrombectomy between August 2013 and July 2020. Analysis of patient demographics and clinical characteristics, thrombus-related factors, and operative details was performed. Primary endpoints included survival, safety, and technical success. RESULTS: A total of 44 patients met inclusion criteria, 20 of whom with active malignancy. The oncology group had a significantly higher Charlson comorbidity index (P = 0.01). Comparative outcomes between the oncology and non-oncology group showed no difference in survival (P = 0.8) or technical success (OR 3, 95% CI 0.83-10.9). There were 9 complications, including 6 minor, 1 moderate, 1 severe, and 1 death. CONCLUSIONS: AngioVac aspiration thrombectomy of RAT is as safe and effective in patients with cancer as those without cancer.

Iatrogenic Foreign Materials Associated with Retrieved Clot Tissue via Mechanical Thrombectomy.

BACKGROUND AND PURPOSE: Hydrophilic polymers and polytetrafluoroethylene liners, commonly used in the construction of endovascular devices, occasionally separate from devices with subsequent embolization. We determined the frequency of such materials in thrombus specimens retrieved by mechanical thrombectomy in patients with stroke. MATERIALS AND METHODS: We retrospectively reviewed H&E-stained thrombus sections for presence and types of foreign materials. We identified 4 types of foreign materials-Type I: material was light green with refraction and had a homogeneous texture; type II: material was light gray and/or dark gray, thin, and loose or attenuated in texture; type III: material was light green with refraction, solitary in texture, irregular in shape, and was often associated with round or oval bubblelike particles and/or diffuse black particles; and type IV: material had homogeneous texture and was light pink or red. In addition, polymer materials from different layers of used mechanical thrombectomy catheters were compared with the foreign materials found in thrombus specimens. RESULTS: A total of 101 thrombi were evaluated. Foreign materials were found in 53 (52.5%) thrombus samples. The most common type was type I (92%), followed by type II (30%). The histopathologic features of the polymer materials from mechanical thrombectomy catheters were similar to the foreign materials found in thrombus specimens. The inner polytetrafluoroethylene liner and coating layer of catheters resembled type I and type II of the foreign materials, respectively. CONCLUSIONS: Foreign polymer materials are present in approximately half of retrieved thrombi, most commonly polytetrafluoroethylene from catheter liners and less from hydrophilic coatings.

Percutaneous Thrombus Removal in COVID-19-Infected Patient with Pulmonary Embolism.

We present a case describing the use of the AngioVac system (AngioDynamics, Inc.) and SENTINEL™ cerebral protection system (SCPS; Boston Scientific) in a patient with COVID-19 who initially presented with a large deep-vein thrombosis of the left lower extremity, complicated by a pulmonary embolism. Although he initially improved with systemic alteplase, he later developed a second large clot diagnosed in transit in the right atrium. Within 12 hours from initial thrombolysis, this large clot wedged across an incidental patent foramen ovale (PFO), the atrial septum, and the cavotricuspid annulus. We emergently performed a percutaneous clot extraction with preemptive placement of the SCPS in anticipation of cardioembolic phenomenon. A large (> 10 cm) clot was extracted without complication, and the patient was discharged home. The combined use of SCPS and AngioVac in this case suggests a potential role for percutaneous treatment of severe and consequential thromboembolic disease, especially in patients with a PFO, and may be considered as an alternative and less-invasive option in patients with COVID-19. While cerebral embolic protection devices are approved for and widely used in transcatheter aortic valve replacement procedures, there is a theoretical benefit for use in percutaneous thrombolectomies as well.

Mechanical Characterization of Thrombi Retrieved With Endovascular Thrombectomy in Patients With Acute Ischemic Stroke.

Background and Purpose: Mechanical properties of thromboemboli play an important role in the efficacy of endovascular thrombectomy (EVT) for acute ischemic stroke. However, very limited data on mechanical properties of human stroke thrombi are available. We aimed to mechanically characterize thrombi retrieved with EVT, and to assess the relationship between thrombus composition and thrombus stiffness. Methods: Forty-one thrombi from 19 patients with acute stroke who underwent EVT between July and October 2019 were mechanically analyzed, directly after EVT. We performed unconfined compression experiments and determined tangent modulus at 75% strain (Et75) as a measure for thrombus stiffness. Thrombi were histologically analyzed for fibrin/platelets, erythrocytes, leukocytes, and platelets, and we assessed the relationship between histological components and Et75 with univariable and multivariable linear mixed regression. Results: Median Et75 was 560 (interquartile range, 393­1161) kPa. In the multivariable analysis, fibrin/platelets were associated with increased Et75 (aß, 9 [95% CI, 5 to 13]) kPa, erythrocytes were associated with decreased Et75% (aß, −9 [95% CI, −5 to −13]) kPa. We found no association between leukocytes and Et75. High platelet values were strongly associated with increased Et75 (aß, 56 [95% CI, 38­73]). Conclusions: Fibrin/platelet content of thrombi retrieved with EVT for acute ischemic stroke is strongly associated with increased thrombus stiffness. For thrombi with high platelet values, there was a very strong relationship with thrombus stiffness. Our data provide a basis for future research on the development of next-generation EVT devices tailored to thrombus composition.

Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.

BACKGROUND: The purpose of our study is to assess the short-term technical success and the safety of the Indigo System in a series of patients undergoing vacuum-assisted catheter direct thrombus aspiration (IS-CDTA) for acute lower limb ischemia (ALLI) and to evaluate which parameters may affect the outcome. METHODS: All procedures using the IS-CDTA for ALLI, performed in a single-centre Interventional Radiology Unit from February 2016 to March 2020, were retrospectively analysed. Technical success was defined as the achievement of nearly-complete or complete revascularization (TIPI grade 2/3) and considered as a good outcome. Variables potentially correlated with the IS-CDTA outcome were analysed. RESULTS: 33 procedures were performed in 29 patients. Mean age was 69 years old (range 47 - 88), 24 males (83%) and 5 females (18%). The technical success was 70%. Catheter-directed thrombolysis following IS-CDTA was performed in 23 cases and the overall technical success increased from 70% to 90%, afterwards. The median time between symptoms insurgency and IS-CDTA was significantly shorter in patients with good outcome (10 hours; IQR 2.75-48) compared to those with poor outcome (168 hours; IQR 36-336) (P = 0.003). No statistically significant differences were found between the two groups regarding ATK vs. BTK (P = 0.34), native vessel vs. graft (P = 0.25), occlusion nature P = 0.28) or Rutherford score (P = 0.80). CONCLUSION: IS-CDTA is a valid option for a rapid and percutaneous treatment of ALLI. Our experience indicates that the time elapsing from the symptoms insurgency and the endovascular procedure is the best positive predictor of the outcome.