Acute limb ischemia (ALI) remains a vascular emergency with high morbidity and mortality. While the JETi Hydrodynamic Thrombectomy System (Abbott, Abbott Park, IL) offers a percutaneous approach to ...fragment and aspirate thrombus in patients with arterial occlusions, data on its efficacy and safety is limited. This study reports our early experience using the JETi device to treat ALI at our institution.
This is a single-center retrospective review of ALI patients treated with the JETi device between September 2020 and December 2022. Patients were included if the JETi device was used either as primary intervention or as an adjunct procedure. The primary endpoint was technical success defined as <50% residual thrombus post-intervention. Secondary endpoints included achieving complete resolution of the thrombus on angiogram, acute kidney injury (AKI), major bleeding, 30-day major amputation, and 30-day mortality.
A total of 59 JETi procedures for ALI (mean age 62 years IQR 56,71) were performed on 39 males and 20 females. Median time from onset of symptoms to hospitalization was 24 hours (IQR 4-168). Rutherford classifications were I (10), IIa (27), IIb (14) and undocumented (8). Etiology of ALI was native vessel thrombosis (27), embolism (16), graft/stent thrombosis (14), and iatrogenic (2). A total of 124 vessels were treated, with an average of 2.1 vessels per procedure. The primary outcome was achieved in 86% (107/124) of the arteries, with 82% (102/124) successfully opened using the JETi device alone without the need for any adjunctive therapy. Complete resolution of the thrombus using JETi was achieved in 81% (101/124) arteries, with or without the use of adjunctive therapy. 6.7% (4/59) of patients required a major limb amputation within 30 days despite successful recanalization, and one 30-day mortality was recorded. Complications included distal embolization (5), access site hematoma (2), and acute kidney injury (4). No major bleeding, hemolysis-induced AKI, or vessel dissection or perforation were observed.
The JETi device appears to be a safe and effective percutaneous treatment option in the management of ALI. It provides definitive treatment with a high technical success rate of 86% and a good safety profile.
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●Type of Research: Single-center retrospective cohort study.●Key Findings: The JETi Hydrodynamic Thrombectomy System was used in 59 patients with acute limb ischemia treating a total of 124 vessels. The primary outcome (<50% residual thrombus) was achieved in 86% of the arteries – in 82% using the JETi device alone without the need for any adjunctive therapy. Complete resolution of the thrombus using the JETi device was achieved in 81% of arteries with or without the use of adjunctive therapy. No major bleeding, hemolysis-induced AKI, or vessel dissection or perforation were observed. 6.7% of patients required a major limb amputation within 30 days despite successful recanalization.●Take Home Message: The JETi device appears to be a safe and effective percutaneous treatment option in the management of acute limb ischemia. It provides definitive treatment with a high technical success rate of 86% and a good safety profile.
Endovascular mechanical thrombectomy may be used during acute ischemic stroke due to large vessel intracranial occlusion. First-generation MERCI devices achieved recanalization rates of 48% and, when ...coupled with intraarterial thrombolytic drugs, recanalization rates of 60% have been reported. Enhancements in embolectomy device design may improve recanalization rates.
Multi MERCI was an international, multicenter, prospective, single-arm trial of thrombectomy in patients with large vessel stroke treated within 8 hours of symptom onset. Patients with persistent large vessel occlusion after IV tissue plasminogen activator treatment were included. Once the newer generation (L5 Retriever) device became available, investigators were instructed to use the L5 Retriever to open vessels and could subsequently use older generation devices and/or intraarterial tissue plasminogen activator. Primary outcome was recanalization of the target vessel.
One hundred sixty-four patients received thrombectomy and 131 were initially treated with the L5 Retriever. Mean age+/-SD was 68+/-16 years, and baseline median (interquartile range) National Institutes of Health Stroke Scale score was 19 (15 to 23). Treatment with the L5 Retriever resulted in successful recanalization in 75 of 131 (57.3%) treatable vessels and in 91 of 131 (69.5%) after adjunctive therapy (intraarterial tissue plasminogen activator, mechanical). Overall, favorable clinical outcomes (modified Rankin Scale 0 to 2) occurred in 36% and mortality was 34%; both outcomes were significantly related to vascular recanalization. Symptomatic intracerebral hemorrhage occurred in 16 patients (9.8%); 4 (2.4%) of these were parenchymal hematoma type II. Clinically significant procedural complications occurred in 9 (5.5%) patients.
Higher rates of recanalization were associated with a newer generation thrombectomy device compared with first-generation devices, but these differences did not achieve statistical significance. Mortality trended lower and the proportion of good clinical outcomes trended higher, consistent with better recanalization.
The treatment of acute ischemic stroke continues to advance. The mainstay of treatment remains intravenous thrombolysis with alteplase. Recent studies demonstrated that later treatment with alteplase ...is beneficial in patients selected with advanced imaging techniques. Tenecteplase has been evaluated as an alternative thrombolytic drug and evidence suggests that it is as least as effective as alteplase and may lyse large vessel clots more effectively. Endovascular therapy with mechanical thrombectomy has now been shown to be beneficial up to 24 hours after stroke onset in carefully selected patients with proximal, large vessel occlusions. Ongoing studies are evaluating the effectiveness of thrombectomy in patients with more distal vessel occlusions and patients with proximal large vessel occlusions with larger ischemic core volumes and also in patients with milder neurological deficits. Cytoprotection is another potential acute stroke therapy that has not demonstrated efficacy in prior clinical trials. It should be reconsidered as an adjunct to reperfusion and a variety of new clinical trials can be envisioned to evaluate the potential benefits of cytoprotection in patients before and after reperfusion.
Symptomatic intracranial hemorrhage (SICH) pose a major safety concern for endovascular treatment of acute ischemic stroke. This study aimed to evaluate the risk and related factors of SICH after ...endovascular treatment in a real-world practice.
Patients with stroke treated with stent-like retrievers for recanalizing a blocked artery in anterior circulation were enrolled from 21 stroke centers in China. Intracranial hemorrhage was classified as symptomatic and asymptomatic ones according to Heidelberg Bleeding Classification. Logistic regression was used to identify predictors for SICH.
Of the 632 enrolled patients, 101 (16.0%) were diagnosed with SICH within 72 hours after endovascular treatment. Ninety-day mortality was higher in patients with SICH than in patients without SICH (65.3% versus 18.8%;
<0.001). On multivariate analysis, baseline neutrophil ratio >0.83 (odds ratio OR, 2.07; 95% confidence interval CI, 1.24-3.46), pretreatment Alberta Stroke Program Early Computed Tomography Score of <6 (OR, 2.27; 95% CI, 1.24-4.14), stroke of cardioembolism type (OR, 1.91; 95% CI, 1.13-3.25), poor collateral circulation (OR, 1.97; 95% CI, 1.16-3.36), delay from symptoms onset to groin puncture >270 minutes (OR, 1.70; 95% CI, 1.03-2.80), >3 passes with retriever (OR, 2.55; 95% CI, 1.40-4.65) were associated with SICH after endovascular treatment.
Incidence of SICH after thrombectomy is higher in Asian patients with acute ischemic stroke. Cardioembolic stroke, poor collateral circulation, delayed endovascular treatment, multiple passes with stent retriever device, lower pretreatment Alberta Stroke Program Early Computed Tomography Score, higher baseline neutrophil ratio may increase the risk of SICH.
Acute limb ischemia (ALI) carries a 15% to 20% risk of combined death or amputation at 30 days and 50% to 60% at 1 year. Percutaneous mechanical thrombectomy (PT) is an emerging minimally invasive ...alternative to open thrombectomy (OT). However, ALI thrombectomy cases are omitted from most quality databases, limiting comparisons of limb and survival outcomes between PT and OT. Therefore, our aim was to compare in-hospital outcomes between PT and OT using the National Inpatient Sample.
We analyzed survey-weighted National Inpatient Sample data (2015-2020) to include emergent admissions of aged adults (50+ years) with a primary diagnosis of lower extremity ALI undergoing index procedures within 2 days of hospitalization. We excluded hospitalizations with concurrent trauma or dissection diagnoses and index procedures using catheter-directed thrombolysis. Our primary outcome was composite in-hospital major amputation or death. Secondary outcomes included in-hospital major amputation, death, in-hospital reintervention (including angioplasty/stent, thrombolysis, PT, OT, or bypass), and extended length of stay (eLOS; defined as LOS >75th percentile). Adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) were generated by multivariable logistic regression, adjusting for demographics, frailty (Risk Analysis Index), secondary diagnoses including atrial fibrillation and peripheral artery disease, hospital characteristics, and index procedure data including the anatomic thrombectomy level and fasciotomy. A priori subgroup analyses were performed using interaction terms.
We included 23,795 survey-weighted ALI hospitalizations (mean age: 72.2 years, 50.4% female, 79.2% White, and 22.3% frail), with 7335 (30.8%) undergoing PT. Hospitalization characteristics for PT vs OT differed by atrial fibrillation (28.7% vs 36.5%, P < .0001), frequency of intervention at the femoropopliteal level (86.2% vs 88.8%, P = .009), and fasciotomy (4.8% vs 6.9%, P = .006). In total, 2530 (10.6%) underwent major amputation or died. Unadjusted (10.1% vs 10.9%, P = .43) and adjusted (aOR = 0.96 95% CI, 0.77-1.20, P = .74) risk did not differ between the groups. PT was associated with increased odds of reintervention (aOR = 2.10 95% CI, 1.72-2.56, P < .0001) when compared with OT, but this was not seen in the tibial subgroup (aOR = 1.31 95% CI, 0.86-2.01, P = .21, Pinteraction < .0001). Further, 79.1% of PT hospitalizations undergoing reintervention were salvaged with endovascular therapy. Lastly, PT was associated with significantly decreased odds of eLOS (aOR = 0.80 95% CI, 0.69-0.94, P = .005).
PT was associated with comparable in-hospital limb salvage and mortality rates compared with OT. Despite an increased risk of reintervention, most PT reinterventions avoided open surgery, and PT was associated with a decreased risk of eLOS. Thus, PT may be an appropriate alternative to OT in appropriately selected patients.
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Recent positive randomized trials of endovascular therapy for ischemic stroke used predominantly stent retrievers. We pooled data to investigate the efficacy and safety of stent thrombectomy using ...the Solitaire device in anterior circulation ischemic stroke.
Patient-level data were pooled from trials in which the Solitaire was the only or the predominant device used in a prespecified meta-analysis (SEER Collaboration): Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME), Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE), Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial (EXTEND-IA), and Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset (REVASCAT). The primary outcome was ordinal analysis of modified Rankin Score at 90 days. The primary analysis included all patients in the 4 trials with 2 sensitivity analyses: (1) excluding patients in whom Solitaire was not the first device used and (2) including the 3 Solitaire-only trials (excluding ESCAPE). Secondary outcomes included functional independence (modified Rankin Score 0-2), symptomatic intracerebral hemorrhage, and mortality.
The primary analysis included 787 patients: 401 randomized to endovascular thrombectomy and 386 to standard care, and 82.6% received intravenous thrombolysis. The common odds ratio for modified Rankin Score improvement was 2.7 (2.0-3.5) with no heterogeneity in effect by age, sex, baseline stroke severity, extent of computed tomography changes, site of occlusion, or pretreatment with alteplase. The number needed to treat to reduce disability was 2.5 and for an extra patient to achieve independent outcome was 4.25 (3.29-5.99). Successful revascularization occurred in 77% treated with Solitaire device. The rate of symptomatic intracerebral hemorrhage and overall mortality did not differ between treatment groups.
Solitaire thrombectomy for large vessel ischemic stroke was safe and highly effective with substantially reduced disability. Benefits were consistent in all prespecified subgroups.
Objectives
The FlowTriever All‐Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi‐center registry evaluating the safety and effectiveness of percutaneous mechanical ...thrombectomy for treatment of pulmonary embolism (PE) in a real‐world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH.
Background
High‐ and intermediate‐risk PEs are characterized by high mortality rates, frequent readmissions, and long‐term sequelae. Mechanical thrombectomy is emerging as a front‐line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics.
Methods
The primary endpoint is a composite of major adverse events (MAE) including device‐related death, major bleeding, and intraprocedural device‐ or procedure‐related adverse events at 48 h. Secondary endpoints include on‐table changes in hemodynamics and longer‐term measures including dyspnea, heart rate, and cardiac function.
Results
Patients were predominantly intermediate‐risk per ESC guidelines (6.8% high‐risk, 93.2% intermediate‐risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device‐related injuries, clinical deteriorations, or deaths at 48 h. All‐cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on‐table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow‐up.
Conclusions
These interim results provide preliminary evidence of excellent safety in a real‐world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.
This review describes the evolution of endovascular treatment for acute ischemic stroke, current state of the art, and the challenges for the next decade. The rapid development of endovascular ...thrombectomy (EVT), from the first attempts into standard of care on a global scale, is one of the major achievements in modern medicine. It was possible thanks to the establishment of a scientific framework for patient selection, assessment of stroke severity and outcome, technical development by dedicated physicians and the MedTech industry, including noninvasive imaging for patient selection, and radiological outcome evaluation. A series of randomized controlled trials on EVT in addition to intravenous thrombolytics, with overwhelmingly positive results for anterior circulation stroke within 6 h of onset regardless of patient characteristics with a number needed to treat of less than 3 for any positive shift in outcome, paved the way for a rapid introduction of EVT into clinical practice. Within the “extended” time window of 6–24 h, the effect has been even greater for patients with salvageable brain tissue according to perfusion imaging with a number needed to treat below 2. Even so, EVT is only available for a small portion of stroke patients, and successfully recanalized EVT patients do not always achieve excellent functional outcome. The major challenges in the years to come include rapid prehospital detection of stroke symptoms, adequate clinical and radiological diagnosis of severe ischemic stroke cases, enabling effective recanalization by EVT in dedicated angiosuites, followed by personalized post‐EVT stroke care.
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