-
Journal of Thrombosis and Haemostasis :... Jul 2015Superficial vein thrombosis (SVT) is less well studied than deep vein thrombosis (DVT), because it has been considered to be a minor, self-limiting disease that is... (Review)
Review
Superficial vein thrombosis (SVT) is less well studied than deep vein thrombosis (DVT), because it has been considered to be a minor, self-limiting disease that is easily diagnosed on clinical grounds and that requires only symptomatic relief. The most frequently involved sites of the superficial vein system are the lower limbs, especially the saphenous veins, mostly in relation to varicosities. Lower-limb SVT shares the same risk factors as DVT; it can propagate into the deep veins, and have a complicated course with pulmonary embolism. Clinical diagnosis may not be accurate, and ultrasonography is currently indicated for both confirmation and evaluation of SVT extension. Treatment aims are symptom relief and prevention of venous thromboembolism (VTE) in relation to the thrombotic burden. SVT of the long saphenous vein within 3 cm of the saphenofemoral junction (SFJ) is considered to be equivalent to a DVT, and thus deserving of therapeutic anticoagulation. Less severe forms of lower-limb SVT not involving the SFJ have been included in randomized clinical trials of surgery, compression hosiery, non-steroidal anti-inflammatory drugs, unfractionated heparin, and low molecular weight heparins, with inconclusive results. The largest randomized clinical trial available, on 3004 patients with lower-limb SVT not involving the SFJ, showed that fondaparinux 2.5 mg once daily for 6 weeks is more effective than placebo in reducing the risk of the composite of death from any cause and symptomatic VTE (0.9% versus 5.9%). Further studies are needed to define the optimal management strategies for SVT of the lower limbs and other sites, such as the upper limbs.
Topics: Anticoagulants; Blood Coagulation; Combined Modality Therapy; Diagnosis, Differential; Female; Humans; Predictive Value of Tests; Risk Factors; Stockings, Compression; Thrombectomy; Treatment Outcome; Venous Thrombosis
PubMed: 25903684
DOI: 10.1111/jth.12986 -
The New England Journal of Medicine Jun 2015We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry.
METHODS
During a 2-year period at four centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy (including intravenous alteplase when eligible) and endovascular therapy with the Solitaire stent retriever (thrombectomy group) or medical therapy alone (control group). All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging. In all study patients, the use of alteplase either did not achieve revascularization or was contraindicated. The primary outcome was the severity of global disability at 90 days, as measured on the modified Rankin scale (ranging from 0 [no symptoms] to 6 [death]). Although the maximum planned sample size was 690, enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials.
RESULTS
Thrombectomy reduced the severity of disability over the range of the modified Rankin scale (adjusted odds ratio for improvement of 1 point, 1.7; 95% confidence interval [CI], 1.05 to 2.8) and led to higher rates of functional independence (a score of 0 to 2) at 90 days (43.7% vs. 28.2%; adjusted odds ratio, 2.1; 95% CI, 1.1 to 4.0). At 90 days, the rates of symptomatic intracranial hemorrhage were 1.9% in both the thrombectomy group and the control group (P=1.00), and rates of death were 18.4% and 15.5%, respectively (P=0.60). Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals.
CONCLUSIONS
Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset, stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence. (Funded by Fundació Ictus Malaltia Vascular through an unrestricted grant from Covidien and others; REVASCAT ClinicalTrials.gov number, NCT01692379.).
Topics: Acute Disease; Administration, Intravenous; Aged; Brain Ischemia; Combined Modality Therapy; Contraindications; Endovascular Procedures; Female; Fibrinolytic Agents; Humans; Male; Middle Aged; Stents; Stroke; Thrombectomy; Time-to-Treatment; Tissue Plasminogen Activator
PubMed: 25882510
DOI: 10.1056/NEJMoa1503780 -
JACC. Cardiovascular Interventions May 2019The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine,... (Clinical Trial)
Clinical Trial
OBJECTIVES
The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
BACKGROUND
Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis.
METHODS
Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy.
RESULTS
From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up.
CONCLUSIONS
Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.
Topics: Acute Disease; Adult; Aged; Cardiac Catheters; Female; Humans; Male; Middle Aged; Prospective Studies; Pulmonary Embolism; Recovery of Function; Risk Assessment; Risk Factors; Suction; Thrombectomy; Time Factors; Treatment Outcome; United States; Ventricular Function, Left; Ventricular Function, Right
PubMed: 31072507
DOI: 10.1016/j.jcin.2018.12.022 -
EuroIntervention : Journal of EuroPCR... Feb 2023Evidence supporting interventional pulmonary embolism (PE) treatment is needed.
BACKGROUND
Evidence supporting interventional pulmonary embolism (PE) treatment is needed.
AIMS
We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population.
METHODS
FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement.
RESULTS
Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001). Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.
Topics: Humans; Thrombectomy; Treatment Outcome; Pulmonary Embolism; Fibrinolytic Agents; Registries; Thrombolytic Therapy
PubMed: 36349702
DOI: 10.4244/EIJ-D-22-00732 -
Catheterization and Cardiovascular... Mar 2022The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of...
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.
Topics: Hemorrhage; Humans; Prospective Studies; Pulmonary Embolism; Registries; Thrombectomy; Treatment Outcome
PubMed: 35114059
DOI: 10.1002/ccd.30091 -
The New England Journal of Medicine Jun 2015Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome.
METHODS
We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 [no symptoms] to 6 [death]).
RESULTS
The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12).
CONCLUSIONS
In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).
Topics: Acute Disease; Administration, Intravenous; Aged; Brain Ischemia; Combined Modality Therapy; Endovascular Procedures; Female; Fibrinolytic Agents; Humans; Male; Middle Aged; Stents; Stroke; Thrombectomy; Tissue Plasminogen Activator; Treatment Outcome
PubMed: 25882376
DOI: 10.1056/NEJMoa1415061 -
JAMA Aug 2017The benefits of endovascular revascularization using the contact aspiration technique vs the stent retriever technique in patients with acute ischemic stroke remain... (Comparative Study)
Comparative Study Randomized Controlled Trial
Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER Randomized Clinical Trial.
IMPORTANCE
The benefits of endovascular revascularization using the contact aspiration technique vs the stent retriever technique in patients with acute ischemic stroke remain uncertain because of lack of evidence from randomized trials.
OBJECTIVE
To compare efficacy and adverse events using the contact aspiration technique vs the standard stent retriever technique as a first-line endovascular treatment for successful revascularization among patients with acute ischemic stroke and large vessel occlusion.
DESIGN, SETTING, AND PARTICIPANTS
The Contact Aspiration vs Stent Retriever for Successful Revascularization (ASTER) study was a randomized, open-label, blinded end-point clinical trial conducted in 8 comprehensive stroke centers in France (October 2015-October 2016). Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation within 6 hours of symptom onset were included.
INTERVENTIONS
Patients were randomly assigned to first-line contact aspiration (n = 192) or first-line stent retriever (n = 189) immediately prior to mechanical thrombectomy.
MAIN OUTCOMES AND MEASURES
The primary outcome was the proportion of patients with successful revascularization defined as a modified Thrombolysis in Cerebral Infarction score of 2b or 3 at the end of all endovascular procedures. Secondary outcomes included degree of disability assessed by overall distribution of the modified Rankin Scale (mRS) score at 90 days, change in National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, all-cause mortality at 90 days, and procedure-related serious adverse events.
RESULTS
Among 381 patients randomized (mean age, 69.9 years; 174 women [45.7%]), 363 (95.3%) completed the trial. Median time from symptom onset to arterial puncture was 227 minutes (interquartile range, 180-280 minutes). For the primary outcome, the proportion of patients with successful revascularization was 85.4% (n = 164) in the contact aspiration group vs 83.1% (n = 157) in the stent retriever group (odds ratio, 1.20 [95% CI, 0.68-2.10]; P = .53; difference, 2.4% [95% CI, -5.4% to 9.7%]). For the clinical efficacy outcomes (change in NIHSS score at 24 hours, mRS score at 90 days) and adverse events, there were no significant differences between groups.
CONCLUSIONS AND RELEVANCE
Among patients with ischemic stroke in the anterior circulation undergoing thrombectomy, first-line thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful revascularization rate at the end of the procedure.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT02523261.
Topics: Aged; Aged, 80 and over; Angiography; Brain Ischemia; Catheterization; Endovascular Procedures; Female; Humans; Male; Middle Aged; Stents; Stroke; Thrombectomy
PubMed: 28763550
DOI: 10.1001/jama.2017.9644 -
Journal of the American Heart... Mar 2019Background Several randomized trials have shown the efficacy of thrombectomy for large intracranial vessel occlusions in adults. However, the safety and efficacy of...
Background Several randomized trials have shown the efficacy of thrombectomy for large intracranial vessel occlusions in adults. However, the safety and efficacy of thrombectomy in children are unknown. We aimed to investigate the feasibility and outcome of thrombectomy in pediatric patients. Methods and Results We performed a retrospective analysis of all children (<18 years of age) who presented with large-vessel occlusion and were treated with mechanical thrombectomy at 3 German tertiary-care stroke centers. Interventional results and clinical outcomes were assessed using the Pediatric National Institutes of Health Stroke Scale at 24 hours and on day 7 after thrombectomy as well as after 3 months (modified Rankin Scale). After screening of local registries for all performed thrombectomies, 12 children were included. Median Pediatric National Institutes of Health Stroke Scale score on admission was 12.5 (interquartile range 8.0-21.5). Angiographic outcomes for thrombectomy were good in all patients (6×modified Treatment in Cerebral Infarction Score 3, 6×modified Treatment in Cerebral Infarction Score 2b). Moreover, most patients showed an improvement of neurological outcome after thrombectomy with a median Pediatric National Institutes of Health Stroke Scale of 3.5 (interquartile range 1-8) at day 7 and a modified Rankin Scale of 1.0 (interquartile range 0-2.0) at 3 months. No major periprocedural complications were observed. Conclusions In our retrospective study thrombectomy was safe in childhood stroke, and treated children had good neurological outcomes.
Topics: Adolescent; Age of Onset; Brain Ischemia; Cerebral Angiography; Child; Child, Preschool; Disability Evaluation; Feasibility Studies; Female; Germany; Humans; Male; Recovery of Function; Retrospective Studies; Stroke; Thrombectomy; Time Factors; Treatment Outcome
PubMed: 30803281
DOI: 10.1161/JAHA.118.011335 -
Journal of Neurointerventional Surgery Nov 2015
Topics: Arterial Occlusive Diseases; Biomedical Research; Brain Ischemia; Endovascular Procedures; Equipment Design; Humans; Stroke; Thrombectomy
PubMed: 26468274
DOI: 10.1136/neurintsurg-2015-012056 -
Interventional Neuroradiology : Journal... Apr 2023The advent of endovascular therapy for acute large vessel occlusion has revolutionized stroke treatment. Timely access to endovascular therapy, and the ability to... (Review)
Review
The advent of endovascular therapy for acute large vessel occlusion has revolutionized stroke treatment. Timely access to endovascular therapy, and the ability to restore intracranial flow in a safe, efficient, and efficacious manner has been critical to the success of the thrombectomy procedure. The stentriever has been a mainstay of endovascular stroke therapy, and current guidelines recommend the usage of stentrievers in the treatment of large vessel occlusion stroke. Despite the success of existing stentrievers, there continues to be significant development in the field, with newer stentrievers attempting to improve on each of the three key aspects of the thrombectomy procedure. Here, we elucidate the technical requirements that a stentriever must fulfill. We then review the basic variables of stent design, including the raw material and its form, fabrication method, geometric configuration, and further additions. Lastly, a selection of stentrievers from successive generations are reviewed using these engineering parameters, and clinical data is presented. Further avenues of stentriever development and testing are also presented.
Topics: Humans; Endovascular Procedures; Treatment Outcome; Stroke; Thrombectomy; Ischemic Stroke; Brain Ischemia; Stents
PubMed: 35253526
DOI: 10.1177/15910199221081243