Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical ...thrombectomy (MT) for high-risk PE.BackgroundAcute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE.The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs.MethodsThe prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs.Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit.ResultsOf the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit.In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.ConclusionsIn this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.
The rates of pulmonary embolism (PE) are high among lung transplant (LT) recipients. Management is challenging because of elevated bleeding risks and inadequacy of conventional PE risk stratification ...tools. New percutaneous large bore mechanical thrombectomy catheters are being increasingly used effectively to debulk thrombus and restore flow immediately. We describe the use of mechanical thrombectomy (MT) in 8 LT recipients. All patients were diagnosed with intermediate/high-risk proximal PE involving the allograft and underwent successful MT within 30 hours of diagnosis. Estimated blood loss was between 200 and 450 cc, with 3 patients requiring blood transfusions. Improvement in heart rate and oxygenation was seen in all 8 patients after the procedure. In the 30 days after MT, 7 of 8 patients survived. One patient died from major bleeding occurred 16 days after MT and 5 days after venoarterial extracorporeal membrane oxygenator decannulation. Mechanical thrombectomy may provide a feasible management strategy in select LT recipients with pulmonary embolism.
The use of catheter-directed thrombolysis (CDT) may provide clinical benefit in patients with acute deep venous thrombosis (DVT), but significant doubt remains about its indications and risks. We ...assessed technical success in resolution of acute iliofemoral or central DVT after single-session treatment with a novel mechanical aspiration thrombectomy device as an alternative to initiation of CDT.
This was a single-center retrospective review of patients with acute iliofemoral or central DVT treated with the Indigo continuous aspiration mechanical thrombectomy 8 system (Penumbra, Inc, Alameda, Calif) from 2016 to 2017. The primary outcome was technical success, defined as resolution of >70% of thrombus without need for postaspiration CDT, as an initial or adjunctive treatment. Secondary end points included DVT recurrence and treatment complications.
There were 10 patients (50% male) with a median age of 44 years (range, 19-68 years). Indication for treatment was DVT (n = 4), recurrent DVT (n = 1), stent thrombosis (n = 3), high-grade extrinsic narrowing of the inferior vena cava (IVC) due to immunoglobulin G4-related disease (n = 1), and IVC obstruction from liver tumor invasion (n = 1). Five patients had underlying May-Thurner syndrome. Five patients had iliofemoral involvement, two iliocaval, and one iliac vein alone. Two patients had central DVT, one of them involving the IVC and one involving the superior vena cava with brachiocephalic extension. Aspiration thrombectomy was technically successful in a total of six patients. Success was achieved in five of eight patients as the initial or main treatment modality and as an adjunctive treatment in one of two patients. Of the four patients in whom aspiration thrombectomy was not successful, three underwent successful further treatment with CDT. Recurrence after successful aspiration was seen in two patients. One patient developed pulmonary embolism that required no additional treatment. One patient experienced severe headaches treated with oral analgesics.
We observed a technical success of 60% for acute iliofemoral and central DVT with an aspiration thrombectomy system that allowed definitive treatment in one setting. As a novel therapy, this avoided the need for thrombolysis in the majority of selected cases with no bleeding complications and is a promising technique for acute DVT management.
Modern endovascular thrombectomy (MET), using stent retrievers or large-bore distal aspiration catheters in stroke patients with acute basilar artery occlusion (BAO), is routinely performed to date. ...However, more than 35% of BAO patients treated with MET die within 90 days despite high recanalization rates. The purpose of this study is to investigate the parameters associated with 90-day mortality in patients with BAO after MET.
We analyzed 117 consecutive BAO patients included in the Endovascular Treatment in Ischemic Stroke prospective clinical registry of consecutive acute ischemic stroke patients treated with MET (60 patients 51.3% treated with a stent retriever as first-line technique) between March 2010 and April 2017. Successful recanalization was defined as modified thrombolysis In cerebral infarction scores 2b-3 at the end of MET, and mortality was defined as modified Rankin Scale 6 at 90 days. Associations of baseline characteristics (patient and treatment characteristics) and intermediate outcomes (recanalization, complications) with 90-day mortality were investigated in univariate and multivariate analyses.
Overall successful recanalization rate was 79.5, and 41.9% (95% CI 32.8-51.0%) of patients died within 90 days after MET. Patients with successful recanalization had a lower mortality rate (32.9 vs. 74.4%; p < 0.001). Failure of successful recanalization was an independent predictor of mortality (OR 5.1; 95% CI 1.34-19.33). In multivariate analysis, age ≥60 years (OR 6.37; 95% CI 1.74-23.31), admission National Institute of Health Stroke Scale (NIHSS) ≥13 (OR 4.62; 95% CI 1.42-15.03), lower posterior circulation-Alberta Stroke Program Early CT Score (pc-ASPECTS; OR 1.71; 95% CI 1.19-2.44), use of antithrombotic medication prior to stroke onset (OR 3.38; 95% CI 1.03-11.08), absence of intravenous thrombolysis (OR 3.36; 95% CI 1.12-10.03), and angioplasty/stenting of the basilar artery (OR 4.71; 95% CI 1.34-16.54) were independent predictors for mortality after MET.
Failure of successful recanalization was a strong predictor for mortality. In the setting of recanalization, age, admission NIHSS, pc-ASPECTS, absence of intravenous thrombolysis, and angioplasty/stenting of the basilar artery were also independent predictors for mortality after MET of BAO patients.
Endovascular thrombectomy (ET) for acute ischemic stroke is the current standard of care. Although successful ET has high efficacy in improving functional outcomes, the decision to abort a long ...procedure remains a challenge. Longer procedure time (PT) has been associated with lower rates of functional independence.
The objective of this study was to evaluate the impact of PT on outcomes and complications after ET using different techniques at a multicenter level and to define the risk of procedure extension in different patient cohorts.
Patients undergoing ET with a stent retriever (SR) or a direct aspiration at first pass technique at 7 U.S. centers between June 2013 and February 2018 were reviewed from prospectively maintained databases that include baseline variables and technical and clinical outcomes. Multivariate analyses were used to assess impact of PT on 90-day modified Rankin scores, successful recanalization, post-procedural symptomatic hemorrhage (sICH), and complications.
The study included 1,359 patients and demonstrated a decreased likelihood of good functional outcomes (modified Rankin score 0 to 2) when PT extended beyond 30 min (p < 0.01). Rates of sICH and complications increased exponentially with PT (doubling rates of 26 and 50 min, respectively). The cumulative rate of successful recanalization and good outcomes plateaued after 60 min of PT. In patients with PT >30 min, fewer attempts predicted the success of ET and good outcomes (p < 0.01). Successful recanalization was achieved faster with the direct aspiration at first pass technique than in SR. The direct aspiration technique was more sensitive to PT than SR, and posterior stroke was more sensitive to PT than anterior stroke.
Longer ET procedures lead to lower rates of functional independence and higher rates of sICH and complications. Exceeding 60 min or 3 attempts should trigger careful assessment of futility and risks of continuing the procedure.
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First pass effect (FPE) in mechanical thrombectomy is thought to be associated with good clinical outcomes.
To determine FPE rates as a function of thrombectomy technique and to compare clinical ...outcomes between patients with and without FPE.
In July 2020, a literature search on FPE (defined as modified Thrombolysis in Cerebral Infarction (TICI) 2c-3 after a single pass) and modified FPE (mFPE, defined as TICI 2b-3 after a single pass) and mechanical thrombectomy for stroke was performed. Using a random-effects meta-analysis, we evaluated the following outcomes for both FPE and mFPE: overall rates, rates by thrombectomy technique, rates of good neurologic outcome (modified Rankin Scale score ≤2 at day 90), mortality, and symptomatic intracerebral hemorrhage (sICH) rate.
Sixty-seven studies comprising 16 870 patients were included. Overall rates of FPE and mFPE were 28% and 45%, respectively. Thrombectomy techniques shared similar FPE (p=0.17) and mFPE (p=0.20) rates. Higher odds of good neurologic outcome were found when we compared FPE with non-FPE (56% vs 41%, OR=1.78) and mFPE with non-mFPE (57% vs 44%, OR=1.73). FPE had a lower mortality rate (17% vs 25%, OR=0.62) than non-FPE. FPE and mFPE were not associated with lower sICH rate compared with non-FPE and non-mFPE (4% vs 18%, OR=0.41 for FPE; 5% vs 7%, OR=0.98 for mFPE).
Our findings suggest that approximately one-third of patients achieve FPE and around half of patients achieve mFPE, with equivalent results throughout thrombectomy techniques. FPE and mFPE are associated with better clinical outcomes.
Thrombi retrieved from patients with acute ischemic stroke are highly heterogeneous. Recent data suggest that thrombus composition may impact on mechanical thrombectomy, the number of recanalization ...manoeuvres, resistance to retrieval, and on thrombolytic potential. Our aim was to summarize evidence describing the impact of thrombus composition on efficacy of mechanical thrombectomy and thrombolysis in patients with acute ischemic stroke. The scoping review methodology guided by the Joanna Briggs Institute, an adaption of the Arksey and O'Malley, was followed. Comprehensive searches were conducted in MEDLINE, EMBASE, SCOPUS, and Web of Science. Articles were classified into 4 key themes: (1) composition of stroke thrombi, (2) thrombus composition and mechanical thrombectomy, (3) thrombus composition and thrombolytic therapy, and (4) novel imaging and endovascular approaches. Our search identified 698 articles published from 1987 to June 2020. Additional articles were extracted from reference lists of the selected articles. Overall, 95 topic-specific articles identified for inclusion published in 40 different journals were included. Reports showed that thrombus composition in stroke was highly heterogeneous, containing fibrin, platelets, red blood cells, VWF (von Willebrand Factor), and neutrophil extracellular traps. Thrombi could roughly be divided into fibrin- and red blood cell-rich clots. Fibrin-rich clots were associated with increased recanalization manoeuvres, longer procedure time, and less favorable clinical outcomes compared with red blood cell-rich clots. Advances in detection or treatment of thrombi that take into account clot heterogeneity may be able to improve future endovascular and thrombolytic treatment of stroke.
This study evaluates the benefit of endovascular treatment (EVT) for patients with extensive baseline stroke compared with best medical treatment.
This retrospective, multicenter study compares EVT ...and best medical treatment for computed tomography (CT)–based selection of patients with extensive baseline infarcts (Alberta Stroke Program Early CT Score ≤5) attributed to anterior circulation stroke. Patients were selected from the German Stroke Registry and 3 tertiary stroke centers. Primary functional end points were rates of good (modified Rankin Scale score of ≤3) and very poor outcome (modified Rankin Scale score of ≥5) at 90 days. Secondary safety end point was the occurrence of symptomatic intracerebral hemorrhage. Angiographic outcome was evaluated with the modified Thrombolysis in Cerebral Infarction Scale.
After 1:1 pair matching, a total of 248 patients were compared by treatment arm. Good functional outcome was observed in 27.4% in the EVT group, and in 25% in the best medical treatment group (P=0.665). Advanced age (adjusted odds ratio, 1.08 95% CI, 1.05–1.10, P<0.001) and symptomatic intracerebral hemorrhage (adjusted odds ratio, 6.35 95% CI, 2.08–19.35, P<0.001) were independently associated with very poor outcome. Mortality (43.5% versus 28.9%, P=0.025) and symptomatic intracerebral hemorrhage (16.1% versus 5.6%, P=0.008) were significantly higher in the EVT group. The lowest rates of good functional outcome (≈15%) were observed in groups of failed and partial recanalization (modified Thrombolysis in Cerebral Infarction Scale score of 0/1–2a), whereas patients with complete recanalization (modified Thrombolysis in Cerebral Infarction Scale score of 3) with recanalization attempts ≤2 benefitted the most (modified Rankin Scale score of ≤3:42.3%, P=0.074) compared with best medical treatment.
In daily clinical practice, EVT for CT–based selected patients with low Alberta Stroke Program Early CT Score anterior circulation stroke may not be beneficial and is associated with increased risk for hemorrhage and mortality, especially in the elderly. However, first- or second-pass complete recanalization seems to reveal a clinical benefit of EVT highlighting the vulnerability of the low Alberta Stroke Program Early CT Score subgroup.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03356392.
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