A comparative study on endovascular treatment of (sub)acute critical limb ischemia: mechanical thrombectomy vs thrombolysis.
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ABSTRACT: Objective
The aim of this study was to compare different interventional methods for treatment of (sub)acute limb ischemia upon thrombotic occlusions of the lower extremity in terms of their safety and efficacy in a tertiary hospital setting.Design
This is a retrospective, single-center study of non-randomized data.Methods
A total of 202 patients, including 26 critically ill patients, underwent rotational thrombectomy (Rotarex®), local thrombolysis (recombinant tissue plasminogen activator), or combination of both at the University Hospital Heidelberg (2006-2015). The different interventional procedures were compared in terms of overall and amputation-free survival, as well as patency in a 1-year follow-up (Kaplan-Meier analysis).Results
The study demonstrated a primary revascularization success of >98% in all groups. One year after revascularization, primary and secondary patency after mechanical thrombectomy alone were significantly better in comparison to local thrombolysis or a combination of Rotarex® and lysis (63% and 85%, P<0.05). Overall survival 12 months after intervention reached up to 96% in noncritically ill patients, and amputation-free survival was 94.3% in all three groups. Mean hospitalization duration and rate of major bleedings were significantly increased after thrombolysis compared to Rotarex® (P<0.05).Conclusion
In patients with (sub)acute limb ischemia, Rotarex® mechanical thrombectomy represents a safe and effective alternative to thrombolysis and is associated with a reduced rate of major bleedings, shorter hospitalization durations, and lower costs.
SUBMITTER: Kronlage M
PROVIDER: S-EPMC5402877 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
Publications
A comparative study on endovascular treatment of (sub)acute critical limb ischemia: mechanical thrombectomy vs thrombolysis.
Kronlage Mariya M Printz Ilka I Vogel Britta B Blessing Erwin E Müller Oliver J OJ Katus Hugo A HA Erbel Christian C
Drug design, development and therapy 20170418
<h4>Objective</h4>The aim of this study was to compare different interventional methods for treatment of (sub)acute limb ischemia upon thrombotic occlusions of the lower extremity in terms of their safety and efficacy in a tertiary hospital setting.<h4>Design</h4>This is a retrospective, single-center study of non-randomized data.<h4>Methods</h4>A total of 202 patients, including 26 critically ill patients, underwent rotational thrombectomy (Rotarex<sup>®</sup>), local thrombolysis (recombinant ...[more]
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Project description:BackgroundAcute limb ischemia (ALI) is an important clinical event threatening both life and the affected limbs, but the optimal treatment for ALI remains undefined. The aim of this study was to compare the safety and effectiveness of thrombectomy approaches via either catheter-based thrombectomy (CBT) or catheter-directed thrombolysis (CDT).MethodsA total of 98 patients (mean age 69.7 years, 60 male) who underwent endovascular intervention for ALI from January 2015 to July 2019 were included. Of these, 57 were treated with primary CBT via a large-bore catheter, an AngioJet catheter or Rotarex catheter, and/or underwent low-dose CDT, and 41 were treated with primary CDT. The safety and effectiveness of CBT compared to conventional CDT and other various endovascular techniques were evaluated.ResultsMore Rutherford IIb patients were treated with primary CBT (68.4%) than CDT (26.8%; P < .001). Patients who underwent primary CDT achieved a higher technical success rate than those who underwent primary CBT in a shorter procedure time (P < .001), whereas 42.1% of patients who underwent CBT did not need adjunctive CDT. The duration and dosage of adjunctive CDT in the CBT group were significantly decreased compared with those in the primary CDT group (both P < .001), and the CBT group achieved a shorter in-hospital length of stay (P < .001). Subgroup analysis revealed that patients treated with AngioJet and Rotarex catheters achieved slightly lower dosages, shorter CDT durations and shorter in-hospital stay lengths than those treated with large-bore catheters (P > .05). Clinical success was estimated to be achieved in 98.2% of patients who underwent CBT, which is similar to the 97.6% estimated in those who underwent primary CDT (P = 1.000), and this finding was similar among the CBT subgroups. Patients who underwent CBT had a higher procedure-related distal embolization rate and economic cost than those who underwent primary CDT (P < .05), but it had slightly fewer complications than those who underwent primary CDT (P = .059), especially minor complications (P = .036). The freedom from amputation at 6 and 12 months for CBT and CDT was assessed (93.0% vs 90.2% respectively, P = .625; 89.5% vs 82.9%, respectively, P = .34,). Comparable limb salvage was found for different techniques of large bore catheters, AngioJet catheters and Rotarex catheters. The Kaplan-Meier table analysis also showed similar limb salvage rates between groups.ConclusionsEndovascular treatment of ALI with the use of catheter-based therapies is an effective modality that can reduce the requirement for thrombolysis, with expected reductions in hemorrhagic complications, but at the risk of remediable distal emboli and increased economic cost. It has a similar clinical outcome to conventional CDT alone. Different CBT techniques have comparable efficacy but different adverse event profiles.
| S-EPMC8645071 | biostudies-literature
Project description:ImportanceThe Bypass Versus Angioplasty for Severe Ischemia of the Leg randomized controlled trial showed comparable outcomes between endovascular revascularization (ER) and surgical revascularization (SR) for patients with critical limb ischemia (CLI). However, several observational studies showed mixed results. Most of these studies were conducted before advanced endovascular technologies were available.ObjectiveTo compare ER and SR treatment strategies for 6-month outcomes among patients with CLI.Design, setting, and participantsThis retrospective, population-based cohort study used the Nationwide Readmissions Database to identify 66 277 patients with CLI who underwent ER or SR from January 1, 2016, to December 31, 2018. Data analyses were conducted from January 1, 2022, to February 8, 2022. A propensity score with 1:1 matching was applied. Patients with CLI who underwent ER or SR were identified, and those with missing information on the length of stay and/or younger than 18 years were excluded.ExposuresEndovascular or surgical revascularization.Main outcomes and measuresThe primary outcome was a major amputation at 6 months. Significant secondary outcomes were in-hospital and 6-month mortality and an in-hospital safety composite of acute kidney injury, major bleeding, and vascular complication. Subgroup analysis was conducted for major amputation in high-volume centers.ResultsA total of 66 277 patients were identified between 2016 and 2018 who underwent ER or SR for CLI. The Nationwide Readmissions Database does not provide racial and ethnic categories. The mean (SD) age of the cohort was 69.3 (12) years, and 62.5% of patients were male. A total of 54 546 patients (82.3%) underwent ER and 11 731 (17.7%) underwent SR. After propensity score matching, 11 106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10 090 [9.9%] vs 869 of 10 318 [8.4%]; hazard ratio, 1.18; 95% CI, 1.08-1.29; P = .001). However, no difference was observed in major amputation risk when both procedures were performed in high-volume centers. Endovascular revascularization and SR had similar mortality rates (517 of 11 106 [4.7%] vs 490 of 11 106 [4.4%]; hazard ratio, 1.06; 95% CI, 0.93-1.20; P = .39). However, the ER group had a 17% lower risk of in-hospital safety outcomes compared with the SR group (2584 of 11 106 [23.3%] vs 2979 of 11 106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P < .001).Conclusions and relevanceThe results of this study suggest that ER was safer, without any difference in mortality, but ER was associated with an increased risk of major amputation compared with SR. However, the risk of major amputation was similar when both procedures were performed at high-volume centers.
| S-EPMC9391961 | biostudies-literature
Project description:Cerebral venous sinus thrombosis (CVST) is a rare cause of cerebral infarction. Once patients survive the acute phase, long-term prognosis is generally satisfactory. CVST patients who harbored risk factors known for poor prognosis (e.g., deterioration of consciousness/neurological functions and seizures) were oftentimes unresponsive to systemic heparin treatment. The advantage of combined endovascular mechanical thrombectomy (EMT) and on-site chemical thrombolysis (OCT) plus systemic heparin for CVST over the heparin treatment alone has not been proved. A retrospective study was conducted to analyze consecutive patients with CVST from 2005 to 2015. Patients having clinical improvement or stable disease after heparin treatment were in I/S group; patients having continuous deterioration of consciousness/neurological functions and refractory seizures (despite the use of multiple anti-epileptic drugs) after heparin treatment were in D group. EMT and OCT were indicated for patients in D group. Imaging studies and medical records were reviewed for statistical analysis. Safety issues included new-onset/progression of symptomatic intracerebral hemorrhages (ICH) or procedure-related complications. Total thirty patients were included (I/S group = 16; D group = 14). In D group, the mean time frame from the start of heparin treatment to the endovascular treatment was 3.2 days. Compared with I/S group, all patients in D group had complete stenosis of the sinuses, with higher initial mRS, lower initial GCS, and more seizures (p = 0.006, 0.007, and 0.031, respectively), but no significant differences in the mRS at discharge (p = 0.504). Shorter length of thrombosis and lower initial mRS were associated with better outcomes (p = 0.009 and 0.003, respectively). Thrombosis involving the superior sagittal sinus (SSS) was associated with bad outcomes (p = 0.026). There were two patients (6.7%) with worsening symptomatic ICH, one in each group, managed surgically. The overall mortality of the study was 6.7% (2/30). Combined EMT and OCT after heparin treatment for severe CVST were reasonably safe, which might be considered as a salvage treatment in severe CVST patients who are unresponsive to heparin with heavy clot burden involving SSS in the acute phase. However, further studies are needed to confirm its efficacy and validity.
| S-EPMC7080812 | biostudies-literature
Project description:Renal artery embolism (RAE) is an uncommon event that is associated with a high rate of renal loss. We present a case of RAE to a solitary kidney that was treated with combined percutaneous rheolytic thrombectomy, intra-arterial thrombolysis, and supplemental renal artery stent placement.
| S-EPMC3331639 | biostudies-other
Project description:BackgroundThe efficacy and safety of mechanical thrombectomy (MT) in acute large vessel occlusion (LVO) patients with minor stroke (NIHSS ≤ 5) remains undetermined. We aimed to compare the efficacy and safety of intra-arterial thrombolysis (IAT) alone vs. MT for LVO patients with minor stroke.MethodsPatients were selected from the Acute Ischemic Stroke Cooperation Group of Endovascular Treatment (ANGEL) registry, a prospective multicenter registry study, and divided into MT and IAT alone groups. We compared the outcome measures between the two groups, including 90-day functional outcome evaluated by the modified Rankin Scale (mRS), the final recanalization level, intracranial hemorrhage, and mortality within 90-days by logistic regression models with adjustment. Besides the conventional multivariable analysis, we performed a sensitivity analysis by adjusting the propensity score to confirm our results. The propensity score was derived using a logistic regression model.ResultsOf the 120 patients, 63 received IAT alone and 57 received MT as the first-line treatment strategy. As compared to MT group, patients in the IAT alone group were associated with a higher chance of 90-day mRS 0-2 [93.7% vs. 71.9%, odds ratio (OR) = 4.75, 95% confidence interval (CI): 1.20-18.80, P = 0.027], a high chance of 90-day mRS 0-3 (96.8% vs. 86.7%, OR = 11.35, 95% CI: 1.93-66.86, P = 0.007), a shorter median time from puncture to recanalization (PTR) (60 min vs. 100 min, β = -63.70, 95% CI: -81.79- -45.61, P < 0.001), a lower chance of any intracranial hemorrhage (ICH) within 48 h (3.2% vs. 19.3%, OR = 0.15, 95% CI: 0.03-0.79, P = 0.025), and a lower chance of mortablity within 90 days (1.6% vs. 9.2%, OR = 0.05, 95% CI: 0.01-0.57, P = 0.016). Similarly, the sensitivity analysis showed the robustness of the primary analysis.ConclusionsCompared with MT, IAT may improve 90-day clinical outcomes with decreased ICH rate and mortality in LVO patients with minor stroke.
| S-EPMC9315389 | biostudies-literature
Project description:BackgroundThe smoking-paradox of a better outcome in ischemic stroke patients who smoke may be due to increased efficacy of thrombolysis. We investigated the effect of smoking on outcome following endovascular therapy (EVT) with mechanical thrombectomy alone versus in combination with intra-arterial (IA-) thrombolysis.MethodsThe primary endpoint was defined by three-month modified Rankin Scale (mRS). We performed a generalized linear model and reported relative risks (RR) for smoking (adjustment for age, sex, hypertension, atrial fibrillation, stroke severity, time to EVT) in patient data stemming from the Virtual International Stroke Trials Archive-Endovascular database.ResultsAmong 1,497 patients, 740(49.4%) were randomized to EVT; among EVT patients, 524(35.0%) received mechanical thrombectomy alone and 216(14.4%) received it in combination with IA-thrombolysis. Smokers (N = 396) had lower mRS scores (mean 2.9 vs. 3.2; p = 0.02) and mortality rates (10% vs. 17.3%; p<0.001) in univariate analysis. In all patients and in patients treated with mechanical thrombectomy alone, smoking had no effect on outcome in regression analyses. In patients who received IA-thrombolysis (N = 216;14%), smoking had an adjusted RR of 1.65 for an mRS≤1 (95%CI 0.77-3.55). Treatment with IA-thrombolysis itself led to reduced RR for favorable outcome (adjusted RR 0.30); interaction analysis of IA-thrombolysis and smoking revealed that non-smokers with IA-thrombolysis had mRS≤2 in 47 cases (30%, adjusted RR 0.53 [0.41-0.69]) while smokers with IA-thrombolysis had mRS≤2 in 23 cases (38%, adjusted RR 0.61 [0.42-0.87]).ConclusionsSmokers had no clear clinical benefit from EVT that incorporates IA-thrombolysis.
| S-EPMC8136663 | biostudies-literature
Project description:ObjectiveThrombolytic therapy has been a mainstay of treatment for massive or submassive pulmonary embolism (PE), a common and highly morbid pathology. New percutaneous mechanical thrombectomy (PMT) devices have recently become widely available and have been used increasingly for the treatment of acute PE, but evidence demonstrating its efficacy over standard catheter-directed lytic protocol remains limited.MethodsUsing TriNetX Data Network, a global federated database of >250 million patients, we conducted a retrospective cohort study of patients from January 2017 to August 2023 with a diagnosis of PE, treated with either PMT or catheter-directed thrombolysis (CDT). Eligible patients were 1:1 propensity score-matched for preoperative covariates including demographics and comorbidities. We calculated and compared the 30-day outcomes of all-cause mortality, bleeding complications (blood transfusion, gastrointestinal bleed, and intracranial hemorrhage), diagnosis of acute respiratory failure (RF), myocardial infarction (MI), and pulmonary hypertension (PH) using odds ratios (OR) with 95% confidence intervals (CIs). Also, the 5-year outcomes of all-cause mortality, a composite outcome of chronic PH (chronic PE, chronic cor pulmonale, chronic thromboembolic PH), right heart failure (RHF), RF, and emergency department visits, were compared using hazard ratios (HRs) with 95% CIs.ResultsWe identified 2978 patients treated with PMT and 1137 patients treated with CDT. After matching, we compared 1102 patients in each cohort. For 30-day outcomes, all-cause mortality, acute RF, and blood transfusion were similar between the two groups. However, compared with CDT, PMT was associated with a better safety profile, including lower bleeding risk for both ICH (OR, 0.46; 95% CI, 0.24-0.890) and gastrointestinal bleed (OR, 0.42; 95% CI, 0.28-0.63). PMT also demonstrated better immediate functional outcomes, with less PH (OR, 0.53; 95% CI, 0.41-0.68) and MI (OR, 0.54; 95% CI, 0.41-0.76). At 5 years, the all-cause mortality and RF for both procedures were similar, but PMT was associated with lower rates of chronic PH (HR, 0.70; 95% CI, 0.55-0.90), RHF (HR 0.49; 95% CI, 0.37-0.65), and emergency department visits (348 for PMT vs 426 for CDT; P < .01).ConclusionsIn patients undergoing catheter-based therapy for PE, PMT has an improved procedural safety profile vs CDT and results in significantly fewer 30-day postoperative complications, with fewer bleeding events, and is also associated with fewer periprocedural MIs and less acute PH. Perhaps, more important, PMT also demonstrated improved long-term outcomes with significantly fewer chronic PH and RHF diagnoses with fewer emergency department visits.
| S-EPMC11774124 | biostudies-literature
Project description:BackgroundHigh-risk patients with advanced peripheral artery disease (PAD), including critical limb ischemia (CLI), are often excluded from peripheral endovascular device intervention clinical trials, leading to difficulty in translating trial results into real-world practice. There is a need for prospectively assessed studies to evaluate peripheral endovascular device intervention outcomes in CLI patients.MethodsLIBERTY 360 is a prospective, observational, multi-center study designed to evaluate the procedural and long-term clinical outcomes of peripheral endovascular device intervention in real-world patients with symptomatic lower-extremity PAD. One thousand two hundred and four patients were enrolled and stratified based on Rutherford Classification (RC): RC2-3 (N=501), RC4-5 (N=603), and RC6 (N=100). For this sub-analysis, RC5 and RC6 patients (RC5-6; N=404) were pooled and 1-year outcomes were assessed.ResultsProcedural complications rarely (1.7%) resulted in post-procedural hospitalization and 89.1% of RC5-6 patients were discharged to home. Considering the advanced disease state in RC5-6 patients, there was a high freedom from 1-year major adverse event rate of 65.5% (defined as target vessel revascularization, death to 30 days, and major target limb amputation). At 1 year, freedom from major amputation was 89.6%. Wounds identified at baseline on the target limb had completely healed in 172/243 (70.8%) of the RC5-6 subjects by 1 year. Additionally, the overall quality of life, as measured by VascuQoL, improved from baseline to 1 year.ConclusionLIBERTY investigated real-world PAD patients with independent oversight of outcomes. This analysis of LIBERTY RC5-6 patients demonstrates that peripheral endovascular device intervention can be successful in CLI patients, with low rates of major amputation and improvement in wound healing and quality of life through 1-year follow-up.LIBERTY 360, https://clinicaltrials.gov/ct2/show/NCT01855412, ClinicalTrials.gov Identifier: NCT01855412.
| S-EPMC7020930 | biostudies-literature
Project description:ObjectiveOur objective was to analyze periprocedural and 1-year outcomes of peripheral endovascular intervention (PVI) for critical limb ischemia (CLI).MethodsWe reviewed 1244 patients undergoing 1414 PVIs for CLI (rest pain, 29%; tissue loss, 71%) within the Vascular Study Group of New England (VSGNE) from January 2010 to December 2011. Overall survival (OS), amputation-free survival (AFS), and freedom from major amputation at 1 year were analyzed using the Kaplan-Meier method. Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).ResultsThe number of arteries treated during each procedure were 1 (49%), 2 (35%), 3 (12%), and ≥4 (5%). Target arterial segments and TransAtlantic Inter-Society Consensus classifications were aortoiliac, 27% (A, 48%; B, 28%; C, 12%; and D, 12%); femoral-popliteal, 48% (A, 29%; B, 34%; C, 20%; and D, 17%); and infrapopliteal, 25% (A, 17%; B, 14%; C, 25%; D, 44%). Technical success was 92%. Complications included access site hematoma (5.0%), occlusion (0.3%), and distal embolization (2.4%). Mortality and major amputation rates were 2.8% and 2.2% at 30 days, respectively. Overall percutaneous or open reintervention rate was 8.0% during the first year. At 1-year, OS, AFS, and freedom from major amputation were 87%, 87%, and 94% for patients with rest pain and 80%, 71%, and 81% for patients with tissue loss. Independent predictors of reduced 1-year OS (C index = .74) included dialysis (HR, 3.8; 95% CI, 2.8-5.1; P < .01), emergency procedure (HR, 2.5; 95% CI, 1.0-6.2; P = .05), age >80 years (HR, 2.2; 95% CI, 1.7-2.8; P < .01), not living at home preoperatively (HR, 2.0; 95% CI, 1.4-2.8; P < .01), creatinine >1.8 mg/dL (HR, 1.9; 95% CI, 1.3-2.8; P < .01), congestive heart failure (HR, 1.7; 95% CI, 1.3-2.2; P < .01), and chronic β-blocker use (HR, 1.4; 95% CI, 1.0-1.9; P = .03), whereas independent preoperative ambulation (HR, 0.7; 95% CI, 0.6-0.9; P = .014) was protective. Independent predictors of major amputation (C index = .69) at 1 year included dialysis (HR, 2.7; 95% CI, 1.6-4.5; P < .01), tissue loss (HR, 2.0; 95% CI, 1.1-3.7; P = .02), prior major contralateral amputation (HR, 2.0; 95% CI, 1.1-3.5; P = .02), non-Caucasian race (HR, 1.7; 95% CI, 1.0-2.9; P = .045), and male gender (HR, 1.6; 95% CI, 1.1-2.6; P = .03), whereas smoking (HR, .60; 95% CI, 0.4-1.0; P = .042) was protective.ConclusionsSurvival and major amputation after PVI for CLI are associated with different patient characteristics. Dialysis dependence is a common predictor that portends especially poor outcomes. These data may facilitate efforts to improve patient selection and, after further validation, enable risk-adjusted outcome reporting for CLI patients undergoing PVI.
| S-EPMC5315445 | biostudies-literature
Project description:ImportanceIntravenous thrombolysis (IVT) followed by mechanical thrombectomy (MT) is recommended to treat acute ischemic stroke (AIS) with a large vessel occlusion (LVO). Most hospitals do not have on-site MT facilities, and most patients need to be transferred secondarily after IVT (drip and ship), which may have an effect on the neurologic outcome.ObjectiveTo compare the functional independence at 3 months between patients treated under the drip-and-ship paradigm and those treated on site (mothership).Design, setting, and participantsThis study used a prospectively gathered registry of patients with AIS to select patients admitted through the Saint-Antoine and Tenon (drip and ship) or the Fondation Rothschild (mothership) hospitals from January 1, 2013, through April 30, 2016. The study included patients older than 18 years treated with bridging therapy for AIS with LVO of the anterior circulation. Among the 159 patients who received MT at the mothership, 100 had been transferred after IVT from the drip-and-ship hospitals and 59 had received IVT on site.Main outcomes and measuresThe main outcome was 3-month functional independence (modified Rankin scale score ≤2). Both groups were compared using a multivariate linear model, including variables that were significantly different in the 2 groups.ResultsDuring the study period, 497 patients were hospitalized at the drip-and-ship and mothership hospitals for an AIS eligible to reperfusion therapy; 11 patients had a basilar artery occlusion and were excluded, leaving 100 patients in the drip-and-ship group (mean age, 73 years; age range, 60-81 years; 57 men [57.0%]) and 59 in the mothership group (mean age, 70 years; age range, 58-82 years; 29 men [49.2%]). The proportion of patients with a favorable neurologic outcome at 3 months was similar in both groups (drip and ship, 61 [61.0%]; mothership, 30 [50.8%]; P = .26), even after adjusting the analysis for the baseline National Institutes of Health Stroke Scale score, diffusion-weighted imaging Alberta Stroke Program Early Computed Tomography Score, and general anesthesia (P = .82). Patients had less severe conditions in the drip-and-ship group (median baseline National Institutes of Health Stroke Scale score, 15 vs 17 [P = .03]; median diffusion-weighted imaging Alberta Stroke Program Early Computed Tomography Score, 7.5 vs 7 [P = .05]). Process times were longer in the drip-and-ship group (onset-to-needle time, 150 vs 135 minutes; onset-to-puncture time, 248 vs 189 minutes; and onset-to-recanalization time, 297 vs 240 minutes; P < .001). Both groups were similar in terms of substantial recanalization (Thrombolysis in Cerebral Ischemia scores 2B to 3; drip and ship, 84 [84.0%]; mothership, 47 [79.7%]; P = .49) and symptomatic hemorrhagic transformation (drip and ship, 2 [2.0%]; mothership, 2 [3.4%]; P = .63).Conclusions and relevanceThis study found that patients treated under the drip-and-ship paradigm also benefit from bridging therapy, with no statistically significant difference compared with those treated directly in a comprehensive stroke center.
| S-EPMC5822198 | biostudies-literature