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79 result(s) for "Mechanical Thrombolysis - instrumentation"
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Endovascular Treatment with Stent-Retriever Devices for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials
Acute ischemic stroke is a leading cause of death and disability worldwide. Several recent clinical trials have shown that endovascular treatment improves clinical outcomes among patients with acute ischemic stroke. To provide an overall and precise estimate of the efficacy of endovascular treatment predominantly using second-generation mechanical thrombectomy devices (stent-retriever devices) compared to medical management on clinical and functional outcomes among patients with acute ischemic stroke. MEDLINE, EMBASE, Cochrane Collaboration Central Register of Controlled Clinical Trials, Web of Science, and NIH ClinicalTrials.gov were searched through November 2015. Searches returned 3,045 articles. After removal of duplicates, two authors independently screened titles and abstracts to assess eligibility of 2,495 potentially relevant publications. From these, 38 full-text publications were more closely assessed. Finally, 5 randomized controlled trials of endovascular treatment with predominant use of retrievable stents were selected. Three authors independently extracted information on participant and trial characteristics and clinical events using a standardized protocol. Random effects models were used to pool endovascular treatment effects across outcomes. The primary outcome was better functional outcome as measured on the modified Rankin Scale at 90 days of follow-up. Secondary outcomes included all-cause mortality and symptomatic intra-cerebral hemorrhage. Five trials representing 1,287 patients were included. Overall, patients randomized to endovascular therapy experienced 2.22 times greater odds of better functional outcome compared to those randomized to medical management (95% CI, 1.66 to 2.98; P < 0.0001). Endovascular therapy was not associated with mortality [OR (95% CI), 0.78 (0.54, 1.12); P = 0.1056] or symptomatic intracerebral hemorrhage [OR (95% CI), 1.19 (0.69, 2.05); P = 0.5348]. Meta-regression analysis suggested that shorter times from stroke onset to groin puncture and from stroke onset to reperfusion result in better functional outcomes in ischemic stroke patients (P = 0.0077 and P = 0.0089). There were no significant differences in the beneficial effects of endovascular treatment on functional outcomes across categories of gender, age, stroke severity, ischemic changes on computed tomography, or intravenous tissue plasminogen activator administration. This meta-analysis demonstrated superior functional outcomes in subjects receiving endovascular treatment compared to medical management. Further, this analysis showed that acute ischemic stroke patients may receive enhanced functional benefit from earlier endovascular treatment.
REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio (REVISAR)
BackgroundAlthough recently presented randomized trials have failed to prove an overall benefit of mechanical thrombectomy (MT) for patients with medium vessel occlusions (MeVOs), questions remain unanswered, particularly regarding the technology and the role of dedicated small devices. This prospective multicenter, core lab reviewed registry study investigates the efficacy and safety of the APERIO Hybrid used as a first-line device for the treatment of MeVO patients.MethodsData from all MeVO patients who underwent MT with the APERIO or APERIO Hybrid17 as a first-line technique were prospectively included. The primary endpoint was the successful recanalization (Thrombolysis In Cerebral Infarction (TICI) 2b/3) after up to three passes with the APERIO without the use of a rescue technique and without any symptomatic intracranial hemorrhage (ICH).Results134 patients were enrolled from 10 stroke centers. The primary endpoint was reached in 97 patients (81.5%, 95% CI 74.5% to 88.5%). In patients who failed the primary endpoint, TICI 2b/3 was reached with 4 to 6 APERIO passes in 4 patients (3.3%) and with other techniques in 18 patients (15%). Overall recanalization success was 95.8%. TICI 2b/3 with APERIO Hybrid was achieved after the first pass in 76 patients (63.9%), in 23 (19.3%) after 2 passes, and in 1 patient (0.8%) after 3 passes. Modified Rankin Scale (mRS) 0–2 at 90 days was reached by 79.0% of the patients. Symptomatic ICH occurred in no patients, asymptomatic ICH in 16 (13.5%), and subarachnoid hemorrhage in 15 patients (12.6%).ConclusionAPERIO and APERIO Hybrid17 have been proven to be both safe and effective first-line devices for MT in MeVO stroke at different centers and with high rates of successful recanalization.
North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results
Background Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. Methods The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. Results 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2). Conclusions The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.
Development of physiologically relevant synthetic thrombus for use in visual analysis of in vitro mechanical thrombectomy device testing
BackgroundIschemic stroke is a leading cause of death and significant long-term disability worldwide. Mechanical thrombectomy is emerging as a standard treatment for eligible patients. As clinical implementation of stent retrieval and aspiration thrombectomy increases, there is a need for physiologically relevant in vitro device efficacy testing. Critical to this testing is the development of standardized ‘soft’ and ‘hard’ synthetic blood clots that mimic the properties of human thrombi and are compatible with imaging technologies. Synthetic clots allow researchers to extract information regarding clot integration, model hemodynamics, and quantify the physics of thrombectomy.MethodsThis work develops polyacrylamide and alginate-based synthetic clots that are compatible with particle image velocimetry (PIV) and radiographic imaging techniques while maintaining mechanical properties of ‘soft’ and ‘hard’ human clots. Dynamic mechanical analysis testing using an HR2-Rheometer demonstrates comparable mechanical properties to human clots previously tested by this research group and provided in existing literature.ResultsThe synthetic clots are formulated with either 0.5% w/v polyethylene microspheres for PIV visualization or 20% w/v barium sulfate for angiographic visualization, enabling real-time imaging of clot behavior during thrombectomy simulations. The soft formulation shows compressive and shear properties of ~12 kPa and 2–3 kPa, respectively. The hard clots are 3–4 times stiffer, with compressive and shear properties of 41–42 kPa and 8-9 kPa, respectively.ConclusionStandardized synthetic clots offer a platform for reproducible device testing. This provides a greater understanding of mechanical thrombectomy device efficacy, which may lead to quantifiable advances in device development and eventual improved clinical outcomes.
Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever
BackgroundThis study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).MethodsThis was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0–2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.ResultsFifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0–2 at 90 days was 62.0% (95% CI 47.2–75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0–88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9–100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2–19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5–24.3%) for symptomatic cases and 32.0% (19.5–46.7%) for asymptomatic cases.ConclusionThe Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.
Low-profile mechanical thrombectomy devices for large vessel occlusion in pediatric ischemic stroke
BackgroundMechanical thrombectomy (MT) is a well-established treatment modality for large vessel occlusion (LVO) in adults, but there are limited data in the pediatric population. The rarity of the condition makes prospective trial design difficult, and therefore evaluation of MT devices and outcomes is sparse. In pediatric LVO cases, some newer devices may be appropriate for use in revascularization procedures. Furthermore, illustrative specific device-access combinations have rarely been presented in young patients under the age of 5 years.MethodsThis was a single institution experience in intracranial MT procedures for pediatric acute ischemic stroke (AIS). A given procedure was included if there was an attempt at MT between 2015 and 2023.ResultsSixteen endovascular procedures were performed in 15 patients with AIS, with a mean age of 7.4 years; eight patients were <5 years of age. MT was attempted in 15/16 (93.7%) procedures, including 11 (73.3%) in the anterior circulation and four (26.7%) in the posterior circulation; one case recanalized after medical treatment. The most common MT techniques were combined aspiration with a stentriever (n=10, 66.7%) and aspiration alone (n=3, 20%). Traditional stentrievers (4–6 mm) were used in seven cases and low-profile stentrievers in four cases. Improved reperfusion was achieved in all low-profile stentriever cases. Reperfusion of modified Thrombolysis in Cerebral Infaction ≥2b was obtained in 73.3% of cases, including 72.7% of those in which a stentriever was used.ConclusionsLow-profile thrombectomy devices may achieve similar revascularization results to other approaches in challenging clinical scenarios observed in younger children.
Can micro-guidewire advancement forces predict clot consistency and location to assist the first-line technique for mechanical thrombectomy?
BackgroundThe identification of specific clot characteristics before mechanical thrombectomy (MTB) might allow the selection of the most effective first-line technique, thus potentially improving the procedural outcome. We aimed to evaluate if the microwire push forces could extrapolate information on clot consistency and extension before MTB, based on clot mechanical properties.MethodsWe measured in vitro the forces exerted on the proximal extremity of the guidewire during the advancement and retrieval of the guidewire through clot analogs of different compositions. In addition, we analyzed the forces exerted on the guidewire to extrapolate information about the location of the proximal and distal extremities of the clot analogs.ResultsThe maximum forces recorded during the whole penetration phase were significantly different for hard and soft clots (median values, 55.6 mN vs 15.4 mN, respectively; P<0.0001). The maximum slope of the force curves recorded during the advancement of the guidewire for the first 3 s of penetration also significantly differentiated soft from hard clot analogs (7.6 mN/s vs 23.9 mN/s, respectively; P<0.0001). In addition, the qualitative analysis of the shape of the force curves obtained during the advancement and retrieval of the guidewire showed a good potential for the identification of the proximal and distal edges of the clot analogs.ConclusionOur results demonstrated that it was possible to differentiate between soft and hard clot analogs. Furthermore, force measurements could give important information about the location of the clot extremities. Such an approach might support the selection of the first-line MTB technique, with the potential to improve the outcome.
The perplexity of catheter-directed thrombolysis for deep venous thrombosis: the approaches play an important role
The recent adjunctive catheter-directed thrombolysis (ATTRACT) trial rose a controversy about the treatment effect of catheter-directed thrombolysis (CDT) in deep venous thrombosis (DVT). In fact, most studies including the ATTRACT trial did not perform subgroup analysis of catheterization approaches. Different approaches would confound the conclusions. Therefore, a single-center retrospective analysis was performed to compare the differences between the antegrade (AGA) and retrograde (RGA) approaches. Total 217 DVT patients treated with CDT were enrolled from January 2010 to December 2017, with mean age of 55.3 years (67 received antegrade approach, 150 received retrograde approach). The clot burden reduction by segment was evaluated. The mean access establishment time and thrombolytic time were compared. The patency of the iliofemoral vein at 6 months was evaluated. The rate of PTS, quality of life and venous insufficiency were assessed at 1 year. AGA group showed better thrombolytic effect in popliteal and femoral vein than RGA group. The rate of iliofemoral clot burden reduction in RGA group was mostly at Grade II, while most were at Grade III in AGA group. The retrograde approach showed better thrombolysis effect in iliofemoral DVT than popliteal to iliac DVT. The RGA group reported longer mean access establishment time (5.4 ± 1.8 vs 27.0 ± 7.5 min, p < 0.001) and thrombolytic time (6.9 ± 1.5 days vs 6.8 ± 1.5 days, p = 0.586). At 6 months, RGA group had a lower rate of femoral vein patency (52.0% vs 89.6%, p < 0.001) and a higher rate of venous insufficiency (52.0% vs 29.9%, p < 0.001), compared with AGA group. Although there was no difference in the rate of PTS, the RGA group showed higher Villalta scores in the free and mild PTS. The antegrade approach was preferably recommended over the retrograde approach for CDT treatment.
Predictive factors of outcome and hemorrhage after acute ischemic stroke treated by mechanical thrombectomy with a stent-retriever
Introduction The study attempts to identify notable factors predicting poor outcome, death, and intracranial hemorrhage in patients with acute ischemic stroke undergoing mechanical thrombectomy with stent retriever. These data could be useful to improve the selection of patients for thrombectomy. Methods Patients with acute ischemic stroke treated with the Solitaire FR device were retrospectively analyzed from a prospectively collected database. We assessed the effect of selected demographic characteristics, clinical and imaging factors on poor outcome at 3 months (modified Rankin score 3–6), mortality at 3 months, and hemorrhage at day 1 (symptomatic and asymptomatic). Results From May 2010 to April 2012, 59 consecutive patients with an acute ischemic stroke underwent mechanical thrombectomy. At 3 months, 57.6 % of the patients were functionally independent (modified Rankin Scale 0–2) and mortality was 20.4 %. Multivariate analyses revealed that a thrombus length > 14 mm ( p  = 0.02; OR 7.55; 95 % CI 1.35–42.31) and longer endovascular procedure duration ( p  = 0.01; OR 1.04; 95 % CI 1.01–1.07) were independently associated with poor outcome. A higher baseline Alberta Stroke Program Early CT (ASPECT) score ( p  = 0.04; OR 0.79 per point; 95 % CI 0.63–0.99) and successful recanalization ( p  = 0.02; OR 0.07; 95 % CI 0.01–0.72) were independent predictors of good functional outcome. Baseline ASPECT score ( p  < 0.01; OR 0.65; 95 % CI 0.54–0.78) independently predicted symptomatic intracranial hemorrhage at day 1. Conclusion Absolute baseline ASPECT score reflects early symptomatic hemorrhage risk and functional outcome at 3 months. Thrombus length measured on MRI play an important role on functional outcome at 3 months after thrombectomy. Further analyses are needed to determine its importance in the selection of patients for mechanical thrombectomy.
Why Does Mechanical Thrombectomy in Large Vessel Occlusion Sometimes Fail?
Thrombectomy is a technique that has completely changed the management of acute stroke and current devices have shown that they can achieve upwards of 90% successful recanalization in selected cohorts. However, despite the effectiveness of these devices, there are a proportion of patients who still fail to achieve reperfusion of the affected vascular territory and an even larger portion of patients who have poor functional outcomes in spite of successful recanalization. There are no guidelines on how to treat these patients when such failures occur. In an effort to understand the underpinnings of how failed thrombectomy occurs, we extensively reviewed the current literature in clot properties, vascular access problems, stroke pathogenic mechanisms, embolic complications, failed procedures and pre-procedural imaging. A short summary of each of these contentious areas are provided and the current state of the art. Together these elements give a cohesive overview of the mechanisms of failed thrombectomy as well as the controversies facing the field. New techniques and devices can then be developed to minimize such factors during stroke thrombectomy.