Can a Stent Retriever Damage the JET 7 Reperfusion Catheter?
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SUBMITTER: Pearly Ti J
PROVIDER: S-EPMC7963241 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND AND PURPOSE:In 5%-10% of patients with acute ischemic stroke with an intention to treat with mechanical thrombectomy, no reperfusion can be achieved (Thrombolysis in Cerebral Infarction score = 0/1). Purpose of this analysis was a systematic assessment of underlying reasons for reperfusion failures. MATERIALS AND METHODS:An intention-to-treat single-center cohort (n = 592) was re-evaluated for all patients in whom no reperfusion could be achieved (n = 63). Baseline characteristics of patients were compared between patients with and without reperfusion failures. After qualitative review of all cases with reperfusion failures, a classification system was proposed and relative frequencies were reported. In a second step, occurrence of delayed recanalization at 24 hours after reperfusion failure and dependency on IV-tPA were evaluated. RESULTS:In 63/592 patients with an intention to perform stent-retriever thrombectomy, no reperfusion was achieved (TICI 0/1, 10.6%, 95% CI, 8.2%-13.1%). Older patients (adjusted OR per yr = 1.03; 95% CI, 1.01-1.05) and patients with M2 occlusion (adjusted OR = 3.36; 95% CI, 1.82-6.21) were at higher risk for reperfusion failure. In most cases, no reperfusion was a consequence of technical difficulties (56/63, 88.9%). In one-third of these cases, reperfusion failures were due to the inability to reach the target occlusion (20/63, 31.7%), while "stent-retriever failure" occurred in 39.7% (25/63) of patients. Delayed recanalization was very rare (18.2%), without dependence on IV-tPA pretreatment status. CONCLUSIONS:Reasons for reperfusion failure in stent-retriever thrombectomy are heterogeneous. The failure to establish intracranial or cervical access is almost as common as stent-retriever failure after establishing intracranial access. Systematic reporting standards of reasons may help to further estimate relative frequencies and thereby guide priorities for technical development and scientific effort.
| S-EPMC7410746 | biostudies-literature
Project description:BackgroundThe Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system.MethodsSOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b-3) with ≤3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices).ResultsAfter enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10-19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%-91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c-3) of 60% (95% CI, 48.4%-71.1%; 43/72 patients). After noninferiority was confirmed (P<0.01), the ANA device also showed superiority in the rate of successful reperfusion with ≤3 passes (P=0.02). First-pass successful recanalization rate was 55.6% (95% CI, 44.1%-67.0%), with a first-pass complete recanalization rate of 38.9% (95% CI, 27.6%-50.1%). Rescue therapy to obtain a modified Thrombolysis in Cerebral Infarction score 2b-3 was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome (modified Rankin Scale score 0-2) was 57.5% (95% CI, 46.2%-68.9%), and the rate of excellent functional outcome (modified Rankin Scale score 0-1) was 45.2% (95% CI, 33.8%-56.6%). The rate of severe adverse device related was 1.4%.ConclusionsIn this clinical experience, the ANA device achieved a high rate of complete recanalization with a preliminary good safety profile and favorable 90 days clinical outcomes.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT04095767.
| S-EPMC9232250 | biostudies-literature
Project description:Background and purposeRevascularization of large cerebral artery occlusion is the therapeutic goal in stroke therapy. Currently, many recanalization devices are in clinical use. This study compares the outcome parameters, efficacy, and safety of the new generation of stent-retriever devices with the well-established Merci retriever.Materials and methodsAll patients who received endovascular mechanical recanalization therapy were prospectively registered. One hundred twenty-two patients were treated with either new stent retrievers, including the Trevo and Solitaire devices, or the Merci retriever system. Recanalization of the occluded vessel was assessed in accordance with the modified TICI score, and outcome parameters, including the NIHSS and mRS scores, were documented. Clinical status was recorded after neurointervention, at time of discharge, and after 90 days.ResultsThe mean age of all patients was 68 years; 54% were male, with no statistical differences in demographics between both groups. Successful recanalization (TICI 3 and TICI 2b) was achieved in 82% of patients treated with stent retrievers compared with 62% of patients treated with Merci retrievers (P = .016). In the 90-day follow-up, 65% of patients treated with stent retrievers and 35% of those treated with the Merci had achieved a good (mRS = 0-2) clinical outcome (P = .002). Patients treated with stent retrievers had a significantly shorter treatment time (72 versus 122 minutes, P < .01) and less severe intracerebral hemorrhages (10% versus 28%, P < .01).ConclusionsPatients treated with Trevo and Solitaire stents had a better revascularization rate, better clinical outcome, and lower complication rate than patients treated with the Merci retriever.
| S-EPMC7965100 | biostudies-literature
Project description:PurposeRapid revascularization in emergent large vessel occlusion with endovascular embolectomy has proven clinical benefit. We sought to measure device-clot interaction as a potential mechanism for efficient embolectomy.MethodsTwo different radiopaque clot models were injected to create a middle cerebral artery occlusion in a patient-specific vascular phantom. A radiopaque stent retriever was deployed within the clot by unsheathing the device or a combination of unsheathing followed by pushing the device (n=8/group). High-resolution cone beam CT was performed immediately after device deployment and repeated after 5?min. An image processing pipeline was created to quantitatively evaluate the volume of clot that integrates with the stent, termed the clot integration factor (CIF).ResultsThe CIF was significantly different for the two deployment variations when the device engaged the hard clot (p=0.041), but not the soft clot (p=0.764). In the hard clot, CIF increased significantly between post-deployment and final imaging datasets when using the pushing technique (p=0.019), but not when using the unsheathing technique (p=0.067). When we investigated the effect of time on CIF in the different clot models disregarding the technique, the CIF was significantly increased in the final dataset relative to the post-deployment dataset in both clot models (p=0.004-0.007).ConclusionsThis study demonstrates in an in vitro system the benefit of pushing the Trevo stent during device delivery in hard clot to enhance integration. Regardless of delivery technique, clot-device integration increased in both clot models by waiting 5?min.
| S-EPMC5136713 | biostudies-literature
Project description:ObjectiveTo explore the effects of reperfusion grade rates on clinical outcomes in the setting of stent-retriever-based reperfusion therapy for anterior circulation stroke in early time windows.MethodsSystematic searching of Medline and Embase databases was performed to identify stroke trials of stent-retriever-based therapy versus standard care. Mixed effects meta-regression was used to analyze the trial-level association between reperfusion rates and clinical outcomes.ResultsA total of five trials met the inclusion criteria (n?=?1,287). Rates of successful reperfusion [modified thrombolysis in cerebral ischemia grade 2b/3] demonstrated strong evidence for an association with good functional outcomes [modified Rankin scale score (mRS) 0-2] OR 1.59 (95% CI 1.16, 2.19) p?=?0.019 and very strong evidence for an association with excellent functional outcomes (mRS 0-1) OR 2.10 (95% CI 1.46, 3.01) p?=?0.007. In addition, there was weak evidence for an association with symptomatic intracranial hemorrhage OR 0.54 (95% CI 0.28, 1.04) p?=?0.057 and mortality OR 0.69 (95% CI 0.69, 1.01) p?=?0.053.ConclusionIn early, stent-retriever-based acute ischemic stroke treatment, reperfusion appears to be a major predictor of outcomes. Every 10% increase in the rates of successful reperfusion is associated with an 11% increase in the probability of achieving good and 17% increase in the probability of achieving excellent outcomes. Symptomatic intracranial hemorrhage and mortality may be decreased as reperfusion rates are improved.
| S-EPMC5968377 | biostudies-literature
Project description:This retrospective study investigated whether the volume or density of the thrombus is predictive of recanalization in stent retriever (SR) treatment. Consecutive patients treated with SR thrombectomy as the first endovascular modality were enrolled. The thrombus volume and density were measured on thin-section noncontrast computed tomography using 3-dimensional software. The patients were grouped by recanalization status and the number of SR passes. Among 165 patients, recanalization was achieved with the first pass in 68 (50.0%), 2-3 passes in 43 (31.6%), and ?4 passes in 25 (18.4%) patients. The thrombus volume was smaller in patients with (107.5 mm3) than without (173.7 mm3, p?=?0.025) recanalization, and tended to be larger with increasing number of passes (p for trend?=?0.001). The thrombus volume was an independent predictor of first-pass recanalization (odds ratio 0.93 per 10 mm3, 95% confidence interval 0.89-0.97). However, the thrombus density was not associated with recanalization success. Recanalization within 3 passes was associated with a favorable outcome. In conclusion, the thrombus volume was significantly related to recanalization in SR thrombectomy. Measuring the thrombus volume was particularly predictive of first-pass recanalization, which was associated with a higher likelihood of a favorable outcome.
| S-EPMC5698357 | biostudies-literature
Project description:BackgroundThe 'first pass effect' (FPE), which was originally described with stent retrievers, designates a (near-)complete revascularization obtained after a single device pass with no rescue therapy, and is associated with improved clinical outcome and decreased mortality.ObjectiveWe report the rate and benefits of FPE in the Aspiration versus Stent Retriever (ASTER) trial.Materials and methodsASTER is a randomized trial comparing angiographic revascularization with the stent retriever (SR) and contact aspiration (CA) thrombectomy techniques, assessed by an external core laboratory using the modified Thrombolysis in Cerebral Infarction (mTICI) scale. Rates of FPE (defined by mTICI 2c/3 after a single pass with no rescue therapy) were compared between patients treated with SR and CA techniques. Outcomes were compared between FPE-SR and FPE-CA patients, and between FPE and non-FPE patients.ResultsFPE was achieved in 97/336 patients (28.9%), with no significant difference between SR and CA (respectively 53/169 patients (31.3%) vs 44/167 patients (26.3%), adjusted RR for CA versus SR 0.84, 95% CI 0.54 to 1.31; p=0.44). After prespecified adjustment for allocated arm and randomization stratification factors, FPE in patients was associated with a significantly improved clinical outcome and a decreased mortality, and a significantly lower rate of hemorrhagic transformation and procedural complications than in non-FPE patients.ConclusionIn the ASTER trial, similar rates of FPE were achieved with SR and CA, and FPE was associated with a significantly improved outcome. New techniques and devices to improve the rate of FPE are warranted.Trial registration numberUnique identifier: NCT02523261.
| S-EPMC7146919 | biostudies-literature
Project description:Feasibility of endovascular stentectomy using a snare over stent-retriever (SOS) technique was evaluated in a silicon flow model and an in vivo swine model. In vitro, stentectomy of different intracranial stents using the SOS technique was feasible in 22 out of 24 (92%) retrieval maneuvers. In vivo, stentectomy was successful in 10 out of 10 procedures (100%). In one case self-limiting vasospasm was observed angiographically as a technique related complication in the animal model. Endovascular stentectomy using the SOS technique is feasible in an experimental setting and may be transferred to a clinical scenario.
| S-EPMC5444789 | biostudies-literature
Project description:Background and Purpose: The benefits of mechanical thrombectomy (MT) in vertebrobasilar artery occlusions have not been well-studied. We compared clinical, procedural, and safety outcomes of MT for posterior circulation (PC) vs. anterior circulation (AC) occlusions among patients in the STRATIS registry. Methods: Data from STRATIS including patient demographics, procedural characteristics, and outcomes including symptomatic intracranial hemorrhage (sICH) at 24 h, serious adverse events (SAE), substantial reperfusion [modified thrombolysis in cerebral infarction (mTICI) 2b/3], 90-day functional independence [modified Rankin Scale (mRS) 0-2], and 90-day mortality were analyzed. Univariate logistic regression was used to calculate predictors of good clinical outcome. Results: Of 984 STRATIS patients, 43 (4.4%) patients with PC occlusions [mean age 63.0 ± 13.6, 25.6% (11/43) female] and 932 (94.7%) with AC occlusions [mean age 68.5 ± 14.8, 46.9% (437/932) female] were included for analysis. Median National Institutes of Health Stroke Scale (NIHSS) scores at baseline were 17.0 (13.0, 12.0) for the AC group and 12.0 (11.0, 24.0) for the PC group. Time from onset to procedure end was longer for the PC group [median (IQR): 322.0 min (255.0-421.0) vs. 271.0 min (207.0-360.0); p = 0.007]. PC and AC groups had similar rates of substantial reperfusion [89.2% (33/37) vs. 87.7% (684/780)], procedure-related SAE [0.0% (0/43) vs. 1.7% (16/932)], sICH [0.0% (0/38) vs. 1.5% (12/795)], 90-day functional independence [66.7% (26/39) vs. 55.9% (480/858)] and mortality [12.8% (5/39) vs. 15.8% (136/861)]. National Institutes of Health Stroke Scale score and patient sex were significant univariate predictors of good clinical outcome (p < 0.05). Conclusions: Despite longer reperfusion times, MT in PC stroke has similar rates of 90-day functional independence with no significant difference in procedure-related SAE, sICH, or mortality, supporting the use of MT in PC acute ischemic stroke (AIS). Clinical Trial Registration:https://www.clinicaltrials.gov, Identifier: NCT02239640.
| S-EPMC8421856 | biostudies-literature
Project description:BackgroundTigertriever (Rapid Medical, Sunrise, FL) is an adjustable-diameter stent retriever that is being tested in an investigational device exemption clinical trial, Treatment with Intent to Generate Reperfusion (TIGER). The retriever is available in three lengths with corresponding adjustable diameters; however, a single device cannot be used for multiple thrombectomy attempts. A clicker-based expansion mechanism allows incremental expansion of the retriever and step-wise increase in radial force to the parent vessel diameter. The clicker mechanism is used to expand the stent retriever until it is apposed with the vessel walls. Rest of the procedure is similar to a mechanical thrombectomy performed with a conventional stent retriever and is demonstrated in the video.Case descriptionWe present a case of a 59-year-old woman who presented with left-upper extremity weakness, facial droop, and hemineglect. Perfusion imaging demonstrated increased time-to-peak. Angiography showed right internal carotid artery terminus occlusion. The patient underwent successful mechanical thrombectomy (Thrombolysis in Cerebral Infarction 2b reperfusion) using the Tigertriever and was discharged home without any perioperative complications.ConclusionAn adjustable, expandable stent retriever allows operator to size the stent retriever to match the target artery diameter. The expandable design of stent retriever has potential implications for distal vessel occlusion mechanical thrombectomy.
| S-EPMC7771483 | biostudies-literature