Can a Stent Retriever Damage the JET 7 Reperfusion Catheter?
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ABSTRACT:
SUBMITTER: Pearly Ti J
PROVIDER: S-EPMC7963241 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
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Can a Stent Retriever Damage the JET 7 Reperfusion Catheter?
Pearly Ti J J Yeo L L Anil G G
AJNR. American journal of neuroradiology 20201015 12
We encountered 2 separate instances of damage to JET 7 reperfusion catheters when they were used in conjunction with a stent retriever during mechanical thrombectomy. On both occasions, after 1 or 2 passes with a stent retriever, we found that the distal end of the catheter was frayed and it ballooned up on flushing with saline. This mechanical failure could potentially lead to serious complications; hence, it should be shared with fellow neurointerventionalists. ...[more]
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Project description:Background and purposeIn 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 methodsAn 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.ResultsIn 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.ConclusionsReasons 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.
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Project description:BackgroundLarge-bore aspiration catheters enabling greater flow rates and suction force for mechanical thrombectomy might improve outcomes in patients with stroke secondary to large-vessel occlusion. Complete or near-complete reperfusion after a single thrombectomy pass (first-pass effect) is associated with improved clinical outcomes. We assessed the efficacy and safety of novel MIVI Q™ aspiration catheters in combination with stent-retriever devices.MethodsWe retrospectively analyzed demographics, procedure characteristics, and clinical data from consecutive patients with acute anterior large-vessel occlusion treated with a combined approach using MIVI Q™ aspiration catheters and stent retrievers. Reperfusion was defined according to the modified thrombolysis in cerebral infarction (mTICI) score. Clinical outcomes were measured by the National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS) scores.ResultsWe included 52 patients (median age, 75 y IQR: 64-83); 31 (59.6%) women; 14 (26.9%) with terminal internal carotid artery occlusions, 26 (50%) middle cerebral artery (MCA) segment M1 occlusions, and 12 (23.1%) MCA segment M2 occlusions; median NIHSS score at admission was 19 (IQR: 13-22). After the first pass, 25 (48%) patients had mTICI ≥ 2c. At the end of the procedure, 47 (90.4%) had mTICI ≥ 2b and 35 (67.3%) had mTICI ≥ 2c. No serious device-related adverse events were observed. Symptomatic intracranial hemorrhage developed in 1 patient. Mean NIHSS score was 13 at 24 h and 5 at discharge. At 90 days, 24 (46.2%) patients were functionally independent (mRS 0-2).ConclusionThis preliminary study found good efficacy and safety for MIVI Q™ aspiration catheters used in combination with stent-retriever devices.
| S-EPMC9187553 | 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.
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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.
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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:AimsNew thrombectomy strategies have emerged recently. Differences between posterior circulation stroke management via aspiration and stent retriever remain to be evaluated. We compared the safety and efficacy of aspiration and stent retriever in treating posterior circulation stroke.MethodsThree databases (PubMed, Embase, and Cochrane Library) were systematically searched for studies comparing aspiration and stent retriever in patients with posterior circulation stroke. The modified Newcastle-Ottawa scale was used to assess the risk of bias. A random-effects model was used.ResultsFifteen cohort studies with 1451 patients were included. Pooled results showed a significant difference in total complication (odds ratio [OR] 0.48, 95% confidence interval [CI] [0.30, 0.76], p = 0.002). successful recanalization (1.85, [1.30, 2.64], p = 0.0006), favorable outcome (1.30, [1.02, 1.67], p = 0.04), procedure duration (-22.10, [-43.32, -0.88], p = 0.04), complete recanalization (4.96, [1.06, 23.16], p = 0.009), and first-pass effect (2.59, [1.55, 4.32], p = 0.0003) between the aspiration and stent retriever groups, and in favor of aspiration. There was no significant difference in the outcomes of rescue therapy (1.42, [0.66, 3.05], p = 0.37) between the two groups.ConclusionPatients with posterior circulation stroke receiving treatment with aspiration achieved better recanalization, first-pass effect, and shorter procedure time. Aspiration may be more secure than a stent retriever.
| S-EPMC9873527 | 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:ImportanceMechanical thrombectomy using a stent retriever or contact aspiration is widely used for treatment of patients with acute ischemic stroke due to anterior circulation large vessel occlusion, but the additional benefit of combining contact aspiration with stent retriever is uncertain.ObjectiveTo determine whether mechanical thrombectomy for treatment of anterior circulation large vessel occlusion stroke with initial contact aspiration and stent retriever combined results in better final angiographic outcome than with standard stent retriever alone.Design, setting, and participantsThis trial was a multicenter randomized, open-label, blinded end point evaluation that enrolled 408 patients from October 16, 2017, to May 29, 2018, in 11 French comprehensive stroke centers, with a 12-month outcome follow-up. Patients with a large vessel occlusion in the anterior circulation were included up to 8 hours after symptom onset. The final date of follow-up was June, 19, 2019.InterventionsPatients were randomly assigned (1:1 allocation) to receive initial thrombectomy with contact aspiration and stent retriever combined (205) or stent retriever alone (203).Main outcomes and measuresThe primary outcome was the rate of expanded Thrombolysis In Cerebral Infarction score of 2c or 3 (eTICI 2c/3; ie, scores indicate near-total and total reperfusion grades) at the end of the procedure.ResultsAmong the 408 patients who were randomized, 3 were excluded, and 405 (99.3%) patients (mean age, 73 years; 220 [54%] women and 185 [46%] men) were included in the primary analysis. The rate of eTICI 2c/3 at the end of the endovascular procedure was not significantly different between the 2 thrombectomy groups (64.5% [131 of 203 patients] for contact aspiration and stent retriever combined vs 57.9% [117 of 202 patients] for stent retriever alone; risk difference, 6.6% [95% CI, -3.0% to 16.2%]; adjusted odds ratio [OR], 1.33 [95% CI, 0.88 to 1.99]; P = .17). Of 14 prespecified secondary efficacy end points, 12 showed no significant difference. A higher rate of successful reperfusion was achieved in the contact aspiration combined with stent retriever group vs the stent retriever alone group (eTICI 2b50/2c/3, 86.2% vs 72.3%; adjusted OR, 2.54 [95% CI, 1.51 to 4.28]; P < .001) and of near-total or total reperfusion (eTICI 2c/3, 59.6% vs 49.5%; adjusted OR, 1.52 [95% CI, 1.02 to 2.27]; P = .04) after the assigned initial intervention alone.Conclusions and relevanceAmong patients with acute ischemic stroke due to large vessel occlusion, an initial thrombectomy technique consisting of contact aspiration and stent retriever combined, compared with stent retriever alone, did not significantly improve the rate of near-total or total reperfusion (eTICI 2c/3) at the end of the endovascular procedure, although the trial may have been underpowered to detect smaller differences between groups.Trial registrationClinicalTrials.gov Identifier: NCT03290885.
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