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Safety and Efficacy of Mechanical Thrombectomy Using Tigertriever as a Rescue Device After Failed Aspiration-Single Center Experience.

ABSTRACT: Introduction: We evaluated the safety and efficacy of a new stent retriever-Tigertriever-after failed aspiration. Materials and Methods: Patients with acute ischemic stroke treated with Tigertriever between January 2018 and March 2020 were included in the study. Treatment results of Tigertriever in rescue therapy (after failed aspiration) were evaluated. Periprocedural data were retrospectively analyzed. Results: Thirty patients were treated with Tigertriever (14M/16F). There were 20 rescue thrombectomies after failed aspiration. Tigertriver successful recanalization rate (mTICI ? 2B) was 70%: 65% in rescue therapy and 80% in first-line therapy. The type of first line treatment had no impact on mRS after 1 month and 3 months (ns). There was significant improvement in NIHSS in all patients (mean NIHSS: 17 vs. 10, p = 0.028), in rescue treatment (mean NIHSS: 17 vs. 11, p = 0.048) and in first line treatment (mean NIHSS: 16 vs. 8, p = 0.0005). Better results in NIHSS at discharge were linked with first pass success (p = 0.002), better mTICI at the end of the procedure (p = 0.0006), and administration of rtPA (p = 0.013). Conclusions: The new stent retriever Tigertriever is an efficient and safe tool to be used as a rescue device after an unsuccessful first line aspiration technique.

SUBMITTER: Piasecki P

PROVIDER: S-EPMC7859263 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Safety and Efficacy of Mechanical Thrombectomy Using Tigertriever as a Rescue Device After Failed Aspiration-Single Center Experience.

Piasecki Piotr P Wierzbicki Marek M Narloch Jerzy J

Frontiers in neurology 20210121

Introduction: We evaluated the safety and efficacy of a new stent retriever-Tigertriever-after failed aspiration. Materials and Methods: Patients with acute ischemic stroke treated with Tigertriever between January 2018 and March 2020 were included in the study. Treatment results of Tigertriever in rescue therapy (after failed aspiration) were evaluated. Periprocedural data were retrospectively analyzed. Results: Thirty patients were treated with Tigertriever (14M/16F). Ther ...[more]

PMID: 33551964

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Project description:Importance:Achieving complete reperfusion is a key determinant of good outcome in patients treated with mechanical thrombectomy (MT). However, data on treatments geared toward improving reperfusion after incomplete MT are sparse. Objective:To determine whether administration of intra-arterial urokinase is safe and improves reperfusion after failed or incomplete MT. Design, Setting, and Participants:This observational cohort study included a consecutive sample of patients treated with second-generation MT from January 1, 2010, through August 4, 2017. Data were collected from the prospective registry of a tertiary care stroke center. Of 1274 patients screened, 69 refused to participate, and 993 met the observational studies inclusion criteria of a large vessel occlusion in the anterior circulation. Data were analyzed from September 1, 2017, through September 20, 2019. Intervention:One hundred patients received intra-arterial urokinase after failed or incomplete MT using manual microcatheter injections. Main Outcomes and Measures:Primary safety outcome was the occurrence of symptomatic intracranial hemorrhage (sICH) according to the Prolyse in Acute Cerebral Thromboembolism II criteria. Secondary end points included 90-day mortality and 90-day functional independence (defined as modified Rankin Scale score of ?2). Efficacy was evaluated angiographically, applying the Thrombolysis in Cerebral Infarction (TICI) scale. Results:After exclusion of patients with posterior circulation strokes and those treated with intra-arterial thrombolytics only, 993 patients were included in the final analyses (median age, 74.6 [interquartile range, 62.6-82.2] years; 505 [50.9%] women). Additional intra-arterial urokinase was administered in 100 patients (10.1%). The most common reason for administering intra-arterial urokinase was incomplete reperfusion (TICI<3) after MT (53 [53.0%]). After adjusting for baseline characteristics underlying case selection, intra-arterial urokinase was not associated with an increased risk of sICH (adjusted odds ratio [aOR], 0.81; 95% CI, 0.31-2.13) or 90-day mortality (aOR, 0.78; 95% CI, 0.43-1.40). Among 53 cases of partial or near-complete reperfusion and treated with intra-arterial urokinase, 32 (60.4%) had early reperfusion improvement, and 18 of 53 (34.0%) had an improvement in TICI grade. Correspondingly, patients treated with intra-arterial urokinase had higher rates of functional independence after adjusting for the selection bias favoring a priori poor TICI grades in the intra-arterial urokinase group (aOR, 1.93; 95% CI, 1.11-3.37). Conclusions and Relevance:In selected patients, adjunctive treatment with intra-arterial urokinase during or after MT was safe and improved angiographic reperfusion. Systemic evaluation of this approach in a multicenter prospective registry or a randomized clinical trial seems warranted.

Project description:Importance:The treatment effects of individual mechanical thrombectomy devices in large-vessel acute ischemic stroke (AIS) remain unclear. Objective:To determine whether the novel 3-dimensional (3-D) stent retriever used in conjunction with an aspiration-based mechanical thrombectomy device (Penumbra System; Penumbra) is noninferior to aspiration-based thrombectomy alone in AIS. Design, Setting, and Participants:This randomized, noninferiority clinical trial enrolled patients at 25 North American centers from May 19, 2012, through November 19, 2015, with follow-up for 90 days. Adjudicators of the primary end points were masked to treatment allocation. Patients with large-vessel intracranial occlusion AIS presenting with a National Institutes of Health Stroke Scale (NIHSS) score of at least 8 within 8 hours of onset underwent 1:1 randomization to 3-D stent retriever with aspiration or aspiration alone. The primary analyses were conducted in the intention-to-treat population. Interventions:Mechanical thrombectomy using intracranial aspiration with or without the 3-D stent retriever. Main Outcomes and Measures:The primary effectiveness end point was the rate of a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2 to 3 with a 15% noninferiority margin. Device- and procedure-related serious adverse events at 24 hours were the primary safety end points. Results:Of 8082 patients screened, 198 patients were enrolled (111 women [56.1%] and 87 men [43.9%]; mean [SD] age, 66.9 [13.0] years) and randomized, including 98 in the 3-D stent retriever with aspiration group and 100 in the aspiration alone group; an additional 238 patients were eligible but not enrolled. The median baseline NIHSS score was 18.0 (interquartile range, 14.0-23.0). Eighty-two of 94 patients in the 3-D stent retriever and aspiration group (87.2%) had an mTICI grade of 2 to 3 compared with 79 of 96 in the aspiration alone group (82.3%; difference, 4.9%; 90% CI, -3.6% to 13.5%). None of the other measures were significantly different between the 2 groups. Device-related serious adverse events were reported by 4 of 98 patients in the 3-D stent retriever with aspiration group (4.1%) vs 5 of 100 patients in the aspiration only group (5.0%); procedure-related serious adverse events, 10 of 98 (10.2%) vs 14 of 100 (14.0%). A 90-day modified Rankin Scale score of 0 to 2 was reported by 39 of 86 patients in the 3-D stent retriever with aspiration group (45.3%) vs 44 of 96 patients in the aspiration only group (45.8%). Conclusions and Relevance:The present study provides class 1 evidence for the noninferiority of the 3-D stent retriever with aspiration vs aspiration alone in AIS. Future trials should evaluate whether these results can be generalized to other stent retrievers. Trial Registration:clinicaltrials.gov Identifier: NCT01584609.

Project description:PurposeTo demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.Materials and methodsFrom September 2018 until April 2019 39 patients with 41 femorodistal lesions including the femoropopliteal and distal popliteal segments were treated in a prospective, nonrandomized pre-market approval study with 6 months follow up using the ByCross® atherectomy device (ClinicalTrials.gov identifier NCT03724279). Adjunctive treatment with balloon dilatation or stenting was allowed by the protocol. Mean patient age was 72 years with 62% male. The average lesions length was 125 ± 118 mm (30 and 450 mm) with an average reference vessel diameter of 5.2 ± 0.85 mm and a mean stenosis of 96.4 ± 6.2% based on CT or MR angiography measurements. The primary performance endpoint was defined as acute procedural success with angiographically determined residual stenosis of ≤ 50% and of ≤ 30% after atherectomy or adjunctive treatment. The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Secondary endpoints were stenosis of the target lesions measured by duplex ultrasound (DUS) and the ankle-brachial pressure index (ABPI) at discharge, 30 and 180 days as well as any major adverse event (MAE) through 6 months.ResultsThe acute procedural success was achieved in 39/41 (95.12%) lesions, partially without wire guidance (11/41 (26.82%)). No embolic protection was used, and adjunctive angioplasty and stenting was performed in 40/41 (97.56%) and 12/41 (29.26%) lesions, respectively without device related MAE's at 30 days. Mean level of stenosis was 5.7% at discharge and 21.7% at 6 months FU measured by DUS. Mean ABPI was 0.8, 1.0 and 0.8 at baseline, discharge, and 6 months FU respectively.ConclusionsBased on the high technical success rate and the low rates of MAE`s through six months, the BYCROSS® Atherectomy System has shown to be safe and effective for the crossing and atherectomy of complex lower-extremity arterial occlusions.Trial registrationOctober 17, 2018,retrospectively registered.Clinicaltrialsgov Identifier: NCT03724279; https://clinicaltrials.gov/ct2/show/record/NCT03724279.

Dataset Information

Safety and Efficacy of Mechanical Thrombectomy Using Tigertriever as a Rescue Device After Failed Aspiration-Single Center Experience.

Publications

Safety and Efficacy of Mechanical Thrombectomy Using Tigertriever as a Rescue Device After Failed Aspiration-Single Center Experience.

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