Background and Purpose: The Tigertriever is a novel, radially adjustable, fully visible, stentriever that permits the operator to align radial expansion with target vessel diameters. This multicenter trial compared the Tigertriever’s effectiveness and safety compared with established stent retrievers. Methods: Single arm, prospective, multicenter trial comparing the Tigertriever to efficacy and safety performance goals derived from outcomes in six recent pivotal studies evaluating the Solitaire and Trevo stent-retriever devices with a lead-in and a main-study phase. Patients were enrolled if they had acute ischemic stroke with NIHSS≥8 due to large vessel occlusion within 8 hours of onset. The primary efficacy endpoint was successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score 2b-3 within three passes of the Tigertriever. The primary safety endpoint was a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage (sICH). Secondary efficacy endpoints included 3-month good clinical outcome (modified Rankin Scale 0-2) and first-pass successful reperfusion. Results: Between May 2018 and March 2020, 160 patients (43 lead-in, 117 main phase) at 17 centers were enrolled and treated with the Tigertriever. The primary efficacy endpoint was achieved in 84.6% in the main-study phase group compared with the 63.4% performance goal and the 73.4% historical rate (non-inferiority p<0.0001; superiority p<0.01). The first pass successful reperfusion rate was 57.8%. After all interventions, successful reperfusion (mTICI ≥2b) was achieved in 95.7% and excellent reperfusion (mTICI 2c-3) in 71.8%. The primary safety composite endpoint rate of mortality and sICH was 18.1% compared with the 30.4% performance goal and the 20.4% historical rate (non-inferiority p=0.004; superiority p=0.57). Good clinical outcome was achieved in 58% at 90 days. Conclusions: The Tigertriever device was shown to be highly effective and safe compared to Trevo and Solitaire devices to remove thrombus in large vessel occlusive stroke patients eligible for mechanical thrombectomy. Registration: URL: http://www.clinicaltrials.gov; Unique identifier: NCT03474549.
Background and Purpose The utility of prophylactic antiepileptic drug (AED) administration following spontaneous subarachnoid hemorrhage (SAH) remains controversial. AEDs have not clearly been associated with a reduction in seizure incidence and have been associated with both neurologic worsening and delayed functional recovery in this setting. Methods We retrospectively analyzed a prospectively collected database of SAH patients admitted to our institution between 2005 and 2010. Between 2005 and 2007, all patients received prophylactic AEDs upon admission. After 2007 no patients received prophylactic AEDs or had AEDs immediately discontinued if initiated at an outside hospital. A propensity score-matched analysis was then performed to compare the development of clinical and/or electrographic seizures in these two populations. Results 353 patients with spontaneous SAH were analyzed, 43% of whom were treated with prophylactic AEDs upon admission. Overall, 10% of patients suffered clinical and/or electrographic seizures, most frequently occurring within 24-hrs of ictus (47%). The incidence of seizures did not vary significantly based on the use of prophylactic AEDs (11 vs. 8%, p=0.33). Propensity score-matched analyses suggest that patients receiving prophylactic AEDs had a similar likelihood of suffering seizures as those who did not (p=0.49). Conclusions Propensity score-matched analysis suggests that prophylactic AEDs do not significantly reduce the risk of seizure occurrence in patients with spontaneous SAH.
BackgroundInterventional cardiology produced level 1 evidence recommending radial artery-first for coronary angiography given lower vascular complications. Neuroendovascular surgeons have not widely adopted the transradial approach. This prospective, single center, non-inferiority comparative effectiveness study aims to compare the transradial and transfemoral approaches for diagnostic cerebral angiography with respect to efficacy, safety and patient satisfaction.MethodsConsecutive patients presenting for diagnostic cerebral angiography were selected to undergo right radial or femoral access based on date of presentation. Primary outcome was ability to answer the predefined diagnostic goal of the cerebral angiogram using the initial access site and was assessed with a non-inferiority design. Secondary outcomes included technical success per vessel, complications, procedure times and patient satisfaction.ResultsA total of 312 patients were enrolled, 158 and 154 for right radial and femoral access, respectively. The diagnostic goal of the angiogram was achieved in 152 of 154 (99%) patients who underwent attempted femoral access compared with 153 of 158 (97%) patients who underwent radial access, confirming non-inferiority of the transradial approach. Secondary outcomes showed equivalent technical success by vessel, no major complications, and similar frequency of minor complications between the two approaches. In-room time was similar between approaches, though post-procedure recovery room time was significantly shorter for transradial patients. Patient satisfaction results significantly favored the radial approach.ConclusionsIn patients undergoing diagnostic cerebral angiography, transfemoral and transradial access achieve procedural goals with similar effectiveness and safety, though patients strongly prefer the radial approach. Findings support consideration of adopting a radial-first strategy for diagnostic cerebral angiography.
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