Publications by authors named "Ronald F Budzik"
Article Synopsis
- This study analyzed decisions regarding decompressive hemicraniectomy (DHC) and early withdrawal of life-sustaining therapy (WLST) in patients with large vessel occlusion (LVO) and large ischemic strokes from the SELECT2 trial.* -
- Among 352 patients, DHC was utilized in 55 patients, and WLST was chosen for 81, showing no significant differences in usage between those receiving endovascular thrombectomy (EVT) and those treated medically.* -
- About 21% of DHC patients were able to walk independently after one year, indicating that DHC did not negatively impact the benefits of thrombectomy, while WLST generally resulted in poor outcomes.*
Background: The EXCELLENT registry aimed to evaluate the effectiveness of the EMBOTRAP Revascularization Device in an all-comer population in a real-world setting, with a focus on the composition of retrieved clots.
Methods: EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee.
Results: After screening 3799 patients, a total of 997 subjects (mean age, 70.
Article Synopsis
- Endovascular thrombectomy (EVT) has proven safe and effective for patients suffering from large core strokes, but the effects of reperfusion quality and procedure details on outcomes are still unclear.
- In the SELECT2 trial, findings indicated that 80% of patients experienced successful reperfusion, which correlates with better clinical outcomes, particularly in those who achieved near-complete reperfusion.
- Longer procedure times negatively impacted patient outcomes, while the method of thrombectomy (aspiration vs stent-retriever) showed no significant differences in reperfusion success or functional recovery.
Background And Purpose: Intraarterial thrombolysis as an adjunct to mechanical thrombectomy is increasingly being considered to enhance reperfusion in acute ischemic stroke patients. Intraarterial thrombolysis may increase the risk of post-thrombectomy intracerebral hemorrhage (ICH) in certain patient subgroups.
Methods: We analyzed acute ischemic stroke patients treated with mechanical thrombectomy in a multicenter registry.
Endovascular thrombectomy (EVT) safety and efficacy in patients with large core infarcts receiving oral anticoagulants (OAC) are unknown. In the SELECT2 trial (NCT03876457), 29 of 180 (16%; vitamin K antagonists 15, direct OACs 14) EVT, and 18 of 172 (10%; vitamin K antagonists 3, direct OACs 15) medical management (MM) patients reported OAC use at baseline. EVT was not associated with better clinical outcomes in the OAC group (EVT 6 [4-6] vs MM 5 [4-6], adjusted generalized odds ratio 0.
View Article and Find Full Text PDFObjective: We aimed to assess the impact of time to endovascular thrombectomy (EVT) on clinical outcomes in the DAWN trial, while also exploring the potential effect modification of mode of stroke onset on this relationship.
Methods: The association between every 1-h treatment delay with 90-day functional independence (modified Rankin Scale [mRS] score 0-2), symptomatic intracranial hemorrhage, and 90-day mortality was explored in the overall population and in three modes of onset subgroups (wake-up vs. witnessed vs.
Article Synopsis
- Researchers looked at how bleeding in the brain (intracerebral hemorrhage or ICH) affects people who had a specific treatment for severe strokes called endovascular thrombectomy (EVT).
- Out of the 351 patients studied, many experienced bleeding, especially those who had EVT, but serious types of bleeding were rare.
- In the end, having some bleeding didn’t make the patients’ health outcomes worse, and there may be new treatments that could help those with bleeding issues in similar cases.
Article Synopsis
- Patients with large ischemic core strokes often have poor outcomes and are rarely transferred for endovascular thrombectomy (EVT), leading to a need for better understanding of treatment effects in different patient groups.
- The study analyzed data from the SELECT2 trial, focusing on adults with acute ischemic strokes due to specific artery occlusions, comparing those who were directly treated at EVT centers with those who were transferred.
- Results indicated that EVT improved functional outcomes in both transfer and non-transfer patients, suggesting that EVT can benefit patients regardless of transfer delays, although the median ASPECTS score showed a decline during transfers.
Background: Multiple randomised trials have shown efficacy and safety of endovascular thrombectomy in patients with large ischaemic stroke. The aim of this study was to evaluate long-term (ie, at 1 year) evidence of benefit of thrombectomy for these patients.
Methods: SELECT2 was a phase 3, open-label, international, randomised controlled trial with blinded endpoint assessment, conducted at 31 hospitals in the USA, Canada, Spain, Switzerland, Australia, and New Zealand.
Importance: Whether endovascular thrombectomy (EVT) efficacy for patients with acute ischemic stroke and large cores varies depending on the extent of ischemic injury is uncertain.
Objective: To describe the relationship between imaging estimates of irreversibly injured brain (core) and at-risk regions (mismatch) and clinical outcomes and EVT treatment effect.
Design, Setting, And Participants: An exploratory analysis of the SELECT2 trial, which randomized 352 adults (18-85 years) with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) and large ischemic core to EVT vs medical management (MM), across 31 global centers between October 2019 and September 2022.
Background: Large vessel occlusion (LVO) prediction scales are used to triage prehospital suspected stroke patients with a high probability of LVO stroke to endovascular therapy centers. The sensitivities of these scales in the 6-to-24-h time window are unknown. Higher scale score thresholds are typically less sensitive and more specific.
View Article and Find Full Text PDFBackground: Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations.
Methods: We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging.
Article Synopsis
- Reperfusion therapy significantly benefits ischemic stroke patients by reducing infarct growth and cerebral edema, which may be key to improving clinical outcomes.* -
- A study involving 542 patients found that successful reperfusion was linked to decreased infarct growth and midline shift, highlighting their role as mediators in treatment effectiveness.* -
- Although successful reperfusion initially correlated with better functional outcomes, this link diminished when accounting for infarct growth and midline shift, indicating these factors greatly influence treatment success.*
Background And Objectives: The effect of anesthesia choice on endovascular thrombectomy (EVT) outcomes is unclear. Collateral status on perfusion imaging may help identify the optimal anesthesia choice.
Methods: In a pooled patient-level analysis of EXTEND-IA, EXTEND-IA TNK, EXTEND-IA TNK part II, and SELECT, EVT functional outcomes (modified Rankin Scale score distribution) were compared between general anesthesia (GA) vs non-GA in a propensity-matched sample.
Background: Chronological heterogeneity in neurological improvement after endovascular thrombectomy (EVT) for large vessel occlusion (LVO) stroke is commonly observed in clinical practice. Understanding the temporal progression of functional independence after EVT, especially delayed functional independence in patients who do not improve early, is essential for prognostication and rehabilitation. We aim to determine the incidence of early functional independence (EFI) and delayed functional independence (DFI), identify associated predictors after EVT, and develop the Delayed Functional Independence After Neurothrombectomy (DEFIANT) score.
View Article and Find Full Text PDFBackground And Purpose: Collaterals govern the pace and severity of cerebral ischemia, distinguishing fast or slow progressors and corresponding therapeutic opportunities. The fate of sustained collateral perfusion or collateral failure is poorly characterized. We evaluated the nature and impact of collaterals on outcomes in the late time window DAWN trial (Diffusion-Weighted Imaging or Computed Tomography Perfusion Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo).
View Article and Find Full Text PDFBackground And Purpose: The impact of baseline ischemia on Alberta Stroke Program Early CT Score (ASPECTS) and evolution over 24 hours may be distinct in late thrombectomy. We analyzed predictors of serial ASPECTS and clinical outcomes in the DAWN trial (Diffusion-Weighted Imaging or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo).
Methods: The DAWN Imaging Core Laboratory independently scored ASPECTS at baseline and 24 hours.
Background: The effect of time from stroke onset to thrombectomy in the extended time window remains poorly characterized.
Aim: We aimed to analyze the relationship between time to treatment and clinical outcomes in the early versus extended time windows.
Methods: Proximal anterior circulation occlusion patients from a multicentric prospective registry were categorized into early (≤6 h) or extended (>6-24 h) treatment window.
Background: The clinical efficacy of mechanical thrombectomy has been unequivocally demonstrated in multiple randomized clinical trials. However, these studies were performed in carefully selected centers and utilized strict inclusion criteria.
Aim: We aimed to assess the clinical effectiveness of mechanical thrombectomy in a prospective registry.
Background: The PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0-12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16-24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted.
Methods: Up to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0-12 hours of last seen normal.
Background: First pass effect (FPE), defined as near-total/total reperfusion of the territory (modified Thrombolysis in Cerebral Infarction (mTICI) 2c/3) of the occluded artery after a single thrombectomy attempt (single pass), has been associated with superior safety and efficacy outcomes than in patients not experiencing FPE.
Objective: To characterize the clinical features, incidence, and predictors of FPE in the anterior and posterior circulation among patients enrolled in the Trevo Registry.
Methods: Data were analyzed from the Trevo Retriever Registry.
Background: There is a paucity of data regarding mechanical thrombectomy (MT) in distal arterial occlusions (DAO). We aim to evaluate the safety and efficacy of MT in patients with DAO and compare their outcomes with proximal arterial occlusion (PAO) strokes.
Methods: The Trevo Registry was a prospective open-label MT registry including 2008 patients from 76 sites across 12 countries.
Background: It is unknown whether endovascular thrombectomy (EVT) is cost effective in large ischemic core infarcts.
Methods: In the prospective, multicenter, cohort study of imaging selection study (SELECT), large core was defined as computed tomography (CT) ASPECTS<6 or computed tomography perfusion (CTP) ischemic core volume (rCBF<30%) ≥50 cc. A Markov model estimated costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) of EVT compared with medical management (MM) over lifetime.