Kallmes, David F.

Aim: Stent-retriever (SR) thrombectomy has demonstrated superior outcomes in patients with acute ischemic stroke compared with medical management alone, but differences among SRs remain unexplored. We conducted a Systematic Review/Meta-Analysis to compare outcomes between three SRs: EmboTrap ® , Solitaire™, and Trevo ® . Methods: We conducted a PRISMA-compliant Systematic Review among English-language studies published after 2014 in PubMed/MEDLINE that reported SRs in ≥25 patients. Functional and safety outcomes included 90-day modified Rankin scale (mRS 0-2), mortality, symptomatic intracranial hemorrhage (sICH), and embolization to new territory (ENT). Recanalization outcomes included modified thrombolysis in cerebral infarction (mTICI) and first-pass recanalization (FPR). We used a random effects Meta-Analysis to compare outcomes; subgroup and outlier-influencer analysis were performed to explore heterogeneity. Results: Fifty-one articles comprising 9,804 patients were included. EmboTrap had statistically significantly higher rates of mRS 0-2 (57.4%) compared with Trevo (50.0%, p = 0.013) and Solitaire (45.3%, p < 0.001). Compared with Solitaire (20.4%), EmboTrap (11.2%, p < 0.001) and Trevo (14.5%, p = 0.018) had statistically significantly lower mortality. Compared with Solitaire (7.7%), EmboTrap (3.9%, p = 0.028) and Trevo (4.6%, p = 0.049) had statistically significantly lower rates of sICH. There were no significant differences in ENT rates across all three devices (6.0% for EmboTrap, 5.3% for Trevo, and 7.7% for Solitaire, p = 0.518). EmboTrap had numerically higher rates of recanalization; however, no statistically significant differences were found. Conclusion: The results of our Systematic Review/Meta-Analysis suggest that EmboTrap may be associated with significantly improved functional outcomes compared with Solitaire and Trevo. EmboTrap and Trevo may be associated with significantly lower rates of sICH and mortality compared with Solitaire. No significant differences in recanalization and ENT rates were found. These conclusions are tempered by limitations of the analysis including variations in thrombectomy techniques in the field, highlighting the need for multi-arm RCT studies comparing different SR devices to confirm our findings.

Background Funding may impact the quality and findings of systematic reviews (SRs). We aimed to compare the methodological quality of funded and non-funded SRs that investigated the outcomes in ischemic stroke patients undergoing mechanical thrombectomy. Methods We conducted a comprehensive search strategy in different databases, including Ovid Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid Medline (including epub ahead of print, in-process & other non-indexed citations), PubMed, Scopus and Web of Science Core Collection to retrieve all relevant SRs. Random sequence generation matched each funded SR with a non-funded one. A Measurement Tool to Assess Systematic Reviews (AMSTAR)-2 tool was used to assess the bias and quality of the included SRs. We also used uni- and multivariate analysis to perform our analysis, and results were expressed in odds ratio (OR) and 95% confidence interval (CI). Results We retrieved 150 articles, which were randomized and matched into 100 SRs, including 50 funded and 50 non-funded studies. By multivariate analysis, we found that including randomized clinical trials (RCTs) (OR: 5.7; 95% CI: 1.8–17.8; p = 0.003) and reporting conflict of interests (OR: 5.2; 95 CI: 1.1–24; p = 0.036) were the only significant differences between funded and non-funded SRs. No significant differences were found regarding the overall confidence for low-quality (OR: 0.54; 95% CI: 0.09–3.2; p = 0.49) and moderate/high-quality SRs (OR: 0.17; 95% CI: 0.02–1.87; p = 0.14). Conclusion Funded studies tend to include RCTs more often and report conflict of interests with no significant impact on overall confidence.

Background Collateral status may facilitate clot removal and affect rates of successful reperfusion following endovascular therapy (EVT) for acute ischemic stroke (AIS). Methods Following the PRISMA guidelines, a systematic literature review of the English language literature was conducted using PubMed, Scopus, Web of Science, and Embase. Papers which focused on collateral status and patients treated with EVT for AIS were included in our analysis. Outcomes of interest included collateral score grading, rates of successful reperfusion defined as thrombolysis in cerebral infarction (TICI) score 2b-3 and onset to revascularization time. We calculated pooled odds ratio (OR) or mean difference (MD) and their corresponding 95% confidence intervals (CI) based on collateral status. Results 16 studies, with 6073 patients, were included in our analysis. Among the included studies, there were six different collateral grading scales, which were dichotomized into “good to moderate” and “poor” collaterals. Odds of successful reperfusion were significantly higher among patients with good to moderate collateral circulation compared to those with poor collaterals (OR = 1.61; 95% CI = 1.24 to 2.09; P -value < 0.001); however, there was heterogeneity among included studies (I2 = 5 4%; P -value = 0.008). Onset to revascularization time was comparable between patients with good to moderate collateral circulation compared to those with poor collaterals (MD = 3.91 min; 95% CI = −8.71 to 16.53; P -value = 0.544); however, there was heterogeneity among included studies (I2= 60%; P -value = 0.014). Conclusions The presence of good collaterals may increase the odds of achieving successful reperfusion following EVT for AIS. Improved collateral flow was associated with improved angiographic outcomes, although future work is needed to determine if a causal relationship exists.

Background In 2015, mechanical thrombectomy (MT) was deemed the standard of care for acute ischemic stroke (AIS) in the anterior circulation due to large vessel occlusion (LVO). To determine if outcomes in patients treated with MT have changed, we conducted a systematic review and meta-analysis of published randomized controlled trials (RCTs). Methods A systematic literature review of the English language literature was conducted using PubMed. We included RCTs that focused on patients with AIS treated with MT. The primary outcome of interest was good functional outcome defined as modified Rankin Scale (mRS) 0–2 at 90 days. Safety outcomes included rates of symptomatic intracranial hemorrhage (sICH) and mortality at 90 days. Using Joinpoint Regression Analysis Program, we calculated the average annual percent change (AAPC) for the outcomes of interest. Results We included 23 RCTs with 5784 patients. The years of mid-enrollment among the included RCTs ranged from 2012–2020. There was an AAPC of +3.82% between 2012 and 2020 (95% CI 0.4 to 7.3; P -value = 0.033) in rates of good functional outcome. There was an AAPC of +6.98% between 2012 and 2020 (95% CI 0.5 to 13.9; P -value = 0.039) in rates of sICH. There was an AAPC of −0.49% between 2012 and 2020 (95% CI −4.4 to 3.5; P -value = 0.77) in rates of mortality. Conclusion Between 2012 and 2020, rates of good functional outcome and sICH increased, while rates of mortality remained consistent in RCTs investigating MT for AIS. Multiple factors likely influenced our results, including increased use of MT and utilization of adjunctive therapies alongside MT.

Background Mechanical thrombectomy (MT) has become the standard of care for stroke patients. The majority of the clinical trials and publications analyzing the outcomes related to the procedures report interventional performance by experienced practitioners. However, few of them individualize their preliminary metrics according to the operator's experience. Objective To summarize the literature and report safety and efficacy outcomes following MT procedures and correlate them with the operator's experience. Primary outcomes were successful recanalization, defined as modified thrombolysis in cerebral infarction greater or equal to 2b or 3, duration of the procedure measured in minutes, and serious adverse event. Methods This systematic review was performed according to the PRISMA guidelines. The PubMed, Embase, and Cochrane databases were utilized. Results There were six studies comprising 9348 patients (mean age 69.8 years; 51.2% males), and 9361 MT procedures were included. Each publication used for this review used a different experience definition to report their data. Higher interventionists’ experience demonstrated a positive relationship with the possibility of successful recanalization and an inverse relationship with the duration needed for the operation in almost all of the included studies. As for the complications, none of the authors reported a statistically significant risk reduction of an adverse event, except Olthuis et al. correlating increasing training with lower odds of stroke progression. Conclusions A higher experience level is associated with better recanalization rates and shorter procedural duration in MT operations. Further studies are warranted to define the minimum required level of experience for operational autonomy.

Background Endovascular coil embolization (ECE) for intracranial aneurysms has been proven as an effective minimally invasive treatment. However, the aneurysm recanalization after coiling is a serious complication of this technique. Among all the proposed factors associated with recanalization, the impact of packing density (PD) is still controversial. Objective To clarify the role of PD in the aneurysm recanalization following ECE, via conducting a systematic review and meta-analysis. Methods A systematic literature search was conducted using PubMed, Scopus, Embase, and Web of Science databases, until November 28, 2022, by adhering to the Preferred Reporting Items for Systematic Review and Meta-Analyses statement guidelines. Considering the eligibility criteria, all the studies reporting the outcomes of interest were included. Data elements of interest were extracted and analyzed using R software version 4.2.1. Results The pooled analysis of the 17 eligible papers revealed a 29% higher PD of the nonrecanalized aneurysms (ROM = 1.29, 95% confidence interval [CI] = 1.18–1.40, p < 0.001), even after removing outlier studies to reduce heterogeneity. However, the pooled estimates from multivariable regression models within nine included studies showed no significant effect of PD on recanalization odds when incorporated into a multivariable model with other predictors (odds ratio [OR] = 0.93, 95% CI = 0.84–1.02, p = 0.126), even after removing outlier studies. Conclusion The current literature does not support PD as a significant predictor of aneurysm treatment outcomes, especially with adjusting for other variables. This finding necessitates further prospective multicenter studies with a larger sample size to overcome the current methodological shortcomings.

Introduction Mechanical thrombectomy (MT) is the standard of care in eligible patients presenting with acute ischemic stroke (AIS). The question of whether intravenous thrombolysis (IVT) improves outcomes in conjunction with MT remains unanswered. We performed a systematic review and meta-analysis of published randomized controlled trials (RCT) to explore outcomes of MT with and without IVT. Methods Following the PRISMA guidelines, a systematic literature review of the English language literature was conducted using PubMed, Embase, Web of science, and Scopus. Outcomes of interest included 90-day modified Rankin Scale (mRS) 0–2, thrombolysis in cerebral infarction (TICI) score 2b-3, symptomatic intracranial hemorrhage (sICH), distal embolization, and mortality. We calculated pooled risk ratios (RRs) and their corresponding 95% confidence intervals (CI). Results Six RCTs with 2334 patients compared outcomes of patients treated with MT alone and MT with IVT. Both treatments resulted in comparable rates of mRS 0–2 (RR = 0.96, 95% CI = 0.88–1.04; p -value = 0.282), sICH (RR = 0.80, 95% CI = 0.55–1.17; p -value = 0.253), mortality at 90-days (RR = 1.06, 95% CI = 0.88–1.28; p -value = 0.529), and distal embolization (RR = 1.10, 95% CI = 0.79–1.52; p -value = 0.572). MT alone was associated with a lower rate of TICI 2b-3 compared to MT with IVT (RR = 0.96, 95% CI = 0.93–0.99; p -value = 0.006). Conclusions In this meta-analysis of six RCTs, MT alone was comparable to MT plus IVT for mRS 0–2, sICH, mortality, and distal embolization; however, MT alone resulted in lower rates of TICI 2b-3. Further trials are needed to determine which patient populations benefit from MT plus IVT and to increase the power of future meta-analyses.

Background: Understanding clot composition may allow for better technical planning and improved outcomes in mechanical thrombectomy (MT). We sought to correlate clot composition with reperfusion outcomes in MT. Methods: Clinical, imaging, and clot data from patients enrolled in the STRIP Registry from September 2016 to September 2020 were analyzed. Samples were fixed in 10% phosphate-buffered formalin and stained with hematoxylin and eosin and Martius Scarlett Blue. Percent composition, richness, and gross appearance were evaluated. Outcome measures included the rate of First-Pass Effect (mTICI2c/3, FPE) and the number of device passes. Results: A total of 1430 patients (mean age, 68.4±13.5years; median [IQR] baseline NIHSS,17.2 [10.5-23]; IV-tPA use, 36%; Stent-Retrievers [SR], 27%; Contact Aspiration [CA], 27%; Combined SR + CA, 43%) were included. The median [IQR] number of passes was 1 [1-2]. FPE was achieved in 39.3% of the cases. There was no association between percent histological composition or clot richness and FPE in the overall population. However, the combined technique resulted in lower FPE rates for RBC-rich (P<0.0001), platelet-rich (P=0.003), and mixed (P<0.0001) clots. Fibrin-rich and platelet-rich clots required a higher number of passes compared to RBC-rich and mixed clots (median, 2 and 1.5 vs.1, respectively, P=0.02). CA displayed a trend towards a higher number of passes with fibrin-rich clots (2 vs.1, P=0.12). By gross appearance, mixed/heterogeneous clots had lower FPE rates than red and white clots. Conclusion: Despite the lack of correlation between clot histology and FPE in the overall population, our study adds to the growing body of evidence supporting the notion that clot composition influences reperfusion treatment strategy outcomes. Additional studies are needed.