Search

Background: The relationship between angiographic findings and fractional flow reserve (FFR) according to gender is currently unknown., Aims: To examine gender-based differences in the concordance between angiographic and functional assessment of coronary stenosis severity., Methods: We examined 3770 coronary stenoses of stable patients undergoing both quantitative coronary angiography and FFR measurements in at least one coronary stenosis., Results: Median FFR values were higher in female as compared with male patients (0.84 vs. 0.81, p < 0.001) in the overall cohort and in the first three quartiles of diameter stenosis (DS). At receiver operator characteristics (ROC) analysis, DS was effective in predicting ischemic FFR values in both men and women. A 50% DS was the optimal cut off to identify functionally significant stenoses in the entire cohort and in male patients. In females, a higher DS threshold (≥ 59%) significantly improved lesions classification (69.4% vs. 72.4%, p = 0.034), yet at the cost of an increased false negatives rate (10.5% vs. 20.8%, p < 0.001). A lower cut-off of 50% showed a superior diagnostic accuracy for ischemic FFR values (i.e., FFR values ≤ 0.80, AUC: 0.697 vs. 0.661, p = 0.006). Female gender was independently associated with a reduced risk of ischemic FFR (OR 0.51 95% CI [0.43-0.61])., Conclusions: Female patients show higher FFR values across different DS thresholds compared to male patients. A DS ≥ 50% is the best threshold to identify ischemic FFR in both males and females. A higher threshold of DS (≥ 59%) is associated with a significant improvement in lesion classification, despite leading to increased false negatives rate., (© 2024 Wiley Periodicals LLC.)

Background and Objectives: Intracranial atherosclerotic disease (ICAD) large vessel occlusion (LVO) is responsible for up to 30% of LVO. In this study, we aimed to determine the likelihood of favorable functional outcomes (modified Rankin Scale 0-3) in acute ICAD-LVO basilar occlusion compared with embolic basilar occlusion., Methods: This is an analysis of the Posterior Circulation Ischemic Stroke Evaluation: Analyzing Radiographic and Intraprocedural Predictors for Mechanical Thrombectomy Registry in which patients with acute basilar artery occlusions from 8 comprehensive stroke centers were included from 2015 to 2021. Patients were dichotomized into with (ICAD-LVO) or without underlying ICAD (embolic). Descriptive statistics for each group and multivariate logistic analysis were performed on the primary outcome., Results: Three hundred forty-six patients were included. There were 215 patients with embolic (62%) and 131 patients with ICAD-LVO (38%). Baseline demographics were equivalent between the 2 groups except for sex (male 47% vs 67%; P < .001), history of stroke (12% vs 25%; P = .002), and atrial fibrillation (31% vs 17%; P = .003). At 90 days, patients in the ICAD-LVO cohort were less likely to achieve favorable functional outcomes (odds ratio [OR] 0.41, 95% CI 0.22-0.72; P = .003) after adjusting for potentially confounding factors. In addition, ICAD-LVO strokes were less likely to achieve thrombolysis in cerebral infarction ≥2b (OR 0.29, 95% CI 0.14-0.57; P < .001). ICAD-LVO lesions were more likely to require stent placement (OR 14.94, 95% CI 4.91-45.49; P < .001). Subgroup analysis demonstrated favorable functional outcomes in patients who underwent stenting and angioplasty compared with failed recanalization cohort (OR 4.96, 95% CI 1.68-14.64; P < .004)., Conclusion: Patients with acute basilar ICAD-LVO have higher morbidity and mortality compared with patients with embolic source. Lower rates of successful recanalization in the ICAD-LVO cohort support this finding. Our subgroup analysis demonstrates that stenting should be considered in patients with recanalization failure. Rates of symptomatic intracranial hemorrhage were similar between the ICAD-LVO and embolic cohorts., (Copyright © Congress of Neurological Surgeons 2024. All rights reserved.)

Background: We aimed to investigate whether rescue stenting (RS) following failed mechanical thrombectomy (MT) for acute basilar artery occlusion (BAO) results in superior functional outcomes and enhanced safety compared to the natural history of failed mechanical thrombectomy (MT)., Methods: This retrospective cohort study utilized data from the PC-SEARCH registry, encompassing eight high-volume centers in the United States and covering the period from 2015 to 2021. Patients with BAO who experienced failed MT (mTICI score of 0-2a after at least one attempt of clot retrieval) were categorized based on whether they received additional intervention with RS. The primary outcome was a shift analysis of the 90-day mRS. Multivariable logistic regression was employed to assess both efficacy and safety outcomes., Results: Of a total of 444 patients, 119 presented failed MT and were included in the analysis. The RS group comprised 65 (14.6%) patients, while the control group consisted of 54 (12.2%) patients. After adjusting, the RS group showed a favorable shift in the overall 90-day mRS distribution (acOR=4.56; 95% CI 1.67-12.45; p=0.003) and higher rates of 90-day 0-3 mRS (RS: 44.6% vs. control: 18.5%, aOR=7.57; 95% CI 1.91-30.12; p = 0.004) compared to the control group. RS also showed lower rates of 90-day mortality (RS: 43.1% vs. control: 64.8%, aOR=0.27; 95% CI 0.09-0.80; p=0.018) and comparable rates of sICH (RS: 3.1% vs. control: 13%, aOR=0.31; 95% CI 0.05-1.95; p=0.214)., Conclusions: Our study demonstrated that RS is associated with improved functional outcomes and reduced mortality in BAO patients presenting MT failure. Further randomized trials are needed to validate these findings.

Endovascular thrombectomy (EVT) was shown to be safe and efficacious in patients with large core stroke in multiple randomized controlled trials. However, the impact of reperfusion and other procedural metrics on EVT outcomes in this population has not been well-characterized., Methods: From the SELECT2 trial, we evaluated the association between reperfusion status, first-pass effect (near-complete or complete reperfusion [extended thrombolysis in cerebral infarction (eTICI) 2c-3] in 1 pass), procedure time and primary technique (aspiration vs stent-retriever) with functional outcomes in patients receiving EVT across ASPECTS (3 vs 4 vs 5) and core estimate strata (<70 vs ≥70ml, <100 vs ≥100ml, and <150 vs ≥150ml)., Results: Of 180 patients who received thrombectomy, 144 (80%) achieved successful reperfusion (eTICI 2b-3) and demonstrated better clinical outcomes (adjusted generalized odds ratios [aGenOR]: 1.48, 95% confidence interval [CI]: 1.01-2.15), compared with unsuccessful reperfusion. Results were consistent across ASPECTS and core estimate strata. Additionally, complete or near-complete reperfusion (eTICI 2c-3) was associated with better functional outcome (aGenOR: 1.99, 95% CI: 1.33-2.97) in patients achieving successful reperfusion. Functional outcome point estimates favored those with first-pass-effect (42 of 167 (25%), aGenOR: 1.46, 95% CI: 0.96-2.24). Longer procedure time was associated with worse modified Rankin scale (mRS) distribution (aGenOR: 0.92, 95% CI: 0.87-0.96, p-value = 0.001 for 10 minutes increment). Aspiration-first technique was used in 43 of 154 (25%) patients and was not associated with higher reperfusion (88% vs 78%, p = 0.18) or better functional outcome (aGenOR: 0.74, 95% CI: 0.50-1.10) as compared with stent-retriever first., Interpretation: Successful reperfusion resulted in improved clinical outcomes in large core patients across baseline ischemic core strata. Near complete or complete reperfusion was further associated with better outcomes, whereas prolonged procedures were associated with worse outcomes. Results were consistent regardless of the technique used. ANN NEUROL 2024., (© 2024 American Neurological Association.)

Background: Flow diversion has revolutionized the management of wide-necked intracranial aneurysms (IAs). We aimed to assess the effectiveness and safety of the new generation 64-wire Surpass Evolve for the treatment of unruptured small/medium-sized IAs., Methods and Results: This is a subanalysis from the SEASE (Safety and Effectiveness Assessment of the Surpass Evolve) registry, an observational cohort study including 15 academic institutions in North America and Europe between July 2020 and October 2022. Patients with wide-necked saccular IAs, measuring <12 mm along the internal carotid artery and vertebrobasilar system, and treated with the Surpass Evolve were included. Primary effectiveness was complete occlusion (Raymond-Roy class 1) at follow-up (core laboratory adjudicated), and primary safety was major stroke (ischemic/hemorrhagic) in the territory supplied by the target artery or death. A total of 129 cases with 135 IAs were included (median age 59 years, 85.3% women). Median maximum IAs size and neck size were 5.1 and 3.9 mm, respectively. Most IAs were in the internal carotid artery C6 (65.9%, 89/135) and C7 (14.1%, 19/135) segments. At a median follow-up time of 10.2 months (interquartile range, 6.4-12.8), complete occlusion was 77.1% (101/131), ≥50% in-stent stenosis was 8.8% (11/125), and retreatment was 0.8% (1/125). Major stroke and mortality were reported in 2 (1.6%) patients and 1 (0.8%) patient, respectively. Size was the only factor associated with higher odds of incomplete occlusion (adjusted odds ratio, 1.2 [95% CI, 1.02-1.5]; P =0.03)., Conclusions: Patients with small/medium-sized IAs can be effectively treated using the Surpass Evolve, a new generation, 64-wire, cobalt-chromium flow diverter.

Background : There are limited data about left atrial appendage closure (LAAC) in patients with cancer. We therefore sought to compare the outcome after LAAC in patients with vs. without cancer in a multicentre registry. Methods : In this sub-analysis of the prospective Austrian LAAC Registry, we analysed consecutive patients undergoing LAAC to assess the relationship between baseline characteristics and outcome in patients with vs. without cancer. Inverse probability weighting was performed to adjust for differences in baseline characteristics. Results : A total of 486 consecutive patients from 9 centres with a median age of 75 years (IQR 70-79 years; 35.8% female) were included. Fifty-seven patients (11.7%) had a history of cancer. The median CHA 2 DS 2 -VASc and HAS-BLED scores were similar in both groups (median [IQR], 4 [4-6] vs. 5 [3-5], p = 0.415; 4 [3-4] vs. 3 [3-4], p = 0.428 in cancer vs. other patients). Cancer patients were significantly older, and anaemia and gastrointestinal bleeding were significantly more common. Major procedural complications occurred in 5.3% vs. 7.0% ( p = 0.276) of patients. The cumulative five-year survival rates were 80.7% and 84.8% in cancer vs. other patients (adjusted hazard ratio for death 1.29 [95% CI 0.67-2.48], p = 0.443). There were also no differences in one-year survival (96.1% vs. 94.0%, p = 0.582) and five-year event-free survival (64.9% vs. 74.4%, p = 0.124). Conclusions : In daily clinical practice, LAAC has already been accepted as a treatment option in patients with cancer. This retrospective analysis shows that short-term and adjusted long-term complications are similar in patients with vs. without cancer undergoing LAAC.

Background: The availability of mechanical thrombectomy (MT) for acute ischemic stroke is limited, and vast disparities exist between countries. We aim to create a MT access score to measure the drivers of access to help quantify and accelerate treatment worldwide., Methods: We used a systematic review complemented by a modified Delphi method. In the first of 3 rounds, 4 independent investigators performed a systematic literature review using key search terms that drive MT access, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In the second round, a panel of 6 anonymous international experts selected key attributes needed for scoring. In the final round, a total of 12 attributes were selected on consensus, each given a score on a 0 to 3 scale. An ultimate MT access score (range, 0-36) was proposed as a new tool to use in identifying barriers to MT access and assist in providing an initial framework for public health interventions., Results: Of 2864 abstracts screened, 121 studies were included in the final systematic review. A total of 34 attributes that potentially drive MT access were initially identified. In the final round, 12 attributes were selected by the expert panel: public awareness, emergency medical services transportation, prehospital large vessel occlusion screening, interhospital transfer policy, emergency department protocols, stroke imaging protocols, emergency department stroke expertise or telestroke availability, interventionalists, MT-capable centers, device availability, and insurance coverage. These attributes were weighted as part of the final score of 0 to 36., Conclusions: The MT access score represents the first tool to quantify barriers to global MT access. Its implementation stands not just as an academic achievement but as a beacon of hope for improving stroke care and outcomes worldwide, bringing us a step closer to bridging the gap in stroke treatment disparities.

Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease that is characterized by left ventricular hypertrophy unexplained by secondary causes. Based on international epidemiological data, around 20,000-40,000 patients are expected to be affected in Austria. Due to the wide variety of clinical and morphological manifestations the diagnosis can be difficult and the disease therefore often goes unrecognized. HCM is associated with a substantial reduction in quality of life and can lead to sudden cardiac death, especially in younger patients. Early and correct diagnosis, including genetic testing, is essential for comprehensive counselling of patients and their families and for effective treatment. The latter is especially true as an effective treatment of outflow tract obstruction has recently become available in the form of a first in class cardiac myosin ATPase inhibitor, as a noninvasive alternative to established septal reduction therapies. The aim of this Austrian consensus statement is to summarize the recommendations of international guidelines with respect to the genetic background, pathophysiology, diagnostics and management in the context of the Austrian healthcare system and resources, and to present them in easy to understand algorithms., (© 2024. The Author(s).)

Background: The 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss., Aims: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns., Methods: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing., Results: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm 2 to 4.75 mm 2 ; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) - a unique neointimal presentation observed following resorbable magnesium scaffold implantation - was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months., Conclusions: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.

Introduction: Recent randomized controlled trials demonstrated superiority of mechanical thrombectomy compared to medical therapy in acute basilar artery occlusions, however, little data is available to guide clinicians in functional prognosis and risk stratification., Patients and Methods: Data from the retrospectively established PC-SEARCH Thrombectomy registry, which included patients with basilar artery occlusion from eight sites from January 2015 to December 2021, was interrogated. Outcomes were dichotomized into 90-day favorable (mRS ⩽ 3) and unfavorable (mRS > 3). Multivariate logistic regression analysis was performed with respect to the outcome groups and were adjusted for potential confounding baseline characteristics., Results: Four-hundred-forty-four patients were included in this analysis. Mean age was 66 [SD 15], with 56% male, and comprised of 76% Caucasian. Patients presented with an initial median NIHSS of 18 and 199 patients (44.8%) achieved favorable 90-day functional outcomes. Independent predictors of favorable outcomes included younger age, pc-ASPECTS > 8 (OR 2.30 p  < 0.001), and TICI ⩾ 2b (OR 7.56 p  < 0.001). Unfavorable outcomes were associated with increasing number of passes (OR 1.29 p  = 0.004) and sICH (OR 4.19 p  = 0.015). IA-tPA was an independent risk factor for sICH (OR 7.15 p  = 0.002) without improving favorable functional outcomes., Conclusion and Discussion: PC-ASPECTS > 8, successful recanalization (TICI ⩾ 2b), first-pass recanalization, and younger age are independent predictors of favorable 90-day functional outcome in thrombectomy treated patients with acute basilar artery occlusion. Conversely, sICH were independent predictors of unfavorable outcomes. IA-tPA and unsuccessful recanalization are independently associated with sICH., Competing Interests: Declaration of conflicting interestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The authors listed do not have any conflicts of interest to disclose. The following payments are reported by the listed authors but do not conflict with this analysis. Dr. Mouhammad Jumaa has received general payments (<$1000) and academic funding from Chiesi USA, Genentech, Medtronic, and Stryker. Dr. Sami Al Kasab has received general payments (<$1000) from AstraZeneca Pharmaceuticals, MicroVention, and Stryker. Dr. Santiago Ortega Gutierrez has received general payments and academic funding from Medtronic, and Siemens Medical Solutions USA, Stryker. Dr. Ashutosh P Jadhav has received general payments (<$1000) and academic funding from Medtronic, Viz AI, and Medical Device Business Services, Inc. Dr. Toth Gabor has received general payments (<$1000) and academic funding from BioSense Webster, Medtronic, and Stryker. Dr. Thanh Nguyen has received academic funding from AtriCure.

Background: Flow diversion (FD: flow diversion, flow diverter) is an endovascular treatment for many intracranial aneurysm types; however, limited reports have explored the use of FDs in bifurcation aneurysm management. We analyzed the safety and efficacy of FD for the management of intracranial bifurcation aneurysms., Methods: A systematic review identified original research articles that used FD for treating intracranial bifurcation aneurysms. Articles with >4 patients that reported outcomes on the use of FDs for the management of bifurcation aneurysms along the anterior communicating artery (AComA), internal carotid artery terminus (ICAt), basilar apex (BA), or middle cerebral artery bifurcation (MCAb) were included. Meta-analysis was performed using a random effects model., Results: 19 studies were included with 522 patients harboring 534 bifurcation aneurysms (mean size 9 mm, 78% unruptured). Complete aneurysmal occlusion rate was 68% (95% CI 58.7% to 76.1%, I 2 =67%) at mean angiographic follow-up of 16 months. Subgroup analysis of FD as a standalone treatment estimated a complete occlusion rate of 69% (95% CI 50% to 83%, I 2 =38%). The total complication rate was 22% (95% CI 16.7% to 28.6%, I 2 =51%), largely due to an ischemic complication rate of 16% (95% CI 10.8% to 21.9%, I 2 =55%). The etiologies of ischemic complications were largely due to jailed artery hypoperfusion (47%) and in-stent thrombosis (38%). 7% of patients suffered permanent symptomatic complications (95% CI 4.5% to 9.8%, I 2 =6%)., Conclusion: FD treatment of bifurcation aneurysms has a modest efficacy and relatively unfavorable safety profile. Proceduralists may consider reserving FD as a treatment option if no other surgical or endovascular therapy is deemed feasible., Competing Interests: Competing interests: MB is a consultant for Cerenovus, consultant for Integra, and a member of the advisory board for Stryker. GT is a consultant for Dynamed and a Steering Committee member for Medtronic. GT is an Associate Editor for Journal of Neurointerventional Surgery. All other authors have no conflicts of interest to report., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Age is often used as a predictor in determining outcomes in large vessel occlusions treated with mechanical thrombectomy. However, limited data exist for octo/nonagenarian outcomes compared to younger individuals in acute basilar artery occlusions treated with thrombectomy., Methods: Patient data were obtained from the PC-SEARCH Thrombectomy Registry which consists of 444 acute basilar artery occlusions treated with mechanical thrombectomy. Individuals were dichotomized based on age (>80 and ≤80 years old). Primary outcome was defined as modified Rankin Scale of 0-3 at 90 days. Logistic and multivariate regression, as well as control-matched analysis, were performed., Results: There were 373 and 71 patients in the younger and older cohorts, respectively. Gender, ethnicity, smoking status, atrial fibrillation, and coronary artery disease were noted to be significantly different between cohorts. At 90 days, 178 (47.7%) and 23 (32.4%) patients achieved primary outcome at 90 days (p = 0.02), however, after controlling for potentially confounding factors this association lost significance (OR 0.50 95% CI 0.24-1.05; p = 0.07). There were 84 patients included in the control matched analysis and demonstrated no significant differences on multivariate analysis between cohorts (OR 0.68 95% CI 0.25-1.84; p = 0.45)., Interpretation: Octa/nonagenarians presenting with an acute basilar artery occlusion treated with mechanical thrombectomy can achieve acceptable rates of favorable functional outcomes compared to younger individuals with similar baseline demographic and stroke characteristics., Competing Interests: Authors’ contributionThe authors who have contributed to at least one of the key contributions that justify authorship, including (1) conception and design of the study (ATM, PPR, MJ), (2) acquisition and analysis of data (ATM, PPR, MJ) or (3) drafting a significant portion of the manuscript or figures (i.e., a substantial contribution beyond copy editing and approval of the final draft, which is expected of all authors) (ATM, PPR, MJ). Individuals who contributed data acquisition (including phenotyping and gathering information on patients) but not to the final analysis that is unique to this manuscript (e.g., site investigators in a large clinical trial or contributors to a large patient database) (PC-SEARCH Thrombectomy REGISTRY Group includes: NA, KG, EA, SZ, AN, SAK, SOG, JVS, MF, APJ, SD, GT, AA, TNN, PK, MA, ZW, SV, and NV). Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Mouhammad Jumaa has received general payments (<$1000) and academic funding from Chiesi USA, Genentech, Medtronic, and Stryker. Dr Sami Al Kasab has received general payments (<$1000) from AstraZeneca Pharmaceuticals, MicroVention, and Stryker. Dr Santiago Ortega Gutierrez has received general payments and academic funding from Medtronic, and Siemens Medical Solutions USA, Stryker. Dr Ashutosh P Jadhav has received general payments (<$1000) and academic funding from Medtronic, Viz AI, and Medical Device Business Services, Inc. Dr Toth Gabor has received general payments (<$1000) and academic funding from BioSense Webster, Medtronic, and Stryker. Dr Thanh Nguyen has received academic funding from AtriCure.

Objectives: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018., Background: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes., Methods: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality., Results: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68])., Conclusion: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm., (© 2024. The Author(s).)

Background: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI)., Methods: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed., Results: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001)., Conclusions: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment., Methods: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator., Results: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2., Conclusions: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times., Competing Interests: Competing interests: DG: research funding from the National Institutes of Health, Focused Ultrasound Foundation, MicroVention, University of Calgary, and University of Maryland Medical Center; consultant for Navigantis. CS: research support from MicroVention, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Balt, Penumbra, Medtronic, Cerenovus, Route 92, MIVI, Stryker; consultant for Medtronic, Stryker, Balt, Werfen, Viz.ai, MicroVention; shareholder for Neurotechnology Investors, REIST. DHS: consultant for Medtronic, Stryker, and Kaneka; speaker for Medtronic; proctor for Medtronic; grant support from MicroVention; advisory board for Scientia and Vasorum; stockholder of Scientia and Vasorum. GT: consultant for Dynamed, Medtronic, and Penumbra. DF: consultant for Medtronic, Cerenovus, MicroVention, Penumbra, Stryker, Balt USA, MENTICE, Neurogami, RAPID. AI, RAPID Medical, Phenox Medical, Scientia Medical, Perfuze, Vesalio; proctor for Medtronic, MicroVention; research support from MicroVention, Penumbra, Stryker, Balt USA, Siemens; advisory board on Arsenal Medical, NVMed, Perfuze; stock holder in Neurogami, Arsenal Medical, Scientia Medical, NVMed, and Perfuze., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Arteriovenous malformation (AVM)-associated aneurysms represent a high-risk feature predisposing them to rupture. Infratentorial AVMs have been shown to have a greater incidence of associated aneurysms, however the existing data is outdated and biased. The aim of our research was to compare the incidence of supratentorial vs infratentorial AVM-associated aneurysms., Methods: Patients were identified from our institutional AVM registry, which includes all patients with an intracranial AVM diagnosis since 2000, regardless of treatment. Records were reviewed for clinical details, AVM characteristics, nidus location (supratentorial or infratentorial), and presence of associated aneurysms. Statistical comparisons were made using Fisher's exact or Wilcoxon rank sum tests as appropriate. Multivariable logistic regression analysis determined independent predictors of AVM-associated aneurysms. As a secondary analysis, a systematic literature review was performed, where studies documenting the incidence of AVM-associated aneurysms stratified by location were of interest., Results: From 2000-2024, 706 patients with 720 AVMs were identified, of which 152 (21.1%) were infratentorial. Intracranial hemorrhage was the most common AVM presentation (42.1%). The incidence of associated aneurysms was greater in infratentorial AVMs compared with supratentorial cases (45.4% vs 20.1%; P<0.0001). Multivariable logistic regression demonstrated that infratentorial nidus location was the singular predictor of an associated aneurysm, odds ratio: 2.9 (P<0.0001). Systematic literature review identified eight studies satisfying inclusion criteria. Aggregate analysis indicated infratentorial AVMs were more likely to harbor an associated aneurysm (OR 1.7) and present as ruptured (OR 3.9), P<0.0001., Conclusions: In this modern consecutive patient series, infratentorial nidus location was a significant predictor of an associated aneurysm and hemorrhagic presentation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Different studies have demonstrated the benefit of endovascular treatment (EVT) up to 24 hours after acute ischemic stroke (AIS) onset. Recent cohort observational studies suggest that patients with large vessel occlusion AIS may benefit from EVT beyond 24 hours from the last known well (LKW) when adequately selected. We aimed to examine the safety and efficacy of EVT beyond 24 hours from LKW using a meta-analysis of all the literature available., Methods: A systematic search from inception to April 2023 was conducted for studies including AIS patients with EVT beyond 24 hours from LKW in Medline, Embase, Scopus, and Web of Science. Outcomes of interest included favorable functional outcome (90-day modified Rankin scale (mRS) 0-2), successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3), symptomatic intracerebral hemorrhage (sICH), and 90-day mortality. Data were pooled using a random-effects model., Results: Twelve studies with 894 patients were included. The rate of favorable functional outcome was 40% (95% CI 31% to 49%; I 2 =76%). The rate of successful reperfusion was 83% (95% CI 80% to 85%; I 2 =0%). The sICH rate was 7% (95% CI 5% to 9%; I 2 =0%) and the 90-day mortality rate was 28% (95% CI 24% to 33%; I 2 =0%). There was no significant difference in favorable outcomes (OR=0.69; 95% CI 0.41 to 1.14) and 90-day mortality (OR=1.35; 95% CI 0.90 to 2.00) among patients who underwent EVT <24 hours versus >24 hours., Conclusions: EVT beyond 24 hours from LKW may achieve favorable clinical outcomes and high reperfusion rates, with acceptable intracranial hemorrhage rates in selected patients. Considering the current certainty of the evidence and heterogenous individual study results, larger prospective trials are warranted., Competing Interests: Competing interests: SOG: grants from NIH, Stryker, Medtronic, Microvention, MEthinks, IschemiaView, Viz.ai, Siemens; consulting fees from Medtronic and Stryker. TGJ: advisor and investor for Anaconda, Route92, Viz.AI, FreeOx, Blockade Medical, and Methinks; grant support from Medtronic and from Stryker Neurovascular in his capacity as principal investigator for DAWN and AURORA; he received personal fees in his role on the Data Safety Monitoring Board. GT: consultant: Dynamed and Micronvention. AS: principal investigator of the SELECT (Optimizing Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke) and SELECT-2 trials through a grant from Stryker Neurovascular to the University of Texas McGovern–Houston; consultant: Stryker; speaker bureau member: Stryker., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Intracranial aneurysms (IAs) remain a challenging neurological diagnosis associated with significant morbidity and mortality. There is a plethora of microsurgical and endovascular techniques for the treatment of both ruptured and unruptured aneurysms. There is no definitive consensus as to the best treatment option for this cerebrovascular pathology. The Aneurysm, Arteriovenous Malformation, and Chronic Subdural Hematoma Roundtable Discussion With Industry and Stroke Experts discussed best practices and the most promising approaches to improve the management of brain aneurysms., Methods: A group of experts from academia, industry, and federal regulators convened to discuss updated clinical trials, scientific research on preclinical system models, management options, screening and monitoring, and promising novel device technologies, aiming to improve the outcomes of patients with IA., Results: Aneurysm, Arteriovenous Malformation, and Chronic Subdural Hematoma Roundtable Discussion With Industry and Stroke Experts suggested the incorporation of artificial intelligence to capture sequential aneurysm growth, identify predictors of rupture, and predict the risk of rupture to guide treatment options. The consensus strongly recommended nationwide systemic data collection of unruptured IA radiographic images for the analysis and development of machine learning algorithms for rupture risk. The consensus supported centers of excellence for preclinical multicenter trials in areas such as genetics, cellular composition, and radiogenomics. Optical coherence tomography and magnetic resonance imaging contrast-enhanced 3T vessel wall imaging are promising technologies; however, more data are needed to define their role in IA management. Ruptured aneurysms are best managed at large volume centers, which should include comprehensive patient management with expertise in microsurgery, endovascular surgery, neurology, and neurocritical care., Conclusions: Clinical and preclinical studies and scientific research on IA should engage high-volume centers and be conducted in multicenter collaborative efforts. The future of IA diagnosis and monitoring could be enhanced by the incorporation of artificial intelligence and national radiographic and biologic registries. A collaborative effort between academic centers, government regulators, and the device industry is paramount for the adequate management of IA and the advancement of the field., Competing Interests: Disclosures Dr Tjoumakaris reports compensation from Medtronic for consultant services, MicroVention, Inc, for consultant services, and MicroVention, Inc, for consultant services. Dr Hanel reports compensation from Cerenovous for consultant services; stock holdings in eLum and BlinkTBI; compensation from Medtronic for consultant services; stock holdings in Endostream; compensation from Stryker for consultant services; stock holdings in Scientia, Cerebrotech, and RisT; compensation from MicroVention, Inc, for consultant services; compensation from Balt USA, LLC, for consultant services; stock holdings in Corindus, Inc, InNeuroCo, NTI, and Three Rivers Medical, Inc; and compensation from phenox, Inc, Q’Apel, and Rapid Medical Ltd for consultant services. Dr Mocco reports compensation from CVAid for consultant services; stock options in Tulavi; compensation from Penumbra, Inc, for other services; stock holdings in Q’Apel, Spinaker, Endostream, Sim&Cure, and Cerebrotech; compensation from Perflow for consultant services; stock options in Songbird, NRT, and Borvo; grants from PCORI; stock options in E8; employment by Mount Sinai Health System; stock holdings in Imperative Care, Inc; compensation from CVAid and RIST for consultant services; stock holdings in Viseon, Inc, Radical, Vastrax, and Neurolutions; compensation from Synchron for consultant services; stock options in Spinaker; compensation from MicroVention, Inc, for other services; stock holdings in Blinktbi, Echovate, NTI Managers, and Vizai; and compensation from Stryker for other services. Dr Ali-Aziz Sultan reports compensation from MicroVention, Inc, for other services. Dr Froehler reports compensation from OCULUS, Inc, Cerenovus, and Siemens for consultant services; grants from Genentech, Inc; grants from Siemens; and compensation from Balt USA, LLC, for consultant services. Dr Lieber reports stock holdings in Prometheus Therapapeutics, Inc. Dr Coon reports compensation from Medtronic, Inc, Imperative Care, Inc, MicroVention, Inc, Rapid Medical Ltd, Stryker Corporation, and Johnson and Johnson for consultant services. Dr Tateshima reports compensation from Rapid Medical Ltd, Medtronic, phenox, Inc, Cerenovus, MicroVention, Inc, and Stryker for consultant services. Dr Altschul reports securities holdings in Von Vascular, Inc, and compensation from Johnson and Johnson International, Stryker Corporation, Medtronic USA, Inc, and MicroVention, Inc, for consultant services. Dr Narayanan reports compensation from MicroVention, Inc, Johnson & Johnson Health Care Systems, Inc, and Imperative Care, Inc, for consultant services. Dr Taussky reports compensation from Medtronic for consultant services; compensation from phenox, Inc, for data and safety monitoring services; and compensation from Johnson & Johnson Health Care Systems, Inc, for consultant services. Dr Hoh reports stock options in Progressive Neuro; compensation from AstraZeneca for other services; stock options in Galaxy Therapeutics; grants from the National Institutes of Health; compensation from Janssen Pharmaceuticals for other services; employment by the College of Medicine, University of Florida; grants from the Brain Aneurysm Foundation; and stock options in Proprio Vision. Dr Gounis reports compensation from Wallaby Medical, Imperative Care, Inc, and Mivi Neurosciences for consultant services; stock holdings in GalaxyTherapeutics; compensation from Medtronic Neurovascular for consultant services; stock holdings in InNeuroCo, LLC; compensation from Q’Apel Medical, phenox, Inc, Cerenovus, Route 92 Medical, Inc, Alembic, LLC, and Stryker Corporation for consultant services; and stock holdings in Imperative Care, Inc, and Synchron. Dr Liebeskind reports compensation from Stryker, Medtronic, Rapid Medical Ltd, Cerenovus, and Genentech for consultant services. Dr Volovici reports employment by Erasmus Medisch Centrum and compensation from JAMA for consultant services. Dr Toth reports compensation from Medtronic USA, Inc, for other services and compensation from EBSCO and Penumbra, Inc, for consultant services. Dr Arthur reports compensation from Balt USA, LLC, Penumbra, Inc, MicroVention, Inc, Johnson and Johnson International, Siemens Medical Solutions USA, Inc, Stryker Corporation, Perfuze, Scientia, and Medtronic USA, Inc, for consultant services. Dr Wakhloo reports compensation from Stryker Corporation for consultant services, an ownership stake in Deinde Medical, compensation from Acotec for consultant services, an ownership stake in Prometheus Therapeutics, grants from Philips, an ownership stake in Neurofine, and compensation from Cerenovus Johnson & Johnson for consultant services. The other authors report no conflicts.

Background: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE., Methods: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality., Results: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively., Conclusion: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs., Competing Interests: Competing interests: Vivanco-Suarez – None; Dibas – None; Klee Lopes – Consultant: Asahi, Stryker, Corindus, Siemens, and Medtronic. Honoraria: Cerenovus, Medtronic, and Stryker. Advisory Board: INFINITY [trial]. Grants: Mentice. Leadership role: WLNC and Advocate Health. Stock: Syncron, Three Rivers Inc., Q’apel, VIZ.AI, Methinks, Vastrax, Borvo, BendIT, Collavidence, NDI, Prometheus, NextGen, Galaxy, Global Intervention, and Sim&Cure. Hanel – Consultant: Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. Advisory board: MiVI, eLum, Three Rivers Medical Inc., Shape Medical, and Corindus. Grants: from NIH, Interline Endowment, Microvention, Stryker, and CNX. Investor/Stoker: InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc., Scientia, RisT, BlinkTBI, and Corindus. Martinez-Galdamez – Consultant: Medtronic. Rodriguez-Calienes – None; Cortez – None; Fifi – Consultant: Penumbra, Stryker, Microvention, and Cerenovus. Grants: Viz. Investor/Stoker: Imperative care and Cerebrotech. Devarajan – None; Toth – Consultant: Medtronic and Dynamed. Patterson – None; Altschul – Consultant: Microvention, Stryker, and Von Vascular Inc. Pereira – Consultant: Stryker, Medtronic, Penumbra, Neurovasc, and Balt. Liu – None; Puri – Consultant: Medtronic, Stryker, Cerenovus, Microvention, Agile, Merit, Corindus, Q’apel, Arsenal, and Imperative Care. Grants: Medtronic, Stryker, and Cerenovus. Kühn – None; Guerrero – None; Khandelwal – Consultant: Stryker and Medtronic. Bach – None; Kan – Consultant: Stryker, Imperative Care, Cerenovus, and Microvention. Grants: NIH, Siemens, Joe Niekro, and Medtronic. Editorial board: Journal of NeuroInterventional Surgery. Edhayan – None; Given – Consultant: Stryker and Medtronic. Gross – Consultant: Medtronic, Microvention, and Stryker. Farooqui – None; Galecio-Castillo – None; Derakhshani – None; Ortega-Gutierrez – Grants: NIH-NINDS (R01NS127114-01, RO3NS126804-01), Stryker, Medtronic, Microvention, Methinks, Viz.ai. Consulting fees: Medtronic, Stryker Neurovascular., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up., Methods and Results: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001., Conclusion: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue., Competing Interests: Conflict of interest: H.M.G.-G., R.W., G.D.M., M.G., S.B., A.K., and M.B.L. were core laboratory members, and the remaining authors were investigators of the trial. H.M.G.-G. has grants or contracts from Medtronic, Biotronik, Abbott, Neovasc, Corflow, Alucentbio, Philips, and Chiesi (paid to institution), received consulting fees from Boston Scientific and ACIST, and participates in DSMB/advisory board of the VIVID study. R.W. has grants or contracts from Amgen, Biotronik, Boston Scientific, Medtronic, and Philips IGT; received consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; received honoraria from AstraZeneca; participates in DSMB/advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; and is an investor in MedAlliance and Transmural Systems Inc. J.T. reports grants and contracts from Abbott paid to his institution, speaker honoraria and support for attending meetings from Biotronik, and is an associate editor of Cardiovascular Biologics and Regenerative Medicine and Frontiers in Cardiovascular Medicine. J.E. reports personal fees/speaker honoraria from Abbott, Boston Scientific, Philips, and Shockwave, patents from Shared, and participation in advisory boards of Abbott and Phillips. The institution of J.F.I. receives grants or contracts from Terumo Corp, Biosensors, Concept Medical, Biotronik, Abbott Vascular, and Philips Volcano. J.F.I. reports consulting fees from Biotronik, Medtronic, Cordis, Terumo Corp., and ReCor Medical; speaker fees/honoraria from Terumo Corp, Biosensors, Medalliance, OrbusNeich, Concept Medical, Bristol Myers Squibb/Pfizer, Novartis, Cordis, AstraZeneca, and Philips Volcano; and support to attend meetings from Biotronik and Amgen. The institution of J.B. receives grants or contracts from Shockwave IVLS. J.B. receives consulting fees from Biotronik AG and Boston Scientific and speaker fees/honoraria from Biotronik AG, Boston Scientific, and Abbott Vascular, participates in the DSMB of Boston Scientific, and has a leadership or fiduciary role for Biotronik. G.G.T. reports consulting fees from Biotronik, Medtronic, Abbott, and Terumo and honoraria from Biotronik, Medtronic, Abbott, and Terumo. M.J. reports grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from AlchiMedics SAS, Biotronik, TriCares, Veryan, and Shockwave; speaker fees/honoraria from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, Cardiac Dimensions, AstraZeneca, Recor Medical, and Shockwave; travel support from SIS Medical, Edwards Lifesciences, Boston Scientific, and Cardiac Dimensions; and participation in Steering Committees of Biotronik and Edwards Lifesciences. R.T. reports lecture fees from Biotronik. M.W. reports speaker honoraria and conference attendance support from Biotronik. G.O. reports lecturer honoraria from Abbott Vascular, Biotronik, and Cordis and is a DSMB member of the SCIENCE trial and a CEC-member of the BIOFREEDOM STEMI trial. M.H. reports grants/contracts from Biotronik, Cardiac Dimensions, OrbusNeich, and Philips; consulting fees from Biotronik, Cardiac Dimensions, Shockwave Medical, and OrbusNeich; honoraria/speaker fees from Biotronik, Cardiac Dimensions, Shockwave Medical, OrbusNeich, and Philips; and support to attend meetings/travel support from Biotronik, is a steering committee member of the BIOSOLVE and BIOMAG trials, and is a past president of EAPCI. All other authors have no conflict of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

(1) Background : Mechanical circulatory support (MCS) in myocardial infarction-associated cardiogenic shock is subject to debate. This analysis aims to elucidate the impact of MCS's timing on patient outcomes, based on data from the PREPARE CS registry. (2) Methods : The PREPARE CS prospective registry includes patients who experienced cardiogenic shock (SCAI classes C-E) and were subsequently referred for cardiac catheterization. Our present analysis included a subset of this registry, in whom MCS was used and who underwent coronary intervention due to myocardial infarction. Patients were categorized into an Upfront group and a Procedural group, depending on the timing of MCS's introduction in relation to their PCI. The endpoint was in-hospital mortality. (3) Results : In total, 71 patients were included. MCS was begun prior to PCI in 33 (46%) patients (Upfront), whereas 38 (54%) received MCS during or after the initiation of PCI (Procedural). The groups' baseline characteristics and hemodynamic parameters were comparable. The Upfront group had a higher utilization of the Impella ® device compared to extracorporeal membrane oxygenation (67% vs. 33%), while the Procedural group exhibited a balanced use of both (50% vs. 50%). Most patients suffered from multi-vessel disease in both groups (82% vs. 84%, respectively; p = 0.99), and most patients required a complex PCI procedure; the latter was more prevalent in the Upfront group (94% vs. 71%, respectively; p = 0.02). Their rates of complete revascularization were comparable (52% vs. 34%, respectively; p = 0.16). Procedural CPR was significantly more frequent in the Procedural group (45% vs. 79%, p < 0.05); however, in-hospital mortality was similar (61% vs. 79%, respectively; p = 0.12). (4) Conclusions : The upfront implantation of MCS in myocardial infarction-associated CS did not provide an in-hospital survival benefit.

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., Intervention: EVT vs MM., Main Outcomes and Measures: Primary outcome was functional outcome-90-day mRS score (0, no symptoms, to 6, death) assessed by adjusted generalized OR (aGenOR; values >1 represent more favorable outcomes). Benefit of EVT vs MM was assessed across levels of ischemic injury defined by noncontrast CT using ASPECTS score and by the volume of brain with severely reduced blood flow on CT perfusion or restricted diffusion on MRI., Results: Among 352 patients randomized, 336 were analyzed (median age, 67 years; 139 [41.4%] female); of these, 168 (50%) were randomized to EVT, and 2 additional crossover MM patients received EVT. In an ordinal analysis of mRS at 90 days, EVT improved functional outcomes compared with MM within ASPECTS categories of 3 (aGenOR, 1.71 [95% CI, 1.04-2.81]), 4 (aGenOR, 2.01 [95% CI, 1.19-3.40]), and 5 (aGenOR, 1.85 [95% CI, 1.22-2.79]). Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for EVT vs MM was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) for ≥100 mL, and 1.47 (95% CI, 0.84-2.56) for ≥150 mL. In the EVT group, outcomes worsened as ASPECTS decreased (aGenOR, 0.91 [95% CI, 0.82-1.00] per 1-point decrease) and as CT perfusion/MRI ischemic core volume increased (aGenOR, 0.92 [95% CI, 0.89-0.95] per 10-mL increase). No heterogeneity of EVT treatment effect was observed with or without mismatch, although few patients without mismatch were enrolled., Conclusion and Relevance: In this exploratory analysis of a randomized clinical trial of patients with extensive ischemic stroke, EVT improved clinical outcomes across a wide spectrum of infarct volumes, although enrollment of patients with minimal penumbra volume was low. In EVT-treated patients, clinical outcomes worsened as presenting ischemic injury estimates increased., Trial Registration: ClinicalTrials.gov Identifier: NCT03876457.

Background: Discordance between coronary angiographic findings and invasive functional significance is well-established. Yet, the prevalence of this mismatch in an era increasingly utilizing invasive functional assessments, such as fractional flow reserve (FFR), remains unclear. This study examines the extent of such discrepancies in current clinical practice., Methods: This single-center prospective registry included consecutive patients with chronic coronary syndrome (CCS) who underwent elective coronary angiography, with or without revascularization. Coronary angiograms deemed not requiring FFR due to clear anatomical distinctions, either anatomically severe indicating a need for revascularization or mild suggesting no need for intervention, were selected for evaluation. These were then subjected to post-hoc analysis by three independent operators who were blinded to the definitive treatment strategies. Importantly, the post-hoc analysis was conducted in two distinct phases: firstly, a re-evaluation of coronary stenosis, and secondly, a separate functional assessment, each carried out independently. Coronary stenosis severity was assessed visually, while functional relevance was determined by quantitative flow ratio (QFR), calculated using a computational fluid dynamics algorithm applied to angiographic images. Analysis focused on discrepancies between QFR-based functional indications and revascularization strategies actually performed., Results: In 191 patients, 488 vessels were analyzed. Average diameter stenosis (DS) was 37 ± 34%, and QFR was 0.87 ± 0.15, demonstrating a moderate correlation ( r  = -0.84; 95% CI: -0.86 to -0.81, p  < 0.01). Agreement with QFR at conventional anatomical cutoffs was 88% for 50% DS and 91% for 70% DS. Mismatches between revascularization decisions and QFR indications occurred in 10% of cases. Discrepancies were more frequent in the left anterior descending artery (14%) compared to the left circumflex (6%) and the right coronary artery (9%; p  = 0.07)., Conclusion: In a cardiac-center where FFR utilization is high, discordance between coronary angiography and functional significance persists, even when operators are confident in their decisions not to use functional interrogation. This gap, most evident in the left anterior descending artery, highlights the potential need for integrated angiography-based functional assessments to refine revascularization decisions in CCS., Competing Interests: GT receives personal fees from Abbott, Medtronic, Biotronik and Boston Scientific, outside the present work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Kanoun Schnur, Pranevičius, Stark, Prunea, Andreka, Schmidt, Harb, Ruzsa, Zweiker, Kane and Toth.)

Background and Importance: Neurointervention is a very competitive specialty in the United States due to the limited number of training spots and the larger pool of applicants. The training standards are continuously updated to ensure solid training experiences. Factors affecting candidate(s) selection have not been fully established yet. Our study aims to investigate the factors influencing the selection process., Methods: A 52-question survey was distributed to 93 program directors (PDs). The survey consisted of six categories: (a) Program characteristics, (b) Candidate demographics, (c) Educational credentials, (d) Personal traits, (e) Research and extracurricular activities, and (f) Overall final set of characteristics. The response rate was 59.1%. As per the programs' characteristics, neurosurgery was the most involved specialty in running the training programs (69%). Regarding demographics, the need for visa sponsorship held the greatest prominence with a mean score of 5.9 [standard deviation (SD) 2.9]. For the educational credentials, being a graduate from a neurosurgical residency and the institution where the candidate's residency training is/was scored the highest [5.4 (SD = 2.9), 5.4 (SD = 2.5), respectively]. Regarding the personal traits, assessment by faculty members achieved the highest score [8.9 (SD = 1)]. In terms of research/extracurricular activities, fluency in English had the highest score [7.2 (SD = 1.9)] followed by peer-reviewed/PubMed-indexed publications [6.4 (SD = 2.2)]., Conclusion: Our survey investigated the factors influencing the final decision when choosing the future neurointerventional trainee, including demographic, educational, research, and extracurricular activities, which might serve as valuable guidance for both applicants and programs to refine the selection process., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Importance: Stroke-to-recanalization time is a strong predictor of outcomes in anterior circulation large-vessel occlusion (LVO). The authors aimed to evaluate functional outcomes in early (<6 h) vs. late (6-24 h) time windows for thrombectomy-treated basilar artery occlusions., Methods: Patients were derived from the Posterior Circulation Ischemic Stroke Evaluation: Analyzing Radiographic and Intra-procedural Predictors of Mechanical Thrombectomy (PC-SEARCH) Registry and retrospectively analyzed early and late basilar artery thrombectomy time windows cohorts. Patients were dichotomized based on the last known well and correlated to 90-day functional outcomes (mRS 0-3). A multiple logistic regression analysis was performed., Results: A total of 405 patients were included in this study: 216 and 189 patients in the early and late time windows, respectively. Baseline demographic, stroke, radiographic, and intraprocedural characteristics were similar between the groups. A total of 99 (46%) and 79 (42%) patients in the early and late time windows, respectively, achieved favorable functional outcomes at 90 days ( p  = 0.41), and multiple logistic regression analysis did not reveal differences between cohorts (OR: 0.74; 95% CI: 0.46-1.19; p  = 0.22). Symptomatic hemorrhage (7% vs. 5%; p  = 0.69) and neurological complications (8% vs. 9%; p  = 0.83) were similar between the groups; however, hospital complications were more common in the early time window cohort (22% vs. 13%; p  = 0.01)., Conclusion: The early and late thrombectomy time windows can achieve similar rates of 90-day favorable functional outcomes. However, timely thrombectomy influences the likelihood of achieving excellent functional outcomes (mRS ≤ 2) within the early time window., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Mierzwa, Rao, Al Kasab, Nelson, Ortega-Gutierrez, Vivanco-Suarez, Farooqui, Jadhav, Desai, Toth, Alrohimi, Nguyen, Klein, Abdalkader, Salahuddin, Pandey, Wilseck, Koduri, Vora, Aladamat, Gharaibeh, Afreen, Zaidi and Jumaa.)

Background and Objectives: Data regarding radiographic occlusion rates after repeat flow diversion after initial placement of a flow diverter (FD) in large intracranial aneurysms are limited. We report clinical and angiographic outcomes on 7 patients who required retreatment with overlapping FDs after initial flow diversion for large intracranial aneurysms., Methods: We performed a retrospective review of a prospectively maintained database of cerebrovascular procedures performed at our institution from 2017 to 2021. We identified patients who underwent retreatment with overlapping FDs for large (>10 mm) cerebral aneurysms after initial flow diversion. At last angiographic follow-up, occlusion grade was evaluated using the O'Kelly-Marotta (OKM) grading scale., Results: Seven patients (median age 57 years) with cerebral aneurysms requiring retreatment were identified. The most common aneurysm location was the ophthalmic internal carotid artery (n = 3) and basilar trunk (n = 3). There were 4 fusiform and 3 saccular aneurysms. The median aneurysm width was 18 mm; the median neck size for saccular aneurysms was 7 mm; and the median dome-to-neck ratio was 2.8. The median time to retreatment was 9 months, usually due to symptomatic mass effect. After retreatment, the median clinical follow-up was 36 months, MRI/magnetic resonance angiography follow-up was 15 months, and digital subtraction angiography follow-up was 14 months. Aneurysm occlusion at last angiographic follow-up was graded as OKM A (total filling, n = 1), B (subtotal filling, n = 2), C (early neck remnant, n = 3), and D (no filling, n = 0). All patients with symptomatic improvement were OKM C, whereas patients with worsened symptom burden were OKM A or B. Two patients required further open surgical management for definitive management of the aneurysm remnant., Conclusion: Although most patients demonstrated a decrease in aneurysm remnant size, many had high-grade persistent filling (OKM grades A or B) in this subset of mostly large fusiform aneurysms. Larger studies with longer follow-up are warranted to optimize treatment strategies for atypical aneurysm remnants after repeat flow diversion., (Copyright © Congress of Neurological Surgeons 2024. All rights reserved.)

Background: Significant controversy exists about the management of unruptured cerebral arteriovenous malformations (AVMs). Results from A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) suggested that intervention increases the risk of stroke/death compared with medical management. However, numerous study limitations raised concerns about the trial's generalizability., Objective: To assess the rate of stroke/death and functional outcomes in ARUBA-eligible patients from a multicenter database, the Neurovascular Quality Initiative-Quality Outcomes Database (NVQI-QOD)., Methods: We performed a retrospective analysis of prospectively collected data of ARUBA-eligible patients who underwent intervention at 18 participating centers. The primary endpoint was stroke/death from any cause. Secondary endpoints included neurologic, systemic, radiographic, and functional outcomes., Results: 173 ARUBA-eligible patients underwent intervention with median follow-up of 269 (25-722.5) days. Seventy-five patients received microsurgery±embolization, 37 received radiosurgery, and 61 received embolization. Baseline demographics, risk factors, and general AVM characteristics were similar between groups. A total of 15 (8.7%) patients experienced stroke/death with no significant difference in primary outcome between treatment modalities. Microsurgery±embolization was more likely to achieve AVM obliteration (P<0.001). Kaplan-Meier survival curves demonstrated no difference in overall death/stroke outcomes between the different treatment modalities' 5-year period (P=0.087). Additionally, when compared with the ARUBA interventional arm, our patients were significantly less likely to experience death/stroke (8.7% vs 30.7%; P<0.001) and functional impairment (mRS score ≥2 25.4% vs 46.2%; P<0.01)., Conclusion: Our results suggest that intervention for unruptured brain AVMs at comprehensive stroke centers across the United States is safe., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging., Methods: The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups., Results: Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar., Conclusion: Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653)., Non-Standard Abbreviations and Acronyms: BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy., Competing Interests: Declaration of competing interest G.G.T. reports consultancy fees and unrestricted research supports from Medtronic, Biotronik, Terumo and Abbott, outside of this project. D.E.K. reports institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc., Orbus Neich, Teleflex, Medtronic and Ablative Solutions; and personal consulting honoraria from Ablative Solutions, Cardiovascular Systems, Inc., Magenta Medical, Medtronic, and Terumo. A.J.K. reports institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Neurotronic. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: Consulting from IMDS; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. S.W. reports research and educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. He serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. A. Latib reports consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. E.K. has speaker honoraria from Medtronic, Abbott, Aortic Lab, and has received institutional grants from Abbott and Medtronic. R.M. reports institutional research payments from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, Philips, RenalPro, Vivasure, Zoll; personal fees from Cine-Med Research, WebMD; consulting fees paid to the institution from Abbott, Janssen, Medtronic, Novartis; Equity <1 % in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, ACC (BOT Member), SCAI (Women in Innovations Committee Member), JAMA Associate Editor; Faculty CRF (no fee). M.J.P. reports consulting and speaker's honoraria from Abbott Vascular, Baylis Medical, Boston Scientific, Medtronic, Shockwave Medical, and W.L. Gore and consulting honoraria from Biotronik, InnovHeart, and Philips. J.W.C. is an advisory board member for Medtronic and is on the speaker bureau for Shockwave Medical. R.C. has nothing to disclose. R.T. reports institutional grant/support from Medtronic, Biotronik, Micell Technologies, B/Braun, Sahajanand Medical Technologies, Abbot Vascular, Pfizer, Amgen, Regeneron, Novartis, Bayer, Medicins Company, Esperion, Daiichi Sankyo, CLS Behring, Boehringer Ingelheim, and Celecor Therapeutics. E.D. has nothing to disclose. S.S. has nothing to disclose. S.S.B. reports institutional research/grant support from Medtronic, Boston Scientific, and Edwards Lifesciences. A. Loussararian has nothing to disclose. S.C. is a consultant for CoreValve and Medtronic. M.T. has nothing to disclose. G.W.S. has received speaker honoraria from Medtronic, Pulnovo, Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, Amgen; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, Xenter. Dr. Stone's daughter is an employee at Medtronic. Institutional disclosure: Dr. Stone's employer, Mount Sinai Hospital, receives research support from Abbott, Bioventrix, Cardiovascular Systems Inc., Phillips, Biosense-Webster, Shockwave, Vascular Dynamics and V-wave. T.L. is an employee and shareholder of Medtronic. D.M. reports proctor and consultation fees from Medtronic, Boston Scientific, and Microport., (Copyright © 2023. Published by Elsevier Inc.)

Background: Both left ventricular systolic function and fractional flow reserve (FFR) are prognostic factors after percutaneous coronary intervention (PCI). However, how these prognostic factors are inter-related in risk stratification of patients after PCI remains unclarified., Objectives: This study evaluated differential prognostic implication of post-PCI FFR according to left ventricular ejection fraction (LVEF)., Methods: A total of 2,965 patients with available LVEF were selected from the POST-PCI FLOW (Prognostic Implications of Physiologic Investigation After Revascularization with Stent) international registry of patients with post-PCI FFR measurement. The primary outcome was a composite of cardiac death or target-vessel myocardial infarction (TVMI) at 2 years. The secondary outcome was target-vessel revascularization (TVR) and target vessel failure, which was a composite of cardiac death, TVMI, or TVR., Results: Post-PCI FFR was independently associated with the risk of target vessel failure (per 0.01 decrease: HR adj : 1.029; 95% CI: 1.009-1.049; P = 0.005). Post-PCI FFR was associated with increased risk of cardiac death or TVMI (HR adj : 1.145; 95% CI: 1.025-1.280; P = 0.017) among patients with LVEF ≤40%, and with that of TVR in patients with LVEF >40% (HR adj : 1.028; 95% CI: 1.005-1.052; P = 0.020). Post-PCI FFR ≤0.80 was associated with increased risk of cardiac death or TVMI in the LVEF ≤40% group and with that of TVR in LVEF >40% group. Prognostic impact of post-PCI FFR for the primary outcome was significantly different according to LVEF ( P interaction  = 0.019)., Conclusions: Post-PCI FFR had differential prognostic impact according to LVEF. Residual ischemia by post-PCI FFR ≤0.80 was a prognostic indicator for cardiac death or TVMI among patients with patients with LVEF ≤40%, and it was associated with TVR among patients with patients with LVEF>40%. (Prognostic Implications of Physiologic Investigation After Revascularization with Stent [POST-PCI FLOW]; NCT04684043)., Competing Interests: Dr Joo Myung Lee has received an institutional research grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Donga-ST, and Zoll Medical. Dr Bon-Kwon Koo has received an institutional research grant from St. Jude Medical (Abbott Vascular) and Philips Volcano. Dr Joon Hyung Doh has received a research grant from Philips Volcano. Dr Shao-Liang Chen is a consultant for Microport and Boston Scientific International; and has received a grant from the National Natural Scientific Foundation of China. Dr Toth receives consultancy fees and unrestricted research grants from Abbott, Medtronic, and Terumo. Dr Johnson has received institutional research support from Volcano/Philips (DEFINE-FLOW, NCT02328820), Abiomed (for study of Impella-related coronary physiology) and St. Jude Medical (CONTRAST, NCT02184117); has an institutional licensing agreement with Boston Scientific for the smart-minimum FFR algorithm commercialized under 510(k) K191008; and has pending patents on diagnostic methods for quantifying aortic stenosis and TAVR physiology, and also algorithms to correct pressure tracings from fluid-filled catheters. Dr Leesar has received an institutional research grant from ACIST. Dr Azzalini has received honoraria from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Philips, Abbott Vascular, and Cardiovascular System, Inc. Dr Diletti has received an institutional research grant to Erasmus University Medical Center; and has served as a consultant to ACIST Medical Systems. Dr Collison has received consultancy/speaker fees from Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months., Aims: We aimed to report the final study outcomes at 5 years., Methods: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components)., Results: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups., Conclusions: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.

The proper regeneration of vessel anastomoses in microvascular surgery is crucial for surgical safety. Pituitary adenylate cyclase-activating polypeptide (PACAP) can aid healing by decreasing inflammation, apoptosis and oxidative stress. In addition to hematological and hemorheological tests, we examined the biomechanical and histological features of vascular anastomoses with or without PACAP addition and/or using a hemostatic sponge (HS). End-to-end anastomoses were established on the right femoral arteries of rats. On the 21st postoperative day, femoral arteries were surgically removed for evaluation of tensile strength and for histological and molecular biological examination. Effects of PACAP were also investigated in tissue culture in vitro to avoid the effects of PACAP degrading enzymes. Surgical trauma and PACAP absorption altered laboratory parameters; most notably, the erythrocyte deformability decreased. Arterial wall thickness showed a reduction in the presence of HS, which was compensated by PACAP in both the tunica media and adventitia in vivo. The administration of PACAP elevated these parameters in vitro. In conclusion, the application of the neuropeptide augmented elastin expression while HS reduced it, but no significant alterations were detected in collagen type I expression. Elasticity and tensile strength increased in the PACAP group, while it decreased in the HS decreased. Their combined use was beneficial for vascular regeneration.

Background: Cardiogenic shock (CS) exhibits high (~50%) in-hospital mortality. The recently published Extracorporeal life Support in Cardiogenic Shock (ECLS-SHOCK) trial demonstrated the neutral effects of the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) on all-cause death, as well as on all secondary outcomes in subjects presenting with myocardial-infarction (MI)-related CS. Here, we compared ECLS-SHOCK eligibility criteria with a real-world cohort of CS patients., Methods and Results: ECLS-SHOCK eligibility criteria were applied to a prospective single-center CS registry (the PREPARE CS registry) consisting of 557 patients who were consecutively admitted to the catheterization laboratory (cath lab) of the Medical University of Graz, Austria, due to CS (SCAI C-E). Overall use of mechanical circulatory support (MCS) in this cohort was 19%. Sixty-nine percent of the entire cohort had MI-related CS, 38% of whom would have met ECLS-SHOCK eligibility criteria, thus representing only 27% of the PREPARE CS registry. Exclusion from the ECLS-SHOCK trial was based on patients with initial lactate values below 3 mmol/L (n = 168; 43.6%), aged over 80 years (n = 65; 16.9%), and with a duration of cardiopulmonary resuscitation (CPR) exceeding 45 min (n = 22; 5.7%). The 30-day mortality of patients of the PREPARE CS registry who met the ECLS-SHOCK eligibility criteria was 57.0%, compared to 48.4% of patients in the ECLS-SHOCK trial. The patients' baseline characteristics, however, differed considerably with respect to type of infarction, age, and gender., Conclusions: In a real-world cohort of patients with MI-related CS, only 38% of patients met the eligibility criteria of the ECLS-SHOCK trial. Thus, the impact of the use of VA-ECMO on outcome parameters in MI-related CS, as observed in the ECLS-SHOCK trial, may differ in a more heterogeneous real-world CS population of the PREPARE CS registry.

Since the publication of the 2015 EAPCI consensus on rotational atherectomy, the number of percutaneous coronary interventions (PCI) performed in patients with severely calcified coronary artery disease has grown substantially. This has been prompted on one side by the clinical demand for the continuous increase in life expectancy, the sustained expansion of the primary PCI networks worldwide, and the routine performance of revascularization procedures in elderly patients; on the other side, the availability of new and dedicated technologies such as orbital atherectomy and intravascular lithotripsy, as well as the optimization of the rotational atherectomy system, has increased operators' confidence in attempting more challenging PCI. This current EAPCI clinical consensus statement prepared in collaboration with the EURO4C-PCR group describes the comprehensive management of patients with heavily calcified coronary stenoses, starting with how to use non-invasive and invasive imaging to assess calcium burden and inform procedural planning. Objective and practical guidance is provided on the selection of the optimal interventional tool and technique based on the specific calcium morphology and anatomic location. Finally, the specific clinical implications of treating these patients are considered, including the prevention and management of complications and the importance of adequate training and education., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Anemia is a severe global public health issue. Testing practices for anemia suggest overuse of screening laboratory tests and misinterpretation of studies even in "easy-to-diagnose" underlying causes, leading to late diagnoses and missed treatment opportunities. We aimed to develop a complete and efficient algorithm for clinical pathologists and laboratory medicine physicians for the differential diagnosis of anemia., Methods: Comprehensive literature search encompassing original articles, studies, reviews, gold standard books, and other evidence., Results: We created a complex algorithm, primarily for clinical pathology/laboratory use, that explores all major and several rare causes of anemia in an efficient and evidence-based manner. The algorithm includes gold-standard diagnostic laboratory tests available in most clinical laboratories and indices that can be easily calculated to provide an evidence-based differential diagnosis of anemia., Conclusions: The diagnostic strategy combines previously available diagnostic tests and protocols in an efficient order. Clinical pathologists following the algorithm can independently provide valuable diagnostic support for healthcare providers. Clinical pathologists providing complete differential diagnostic services with the proposed algorithm may create an opportunity for an advanced diagnostic service that supports diagnostic excellence and helps patients receive a timely diagnosis and early treatment opportunities., (© 2023 the author(s), published by De Gruyter, Berlin/Boston.)

Background: Low fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) has been associated with adverse clinical outcomes. Hitherto, this assessment has been independent of the epicardial vessel interrogated., Objectives: This study sought to assess the predictive capacity of post-PCI FFR for target vessel failure (TVF) stratified by coronary artery., Methods: We performed a systematic review and individual patient-level data meta-analysis of randomized clinical trials and observational studies with protocol-recommended post-PCI FFR assessment. The difference in post-PCI FFR between left anterior descending (LAD) and non-LAD arteries was assessed using a random-effect models meta-analysis of mean differences. TVF was defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization., Results: Overall, 3,336 vessels (n = 2,760 patients) with post-PCI FFR measurements were included in 9 studies. The weighted mean post-PCI FFR was 0.89 (95% CI: 0.87-0.90) and differed significantly between coronary vessels (LAD = 0.86; 95% CI: 0.85 to 0.88 vs non-LAD = 0.93; 95% CI: 0.91-0.94; P < 0.001). Post-PCI FFR was an independent predictor of TVF, with its risk increasing by 52% for every reduction of 0.10 FFR units, and this was mainly driven by TVR. The predictive capacity for TVF was poor for LAD arteries (AUC: 0.52; 95% CI: 0.47-0.58) and moderate for non-LAD arteries (AUC: 0.66; 95% CI: 0.59-0.73; LAD vs non-LAD arteries, P = 0.005)., Conclusions: The LAD is associated with a lower post-PCI FFR than non-LAD arteries, emphasizing the importance of interpreting post-PCI FFR on a vessel-specific basis. Although a higher post-PCI FFR was associated with improved prognosis, its predictive capacity for events differs between the LAD and non-LAD arteries, being poor in the LAD and moderate in the non-LAD vessels., Competing Interests: Funding Support and Author Disclosures Dr Collet received research grants from Biosensors, HeartFlow Inc, Abbott Vascular, Insight Lifetech, GE Healthcare, Siemens and Shockwave Medical. Dr Johnson has received internal funding from the Weatherhead PET Center for Preventing and Reversing Atherosclerosis; has received significant institutional research support from St. Jude Medical (CONTRAST, NCT02184117) and Philips Volcano (DEFINE-FLOW, NCT02328820) for studies using intracoronary pressure and flow sensors; has an institutional licensing agreement with Boston Scientific for the smart-minimum FFR algorithm commercialized under 510(k) K191008; and has pending patents on diagnostic methods for quantifying aortic stenosis and TAVI physiology and also algorithms to correct pressure tracings from fluid-filled catheters. Dr Mizukami has received consultancy fees from Zeon Medical. Dr Fearon receives institutional research support from Abbott Vascular, Boston Scientific, Medtronic, and Edwards Lifesciences; he has a consulting relationship with CathWorks and Siemens; and he owns minor stock options in HeartFlow. Dr Berry receives research funding from the British Heart Foundation grant (RE/18/6134217); and is employed by the University of Glasgow, which holds consultancy and research agreements for his work with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Causeway Therapeutics, Coroventis, Genentech, GlaxoSmithKline, HeartFlow, Menarini, Neovasc, Siemens Healthcare, and Valo Health. Dr Sonck is supported by a grant provided by the CardioPath PhD program. Dr Collison has received honoraria/speaker fees from Abbott. Dr Koo has received an institutional research grant from St. Jude Medical (Abbott Vascular) and Philips Volcano. Dr Meneveau has received consultancy and speaker fees from Abbott Vascular, Edwards Lifesciences, Terumo, Boston Scientific, Bayer Healthcare, BMS-Pfizer, Boehringer, and AstraZeneca. Dr Oldroyd is an employee of Biosensors International. Dr Leipsic is a consultant for and holds stock options in Circle CVI and HeartFlow; and has a research grant from GE Healthcare. Dr Taylor is an employee of HeartFlow Inc. Dr Ko has received consultancy fees from Abbott Vascular and Medtronic; and has received research support from Canon Medical. Dr Perera has received research grant support from Abbott Vascular, HeartFlow, and Philips. Dr Leone received consultant fees and honoraria for lectures in sponsored symposia with Abbott Vascular and Bracco Imaging/ACIST Medical. Dr Matsuo has received consultancy fees from Zeon Medical; and has received speaker fees from Abbott Vascular Japan, Philips, and Boston Scientific. Dr Amabile reports consulting/proctoring fees from Abbott Vascular, Boston Scientific, and Shockwave Medical; and has received an institutional research grant from Abbott Vascular and Boston Scientific. Dr Piróth has received consultancy and speaker fees from Abbott Vascular, Opsens, and Boston Scientific. Dr Toth has received consultancy fees and research support from Abbott, Biotronik, Medtronic, and Terumo. Dr Ihdayhid reports receiving consulting honorarium from Abbott Medical, Edwards Lifesciences, Boston Scientific, Artrya Pty Ltd (including equity interest). Dr West is an employee of Abbott Vascular. Dr Munhoz is supported with a PhD grant from CardioPath. Dr Barbato has received speaker fees from Abbott and Boston Scientific. Dr Engstrøm has received consultancy and speaker fees from Abbott Vascular, Novo Nordisk, and Bayer AS. Dr Escaned is supported by the Intensification of Research Activity project INT22/00088 from Spanish Instituto de Salud Carlos III, and served as speaker and advisory board member for Abbott and Philips. Dr Ali has received institutional grant support Abbott, Abiomed, ACIST Medical, Amgen, Boston Scientific, Cathworks, Canon, Conavi, Heartflow, Inari, Medtronic Inc, National Institute of Health, Nipro, Opsens Medical, Medis, Philips, Shockwave, Siemens, Spectrawave, Teleflex; and consulting fees from Abiomed, AstraZeneca, Boston Scientific, Cathworks, Opsens, Philips, Shockwave and equity in Elucid, Lifelink, Spectrawave, Shockwave, VitalConnect. Dr Kern has received speaker fees from Abbott, ACIST Medical, Boston Scientific, Opsens, and Philips. Dr Pijls has received research grants from Abbott and Hexacath and consultancy fees from Abbott, GE, Philips, and HeartFlow and have equity in GE, Philips, and Heartflow. Dr De Bruyne has received institutional consulting fees from Abbott Vascular, Boston Scientific, Siemens, and GE; has received institutional grant support from Abbott Vascular, Boston Scientific, Biotronic, CathWorks, Pie Medical, and HeartFlow; and holds minor equities in Philips, Siemens, GE, Bayer, HeartFlow, Edwards Lifesciences, and Ceyliad. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective/aim: To investigate the effect of cerebral microbleeds (CMBs) on the functional and safety outcomes of endovascular thrombectomy (EVT) in patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO)., Methods: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines for systematic review and meta-analysis. We included observational studies that recruited AIS-LVO patients, used susceptibility-sensitive magnetic resonance imaging (MRI) to detect CMBs, and examined the association between them and predefined outcome events. The extracted data included study and population characteristics, risk of bias domains, and outcome measures. The outcomes of interest included functional independence, revascularization success, procedural and hemorrhagic adverse events. We conducted a meta-analysis using the Mantel-Haenszel method and calculated the risk ratios., Results: Four studies with a total of 1,514 patients were included. A significant reduction in the likelihood of achieving a favorable functional outcome was observed in patients with CMBs (Risk ratio (RR) 0.69, 95% confidence interval (CI): 0.52 to 0.91, P=0.01). No significant differences were observed between the CMBs and no CMBs groups in terms of successful revascularization, mortality, intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), and parenchymal hematoma., Conclusions: The presence of CMBs significantly reduced the likelihood of achieving functional independence post-EVT in AIS-LVO patients. However, CMBs did not impact the rates of successful revascularization, mortality, or the occurrence of various hemorrhagic events. Future research should explore the mechanisms of this association and strategies to mitigate its impact., Competing Interests: Declaration of Competing Interest The Authors declare that they did not receive any financial and personal relationships with other people or organizations that could inappropriately influence (bias) this work., (Copyright © 2023. Published by Elsevier Inc.)

The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y 12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent.Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y 12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Aspiration catheters (ASPs) and stentriever thrombectomy devices have comparable safety and efficacy in anterior circulation ischemic strokes. However, there is lack of high-quality comparative data in acute basilar artery occlusions. Our objective is to compare the outcomes and safety of ASPs and stentriever devices in acute basilar artery occlusions., Methods: This is an analysis of the retrospectively established PC-SEARCH Thrombectomy (Posterior-Circulation Ischemic Stroke Evaluation: Analyzing Radiographic and Intraprocedural Predictors for Mechanical Thrombectomy) registry. Patients were dichotomized based on their first-line thrombectomy device (ASP and stentriever) and associated with their 90-day functional outcomes, intraprocedural metrics, and safety measures. Propensity analysis based on unequal baseline characteristics was performed. Consecutive patients with acute basilar artery occlusions who received mechanical thrombectomy were included from January 2015 to December 2021. Patients received either first-line contact aspiration or stentriever mechanical thrombectomy. Primary clinical and safety outcomes were 90-day functional independence measured by a modified Rankin Scale score of 0 to 3 and symptomatic intracranial hemorrhage, respectively. Secondary outcomes included puncture-recanalization times, first-pass recanalization rates, crossovers to other thrombectomy device, and neurological/hospital complications., Results: Five hundred eighteen patients were included in the registry, and a total of 383 patients were included (mean [SD] age, 65.5 [15] years; 228 [59%] men) in this analysis. Of these, 219 patients were first-line ASP while 164 patients received first-line stentriever devices. Median premorbid modified Rankin Scale was zero and median presenting National Institutes of Health Stroke Scale was 17 (interquartile range, 8-26). The proportion of favorable functional outcome was similar between the 2 techniques before (47.3% versus 42.5%; odds ratio, 1.22 [95% CI, 0.78-1.89]; P =0.38) and after propensity matching (odds ratio, 1.46 [95% CI, 0.85-2.49]; P =0.17). In our propensity-matched cohorts, puncture-recanalization times (18 versus 52 minutes; P <0.01) favored first-line ASP; however, first-pass recanalization rates (43.5% versus 44.5%; P =0.90) were similar between groups. First-line ASP was associated with higher rates of crossover (22% versus 6%; P <0.01), whereas stentriever was associated with higher rates of symptomatic intracranial hemorrhage (9.8% versus 3.4%; P =0.04)., Conclusions: First-line ASP and stentriever methods demonstrated similar functional outcome and recanalization rates. Stentriever methods were associated with higher rates of symptomatic intracranial hemorrhage, whereas ASPs were associated with higher rates of crossover to alternative technique in patients with acute basilar occlusions., Competing Interests: Disclosures Dr Jumaa reports grants from Medtronic to other services. Dr Al Kasab reports compensation from Stryker for other services. Dr Toth reports compensation from EBSCO for consultant services and compensation from Medtronic USA, Inc, for other services. Dr Nguyen reports compensation from Medtronic for other services; grants from the Society of Vascular and Interventional Neurology; and compensation from Idorsia for other services. Dr Ortega Gutierrez reports grants from Siemens; grants from the National Institutes of Health; grants from Stryker; grants from MicroVention, Inc; compensation from MicroVention, Inc, for consultant services; compensation from Medtronic for consultant services; employment by Carver College of Medicine, University of Iowa; compensation from Stryker for consultant services; and grants from methinks. Dr Jadhav reports employment by Barrow Brain and Spine; a patent issued for novel stent retriever device licensed to Basking Biosciences; compensation from Basking Biosciences for consultant services; and stock options in Gravity Medical Technology. The other authors report no conflicts.

Background and Aims: Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) reflects residual atherosclerotic burden and is associated with future events. How much post-PCI FFR can be predicted based on baseline basic information and the clinical relevance have not been investigated., Methods: We compiled a multicenter registry of patients undergoing pre- and post-PCI FFR. Machine-learning (ML) algorithms were designed to predict post-PCI FFR levels from baseline demographics, quantitative coronary angiography, and pre-PCI FFR. FFR deviation was defined as actual minus ML-predicted post-PCI FFR levels, and its association with incident target vessel failure (TVF) was evaluated., Results: Median (IQR) pre- and post-PCI FFR values were 0.71 (0.61, 0.77) and 0.88 (0.84, 0.93), respectively. The Spearman correlation coefficient of the actual and predicted post-PCI FFR was 0.54 (95% CI: 0.52, 0.57). FFR deviation was non-linearly associated with incident TVF (HR [95% CI] with Q3 as reference: 1.65 [1.14, 2.39] in Q1, 1.42 [0.98, 2.08] in Q2, 0.81 [0.53, 1.26] in Q4, and 1.04 [0.69, 1.56] in Q5). A model with polynomial function of continuous FFR deviation indicated increasing TVF risk for FFR deviation ≤0 but plateau risk with FFR deviation >0., Conclusions: An ML-based algorithm using baseline data moderately predicted post-PCI FFR. The deviation of post-PCI FFR from the predicted value was associated with higher vessel-oriented event., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Koo reported receiving grants from Abbott Vascular and Philips Volcano during the conduct of the study. Dr. Tanaka reported receiving personal fees from Abbott Vascular Japan and personal fees from Daiichi-Sankyo Co Ltd during the conduct of the study. Dr. Azzalini received honoraria from Teleflex, Abiomed, Asahi Intecc, Philips, GE Healthcare, Abbott Vascular, and Cardiovascular System, Inc. No other disclosures were reported. Data described in the manuscript, code book, and analytic code will be made available upon request pending application and approval., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI., Methods: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha., Results: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P <0.0001 for noninferiority for both tests)., Conclusions: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT04137510., Competing Interests: Disclosures Dr Valgimigli reports grants and personal fees from Terumo and personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, IDORSIA Pharmaceuticals Ltd, Universität Basel, Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio. Dr Wlodarczak has no conflicts of interest to report. Dr Tölg reports personal fees for lectures from Biotronik. Dr Merkely reports personal fees from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, CSL Behring, Daiichi Sankyo, Duke Clinical Research Institute, Medtronic, and Novartis, and institutional grants from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo, Duke Clinical Institute, Eli Lilly, Medtronic, Novartis, Terumo, and VIFOR Pharma. Dr Kelbæk has no conflicts of interest to report. Dr Legutko reports lecture fees from Abiomed, AstraZeneca, Berlin Chemie-Menarini, Abbott, Bayer AG, Ely Lilly, Medtronic, MSD, Philips-Volcano, Procardia, Sanofi, and Novartis; meeting or travel fees from Abbott, Boston, Medtronic, and Abiomed; and data safety monitoring board or advisory board fees from AstraZeneca, Berlin Chemie-Menarini, Abbott, Sanofi, Gedeon Richte, Hemolens Diagnostics, Novartis, and Ferrer. Dr Galli reports consulting fees from BIOACADEMY and lecture fees from PCR. Dr Godin reports lecture fees from B. Braun, Medtronic, and Edwards, and data safety monitoring board or advisory board fees from Terumo and Microport. Dr Toth reports grants and personal fees from Terumo, Abbott Vascular, Biotronik, and Medtronic. Dr Lhermusier reports consulting fees from Abbott and meeting or travel fees from Medtronic. Dr Honton reports consulting fees from Medtronic, Shockwave, Terumo, and Microport; lecture fees from Shockwave, Medtronic, and Boston; and data safety monitoring board or advisory board fees from Microport, Terumo, and Medtronic. Dr Dietrich reports educational event fees to his institution from Cordis. Drs. Stammen and Ferdinande have no conflicts of interest to report. Dr Silvain reports consulting fees from AstraZeneca, Bayer Health Care SAS, CSL Behring SA, Sanofi-Aventis France, and Zoll, and stock options without payment at 4P-Pharma. Dr Capodanno reports honoraria fees from Biotronik and honoraria fees to his institution from Medtronic. Dr Cayla reports personal consulting fees from Edwards, Medtronic, and Microport CRM, and personal honoraria fees from Amgen, AstraZeneca, Abbott, Bayer, Biotronik, Bristol-Myers Squibb, Edwards, Microport, Medtronic, Pfizer, and Sanofi-Aventis.

Background Cardiac death or myocardial infarction still occurs in patients undergoing contemporary percutaneous coronary intervention (PCI). We aimed to identify adverse clinical and vessel characteristics related to hard outcomes after PCI and to investigate their individual and combined prognostic implications. Methods and Results From an individual patient data meta-analysis of 17 cohorts of patients who underwent post-PCI fractional flow reserve measurement after drug-eluting stent implantation, 2081 patients with available clinical and vessel characteristics were analyzed. The primary outcome was cardiac death or target-vessel myocardial infarction at 2 years. The mean age of patients was 64.2±10.2 years, and the mean angiographic percent diameter stenosis was 63.9%±14.3%. Among 11 clinical and 8 vessel features, 4 adverse clinical characteristics (age ≥65 years, diabetes, chronic kidney disease, and left ventricular ejection fraction <50%) and 2 adverse vessel characteristics (post-PCI fractional flow reserve ≤0.80 and total stent length ≥54 mm) were identified to independently predict the primary outcome (all P <0.05). The number of adverse vessel characteristics had additive predictability for the primary end point to that of adverse clinical characteristics (area under the curve 0.72 versus 0.78; P =0.03) and vice versa (area under the curve 0.68 versus 0.78; P =0.03). The cumulative event rate increased in the order of none, either, and both of adverse clinical characteristics ≥2 and adverse vessel characteristics ≥1 (0.3%, 2.4%, and 5.3%; P for trend <0.01). Conclusions In patients undergoing drug-eluting stent implantation, adverse clinical and vessel characteristics were associated with the risk of cardiac death or target-vessel myocardial infarction. Because these characteristics showed independent and additive prognostic value, their integrative assessment can optimize post-PCI risk stratification. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04684043. www.crd.york.ac.uk/prospero/. Unique Identifier: CRD42021234748.

Despite the high probability of glaucoma-related blindness, its cause is not fully understood and there is no efficient therapeutic strategy for neuroprotection. Vascular factors have been suggested to play an important role in glaucoma development and progression. Previously, we have proven the neuroprotective effects of pituitary adenylate-cyclase-activating polypeptide (PACAP) eye drops in an inducible, microbeads model in rats that is able to reproduce many clinically relevant features of human glaucoma. In the present study, we examined the potential protective effects of PACAP1-38 on the retinal vasculature and the molecular changes in hypoxia. Ocular hypertension was induced by injection of microbeads into the anterior chamber, while control rats received PBS. PACAP dissolved in vehicle (1 µg/drop) or vehicle treatment was started one day after the injections for four weeks three times a day. Retinal degeneration was assessed with optical coherence tomography (OCT), and vascular and molecular changes were assessed by immunofluorescence labeling. HIF1-α and VEGF-A protein levels were measured by Western blot. OCT images proved severe retinal degeneration in the glaucomatous group, while PACAP1-38 eye drops had a retinoprotective effect. Vascular parameters were deteriorated and molecular analysis suggested hypoxic conditions in glaucoma. PACAP treatment exerted a positive effect against these alterations. In summary, PACAP could prevent the severe damage to the retina and its vasculature induced by ocular hypertension in a microbeads model.

The clinical value of fractional flow reserve and non-hyperaemic pressure ratios are well established in determining an indication for percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD). In addition, over the last 5 years we have witnessed a shift towards the use of physiology to enhance procedural planning, assess post-PCI functional results, and guide PCI optimisation. In this regard, clinical studies have reported compelling data supporting the use of longitudinal vessel analysis, obtained with pressure guidewire pullbacks, to better understand how obstructive CAD contributes to myocardial ischaemia, to establish the likelihood of functionally successful PCI, to identify the presence and location of residual flow-limiting stenoses and to predict long-term outcomes. The introduction of new functional coronary angiography tools, which merge angiographic information with fluid dynamic equations to deliver information equivalent to intracoronary pressure measurements, are now available and potentially also applicable to these endeavours. Furthermore, the ability of longitudinal vessel analysis to predict the functional results of stenting has played an integral role in the evolving field of simulated PCI. Nevertheless, it is important to have an awareness of the value and challenges of physiology-guided PCI in specific clinical and anatomical contexts. The main aim of this European Association of Percutaneous Cardiovascular Interventions clinical consensus statement is to offer up-to-date evidence and expert opinion on the use of applied coronary physiology for procedural PCI planning, disease pattern recognition and post-PCI optimisation.

Background: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES)., Aims: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold., Methods: This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years., Results: A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent., Conclusions: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES., Clinicaltrials: gov: NCT04157153.

Introduction: Endovascular thrombectomy (EVT) is the standard treatment of acute ischemic stroke (AIS) due to large vessel occlusion (LVO). Although > 70% of patients in the trials assessing EVT for AIS-LVO had successful recanalization, only a third ultimately achieved favorable outcomes. A "no-reflow" phenomenon due to distal microcirculation disruption might contribute to such suboptimal outcomes. Combining intra-arterial (IA) tissue plasminogen activator (tPA) and EVT to reduce the distal microthrombi burden was investigated in a few studies. We present a pooled-data meta-analysis of the existing evidence of this combinatorial treatment., Methods: We followed the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) recommendations. We aimed to include all original studies investigating EVT plus IA tPA in AIS-LVO patients. Using R software, we calculated pooled odds ratios (ORs) with corresponding 95% confidence intervals (CI). A fixed-effects model was adopted to evaluate pooled data., Results: Five studies satisfied the inclusion criteria. Successful recanalization was comparable between the IA tPA and control groups at 82.9% and 82.32% respectively. The 90-day functional independence was similar between both groups (OR= 1.25; 95% CI= 0.92-1.70; P= 0.154). Symptomatic intracranial hemorrhage (sICH) was also comparable between both groups (OR= 0.66; 95% CI= 0.34-1.26; P= 0.304)., Conclusion: Our current meta-analysis does not show significant differences between EVT alone and EVT plus IA tPA in terms of functional independence or sICH. However, with the limited number of studies and included patients, more randomized controlled trials (RCTs) are needed to further investigate the benefits and safety of combined EVT and IA tPA., Competing Interests: Declaration of Competing Interest The Authors declare that they did not receive any financial and personal relationships with other people or organizations that could inappropriately influence (bias) this work., (Copyright © 2023. Published by Elsevier Inc.)