Nondisabling Stroke Research Articles

Dual antiplatelet versus alteplase in anterior and posterior circulation minor stroke

ObjectiveThe Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy (DAPT) to alteplase in minor non-disabling stroke. This prespecified secondary analysis aimed...

Dual Antiplatelet Versus Alteplase for Early Neurologic Deterioration in Minor Stroke With Versus Without Large Vessel Occlusion: Prespecified Post Hoc Analysis of the ARAMIS Trial.

Dual antiplatelet therapy (DAPT) was noninferior to alteplase in minor nondisabling strokes in the ARAMIS trial (Antiplatelet Versus R-tPA for Acute Mild Ischemic Stroke); however, early neurological deterioration (END) associated with vessel stenosis may benefit from DAPT. We investigated whether the efficacy of DAPT was greater than alteplase in minor strokes with no large vessel occlusion (LVO). This study was a prespecified post hoc analysis of the ARAMIS trial and included patients with responsible vessel examination in the as-treated analysis set of the ARAMIS trial who were divided into LVO group and non-LVO group. In each group, patients were further classified into DAPT and intravenous alteplase treatments. Primary outcome was END at 24 hours defined as more than or equal to 4-point National Institutes of Health Stroke Scale score increase compared with baseline, and safety outcomes were symptomatic intracerebral hemorrhage and bleeding events during study. The primary analysis was estimated with a risk difference calculated by a generalized linear model including adjusted different baseline characteristics between treatments. Of 723 patients from the ARAMIS trial, 480 patients were included: 36 were categorized into LVO group and 444 into non-LVO group, of whom 20 patients had END. Compared with intravenous alteplase, a lower proportion of END was found after DAPT treatment in the non-LVO group (adjusted risk difference, -4.8% [95% CI, -6.9% to -2.6%]; P<0.001), but not in the LVO group (adjusted risk difference, 2.3% [95% CI, -17.6% to 22.3%]; P=0.82). The interaction was marginally significant between groups (P=0.06). In the non-LVO group, a lower proportion of bleeding events was found after DAPT treatment than intravenous alteplase (adjusted risk difference, -6.4% [95% CI, -8.9% to -3.9%]; P<0.001). Other safety outcomes were similar between the 2 treatments. Among minor nondisabling acute ischemic stroke without LVO, DAPT may be superior to intravenous alteplase regarding preventing END with a better safety profile. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03661411.

Intravenous thrombolysis or antiplatelet therapy for acute nondisabling ischemic stroke: A systematic review and network meta-analysis.

Uncertainties remain on the optimal treatment for acute minor stroke with nondisabling symptoms. The two most common therapeutic approaches are intravenous thrombolysis (IVT) and antiplatelet therapy, notably dual antiplatelet therapy (DAPT). We synthesized data from the literature to compare IVT to DAPT and identify the best treatment for this population. We systematically searched Pubmed, Web of Science and the Cochrane Library for randomized trials and observational studies comparing IVT, aspirin, and/or DAPT, started within 24 h of symptom onset in patients with minor stroke (NIHSS ⩽ 5) and nondisabling symptoms. Random-effects Bayesian network meta-analysis was conducted. The primary outcome was excellent functional outcome at 3 months (mRS 0-1). Secondary outcomes included mRS 0-2, symptomatic intracranial hemorrhage, mortality, and recurrent stroke. Four randomized trials and 2 observational studies (5897 patients for the analysis of the primary outcome) were included. Compared with IVT (alteplase), DAPT (clopidogrel + aspirin) was significantly associated with higher odds of mRS 0-1 (OR = 1.52, 95% CrI, 1.09-2.35), but aspirin alone was not (OR = 1.36, 95% CrI, 0.87-2.30). DAPT was also associated with lower odds of symptomatic intracranial hemorrhage than alteplase (OR = 0.14, 95% CrI, 0.03-0.91). There were no significant differences between treatment groups regarding the other outcomes. For each outcome, the ranking for the best treatment was DAPT, then aspirin, and then IVT. This network meta-analysis suggests that DAPT may be the optimal treatment for acute nondisabling stroke, with higher odds of excellent functional outcome compared with IVT.Registration: PROSPERO ID: CRD42024522038.

Emergent endovascular treatment versus medical treatment for acute large vessel occlusions with nondisabling symptoms.

The aim of this study is to analyze the effectiveness and safety of medical treatment (MT) versus endovascular treatment (EVT) in acute large vessel occlusion patients with mild nondisabling stroke symptoms. This study is a multicenter observational study in which data from patients at three stroke centers were prospectively obtained and retrospectively analyzed. Patients were included if they arrived for treatment within 6 h of stroke onset or last known well time and had a baseline National Institutes of Health Stroke Scale (NIHSS) score of ≤5. Primary outcome was modified Rankin Scale (mRS) score 0-2 at 90 days. Secondary outcomes included symptomatic intracranial hemorrhage (sICH), discharge NIHSS score, 90-day all-cause mortality and length of stay. Clinical outcomes were compared through a multivariable logistic regression after adjusting for age, treatment type admission and discharge NIHSS score, admission Alberta Stroke Program Early CT (ASPECT) score and length of stay. Of the 82 patients included in the study, 42 were in the EVT group and 40 were in the MT group. The groups were similar in age (MT:66, EVT:64 age; p = .62), gender (MT:55%, EVT:54.8%; male) admission NIHSS score (MT:2, EVT:3 points; p = .26), ASPECT score (MT:10, EVT:9; p = .15). While discharge NIHSS score was found to be statistically significant between the groups (MT:1, EVT:2; p = .04). There was no difference between the two groups in terms of 90-day mRS scores (MT:1, EVT:1, p = .86) and mortality rates (MT:4, EVT:4; p = .94). In unadjusted analysis, sICH rates were similar between the MT and EVT groups (MT 5%, EVT 7.1%, p = .52). Neurological intensive care unit length of stay (MT:5 days, EVT:2 days p < .001), inpatient clinic length of stay (MT:3, EVT:2 days p = .041), and total length of stay (MT:9 days, EVT:4 days p < .001) were significantly longer in the MT group. Our multicenter study demonstrated that MT with blood pressure augmentation and anticoagulation at hyperacute stage is an alternative option for emergency large vessel occlusion patients with nondisabling mild stroke symptoms.

Intravenous thrombolysis versus dual antiplatelet therapy in minor ischemic stroke within the thrombolytic window (TAMIS): a multicenter cohort study.

Intravenous thrombolysis (IVT) and dual antiplatelet therapy (DAPT) have been widely used in minor ischemic stroke (MIS) treatment. However, the clinical outcomes and safety of these two treatments have not been compared within the early thrombolytic time window. Here, we conducted a multicenter, ambispective cohort study involving patients with MIS presenting within 4.5 h of symptom onset at 3 affiliated hospitals of Jinan University from 2018-2022. The patients were divided into the IVT group and DAPT group. The primary outcome was a 90-day excellent outcome (mRS ≤ 1). A total of 1,026 patients were enrolled, of whom 492 were assigned to the IVT group and 534 were assigned to the DAPT group. The IVT group had better 90-day excellent outcomes (mRS ≤ 1) than the DAPT group (OR 1.69, 95% CI 1.14-2.52, P = 0.010). Among the 623 patients with nondisabling stroke, the proportion of mRS ≤ 1 in the IVT group was higher than the DAPT group (P = 0.009). In the subtypes of MIS with large vessel occlusion/stenosis and with isolated symptoms, the 90-day outcomes of the IVT group and DAPT group were not different (P > 0.05). In conclusion, compared with DAPT, IVT was associated with better 90-day clinical outcomes in patients with MIS (in particular, for those with mRS > 1), including earlier clinical improvement.IVT also benefited the early neurological improvement of patients with severe stenosis/occlusion of intracranial large vessels, nondisabling mild stroke, nondisabling mild stroke with isolated symptoms.

Outcomes of the lateral caval flap and conventional techniques for repair of right-sided partial anomalous pulmonary venous connection in adults

ObjectiveIn an effort to overcome limitations of conventional techniques for surgical repair of partial anomalous pulmonary venous connection (PAPVC), we developed the lateral caval flap (LCF) technique, which leverages a native endocardial surface to create unobstructed recruitment of the anomalous pulmonary veins to the left atrium. In this study, we report the long-term outcomes of the LCF and conventional techniques for repair of right-sided PAPVC. MethodsIn total, 109 adult patients (mean age 48 years; 57% male) who underwent right-sided PAPVC repair (53 LCF, 34 single-patch, 13 double-patch, 7 pericardial roll, and 2 Warden procedure) from 1997 to 2022 were retrospectively reviewed. Outcomes included operative mortality, major morbidity, arrythmias, systemic and pulmonary venous pathway obstruction, survival, and reintervention. ResultsOperative mortality was 1% and there were no in-hospital deaths after LCF repair; 4 patients had strokes (4%) including 2 nondisabling strokes after LCF repair (4%), 19 patients developed new postoperative atrial fibrillation/flutter (24%) including 9 after LCF repair (24%), and 27 patients developed new early sinus node dysfunction (26%) including 13 after LCF repair (26%). Although sinus-node dysfunction was transient in most patients, 7 required permanent pacemaker implantation (7%). Survival at 1, 5, 10, and 15 years was 95%, 89%, 86%, and 81%, respectively. At a median follow-up of 6 years, 9 patients developed systemic or pulmonary venous pathway obstruction. Freedom from cardiac reintervention at 5 years was 89% overall and 98% after LCF repair. ConclusionsAll of the described techniques for repair of right-sided PAPVC yielded acceptable short- and long-term outcomes. LCF is a valid technique for right-sided PAPVC repair with a low risk of venous pathway obstruction compared with conventional techniques. Sinus node dysfunction and atrial tachyarrhythmias remain challenges.

Incident Infarcts in Patients With Stroke and Cerebral Small Vessel Disease: Frequency and Relation to Clinical Outcomes.

Factors associated with cerebral small vessel disease (SVD) progression, including incident infarcts, are unclear. We aimed to determine the frequency of incident infarcts over 1 year after minor stroke and their relation to baseline SVD burden, vascular risks, and recurrent stroke and cognitive outcomes. We recruited patients with lacunar or nondisabling cortical stroke. After diagnostic imaging, we repeated structural MRI at 3-6 monthly intervals for 12 months, visually assessing incident infarcts on diffusion-weighted imaging or FLAIR. We used logistic regression to determine associations of baseline vascular risks, SVD score, and index stroke subtype with subsequent incident infarcts. We assessed cognitive and functional outcomes at 1 year using Montreal Cognitive Assessment (MoCA) and modified Rankin scale (mRS), adjusting for baseline age, mRS, MoCA, premorbid intelligence, and SVD score. We recruited 229 participants, mean age 65.9 (SD 11.1). Over half of all participants, 131 of 229 (57.2%) had had an index lacunar stroke. From baseline to 1-year MRI, we detected 117 incident infarcts in n = 57/229 (24.8%) participants. Incident infarcts were mainly of the small subcortical (86/117 [73.5%] in n = 38/57 [66.7%]) vs cortical infarct subtype (n = 19/57 [33.3%]). N = 39/57 participants had incident infarcts at 1 visit; 18 of 57 at 2 or more visits; and 19 of 57 participants had multiple infarcts at a single visit. Only 7 of 117 incident infarcts corresponded temporally to clinical stroke syndromes. The baseline SVD score was the strongest predictor of incident infarcts (adjusted odds ratio [OR] 1.87, 95% CI 1.39-2.58), while mean arterial pressure was not associated. All participants with incident infarcts were prescribed an antiplatelet or anticoagulant. Lower 1-year MoCA was associated with lower baseline MoCA (β 0.47, 95% CI 0.33-0.61), lower premorbid intelligence, and older age. Higher 1-year mRS was associated with higher baseline mRS only (OR 5.57 [3.52-9.10]). Neither outcome was associated with incident infarcts. In the year after stroke in a population enriched for lacunar stroke, incident infarcts occurred in one-quarter and were associated with worse baseline SVD. Most incident infarcts detected on imaging did not correspond to clinical stroke/transient ischemic attack. Worse 1-year cognition and function were not associated with incident infarcts.

Preliminary experience of the isolate left subclavian artery in-situ fenestration during 'zone 2' thoracic endovascular aortic repair.

To evaluate the results of isolated left subclavian artery in-situ fenestration (ISF) during 'zone 2' thoracic endovascular aortic repair (TEVAR) using a new adjustable needle puncturing device system. It is a multicentre, retrospective, physician-initiated cohort study of patients treated from 28 July 2021 to 3 April 2024. Inclusion criteria were isolate left subclavian artery revascularization for elective or urgent/emergent 'zone 2' TEVAR. The primary outcome was technical success and freedom from ISF TEVAR-related reintervention or endoleak. We treated 50 patients: 28 (56.0%) atherosclerotic thoracic aneurysms, 12 (24.0%) type B aortic dissection and 10 (20.0%) penetrating aortic ulcers. Elective intervention was carried out in 46 (92.0%) cases. ISF was successful in all cases, with a procedural primary technical success in 47 (94.0%) cases. The median time of intervention was 184 min (interquartile range 135-220) with a median fenestration time of 20 min (interquartile range 13-35). Operative mortality did not occur. We observed 1 case of spinal cord ischaemia and 2 cases of bilateral posterior non-disabling stroke. Mortality at 30 days occurred in 1 (2.0%) patient (not aorta-related). The median follow-up was 4 months (interquartile range 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. ISF-related reintervention was never required. ISF TEVAR using the Ankura™-II device with the self-centring adjustable needle system showed high technical success, promising stability and stable aortic-related outcomes. Owing to these results, it represents a safe and effective alternative for standard 'zone 2' TEVAR.

Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis.

In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup. The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the firstFDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes. From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm². The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.

360 Driving Technology for Endovascular Aortic Arch Repair: An International Analysis of Relay Branched Outcomes

Abstract Aim The introduction of endovascular aortic arch repair (EAR) represents a paradigm shift in the management of complex arch pathologies. In this multicentre study, a comparative analysis of international outcomes data on the single-, double- and triple-branch RELAY™ endografts is presented. Method Multicentre data was collected prospectively (2019-2022) and stored in an international registry. This was later retrieved and analysed retrospectively. All patients were followed-up for 24 months. Outcomes measured included target vessel patency (TVP), reintervention, stroke, and mortality. Results Of the total 148 patients, 17 (11.5%) received the single-branch RELAY™, 108 (73%) double-branch, and 23 (15.5%) triple-branch. The group characteristics were similar at baseline. Target vessel cannulation and technical success were achieved in 99.3% of patients. TVP at 30 days post-EAR was 100% in all groups, however, this became 93.8%, 74.0% and 100% at 24 months in the single-, double- and triple-branch endograft groups, respectively. As for reinterventions, these were only required with the double-branch RELAY™ (n=50, 34%). Similarly, disabling strokes were only observed in the double-branch group (n=35, 32.4%), and the overall study incidence was 23.8%. Non-disabling strokes had an overall incidence of 12.8% (n=19). The overall mortality rate was 2.7%, with all 4 deaths recorded occurring in the double-branch group. Logistic regression analysis showed a significant association between urgency (acute) and reintervention. Conclusions Our results clearly demonstrate that EAR using RELAY™ Branched is a highly efficacious strategy. Nevertheless, it seems that clinical outcomes with the single- and triple-branch RELAY™ are more favourable than with the double-branch configuration.

Systolic blood pressure and early neurological deterioration in minor stroke: A post hoc analysis of ARAMIS trial.

Systolic blood pressure (SBP) was a predictor of early neurological deterioration (END) in stroke. We performed a secondary analysis of ARAMIS trial to investigate whether baseline SBP affects the effect of dual antiplatelet versus intravenous alteplase on END. This post hoc analysis included patients in the as-treated analysis set. According to SBP at admission, patients were divided into SBP ≥140 mmHg and SBP <140 mmHg subgroups. In each subgroup, patients were further classified into dual antiplatelet and intravenous alteplase treatment groups based on study drug actually received. Primary outcome was END, defined as an increase of ≥2 in the NIHSS score from baseline within 24 h. We investigated effect of dual antiplatelet vs intravenous alteplase on END in SBP subgroups and their interaction effect with subgroups. A total of 723 patients from as-treated analysis set were included: 344 were assigned into dual antiplatelet group and 379 into intravenous alteplase group. For primary outcome, there was more treatment effect of dual antiplatelet in SBP ≥140 mmHg subgroup (adjusted RD, -5.2%; 95% CI, -8.2% to -2.3%; p < 0.001) and no effect in SBP <140 mmHg subgroup (adjusted RD, -0.1%; 95% CI, -8.0% to 7.7%; p = 0.97), but no significant interaction between subgroups was found (adjusted p = 0.20). Among patients with minor nondisabling acute ischemic stroke, dual antiplatelet may be better than alteplase with respect to preventing END within 24 h when baseline SBP ≥140 mmHg.

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Sex Differences in the Dual Antiplatelet Therapy Versus Alteplase for Patients with Minor Nondisabling Acute Ischemic Stroke: A Secondary Analysis of the ARAMIS Study.

Sex is associated with clinical outcome in stroke. The present study aimed to determine the effect of sex on efficacy of dual antiplatelet (DAPT) versus alteplase in ischemic stroke based on Antiplatelet versus recombinant tissue plasminogen activator (R-tPA) for Acute Mild Ischemic Stroke (ARAMIS) trial. In this secondary analysis of the ARAMIS study, eligible patients aged 18 years or older with minor nondisabling stroke who received dual antiplatelet therapy or intravenous alteplase within 4.5 h of stroke onset were divided into two groups: men and women. The primary endpoint was an excellent functional outcome, defined as a modified Rankin Scale (mRS) 0-1 at 90 days. Binary logistic regression analyses and generalized linear models were used. Of the 719 patients who completed the study, 31% (223) were women, and 69% (496) were men. There were no significant sex differences in excellent functional outcome (unadjusted p = 0.304 for men and p = 0.993 for women; adjusted p = 0.376 for men and p = 0.918 for women) and favorable functional outcome (mRS score of 0-2; unadjusted p = 0.968 for men and p = 0.881 for women; adjusted p = 0.824 for men and p = 0.881 for women). But for the secondary outcomes, compared with alteplase, DAPT was associated with a significantly decreased proportion of early neurological deterioration within 24 h in men {unadjusted odds ratio [OR] = 0.440 [95% confidence interval (CI), 0.221-0.878]; p = 0.020; adjusted OR = 0.436 [95% CI, 0.216-0.877]; p = 0.020}, but not in women [unadjusted OR = 0.636 (95% CI, 0.175-2.319), p = 0.490; adjusted OR = 0.687 (95% CI, 0.181-2.609), p = 0.581]. For the safety outcomes, compared with the DAPT group, alteplase was associated with a significantly increased proportion of any bleeding events in men [unadjusted OR = 3.110 (95% CI, 1.103-8.770); p = 0.032], but not in women [unadjusted OR = 5.333 (95% CI, 0.613-46.407), p = 0.129; adjusted OR = 5.394 (95% CI, 0.592-49.112), p = 0.135]. Sex did not influence the effect of dual antiplatelet therapy versus intravenous alteplase in minor nondisabling stroke, but more early neurological deterioration and bleeding events occurred in men who received alteplase.

16-year outcomes of blunt thoracic aortic injury treated with thoracic endovascular aortic repair: A single-institution experience.

Blunt thoracic aortic injury (BTAI) is associated with considerable mortality and morbidity. Thoracic endovascular aortic repair (TEVAR) has essentially replaced open aortic repair (OAR) with superior outcome. The objective of this study was to evaluate the early and intermediate-term outcomes in patients sustaining BTAI treated with TEVAR, and to evaluate the prevalence and impact of left subclavian artery (LSA) coverage. This retrospective analysis includes patients undergoing TEVAR for BTAI between February 2006 and December 2022 at the Helsinki University Hospital, Finland. The primary endpoints were 30-day and 2-year mortality, technical success of stent-graft system deployment, and procedural and device-related complications. The secondary endpoints pertained to reintervention events: conversion to OAR, re-TEVAR, any endovascular/surgical reinterventions for optimal stent-graft function, or any reinterventions during follow-up. A total of 38 consecutive BTAI patients treated with TEVAR were included in the analyses. Median patient age was 45.5 years (range, 15-79) and 66% were male. The median follow-up period was 39 months. Technical success was 100%, 30-day mortality was 0%, and 2-year mortality was 11% in the study cohort. Coverage of LSA without revascularization (13/18) resulted in one postoperative nondisabling stroke (1/13), no paraplegia, and one had ischemic left arm findings (1/13). Only one patient required reintervention (LSA embolization; 1/38). In this institutional series, we provide further evidence in favor of TEVAR for BTAI treatment. We demonstrated that TEVAR is linked to highly favorable outcomes in the short and intermediate term, and coverage of LSA without revascularization was quite well tolerated.

Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial.

Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS. The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months. A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), -2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7-2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5-2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8-18.5) treated with TAVI or surgery, respectively (P for interaction = .1). Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134). ClinicalTrials.gov NCT02825134.

Long-term outcomes of a novel fully magnetically levitated ventricular assist device for the treatment of advanced heart failure in China

PurposeLeft ventricular assist devices (LVADs) are well-established for treating end-stage heart failure, but this therapy is only available to Chinese patients in recent years. The CH-VAD is the first used fully magnetically levitated pump and the most widely used device in China. This study reports the long-term outcomes of a cohort supported by the CH-VAD for the first time. MethodsFrom June 2017 to August 2023, 50 consecutive patients received CH-VAD implantation in Fuwai Hospital. Clinical data were collected during follow-up and retrospectively analyzed. ResultsBaseline characteristics included a mean age of 47.9±13.9 years, 90% male, and 26% ischemic etiology. The INTERMACS profile revealed 12% Profile 1, 56% Profile 2, 26% Profile 3 and 6% Profile 4. Mean support duration was 868 ± 630 days (range 33 days-6.4 years). Kaplan-Meier survival rate was 96% (95% confidence interval [CI], 85 to 99) at 6 months, 93% (95% CI, 79-98) at 1 year, 93% (95% CI, 79-98) at 2 years and 89% (95% CI, 71-96) at 3 years. 40 patients (80%) currently remain on support, 3 were bridged to recovery, 2 received transplant, and 5 expired during support. Major adverse events included right heart failure (10%), surgical related bleeding (8%), arrhythmia (8%) and driveline infection (16%). Major hemocompatibility-related adverse events were limited to 3 non-disabling strokes and 1 gastrointestinal bleeding. There was no major device malfunction during the follow-up period. ConclusionsThe largest single-center experience with the leading LVAD in China shows high survival with low complication rates, demonstrating the CH-VAD is safe and efficient in providing long-term support for end-stage heart failure patients.

Urgent Carotid Endarterectomy for Stroke: A Case Report

Urgent carotid endarterectomy (CEA) is beneficial in patients with non-disabling stroke or transient ischemic attack and significant ipsilateral carotid artery stenosis. It is recommended to be performed within 2-4 weeks of the event; however, its safety when done within 48 hours is still under investigation with potential risks of recurrent ipsilateral stroke and death being reported. This case highlights that urgent CEA done within 48 hours can result in significant neurological improvement. NICE advises within 48 hours of diagnosis and &lt;7 days of radiological imaging while some large studies- especially a Swedish study of &gt;2000 patients concluded an increased risk of stroke and death when performed within 48 hours. Evidence is still developing. In selected cases, this timely intervention can be the standard of care in the Caribbean setting in keeping with international best practice.

Abstract 1158: Antiplatelet Therapy Versus Intravenous Thrombolysis For Mild Nondisabling Acute Ischemic Stroke: A Living Systematic Review And Meta-analysis

Background: Previous studies have shown contradictory results between early application of antiplatelet therapy and intravenous thrombolysis (IVT) for mild nondisabling (defined as NIHSS score of 0 to 5) acute ischemic stroke (AIS). Objective: To compare the benefits and risks of antiplatelet therapy and IVT in patients with mild nondisabling AIS. Methods: A systematic search of MEDLINE, Embase, and Cochrane Library was conducted from database inception until July 26, 2023, without language restriction. Randomized clinical trials (RCTs) or observational studies were selected. The primary outcomes were 90-day functional outcomes, measured by the modified Rankin Scale (mRS) score. The protocol has been registered before data collection (PROSPERO CRD42023447862). Results: Two RCTs and four observational studies with relatively low risk of bias that enrolled 3975 patients were analyzed (2454 in antiplatelet therapy and 1521 in IVT therapy). There were no significant differences between antiplatelet therapy and IVT in 90-day functional outcomes (mRS 0-1, odds ratio [OR], 1.08 [95% CI, 0.73-1.58]; mRS 0-2, OR, 1.04 [95% CI, 0.63-1.73]), death (OR, 0.64 [95% CI, 0.19-2.13]), and stroke recurrence (OR, 0.71 [95% CI, 0.28-1.79]). Antiplatelet therapy was associated with a reduced risk of sICH compared with IVT (OR, 0.20 [95% CI, 0.06-0.69]). Conclusions: Among patients with mild nondisabling AIS, compared with IVT, early application of antiplatelet therapy was not significantly associated with improved functional outcomes, reduced mortality, or stroke recurrence, but was significantly associated with a reduced risk of sICH. Regular updates will provide the best available evidence as new researches are published.

Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study

Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing. Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (pnon-inferiority<0·0001). This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. JenaValve Technology.

O174: Designed to respect and repair the aortic arch: An international comparative analysis of RELAY™ Branched endograft outcomes

Abstract The introduction of endovascular aortic arch repair (EAR) represents a paradigm shift in the management of complex arch pathologies. In this multicentre original study, a comparative analysis of international outcomes data on the single-, double- and triple-branch RELAY™ endografts is presented. Multicentre data was collected prospectively (2019-2022) and stored in an international registry. This was later retrieved and analysed retrospectively. All patients were followed-up for 24 months. Outcomes measured included target vessel patency (TVP), reintervention, stroke, and mortality. Of the 148 patients, 17 (11.5%) received a single-branch RELAY™, 108 (73%) double-branch, and 23 (15.5%) triple-branch. The group characteristics were similar at baseline. Target vessel cannulation and technical success were achieved in 99.3% of patients. TVP at 30 days post-EAR was 100% in all groups, however, this became 93.8%, 74.0% and 100% at 24 months in the single-, double- and triple-branch endograft groups, respectively. As for reinterventions, these were only required with the double-branch RELAY™ (n=50, 34%). Similarly, disabling strokes were only observed in the double-branch group (n=35, 32.4%), and the overall study incidence was 23.8%. Non-disabling strokes had an overall incidence of 12.8% (n=19). The overall mortality rate was 2.7%, with all 4 deaths recorded occurring in the double-branch group. Logistic regression analysis showed a significant association between urgency (acute) and reintervention. Our results clearly demonstrate that EAR using RELAY™ Branched is a highly efficacious strategy that yields favourable results. Nevertheless, it seems that clinical outcomes with the single- and triple-branch RELAY™ are more optimal than with the double-branch configuration.