Reduction In Stroke Rate Research Articles

Sickle cell anemia and early stroke detection and prevention in Nigeria

Sickle cell disease (SCD) is the most common hereditary blood disorder worldwide, and sickle cell anemia (SCA), the homozygous state of SCD, is the most common and severe variant of the disease. Nigeria has the highest burden of SCA in the world. Hemolysis and vaso-occlusion can lead to a wide range of complications, including stroke which is one of the most devastating manifestations of SCA with significant morbidity and mortality. SCA remains the leading cause of stroke in black children. Without any intervention, strokes occur in approximately 11% of children with SCA before their 20th birthday, with the greatest risk in very young children between 2 and 5 years of age. In resource-constrained countries, where the burden of SCA is highest, stroke is underreported, hence the need to develop strategies for stroke prevention and early detection. Improving awareness among healthcare providers and the community can significantly reduce stroke rates and improve stroke detection. The goal of this manuscript is to discuss the progress that has been made in stroke prevention and detection in children with SCA in Nigeria and outline current challenges and future goals. We believe that our experience will be valuable not only in Nigeria which has the highest burden of SCA globally, but also in other low- and middle-income countries.

Herpes zoster vaccine and the risk of stroke: a population-based cohort study using linked data from the Clinical Practice Research Datalink

BackgroundStudies report herpes zoster associated with short-term stroke risk, but it is unclear whether herpes zoster vaccine reduces stroke risk.MethodsWe performed cohort studies using Clinical Practice Research Datalink Aurum linked...

Systematic review and meta-analysis of left atrial appendage closure's influence on early and long-term mortality and stroke

ObjectiveLeft atrial appendage closure (LAAC) concomitant to heart surgery in patients with underlying atrial fibrillation (AF) has gained attention because of long-term reduction of thromboembolic complications. As of mortality benefits in the setting of non-AF, data from both observational studies and randomized controlled trials are conflicting. MethodsOn-line databases were screened for studies comparing LAAC versus no LAAC concomitant to other heart surgery. End points assessed were all-cause mortality and stroke at early and longest-available follow-up. Subgroup analyses stratified on preoperative AF were performed. Risk ratios (RR) with 95% CIs served as primary statistics. ResultsElectronic search yielded 25 studies (N = 660 [158 patients]). There was no difference between LAAC and no LAAC in terms of early mortality. In the overall population analysis, LAAC reduced long-term mortality (RR, 0.86; 95% CI, 0.74-1.00; P = .05; I2 = 88%), reduced early stroke risk by 19% (RR, 0.81; 95% CI, 0.72-0.93; P = .002; I2 = 57%), and reduced late stroke risk by 13% (RR, 0.87; 95% CI, 0.84-0.90; P < .001; I2 = 58%). Subgroup analysis showed lower mortality (RR, 0.85; 95% CI, 0.72-1.01; P = .06; I2 = 91%), short-, and long-term stroke risk reduction only in patients with preoperative AF (RR, 0.81; 95% CI, 0.71-0.93; P = .003; I2 = 71% and RR, 0.87; 95% CI, 0.84-0.91; P < .001; I2 = 70%, respectively). No benefit of LAAC in patients without AF was found. ConclusionsConcomitant LAAC was associated with reduced stroke rates at early and long-term and possibly reduced all-cause mortality at the long-term follow-up but the benefits were limited to patients with preoperative AF. There is not enough evidence to support routine concomitant LAAC in non-AF settings.

Performance Development of European Swimmers Across the Olympic Cycle.

The aims of the study were to (1) quantify the performance development of race times and key performance indicators of European swimmers across the last Olympic cycle (from 2016 to 2021) and (2) provide reference values for long-course swimming pool events for both sexes from 50 m to 1,500 m including butterfly, backstroke, breaststroke, freestyle, and individual medley. Individual events from the 2016 and 2021 European swimming championships were included. Specifically, 246 men (age: 24.2 ± 3.4 years, FINA points: 890 ± 40) and 256 women races (age: 24.2 ± 4, FINA points: 879 ± 38) of the finalists were recorded and key performance indicators and split times analyzed. Performance differences in finalists of the 2016 and 2021 European championships were determined by an independent t-test and Cohen's d effect size. Reference values were retrieved from 2021 European championship finalists and are provided for all key performance indicators. Race times improved significantly (P < 0.05) or showed moderate (d = 0.5–1) to large effect sizes (d > 1) in 14 (men) and 6 (women) out of 16 events. Improvements were primarily evident in 100 m and 200 m events for males, as well as BR and sprint events for female swimmers. While start times improved in 15 (men) and 14 (women) events, turn times remained inconclusive in both sexes. Generally, breakout distances increased. Clean swimming velocities were faster in 12 (men) and 5 (women) events. In particular, for alternating swimming strokes, i.e., backstroke and freestyle, effect sizes indicated improved swimming efficiency with an inverse relationship between reduced stroke rate and increased distance per stroke. Coaches and performance analysts may use the present reference values as comparative data for race analyses and to specifically prepare swimmers for the various race sections. Data on the performance development should be used to analyze swimmers' potential and set goals for the various events and the next Olympic cycle.

High frequency of anticoagulation management errors preceding ischaemic strokes in atrial fibrillation.

Anticoagulants are recommended to prevent cardioembolic stroke in most patients with atrial fibrillation (AF). Management errors with anticoagulation and use of aspirin instead of anticoagulants have been documented worldwide, especially with vitamin K antagonists. To assess the rate of anticoagulant mismanagement errors in patients admitted with ischaemic stroke and the clinical correlates with stroke outcomes in the era of non-vitamin K oral anticoagulants. We performed a retrospective analysis of patients admitted with ischaemic stroke and history of AF to a single-centre tertiary hospital stroke unit in Melbourne, Australia, between January 2016 and June 2019. We assessed management errors as defined using European Heart Rhythm Association criteria with anticoagulation in the 2 weeks prior to the index stroke. A total of 306 patients with AF and ischaemic stroke was included, of whom 196 (64%) had management errors. Patients with management errors were older (median age 84 vs 81 years; P = 0.002) and more often female (53% vs 38%; P = 0.02). Of those with management errors, 74 (37%) were not prescribed any anticoagulation despite increased stroke risk and absence of contraindications and 40 (20%) had anticoagulation inappropriately ceased. Mortality at 3 months was 32% in those with management errors, compared with 17% in the appropriately anticoagulated group (P = 0.005). Inappropriate management of anticoagulants is present in the majority of acute ischaemic stroke in the 2 weeks preceding the event and is linked to higher mortality. Improved anticoagulation practice has the potential to substantially reduce stroke rates in patients with AF.

Abstract 12351: Perioperative Interventions for Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery: A Systematic Review and Network Meta-Analysis

Background: Postoperative atrial fibrillation (POAF) is the most common complication of cardiac surgery, which increases the risk of stroke and death, the length of hospital stays, and costs. Guidelines recommendations on the use of β-blockers (BBs) have only a modest influence on overall rates of POAF. The key clinical outcomes such as stroke and death have not been improved. The best approach to prophylaxis remains obscure. Method: We used Bayesian network meta-analysis to synthesize evidences from randomized controlled trials (RCTs) that compared interventions for POAF prophylaxis. The primary outcomes were incidence of POAF hypotension and bradycardia. Results: We included 262 RCTs with 52636 participants (age &gt; 18, undergoing CABG, valvular or combined surgery), in which 14 different interventions were investigated. For the incidence of POAF, sotalol, amiodarone, BBs, posterior pericardiotomy, atrial pacing, magnesium, polyunsaturated fatty acids, colchicine, glucocorticoid and statin had positive results compared to placebo with statistical significance. The best three therapeutics were sotalol (OR 0.29, 95% CI 0.21-0.41; probability of being best 84.6%), amiodarone (OR 0.39, 95% CI 0.31-0.48) and BBs (OR 0.39, 95% CI 0.31-0.49). For safety, BBs (OR 4.09, 95% CI 2.10-7.96), magnesium (OR 2.51, 95% CI 1.09-5.76) and sotalol (OR 2.07, 95% CI 1.06-4.05) were associated with higher incidence of hypotension. Sotalol (OR 2.80, 95% CI 1.66-4.74) and amiodarone (OR 2.27, 95% CI 1.66-3.10) were associated with higher incidence of bradycardia. For secondary outcomes, no significant effect on all-cause or cardiovascular mortality was observed. Amiodarone was the only intervention that reduced stroke rate (OR 0.57, 95% CI 0.34-0.96). Conclusions: Sotalol appeared to be superior in efficiency compared with others. BBs do not work as well as we expected with the highest incidence of hypotension.Further studies are required to define the better interventions

Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial.

AimsOver decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous‐flow pumps which have substantially improved long‐term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility‐related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3 LVAD suggests near elimination of de‐novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous‐flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced.MethodsTo evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first‐ever international prospective, randomized, double‐blind and placebo‐controlled, non‐inferiority trial in a patient population implanted with a LVAD.ConclusionThis paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial.

Stroke prevention by Non-vitamin K Oral Anticoagulant (NOAC) agents in the absence of atrial fibrillation: meta-analysis of randomized control trials

Abstract Background Anticoagulation to prevent stroke is a mainstay of atrial fibrillation (AF) management. Patients with established cardiovascular disease (CVD) may have conditions that fulfil Virchow's triad for thrombogenesis even in sinus rhythm. Previous investigation into the benefit of warfarin compared to placebo or antiplatelet drug in sinus rhythm found a reduction in stroke rates, but with an increase in bleeding. The efficacy and safety of non-vitamin K oral anticoagulant (NOAC) agents has not been studied. Purpose To assess the safety and efficacy of NOAC agents in patients without AF. Methods An electronic database search for randomized controlled trials that evaluated a NOAC and control drug (placebo or antiplatelet) in non-AF patients with CVD was conducted up until 1 September 2019. The primary efficacy and safety outcomes were ischemic stroke and major bleeding, respectively. The net clinical benefit (NCB) was calculated as a weighted sum of rate differences of ischemic stroke and major bleeding. Groups were stratified according to intensity of anticoagulation (full vs. low dose NOAC). Results Twelve randomized controlled trials were identified with a total of 83,008 patients (50,617 on NOAC, 32391 on control drug; mean age 66±2.7 years). CVD included coronary artery disease (78.3%), hypertension (73.7%), diabetes mellitus (34.7%), peripheral arterial disease (30.3%), previous stroke (21.7%), renal disease (22.9%) and heart failure (18.4%). Over a mean follow-up of 17.3 months, 1347 (1.6%) ischemic strokes occurred. Use of NOAC was associated with 28% reduction in ischemic stroke (odds-ratio [OR] 0.72, 95% confidence-interval [CI] 0.60 to 0.87; 1.1 vs. 1.8 events per 100-person years), with numbers needed to treat of 145 patients to prevent one stroke. Major bleeding was increased nearly 2-fold (OR 1.83, 95% CI 1.46 to 2.29; 2.1 vs. 1.0 events per 100-person years). The NCB demonstrated overall harm with the use of NOAC agents in this patient population (NCB = −0.28, 95% CI: −0.79 to 0.23). Use of full dose NOAC was widely unsafe (NCB = −0.35, 95% CI: −1.25 to 0.54) and low dose NOAC approached null therapeutic safety advantage (NCB = −0.06, 95% CI: −0.47 to 0.35). Conclusion Patients with CVD are at increased of ischemic stroke in the absence of AF. The use of NOAC agents in this non-AF population reduces rate of ischemic stroke however overall risk of bleeding exceeds antithrombotic benefit. Low-dose NOACs demonstrate a neutral NCB suggesting a point of clinical equipoise and deserve further scrutiny. Ischemic stroke vs major bleeding Funding Acknowledgement Type of funding source: None

Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants.

As left atrial appendage occlusion devices (LAAO) implantation rates grow, continued evaluation on best patient practices is important. We report pooled Watchman outcomes at a multicenter Texas healthcare system with an emphasis on clinical outcomes and post-implantation anticoagulation with direct oral anticoagulants (DOACs) versus warfarin. Data for 163 patients with atrial fibrillation (AF) undergoing Watchman implantation was collected via retrospective chart review between June 2016 and June 2018. A Fisher's exact test was utilized to evaluate associations in bivariate comparisons of categorical data. Tests of non-inferiority, applied between DOACs and warfarin, utilized a ratio of 2. Outcomes were significant for similar rates of stroke, disabling stroke, major bleeds, and all-cause mortality when compared to published clinical trials. Most patients with cerebrovascular events were found to have >5mm peri-device leaks (PDLs), were on warfarin at the time of the event (75%), and all occurred within the first 6months post implant. A significant number of patients were discharged on DOACs (42%). DOACs were shown to be non-inferior to warfarin with respect to stroke (p = 0.0048), disabling stroke (p = 0.0383), gastrointestinal bleeding (p = 0.0287), mortality (p = 0.0165), and combined adverse outcomes (p = 0.0040). DOACs were associated with less combined adverse outcomes (p = 0.021). Our findings suggest that additional imaging or aggressive management of PDLs in Watchman recipients within the initial 6-month follow-up may aid in reducing stroke rates. Additionally, anticoagulation with DOACs' post Watchman implantation was found non-inferior to warfarin, with some evidence of lower risk for adverse outcomes favoring DOACs.

Advanced ultrasound methods in assessment of carotid plaque instability: a prospective multimodal study

BackgroundA significant proportion of ischemic strokes are caused by emboli from atherosclerotic, unstable carotid artery plaques. The selection of patients for endarterectomy in current clinical practice is primarily based on the degree of carotid artery stenosis and clinical symptoms. However, the content of the plaque is known to be more important for stroke risk. Intraplaque neovascularization (IPN) has recently emerged as a possible surrogate marker for plaque instability. Neo-microvessels from the adventitial vasa vasorum grow into the full thickness of the vessel wall in an adaptive response to hypoxia, causing subsequent intraplaque haemorrhage and plaque rupture. Conventional ultrasound cannot detect IPN. Contrast-enhanced ultrasound and Superb Microvascular Imaging (SMI), have, however, shown promise in IPN assessment. Recent research using Shear Wave Elastography (SWE) has also reported reduced tissue stiffness in the artery wall (reduced mean Young’s modulus) in unstable compared to stable plaques. The purpose of this study is to identify unstable carotid artery plaques at risk of rupture and future ischemic stroke risk using multimodal assessments.MethodsForty five symptomatic and 45 asymptomatic patients > 18 years, with > 50% carotid stenosis referred to Oslo University Hospital ultrasound lab will be included in this on-going project. Patients will undergo contrast enhanced ultrasound, SMI, carotid-MRI and PET-(18F-FDG). Contrast enhanced ultrasound will be analyzed semi-quantitatively (5-levels visual classification) and quantitatively by plotting time-intensity curve analyses to obtain plaque peak contrast enhancement intensity. Plaques removed at carotid endarterectomy will be assessed histologically and the number of microvessels, areas of inflammation, granulation, calcification, lipid and fibrosis will be measured.DiscussionThis multimodality study will primarily provide information on the clinical value of advanced ultrasound methods (SMI, SWE) for the detection of unstable carotid artery plaque in comparison with other methods including contrast-enhanced ultrasound, carotid-MRI and PET-(18F-FDG) using histology as the gold standard. Secondly, findings from the methods mentioned above will be related to cerebrovascular symptoms, blood tests (leukocytes, CRP, ESR, lipoproteins and inflammatory markers) and cardiovascular risk factors at inclusion and at 1-year follow-up. The overall aim is to optimize detection of plaque instability which can lead to better preventive decisions and reduced stroke rate.

Is Swimmers' Performance Influenced by Wetsuit Use?

To observe changes in performance, physiological, and general kinematic variables induced by the use of wetsuits vs swimsuits in both swimming-pool and swimming-flume conditions. In a randomized and counterbalanced order, 33 swimmers (26.46 [11.72]y old) performed 2 × 400-m maximal front crawl in a 25-m swimming pool (with wetsuit and swimsuit), and their mean velocities were used later in 2 swimming-flume trials with both suits. Velocity, blood lactate concentration, heart rate (HR), Borg scale (rating of perceived exertion), stroke rate, stroke length (SL), stroke index, and propelling efficiency were evaluated. The 400-m performance in the swimming pool was 0.07m·s-1 faster when using the wetsuit than when using the swimsuit, evidencing a reduction of ∼6% in time elapsed (P < .001). Maximal HR, maximal blood lactate concentration, rating of perceived exertion, stroke rate, and propelling efficiency were similar when using both swimsuits, but SL and stroke index presented higher values with the wetsuit in both the swimming pool and the swimming flume. Comparing swimming conditions, maximal HR and maximal blood lactate concentration were lower, and SL, stroke index, and propelling efficiency were higher when swimming in the flume than when swimming in the pool with both suits. The 6% velocity improvement was the result of an increase of 4% in SL. Swimmers reduced stroke rate and increased SL to benefit from the hydrodynamic reduction of the wetsuit and increase their swimming efficiency. Wetsuits might be utilized during training seasons to improve adaptations while swimming.

P1000Do patients with atrial fibrillation being at high-risk for stroke benefit from concomitant left atrial appendix closure during cardiac surgery

Abstract Background Left atrial appendix, as an essential source of systemic embolism and stroke in patients with atrial fibrillation, can be excluded during cardiac surgery, however the clinical benefit is as yet uncertain. Methods A total of 376 out of 3741 consecutive patients with atrial fibrillation presenting a high risk for stroke (CHA2DS2-VASc-Score ≥2 for men and ≥3 for women) who underwent heart surgery with cardiopulmonary bypass between 01/2012 and 12/2015 were analysed for mortality and stroke rate at 30 days, 12 and 24 months. Patients with concomitant LAA-closure alone (group1; n=107) were compared to patients with concomitant surgical ablation and LAA-closure (group2; n=85), and patients without surgical ablation and no LAA-closure (group3; n=184) as controls. To further adjust for pre- and intraoperative risk factors, a propensity score stratification analysis based on patients age, gender, EuroSCORE-2, CHA2DS2-VASc-Score and type of procedure was performed. Results Patients age was 72±8 years (mean±SD) and 33% were female. EuroSCORE-2 was 8.7±7.7%, 5.7±3.9%, and 5.4±8.4% and CHA2DS2-VASc-Score was 4.2±1.5, 3.9±1.4, and 4.1±1.4 on average for the respective groups. Mortality did not differ between groups at 30 days, 12 and 24 months. The incidence of stroke was 1.9% at 30 days, 4.8% at 12 and 6.7% at 24 months in group1. There was no stroke at 30 days and 12 months and 1.3% at 24 months in group2, and 1.8% at 30 days, 3.0% at 12 and 24 months in control group3. The overall mortality at 24 months was 27.1%, 20% and 24.6% respectively. After propensity score stratification, stroke rate showed significant benefit in group 2 (P=0.05) at 12 months and a hazard ratio of 0.17, 95% confidents limits 0.02–1.50, (P=0.08) at 24 months, whereas overall mortality did not significantly differ between the groups at 12 and 24 months follow-up. Conclusions In this propensity score stratification analysis, patients undergoing cardiac surgery with surgical ablation and concomitant LAA-closure had significant fewer strokes at 12 months follow-up compared to patients undergoing cardiac surgery with LAA-closure alone. Overall mortality did not significantly differ between the groups. Therefore, a concomitant LAA closure during heart surgery without additional surgical ablation does not show any clinical benefit in terms of reduced stroke rate or survival until 12 and 24 months follow-up.

Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement

BackgroundTransfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes. ObjectivesThis study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade. MethodsThe CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex. ResultsWe included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time. ConclusionsIn this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.

Trends and Racial Differences in First Hospitalization for Stroke and 30-Day Mortality in the US Medicare Population From 1988 to 2013.

The main purpose of this study was to determine whether there were temporal differences in the rates of first stroke hospitalizations and 30-day mortality after stroke between black and white Medicare enrollees. We used a 20% sample of Medicare beneficiaries aged 65 years or older and described the annual rate of first hospitalization for ischemic and hemorrhagic strokes from years 1988 to 2013, as well as 30-day mortality after stroke hospitalization. We used linear tests of trend to determine whether stroke rates changed over time, and tested the interaction term between race and year to determine whether trends differed by race. We identified 1,009,057 incident hospitalizations for ischemic strokes and 147,817 for hemorrhagic strokes. Annual stroke hospitalizations decreased significantly over time for both blacks and whites, and in both stroke subtypes (P-values for all trend <0.001). Reductions in stroke rates were comparable between blacks and whites: among men, the odds ratio for the interaction term for race by year was 1.008 [95% confidence interval (CI), 1.004-1.012] for ischemic and 1.002 (95% CI, 0.999-1.004) for hemorrhagic; for women, it was 1.000 (95% CI, 0.997-1.004) for ischemic and 1.003 (95% CI, 1.001-1.006) for hemorrhagic. Both black men and women experienced greater improvements over time in terms of 30-day mortality after strokes. Rates of incident hospitalizations for ischemic and hemorrhagic strokes fell significantly over a 25-year period for both black and white Medicare enrollees. Black men and women experienced greater improvements in 30-day mortality after both ischemic and hemorrhagic stroke.

Abstract 180: Association of Risk Factor-Based Educational Programs on Stroke Hospitalization and Death Rates in West Central Florida

Background: Since 2003 six public health educational campaigns were begun in Florida to reduce stroke rate and mortality by increasing public awareness of stroke-related symptoms and its risk factors. Hypothesis: The public health campaigns reduced hospitalization and death rates due to stroke in West Central Florida (WCF). Methods: Using the Florida Department of Health databases, we tabulated the annual stroke-related rates of hospitalization and death in 10 WCF counties (Polk, Hardee, Sarasota, Hillsborough, Hernando, Pasco, Pinellas, Manatee, Desoto, and Highlands) from 1997-2016. Population (total: 4.75 million), median age, race/ethnicity distribution, and median income were recorded for each county. The pre-campaign period was defined from 1997 to 2002. Annual rates/100,000 population for stroke-related hospitalization and death were compared yearly before and after the campaigns were launched to determine their impact. Results (graphs): Compared to other WCF counties, Sarasota had the lowest baseline rate for stroke hospitalization, but its death rates did not significantly differ. Post-initiation, yearly declines average hospitalization (6.51%) and death rates (0.67%) were observed, but the decline in annual death rate was attenuated after 2006, suggesting the greatest impact was due to the Get With The Guidelines® campaign begun in 2003. Conclusions: Public health campaigns were associated with an almost linear decline in West Central Florida stroke hospitalization rates, suggesting a benefit from improved stroke recognition and risk factor reduction. The blunted effect on the death rate may reflect the limitations of therapeutic measures and implementation protocols employed during this period.

Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis.

The role of cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR) remains controversial. Randomized trials have not been powered to demonstrate a reduction in stroke rates. The aim of this patient level pooled analysis was to validate the impact of the dual-filter CEP device (Claret Medical Inc., CA, USA) on peri-procedural stroke in a large number of TAVR patients. Patients from the SENTINEL US IDE trial were combined with the CLEAN-TAVI and SENTINEL-Ulm study in a patient level pooled analysis (N = 1306). Propensity score matching was performed to adjust for possible confounders. The primary endpoint was procedural stroke within 72 h post-TAVR according to Valve Academic Research Consortium-2 criteria. The secondary endpoint was the combination of all-cause mortality or all-stroke within 72 h after TAVR. In the propensity-matched population, 533 patients underwent TAVR without CEP and 533 patients underwent TAVR with CEP. TAVR patients without vs. with CEP were similar with respect to baseline characteristics, procedural approach, or valve type. In patients undergoing TAVR with dual-filter CEP, procedural all-stroke was significantly lower compared with unprotected procedures [1.88% vs. 5.44%, odds ratio 0.35, 95% confidence interval (CI) 0.17-0.72, relative risk reduction 65%, P = 0.0028]. In addition, all-cause mortality and all-stroke were significantly lower (2.06% vs. 6.00%, odds ratio 0.34, 95% CI 0.17-0.68, relative risk reduction 66%, P = 0.0013). Our findings suggest that TAVR with the dual-filter CEP device is associated with a significant lower rate of peri-procedural stroke compared with unprotected procedures. However, randomized trials are still needed to clarify this issue.

A First-in-Human Evaluation of a Novel Mesh-Covered Stent for Treatment of Carotid Stenosis in Patients at High Risk for Endarterectomy: 30-Day Results of the SCAFFOLD Trial

ObjectivesThe primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days. BackgroundRates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates. MethodsThe SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days. ResultsA total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related. ConclusionsLow death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients.

HVAD: The ENDURANCE Supplemental Trial

ObjectivesThe aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System. BackgroundThe ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects. Post hoc analyses demonstrated increased mean arterial blood pressure as a significant independent risk factor for stroke. MethodsThe ENDURANCE Supplemental Trial was a prospective, multicenter evaluation of 465 patients with advanced heart failure ineligible for transplantation, randomized 2:1 to HVAD (n = 308) or control (n = 157). The primary endpoint was the 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event. Secondary endpoints included the composite of freedom from death, disabling stroke, and need for device replacement or urgent transplantation, as well as comparisons of stroke or transient ischemic attack rates in HVAD cohorts in ENDURANCE Supplemental and ENDURANCE. ResultsThe enhanced blood pressure protocol significantly reduced mean arterial blood pressure. The primary endpoint was not achieved (14.7% with HVAD vs. 12.1% with control, noninferiority [margin 6%] p = 0.14). However, the secondary composite endpoint demonstrated superiority of HVAD (76.1%) versus control (66.9%) (p = 0.04). The incidence of stroke in HVAD subjects was reduced 24.2% in ENDURANCE Supplemental compared with ENDURANCE (p = 0.10), and hemorrhagic cerebrovascular accident was reduced by 50.5% (p = 0.02). ConclusionsThe ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System [ENDURANCE SUPPLEMENTAL TRIAL] [DT2]; NCT01966458)

Updated Meta-analysis on the Closure of Patent Foramen Ovale in Reduction of Stroke Rates: the DEFENSE-PFO Trial Does not Change the Scenario.

ObjectiveWe aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial.IntroductionThe clinical benefit of closing a PFO has been an open question, so it is necessary to review the current state of published medical data in regards to this subject.MethodsMEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were used to search for randomized controlled trials (RCTs) that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Six studies fulfilled our eligibility criteria and included 3560 patients (1889 for PFO closure and 1671 for medical therapy.ResultsThe risk ration (RR) for stroke in the “closure” group compared with the “medical therapy” showed a statistically significant difference between the groups, favouring the “closure” group (RR 0.366; 95%CI 0.171–0.782, P=0.010). There was no statistically significant difference between the groups regarding the safety outcomes, death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the “closure” group (RR 4.131; 95%CI 2.293–7.443, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke.ConclusionThis meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of hypertension, atrial septal aneurysm and effective closure. The publication of a new trial did not change the scenario in the medical literature.

Carotid artery stenosis as an independent risk factor for perioperative strokes following mitral valve surgical intervention

ObjectiveTo examine the role of carotid stenosis (CS) and other independent risk factors of perioperative stroke following either mitral valve repair or replacement. MethodsUsing data from the National Inpatient Sample (NIS) database for analysis, all patients who underwent either mitral valve repair or replacement were identified using ICD-9 codes. ResultsA total of 79,583 patients who underwent either mitral valve replacement or repair were studied. 3.39% of the total cohort developed perioperative stroke. With a mean age of 62.78±0.23, there was a statistically significant amount of stroke cases in age ranges 65–74 and 75–84 (p<0.05). Risk stratification was done using Van Walraven (VWR) scoring and the cohort had a mean of 2.73±0.06. The following independent predictors were found to be significant: age, female gender, moderate and high VWR risk, both symptomatic and asymptomatic CS, atrial fibrillation, previous h/o smoking, and other cardiac valve procedures performed, and congestive heart failure (CHF). ConclusionCS is a significant risk factor for perioperative strokes following mitral valve surgery. Further prospective clinical studies are needed that look into risk stratification of patients for better patient selection and the question of whether carotid revascularization procedures will be beneficial in reducing stroke rates.