Composite Endpoint Of Stroke Research Articles

Symptoms of Anxiety and Depression (SAD) in patients undergoing transcatheter aortic valve implantation. A multicentre Australian experience: The SAD-TAVI Study

Abstract Background Symptoms of anxiety and/or depression (SAD) commonly co-exist in severe aortic stenosis, associated with increased morbidity and mortality following transcatheter aortic valve implantation (TAVI). Despite this, mental health remains under-researched in the TAVI literature. Purpose To characterise the prevalence of SAD in those undergoing TAVI and identify patient phenotypes at highest risk of these symptoms. We also aimed to examine how SAD evolve following TAVI and establish factors predictive of improvement and regression in mental health. Methods Retrospective review of prospectively collected data from patients undergoing TAVI between 2018 and 2023 included in an Australian TAVI registry. Results Of 1279 patients, median age was 82 (IQR 77, 87), 41% were female and median STS score was 3.9 (2.3, 5.9). 353 (28%) patients reported moderate or worse SAD at baseline. Of this group, 260 (74%) had complete resolution in symptoms within 30-days. Body Mass Index<25 (adjusted odds ratio [aOR] 3.4, p<0.001), vascular site complications (aOR 3.4, p=0.029) and non-home discharge (aOR 2.4, p=0.036) independently predicted failed improvement in SAD. Onset of new SAD was uncommon, present in only 72 (8%) patients. Non-home discharge (19% vs 8%, p=0.006) and a composite endpoint of stroke, acute myocardial infarction, and heart-failure readmission (11% vs 4%, p=0.012) were more prevalent in this cohort. Conclusion Symptoms of anxiety and depression are common but under recognised in severe aortic stenosis. TAVI is highly effective at improving these symptoms. Regular screening for mental health should be adopted as a standard of care in TAVI.Evolution of SAD Following TAVI

Optimizing Treatment of Significant Carotid Artery Stenosis in Times of Logistic Restraints as a Result of COVID-19 Pandemic

BackgroundCOVID-19 confronted medical care with many challenges. During the pandemic, several resources were limited resulting in renouncing or postponing medical care like carotid endarterectomy (CEA) for patients with significant carotid artery stenosis. Although according to international guidelines CEA is the first choice, carotid artery stenting (CAS) could potentially be a reasonable alternative especially during logistical restraints. PurposeTo evaluate outcomes of CAS versus CEA before, during and after the COVID-19 pandemic. Our hypothesis was that a CAS first approach yielded comparable outcomes compared to a CEA first approach. MethodsRetrospective analysis of consecutive patients with significant carotid artery stenosis treated with CEA or CAS between September 2018 and March 2023. Each consecutive period of 1.5 year marked a new (treatment) period: pre-COVID (CEA first strategy), during COVID (CAS first strategy) and post COVID (patient tailored approach). Primary outcome was the composite endpoint of stroke, TIA or death within 30 days. Secondary outcome consisted of the rate of technical success, cerebral hyperperfusion syndrome, myocardial infarction or other cardiac complications needing intervention, bleeding of the surgical site needing intervention, nerve palsy, unintended IC admission, pseudoaneurysm, restenosis or occlusion. ResultsA total of 318 patients were included. Out of 137 patients treated with CEA, 55, 36 and 46 were treated pre-COVID, during COVID and post-COVID, respectively. Out of 181 CAS procedures, 38, 59 and 84, respectively, were performed in each time period. Primary outcome occurred in 5.5%, 0% and 2.2% in the CEA group and 0%, 1.7% and 3.6% in the CAS group (p = .27; p = 1.00; p = 1.00, respectively). Overall technical success was 100% for CEA and 99.4% for CAS (p = 1.00). Rate of restenosis was the only secondary outcome measure which was significantly better after CAS compared to CEA in the pre- and post-COVID period (CEA vs CAS, 12.7% vs 7.9% and 23.9% vs 4.8% with a p-value of .03 and .03, respectively). Hospital presentation to treatment interval did not differ significantly during the pandemic. ConclusionOutcomes were comparable between CAS versus CEA in patients with significant carotid artery stenosis before, during and after the COVID-19 pandemic. CAS showed better results in terms of other complications (i.e., restenosis rate) in the pre- and post-COVID period compared to CEA. Our results may support a CAS first approach when no relevant contra-indications exist without exposing the patient to complications associated with an open surgical approach. Discussion in a multidisciplinary team is advised.

Concomitant Surgical Ablation in Paroxysmal vs Persistent Atrial Fibrillation During Mitral Surgery

BackgroundDespite prospective randomized evidence supporting concomitant treatment of atrial fibrillation (AF) during mitral valve (MV) surgery, variation in surgical management of AF remains. We assessed longitudinal outcomes after surgical treatment of persistent or paroxysmal AF during MV surgery in Medicare beneficiaries. MethodsAll Medicare beneficiaries with a diagnosis of AF undergoing MV surgery (2018-2020) were evaluated. Patients were stratified by no AF treatment, left atrial appendage obliteration (LAAO) alone, or surgical ablation and LAAO (SA+LAAO). Doubly robust risk adjustment and subgroup analysis by persistent or paroxysmal AF were performed. ResultsA total of 7517 patients with preoperative AF underwent MV surgery (32.1% no AF treatment, 23.1% LAAO alone, 44.7% SA+LAAO). After doubly robust risk adjustment, AF treatment with SA+LAAO or LAAO alone were associated with lower 3-year readmission for stroke or bleeding. However, SA+LAAO was associated with reduced 3-year mortality and readmission for AF or heart failure compared with no AF treatment or LAAO alone. Compared with no AF treatment or LAAO alone, SA+LAAO was associated with lower composite end point of stroke (hazard ratio, 0.75) or death (hazard ratio, 0.83) at 3 years. Subgroup analysis identified similar longitudinal benefits of SA+LAAO in patients with persistent or paroxysmal AF. ConclusionsIn Medicare beneficiaries with AF undergoing MV surgery, SA+LAAO was associated with improved longitudinal outcomes compared with LAAO alone or no AF treatment in patients with paroxysmal or persistent AF. These contemporary real-world data further clarify the benefit of SA+LAAO during MV surgery across all types of AF.

Heart rate variability and stroke or systemic embolism in patients with atrial fibrillation

BackgroundStroke remains one of the most serious complications in atrial fibrillation (AF) patients and has been linked to disturbances of the autonomic nervous system. ObjectiveThe purpose of this study was to test the hypothesis that impaired cardiac autonomic function might be associated with an enhanced stroke risk in AF patients. MethodsA total of 1922 AF patients who were in either sinus rhythm (SR group; n = 1121) or AF (AF group; n = 801) on a 5-minute resting electrocardiographic (ECG) recording were enrolled in the study. Heart rate variability triangular index (HRVI), standard deviation of normal-to-normal intervals, root mean square root of successive differences of normal-to-normal intervals, mean heart rate, 5-minute total power, and power in the high-frequency, low-frequency, and very-low-frequency ranges were calculated. Cox regression models were constructed to examine the association of heart rate variability (HRV) parameters with the composite endpoint of stroke or systemic embolism. ResultsMean age was 71 ± 8 years in the SR group and 75 ± 8 years in the AF group. Thirty-seven patients in the SR group (3.4%) and 60 patients in the AF group (8.0%) experienced a stroke or systemic embolism during follow-up of 5 years. In patients with SR, HRVI <15 was the strongest HRV parameter to be associated with stroke or systemic embolism (hazard ratio 3.04; 95% confidence interval 1.3–7.0; P = .009) after adjustment for multiple confounders. In the AF group, no HRV parameter was found to be associated with the composite endpoint. ConclusionHRVI measured during SR on a single 5-minute ECG recording is independently associated with stroke or systemic embolism in AF patients. HRV analysis in SR may help to improve risk stratification in AF patients.

Efficacy and safety of oral factor Xa inhibitors versus vitamin-K antagonists in the early phase after acute ischemic stroke or TIA in the real-world setting: The PRODAST study.

Factor Xa (FXa) inhibitors are superior to vitamin K antagonists (VKAs) in terms of avoiding hemorrhagic complications. However, no robust data are available to date as to whether this also applies to the early phase after stroke. In this prospective registry study, we aimed to investigate whether anticoagulation with FXa inhibitors in the early phase after acute ischemic stroke or transient ischemic attack (TIA) is associated with a lower risk of major bleeding events compared with VKAs. The Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) study is a prospective, multicenter, observational, post-authorization safety study at 86 German stroke units between July 2015 and November 2020. Primary outcome was a major bleeding event during hospital stay. Secondary endpoints were recurrent strokes, recurrent ischemic strokes, TIA, systemic/pulmonary embolism, myocardial infarction, death and the composite endpoint of stroke, systemic embolism, life-threatening bleeding and death. In total, 10,039 patients have been recruited. 5,874 patients were treated with FXa inhibitors and 1,050 patients received VKAs and were eligible for this analysis. Overall, event rates were low. We observed 49 major bleeding complications during 33,297 treatment days with FXa-inhibitors (rate of 14.7 cases per 10,000 treatment days) and 16 cases during 7,714 treatment days with VKAs (rate of 20.7 events per 10,000 treatment days), translating into an adjusted hazard ratio (aHR) of 0.70 (95% confidence interval (95% CI): 0.37-1.32) in favor of FXa inhibitors. Hazards for ischemic endpoints (63 vs 17 strokes, aHR: 0.96 (95% CI: 0.53-1.74), mortality (33 vs 6 deaths, aHR: 0.87 (95% CI: 0.33-2.34)) and the combined endpoint (154 vs 39 events, aHR: 0.99 (95% CI: 0.65-1.41) were not substantially different. This large real-world study shows that FXa inhibitors appear to be similarly effective in terms of bleeding events and ischemic endpoints compared to VKAs in the early post-stroke phase of hospitalization. However, the results need to be interpreted with caution due to the low precision of the estimates.

Catheter ablation of atrial fibrillation in patients with left bundle branch block.

Left bundle branch block (LBBB) and atrial fibrillation (AF) are commonly coexisting conditions. The impact of LBBB on catheter ablation of AF has not been well determined. This study aims to explore the long-term outcomes of patients with AF and LBBB after catheter ablation. Forty-two patients with LBBB of 11,752 patients who underwent catheter ablation of AF from 2011 to 2020 were enrolled as LBBB group. After propensity score matching in a 1:4 ratio, 168 AF patients without LBBB were enrolled as non-LBBB group. Late recurrence and a composite endpoint of stroke, all-cause mortality, and cardiovascular hospitalization were compared between the two groups. Late recurrence rate was significantly higher in the LBBB group than that in the non-LBBB group (54.8%vs. 31.5%, p=.034). Multivariate analysis showed that LBBB was an independent risk factor for late recurrence after catheter ablation of AF (hazard ratio [HR] 2.19, 95% confidence interval [CI] 1.09-4.40, p=.031). LBBB group was also associated with a significantly higher incidence of the composite endpoint (21.4%vs. 6.5%, HR 3.98, 95% CI 1.64-9.64, p=.002). LBBB was associated with a higher risk for late recurrence and a higher incidence of composite endpoint in the patients underwent catheter ablation.

Novel Size-Based High-Density Lipoprotein Subspecies and Incident Vascular Events.

Background High-density lipoprotein (HDL) particle concentration likely outperforms HDL cholesterol in predicting atherosclerotic cardiovascular events. Whether size-based HDL subspecies explain the atheroprotective associations of HDL particle concentration remains unknown. Our objective was to assess whether levels of specific size-based HDL subspecies associate with atherosclerotic cardiovascular disease in a multiethnic pooled cohort and improve risk prediction beyond traditional atherosclerotic cardiovascular disease risk factors. Methods and Results Seven HDL size-based subspecies were quantified by nuclear magnetic resonance (LP4 algorithm; H1=smallest; H7=largest) among participants without prior atherosclerotic cardiovascular disease in ARIC (Atherosclerosis Risk in Communities), MESA (Multi-Ethnic Study of Atherosclerosis), PREVEND (Prevention of Renal and Vascular Endstage Disease), and DHS (Dallas Heart Study) cohorts (n=15 371 people). Multivariable Cox proportional hazards models were used to evaluate the association between HDL subspecies and incident myocardial infarction (MI) or ischemic stroke at follow-up (average 8-10 years) adjusting for HDL cholesterol and risk factors. Improvement in risk prediction was assessed via discrimination and reclassification analysis. Within the pooled cohort (median age 57 years; female 54%; Black 22%) higher H1 (small) and H4 (medium) concentrations were inversely associated with incident MI (hazard ratio [HR]/SD, H1 0.88 [95% CI, 0.81-0.94]; H4 0.89 [95% CI, 0.82-0.97]). H4 but not H1 improved risk prediction indices for incident MI. Increasing H2 and H4 were inversely associated with improved risk prediction indices for composite end point of stroke, MI, and cardiovascular death (HR/SD, H2 0.94 [95% CI, 0.88-0.99]; H4 0.91 [95% CI, 0.85-0.98]). Levels of the large subspecies (H6 and H7) were not associated with any vascular end point. Conclusions Two of 7 HDL size-based subspecies modestly improved risk prediction for MI and composite vascular end points in a large multiethnic pooled cohort. These findings support assessment of precise HDL subspecies for future studies regarding clinical utility.

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol

IntroductionAtrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring...

Comparative effectiveness of SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, and sulfonylureas on risk of major adverse cardiovascular events: emulation of a randomised target trial using electronic health records

Randomised clinical trials showed that compared with placebo, SGLT2 inhibitors and GLP-1 receptor agonists reduced risk of adverse cardiovascular events. The evidence base for the older antihyperglycaemic drug classes (DPP-4 inhibitors and sulfonylureas) is generally less well developed. Because most randomised trials evaluated one antihyperglycaemic medication versus placebo, a head-to-head comparative effectiveness analysis of the newer drug classes (SGLT2 inhibitors vs GLP-1 receptor agonists) or newer (SGLT2 inhibitors or GLP-1 receptor agonists) versus older (DPP-4 inhibitors or sulfonylureas) drug classes on risk of major adverse cardiovascular events (MACE) is not available. In this study, we aimed to evaluate the comparative effectiveness of incident use of SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or sulfonylureas on risk of MACE. We first specified the protocol of a four-arm randomised pragmatic clinical trial and then emulated it using the health-care databases of the US Department of Veterans Affairs. We built a cohort of metformin users with incident use of SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or sulfonylureas between Oct 1, 2016 and Sept 30, 2021, and followed up until Dec 31, 2022. We used the overlap weighting approach to balance the treatment groups using a battery of predefined variables and a set of algorithmically selected variables from high-dimensional data domains. Both intention-to-treat and per-protocol analyses (the latter estimated the effect of maintained use of the antihyperglycaemic throughout follow-up) were conducted to estimate risk of MACE-defined as a composite endpoint of stroke, myocardial infarction, and all-cause mortality. The final cohort consisted of 283 998 new users of SGLT2 inhibitors (n=46 516), GLP-1 receptor agonists (n=26 038), DPP-4 inhibitors (n=55 310), or sulfonylureas (n=156 134). In intention-to-treat analyses, compared with sulfonylureas, SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors were associated with lower risk of MACE (hazard ratio [HR] 0·77 [95% CI 0·74-0.80], 0·78 [0·74-0·81), and 0·90 [0·86-0.93], respectively). Both SGLT2 inhibitors and GLP-1 receptor agonists were associated with a lower risk of MACE when compared with DPP-4 inhibitors (HR 0·86 [0·82-0·89] and 0·86 [0·82-0·90], respectively). The risk of MACE between SGLT2 inhibitors and GLP-1 receptor agonists yielded an HR of 0·99 (0·94-1·04). In per-protocol analyses, compared with sulfonylureas, SGLT2 inhibitors, GLP1 receptor agonists, and DPP-4 inhibitors were associated with reduced risk of MACE (HR 0·77 [95% CI 0·73-0·82], 0·77 [0·72-0·82], and 0·88 [0·83-0·93], respectively). Both SGLT2 inhibitors and GLP-1 receptor agonists were associated with a lower risk of MACE when compared with DPP-4 inhibitors (HR 0·88 [0·83-0·93] and 0·88 [0·82-0·93], respectively). The risk of MACE between SGLT2 inhibitors and GLP-1 receptor agonists yielded an HR of 1·01 (0·94-1·07). Both SGLT2 inhibitors and GLP-1 receptor agonists were associated with reduced risk of MACE compared with DPP-4 inhibitors or sulfonylureas. DPP-4 inhibitors were associated with reduced risk of MACE compared with sulfonylureas. There was no statistically significant difference in risk of MACE between SGLT2 inhibitors and GLP-1 receptor agonists. The results provide evidence of the real-world comparative effectiveness of the four most commonly used second-line antihyperglycaemics and could guide choice of antihyperglycaemic therapy. US Department of Veterans Affairs and the American Society of Nephrology.

Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study.

The optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant (NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications. In this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA. PRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective, multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (⩽ 7 days) or late (> 7 days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic stroke, TIA, systemic embolism, myocardial infarction, death, and a composite endpoint of stroke, systemic embolism, life-threatening bleeding and death. Major bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9 for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared to VKA use. The difference was pronounced for intracranial hemorrhages with an adjusted hazard ratio (HR) of 0.47 (95% confidence interval (CI): 0.10-2.21) for early dabigatran use versus VKA use and an adjusted HR of 0.09 (95% CI: 0.00-13.11) for late dabigatran use versus VKA use. No differences were found between early initiation of dabigatran versus VKA use regarding ischemic endpoints. The early application of dabigatran appears to be safer than VKA administered at any time point with regards to the risk of hemorrhagic complications and in particular for intracranial hemorrhage. This result, however, must be interpreted with caution in view of the low precision of the estimate.

Better Survival in Morbidly Obese Patients with Atrial Fibrillation Treated with Non-vitamin K-dependent Oral Anticoagulants.

The efficacy and safety of non-vitamin K-dependent anticoagulants (NOAC) are not well investigated in the obese population, and fixed dosing could lead to under-anticoagulation. Our objective was to evaluate the effect of obesity on anticoagulation outcomes and survival in non-valvular atrial fibrillation (AF) patients. We enrolled 755 patients who required anticoagulation for AF from 2015 to 2016. We grouped the patients into four groups. Group 1 (n = 297) included patients with BMI< 40 kg/m2 treated with NOACs, Group 2 (n = 358) included patients on warfarin with BMI< 40 kg/m2, Group 3 (n = 57) had patients on NOACs with BMI≥ 40 kg/m2 and Group 4 (n = 43) included patients on warfarin and BMI≥ 40 kg/m2. Study outcomes were the composite endpoint of stroke, bleeding, and survival. Competing risk regression showed that stroke and bleeding were not affected by obesity or treatment (SHR: 1.09 (95% CI: 0.79-1.51); P = 0.62). Older age was the predictor of stroke/bleeding (HR:1.03 (95% CI:1.01-1.06); P = 0.02). Predictors of mortality were heart failure (HR:2.23 (95% CI:1.25-3.97); P = 0.007), lower creatinine clearance (HR: 0.98 (95% CI:0.97-0.98): P < 0.001), non-obese patients on warfarin (HR:3.51 (95%CI:1.6-7.7): P = 0.002) and obese patients on warfarin (HR: 6.7 (95% CI:2.51-17.92); P < 0.001). NOACs could have a similar risk profile to warfarin in obese and non-obese patients with non-valvular AF but could have better survival. Larger randomized trials are recommended.

Long-Term Tailor-Made Exercise Intervention Reduces the Risk of Developing Cardiovascular Diseases and All-Cause Mortality in Patients with Diabetic Kidney Disease.

This study aimed to determine the effect of long-term exercise on the risk of developing cardiovascular diseases (CVD) and all-cause mortality in patients with diabetic kidney disease (DKD). A single-center, prospective intervention study using propensity score matching was performed over 24 months. The intervention group (n = 67) received six months of individual exercise instruction from a physical therapist, who performed aerobic and muscle-strengthening exercises under unsupervised conditions. New events were defined as the composite endpoint of stroke or CVD requiring hospitalization, initiation of hemodialysis or peritoneal dialysis, or all-cause mortality. The cumulative survival rate without new events at 24 months was significantly higher in the intervention group (0.881, p = 0.016) than in the control group (n = 67, 0.715). Two-way analysis of variance revealed a significant effect of the group factor on high density lipoprotein-cholesterol (HDL-C) which was higher in the intervention group than in the control group (p = 0.004); eGFRcr showed a significant effect of the time factor, which was lower at 24 months than before intervention (p = 0.043). No interactions were observed for all items. In conclusion, aerobic exercises combined with upper and lower limb muscle strengthening for six months reduce the risk of developing CVD and all-cause mortality in patients with DKD.

Isolated surgical vs. transcatheter aortic valve replacement: a propensity score analysis

BackgroundThe debate about the optimal approach for aortic valve replacement continues. We compared the hospital and long-term outcomes (survival, aortic valve reintervention, heart failure readmissions, and stroke) between transcatheter vs. surgical (TAVR vs. SAVR) aortic valve replacement. The study included 789 patients; 293 had isolated SAVR, and 496 had isolated TAVR. Patients with concomitant procedures were excluded. Propensity score matching identified 53 matched pairs.ResultsPatients who had TAVR were significantly older (P ˂ 0.001) and had significantly higher EuroSCORE II (P ˂ 0.001), NYHA class (P ˂ 0.001), and more prevalence of diabetes mellitus (P ˂ 0.001), hypertension (P ˂ 0.001), chronic lung disease (P = 0.001), recent myocardial infarction (P = 0.002), and heart failure (P ˂ 0.001), stroke (P = 0.02), atrial fibrillation (P = 0.004), and previous percutaneous coronary interventions (P ˂ 0.001) than SAVR patients. In the matched cohort, atrial fibrillation occurred more frequently after SAVR (P = 0.01), and hospital stay was significantly longer in SAVR patients (P ˂ 0.001). There were no differences in hospital mortality between groups (P ˃ 0.99). Survival at 1, 3, and 5 years was 97%, 95%, and 94% for SAVR and 91%, 79%, and 58% for TAVR patients. Survival was lower in TAVR patients before matching (P ˂ 0.001) and after matching (P = 0.045). Freedom from the composite endpoint of stroke, aortic valve reintervention, and heart failure readmission at 1, 3, and 5 years was 98.9%, 96%, and 94% for SAVR and 94%, 86%, and 75% for TAVR. The composite endpoint was significantly higher in the TAVR group than in SVR before matching (P ˂ 0.001), while there was no difference after matching (P = 0.07). There was no significant difference in the change in ejection fraction between groups (β: −0.88 (95% CI: −2.20–0.43), P = 0.19), and the reduction of the aortic valve peak gradient was significantly higher with TAVR (β: −7.80 (95% CI: −10.70 to −4.91); P ˂ 0.001).ConclusionsTAVR could reduce postoperative atrial fibrillation and hospital stay. SAVR could have long-term survival benefits over TAVR with comparable long-term stroke, heart failure readmission, and aortic valve reinterventions between SAVR and TAVR.

Evaluating postoperative outcomes in patients with hostile neck anatomy undergoing transcarotid artery revascularization versus transfemoral carotid artery stenting.

Carotid endarterectomy is relatively contraindicated in patients with a hostile neck anatomy who were historically revascularized with transfemoral carotid artery stenting (TFCAS). As transcarotid artery revascularization (TCAR) has progressively replaced TFCAS, evidence pertaining to hostile neck anatomy and TCAR is necessary to establish its safety and feasibility in this subgroup of patients. Therefore, we analyzed the impact of a hostile neck anatomy on outcomes in patients undergoing TCAR and further compared them with those undergoing TFCAS to establish recommendations for standard of care. All patients undergoing TCAR and TFCAS from November 2016 to June 2021 in the Vascular Quality Initiative database were included. Patients were characterized into two groups based on the neck anatomy. Hostile neck anatomy was defined as a history of neck radiation or prior neck surgery including prior carotid endarterectomy or radical neck dissection. Primary outcomes included technical failure, access site complications (hematoma, stenosis, infection, pseudoaneurysm and arteriovenous fistula), and stroke or death. Secondary outcomes included stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and a composite end point of stroke or TIA. Patients with nonatherosclerotic or multiple lesions were excluded from the analysis. Primary analysis was performed with all patients undergoing TCAR and outcomes between patients with hostile and nonhostile neck anatomy were compared. Further analysis included a comparison of patients with a hostile neck anatomy undergoing TCAR and TFCAS. Univariable and multivariable logistic regression was used to assess impact of hostile neck anatomy on postoperative outcomes. Results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, comorbidities, preoperative medications, anesthesia type, and protamine use. Among the 19,859 patients who underwent TCAR during the study period, 3636 (18.3%) had a hostile neck anatomy. On univariate analysis, both groups had comparable outcomes except for higher rates of stroke or death in patients with hostile neck anatomy. After adjusting for potential confounders, there were no differences in technical failure (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 0.59-2.21; P= .699), stroke (aOR, 0.86; 95% CI, 0.58-1.28; P= .464), death (aOR, 0.82; 95% CI, 0.39-1.71; P= .598), and MI (aOR, 1.18; 95% CI, 0.71-1.97; P= .518). However, patients with hostile neck were at a 30% increased risk of access site complications (aOR, 1.30; 95% CI, 1.0-1.6; P= .023). Further adjusted analysis comparing the outcomes in TFCAS and TCAR among patients with hostile neck anatomy showed an almost four-fold increase in risk of death (aOR, 3.77; 95% CI, 1.49-9.53; P= .005) and technical failure (aOR, 3.69; 95% CI, 1.82-7.47; P< .001) among patients undergoing treatment with TFCAS. Patients with a hostile neck anatomy undergoing TCAR experienced an increased risk of access site complications; however, the risk for technical failure and postoperative stroke/death, stroke, TIA, MI, or death was similar among both groups. TFCAS was associated with significant increase in the risk of death and technical failure compared with TCAR in this group of patients. These results confirm that TCAR should be the preferred minimally invasive revascularization procedure for patients with hostile neck anatomy.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting

ObjectiveCurrent guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). MethodsWe identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. ResultsOf the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. ConclusionsCompared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

Surgical vs Transcatheter Aortic Valve Replacement in Patients With a Low Ejection Fraction.

Currently, there is no preference for surgical (SAVR) vs transcatheter (TAVR) aortic valve replacement in patients with low ejection fraction (EF). The present study retrospectively compared the outcomes of SAVR vs TAVR in patients with EF ≤40% (70 SAVR and 117 TAVR patients). Study outcomes were survival and the composite endpoint of stroke, aortic valve reintervention, and heart failure readmission. The patients who had TAVR were older (median: 75 (25-75th percentiles: 69-81) vs 51 (39-66) years old; P < .001) with higher EuroSCORE II (4.95 (2.99-9.85) vs 2 (1.5-3.25); P < .001). Postoperative renal impairment was more common with SAVR (8 (12.5%) vs 4 (3.42%); P = .03), and they had longer hospital stay [9 (7-15) vs 4 (2-8) days; P < .001). There was no difference between groups in stroke, reintervention, and readmission (Sub-distributional Hazard ratio: .95 (.37-2.45); P = .92). Survival at 1 and 5 years was 95% and 91% with SAVR and 89% and 63% with TAVR. Adjusted survival was comparable between groups. EF improved significantly (β: .28 (.23-.33); P < 0.001) with no difference between groups (P = .85). In conclusion, TAVR could be as safe as SAVR in patients with low EF.

Preoperative anxiety as predictor of perioperative clinical events following carotid surgery: a prospective observational study

BackgroundPsychological factors like anxiety and depression are recognised to play a causal role in the development of cardiovascular disease and they may also influence outcome after vascular surgery procedures. The aim of this study was to investigate the association of anxiety and depression with postoperative outcome following elective carotid surgery.MethodsSingle centre prospective observational study of patients treated for asymptomatic carotid artery stenosis at an academic vascular surgery centre. Preoperative anxiety and depression were evaluated using self-reporting questionnaires: Spielberger State-Trait Anxiety Inventory (STAI-S/-T) and Hospital Anxiety and Depression Scale (HADS-A/-D). Postoperative morbidity and mortality were assessed with the primary composite endpoint of stroke, myocardial infarction (MI) and death. Standard reporting guidelines for carotid disease were applied.ResultsFrom June 2012 to November 2015, 393 carotid endarterectomies (CEA) were performed at our institution. Out of those, 98 asymptomatic patients were available for analysis (78% male; median age, 71.1 years). Median scores of self-reporting questionnaires did not differ from published data of the general population (STAI-T, trait component, median, 36; IQR, 31-42.75; STAI-S, state component, median, 38; IQR, 32-43; HADS-A median, 6; IQR, 3-8; HADS-D median, 4; IQR, 2-7). Cardiovascular risk factors were similar in anxious and non-anxious patients. The composite endpoint of stroke, MI and death occurred significantly more often in patients presenting with a preoperative HADS-A score higher than 6 (10.5%, 95% CI, 3-25; p =.020).ConclusionsThe present study indicates that preoperative anxiety is associated with the occurrence of intra- and postoperative neurological events in patients undergoing CEA. Patients who had a preoperative HADS-A score of 6 or less had a very low probability of experiencing these complications.

Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial

The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed. The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA). Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up. The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.

National Outcomes of Elective Hybrid Arch Debranching with Endograft Exclusion versus Total Arch Replacement Procedures: Analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database.

Objective Hybrid arch procedures (arch vessel debranching with thoracic endovascular aneurysm repair [TEVAR] coverage of arch pathology) have been presented as an alternative to total arch replacement (TAR). But multicenter-based analyses of these two procedures are needed to benchmark the field and establish areas of improvement. Methods The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database from July 2014 to December 2015 was queried for elective TAR and hybrid arch procedures. Demographics and operative characteristics were compared and stepwise variable selection was used to create a risk-set used for adjustment of all multivariable models. Results A total of 1,011 patients met inclusion criteria, 884 underwent TAR, and 127 had hybrid arch procedures. TAR patients were younger (mean age: 62.7 ± 13.3 vs. 66.7 ± 11.9 years; p = 0.001) and had less peripheral vascular disease (34.0 vs. 49.6%; p < 0.001) and preoperative dialysis (1.7 vs. 4.7%; p = 0.026), but similar history of stroke ( p = 0.91)/cerebrovascular disease ( p = 0.52). TAR patients had more concomitant procedures (60 vs. 34.6%; p < 0.0001). TAR patients had lower mortality (6.7 vs. 12.6%; p = 0.02), stroke (6.9 vs. 15%; p = 0.002), paralysis (1.8 vs. 7.1%; p = 0.002), renal failure (4.6 vs. 8.7%; p = 0.045), and STS morbidity (34.2 vs. 42.5%; p = 0.067). Composite mortality, stroke, and paralysis were significantly lower with TAR (11.5 vs. 25.2%; p = 0.0001). After risk adjustment, analysis showed hybrid arch procedures imparted an increased odds of mortality (odds ratio [OR] = 1.91, p = 0.046), stroke (OR = 2.3, p = 0.005), and composite endpoint of stroke or mortality (OR = 2.31, p = 0.0002). Conclusion TAR remains the gold standard for elective aortic arch pathologies. Despite risk adjustment, hybrid arch procedures were associated with increased risk of mortality and stroke, advocating for careful adoption of these strategies.

OP340 Adverse Clinical Events And Associated Risk Factors In Patients With Very-High-Risk Atherosclerotic Cardiovascular Disease

IntroductionClinical atherosclerotic cardiovascular disease (ASCVD) patients are judged to be very-high-risk if they had a history of multiple major ASCVD events, or one major ASCVD event with multiple high-risk conditions. Very-high-risk ASCVD patients are under high risk of adverse clinical events and need more attention in the management of secondary prevention. This real-world study aimed at estimating the prevalence of very-high-risk ASCVD and investigating the occurrence of adverse clinical events and associated risk factors among patients with very-high-risk ASCVD in China.MethodsData were obtained from the Urban Employee Basic Medical Insurance database in Tianjin, China. Very-high-risk ASCVD patients were identified from 2014 to 2015 through the history of ASCVD events and evidence of high-risk conditions, and followed for 24 months. Adverse clinical events were measured by major adverse cardiovascular events (MACE), a composite endpoint of stroke, myocardial infarction (MI) and death. A Cox regression model was used to identify risk factors of MACE, adjusting for potential confounders.ResultsThe percentage of clinical ASCVD patients identified as very-high-risk was 35.2 (N = 41,181), while 34,740 patients with continuous enrollment were included (mean age: 67.1 years; 42.5% female). The percentage of patients who had MACE in the 24-month follow-up period was 27.7, with stroke (22.3%) as the most prevalent event followed by death (6.9%) and MI (1.3%). Male gender, older age, and having MI or ischemic stroke (versus unstable angina) as the index major ASCVD event were risk predictors of MACE.ConclusionsMore than one-third of patients with clinical ASCVD are under very-high-risk in China, and among them 27.7 percent experience MACE during a 24-month follow-up period. Male patients, older patients, and patients who had MI or ischemic stroke are under higher risk of experiencing MACE. Future studies are warranted for comparing the differences in characteristics, pattern of drug use, occurrence of adverse clinical events and medical burden between very-high-risk ASCVD patients and ASCVD patients not at very-high-risk.