Bagur, Rodrigo

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. METHODS: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. RESULTS: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery ( P =0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients ( P <0.001) and lower rates of severe prosthesis-patient mismatch ( P <0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. CONCLUSIONS: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. REGISTRATION: URL: https://clinicaltrials.gov ; Unique identifier: NCT02701283.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P &amp;lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &amp;lt; .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P &amp;lt; .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Background Elderly patients have a higher burden of comorbidities that influence clinical outcomes. We aimed to compare in‐hospital outcomes in patients ≥80 years old to younger patients, and to determine the factors associated with increased risk of major adverse events (MAE) after left atrial appendage closure. Methods and Results The National Inpatient Sample was used to identify discharges after left atrial appendage closure between October 2015 and December 2018. The primary outcome was in‐hospital MAE defined as the composite of postprocedural bleeding, vascular and cardiac complications, acute kidney injury, stroke, and death. A total of 6779 hospitalizations were identified, of which, 2371 (35%) were ≥80 years old and 4408 (65%) were <80 years old. Patients ≥80 years old experienced a higher rate of MAE compared with those aged <80 years old (6.0% versus 4.6%, P =0.01), and this difference was driven by a numerically higher rate of cardiac complications (2.4% versus 1.8%, P =0.09) and death (0.3% versus 0.1%, P =0.05) among individuals ≥80 years old. In patients ≥80 years old, higher odds of in‐hospital MAE were observed in women (1.61‐fold), and those with preprocedural congestive heart failure (≈2‐fold), diabetes (≈1.5‐fold), renal disease (≈2.6‐fold), anemia (≈2.7‐fold), and dementia (≈5‐fold). In patients <80 years old, a higher risk of in‐hospital MAE was encountered among women (≈1.4‐fold) and those with diabetes (≈1.3‐fold), renal disease (≈2.6‐fold), anemia (≈2‐fold), and dyslipidemia (≈1.2‐fold). Conclusions Patients ≥80 years old had higher rates of in‐hospital MAE compared with patients aged <80 years old. Female sex and the presence of heart failure, diabetes, renal disease, and anemia were factors associated with in‐hospital MAE among both groups.

Objective This manuscript aims to explore the impact of race/ethnicity and socioeconomic status on in-hospital complication rates after left atrial appendage closure (LAAC). Methods The US National Inpatient Sample was used to identify hospitalisations for LAAC between 1 October 2015 to 31 December 2018. These patients were stratified by race/ethnicity and quartiles of median neighbourhood income. The primary outcome was the occurrence of in-hospital major adverse events, defined as a composite of postprocedural bleeding, cardiac and vascular complications, acute kidney injury and ischaemic stroke. Results Of 6478 unweighted hospitalisations for LAAC, 58% were male and patients of black, Hispanic and ‘other’ race/ethnicity each comprised approximately 5% of the cohort. Adjusted by the older Americans population, the estimated number of LAAC procedures was 69.2/100 000 for white individuals, as compared with 29.5/100 000 for blacks, 47.2/100 000 for Hispanics and 40.7/100 000 for individuals of ‘other’ race/ethnicity. Black patients were ~5 years younger but had a higher comorbidity burden. The primary outcome occurred in 5% of patients and differed significantly between racial/ethnic groups (p<0.001) but not across neighbourhood income quartiles (p=0.88). After multilevel modelling, the overall rate of in-hospital major adverse events was higher in black patients as compared with whites (OR: 1.60, 95% CI 1.22 to 2.10, p<0.001); however, the incidence of acute kidney injury was higher in Hispanics (OR: 2.19, 95% CI 1.52 to 3.17, p<0.001). No significant differences were found in adjusted overall in-hospital complication rates between income quartiles. Conclusion In this study assessing racial/ethnic disparities in patients undergoing LAAC, minorities are under-represented, specifically patients of black race/ethnicity. Compared with whites, black patients had higher comorbidity burden and higher rates of in-hospital complications. Lower socioeconomic status was not associated with complication rates.

Objective To estimate the risk of in-hospital complications after left atrial appendage closure (LAAC) in relationship with comorbidity burden. Methods Cohort-based observational study using the US National Inpatient Sample database, 1 October 2015 to 31 December 2017. The main outcome of interest was the occurrence of in-hospital major adverse events (MAE) defined as the composite of bleeding complications, acute kidney injury, vascular complications, cardiac complications and postprocedural stroke. Comorbidity burden and thromboembolic risk were assessed by the Charlson Comorbidity Index (CCI), Elixhauser Comorbidity Score (ECS) and CHA2DS2-VASc score. MAE were identified using International Classification of Diseases, Tenth Revision, Clinical Modification codes. The associations of comorbidity with in-hospital MAE were evaluated using logistic regression models. Results A total of 3294 hospitalisations were identified, among these, the mean age was 75.7±8.2 years, 60% were male and 86% whites. The mean CHA2DS2-VASc score was 4.3±1.5 and 29.5% of the patients had previous stroke or transient ischaemic attack. The mean CCI and ECS were 2.2±1.9 and 9.7±5.8, respectively. The overall composite rate of in-hospital MAE after LAAC was 4.6%. Females and non-whites had about 1.5 higher odds of in-hospital AEs as well participants with higher CCI (adjusted OR (aOR): 1.19, 95% CI: 1.13 to 1.24, p<0.001), ECS (aOR: 1.06, 95% CI: 1.05 to 1.08, p<0.001) and CHA2DS2-VASc score (aOR: 1.08, 95% CI: 1.02 to 1.15, p=0.01) were significantly associated with in-hospital MAE. Conclusion In this large cohort of LAAC patients, the majority of them had significant comorbidity burden. In-hospital MAE occurred in 4.6% and female patients, non-whites and those with higher burden of comorbidities were at higher risk of in-hospital MAE after LAAC.

AbstractObjectivesTo assess the Usefulness of oral anticoagulation therapy (OAT) in patients with coronary artery aneurysm (CAA).BackgroundData on the most adequate antithrombotic CAA management is lacking.MethodsPatients included in CAAR (Coronary Artery Aneurysm Registry, Clinical Trials.gov: NCT02563626) were selected. Patients were divided in OAT and non‐OAT groups, according to anticoagulation status at discharge and 2:1 propensity score matching with replacement was performed. The primary endpoint of the analysis was a composite and mutual exclusive endpoint of myocardial infarction, unstable angina (UA), and aneurysm thrombosis (coronary ischemic endpoint). Net adverse clinical events, major adverse cardiovascular events, their single components, cardiovascular death, re‐hospitalizations for heart failure, stroke, aneurysm thrombosis, and bleeding were the secondary ones.ResultsOne thousand three hundred thirty‐one patients were discharged without OAT and 211 with OAT. In the propensity‐matched sample (390 patients in the non‐OAT group, 195 patients in the OAT group), after 3 years of median follow‐up (interquartile range 1–6 years), the rate of the primary endpoint (coronary ischemic endpoint) was significantly less in the OAT group as compared to non‐OAT group (8.7 vs. 17.2%, respectively; p = .01), driven by a significant reduction in UA (4.6 vs. 10%, p < .01) and aneurysm thrombosis (0 vs. 3.1%, p = .03), along with a non‐significant reduction in MI (4.1 vs. 7.7%, p = .13). A non‐significant increase in bleedings, mainly BARC type 1 (55%), was found in the OAT‐group (10.3% in the non‐OAT vs. 6.2% in the OAT group, p = .08).ConclusionOAT decreases the composite endpoint of UA, myocardial infarction, and aneurysm thrombosis in patients with CAA, despite a non‐significant higher risk of bleeding.

Background The management of patients with severe but asymptomatic aortic stenosis is challenging. Evidence on early aortic valve replacement (AVR) versus symptom-driven intervention in these patients is unknown. Methods Electronic databases were searched, articles comparing early-AVR with conservative management for severe aortic stenosis were identified. Pooled adjusted odds ratio (OR) was computed using a random-effect model to determine all-cause and cardiovascular mortality. Results A total of eight studies consisting of 2201 patients were identified. Early-AVR was associated with lower all-cause mortality [OR 0.24, 95% confidence interval (CI) 0.13–0.45, P ≤ 0.00001] and cardiovascular mortality (OR 0.21, 95% CI 0.06–0.70, P = 0.01) compared with conservative management. The number needed to treat to prevent 1 all-cause and cardiovascular mortality was 4 and 9, respectively. The odds of all-cause mortality in a selected patient population undergoing surgical AVR (SAVR) (OR 0.16, 95% CI 0.09–0.29, P ≤ 0.00001) and SAVR or transcatheter AVR (TAVR) (OR 0.53, 95% CI 0.35–0.81, P = 0.003) were significantly lower compared with patients who are managed conservatively. A subgroup sensitivity analysis based on severe aortic stenosis (OR 0.24, 95% CI 0.11–0.52, P = 0.0004) versus very severe aortic stenosis (OR 0.20, 95% CI 0.08–0.51, P = 0.0008) also mirrored the findings of overall results. Conclusion Patients with asymptomatic aortic valve stenosis have lower odds of all-cause and cardiovascular mortality when managed with early-AVR compared with conservative management. However, because of significant heterogeneity in the classification of asymptomatic patients, large scale studies are required.