The aim of this study was to examine the value of frailty to predict in-hospital major bleeding and determine its impact on mid-term mortality following transcatheter (TAVR) or surgical (SAVR) aortic ...valve replacement.
Bleeding complications are harbingers of mortality and major morbidity in patients undergoing TAVR or SAVR. Despite the high prevalence of frailty in this population, little is known about its effects on bleeding risk.
A post hoc analysis was performed of the multinational FRAILTY-AVR (Frailty Aortic Valve Replacement) cohort study, which prospectively enrolled older adults ≥70 years of age undergoing TAVR or SAVR. Trained researchers assessed frailty using a questionnaire and physical performance battery pre-procedure and ascertained clinical data from the electronic health record. The primary endpoint was major or life-threatening bleeding during the index hospitalization, and the secondary endpoint was units of packed red blood cells transfused.
The cohort consisted of 1,195 patients with a mean age of 81.3 ± 6.0 years. The incidence of life-threatening bleeding, major bleeding with a clinically apparent source, and major bleeding without a clinically apparent source was, respectively, 3%, 6%, and 9% in the TAVR group and 8%, 10%, and 31% in the SAVR group. Frailty measured using the Essential Frailty Toolset was an independent predictor of major bleeding and packed red blood cell transfusions in both groups. Major bleeding was associated with a 3-fold increase in 1-year mortality following TAVR (odds ratio: 3.40; 95% confidence interval: 2.22 to 5.21) and SAVR (odds ratio: 2.79; 95% confidence interval: 1.25 to 6.21).
Frailty is associated with post-procedural major bleeding in older adults undergoing TAVR and SAVR, which is in turn associated with a higher risk for mid-term mortality.
The present article provides a brief review of the human and animal literature that has investigated the relationship between fitness training and brain and cognitive function. The animal research ...clearly suggests that improvements in fitness can lead to both morphological and functional changes in the brains of older animals. Results of a recent meta-analysis suggest that fitness training can also have beneficial effects on human cognition, particularly on tasks requiring executive control processing. These effects are also moderated by a number of factors, including the proportion of men and women in the intervention studies, the length of training sessions, the age of the participants, and the combination of fitness training regimes. The article also discusses preliminary results that link, for the first time, fitness training and differences in human brain structure and function. Finally, we discuss the important issue of participant adherence to fitness training programs and the factors that influence fitness participation.
The effect of preoperative mitral regurgitation (MR) on clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. This study sought to examine the ...impact of moderate and severe MR on outcomes after TAVR and surgical aortic valve replacement (SAVR).
Data were drawn from the randomized Placement of Aortic Transcatheter Valve (PARTNER) Trial cohort A patients with severe, symptomatic aortic stenosis undergoing either TAVR (n=331) or SAVR (n=299). Both TAVR and SAVR patients were dichotomized according to the degree of preoperative MR (moderate/severe versus none/mild). At baseline, moderate or severe MR was reported in 65 TAVR patients (19.6%) and 63 SAVR patients (21.2%). At 30 days, among survivors who had isolated SAVR/TAVR, moderate/severe MR had improved in 25 SAVR patients (69.4%) and 30 TAVR patients (57.7%), was unchanged in 10 SAVR patients (27.8%) and 19 TAVR patients (36.5%), and worsened in 1 SAVR patient (2.8%) and 4 TAVR patients (5.8%; all P=NS). Mortality at 2 years was higher in SAVR patients with moderate or severe MR than in those with mild or less MR (49.8% versus 28.1%; adjusted hazard ratio, 1.73; 95% confidence interval, 1.01-2.96; P=0.04). In contrast, MR severity at baseline did not affect mortality in TAVR patients (37.0% versus 32.7%, moderate/severe versus none/mild; hazard ratio, 1.14; 95% confidence interval, 0.72-1.78; P=0.58; P for interaction=0.05).
Both TAVR and SAVR were associated with a significant early improvement in MR in survivors. However, moderate or severe MR at baseline was associated with increased 2-year mortality after SAVR but not after TAVR. TAVR may be a reasonable option in selected patients with combined aortic and mitral valve disease.
http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
The extent of extravalvular cardiac damage is associated with increased risk of adverse events among patients with severe aortic stenosis undergoing aortic valve replacement (AVR).
The goal was to ...describe the association of cardiac damage on health status before and after AVR.
Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by echocardiographic cardiac damage stage at baseline and 1 year as previously described (stage 0-4). We examined the association between baseline cardiac damage and 1-year health status (assessed by the Kansas City Cardiomyopathy Questionnaire Overall Score KCCQ-OS).
Among 1,974 patients (794 surgical AVR, 1,180 transcatheter AVR), the extent of cardiac damage at baseline was associated with lower KCCQ scores both at baseline and at 1 year after AVR (P < 0.0001) and with increased rates of a poor outcome (death, KCCQ-OS <60, or a decrease in KCCQ-OS of ≥10 points) at 1 year (stages 0-4: 10.6% vs 19.6% vs 29.0% vs 44.7% vs 39.8%; P < 0.0001). In a multivariable model, each 1-stage increase in baseline cardiac damage was associated with a 24% increase in the odds of a poor outcome (95% CI: 9%-41%; P = 0.001). Change in stage of cardiac damage at 1 year after AVR was associated with the extent of improvement in KCCQ-OS over the same period (mean change in 1-year KCCQ-OS: improvement of ≥1 stage +26.8 95% CI: 24.2-29.4 vs no change +21.4 95% CI: 20.0-22.7 vs deterioration of ≥1 stage +17.5 95% CI: 15.4-19.5; P < 0.0001).
The extent of cardiac damage before AVR has an important impact on health status outcomes, both cross-sectionally and after AVR. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A), NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B PARTNERII B, NCT02184442; PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis P3, NCT02675114)
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Anticoagulation is required during transcatheter aortic valve replacement (TAVR) procedures. Although an optimal regimen has not been determined, heparin is mainly used. Direct thrombin inhibition ...with bivalirudin may be an effective alternative to heparin as the procedural anticoagulant agent in this setting.
The goal of this study was to determine whether bivalirudin offers an alternative to heparin as the procedural anticoagulant agent in patients undergoing TAVR.
A total of 802 patients with aortic stenosis were randomized to undergo transfemoral TAVR with bivalirudin versus unfractionated heparin during the procedure. The 2 primary endpoints were major bleeding within 48 h or before hospital discharge (whichever occurred first) and 30-day net adverse clinical events, defined as the combination of major adverse cardiovascular events (all-cause mortality, myocardial infarction, or stroke) and major bleeding.
Anticoagulation with bivalirudin versus heparin did not meet superiority because it did not result in significantly lower rates of major bleeding at 48 h (6.9% vs. 9.0%; relative risk: 0.77; 95% confidence interval CI: 0.48 to 1.23; p = 0.27) or net adverse cardiovascular events at 30 days (14.4% vs. 16.1%; relative risk: 0.89; 95% CI: 0.64 to 1.24; risk difference: -1.72; 95% CI: -6.70 to 3.25; p = 0.50); regarding the latter, the prespecified noninferiority hypothesis was met (pnoninferiority < 0.01). Rates of major adverse cardiovascular events at 48 h were not significantly different (3.5% vs. 4.8%; relative risk: 0.73; 95% CI: 0.37 to 1.43; p = 0.35). At 48 h, the bivalirudin group had significantly fewer myocardial infarctions but more acute kidney injury events than the heparin group; at 30 days, these differences were no longer significant.
In this randomized trial of TAVR procedural pharmacotherapy, bivalirudin did not reduce rates of major bleeding at 48 h or net adverse cardiovascular events within 30 days compared with heparin. Although superiority was not shown, the noninferiority hypothesis was met with respect to the latter factor. Given the lower cost, heparin should remain the standard of care, and bivalirudin can be an alternative anticoagulant option in patients unable to receive heparin in TAVR. (International, Multi-center, Open-label, Randomized Controlled Trial in Patients Undergoing TAVR to Determine the Treatment Effect Both Safety and Efficacy of Using Bivalirudin Instead of UFH BRAVO-2/3; NCT01651780).
An increasing number of patients with congenital heart disease (CHD) are entering adulthood. Although prior studies have focused on the causes of death in the pediatric population, the modes of death ...for adults with CHD have not been well defined. In a cross-sectional study performed on a population of 2,609 consecutive adults assessed at a CHD specialty clinic, there were adequate information available in 197 of 199 deceased patients. Mean age at death was 37 ± 15 years. Mortality was highest in patients with congenitally corrected transposition of the great arteries (26%), tricuspid atresia (25%), and univentricular connection (23%). Youngest mean age at death was observed in patients with tricuspid atresia (27 ± 5 years), complete transposition of the great arteries (27 ± 7 years), pulmonary atresia (27 ± 6 years), and aortic coarctation (29 ± 6 years). Sudden death (26%) was the most common cause of death followed by progressive heart failure (21%) and perioperative death (18%). Postmortem examinations were performed in 77 of 197 deceased patients (39%) and provided incremental data on the mechanism of death in 22% of autopsies. Thus, the 3 major causes of death in the growing population of adults with CHD are sudden, perioperative, and progressive heart failure.
OBJECTIVEThis study aims to assess the statistical significance of training parameters in 240 dense UNets (DUNets) used for enhancing low Signal-to-Noise Ratio (SNR) and undersampled MRI in various ...acquisition protocols. The objective is to determine the validity of differences between different DUNet configurations and their impact on image quality metrics.MATERIALS AND METHODSTo achieve this, we trained all DUNets using the same learning rate and number of epochs, with variations in 5 acquisition protocols, 24 loss function weightings, and 2 ground truths. We calculated evaluation metrics for two metric regions of interest (ROI). We employed both Analysis of Variance (ANOVA) and Mixed Effects Model (MEM) to assess the statistical significance of the independent parameters, aiming to compare their efficacy in revealing differences and interactions among fixed parameters.RESULTSANOVA analysis showed that, except for the acquisition protocol, fixed variables were statistically insignificant. In contrast, MEM analysis revealed that all fixed parameters and their interactions held statistical significance. This emphasizes the need for advanced statistical analysis in comparative studies, where MEM can uncover finer distinctions often overlooked by ANOVA.DISCUSSIONThese findings highlight the importance of utilizing appropriate statistical analysis when comparing different deep learning models. Additionally, the surprising effectiveness of the UNet architecture in enhancing various acquisition protocols underscores the potential for developing improved methods for characterizing and training deep learning models. This study serves as a stepping stone toward enhancing the transparency and comparability of deep learning techniques for medical imaging applications.
Abstract Once considered a childhood disease, the number of adults living with congenital heart disease has now exceeded the number of pediatric patients. The landscape of percutaneous intervention ...for adult congenital heart disease (ACHD) has evolved over the last decade and has yet to be characterized in Canada. The aim of this study was to begin to understand the current infrastructure underlying ACHD interventions in Canada and to characterize the type and number of interventions being carried out across the country. A cross-sectional national survey was distributed via email to all Cardiac Catheterization Laboratory Directors in 2015. All Canadian laboratories involved in ACHD interventions responded, encompassing 19 institutions spanning 69 cardiac catheterization laboratories. A total of 1,451 percutaneous interventions were recorded. Nationwide, the most common simple ACHD interventions were atrial septal defect and patent foramen ovale closures. The most common ACHD interventions of increased complexity were coarctation stenting and transcatheter pulmonary valve implantation. There was a marked clustering of procedures in Ontario, Quebec, British Columbia and Alberta, in keeping with Canada’s population density distribution. A total of 23 ACHD operators were identified, half of which had ACHD-specific fellowship training. This data can be used as a starting point to inform the present state of affairs in the area and lays the groundwork for further work to assess resource allocation and human resource planning for the care of ACHD patients in Canada.