Cusp overlap method for self-expanding transcatheter aortic valve replacement.

BACKGROUND: Conduction disturbances and the need for permanent pacemaker (PPM) implantation remains a common complication for transcatheter aortic valve replacement (TAVR), particularly when self-expanding (SE) valves are used. AIMS: We compared in-hospital and 30-day rates of new PPM implantation between patients undergoing TAVR with SE valves using the conventional three-cusp coplanar implantation technique and the cusp-overlap technique. METHODS: We retrospectively compared patients without a pre-existing PPM who underwent a TAVR procedure with SE Evolut R or PRO valves using the cusp-overlap technique from July 2018 to September 2020 (n = 519) to patients who underwent TAVR using standard three-cusp technique from April 2016 to March 2017 (n = 128) in two high volume Canadian centers. RESULTS: There was no significant difference in baseline RBBB between the groups (10.4% vs. 13.2; p = 0.35). The rate of in-hospital new complete heart block (9.4% vs. 23.4%; p ≤ 0.001) and PPM implantation (8% vs. 21%; p ≤ 0.001) were significantly reduced when using the cusp-overlap technique. The incidence of new LBBB (30.4% vs. 29%; p = 0.73) was similar. At 30 days, the rates of new complete heart block (11% vs. 23%; p ≤ 0.001) and PPM implantation (10% vs. 21%, p ≤ 0.001) remained significantly lower in the cusp-overlap group, while the rate of new LBBB (35% vs. 30%; p = 0.73) was similar. CONCLUSION: Cusp-overlap approach offers several potential technical advantages compared to standard three-cusp view, and may result in lower PPM rates in TAVR with SE Evolut valve.

Days alive and out of hospital for adult female and male cardiac surgery patients: a population-based cohort study.

BACKGROUND: Research shows women experience higher mortality than men after cardiac surgery but information on sex-differences during postoperative recovery is limited. Days alive and out of hospital (DAH) combines death, readmission and length of stay, and may better quantify sex-differences during recovery. This main objective is to evaluate (i) how DAH at 30-days varies between sex and surgical procedure, (ii) DAH responsiveness to patient and surgical complexity, and (iii) longer-term prognostic value of DAH. METHODS: We evaluated 111,430 patients (26% female) who underwent one of three types of cardiac surgery (isolated coronary artery bypass [CABG], isolated non-CABG, combination procedures) between 2009 - 2019. Primary outcome was DAH at 30 days (DAH30), secondary outcomes were DAH at 90 days (DAH90) and 180 days (DAH180). Data were stratified by sex and surgical group. Unadjusted and risk-adjusted analyses were conducted to determine the association of DAH with patient-, surgery-, and hospital-level characteristics. Patients were divided into two groups (below and above the 10th percentile) based on the number of days at DAH30. Proportion of patients below the 10th percentile at DAH30 that remained in this group at DAH90 and DAH180 were determined. RESULTS: DAH30 were lower for women compared to men (22 vs. 23 days), and seen across all surgical groups (isolated CABG 23 vs. 24, isolated non-CABG 22 vs. 23, combined surgeries 19 vs. 21 days). Clinical risk factors including multimorbidity, socioeconomic status and surgical complexity were associated with lower DAH30 values, but women showed lower values of DAH30 compared to men for many factors. Among patients in the lowest 10th percentile at DAH30, 80% of both females and males remained in the lowest 10th percentile at 90 days, while 72% of females and 76% males remained in that percentile at 180 days. CONCLUSION: DAH is a responsive outcome to differences in patient and surgical risk factors. Further research is needed to identify new care pathways to reduce disparities in outcomes between male and female patients.

Development and Validation of the CANHEART Population-Based Laboratory Prediction Models for Atherosclerotic Cardiovascular Disease.

BACKGROUND: Prediction of atherosclerotic cardiovascular disease (ASCVD) in primary prevention assessments exclusively with laboratory results may facilitate automated risk reporting and improve uptake of preventive therapies. OBJECTIVE: To develop and validate sex-specific prediction models for ASCVD using age and routine laboratory tests and compare their performance with that of the pooled cohort equations (PCEs). DESIGN: Derivation and validation of the CANHEART (Cardiovascular Health in Ambulatory Care Research Team) Lab Models. SETTING: Population-based cohort study in Ontario, Canada. PARTICIPANTS: A derivation and internal validation cohort of adults aged 40 to 75 years without cardiovascular disease from April 2009 to December 2015; an external validation cohort of primary care patients from January 2010 to December 2014. MEASUREMENTS: Age and laboratory predictors measured in the outpatient setting included serum total cholesterol, high-density lipoprotein cholesterol, triglycerides, hemoglobin, mean corpuscular volume, platelets, leukocytes, estimated glomerular filtration rate, and glucose. The ASCVD outcomes were defined as myocardial infarction, stroke, and death from ischemic heart or cerebrovascular disease within 5 years. RESULTS: Sex-specific models were developed and internally validated in 2 160 497 women and 1 833 147 men. They were well calibrated, with relative differences less than 1% between mean predicted and observed risk for both sexes. The c-statistic was 0.77 in women and 0.71 in men. External validation in 31 697 primary care patients showed a relative difference less than 14% and an absolute difference less than 0.3 percentage points in mean predicted and observed risks for both sexes. The c-statistics for the laboratory models were 0.72 for both sexes and were not statistically significantly different from those for the PCEs in women (change in c-statistic, -0.01 [95% CI, -0.03 to 0.01]) or men (change in c-statistic, -0.01 [CI, -0.04 to 0.02]). LIMITATION: Medication use was not available at the population level. CONCLUSION: The CANHEART Lab Models predict ASCVD with similar accuracy to more complex models, such as the PCEs. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research.

Mapping Theories, Models, and Frameworks to Evaluate Digital Health Interventions: Scoping Review.

BACKGROUND: Digital health interventions (DHIs) are a central focus of health care transformation efforts, yet their uptake in practice continues to fall short of their potential. In order to achieve their desired outcomes and impact, DHIs need to reach their target population and need to be used. Many factors can rapidly intersect between this dynamic of users and interventions. The application of theories, models, and frameworks (TMFs) can facilitate the systematic understanding and explanation of the complex interactions between users, practices, technology, and health system factors that underpin research questions. There remains a gap in our understanding of how TMFs have been applied to guide the evaluation of DHIs with real-world health system operations. OBJECTIVE: This study aims to map TMFs used in studies to guide the evaluation of DHIs. The objectives are to (1) describe the TMFs and the constructs they target, (2) identify how TMFs have been prospectively used (ie, their roles) in primary studies to evaluate DHIs, and (3) to reflect on the relevance and utility of our findings for knowledge users. METHODS: This scoping review was conducted in partnership with knowledge users using an integrated knowledge translation approach. We included papers (eg, reports; empirical quantitative, qualitative, and mixed methods studies; conference proceedings; and dissertations) if primary insights resulting from the application of TMFs were presented. Any type of DHI was eligible. Papers published from 2000 and onward were mainly identified from the following databases: MEDLINE (Ovid), CINAHL Complete (EBSCOhost), PsycINFO (Ovid), EBM Reviews (Ovid), and Embase (Ovid). RESULTS: A total of 156 studies published between 2000 and 2022 were included. A total of 68 distinct TMFs were identified across 85 individual studies. In more than half (85/156, 55%) of the included studies, 1 of following 6 prevailing TMFs were reported: Consolidated Framework for Implementation Research (n=39); the Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework (n=17); the Technology of Acceptance Model (n=16); the Unified Theory on Acceptance and Use of Technology (n=12); the Diffusion of Innovation Theory (n=10); and Normalization Process Theory (n=9). The most common intended roles of the 6 TMFs were to inform data collection (n=86), to inform data analysis (n=69), and to identify key constructs that may serve as barriers and facilitators (n=52). CONCLUSIONS: As TMFs are most often reported to be applied to support data collection and analysis, researchers should consider more clearly synthesizing key insights as practical use cases to both increase the relevance and digestibility of their findings. There is also a need to adapt or develop guidelines for better reporting DHIs and the use of TMFs to guide evaluation. Hence, it would contribute to ensuring ongoing technology transformation efforts are evidence and theory informed rather than anecdotally driven.

ESC/EACTS vs. ACC/AHA guidelines for the management of severe aortic stenosis.

Aortic stenosis (AS) is a serious and complex condition, for which optimal management continues to evolve rapidly. An understanding of current clinical practice guidelines is critical to effective patient care and shared decision-making. This state of the art review of the 2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines and 2020 American College of Cardiology/American Heart Association Guidelines compares their recommendations for AS based on the evidence to date. The European and American guidelines were generally congruent with the exception of three key distinctions. First, the European guidelines recommend intervening at a left ventricular ejection fraction of 55%, compared with 60% over serial imaging by the American guidelines for asymptomatic patients. Second, the European guidelines recommend a threshold of ≥65 years for surgical bioprosthesis, whereas the American guidelines employ multiple age categories, providing latitude for patient factors and preferences. Third, the guidelines endorse different age cut-offs for transcatheter vs. surgical aortic valve replacement, despite limited evidence. This review also discusses trends indicating a decreasing proportion of mechanical valve replacements. Finally, the review identifies gaps in the literature for areas including transcatheter aortic valve implantation in asymptomatic patients, the appropriateness of Ross procedures, concomitant coronary revascularization with aortic valve replacement, and bicuspid AS. To summarize, this state of the art review compares the latest European and American guidelines on the management of AS to highlight three areas of divergence: timing of intervention, valve selection, and surgical vs. transcatheter aortic valve replacement criteria.

Association of Neighborhood-Level Material Deprivation With Atrial Fibrillation Care in a Single-Payer Health Care System: A Population-Based Cohort Study.

BACKGROUND: There are limited data on the association of material deprivation with clinical care and outcomes after atrial fibrillation (AF) diagnosis in jurisdictions with universal health care. METHODS: This was a population-based cohort study of individuals ≥66 years of age with first diagnosis of AF between April 1, 2007, and March 31, 2019, in the Canadian province of Ontario, which provides public funding and prohibits private payment for medically necessary physician and hospital services. Prescription medications are subsidized for residents >65 years of age. The primary exposure was neighborhood material deprivation, a metric derived from Canadian census data to estimate inability to attain basic material needs. Neighborhoods were categorized by quintile from Q1 (least deprived) to Q5 (most deprived). Cause-specific hazards regression was used to study the association of material deprivation quintile with time to AF-related adverse events (death or hospitalization for stroke, heart failure, or bleeding), clinical services (physician visits, cardiac diagnostics), and interventions (anticoagulation, cardioversion, ablation) while adjusting for individual characteristics and regional cardiologist supply. RESULTS: Among 347 632 individuals with AF (median age 79 years, 48.9% female), individuals in the most deprived neighborhoods (Q5) had higher prevalence of cardiovascular disease, risk factors, and noncardiovascular comorbidity relative to residents of the least deprived neighborhoods (Q1). After adjustment, Q5 residents had higher hazards of death (hazard ratio [HR], 1.16 [95% CI, 1.13-1.20]) and hospitalization for stroke (HR, 1.16 [95% CI, 1.07-1.27]), heart failure (HR, 1.14 [95% CI, 1.11-1.18]), or bleeding (HR, 1.16 [95% CI, 1.07-1.25]) relative to Q1. There were small differences across quintiles in primary care physician visits (HR, Q5 versus Q1, 0.91 [95% CI, 0.89-0.92]), echocardiography (HR, Q5 versus Q1, 0.97 [95% CI, 0.96-0.99]), and dispensation of anticoagulation (HR, Q5 versus Q1, 0.97 [95% CI, 0.95-0.98]). There were more prominent disparities for Q5 versus Q1 in cardiologist visits (HR, 0.84 [95% CI, 0.82-0.86]), cardioversion (HR, 0.80 [95% CI, 0.76-0.84]), and ablation (HR, 0.45 [95% CI, 0.30-0.67]). CONCLUSIONS: Despite universal health care and prescription medication coverage, residents of more deprived neighborhoods were less likely to visit cardiologists or receive rhythm control interventions after AF diagnosis, even though they exhibited higher cardiovascular disease burden and higher risk of adverse outcomes.

Predicting left main stenosis in stable ischemic heart disease using logistic regression and boosted trees.

BACKGROUND: The ISCHEMIA trial showed similar cardiovascular outcomes of an initial conservative strategy as compared with invasive management in patients with stable ischemic heart disease without left main stenosis. We aim to assess the feasibility of predicting significant left main stenosis using extensive clinical, laboratory and non-invasive tests data. METHODS: All adult patients who had stress testing prior to undergoing an elective coronary angiography for stable ischemic heart disease in Ontario, Canada, between April 2010 and March 2019, were included. Candidate predictors included comprehensive demographics, comorbidities, laboratory tests, and cardiac stress test data. The outcome was stenosis of 50% or greater in the left main coronary artery. A traditional model (logistic regression) and a machine learning algorithm (boosted trees) were used to build prediction models. RESULTS: Among 150,423 patients included (mean age: 64.2 ± 10.6 years; 64.1% males), there were 9,225 (6.1%) with left main stenosis. The final logistic regression model included 24 predictors and 3 interactions, had an optimism-adjusted c-statistic of 0.72 and adequate calibration (optimism-adjusted Integrated Calibration Index 0.0044). These results were consistent in subgroups of males and females, diabetes and non-diabetes, and extent of ischemia. The boosted tree algorithm had similar accuracy, also resulting in a c-statistic of 0.72 and adequate calibration (Integrated Calibration Index 0.0054). CONCLUSIONS: In this large population-based study of patients with stable ischemic heart disease using extensive clinical data, only modest prediction of left main coronary artery disease was possible with traditional and machine learning modelling techniques.

Evaluation and management of drug-eluting stent in-stent restenosis.

PURPOSE OF REVIEW: In-stent restenosis (ISR) is the most common cause of stent failure. Although the rate of ISR is significantly lower with contemporary drug-eluting stents (DES), it remains a challenging clinical entity to treat. RECENT FINDINGS: In this review, we focus on a practical approach to management of DES ISR with intravascular imaging at its core, as supported by several recently published articles. This facilitates assessment of the underlying mechanism(s) essential to the successful treatment of ISR allowing for a tailored selection of treatment modalities. SUMMARY: The successful treatment of DES ISR requires identification of the causative mechanism(s). Individualized treatment may include high-pressure balloon angioplasty alone, cutting or scoring balloons, intravascular lithotripsy, atheroablative therapies and a selection of either repeat DES implantation or drug-coated balloon treatment.

Variation and clinical consequences of wait-times for atrial fibrillation ablation: population level study in Ontario, Canada.

AIMS: Atrial fibrillation (AF) is the most common cardiac rhythm disorder. Emerging evidence supporting the efficacy of catheter ablation in managing AF has led to increased demand for this therapy, potentially outpacing the capacity to perform this procedure. Mismatch between demand and capacity for AF ablation results in wait-times which have not been comprehensively evaluated at a population level. Additionally, the consequences of such delays in AF ablation, namely the risk of hospitalization or adverse events, have not been studied. METHODS AND RESULTS: This observational cohort study included adults referred for catheter ablation to treat AF in Ontario, Canada, between 1 April 2016 and 31 March 2020. Wait-time was defined from referral to the earliest of ablation, death, off-list, or the study endpoint of 31 March 2022. The outcomes of interest included a composite of death, hospitalization for AF/heart failure, and emergency department visit for AF/heart failure. Our study cohort included 6253 patients referred for de novo AF ablation. The median wait-time for patients who received and who did not receive ablation was 218 days (IQR: 112-363) and 520 days (IQR: 270-763), respectively. Wait-time increased consistently for patients referred between October 2017 and March 2020. Mortality was rare, but significant morbidity was observed, affecting 19.2% of patients on the waitlist for AF ablation. Paroxysmal AF was associated with a statistically significant greater risk for adverse outcomes on the waitlist (HR 1.51, 95% CI 1.18-1.93). CONCLUSION: Wait-times for AF ablation are increasing and are associated with significant morbidity.

Association Between Hospital Postoperative Troponin Use and Patient Outcomes After Vascular Surgery.

BACKGROUND: Acute myocardial injury after noncardiac surgery, which is most often symptomatically silent, is associated with increased mortality and morbidity. However, it is not known if routine postoperative troponin testing will affect patient outcomes. METHODS: We assembled a cohort of patients who underwent carotid endarterectomy or abdominal aortic aneurysm repair in Ontario, Canada, from 2010 to 2017. Hospitals were categorized into high, medium, and low troponin testing intensity based on the proportion of patients who received postoperative troponin testing. Cox proportional hazards modeling was used to assess the association between hospital-specific testing intensity and 30-day and 1-year major adverse cardiovascular events (MACEs) while adjusting for patient-, surgery-, and hospital-level factors. RESULTS: The cohort consisted of 18,467 patients from 17 hospitals. Mean age was 72 years, and 74.0% were men. Rates of postoperative troponin testing were 77.5%, 35.8%, and 21.6% in the high-, medium-, and low-testing intensity hospitals, respectively. At 30 days, 5.3%, 5.3%, and 6.5% of patients in high-, medium-, and low-testing intensity hospitals experienced MACE, respectively. Higher troponin testing rate was associated with lower adjusted hazard ratios (HRs) for MACE at 30 days (0.94; 95% confidence interval [CI], 0.89-0.98) and at 1 year (0.97; 95% CI, 0.94-0.99) for each 10% increase in hospital troponin rate. Hospitals with high-testing intensity had higher rates of postoperative cardiology referrals, cardiovascular testing, and rates of new cardiovascular prescriptions. CONCLUSIONS: Patients undergoing vascular surgery at hospitals with higher postoperative troponin testing intensity experienced fewer adverse outcomes than patients who had surgery at hospitals with lower testing intensity.

Comorbidity-stratified estimates of 30-day mortality risk by age for unvaccinated men and women with COVID-19: a population-based cohort study.

BACKGROUND: The mortality risk following COVID-19 diagnosis in men and women with common comorbidities at different ages has been difficult to communicate to the general public. The purpose of this study was to determine the age at which unvaccinated men and women with common comorbidities have a mortality risk which exceeds that of 75- and 65-year-old individuals in the general population (Phases 1b/1c thresholds of the Centre for Disease Control Vaccine Rollout Recommendations) following COVID-19 infection during the first wave. METHODS: We conducted a population-based retrospective cohort study using linked administrative datasets in Ontario, Canada. We identified all community-dwelling adults diagnosed with COVID-19 between January 1 and October 31st, 2020. Exposures of interest were age (modelled using restricted cubic splines) and the following conditions: major cardiovascular disease (recent myocardial infarction or lifetime history of heart failure); 2) diabetes; 3) hypertension; 4) recent cancer; 5) chronic obstructive pulmonary disease; 6) Stages 4/5 chronic kidney disease (CKD); 7) frailty. Logistic regression in the full cohort was used to estimate the risk of 30-day mortality for 75- and 65-year-old individuals. Analyses were repeated after stratifying by sex and medical condition to determine the age at which 30-day morality risk in strata exceed that of the general population at ages 65 and 75 years. RESULTS: We studied 52,429 individuals (median age 42 years; 52.5% women) of whom 417 (0.8%) died within 30 days. The 30-day mortality risk increased with age, male sex, and comorbidities. The 65- and 75-year-old mortality risks in the general population were exceeded at the youngest age by people with CKD, cancer, and frailty. Conversely, women aged < 65 years who had diabetes or hypertension did not have higher mortality than 65-year-olds in the general population. Most people with medical conditions (except for Stage 4-5 CKD) aged < 45 years had lower predicted mortality than the general population at age 65 years. CONCLUSION: The mortality risk in COVID-19 increases with age and comorbidity but the prognostic implications varied by sex and condition. These observations can support communication efforts and inform vaccine rollout in jurisdictions with limited vaccine supplies.

Performance of administrative database frailty instruments in predicting clinical outcomes and cost for patients undergoing transcatheter aortic valve implantation: a historical cohort study.

PURPOSE: Frailty instruments may improve prognostic estimates for patients undergoing transcatheter aortic valve implantation (TAVI). Few studies have evaluated and compared the performance of administrative database frailty instruments for patients undergoing TAVI. This study aimed to examine the performance of administrative database frailty instruments in predicting clinical outcomes and costs in patients who underwent TAVI. METHODS: We conducted a historical cohort study of 3,848 patients aged 66 yr or older who underwent a TAVI procedure in Ontario, Canada from 1 April 2012 to 31 March 2018. We used the Johns Hopkins Adjusted Clinical Group (ACG) frailty indicator and the Hospital Frailty Risk Score (HFRS) to assign frailty status. Outcomes of interest were in-hospital mortality, one-year mortality, rehospitalization, and healthcare costs. We compared the performance of the two frailty instruments with that of a reference model that adjusted baseline covariates and procedural characteristics. Accuracy measures included c-statistics, Akaike information criterion (AIC), Bayesian information criterion (BIC), integrated discrimination improvement (IDI), net reclassification index (NRI), bias, and accuracy of cost estimates. RESULTS: A total of 863 patients (22.4%) were identified as frail using the Johns Hopkins ACG frailty indicator and 865 (22.5%) were identified as frail using the HFRS. Although agreement between the frailty instruments was fair (Kappa statistic = 0.322), each instrument classified different subgroups as frail. Both the Johns Hopkins ACG frailty indicator (rate ratio [RR], 1.13; 95% confidence interval [CI], 1.06 to 1.20) and the HFRS (RR, 1.14; 95% CI, 1.07 to 1.21) were significantly associated with increased one-year costs. Compared with the reference model, both the Johns Hopkins ACG frailty indicator and HFRS significantly improved NRI for one-year mortality (Johns Hopkins ACG frailty indicator: NRI, 0.160; P < 0.001; HFRS: NRI, 0.146; P = 0.001) and rehospitalization (Johns Hopkins ACG frailty indicator: NRI, 0.201; P < 0.001; HFRS: NRI, 0.141; P = 0.001). These improvements in NRI largely resulted from classification improvement among those who did not experience the event. With one-year mortality, there was a significant improvement in IDI (IDI, 0.003; P < 0.001) with the Johns Hopkins ACG frailty indicator. This improvement in performance resulted from an increase in the mean probability of the event among those with the event. CONCLUSION: Preoperative frailty assessment may add some predictive value for TAVI outcomes. Use of administrative database frailty instruments may provide small but significant improvements in case-mix adjustment when profiling hospitals for certain outcomes.

RéSUMé: OBJECTIF: L'utilisation d'indicateur de fragilité pourrait améliorer l'évaluation pronostique des patients bénéficiant d'un remplacement valvulaire aortique par voie percutanée (procédure TAVI). Peu d'études ont évalué et comparé la performance des instruments d'évaluation de la fragilité développés à partir de données administratives chez les patients bénéficiant d'un TAVI. Nous avions pour objectif d'examiner la performance des instruments d'évaluation de la fragilité développés à partir de données administratives dans la prédiction des issues cliniques et des coûts chez les patients ayant bénéficié d'un TAVI. MéTHODE: Nous avons réalisé une étude de cohorte historique auprès de 3848 patients âgés de 66 ans ou plus qui ont bénéficié d'une procédure TAVI en Ontario, Canada, du 1er avril 2012 au 31 mars 2018. Nous avons utilisé l'indicateur de fragilité ACG (Adjusted Clinical Group) de Johns Hopkins et le score de risque de fragilité à l'hôpital (HFRS) pour définir la fragilité. Les critères d'évaluation étaient la mortalité hospitalière, la mortalité à un an, la réhospitalisation et les coûts des soins de santé. Nous avons comparé la performance des deux instruments d'évaluation de la fragilité à celle d'un modèle de référence qui ajustait les covariables de base et les caractéristiques procédurales. Les mesures d'exactitude comprenaient l'analyse statistique c, le critère d'information d'Akaike (AIC), le critère d'information bayésien (BIC), l'amélioration de la discrimination intégrée (IDI), l'indice NRI (net reclassification index), le biais et l'exactitude des estimations de coûts. RéSULTATS: Au total, 863 patients (22,4 %) ont été identifiés comme fragiles à l'aide de l'indicateur de fragilité ACG de Johns Hopkins, et 865 (22,5 %) ont été identifiés comme fragiles à l'aide du HFRS. Bien que l'agrément entre les instruments d'évaluation de la fragilité ait été acceptable (statistique de Kappa = 0,322), chaque instrument a classé des sous-groupes différents comme étant fragiles. L'indicateur de fragilité ACG de Johns Hopkins (rapport de taux [RR], 1,13; intervalle de confiance à 95 % [IC], 1,06 à 1,20) et le HFRS (RR, 1,14; IC 95 %, 1,07 à 1,21) étaient associés de façon significative à une augmentation des coûts sur un an. Par rapport au modèle de référence, l'indicateur de fragilité ACG de Johns Hopkins améliorent de façon significative le NRI pour la mortalité (l'indicateur de fragilité ACG de Johns Hopkins: NRI, 0.160; P < 0.001; HFRS: NRI, 0.146; P = 0.001) et la réhospitalisation (l'indicateur de fragilité ACG: NRI, 0.201; P < 0.001; HFRS: NRI, 0.141; P = 0.001) à un an. Ces améliorations du NRI résultent en grande partie de l'amélioration de la classification chez ceux qui n'ont pas bénéficié d'un TAVI. En ce qui a trait à la mortalité à un an, il y a eu une amélioration significative de l'IDI (IDI, 0,003; P < 0,001) avec l'indicateur de fragilité ACG de Johns Hopkins. Cette amélioration de la performance résultait d'une augmentation de la probabilité moyenne de TAVI chez les personnes ayant vécu l'événement. CONCLUSION: L'évaluation préopératoire de la fragilité peut ajouter une certaine valeur prédictive aux issues cliniques suivant une procédure de TAVI. L'utilisation d'instruments d'évaluation de la fragilité développés à partir de données administratives peut apporter des améliorations mineures mais significatives pour l'ajustement de risque lors de l'évaluation des hôpitaux en fonction de certaines issues cliniques.

Ethnicity-dependent performance of the Global Registry of Acute Coronary Events risk score for prediction of non-ST-segment elevation myocardial infarction in-hospital mortality: nationwide cohort study.

AIMS: The Global Registry of Acute Coronary Events (GRACE) score was developed to evaluate risk in patients with the acute coronary syndrome with or without ST-segment elevation. Little is known about its performance at predicting in-hospital mortality for ethnic minority patients. METHODS AND RESULTS: We identified 326 160 admissions with non-ST-segment elevation myocardial infarction (NSTEMI) in the Myocardial Infarction National Audit Project (MINAP), 2010-17, including White (n = 299 184) and ethnic minorities (excluding White minorities) (n = 26 976). We calculated the GRACE score for in-hospital mortality and assessed ethnic group baseline characteristics by low, intermediate and high risk. The performance of the GRACE risk score was estimated by discrimination [area under the receiver operating characteristic curve (AUC)] and calibration (calibration plots). Ethnic minorities presented younger and had increased prevalence of cardiometabolic risk factors in all GRACE risk groups. The GRACE risk score for White [AUC 0.87, 95% confidence interval (CI) 0.86-0.87] and ethnic minority (AUC 0.87, 95% CI 0.86-0.88) patients had good discrimination. However, whilst the GRACE risk model was well calibrated in White patients (expected to observed (E : O) in-hospital death rate ratio 0.99; slope 1.00), it overestimated risk in ethnic minority patients (E : O ratio 1.29; slope: 0.94). CONCLUSION: The GRACE risk score provided good discrimination overall for in-hospital mortality, but was not well calibrated and overestimated risk for ethnic minorities with NSTEMI.

Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations.

Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent consistency and uniform interpretability of reported results in CTO intervention. To standardize the field, we therefore assembled a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools, and techniques for CTO interventions. This article summarizes the effort and is organized into 3 sections: key elements and procedural definitions, end point definitions, and clinical trial design principles. The Chronic Total Occlusion Academic Research Consortium is a first step toward improved comparability and interpretability of study results, supplying an increasingly growing body of CTO percutaneous coronary intervention evidence.

Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.

Troponin testing after noncardiac surgery: a population-based historical cohort study on variation and factors associated with testing in Ontario.

BACKGROUND: International practice guidelines make different recommendations for postoperative troponin testing to detect perioperative myocardial infarction and myocardial injury after noncardiac surgery. To gain insights into current testing patterns, we evaluated predictors of routine troponin testing after three commonly performed major noncardiac surgeries. METHODS: We conducted a population-based historical cohort study of adults having major orthopedic, colorectal, or vascular surgery in Ontario, Canada from 1 January 2010 to 31 December 2017. We used hierarchical logistic regression modelling to assess the association of patient, surgery, and hospital factors with postoperative troponin testing, while accounting for clustering at the hospital level. We characterized hospital-level variation by the intraclass correlation coefficient (ICC), which was adjusted for various characteristics. RESULTS: The cohort included 176,454 eligible patients. Hospital-specific adjusted testing rates ranged from 0-20.1% for orthopedic surgery, 0-43.8% for colorectal surgery, and 19.6-88.0% for vascular surgery. Older age, urgent surgery status, and surgery duration were consistently associated with higher rates of testing for all three surgeries. Higher Revised Cardiac Risk Index scores were associated with higher odds of testing for orthopedic and colorectal surgery, but not for vascular surgery. Even after adjustment, the ICCs were 9.2%, 7.4%, and 24.1% for orthopedic, general, and vascular surgery, respectively. CONCLUSIONS: Troponin testing varied substantially across hospitals for selected major noncardiac surgery procedures even after accounting for differences in patient-level cardiac risk factors. Our observations lend support to a more standardized approach for troponin testing after noncardiac surgery.

RéSUMé: CONTEXTE: Les directives de pratique internationales émettent différentes recommandations en ce qui concerne les dosages postopératoires de troponines afin de détecter l'infarctus du myocarde et les lésions myocardiques périopératoires après une chirurgie non cardiaque. Pour mieux comprendre les habitudes de test actuelles, nous avons évalué les prédicteurs de dosage de troponines de routine après trois chirurgies non cardiaques majeures couramment réalisées. MéTHODE: Nous avons réalisé une étude de cohorte historique basée sur la population d'adultes bénéficiant d'une chirurgie orthopédique, colorectale ou vasculaire majeure en Ontario, au Canada, entre le 1er janvier 2010 et le 31 décembre 2017. Nous avons utilisé un modèle de régression logistique hiérarchique afin d'évaluer l'association des facteurs liés au patient, à la chirurgie et à l'hôpital avec les dosages de troponines postopératoires, tout en tenant compte des groupements au niveau hospitalier. Nous avons caractérisé la variation hospitalière par le coefficient de corrélation intraclasse (CCI), qui a été ajusté pour tenir compte de diverses caractéristiques. RéSULTATS: La cohorte comprenait 176 454 patients éligibles. Les taux de tests ajustés propres à l'hôpital variaient de 0 à 20,1 % pour les chirurgies orthopédiques, de 0 à 43,8 % pour les chirurgies colorectales et de 19,6 à 88,0 % pour les chirurgies vasculaires. Un âge plus avancé, un statut de chirurgie urgente et la durée de la chirurgie étaient systématiquement associés à des taux plus élevés de dosages pour les trois chirurgies. Des scores plus élevés sur l'Indice de risque cardiaque révisé étaient associés à des probabilités plus élevées de dosages pour les chirurgies orthopédiques et colorectales, mais pas pour les chirurgies vasculaires. Même après ajustement, les CCI étaient de 9,2 %, 7,4 % et 24,1 % pour les chirurgies orthopédiques, générales et vasculaires, respectivement. CONCLUSION: Les dosages de troponines varient considérablement d'un hôpital à l'autre pour certaines interventions chirurgicales non cardiaques majeures, même après avoir pris en compte les différences dans les facteurs de risque cardiaques liés au patient. Nos observations appuient une approche plus standardisée des dosages de troponines après une chirurgie non cardiaque.

Relationship of frailty with excess mortality during the COVID-19 pandemic: a population-level study in Ontario, Canada.

BACKGROUND: There is a paucity of the literature on the relationship between frailty and excess mortality due to the COVID-19 pandemic. METHODS: The entire community-dwelling adult population of Ontario, Canada, as of January 1st, 2018, was identified using the Cardiovascular Health in Ambulatory Care Research Team (CANHEART) cohort. Residents of long-term care facilities were excluded. Frailty was categorized through the Johns Hopkins Adjusted Clinical Groups (ACG® System) frailty indicator. Follow-up was until December 31st, 2020, with March 11th, 2020, indicating the beginning of the COVID-19 pandemic. Using multivariable Cox models with patient age as the timescale, we determined the relationship between frailty status and pandemic period on all-cause mortality. We evaluated the modifier effect of frailty using both stratified models as well as incorporating an interaction between frailty and the pandemic period. RESULTS: We identified 11,481,391 persons in our cohort, of whom 3.2% were frail based on the ACG indicator. Crude mortality increased from 0.75 to 0.87% per 100 person years from the pre- to post-pandemic period, translating to ~ 13,800 excess deaths among the community-dwelling adult population of Ontario (HR 1.11 95% CI 1.09-1.11). Frailty was associated with a statistically significant increase in all-cause mortality (HR 3.02, 95% CI 2.99-3.06). However, all-cause mortality increased similarly during the pandemic in frail (aHR 1.13, 95% CI 1.09-1.16) and non-frail (aHR 1.15, 95% CI 1.13-1.17) persons. CONCLUSION: Although frailty was associated with greater mortality, frailty did not modify the excess mortality associated with the pandemic.

Impact of Transcatheter Aortic Valve Durability on Life Expectancy in Low-Risk Patients With Severe Aortic Stenosis.

BACKGROUND: Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain. METHODS: Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years). RESULTS: Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was <0.10 between TAVR and SAVR until transcatheter valve prosthesis failure time was 70% shorter than that of surgical prostheses. At a transcatheter valve failure time <30% compared with surgical valves, SAVR was the preferred option. In younger patients, life expectancy was reduced when TAVR durability was 30%, 40%, and 50% shorter than that of surgical valves in 40-, 50-, and 60-year-old patients, respectively. CONCLUSIONS: According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

Economic Evaluation of Andexanet Versus Prothrombin Complex Concentrate for Reversal of Factor Xa-Associated Intracranial Hemorrhage.

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Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.