Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large ...unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce.
Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%). The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19).
The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.
Abstract Objectives The aim of this study was to verify the hypothesis that multidetector computed tomography (MDCT) is superior to echocardiography for measuring the left ventricular outflow tract ...(LVOT) and calculating the aortic valve area (AVA) with regard to hemodynamic correlations and survival outcome prediction after a diagnosis of aortic stenosis (AS). Background MDCT demonstrated that the LVOT is noncircular, casting doubt on the AVA measurement by 2-dimensional (2D) echocardiography. Methods A total of 269 patients (76 ± 11 years of age, 61% men) with isolated calcific AS (mean gradient 44 ± 18 mm Hg; ejection fraction 58 ± 15%) underwent Doppler echocardiography and MDCT within the same episode of care. AVA was calculated by echocardiography (AVAEcho ) and by MDCT (AVACT ) using each technique measurement of LVOT area. In the subset of patients undergoing dynamic 4-dimensional MDCT (n = 135), AVA was calculated with the LVOT measured at 70% and 20% of the R-R interval and measured by planimetry (AVAPlani ). Results Phasic measurements of the LVOT by MDCT yielded slight differences in eccentricity and size (all p < 0.001) but with excellent AVA correlation (r = 0.92, p < 0.0001) and minimal bias (0.05 cm2 ), whereas the AVAPlani showed poor correlations with all other methods (all r values <0.58). AVACT was larger than AVAEcho (difference 0.12 ± 0.16 cm2 ; p < 0.0001) but did not improve outcome prediction. Correlation gradient-AVA was slightly better with AVAEcho than AVACT (r = −0.65 with AVAEcho vs. −0.61 with AVACT ; p = 0.01), and discordant gradient-AVA was not reduced. For long-term survival, after multivariable adjustment, AVAEcho or AVACT were independently predictive (hazard ratio HR: 1.26, 95% confidence interval CI: 1.13 to 1.42; p < 0.0001 or HR: 1.18, 95% CI: 1.09 to 1.29 per 0.10 cm2 decrease; p < 0.0001) with a similar prognostic value (p ≥ 0.80). Thresholds for excess mortality differed between methods: AVAEcho ≤1.0 cm2 (HR: 4.67, 95% CI: 2.22 to 10.50; p < 0.0001) versus AVACT ≤1.2 cm2 (HR: 3.16, 95% CI: 1.64 to 6.43; p = 0.005), with simple translation of spline-curve analysis. Conclusions Head-to-head comparison of MDCT and Doppler echocardiography refutes the hypothesis of MDCT superiority for AVA calculation. AVACT is larger than AVAEcho but does not improve the correlation with transvalvular gradient, the concordance gradient-AVA, or mortality prediction compared with AVAEcho . Larger cut-point values should be used for severe AS if AVACT (<1.2 cm2 ) is measured versus AVAEcho (<1.0 cm2 ).
Aims
More evidence is needed to quantify the association between tricuspid regurgitation (TR) and mortality in patients with heart failure (HF).
Methods and results
Between 2008–2017, using the Optum ...longitudinal database, a patient‐level database that integrates multiple US‐based electronic health and claim records from several health care providers, we identified 435 679 patients with new HF diagnosis and both an assessment of the left ventricular ejection fraction and at least 1 year of history. TR was graded as mild, moderate or severe and classified as prevalent (at the time of the initial HF diagnosis) or incident (subsequent new cases thereafter). For prevalent TR, the analysis was performed using a Cox proportional hazards model with adjustment for patient covariates. Incident TR was modelled as a time‐updated covariate, as were other non‐fatal events during follow‐up. Prevalence of mild, moderate and severe TR at baseline was 10.1%, 5.1% and 1.4%, respectively. Over a median follow‐up of 1.5 years, 121 273 patients (27.8%) died and prevalent TR was independently associated with survival. Compared to patients with no TR at baseline, the adjusted hazard ratios for mortality were 0.99 95% confidence interval (CI) 0.97–1.01, 1.17 (95% CI 1.14–1.20) and 1.34 (95% CI 1.28–1.39) for mild, moderate and severe TR, respectively. In the 363 270 patients free from TR at baseline, incident TR (at least mild, at least moderate, or severe) developed during follow‐up in 12.1%, 5.1% and 1.1%, respectively. Adjusted mortality hazard ratios for such new cases were 1.48 (95% CI 1.44–1.52), 1.92 (95% CI 1.86–1.99) and 2.44 (95% CI 2.32–2.57), respectively. Findings were consistent across all patient subgroups based on age, gender, rhythm, associated comorbidities, prior cardiac surgery, B‐type natriuretic peptide/N‐terminal pro‐B‐type natriuretic peptide, and left ventricular ejection fraction.
Conclusions
In this large contemporary patient‐level database of almost half‐million US patients with HF, TR was associated with a marked increases in mortality risk overall and in all subgroups. Future randomized controlled trials will evaluate the impact of TR correction on clinical outcomes and the causal relationship between TR and mortality.
Computed tomography aortic valve calcium scoring (CT-AVC) holds promise for the assessment of patients with aortic stenosis (AS). We sought to establish the clinical utility of CT-AVC in an ...international multicenter cohort of patients.
Patients with AS who underwent ECG-gated CT-AVC within 3 months of echocardiography were entered into an international, multicenter, observational registry. Optimal CT-AVC thresholds for diagnosing severe AS were determined in patients with concordant echocardiographic assessments, before being used to arbitrate disease severity in those with discordant measurements. In patients with long-term follow-up, we assessed whether CT-AVC thresholds predicted aortic valve replacement and death. In 918 patients from 8 centers (age, 77±10 years; 60% men; peak velocity, 3.88±0.90 m/s), 708 (77%) patients had concordant echocardiographic assessments, in whom CT-AVC provided excellent discrimination for severe AS (C statistic: women 0.92, men 0.89). Our optimal sex-specific CT-AVC thresholds (women 1377 Agatston unit and men 2062 Agatston unit) were nearly identical to those previously reported (women 1274 Agatston unit and men 2065 Agatston unit). Clinical outcomes were available in 215 patients (follow-up 1029 126-2251 days). Sex-specific CT-AVC thresholds independently predicted aortic valve replacement and death (hazard ratio, 3.90 95% confidence interval, 2.19-6.78;
<0.001) after adjustment for age, sex, peak velocity, and aortic valve area. Among 210 (23%) patients with discordant echocardiographic assessments, there was considerable heterogeneity in CT-AVC scores, which again were an independent predictor of clinical outcomes (hazard ratio, 3.67 95% confidence interval, 1.39-9.73;
=0.010).
Sex-specific CT-AVC thresholds accurately identify severe AS and provide powerful prognostic information. These findings support their integration into routine clinical practice.
URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01358513, NCT02132026, NCT00338676, NCT00647088, NCT01679431.
Abstract Background Aortic valve calcification (AVC) load measures lesion severity in aortic stenosis (AS) and is useful for diagnostic purposes. Whether AVC predicts survival after diagnosis, ...independent of clinical and Doppler echocardiographic AS characteristics, has not been studied. Objectives This study evaluated the impact of AVC load, absolute and relative to aortic annulus size (AVCdensity ), on overall mortality in patients with AS under conservative treatment and without regard to treatment. Methods In 3 academic centers, we enrolled 794 patients (mean age, 73 ± 12 years; 274 women) diagnosed with AS by Doppler echocardiography who underwent multidetector computed tomography (MDCT) within the same episode of care. Absolute AVC load and AVCdensity (ratio of absolute AVC to cross-sectional area of aortic annulus) were measured, and severe AVC was separately defined in men and women. Results During follow-up, there were 440 aortic valve implantations (AVIs) and 194 deaths (115 under medical treatment). Univariate analysis showed strong association of absolute AVC and AVCdensity with survival (both, p < 0.0001) with a spline curve analysis pattern of threshold and plateau of risk. After adjustment for age, sex, coronary artery disease, diabetes, symptoms, AS severity on hemodynamic assessment, and LV ejection fraction, severe absolute AVC (adjusted hazard ratio HR: 1.75; 95% confidence interval CI: 1.04 to 2.92; p = 0.03) or severe AVCdensity (adjusted HR: 2.44; 95% CI: 1.37 to 4.37; p = 0.002) independently predicted mortality under medical treatment, with additive model predictive value (all, p ≤ 0.04) and a net reclassification index of 12.5% (p = 0.04). Severe absolute AVC (adjusted HR: 1.71; 95% CI: 1.12 to 2.62; p = 0.01) and severe AVCdensity (adjusted HR: 2.22; 95% CI: 1.40 to 3.52; p = 0.001) also independently predicted overall mortality, even with adjustment for time-dependent AVI. Conclusions This large-scale, multicenter outcomes study of quantitative Doppler echocardiographic and MDCT assessment of AS shows that measuring AVC load provides incremental prognostic value for survival beyond clinical and Doppler echocardiographic assessment. Severe AVC independently predicts excess mortality after AS diagnosis, which is greatly alleviated by AVI. Thus, measurement of AVC by MDCT should be considered for not only diagnostic but also risk-stratification purposes in patients with AS.
Left atrial enlargement is frequent in degenerative mitral regurgitation (DMR), but its link to outcomes remains unproven in routine clinical practice.
The purpose of this study was to assess whether ...left atrial volume index (LAVI) measured in routine clinical practice of multiple sonographers/cardiologists is associated independently with DMR survival.
A cohort of 5,769 (63 ± 16 years, 47% women) consecutive patients with degenerative mitral valve disease, in whom LAVI was prospectively measured, was enrolled and the long-term survival was analyzed.
LAVI (43 ± 24 ml/m2) was widely distributed (<40 ml/m2 in 3,154 patients, 40 to 59 ml/m2 in 1,606, and ≥60 ml/m2 in 1,009). Overall survival throughout follow-up (10-year 66 ± 1%) was strongly associated with LAVI (79 ± 1% vs. 65 ± 2% and 54 ± 2% for LAVI <40, 40 to 59, and ≥60 ml/m2, respectively; p < 0.0001) even after comprehensive adjustment, including for DMR severity (adjusted hazard ratio HR: 1.05 95% confidence interval (CI): 1.03 to 1.08 per 10 ml/m2; p < 0.0001). Mortality under medical management was profoundly affected by LAVI (adjusted HR: 1.07 95% CI: 1.04 to 1.10 per 10 ml/mm2 and 1.55 95% CI: 1.31 to 1.84 for LAVI ≥60 ml/m2 vs. <40 ml/m2; both p < 0.0001) incrementally to adjusting variables (p < 0.0001) and in all subgroups, particularly sinus rhythm (adjusted HR: 1.25 95% CI: 1.21 to 1.28) or atrial fibrillation (adjusted HR: 1.10 95% CI: 1.06 to 1.13 per 10 ml/m2; both p < 0.0001). Thresholds of excess mortality in spline curve analysis were approximated at 40 ml/m2 in all subgroups. Survival markedly improved after mitral surgery (time-dependent adjusted HR: 0.43 95% CI: 0.36 to 0.53; p < 0.0001) but remained modestly linked to LAVI (10-year survival 85 ± 3% vs. 86 ± 2% and 75 ± 3% for LAVI <40, 40 to 59, and ≥60 ml/m2, respectively; p < 0.0001).
The frequent left atrial enlargement of DMR as measured by LAVI in routine practice displays, overall and in all subsets, a powerful, incremental, and independent link to excess mortality, which is partially alleviated by mitral surgery. Hence, LAVI measurement should be part of routine DMR evaluation and the clinical decision-making process.
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Objectives The purpose of this paper was to assess the link between left atrial (LA) volume at diagnosis and outcome of patients with mitral regurgitation (MR). Background Left atrial enlargement is ...a consequence of organic MR, but its association with clinical outcome independently of MR severity is uncertain. Methods We prospectively enrolled 492 patients (age 63 ± 15 years, 60% men) in sinus rhythm with organic MR (regurgitant volume 68 ± 42 ml/beat) and performed at baseline triple echocardiographic quantitation (MR severity, LA volume, and left ventricular characteristics). Outcome with medical and surgical management was analyzed. Results Left atrial volume indexed to body surface area (LA index) was 55 ± 26 ml/m2 (<40 ml/m2 in 158 patients, 40 to 59 ml/m2 in 160 patients, and ≥60 ml/m2 in 174 patients). Under medical management, 5-year survival was 80 ± 2.9% and cardiac events 28 ± 3%. Adjusting for established predictors of outcome, LA index was independently associated with survival after diagnosis (hazard ratio HR: 1.3 95% confidence interval (CI): 1.1 to 1.5 per 10 ml/m2 increment, p = 0.001). Patients with LA index ≥60 ml/m2 had lower 5-year survival than those with no or mild LA enlargement (p < 0.0001) and than the rates of survival expected in the U.S. population (53 ± 8.6% vs. 76%, p = 0.017). Compared with patients with LA index <40 ml/m2 , those with LA index ≥60 ml/m2 had increased mortality (HR: 2.8 95% CI: 1.2 to 6.5, p = 0.016) and cardiac events (HR: 5.2 95% CI: 2.6 to 10.9, p < 0.0001) with medical management. Mitral surgery was associated with decreased mortality (HR: 0.46 95% CI: 0.26 to 0.84, p = 0.01) and cardiac events (HR: 0.38 95% CI: 0.23 to 0.62, p = 0.0001) and after surgery patients with LA index ≥60 ml/m2 versus <60 ml/m2 did not incur excess mortality or cardiac events (both p > 0.30). Conclusions In organic MR, LA index at diagnosis predicts long-term outcome, incrementally to known predictors of outcome. This marker of risk is particularly important because mitral surgery in these patients markedly improves outcome and restores life expectancy. LA index should be measured in routine clinical practice for risk-stratification and for clinical decision making in patients with organic MR.
Purpose
The effect of chronic use of low‐dose aspirin (LDA) on overall cancer is still unclear owing to many controversial results and methodological limitations of studies. This study aimed to ...assess the effect of LDA use on overall cancer incidence among the French population.
Methods
We conducted a 10‐year historical cohort study using the permanent sample of the French national health care databases: the Système National des Données de Santé (SNDS). We used data for 111 025 individuals aged 50 to 80 years at study entry (January 1, 2006) without prevalent cancer or LDA use. Individuals were followed until the earliest of cancer incidence, death from any cause, exit from the database, or end of the study on December 31, 2015. We estimated the effect of LDA on cancer incidence by using a dynamic model to account for the competing risk of death in the presence of time‐dependent exposure and risk factors.
Results
LDA use was associated with reduced 10‐year risk of cancer (subdistribution hazard ratio SHR 0.81 95% CI 0.77‐0.86). The SHRs were 0.88 0.82‐0.94 for men and 0.93 0.85‐1.02 for women. Moreover, each additional year of LDA use was associated with reduced 10‐year risk of cancer (SHR 0.93 0.92‐0.95). LDA use was also associated with reduced 10‐year risk of death (SHR 0.86 0.82‐0.91).
Conclusions
This is the first population‐based study to demonstrate a protective effect of LDA on overall cancer incidence and to account for the main methodological issues of previous observational studies.
Abstract
Aims
The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of ...consecutive patients who underwent the Cardioband procedure between 2013 and 2016.
Methods and results
Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guideline-recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year but worsened by at least one grade in 11 patients (22%). Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (−19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01).
Conclusion
In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.
Abstract
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