Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry).

Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.

Impact of Baseline Atrial Fibrillation on Outcomes Among Women Who Underwent Contemporary Transcatheter Aortic Valve Implantation (from the Win-TAVI Registry).

Pre-existing atrial fibrillation (AF) is common among patients who underwent transcatheter aortic valve implantation (TAVI) and has been associated with adverse outcomes. The specific impact of AF at baseline in women who underwent TAVI, however, remains unknown. The Women's International Transcatheter Aortic Valve Implantation is a prospective, multinational registry evaluating the safety and performance of contemporary TAVI in women in 19 centers between January 2013 and December 2015. Patients with available electrocardiogram at baseline were compared according to the presence of AF. All events were adjudicated according to the Valve Academic Research Consortium 2 criteria. Associations between AF and outcomes were tested using multivariate Cox regression model. Of the 993 women with available baseline electrocardiogram included in the study, 200 (20.1%) presented with AF. Patients with AF at baseline had higher Euroscore I score values and more frequently had chronic kidney disease or prior stroke. Patients without AF more frequently had coronary artery disease. There was no difference regarding in-hospital events between the two groups aside from longer length of stay for patients with AF (13.3 ± 11 vs 11.5 ± 7.1 days, p = 0.01). In multivariate analysis, AF at baseline was associated with an increase of all-cause and cardiovascular death at 12 months (adjHR 1.67 95%CI 1.11 to 2.50, p = 0.013 and adjHR 1.85 95%CI 1.19 to 2.86, p = 0.006 respectively). In conclusion, in this prospective registry of women who underwent contemporary TAVI, the presence of AF at baseline was associated with significantly increased 12-month mortality.

1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry.

OBJECTIVES: This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes. BACKGROUND: Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods. RESULTS: A total of 1,019 intermediate to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 ± 11.7% and mean Society of Thoracic Surgeons score 8.3 ± 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.027) were independent predictors of the VARC-2 efficacy endpoint. Similarly, EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.013), baseline atrial fibrillation (HR: 1.58; 95% CI: 1.07 to 2.33; p = 0.022), and prior percutaneous coronary intervention (HR: 1.50; 95% CI: 1.03 to 2.19; p = 0.035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes. CONCLUSIONS: Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke.

Multi-Biomarker Profiling and Recurrent Hospitalizations in Heart Failure.

BACKGROUND: Despite advances in pharmacologic therapy and devices, patients with heart failure (HF) continue to have significant rehospitalization rates and risk prediction remains challenging. We sought to explore the value of a multi-biomarker panel [including NT-proBNP, high-sensitivity cardiac troponin T (hs-TnT), and ST2] on top of clinical assessment for long-term prediction of recurrent hospitalizations in HF. METHODS AND RESULTS: NT-proBNP, hs-TnT, and ST2 (suppression of tumorigenicity-2) levels were measured in 891 consecutive ambulatory HF patients. The independent association between the multi-biomarker panel and recurrent hospitalizations was assessed through a multivariable negative binomial regression and expressed as incidence rates ratios. McFadden pseudo-R2 and goodness-of-fit measures were also used. The total number of unplanned hospitalizations [all-cause, cardiovascular (CV)-, and HF-related] were selected as the primary endpoints. At a mean follow-up of 4.2 ± 2.1 years, 1623 all-cause hospitalizations in 498 patients (55.9%), 710 CV-related hospitalizations in 331 patients (37.2%), and 444 HF-related hospitalizations in 214 patients (24.1%) were registered. The crude incidence of all-cause, CV-, and HF-related recurrent hospitalizations was significantly higher for patients with the multi-biomarker panel above the cut-point (hs-TnT > 14 ng/L, NT-proBNP > 1000 ng/L, and ST2 > 35 ng/mL) (all P < 0.001). For all-cause, CV-, and HF-related recurrent hospitalizations, the McFadden R2, Akaike information criterion, and Bayesian information criterion supported the superiority of incorporating the multi-biomarker panel into a clinical predictive model. CONCLUSION: A multi-biomarker approach based on NT-proBNP, hs-TnT, and ST2 better identifies HF patients at risk for recurrent hospitalizations as compared to approaches entailing just one or two of these biomarkers. Elucidation of new biophysiological predictors for recurrent hospitalizations may identify patient profiles for focused intervention.

Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry.

OBJECTIVES: The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. BACKGROUND: Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). RESULTS: Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62; 95% CI: 1.07 to 6.40), new device generation (OR: 0.59; 95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95% CI: 0.37 to 0.85). CONCLUSIONS: Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.

Evaluación de los cambios dinámicos de las placas coronarias y sus consecuencias clínicas en pacientes con diabetes mellitus tipo 2: un estudio de ecografía intracoronaria seriada / Assessment of dynamic coronary plaque changes and the clinical consequences in type-II diabetic patients: a serial intracoronary ultrasound study

Introducción y objetivos. Uno de los objetivos de la prevención secundaria es conseguir la estabilización de la placa. En este estudio se investigaron las consecuencias clínicas y los factores predictivos del cambio en el tipo de placa (CTP) mediante ecografía intracoronaria seriada en pacientes con diabetes mellitus tipo 2 y enfermedad coronaria conocida. Métodos. Se estudiaron 237 segmentos (45 pacientes) de los ensayos DIABETES I, II y III. La ecografía intracoronaria se realizó con retirada motorizada (0,5mm/s) tras la intervención inicial y en un seguimiento angiográfico llevado a cabo a los 9 meses en el mismo segmento coronario. Se incluyeron las lesiones leves no tratadas (estenosis angiográfica < 25%) con grosor de la placa >= 0,5 mm y longitud >= 5 mm evaluadas mediante ecografía intracoronaria. Dado que puede haber diferentes tipos de placas en distintos lugares de una determinada lesión coronaria, cada lesión evaluada se dividió en tres segmentos para los análisis seriados cuantitativos y cualitativos. Se aplicó un ajuste estadístico por múltiples segmentos por lesión por paciente (método de ecuaciones de estimación generalizada). Se definió como CTP cualquier cambio cualitativo del tipo de placa observado en el seguimiento. En el seguimiento realizado a 1 año, se registraron los eventos adversos cardiacos mayores (muerte, infarto de miocardio y revascularización del vaso diana). Resultados. Se observó un CTP en 48 lesiones (20,2%) y su aparición fue más frecuente (52,1%) en las placas mixtas. Los factores predictivos independientes del CTP fueron las cifras de glucohemoglobina (odds ratio [OR]=1,2; intervalo de confianza [IC] del 95%, 1,01-1,5; p=0,04); los inhibidores de la glucoproteína IIb/IIIa (OR=0,3; IC del 95%, 0,1-0,7; p=0,004) y la administración de estatinas (OR=0,3; IC del 95%, 0,1-0,8; p=0,02). En el seguimiento realizado a 1 año, el CTP se asoció a un aumento de la tasa de eventos adversos cardiacos mayores (CTP, 20,8% frente a ausencia de CTP, 13,8%; p=0,008; hazard ratio=1,9; IC del 95%, 1,3-1,9; p=0,01). Conclusiones. Los cambios cualitativos en las estenosis leves documentados mediante ecografía intracoronaria en los pacientes con diabetes mellitus tipo 2 se asocian a una prevención secundaria subóptima y pueden tener consecuencias clínicas (AU)

Introduction and objectives. One of the aims of secondary prevention is to achieve plaque stabilization. This study sought to investigate the clinical consequences and predictive factors of the change in the type of plaque (CTP) as assessed by serial intracoronary ultrasound in type II diabetic patients with known coronary artery disease. Methods. 237 segments (45 patients) from the DIABETES I, II, and III trials were included. Intracoronary ultrasound from motorized pullbacks (0.5mm/s) after index procedure and at 9-month angiographic follow-up was performed in the same coronary segment. Nontreated mild lesions (angiographic stenosis<25%) with >=0.5mm plaque thickening and >=5mm of length assessed by intracoronary ultrasound were included. As different types of plaques may be encountered throughout a given coronary lesion, each study lesion was divided into 3 segments for serial quantitative and qualitative analyses. Statistical adjustment by multiple lesion segments per patient (generalized estimating equations method) was performed. A CTP was defined as any qualitative change in plaque type at follow-up. At 1-year follow-up, major adverse cardiac events – death, myocardial infarction and target vessel revascularization) – were recorded. Results. A CTP was observed in 48 lesions (20.2%) and occurred more frequently (52.1%) in mixed plaques. Independent predictors of CTP were glycated hemoglobin levels (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.01-1.5; P=.04); glycoprotein IIb-IIIa inhibitors (OR 0.3; 95% CI 0.1-0.7; P=.004) and statin administration (OR 0.3; 95% CI 0.1-0.8; P=.02). At 1-year follow-up CTP was associated with an increase in major adverse cardiac events rate (CTP 20.8% vs non-CTP 13.8%, P=.008; hazard ratio=1.9, 95% CI 1.3-1.9, P=.01). Conclusions. Qualitative changes in mild stenosis documented by intracoronary ultrasound in type II diabetics are associated with suboptimal secondary prevention and may have clinical consequences (AU)

[Assessment of dynamic coronary plaque changes and the clinical consequences in type-II diabetic patients: a serial intracoronary ultrasound study]. / Evaluación de los cambios dinámicos de las placas coronarias y sus consecuencias clínicas en pacientes con diabetes mellitus tipo 2: un estudio de ecografía intracoronaria seriada.

INTRODUCTION AND OBJECTIVES: One of the aims of secondary prevention is to achieve plaque stabilization. This study sought to investigate the clinical consequences and predictive factors of the change in the type of plaque (CTP) as assessed by serial intracoronary ultrasound in type II diabetic patients with known coronary artery disease. METHODS: 237 segments (45 patients) from the DIABETES I, II, and III trials were included. Intracoronary ultrasound from motorized pullbacks (0.5mm/s) after index procedure and at 9-month angiographic follow-up was performed in the same coronary segment. Nontreated mild lesions (angiographic stenosis <25%) with ≥0.5mm plaque thickening and ≥5mm of length assessed by intracoronary ultrasound were included. As different types of plaques may be encountered throughout a given coronary lesion, each study lesion was divided into 3 segments for serial quantitative and qualitative analyses. Statistical adjustment by multiple lesion segments per patient (generalized estimating equations method) was performed. A CTP was defined as any qualitative change in plaque type at follow-up. At 1-year follow-up, major adverse cardiac events - death, myocardial infarction and target vessel revascularization) - were recorded. RESULTS: A CTP was observed in 48 lesions (20.2%) and occurred more frequently (52.1%) in mixed plaques. Independent predictors of CTP were glycated hemoglobin levels (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.01-1.5; P=.04); glycoprotein IIb-IIIa inhibitors (OR 0.3; 95% CI 0.1-0.7; P=.004) and statin administration (OR 0.3; 95% CI 0.1-0.8; P=.02). At 1-year follow-up CTP was associated with an increase in major adverse cardiac events rate (CTP 20.8% vs non-CTP 13.8%, P=.008; hazard ratio=1.9, 95% CI 1.3-1.9, P=.01). CONCLUSIONS: Qualitative changes in mild stenosis documented by intracoronary ultrasound in type II diabetics are associated with suboptimal secondary prevention and may have clinical consequences. Full English text available from: www.revespcardiol.org.

Diastolic dysfunction in diabetic patients assessed with Doppler echocardiography: relationship with coronary atherosclerotic burden and microcirculatory impairment.

INTRODUCTION AND OBJECTIVES: Diabetes mellitus (DM) is associated with the development of both impaired left ventricular diastolic function (LVDF) and pathological changes in the coronary macro- and microcirculation. The aim of this study was to investigate the relationship between these manifestations of diabetic heart disease. METHODS: The severity of atherosclerosis in the left anterior descending coronary artery (LAD) was quantified using intravascular ultrasound (IVUS) in 13 patients with DM and ischemic heart disease. The coronary flow velocity reserve (CFVR), instantaneous hyperemic diastolic velocity pressure slope index (IHDVPS) and zero-flow pressure were derived from digital intracoronary pressure and flow velocity measurements. The relationships between indices of LVDF (i.e. E/A and E/e' ratios) and intracoronary measurements were assessed. RESULTS: The left ventricular ejection fraction was 66+/-7%, and the LVDF indices were: E/A=0.92+/-0.38 and E/e'=9.90+/-2.80. There was a direct proportional relationship (r=0.62; P=.02) between E/e' and coronary resistance (1.93+/-0.74 mmHg/s) and an inverse proportional relationship (r=-0.64; P=.02) between E/e' and IHDVPS (1.56+/-0.50 cm/s/mmHg). However, no significant relationship was found between either LVDF index and CFVR (2.43+/-0.56) or coronary zero-flow pressure (40.41+/-10.66 mmHg). The volume of atheroma in the proximal 20 mm of the LAD (179.34+/-57.48 .l, with an average plaque area of 8.39+/-2.20 mm2) was not related to either LVDF index. CONCLUSIONS: In patients with DM and coronary atherosclerosis, there appeared to be a relationship between LVDF impairment (assessed by the E/e' ratio) and structural changes in the microcirculation.