Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome.

PURPOSE: This study evaluated whether patient support, administered via an electronic device-based app, increased adherence to treatment and lifestyle changes in patients with acute coronary syndrome (ACS) treated with ticagrelor in routine clinical practice. METHODS: Patients (aged ≥ 18 years) with diagnosed ACS treated with ticagrelor co-administered with low-dose acetylsalicylic acid were randomized into an active group (with support tool app for medication intake reminders and motivational messages) and a control group (without support tool app), and observed for 48 weeks (ClinicalTrials.gov Identifier: NCT02615704). Patients were asked to complete the 36-item Short-Form Health Survey (SF-36) and Lifestyle Changes Questionnaire (LSQ), and were assessed for blood pressure and body mass index (BMI) at baseline (visit 1) and at the end of the study (visit 2). Medication adherence was measured using the Brilique Adherence Questionnaire (BAQ). RESULTS: Patients (N = 676) were randomized to an active (n = 342) or a control (n = 334) group. BAQ data were available for 174 patients in the active group and 174 patients in the control group. Over the 48-week period, mean (standard deviation) adherence for the active and control groups was 96.4% (13.2%) and 91.5% (23.1%), respectively (effect of app intervention, p < 0.05). There were no significant differences in blood pressure and BMI between visits. General improvements in SF-36 and LSQ scores were observed for both groups. CONCLUSION: The patient support tool app was associated with significant improvements in patient-reported treatment adherence compared with a data collection app alone in patients prescribed ticagrelor for ACS.

Serum insulin-like growth factor-1 and its binding protein-7: potential novel biomarkers for heart failure with preserved ejection fraction.

BACKGROUND: Insulin-like growth factor binding protein-7 (IGFBP-7) modulates the biological activities of insulin-like growth factor-1 (IGF-1). Previous studies demonstrated the prognostic value of IGFBP-7 and IGF-1 among patients with systolic heart failure (HF). This study aimed to evaluate the IGF1/IGFBP-7 axis in HF patients with preserved ejection fraction (HFpEF). METHODS: Serum IGF-1 and IGFBP-7 levels were measured in 300 eligible consecutive patients who underwent comprehensive cardiac assessment. Patients were categorized into 3 groups including controls with normal diastolic function (n = 55), asymptomatic left ventricular diastolic dysfunction (LVDD, n = 168) and HFpEF (n = 77). RESULTS: IGFBP-7 serum levels showed a significant graded increase from controls to LVDD to HFpEF (median 50.30 [43.1-55.3] vs. 54.40 [48.15-63.40] vs. 61.9 [51.6-69.7], respectively, P < 0.001), whereas IGF-1 levels showed a graded decline from controls to LVDD to HFpEF (120.0 [100.8-144.0] vs. 112.3 [88.8-137.1] vs. 99.5 [72.2-124.4], p < 0.001). The IGFBP-7/IGF-1 ratio increased from controls to LVDD to HFpEF (0.43 [0.33-0.56] vs. 0.48 [0.38-0.66] vs. 0.68 [0.55-0.88], p < 0.001). Patents with IGFB-7/IGF1 ratios above the median demonstrated significantly higher left atrial volume index, E/E' ratio, and NT-proBNP levels (all P ≤ 0.02). CONCLUSION: In conclusion, this hypothesis-generating pilot study suggests the IGFBP-7/IGF-1 axis correlates with diastolic function and may serve as a novel biomarker in patients with HFpEF. A rise in IGFBP-7 or the IGFBP-7/IGF-1 ratio may reflect worsening diastolic function, adverse cardiac remodeling, and metabolic derangement.

Quantitative flow ratio or angiography for the assessment of non-culprit lesions in acute coronary syndromes, a randomized trial.

BACKGROUND: Patients undergoing percutaneous coronary intervention for acute coronary syndromes often have multivessel disease (MVD). Quantitative flow ratio (QFR) is an angiography-based technology that may help quantify the functional significance of non-culprit lesions, with the advantage that measurements are possible also once the patient is discharged from the catheterization laboratory. AIM: Our two-center, randomized superiority trial aimed to test whether QFR, as compared to angiography, modifies the rate of non-culprit lesion interventions (primary functional endpoint) and improves the outcomes of patients with acute coronary syndromes and MVD (primary clinical endpoint). METHODS: In total, 202 consecutive patients (64 [56-71] years of age, 160 men) with STEMI (n = 69 (34%)), NSTEMI (n = 94 (47%)), or unstable angina (n = 39 (19%)) and MVD who had undergone successful treatment of all culprit lesions were randomized 1:1 to angiography- vs. QFR-guided delayed revascularization of 246 non-culprit stenoses (1.2/patient). RESULTS: The proportion of patients assigned to percutaneous intervention was not different between groups (angiography group: 45 (45%) vs. QFR: 56 (55%), P = 0.125; relative risk = 0.80 (0.60-1.06)). At 12 months, a primary clinical endpoint event (composite of death, nonfatal myocardial infarction, revascularization, and significant angina) occurred in 24 patients (angiography-guided) and 23 patients (QFR-guided; P = 0.637, HR = 1.16 [0.63-2.15]). None of its components was different between groups. DISCUSSION: QFR guidance based on analysis of images from the primary intervention was not associated with a difference in the rate of non-culprit lesion staged revascularization nor in the 12-month incidence of clinical events in patients with acute coronary syndromes and multivessel disease. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04808310).

Design and rationale for the "Me & My Heart" (eMocial) study: A randomized evaluation of a new smartphone-based support tool to increase therapy adherence of patients with acute coronary syndrome.

A novel smartphone-based patient support tool was developed to increase the adherence to antiplatelet therapy and lifestyle changes in patients after coronary angioplasty for acute coronary syndrome (ACS). The eMocial study (ClinicalTrials.gov Identifier: NCT02615704) investigates whether an electronic support tool will improve adherence to comedication and lifestyle changes in ACS patients. The primary hypothesis of this trial is that an electronic support tool can increase adherence to comedication (primary endpoint) thereby supporting positive lifestyle changes (secondary endpoints). Patients hospitalized with ACS (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial infarction [NSTEMI], or unstable angina pectoris) and treated with ticagrelor coadministered with low-dose acetylsalicylic acid will be randomized 1:1 to an active group receiving the patient support tool via a smartphone-based application or to a control group without the patient support tool. Patient questionnaires to evaluate lifestyle changes and quality of life will be used at baseline and at the end of the 48-week observation phase. Patients are asked to fill out questionnaires to determine their adherence, treatment attitudes, health-care utilization and risk factors on a monthly basis. The study was started in February 2016 and the completion date is scheduled for October 2019. For final analysis 664 patients are expected be available. Preliminary baseline demographics were unstable angina pectoris (13.7%), NSTEMI (49.9%), STEMI (36.4%), male gender (86.3%), and diabetes mellitus (17.6%). Our study could significantly help to understand how inadequate adherence to antiplatelet therapy in ACS patients could be improved with a smartphone-based application.

Assessment of aortic valve area combining echocardiography and magnetic resonance imaging.

BACKGROUND: Transthoracic echocardiography (TTE) is routinely used to calculate aortic valve area (AVA) by continuity equation (CE). However, accurate measurement of the left ventricular outflow tract (LVOT) can be difficult and flow acceleration in the LVOT may lead to miscalculation of the AVA. OBJECTIVE: The aim of our study was to compare AVA measurements by standard TTE, cardiac magnetic resonance imaging (MRI) and a hybrid approach combining both techniques. METHODS: AVA was calculated in 38 patients (age 73±9 years) with standard TTE, cine-MRI planimetry and a hybrid approach: Hybrid Method 1: TTE-derived LVOT measurement in the CE numerator was replaced by the MRI assessment of the LVOT and AVA was calculated: (LVOT(MRI)/*LVOT-VTI(TTE))/transaortic-VTI(TTE). Method 2: We replaced the SV in the numerator by the MRI-derived SV and calculated AVA = SV(MRI)/ transaortic-VTI(TTE). RESULTS: Mean AVA derived by TTE was 0.86 cm(2)±0.23 cm(2) and 0.83 cm(2)±0.3 cm(2) by MRI- planimetry, respectively. The mean absolute difference in AVA was 0.03 cm(2) for TTE vs. MRI planimetry. AVA calculated with method 1 and method 2 was 1.23 cm(2)±0.4 cm(2) and 0.92 cm(2)±0.32 cm(2), respectively. The mean absolute difference between TTE and method 1 and method 2 was 0.37 cm(2) and 0.06 cm(2), respectively (p<0.001). CONCLUSION: MRI-planimetry of AVA and hybrid method 2 are accurate and showed a good agreement with standard TTE measurements. Therefore, hybrid method 1 is a reasonable alternative if poor acoustic windows or LVOT flow accelerations limit the accuracy of TTE, particularly in patients at high risk for an invasive hemodynamic study.

Screening for overt diabetes by oral glucose tolerance test: stratification by fasting blood glucose and patients' age improve practicability of guidelines in cardiological routine.

BACKGROUND/OBJECTIVES: Guidelines recommend screening all patients with cardiovascular disease by oral glucose tolerance test (OGTT). Due to its time-consuming protocol, costs and overall inconvenience performance of OGTT is limited in cardiological routine. Thus, we aimed to identify easily available parameters that could help to reduce the numbers of OGTT needed. METHODS: OGTTs (n=1215) were performed in all patients without known type 2 diabetes mellitus (T2DM) that were submitted to the heart center Wuppertal with known or suspected coronary artery disease for an elective coronary angiography from January to October 2007. RESULTS: 31.4% had normal glucose tolerance; prediabetes was present in 50.7%, whereas 17.9% were newly diagnosed with T2DM. Thus, 998 OGTTs did not result in the new diagnosis of so far undiagnosed T2DM. Multiple logistic regression and receiver operated characteristic analyses demonstrated that fasting blood glucose (FBG)≥ 90 mg/dl and age ≥ 55 years were predictive for so far undiagnosed T2DM. Considering these two parameters 81.1% (=sensitivity) of so far undiagnosed T2DM patients would have been identified (specificity=63.4%) and the number of OGTTs could have been reduced from 1215 to 541. CONCLUSIONS: About 70% of patients were newly diagnosed with impaired glucose metabolism. FBG ≥ 90 mg/dl and age ≥ 55 years were predictive for so far undiagnosed T2DM and OGTTs could be reduced by 55.5%. This should alleviate the implementation of the current guidelines in daily cardiological practice.

Increased serum levels of tissue inhibitor of metalloproteinase-1 in patients with acute myocardial infarction.

It has been suggested that matrix-metalloproteinases (MMPs) and their inhibitors (tissue inhibitors of metalloproteinases (TIMPs) play a major role in the regulation of myocardial remodeling. Myocardial extracellular matrix (ECM) is highly susceptible to ischemic injury in acute myocardial infarction (AMI).We measured serum levels of TIMP-1 in the early hours of AMI to study the kinetics of these enzymes in an early ischemic phase.TIMP-1 was measured in 25 patients with AMI and 116 healthy controls. Blood samples were obtained during the first 12 hours after hospital admission. Left ventricular function (LVF) and hemodynamic data were collected during coronary intervention.TIMP-1 was significantly elevated in patients with AMI within the first hours compared to controls (P<0.05). No significant difference was observed between patients with preserved LVF and with impaired LVF. Elevated TIMP-1 levels did not correlate with increased levels of CK or CK-MB band during the first hours after AMI.Increased TIMP-1 can be detected within 12 hours in patients with AMI, suggesting early onset of remodeling. Elevation of TIMP-1 may be a surrogate marker for increased ECM-turnover. The prognostic relevance needs to be proved in long-term studies.

Avaliação da área valvar aórtica combinando ecocardiografia e ressonância magnética / Assessment of aortic valve area combining echocardiography and magnetic resonance imaging / Evaluación del área valvular aórtica combinando ecocardiografía y resonancia magnética

FUNDAMENTO: A ecocardiografia transtorácica (ETT) é rotineiramente utilizada para calcular a área da valva aórtica (AVA) pela equação de continuidade (EC). No entanto, a medida exata das vias de saída do ventrículo esquerdo (VSVE) pode ser difícil e a aceleração do fluxo no VSVE pode levar a erro de cálculo da AVA. OBJETIVO: O objetivo do nosso estudo foi comparar as medições da AVA por ETT padrão, ressonância magnética cardíaca (RM) e uma abordagem híbrida que combina as duas técnicas. MÉTODOS: A AVA foi calculada em 38 pacientes (idade 73 ± 9 anos) com a ETT padrão, planimetria cine-RM e uma abordagem híbrida: Método híbrido 1: a medição da VSVE derivada pelo ETT no numerador CE foi substituída pela avaliação de ressonância magnética da VSVE e a AVA foi calculada: (VSVE RM/*VSVE-VTI ETT)/transaórtico-VTI ETT; Método 2: Substituímos o VS no numerador pelo VS derivado pela RM e calculamos a AVA = VS RM/transaórtico-VTI ETT. RESULTADOS: Amédia de AVAobtida pela ETTfoi 0,86 cm² ± 0,23 cm² e 0,83 cm² ± 0,3 cm² pela RM-planimetria, respectivamente. A diferença média absoluta da AVA foi de 0,03 cm² para a RM versus planimetria-ressonância magnética. A AVA calculada com o método 1 e o método 2 foi de 1,23 cm² ± 0,4 cm² e 0,92cm² ± 0,32 cm², respectivamente. A diferença média absoluta entre a ETT e os métodos 1 e 2 foi de 0,37 cm² e 0,06 cm², respectivamente (p < 0,001). CONCLUSÃO: A RM-planimetria da AVA e o método híbrido 2 são precisos e demonstraram boa consistência com as medições padrão obtidas pela ETT. Portanto, o método híbrido 2 é uma alternativa razoável na eventualidade de janelas acústicas ruins ou em caso de acelerações de fluxo VSVE que limitem a precisão da ETT, particularmente em pacientes com alto risco de um estudo hemodinâmico invasivo.

BACKGROUND: Transthoracic echocardiography (TTE) is routinely used to calculate aortic valve area (AVA) by continuity equation (CE). However, accurate measurement of the left ventricular outflow tract (LVOT) can be difficult and flow acceleration in the LVOT may lead to miscalculation of the AVA. OBJECTIVE: The aim of our study was to compare AVA measurements by standard TTE, cardiac magnetic resonance imaging (MRI) and a hybrid approach combining both techniques. METHODS: AVA was calculated in 38 patients (age 73±9 years) with standard TTE, cine-MRI planimetry and a hybrid approach: Hybrid Method 1: TTE-derived LVOT measurement in the CE numerator was replaced by the MRI assessment of the LVOT and AVA was calculated: (LVOT MRI/*LVOT-VTI TTE)/transaortic-VTI TTE. Method 2: We replaced the SV in the numerator by the MRI-derived SV and calculated AVA = SV MRI/ transaortic-VTI TTE. RESULTS: Mean AVA derived by TTE was 0.86 cm²±0.23 cm² and 0.83 cm²±0.3 cm² by MRI- planimetry, respectively. The mean absolute difference in AVA was 0.03cm² for TTE vs. MRI planimetry. AVA calculated with method 1 and method 2 was 1.23 cm²±0.4cm² and 0.92cm²±0.32cm², respectively. The mean absolute difference between TTE and method 1 and method 2 was 0.37cm² and 0.06cm², respectively (p<0.001). CONCLUSION: MRI-planimetry of AVA and hybrid method 2 are accurate and showed a good agreement with standard TTE measurements. Therefore, hybrid method 1 is a reasonable alternative if poor acoustic windows or LVOT flow accelerations limit the accuracy of TTE, particularly in patients at high risk for an invasive hemodynamic study.

FUNDAMENTO: La ecocardiografía transtorácica (ETT) es habitualmente utilizada para calcular el área de la válvula aórtica (AVA) por la ecuación de continuidad (EC). Mientras tanto, la medida exacta de las vías de salida del ventrículo izquierdo (VSVI) puede ser difícil y la aceleración del flujo en el VSVI puede llevar a error de cálculo del AVA. OBJETIVO: El objetivo del nuestro estudio fue comparar las mediciones del AVA por ETT estándar, resonancia magnética cardíaca (RM) y un abordaje híbrido que combina las dos técnicas. MÉTODOS: AEI AVA fue calculada en 38 pacientes (edad 73 ± 9 años) con la ETT estándar, planimetría cine-RM y un abordaje híbrido: Método híbrido 1: la medición de la VSVI derivada por el ETT en el numerador CE fue substituida por la evaluación de resonancia magnética de la VSVI y el AVA fue calculada: (VSVI RM/*VSVI-VTI ETT)/transaórtico-VTI ETT; Método 2: Substituimos el VS en el numerador por el VS derivado por la RM y calculamos el AVA = VS RM/transaórtico-VTI ETT. RESULTADOS: La media de AVA obtenida por la ETT fue 0,86 cm² ± 0,23 cm2 y 0,83 cm² ± 0,3 cm² por la RM-planimetría, respectivamente. La diferencia media absoluta del AVA fue de 0,03 cm² para la RM versus planimetría-resonancia magnética. El AVA calculada con el método 1 y el método 2 fue de 1,23 cm² ± 0,4 cm² y 0,92cm² ± 0,32 cm², respectivamente. La diferencia media absoluta entre la ETT y los métodos 1 y 2 fue de 0,37 cm² y 0,06 cm², respectivamente (p < 0,001). CONCLUSION: La RM-planimetría del AVA y el método híbrido 2 son precisos y demostraron buena consistencia con las mediciones estándar obtenidas por la ETT. Por lo tanto, el método híbrido 2 es una alternativa razonable en la eventualidad de ventanas acústicas malas o en caso de aceleraciones de flujo VSVI que limiten la precisión de la ETT, particularmente en pacientes con alto riesgo de un estudio hemodinámico invasivo.