A Reproducible and Standardised Clinical Registry for Clinical and Economic Outcomes of Heart Transplantation Patients

This study describes the creation and implementation of a prospective, reproducible and standardised clinical registry of outpatients who underwent heart transplantation.  Methods and Results: The following steps were carried out: i) data were standardised in accordance with national and international standard data elements, ii) an initial data collection and clinical research workflow was developed, iii) electronic case reports were developed in accordance with the HIPAA privacy rule using REDCap, iv) pilot testing and validation of the data collection, clinical research workflows and case report forms was undertaken, and v) an automated data quality report was developed using REDCap. All patients undergoing heart transplantation in a reference cardiology hospital were included. Patients were excluded if they did not agree to participate in the study. The registry was designed to become multicentre in the future. Data were collected from the moment of the inclusion (hospital admission), at hospital discharge, and 1, 3 and 6 months and yearly after surgery. Clinical and cost-related outcomes included all-causes mortality, cardiovascular mortality, non-fatal myocardial infarction, stroke, hospital admissions, visits to the emergency department, organ rejection, infection, need for re-operation, any adverse event, costs related to treatment and procedures, and quality of life.   Conclusions: This registry represents a powerful tool for assisting quality improvement, healthcare services management, technology assessment, health policies and clinical research since it contains comprehensive and representative data of the clinical practice and allows for interoperability and data integration with other datasets

The Re-Heart Registry: A Prospective, Interoperable, Standardised Clinical Registry of Outpatients With Heart Failure

Purpose: To describe the creation and implementation of the RE-Heart Registry, a prospective, interoperable, highly scalable and standardised clinical registry of outpatients with heart failure (HF). Methods and Results: We carried out the steps, as follows: (1) data standardisation in accordance with national and international data elements. Dataset included all applicable standardised data elements published by the American Heart Association (AHA), American College of Cardiology (ACC) with the National Cardiovascular Data Registry (NCDR)and the Brazilian Cardiovascular Registries, as a reference the BREATHE (I Brazilian Registry of Heart Failure) and PINNACLE (heart failure and atrial fibrillation); (2) development of an initial data collection and clinical research workflow; (3) development of electronic case reports using REDCap and in accordance with the HIPAA privacy rule; (4) pilot test and validation of the data collection and clinical research workflows and CRFs; (5) development of automated data quality reporting using REDCap. Data collection occurs at the outpatient department at the moment of inclusion and every 6 months (phone calls and visits to the outpatients department). Conclusions: The RE-Heart Registry represents a comprehensive database capable to represent real clinical practice favouring clinical research, technology assessment, services management and health policies

The five-point Likert scale for dyspnea can properly assess the degree of pulmonary congestion and predict adverse events in heart failure outpatients

OBJECTIVES: Proper assessment of dyspnea is important in patients with heart failure. Our aim was to evaluate the use of the 5-point Likert scale for dyspnea to assess the degree of pulmonary congestion and to determine the prognostic value of this scale for predicting adverse events in heart failure outpatients. METHODS: We undertook a prospective study of outpatients with moderate to severe heart failure. The 5-point Likert scale was applied during regular outpatient visits, along with clinical assessments. Lung ultrasound with ≥15 B-lines and an amino-terminal portion of pro-B-type natriuretic peptide (NT-proBNP) level >;1000 pg/mL were used as a reference for pulmonary congestion. The patients were then assessed every 30 days during follow-up to identify adverse clinical outcomes. RESULTS: We included 58 patients (65.5% male, age 43.5±11 years) with a mean left ventricular ejection fraction of 27±6%. In total, 29.3% of these patients had heart failure with ischemic etiology. Additionally, pulmonary congestion, as diagnosed by lung ultrasound, was present in 58% of patients. A higher degree of dyspnea (3 or 4 points on the 5-point Likert scale) was significantly correlated with a higher number of B-lines (p = 0.016). Patients stratified into Likert = 3-4 were at increased risk of admission compared with those in class 1-2 after adjusting for age, left ventricular ejection fraction, New York Heart Association functional class and levels of NT-proBNP >;1000 pg/mL (HR = 4.9, 95% CI 1.33-18.64, p = 0.017). CONCLUSION: In our series, higher baseline scores on the 5-point Likert scale were related to pulmonary congestion and were independently associated with adverse events during follow-up. This simple clinical tool can help to identify patients who are more likely to decompensate and whose treatment should be intensified

Lung Ultrasound for the Evaluation of Pulmonary Congestion in Outpatients

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Association between serum lactate levels and mortality in patients with cardiogenic shock receiving mechanical circulatory support : a multicenter retrospective cohort study

Background: To evaluate the prognostic value of peak serum lactate and lactate clearance at several time points in cardiogenic shock treated with temporary mechanical circulatory support (MCS) using veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella CP®. Methods: Serum lactate and clearance were measured before MCS and at 1 h, 6 h, 12 h, and 24 h post-MCS in 43 patients at four tertiary-care centers in Southern Brazil. Prognostic value was assessed by univariable and multivariable analysis and receiver operating characteristic (ROC) curves for 30-day mortality. Results: VA-ECMO was the most common MCS modality (58%). Serum lactate levels at all time points and lactate clearance after 6 h were associated with mortality on unadjusted and adjusted analyses. Lactate levels were higher in non-survivors at 6 h, 12 h, and 24 h after MCS. Serum lactate >1.55 mmol/L at 24 h was the best single prognostic marker of 30-day mortality [area under the ROC curve=0.81 (0.67–0.94); positive predictive value=86%). Failure to improve serum lactate after 24 h was associated with 100% mortality. Conclusions: Serum lactate was an important prognostic biomarker in cardiogenic shock treated with temporary MCS. Serum lactate and lactate clearance at 24 h were the strongest independent predictors of short-term survival

Pulmonary congestion evaluated by lung ultrasound predicts decompensation in heart failure outpatients

BACKGROUND: Pulmonary congestion is the main cause of hospital admission among heart failure (HF) patients. Lung ultrasound (LUS) assessment of B-lines has been recently proposed as a reliable and easy tool for evaluating pulmonary congestion. OBJECTIVE: To determine the prognostic value of LUS in predicting adverse events in HF outpatients. METHODS: Single-center prospective cohort of 97 moderate-to-severe systolic HF patients (53\ub113years; 61% males) consecutively enrolled between November 2011 and October 2012. LUS evaluation was performed during the regular outpatient visit to evaluate the presence of pulmonary congestion, determined by B-lines number. Patients were followed up for 4months to assess admission due to acute pulmonary edema. RESULTS: During follow-up period (106\ub112days), 21 hospitalizations for acute pulmonary edema occurred. At Cox regression analysis, B-lines number 6530 (HR 8.62; 95%CI: 1.8-40.1; p=0.006) identified a group at high risk for acute pulmonary edema admission at 120days, and was the strongest predictor of events compared to other established clinical, laboratory and instrumental findings. No acute pulmonary edema occurred in patients without significant pulmonary congestion at LUS (number of B-lines<15). CONCLUSION: In a HF outpatient setting, B-line assessment by LUS identifies patients more likely to be admitted for decompensated HF in the following 4months. This simple evaluation could allow prompt therapy optimization in those patients who, although asymptomatic, carry a significant degree of extravascular lung water