Introduction: Heart failure (HF) is a syndrome increasing worldwide, and literature shows that the hospitalizations are associated with greater mortality rates. A patient-centered method combined with optimized medical treatment and palliative care may improve HF outcomes, and some advocate a multifaceted approach to achieve a perfect management of chronic HF (CHF). Objective: The objective of this study was to present the study protocol of GENICA project which aims to optimize the ambulatory approach of CHF patients, and reduce their re-hospitalization, emergency readmission, and global death rate. Design: Prospective cohort including patients referred to HF consultation and collecting sociodemographic, clinical, and analytical variables among others. The outcomes will be mortality, re-hospitalization, and emergency readmission rates. The association between the independent variables and outcomes will be assessed by logistic regression. Comparison between GENICA patients and controls will be made by χ2 test. Significance at p level of less than 0.05. Results: GENICA will offer a wide range of longitudinal data with evidence that will influence future healthcare of CHF patients at an ambulatory basis. Discussion: GENICA will provide practical evidence of real HF patient’s profile and develop workable decision algorithms, which will influence future ambulatory care of CHF. HF patients will be safer at home and will keep stability for longer periods, consuming less health resources and slow the progression of the disease. Being a matched cohort, GENICA benefits from an accuracy similar to that of randomized controlled trials, without the need to perform a rigorous allocation of the intervention. Being prospective there’s no problem about response bias. Conclusion: CHF should be approached with a multidisciplinary and multifaceted strategy privileging the outpatient setting, including home monitoring, and GENICA is the paramount protocol enabling this. GENICA may come to show health policy makers that the asset is not to divide and rule, but to converge strategies, therapies, and knowledge.
Funding Acknowledgements Type of funding sources: None. Introduction Cardiopulmonary exercise testing (CPET) is used for risk stratification in patients with chronic heart failure (CHF). However, there is a lack of information regarding CPET prognostic power in patients under new HF therapies such as sacubitril/valsartan, Mitraclip, IV iron or SGLT2 inhibitors. The aim of this study was to evaluate the prognostic value of CPET parameters in a contemporary subset of patients with optimal medical and device therapy for CHF. Methods Retrospective evaluation of patients with CHF submitted to CPET in a tertiary center. Patients were followed up for 24 months for the composite endpoint of cardiac death, urgent heart transplantation or left ventricular assist device. CPET parameters, including peak oxygen consumption (pVO2) and VE/VCO2 slope, were analysed and their predictive power was measured. HF events were stratified according to cut-off values defined by the International Society for Heart and Lung Transplantation (ISHLT) guidelines: pVO2 of ≤12 mL/Kg/min and VE/VCO2 slope of >35. Results CPET was performed in 204 patients, from 2014 to 2018. Mean age was 59 ± 13 years, 83% male, with a mean left ventricular ejection fraction of 33 ± 8%, and a mean Heart Failure Survival Score of 8.6 ± 1.3. The discriminative power of CPET parameters is displayed in the Table. In patients with pVO2 ≤12 mL/Kg/min, the composite endpoint occurred in 18% of patients. A pVO2 value of ≤12 mL/Kg/min had a positive predictive power of 18% while pVO2 >12 had a negative predictive power of 93%. Regarding VE/VCO2 slope >35, the composite endpoint occurred in 13% of patients. A VE/VCO2 slope value of >35 had a positive predictive power of 13% while VE/VCO2 slope <35 had a negative predictive power or 94%. Conclusion Using ISHLT guideline cut-off values for advanced HF therapies patient selection, there was a reduced number of HF events (<20%) at 24 months in patients under optimal CHF therapy. While pVO2 and VE/VCO2 slope are still valuable parameters in risk stratification, redefining cut-off values may be necessary in a modern HF population. Discriminative power of CPET parameters Parameters HR; 95% CI AUC p-value Peak VO2 0.824 (0.728-0.934) 0.781 0.001 Percent of predicted pVO2 0.942 (0.907-0.978) 0.774 0.002 VE/VCO2 slope 1.068 (1.031-1.106) 0.756 0.008 Cardiorespiratory optimal point 1.118 (1.053-1.188) 0.746 0.004 PETCO2 maximum exercise 0.854 (0.768-0.950) 0.775 0.003 Ventilatory Power 0.358 (0.176-0.728) 0.796 0.002 HR Hazard ratio, AUC: Area under the curve, PETCO2: end-tidal CO2 pressure
Funding Acknowledgements Type of funding sources: None. Introduction and purpose The optimal timing for pulmonary valve replacement (PVR) in asymptomatic patients with repaired tetralogy of Fallot (TOF) and pulmonary regurgitation (PR) remains uncertain but is often guided by imaging characterization of the right ventricle. As cardiopulmonary exercise testing (CPET) performance is an accessible prognostic indicator, we assessed which CPET parameters best correlate with pulmonary regurgitation severity to potentially improve identification of high-risk patients. Methods A retrospective chart review was done from 2009 to 2018 on adult patients with repaired TOF who underwent maximal effort cardiopulmonary exercise testing with cycle ergometry and with concurrent pulmonary function testing. Demographics, standard measures of CPET interpretation, and major cardiovascular outcomes were collected. Results Cardiopulmonary exercise testing was performed in 54 adult repaired TOF patients (59% male), with a mean follow-up of 60 ± 33 months. The mean age was 34 ± 9 years. 30 patients (56%) had severe pulmonary regurgitation and 26 patients (48%) were submitted to PVR, with a 0% mortality rate. PVR was performed a mean 28 ± 7 years after TOF repair surgery. There was moderate to severe right ventricular dysfunction in 11 patients (20%). 12 patients (22%) had a hospitalization for heart failure. Arrhythmic events occurred in 9 patients (17%), mainly atrial fibrillation or atrial flutter (67%). 2 patients (4%) received an implantable cardioverter-defibrillator for secondary prevention of sudden cardiac death. Peak VO2 consumption (pVO2) showed no statistically significant correlation with severity of pulmonary regurgitation (HR 0.26, 95% CI 0.879-1.036, p= 0.262) or PVR (HR 0.92, 95% CI 0.829-1.028, p = 0.914), while percent of predicted pVO2 significantly correlated with severity of pulmonary regurgitation (HR 0.95, 95% CI 0.918-0.993, p = 0.020) and PVR (HR 0.94, 95% CI 0.886-0.992, p = 0.025). VE/VCO2 slope was not a significant predictor of severity of pulmonary regurgitation (HR 1.03, 95% CI 0.929-1.130, p = 0.622) or PVR (HR 1.04, 95% CI 0.952-1.128, p = 0.414) or) and neither cardiorespiratory optimal point (HR 0.94, 95% CI 0.786-1.120, p = 0.480) nor maximum end-tidal carbon dioxide pressure (PETCO2) (HR 0.93, 95% CI 0.846-1.037, p = 0.213) correlated with severity of pulmonary regurgitation or PVR. Conclusion Percent of predicted peak VO2 had the highest predictive power of all CPET parameters analysed in adult repaired TOF patients. Preoperative CPET could be an accessible way to identify high-risk patients earlier for PVR and should therefore be included in the routine assessment of these patients.
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