Safety and Efficacy of the Combination of Sacubitril/Valsartan and SGLT2i in HFrEF Patients (SECSI Registry).

ABSTRACT: Recent studies have proven benefit of SGLT2i drugs in patients with heart failure with reduced ejection fraction (HFrEF), but their safety when combined with angiotensin-neprilysin inhibitor (ARNI) has not been established. The Safety and Efficacy of the Combination of Sacubitril/Valsartan and SGLT2i in HFrEF Patients registry was conducted to address this issue. SECSI registry is a consecutive, observational, retrospective, multicentre study conducted in 3 Heart Failure Units in Spain. It included 144 HFrEF patients who were treated with ARNI and iSGLT2. Data were collected at baseline, month 2, and month 6. The primary endpoint was the estimated glomerular filtration rate (eGFR), after the initiation of ARNI and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Secondary endpoints included potassium levels and functional class (New York Heart Association class). There were 3 prespecified subgroup analyses: Elderly patients (≥70 years), patients with chronic kidney disease (KDIGO classification G3), and the sequence of drug initiation. Mean age was 69.9 ± 10.1 years, and 110 (76.4%) were men. Left ventricular ejection fraction was 32 ± 7.8%, and most patients were symptomatic [123 (87.2%) New York Heart Association II/III/IV]. eGFR decreased at month 2 and this trend was maintained at month 6 [eGFR baseline 68.5 ± 17.3, month 2 62 ± 19.7 and month 6 64.7 ± 8.6 mL/min/1.73 m2 (P < 0.01 for both)]. In prespecified analysis, elder patients and those who simultaneously initiate both treatments showed the steeper decrease in eGFR. To conclude, co-administration of SGLT2i and ARNI in routine care in HFrEF patients produced a slight decrease in eGFR at 6 months of follow-up. This decrease was especially significant in elder patients and those who initiate both drugs simultaneously.

Heart Failure in the Time of COVID-19.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as a new threat to healthcare systems. In this setting, heart failure units have faced an enormous challenge: taking care of their patients while at the same time avoiding patients' visits to the hospital. OBJECTIVE: The aim of this study was to evaluate the results of a follow-up protocol established in an advanced heart failure unit at a single center in Spain during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: During March and April 2020, a protocolized approach was implemented in our unit to reduce the number of outpatient visits and hospital admissions throughout the maximum COVID-19 spread period. We compared emergency room (ER) visits, hospital admissions, and mortality with those of January and February 2020. RESULTS: When compared to the preceding months, during the COVID pandemic there was a 56.5% reduction in the ER visits and a 46.9% reduction in hospital admissions, without an increase in mortality (9 patients died in both time periods). A total of 18 patients required a visit to the outpatient clinic for decompensation of heart failure or others. CONCLUSION: Our study suggests that implementing an active-surveillance protocol in acutely decompensated heart failure units during the SARS-CoV-2 pandemic can reduce hospital admissions, ER visits and, potentially, viral transmission, in a cohort of especially vulnerable patients.

Right Bundle Branch Block Predicts Appropriate Implantable Cardioverter Defibrillator Therapies in Patients with Non-Ischemic Dilated Cardiomyopathy and a Prophylactic Implantable Cardioverter Defibrillator.

Background: The benefit of prophylactic implantable cardioverter defibrillators (ICDs) in patients with severe systolic dysfunction of non-ischemic origin is still unclear, and the identification of patients at risk for sudden cardiac death remains a major challenge. Aims/Methods: We retrospectively reviewed all consecutive patients with non-ischemic dilated cardiomyopathy (NICM) who underwent prophylactic ICD implantation between 2008 and 2020 in two tertiary centers. Our main goal was to identify the predictors of appropriate ICD therapies (anti-tachycardia pacing [ATP] and/or shocks) in this cohort of patients. Results: A total of 224 patients were included. After a median follow-up of 51 months, 61 patients (27.2%) required appropriate ICD therapies. Patients with appropriate ICD therapies were more frequently men (87% vs. 69%, p = 0.006), of younger age (59 years, (53-65) vs. 64 years, (57-70); p = 0.02), showed more right bundle branch blocks (RBBBs) (15% vs. 4%, p = 0.007) and less left bundle branch blocks (LBBBs) (26% vs. 47%, p = 0.005) in the ECG, and had higher left ventricular end-diastolic (100 mL/m2, (90-117) vs. 86, (71-110); p = 0.011) and systolic volumes (72 mL/m2, (59-87) vs. 61, (47-81), p = 0.05). In a multivariate competing-risks regression analysis, RBBB (HR 2.26, CI 95% 1.02-4.98, p = 0.043) was identified as an independent predictor of appropriate ICD therapies. Conclusion: RBBBs may help to identify patients with NICM at high risk of ventricular arrhythmias and requiring ICD intervention.

Remote Dielectric Sensing Before and After Discharge in Patients With ADHF: The ReDS-SAFE HF Trial.

BACKGROUND: Incomplete treatment of congestion often leads to worsening heart failure (HF). The remote dielectric sensing (ReDS) system is an electromagnetic energy-based technology that accurately quantifies changes in lung fluid concentration noninvasively. OBJECTIVES: This study sought to assess whether an ReDS-guided strategy during acutely decompensated HF hospitalization is superior to routine care for improving outcomes at 1 month postdischarge. METHODS: ReDS-SAFE HF (Use of ReDS for a SAFE discharge in patients with acute Heart Failure) was an investigator-initiated, multicenter, single-blind, randomized, proof-of-concept trial in which 100 patients were randomized to a routine care strategy, with discharge criteria based on current clinical practice, or an ReDS-guided decongestion strategy, with discharge criteria requiring an ReDS value of ≤35%. ReDS measurements were performed daily and at a 7-day follow-up visit, with patients and treating physicians in the routine care arm blinded to the results. The primary outcome was a composite of unplanned visits for HF, HF rehospitalization, or death at 1 month after discharge. RESULTS: The mean age was 67 ± 14 years, and 74% were male. On admission, left ventricular ejection fraction was 37% ± 16%, and B-type natriuretic peptide was 940 pg/L (Q1-Q3: 529-1,665 pg/L). The primary endpoint occurred in 10 (20%) patients in the routine care group and 1 (2%) in the ReDS-guided strategy group (log-rank P = 0.005). The ReDS-guided strategy group experienced a lower event rate, with an HR of 0.094 (95% CI: 0.012-0.731; P = 0.003), and a number of patients needed to treat of 6 to avoid an event (95% CI: 3-17), mainly resulting from a decrease in HF readmissions. The median length of stay was 2 days longer in the ReDS-guided group vs the routine care group (8 vs 6; P = 0.203). CONCLUSIONS: A ReDS-guided strategy to treat congestion improved 1-month prognosis postdischarge in this proof-of-concept study, mainly because of a decrease of the number of HF readmissions. (Use of ReDS for a SAFE discharge in patients with acute Heart Failure [ReDS-SAFE HF]; NCT04305717).

Lack of Usefulness of Donor-Derived Cell-Free DNA as a Biomarker for Cardiac Allograft Vasculopathy: A Prospective Study.

Background: Cardiac allograft vasculopathy (CAV) remains a major cause of morbidity and mortality among long-term heart transplant recipients. There is an unmet need for a non-invasive biomarker of CAV that could obviate the need to perform surveillance coronary angiograms in these patients. Our aim was to evaluate the performance of Donor-derived Cell Free DNA (dd-cfDNA) as a biomarker of CAV. Methods: We prospectively measured dd-cfDNA levels in all patients undergoing routine coronary angiography >1 year after heart transplant at a single center. Endpoints included the association between dd-cfDNA levels and the presence CAV, according to several prespecified criteria. Results: We included 94 heart transplant recipients, a median of 10.9 years after transplant. Coronary angiogram revealed CAV0, CAV1, CAV2, and CAV3 in 61, 19, 14, and 6% of patients, respectively. Comparison of dd-cfDNA levels in patients with CAV0 and CAV1-2-3 (primary end-point) did not show significant differences (0.92%, IQR 0.46-2.0 vs. 0.46%, IQR 0.075-1.5, p = 0.059), nor did the comparison between patients with stable CAV (no new coronary lesions since previous angiogram, n = 77) and progressive CAV (n = 17); dd-cfDNA values 0.735% (IQR 0.195-2.0) vs. 0.9% (IQR 0.12-1.8), p = 0.76. However, we found an association between NTproBNP levels and CAV degree (p = 0.017). Dd-cfDNA levels did not correlate with NTproBNP (ρ = -0.095). Conclusion: In this study, dd-cfDNA did not perform as a useful biomarker to avoid surveillance coronary angiograms for CAV diagnosis. Clinical Trial Notation: Potential Role of Donor-derived Cell Free DNA as a Biomarker in Cardiac Allograft Vasculopathy, NCT04791852.

Value of advanced interatrial block in the diagnosis of the ischemic stroke's aetiology: A cohort study.

INTRODUCTION AND OBJECTIVES: Advanced interatrial block has been linked with atrial fibrillation (AF) (Bayes syndrome). On the other hand, the aetiology of the stroke remains unknown in approximately 20-25% of patients admitted due to ischaemic stroke. The aim of this study was to evaluate whether advanced interatrial block and CHADS2-VASC scale is linked to AF in patients admitted due to ischaemic stroke without previous AF history. METHODS: A prospective analysis of consecutive in-hospital patients admitted with ischemic stroke between January/2018 and April/2019 in a stroke hospital was performed. Patients had to be in sinus rhythm at admission and without previous history of AF/atrial flutter. During follow up patients receive the usual care. RESULTS: A total of 236 patients were included. The median follow-up was 540 days (407-695). 19 patients (8.1%) had advanced interatrial block at admission. Advanced interatrial block was associated with the diagnosis of AF during follow up (5 (26.3%) Vs 21 (9.7%) p=0.027). A CHADS2-VASC score>4 at admission was also associated with AF diagnosis during follow up (23(14.6%) vs 3(3.9%) p=0.009). CONCLUSION: This study confirms the association of advanced interatrial block and CHADS2-VASC>4 at admission with the diagnosis of AF during follow up in patients with ischemic stroke. This association could have important implications in patients with ischemic stroke who present advanced interatrial block and without previous history of AF.

Role of sex on the efficacy of pharmacological and non-pharmacological treatment of heart failure with reduced ejection fraction: A systematic review.

Background: Heart Failure (HF) is a growing epidemic with a similar prevalence in men and women. However, women have historically been underrepresented in clinical trials, leading to uneven evidence regarding the benefit of guideline-directed medical therapy (GDMT). This review aims to outline the sex differences in the efficacy of pharmacological and non-pharmacological treatment of HF with reduced ejection fraction (HFrEF). Methods and results: We conducted a systematic review via Medline from inception to 31 January 2022, including all randomized clinical trials published in English including adult patients suffering HFrEF that reported data on the efficacy of each drug. Baseline clinical characteristics, primary outcomes, and sex-specific effects are summarized in tables. The systemic review has been conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. In total, 29 articles were included in the systematic review. We observed that the proportion of women enrolled in clinical trials was generally low, the absence of a prespecified analysis of efficacy by sex was frequent, and the level of quality of evidence on the efficacy of GDMT and implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-) in women was relatively poor. Conclusions: Sex influences the response to treatment of patients suffering from HFrEF. All the results from the landmark randomized clinical trials are based on study populations composed mainly of men. Further studies specifically designed considering sex differences are warranted to elucidate if GDMT and new devices are equally effective in both sexes.

A suicide attempt on a left ventricular assist device patient during COVID-19 pandemic: can we only blame the virus? A case report.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has emerged as a new threat, not only to Health Care systems but also to citizen's freedom of movement in many developed countries. CASE SUMMARY: We report a suicidal attempt in a destination therapy left ventricular assist device patient, potentially triggered by coronavirus disease 2019 (COVID-19) lockdown, highlighting the importance of regular and long-term psychological support for this vulnerable population. DISCUSSION: The psychological consequences of this pandemic, particularly in chronically ill patients, are yet to be defined.

Value of advanced interatrial block in the diagnosis of the ischemic stroke's aetiology: A cohort study

Introduction and objectives: Advanced interatrial block has been linked with atrial fibrillation (AF) (Bayes syndrome). On the other hand, the aetiology of the stroke remains unknown in approximately 20–25% of patients admitted due to ischaemic stroke. The aim of this study was to evaluate whether advanced interatrial block and CHADS2-VASC scale is linked to AF in patients admitted due to ischaemic stroke without previous AF history.MethodsA prospective analysis of consecutive in-hospital patients admitted with ischemic stroke between January/2018 and April/2019 in a stroke hospital was performed. Patients had to be in sinus rhythm at admission and without previous history of AF/atrial flutter. During follow up patients receive the usual care.ResultsA total of 236 patients were included. The median follow-up was 540 days (407–695). 19 patients (8.1%) had advanced interatrial block at admission. Advanced interatrial block was associated with the diagnosis of AF during follow up (5 (26.3%) Vs 21 (9.7%) p=0.027). A CHADS2-VASC score>4 at admission was also associated with AF diagnosis during follow up (23(14.6%) vs 3(3.9%) p=0.009).ConclusionThis study confirms the association of advanced interatrial block and CHADS2-VASC>4 at admission with the diagnosis of AF during follow up in patients with ischemic stroke. This association could have important implications in patients with ischemic stroke who present advanced interatrial block and without previous history of AF. (AU)

Introducción y objetivos: El bloqueo interauricular (BIA) completo se relaciona con el desarrollo de arritmias supraventriculares, especialmente de fibrilación auricular (FA) (síndrome de Bayés). En este trabajo evaluamos la utilidad de este fenómeno para discernir la etiología cardioembólica en los pacientes ingresados por ictus isquémico. También se estudió la relación entre la puntuación en la escala CHADS 2-VA 2 Sc y el desarrollo de FA durante el seguimiento.MétodosAnálisis prospectivo de pacientes consecutivos ingresados por ictus isquémico entre enero del 2018 y abril del 2019 en un hospital terciario centro de referencia de ictus. Los pacientes incluidos debían de estar en ritmo sinusal en el momento del ingreso y no tener historia previa de FA/flutter auricular. Se realizó el seguimiento mediante las consultas y estudios de rutina, sin intervenir en su manejo habitual.ResultadosSe incluyó a 236 pacientes. La mediana de seguimiento fue de 540 días (407-695); 19 pacientes (8,1%) presentaron BIA en el electrocardiograma al ingreso. El BIA completo al ingreso se relacionó con el desarrollo posterior de FA (5 [26,3%) vs. 21 [9,7%]; p=0,027). También se observó que un CHADS 2-VA 2 Sc>4 al ingreso se relacionaba con presentar FA durante el seguimiento (23 [14,6%] vs. 3 [3,9%]; p=0,009).ConclusiónCon este estudio se demuestra por primera vez en pacientes con ictus isquémico que tanto el BIA completo como un CHADS 2-VA 2 Sc>4 se asocian con el desarrollo de FA en el seguimiento. Esta asociación puede tener importantes implicaciones prácticas en el manejo de pacientes ingresados por ictus que presenten BIA completo. (AU)