Aims The main terminology used to describe heart failure (HF) is based on measurement of the left ventricular ejection fraction (LVEF). LVEF in the range of 40-49% was recently defined as HF with mid-range EF (HFmrEF) by the 2016 European Society of Cardiology guidelines. The purpose of our study was to assess the clinical profile and prognosis of patients with HF according to this new classification. Methods and results A total of 482 patients referred for HF were retrospectively included over a period of 1 year. There were 258 (53%), 115 (24%), and 109 (23%) patients with HF with reduced EF (HFrEF), HFmrEF, and HF with preserved EF (HFpEF), respectively. Patient age increased, whereas left block bundle branch, brain natriuretic peptide level, and the use of beta-blocker and furosemide decreased from HFrEF to HFpEF. After adjustment for the age, patients with HFpEF and HFmrEF were more likely to have NYHA stage 2 dyspnea, had a higher systolic blood pressure, were less likely to have spironolactone, had lower furosemide dose, and had lower haemoglobin than those with HFrEF. Cardiovascular risk factors and medical history were similar in the three groups of patients. There was a 33% death rate after a mean follow-up of 32.2 AE 14.3 months. The survival was the same among patients whatever the group of HF (P = 0.884). Conclusions Patients with HFrEF, HFmrEF, and HFpEF share the same cardiovascular risk factors, medical history, and prognosis. Patients with HFmrEF have a different clinical profile, which is nearly the same as patients with HFpEF, except for sex. These results question the relevance of this new classification of HF to stimulate research into this new group of patients.
Background:
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce.
Methods:
Nationwide French Registry including all TOF patients with an ICD initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event endpoint was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee.
Results:
A total of 165 patients (mean age 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (IQR) follow-up of 6.8 (2.5-11.4) years, 78 (47.3%) patients received at least one appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively, p=0.03). Overall, 71 (43.0%) patients presented with at least one ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) primary prevention patients, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with respectively no, one, two, or ≥ three guideline-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (HR 3.47, 95% CI 1.19-10.11), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 (p=0.006). Patients with congestive heart failure and/or reduced LVEF had a higher risk of non-arrhythmic death or heart transplantation (HR=11.01, 95% CI: 2.96-40.95).
Conclusions:
Patients with TOF and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification.
Clinical Trial Registration:
URL: https://clinicaltrials.gov Unique Identifier: NCT03837574
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