This article updates the Heart Failure Association of the European Society of Cardiology (ESC) 2007 classification of advanced heart failure and describes new diagnostic and treatment options for these patients. Recognizing the patient with advanced heart failure is critical to facilitate timely referral to advanced heart failure centres. Unplanned visits for heart failure decompensation, malignant arrhythmias, co-morbidities, and the 2016 ESC guidelines criteria for the diagnosis of heart failure with preserved ejection fraction are included in this updated definition. Standard treatment is, by definition, insufficient in these patients. Inotropic therapy may be used as a bridge strategy, but it is only a palliative measure when used on its own, because of the lack of outcomes data. Major progress has occurred with short-term mechanical circulatory support devices for immediate management of cardiogenic shock and long-term mechanical circulatory support for either a bridge to transplantation or as destination therapy. Heart transplantation remains the treatment of choice for patients without contraindications. Some patients will not be candidates for advanced heart failure therapies. For these patients, who are often elderly with multiple co-morbidities, management of advanced heart failure to reduce symptoms and improve quality of life should be emphasized. Robust evidence from prospective studies is lacking for most therapies for advanced heart failure. There is an urgent need to develop evidence-based treatment algorithms to prolong life when possible and in accordance with patient preferences, increase life quality, and reduce the burden of hospitalization in this vulnerable patient population.
Aims Vent‐HeFT is a multicentre randomized trial designed to investigate the potential additive benefits of inspiratory muscle training (IMT) on aerobic training (AT) in patients with chronic heart failure (CHF). Methods and results Forty‐three CHF patients with a mean age of 58 ± 12 years, peak oxygen consumption (peak VO2) 17.9 ± 5 mL/kg/min, and LVEF 29.5 ± 5% were randomized to an AT/IMT group (n = 21) or to an AT/SHAM group (n = 22) in a 12‐week exercise programme. AT involved 45 min of ergometer training at 70–80% of maximum heart rate, three times a week for both groups. In the AT/IMT group, IMT was performed at 60% of sustained maximal inspiratory pressure (SPImax) while in the AT/SHAM group it was performed at 10% of SPImax, using a computer biofeedback trainer for 30 min, three times a week. At baseline and at 3 months, patients were evaluated for exercise capacity, lung function, inspiratory muscle strength (PImax) and work capacity (SPImax), quality of life (QoL), LVEF and LV diameter, dyspnoea, C‐reactive protein (CRP), and NT‐proBNP. IMT resulted in a significantly higher benefit in SPImax (P = 0.02), QoL (P = 0.002), dyspnoea (P = 0.004), CRP (P = 0.03), and NT‐proBNP (P = 0.004). In both AT/IMT and AT/SHAM groups PImax (P < 0.001, P = 0.02), peak VO2 (P = 0.008, P = 0.04), and LVEF (P = 0.005, P = 0.002) improved significantly; however, without an additional benefit for either of the groups. Conclusion This randomized multicentre study demonstrates that IMT combined with aerobic training provides additional benefits in functional and serum biomarkers in patients with moderate CHF. These findings advocate for application of IMT in cardiac rehabilitation programmes.
Background-The prevention of contrast-induced nephropathy, which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast-induced renal vasoconstriction is believed to play a pivotal role in the pathogenesis of contrast-induced nephropathy. The aim of this study was to examine the efficacy of the prostacyclin analog iloprost in preventing contrast-induced nephropathy in patients with renal dysfunction undergoing a coronary procedure. Methods and Results-We conducted a randomized, double-blind, placebo-controlled trial of iloprost in 208 patients with a serum creatinine concentration Ն1.4 mg/dL who underwent coronary angiography and/or intervention. Iloprost 1 ng · kg Ϫ1 · min Ϫ1 or placebo was administered intravenously beginning 30 to 90 minutes before and ending 4 hours after the procedure. Contrast-induced nephropathy was defined by an absolute increase in serum creatinine Ն0.5 mg/dL or a relative increase Ն25% measured 2 to 5 days after the procedure. Contrast-induced nephropathy occurred in 23 of the 105 patients (22%) in the control group and in 8 of the 103 patients (8%) in the iloprost group (odds ratio, 0.29; 95% confidence interval, 0.12 to 0.69; Pϭ0.005). In the control group, the estimated glomerular filtration rate declined from 49.7Ϯ15.5 to 46.6Ϯ16.6 mL · min Ϫ1 · 1.73 m Ϫ2 (Pϭ0.01). In the iloprost group, the estimated glomerular filtration rate increased marginally from 47.5Ϯ14.5 to 48.6Ϯ16.1 mL · min Ϫ1 · 1.73 m Ϫ2 (Pϭ0.26). The mean absolute estimated glomerular filtration rate decline in the control group was greater than its change in the iloprost group (difference, 4.2 mL · min Ϫ1 · 1.73 m Ϫ2; 95% confidence interval, 1.1 to 7.3; Pϭ0.008). Conclusion-Prophylactic
Aims To compare characteristics of left ventricular assist device (LVAD) recipients receiving a cardiac implantable electronic device (CIED) with a defibrillator component (implantable cardioverter‐defibrillator and cardiac resynchronization therapy with defibrillation, CIED‐D) vs. those without one, and to assess whether carrying such a device contiguously with an LVAD is associated with outcomes. Methods and results Overall, 448 patients were analysed (mean age 52 ± 13 years, 82% male) in the multicentre European PCHF‐VAD registry. To account for all active CIED‐Ds during ongoing LVAD treatment, outcome analyses were performed by a time‐varying analysis with active CIED‐D status post‐LVAD as the time‐varying covariate. At the time of LVAD implantation, 235 patients (52%) had an active CIED‐D. Median time on LVAD support was 1.1 years (interquartile range 0.5–2.0 years). A reduction of 36% in the risk of all‐cause mortality was observed in patients with an active CIED‐D [hazard ratio (HR) 0.64, 95% confidence interval (CI) 0.46–0.91; P = 0.012), increasing to 41% after adjustment for baseline covariates (HR 0.59, 95% CI 0.40–0.87; P = 0.008) and 39% after propensity score adjustment (HR 0.61, 95% CI 0.39–0.94; P = 0.027). Other than CIED‐D, age, LVAD implant as redo surgery, number of ventricular arrhythmia episodes and use of vasopressors pre‐LVAD were remaining significant risk factors of all‐cause mortality. Incident ventricular arrhythmias post‐LVAD portended a 2.4‐fold and 2.6‐fold increased risk of all‐cause and cardiovascular death, respectively; carrying an active CIED‐D remained associated with a 47% and 43% reduction in these events, respectively. Conclusions In an analysis accounting for all active CIED‐Ds, including those implanted during LVAD support, carrying such a device was associated with significantly better survival during LVAD support.
OBJECTIVES In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era. METHODS Procedures in adult patients (January 2011–June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011–2013, 2014–2017 and 2018–2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months). RESULTS In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3–2.6) years. The annual number of implants (range: 346–600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4–7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant. CONCLUSIONS In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent.
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