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.
In the so-called evidence-based medicine (EBM) era, pre-market clinical trials showing equivalent or superior benefit from new drugs
versus
existing therapies are required by regulatory bodies, while ...the process for approval of medical devices is less stringent 1. The expansion of device-based therapies for cardiovascular conditions makes cardiology the ideal setting for analysing the peculiarities of this process 2.
Lessons learned from cardiology: the process for approval of medical therapeutic devices must be redesigned
http://ow.ly/bJPm3017ySH
Hypertrophic cardiomyopathy (HCM) is entering a phase of intense translational research that holds promise for major advances in disease‐specific pharmacological therapy. For over 50 years, however, ...HCM has largely remained an orphan disease, and patients are still treated with old drugs developed for other conditions. While judicious use of the available armamentarium may control the clinical manifestations of HCM in most patients, specific experience is required in challenging situations, including deciding when not to treat. The present review revisits the time‐honoured therapies available for HCM, in a practical perspective reflecting real‐world scenarios. Specific agents are presented with doses, titration strategies, pros and cons. Peculiar HCM dilemmas such as treatment of dynamic outflow obstruction, heart failure caused by end‐stage progression and prevention of atrial fibrillation and ventricular arrhythmias are assessed. In the near future, the field of HCM drug therapy will rapidly expand, based on ongoing efforts. Approaches such as myocardial metabolic modulation, late sodium current inhibition and allosteric myosin inhibition have moved from pre‐clinical to clinical research, and reflect a surge of scientific as well as economic interest by academia and industry alike. These exciting developments, and their implications for future research, are discussed.
Previous reports have suggested that despite their dramatic presentation, patients with fulminant myocarditis (FM) might have better outcome than those with acute nonfulminant myocarditis (NFM). In ...this retrospective study, we report outcome and changes in left ventricular ejection fraction (LVEF) in a large cohort of patients with FM compared with patients with NFM.
The study population consists of 187 consecutive patients admitted between May 2001 and November 2016 with a diagnosis of acute myocarditis (onset of symptoms <1 month) of whom 55 required inotropes and/or mechanical circulatory support (FM) and the remaining 132 were hemodynamically stable (NFM). We also performed a subanalysis in 130 adult patients with acute viral myocarditis and viral prodrome within 2 weeks from the onset, which includes 34 with FM and 96 with NFM. Patients with giant-cell myocarditis, eosinophilic myocarditis, or cardiac sarcoidosis and those <15 years of age were excluded from the subanalysis.
In the whole population (n=187), the rate of in-hospital death or heart transplantation was 25.5% versus 0% in FM versus NFM, respectively (
<0.0001). Long-term heart transplantation-free survival at 9 years was lower in FM than NFM (64.5% versus 100%, log-rank
<0.0001). Despite greater improvement in LVEF during hospitalization in FM versus NFM forms (median, 32% interquartile range, 20%-40% versus 3% 0%-10%, respectively;
<0.0001), the proportion of patients with LVEF <55% at last follow-up was higher in FM versus NFM (29% versus 9%; relative risk, 3.32; 95% confidence interval, 1.45-7.64,
=0.003). Similar results for survival and changes in LVEF in FM versus NFM were observed in the subgroup (n=130) with viral myocarditis. None of the patients with NFM and LVEF ≥55% at discharge had a significant decrease in LVEF at follow-up.
Patients with FM have an increased mortality and need for heart transplantation compared with those with NFM. From a functional viewpoint, patients with FM have a more severely impaired LVEF at admission that, despite steep improvement during hospitalization, remains lower than that in patients with NFM at long-term follow-up. These findings also hold true when only the viral forms are considered and are different from previous studies showing better prognosis in FM.
This study evaluates, in a real-world setting, to what extent the recommended therapies by international guidelines, are prescribed after a first hospitalization for heart failure (HF), and to ...analyse adherence and persistence, and the effect of treatment adherence on mortality and re-hospitalization.
From the Lombardy healthcare administrative database, we analysed patients discharged after their incident HF, from 2000 to 2012. Adherence was defined as the proportion of days covered (PDC) ≥80% adjusted for hospitalizations and persistence as the absence of discontinuation of therapy for >30 days. A logit model was used to determine the effect of patients' adherence on mortality and readmissions.
Of 100422 HF patients (52% males, age 75 ± 12 years), 86846 (87%) had a prescription for angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACE/ARBs), 64135 (64%) for beta-blockers (BB), and 36893 (37%) for mineralocorticoid receptor antagonists (MRAs), as mono-, bi- or tri-therapy. In patients on monotherapy, PDC was 78 ± 22% for ACE/ARBs, 69 ± 29% for BB and 54 ± 29% for MRAs; in those on bi-therapy, PDC was 63 ± 31% for ACEI/ARBs+BB, 41 ± 29% for ACEI/ARBs+MRAs, and 40 ± 26% for MRAs+BB; for patients on tri-therapy, PDC was 42 ± 28%. Medication persistence was present in 47% of patients treated with ACEI/ARBs, in 35% of patients treated with BB and in 14% of patients treated with MRAs. Re-hospitalizations and in mortality were significantly reduced in adherent patients (p < 0.000).
Polypharmacy is associated with an increased rate of non-adherence and non-persistence in incident HF. Non-adherence is associated with an increased risk of mortality and re-hospitalizations.
•· From the Lombardy healthcare database, we analyzed, in patients after incident HF, treatment prescriptions, adherence and persistence.•Polypharmacy is associated with an increased rate of non-adherence and non-persistence.•Non-adherence is associated with an increased risk of mortality and re-hospitalizations.•It is necessary to find strategies to improve the treatment adherence and persistence.
Purpose of Review
To review the clinical features of acute myocarditis, including its fulminant presentation, and present a pragmatic approach to the diagnosis and treatment, considering indications ...of American and European Scientific Statements and recent data derived by large contemporary registries.
Recent Findings
Patients presenting with acute uncomplicated myocarditis (i.e., without left ventricular dysfunction, heart failure, or ventricular arrhythmias) have a favorable short- and long-term prognosis: these findings do not support the indication to endomyocardial biopsy in this clinical scenario. Conversely, patients with complicated presentations, especially those with fulminant myocarditis, require an aggressive and comprehensive management, including endomyocardial biopsy and availability of advanced therapies for circulatory support. Although several immunomodulatory or immunosuppressive therapies have been studied and are actually prescribed in the real-world practice, their effectiveness has not been clearly demonstrated. Patients with specific histological subtypes of acute myocarditis (i.e., giant cell and eosinophilic myocarditis) or those affected by sarcoidosis or systemic autoimmune disorders seem to benefit most from immunosuppression. On the other hand, no clear evidence supports the use of immunosuppressive agents in patients with lymphocytic acute myocarditis, even though small series suggest a potential benefit.
Summary
Acute myocarditis is a heterogeneous condition with distinct pathophysiological pathways. Further research is mandatory to identify factors and mechanisms that may trigger/maintain or counteract/repair the myocardial damage, in order to provide a rational for future evidence-based treatment of patients affected by this condition.
Aims
The 2016 European guidelines for the diagnosis and treatment of heart failure classified cardiac rehabilitation as a mandatory class I intervention. We aimed to analyse in heart failure patients ...the impact of an in-hospital cardiac rehabilitation programme on all-cause mortality and readmissions.
Methods
From the Lombardy healthcare administrative database, we analysed in patients with incident heart failure, from 2005 to 2012, the number of all hospitalisations, cardiac rehabilitation admissions, post-discharge deaths, outpatient drug prescriptions and visits. We divided patients into hospitalised for heart failure in acute care only (group A) versus patients with one or more admission to cardiac rehabilitation for an in-hospital cardiac rehabilitation programme (group B).
Results
Of 140,552 incident cases, 100,843 (71%) were in group A and 39,709 (29%) in group B. Patients in group B had 3.26 ± 1.78 admissions to acute care before referral to an in-hospital cardiac rehabilitation programme. Male gender, age in women and comorbidities (more than two) were higher in group B (P < 0.0001). Patients in group B had a higher number of interventional procedures (P < 0.0001), drug prescription and outpatient visit rate (P < 0.0001). Total mortality was 30% in group A versus 29% in group B. At Cox and logistic regression analyses, after adjustment for covariates, group B had a significantly lower risk of mortality (hazard ratio 0.5768, 95% confidence interval 0.5650–0.5888, P < 0.0001) and readmissions (0.7997, 0.7758–0.8244, P < 0.0001) than group A.
Conclusion
This study showed in a large population of heart failure patients that in-hospital cardiac rehabilitation is associated with a reduction of all-cause mortality and rehospitalisations in heart failure. Given its potential significant benefit, referral of heart failure patients to an in-hospital cardiac rehabilitation programme should be promoted.
The aim of this study was to investigate the effects of the use of an occlusal splint on postural balance considering the occlusal splint as a device for treating temporomandibular joint disorder. A ...randomized, controlled, prospective clinical trial was conducted. The research group consisted of 49 patients (36 as test group and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder by Research Diagnostic Criteria/Temporomandibular Disorders questionnaire and magnetic resonance imaging of the temporomandibular joints. Test group was treated with orientations for physiotherapeutic exercises and occlusal splint, whereas control group received orientation for physiotherapeutic exercises only. Postural equilibrium was evaluated by means of a force plate. After 12 weeks, the groups were re‐evaluated. Patients from both groups presented a significant increase in antero‐posterior speed with eyes closed, test group (P < 0.001) and control group (P = 0.046). Only patients of the test group presented a significant increase in antero‐posterior speed with eyes opened (P = 0.023). We concluded that the use of occlusal splint affected the postural balance.
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