Aims To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM‐HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. Methods and results Outpatients with HFrEF in the ESC‐EORP‐HFA Long‐Term Heart Failure (HF‐LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM‐HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM‐HF and guideline criteria, respectively. Absent PARADIGM‐HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub‐optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub‐optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM‐HF and guidelines. One‐year heart failure hospitalization was higher (12% and 17% vs. 12%) and all‐cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM‐HF. Conclusions Among outpatients with HFrEF in the ESC‐EORP‐HFA HF‐LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM‐HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM‐HF enalapril group.
Background: The meaning of viral nucleic acids in the myocardium in many cases is difficult for clinical interpretation, whereas the presence of viral nucleic acids in the serum is a marker of active infection. We determined the diagnostic value of viral nucleic acids in ventricular serum and peripheral serum samples in comparison with endomyocardial biopsy (EMB) specimens in patients with clinically suspected myocarditis. Methods: The viral nucleic acid evaluation was performed in serum samples and EMB specimens by real-time PCR in 70 patients (age: 47 ± 16 years). The biopsy specimens were examined by histo- and immunohistochemistry to detect inflammatory response. Results: The viral nucleic acids were detected in ventricular and peripheral serum, and EMB samples of 10 (14%), 14 (20%), and 32 (46%) patients, respectively. Notably, viral nucleic acids of the same virus as in the EMB sample were present more often in ventricular than in peripheral serum (60 vs. 7%, p = 0.01). A significant concurrence was observed between the positive and the negative results of viral nucleic acids present in EMB and ventricular serum (p = 0.0001). Conclusions: The detection of the same viral nucleic acid type in the myocardium and in ventricular serum being significantly more frequent than in the peripheral serum may suggest that the site of the blood collection is important for more precise and reliable confirmation of the active viral replication in the heart.
Background: Aortic stenosis is a disease of the elderly people, with multiple comorbidities and often with the frailty syndrome. Therefore, we decided that frailty as a clinical factor requires precise characterization as it is a valuable supplement to the risk stratification in transcatheter aortic Valve implantation (TAVI). Objective: The aim of our study was to evaluate the prognostic value of the Katz frailty scale in patients undergoing TAVI in relation to the risk of mortality assessed with the STS scale. Material and methods: The study included 105 patients with severe aortic stenosis (AS) treated with TAVI at the Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior. In our group, the Katz frailty syndrome confirmed in all patients, and 48% in the advanced stage. Results: Statistical analysis showed a significant difference between survival and Katz frailty score before TAVI. Analysis using Cox's model confirmed a significant prognostic value for the Katz frailty syndrome before TAVI. Patients with moderate to severe frailty on the Katz score (values ≤ 4) had a 13,68 times higher risk of death per year compared to the group with Katz frailty syndrome ≥ 5. Multivariate regression analysis indicated that Katz frailty score and STS score were prognostically significant factors of cardiovascular death in patients undergoing TAVI. Conclusion: The Katz frailty score had a significant prognostic value in the high- and intermediate risk patients. Katz frailty score and STS risk score significantly correlated with the risk of death from cardiovascular causes in frailty patients undergoing TAVI.
Funding Acknowledgements Type of funding sources: None. Background Left ventricular global longitudinal strain (LV GLS) correlate with the risk of symptoms, irreversible myocardial damage and progressive myocardial fibrosis. LV GLS detects subtle changes in LV function that precede those of LVEF and is associated to outcomes after TAVI. Purpose Evaluation of the LV GLS as the prognostic parameter in patients low-, intermediate and high-risk patients undergoing TAVI and its potential relationship with frailty syndrom. Methods The study included 105 patients (mean age 82.36 ± 4.5) with severe AS treated with TAVI at the Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior in Warsaw. Each patient had laboratory tests, ECG, echocardiography (LV GLS) and was assessed based on the STS scale and the Katz frailty scale. Follow-up observations were carried out at 1 month and 1 year. Results In the study population 46% were men, the mean age was 82.36 ± 4.5 years, the mean STS score was 7.03 ± 4.24. The mean pre-TAVI LVEF was 54.51 ± 6.44% (in 87 (82.8%) patients above 50%). The mean LV GLS before TAVI was -12.82 ± 1.94%. AVAI area was 0.38 ± 0.08 cm/m2, and the mean gradient through the stenotic aortic valve was 51.69 ± 10.66 mmHg. LV GLS was significantly improved in patients after TAVI. LV GLS analysis showed change from -12.82% before TAVI, to -14.35% after 1-month follow-up and -14.47% at 1-year follow-up (p ≤ 0,05, p ≤ 0,05 respectively). LV GLS of -11% was a cut-off value determining the risk of death after 1 year post-TAVI (p < 0,001). The area under the curve was 0,87, which was a statistically significant result that can be used as a significant prognostic factor. In low-risk patients there was a significant improvement of LV GLS in 1-year follow-up, compared to patients with STS 4-8% (p ≤ 0.01) and in patients with STS> 8% (p ≤ 0, 05) (Tab. 1). Logistic regression analysis showed that the change of LV GLS at 1 year significantly correlated with Katz frailty score at 1-month and 1-year follow-up ((p ≤ 0,01, p ≤ 0,01 respectively) (Tab. 2). Conclusion LV GLS of -11% was a cut-off value distinguishing patients with increased risk of death after TAVI. In low-risk patients the improvement in LV GLS indicates a favorable reverse myocardial remodeling after TAVI and better prognosis after TAVI, which was not observed in the intermediate- and high-risk patients. Abstract Figure. Abstract Figure.
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