Comparison of Ferric Sodium EDTA in Combination with Vitamin C, Folic Acid, Copper Gluconate, Zinc Gluconate, and Selenomethionine as Therapeutic Option for Chronic Kidney Disease Patients with Improvement in Inflammatory Status.

Anemia is one of the most frequent and earliest complications of chronic kidney disease (CKD), which impacts a patient's quality of life and increases the risk of adverse clinical outcomes. Patients' inflammatory status is strictly related to the occurrence of functional iron deficiency anemia (IDA) because this causes an increase in hepcidin levels with the consequent inhibition of iron absorption and release from cellular stores into blood circulation. The aim of this study was to evaluate the use of the new oral formulation based on ferric sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate, and selenomethionine (Ferachel Forte®) in patients with moderate CKD and functional IDA, analyzing the inflammatory status in addition to iron blood parameters, in comparison with oral ferrous sulfate and liposomal iron therapies. Sixty-two elderly patients were randomly allocated to one of the following oral treatments for 6 months: ferrous sulfate (Group 1; N = 20), ferric sodium EDTA in combination (Group 2; N = 22), and ferric liposomal formulation (Group 3; N = 20). The evaluated parameters included iron profile parameters of hemoglobin (Hb), sideremia, ferritin, transferrin saturation, C-reactive protein (CRP), and hepcidin. The results showed that in Group 1, there were no improvements. In Group 2, there were statistically significant (p < 0.001) improvements in all evaluated parameters. Finally, in Group 3, there were significant improvements in all evaluated parameters except for hepcidin, which was less than that of Group 2 patients. In conclusion, the findings showed the superior efficacy of the formulation based on ferric sodium EDTA over the other oral iron sources, and that this formulation can contribute to reducing the systemic inflammatory status in patients with CKD.

Cardiovascular risk in scuba divers.

BACKGROUND: We evaluated the role of scuba diving on cardiovascular risk in a small group of divers. METHODS: We have enrolled 14 subjects (12 males and 1 female, mean age 49±12.2 years) undergone to scuba diving (one patient did not complete the period of observation due to the b-blocker treatment). We evaluated electrocardiographyc trace and we have measured QT and RR interval to calculate the QTc index (Bazzet, Fridericia, Hodges and Framingam index) and the Tpeak to Tend index and heart rate variability index before and after scuba diving activity. RESULTS: The results of our study confirm that there is a statistically significant improvement of the RR and QT index but there is not a statistically significant increase of the QTc index (QT interval normalized by heart rate) evaluated before and after scuba diving. In the same cohort of subjects, we have noted a not statistically significant improvement of Tpeak to Tend index. Our study has underlined a statistically significant modification of the SD1 and SD2 indices representative of parasympathetic and orthosympathic activity. Scuba diving activity seems to not be associated with a statistically significant variation of the cardiovascular risk. CONCLUSIONS: Our data confirm that non-linear analysis is characterized by a statistically significant variation of the neurovegetative tone mainly linked to an increased parasympathetic activity. However, further studies are necessary to elucidate these preliminary findings.

Effect of low-dose sacubitril/valsartan on body composition, bioelectrical impedance analysis, heart rate variability and T-peak to T-end index in elderly patients with severe chronic heart failure: a pilot experience.

OBJECTIVE: We evaluated the role of sacubitril/valsartan in heart rate variability, T-peak to T-end index, external cell mass, internal cell mass and total body water in elderly patients with heart failure with reduced ejection fraction (HFrEF). METHODS: Eleven elderly patients (9 males; mean age 77 years, range 70-87; 2 females, mean age 60 years, range 50-71) with HFrEF (<35%) were included in this analysis. Four patients presented moderate chronic kidney failure (creatinine clearance [CrCl] 30-59 mL/min) and four patients with diabetes (HbA1c >6.5%). All patients had hypertension and dyspnoea due to HF. Clinical outcomes of this investigation were kidney function, glucose, brain-natriuretic peptide, heart rate variability, T-peak to T-end index and markers of body water composition with bioelectrical impedance analysis (BIA). RESULTS: One-month therapy with sacubitril/valsartan 24/26 mg/bid was associated with an improved redistribution of body water (extracellular mass: 19.4 ± 3.0 at baseline vs 18.4 ± 2.6 Kg/m at 1 month; p = .001), body weight reduction (81 ± 8 vs 78 ± 8 Kg; p = .002) and improved clinical outcomes (i.e. reduction of dyspnoea, mean duration of symptoms and walking test). CONCLUSIONS: Based on our preliminary results, sacubitril/valsartan could be a new effective approach in the treatment of elderly patients with chronic HFrEF. However, further studies are necessary to confirm these preliminary findings.

A Case of Ventricular Fibrillation in a Frail Patient with Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea Syndrome, and Electrolytic Disorder.

Chronic obstructive pulmonary disease (COPD) is associated with an increased cardiovascular risk, although the pathophysiological mechanisms responsible for this interdependence are not completely known. For instance, the increased sympathetic activity may be implied. The severity of COPD correlates with various arrhythmic manifestations such as atrial fibrillation, atrial flutter, and either sustained or nonsustained ventricular tachycardia. COPD and obstructive sleep apnea syndrome may increase the overall cardiovascular risk, especially in elderly patients. Additionally, electrolytic disorders may precipitate cardiac rhythm disturbances and thus cause important arrhythmic consequences such as ventricular fibrillation, as reported in our clinical case. We discuss here the possible treatment of this association of pathological conditions on the basis of a single case we have successfully treated, and provide a brief review of the available literature regarding cardiovascular comorbidities in COPD patients.

Age and QT variability index during free breathing, controlled breathing and tilt in patients with chronic heart failure and healthy control subjects.

UNLABELLED: The QT variability index (QTVI) indicates temporal dispersion in myocardial repolarization, and a high QTVI is associated with a propensity for sudden death from malignant ventricular arrhythmias in subjects at high risk. In this study, the authors assessed the effects of free breathing, controlled breathing, and sympathetic stress (tilt) on the QTVI in patients with chronic heart failure (CHF) and healthy control subjects. The authors also examined the influence of age on the same variables. To obtain normative data, they calculated 95% confidence intervals for healthy subjects grouped according to age. Under all experimental conditions, the QTVI was larger in the CHF group overall and in the age subsets than in controls. In patients and controls, the QTVI increased significantly during tilt, although no differences were found between the QTVI measured during free and controlled breathing. In healthy controls, the following variables correlated significantly with the QTVI: age and baseline heart rate (P < 0.001). In patients with CHF, aging had no influence on the QTVI. CONCLUSION: Age, sympathetic stress, and CHF all tend to increase the QTVI and could potentially induce sudden death. Further studies should assess the usefulness of the QTVI as a marker predicting sudden cardiac death under the various conditions of risk.

Autonomic cardiovascular control and diastolic dysfunction in hypertensive subjects.

BACKGROUND: Early hypertension is associated with left ventricular diastolic dysfunction due to increased end-diastolic pressure. This increase, through the cardiopulmonary reflexes, can influence autonomic cardiovascular control. METHODS: We assessed autonomic nervous system modulation of cardiovascular signals by power spectral analysis of RR interval and systolic arterial pressure variabilities in subjects with recently diagnosed hypertension with or without diastolic dysfunction and in normotensive control subjects. RESULTS: Both hypertensive groups had higher low-frequency (LF) power expressed in normalized units (NUs) than normotensive controls (p < 0.05; p < 0.001) during controlled breathing at rest. The LF spectral index measured after tilt was greater in hypertensive subjects with diastolic dysfunction than in those without (p < 0.05). LF NUs measured at rest correlated significantly with the E/A wave ratio and after tilt with the E-wave deceleration time. CONCLUSIONS: These results seem to indicate that in subjects with recently diagnosed hypertension sympathetic modulation of the sinus node prevails. During tilt, a maneuver designed to stimulate systemic arterial and cardiopulmonary baroreceptor reflexes, hypertensive subjects with diastolic dysfunction, who presumably also have higher end-diastolic pressures, seem to have greater sympathetic modulation of the sinus node than hypertensive subjects without diastolic dysfunction.

Power spectral analysis of heart rate variability as a predictive test in choosing the most effective length for tilt-training.

BACKGROUND: In patients with refractory neurally mediated syncope, tilt training--standing motionless against a wall for increased periods of time per day over one month--can often eliminate recurrent episodes and reduce presyncopal symptoms. We designed dual retrospective and prospective studies to assess cardiovascular autonomic function in subjects with recurrent syncope and identify the most effective length of tilt training between one and three months. METHODS AND RESULTS: In the retrospective study, before tilt training, and in the prospective study, before and after training, all subjects underwent a recording for short-term spectral analysis of heart rate and systolic blood pressure variability. Before tilt-training, autonomic nervous system function differs in patients with recurrent neurally mediated syncope who respond to tilt training for one month and those who do not. "Responders", patients experiencing no episodes of syncope during the 12-month follow-up, had higher low-frequency power of RR (LF(RR)) (p < 0.05) and LF(RR) in normalized units (NU) (p < 0.001) and lower high-frequency power (HF(RR)) (p < 0.05) and HF(RR)NU (p < 0.001) than "non-responders", patients reporting at least one syncopal episode during the 12-month follow-up. In the retrospective study, no difference was found between spectral data for "non-responders" with positive responses to tilt test with and without nitro derivatives. Prolonging tilt-training to three months increased the number of responders (late-responders) by 80% (p < 0.001) and power spectral analysis of heart rate variability (HRV) before tilt training can identify late-responders by their low LF(RR)NUs (<40) and high HF(RR)Nus (>60). Furthermore in late-responders, tilt training brings about a change in cardiovascular autonomic function: at 3 months, LF(RR)NUs increase and HF(RR)NU diminish. CONCLUSION: Power spectral analysis of HRV seems to be a useful tool to preselect patients who are most likely to benefit from prolonged therapy, thus increasing compliance.