A pilot study on secondary anemia in "frailty" patients treated with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine: safety of treatment explored by HRV non-linear analysis as predictive factor of cardiovascular tolerability.

OBJECTIVE: Iron deficiency anemia (IDA) in patients with heart disease is correlated with decreased exercise capacity and poor health-related quality of life, and predicts worse cardiovascular outcomes, especially for elderly patients. IDA can worsen cardiac function that can be monitored with Heart Rate Variability (HRV) analysis, providing important information about cardiac health. In a recent study we explored the effect and the tolerability of the administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) in "frailty" patients with secondary anemia and low kidney failure, by analysing the HRV frequency domain. The aim of the present study is the further confirmation of the safety of the already evaluated intervention, by analysing non-linear domain of HRV. PATIENTS AND METHODS: In this pilot study we enrolled 52 "frailty" elderly patients, with a recent diagnosis of secondary anemia due to iron deficiency, with Class II New York Heart Association (NYHA) hypertensive heart disease, low kidney failure, and atherosclerosis. The patients were divided in 2 groups: Group A (N=23 patients) received oral administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) 2 tabs/day, containing 60 mg of Fe3+, for 24 days; Group B (N=29 patients) received intravenous administration of ferrous gluconate 63 mg/day added to saline solution, while they were hospitalized (15±5 days). We evaluated laboratory values of hemoglobin (Hb) and sideremia levels. Furthermore, we measured ECG signals before and after treatment, using non-linear analysis techniques. RESULTS: Both intravenous and oral treatments evaluated in this study, were effective and safe about the cardiovascular risk in "frailty" elderly patients, as resulted from non-linear HRV analysis. Efficacy results showed that hemoglobin and sideremia levels after treatments are significantly increased. The HRV non-linear analysis showed that all parameters evaluated, except for the SD1 values in the Group A, were not affected by treatments, confirming the absence of cardiovascular risk of the therapy. CONCLUSIONS: Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) did not impact the cardiovascular risk, without causing adverse events typically reported with other iron supplementation therapies, both oral and intravenous.

Third degree of atrioventricular block: a rare geriatric complication that may cause sudden death. Remarks on two clinical cases.

Two clinical cases are reported that have in common the electrocardiographic detection of a third degree atrioventricular block (AVB), which occurred in the first case in a man of 78 years, hospitalized in our unit after an accidental fall with an ensuing head trauma, and in the second case, in a woman of 67 years, after cataract surgery on her left eye. The complete or third degree AVB is a bradyarrhythmia characterized by the absence of paroxystic or permanent atrioventricular conduction. Several studies conducted on subjects between the ages of 60 and 85 pointed out that the incidence of AVB-type bradyarrhythmias of a degree greater than the first is extremely rare, i.e., it is close to zero. It is, however, necessary to make an early diagnosis of the AVB, as in many cases it may complicate the patient's clinical progress and may often lead to sudden death. Clinical and experimental observations have shown that electrocardiographic alterations and arrhythmias are frequent complications of cerebral accidents such as head traumas, or of ophthalmic surgery. It is therefore necessary, especially in elderly patients in whom bradyarrhythmias are characterized by the presence of widespread histological alterations of the conduction system, to perform a 24-h monitoring of all adverse events that may lead to an AVB.