Patient preference for needleless factor VIII reconstitution device: the Italian experience

Background: Needlestick injuries, mostly due to unsafe needle devices, are a frequent adverse event among health care workers and patients on chronic treatment, such as hemophiliacs. To improve the safety of these procedures, a needleless reconstitution system, Bio-Set\uae has been implemented for the sucrose-formulated recombinant factor VIII (rFVIII-FS) Kogenate\uae Bayer (Bayer Healthcare, Berlin, Germany). The aim of this study was to collect patients' satisfaction and safety data regarding the administration of rFVIII-FS with this new device. Methods: This was a multicenter, prospective, postmarketing surveillance study collecting data from seven Italian Haemophilia Centers within the framework of an international project involving patients from nine European countries. The patients were asked to fill out two preference questionnaires (one assessing the old method and one assessing the new method) directly after the training and two further preference questionnaries (assessing the new method) after a period of about 3 and 12 months. Results: A total of 44 male hemophilia A patients were included in the analysis. At the end of the 12-month observation period, physicians assessed the patients' satisfaction with Kogenate\uae Bayer with Bio-Set\uae in 40.9% (n = 18) as "very satisfied" and in 45.5% (n = 20) as "satisfied", whereas "not satisfied" ratings were given for 9.1% (n = 4) of patients (data missing from two patients, 4.5%). The compliance of the patients compared with the last method before switch to the Bio-Set\uae device was rated as "better", "equal", and "worse" in 72.7% (n = 32), 20.5% (n = 9), and 2.3% (n = 1) of patients, respectively. Three patients (6.8%) experienced adverse events, but only one event was related to rFVIII infusion (inhibitor development in a patient who had little prior exposure to rFVIII) itself and not to the new device per se. Conclusions: The great majority of Italian patients who switched from an older method of rFVIII reconstitution to rFVIII-FS with the new reconstitution method preferred the new method. The ease of use, perceived safety from needlesticks, and the speed of reconstitution were identified as main advantages by the majority patients

Can a single low-intensity premature stimulus induce ventricular arrhythmias in the normal heart?

Previously, we observed that a single low-intensity premature ventricular stimulation could occasionally induce spontaneous ectopic beats in normal rat hearts. Possible hypothesis for the arrhythmia is that a premature beat can encounter a zone of conduction block to initiate reentry. However, enhanced dispersion of repolarization, a necessary condition for initiation of reentry, is unlikely to be present in normal myocardium. Thus, the main objective of the present study was to perform detailed pace mapping measurements in normal ventricular myocardium with a view to identify pacing sites and critical coupling intervals which could induce spontaneous ectopic beats and to characterize the reentrant circuits

Arrhythmia susceptibility in senescent rat hearts

Cardiovascular disease increases with age as well as alterations of cardiac electrophysiological properties, but a detailed knowledge about changes in cardiac electrophysiology relevant to arrhythmogenesis in the elderly is relatively lacking. The aim of this study was to determine specific age-related changes in electrophysiological properties of the ventricles which can be related to a structural-functional arrhythmogenic substrate. Multiple epicardial electrograms were recorded on the ventricular surface of in vivo control and aged rats, while arrhythmia vulnerability was investigated by premature stimulation protocols. Single or multiple ectopic beats and sustained ventricular arrhythmias were frequently induced in aged but not in control hearts. Abnormal ventricular activation patterns during sinus rhythm and unchanged conduction velocity during point stimulation in aged hearts suggest the occurrence of impaired impulse conduction through the distal Purkinje system that might create a potential reentry substrate

Maternal aggression as a model of acute social stress in the rat: a behavioral-electrocardiographic study.

Maternal aggression of lactating rats was used to induce acute social stress in a resident-intruder paradigm. Behavioral and electrocardiographic responses of male intruders were simultaneously recorded. Cardiac electrical activity was measured by means of a telemetry system which ensured preservation of intruder's behavioral repertoire. Behavioral response to maternal attack was evaluated in terms of percent time spent in passive/submissive (p/s) and active/non-submissive (a/ns) patterns. This allowed us to classify the intruders as submissive, non-submissive, and intermediates. During the test, a significant decrease of average R-R interval (R-R) compared to baseline conditions and the occurrence of arrythmias of different nature were found. Ventricular arrhythmias, including premature ventricular beats and ventricular tachycardias, were present in all the intruders while R-R fluctuations and II degree atrioventricular (A-V) blocks only appeared in submissive and intermediate rats. Most ventricular arrhythmias occurred within the upper range of heart rate and were preceded by periods of low R-R variability. These electrocardiographic events were temporally associated with a/ns behavioral patterns and were related to an increased prevalence of sympathetic activity. On the other hand, R-R fluctuations and II degree A-V blocks preceded by high R-R variability were synchronized with p/s behavior and were ascribed to a predominant inhibitory effect of vagal activation which becomes more pronounced as the level of sympathetic activity increases