COMPREHENSIBILITY OF THE PACKAGE LEAFLETS OF ALL MEDICINAL PRODUCTS FOR HUMAN USE: A QUESTIONNAIRE SURVEY ABOUT THE USE OF SYMBOLS AND PICTOGRAMS

Directive 92/27EEC establishes that the package leaflet is a document, which must be included in the package of medicinal products for human use in EU countries. This informative leaflet is directed at the users and it must give full and comprehensible information. The Law suggests the use of symbols but it does not give advice about the subjects to be represented. In order to evaluate the attitude of patients towards package leaflets provided with symbols, we planned a survey interviewing 1004 patients in pharmacies. The data suggest that Italian patients usually read the package leaflet but they neither understand it easily nor find the needed information readily. Most respondents (74.3%) considered the use of symbols helpful in finding the needed information. We proposed five symbols for each heading (therapeutic indications, side effects, paediatric use, contraindications, use in pregnancy) and asked to select which symbol could be used. In the case of 'side effects', 'paediatric use', 'use in pregnancy' and 'dose', most of the respondents chose the same symbol. In the case of 'therapeutic indications' and 'contraindications' there was no uniformity in the answers. The choice depends greatly on education, age and employment of respondents.     

The effects of sleep deprivation in humans: topographical electroencephalogram changes in non‐rapid eye movement (NREM) sleep versus REM sleep

Studies on homeostatic aspects of sleep regulation have been focussed upon non‐rapid eye movement (NREM) sleep, and direct comparisons with regional changes in rapid eye movement (REM) sleep are sparse. To this end, evaluation of electroencephalogram (EEG) changes in recovery sleep after extended waking is the classical approach for increasing homeostatic need. Here, we studied a large sample of 40 healthy subjects, considering a full‐scalp EEG topography during baseline (BSL) and recovery sleep following 40 h of wakefulness (REC). In NREM sleep, the statistical maps of REC versus BSL differences revealed significant fronto‐central increases of power from 0.5 to 11 Hz and decreases from 13 to 15 Hz. In REM sleep, REC versus BSL differences pointed to significant fronto‐central increases in the 0.5–7 Hz and decreases in the 8–11 Hz bands. Moreover, the 12–15 Hz band showed a fronto‐parietal increase and that at 22–24 Hz exhibited a fronto‐central decrease. Hence, the 1–7 Hz range showed significant increases in both NREM sleep and REM sleep, with similar topography. The parallel change of NREM sleep and REM sleep EEG power is related, as confirmed by a correlational analysis, indicating that the increase in frequency of 2–7 Hz possibly subtends a state‐aspecific homeostatic response. On the contrary, sleep deprivation has opposite effects on alpha and sigma activity in both states. In particular, this analysis points to the presence of state‐specific homeostatic mechanisms for NREM sleep, limited to <2 Hz frequencies. In conclusion, REM sleep and NREM sleep seem to share some homeostatic mechanisms in response to sleep deprivation, as indicated mainly by the similar direction and topography of changes in low‐frequency activity.     

Five Years of Catheter Ablation Procedures in South-Western Europe: Meta-Analysis of National Registries

Background: Radiofrequency catheter ablation is a well-established approach to treating several types of cardiac arrhythmias. The aim of our study was to provide data on the diffusion of catheter ablation procedures in clinical practice through a meta-analysis of National Registries of electrophysiological procedures performed over a 5-year period, from 2000 to 2005.
Methods: We found only two national registries of catheter ablation procedures published in the journals indexed in PubMed: The Spanish Catheter Ablation Registry and the Portuguese National Registry on Cardiac Electrophysiology. In addition, we included in our analysis the data from the Italian Registry of Electrophysiological Procedures.
Results and Conclusions: This meta-analysis revealed a steady increase in the total number of catheter ablation procedures, particularly for the ablation of atrial flutter, of tachycardia due to double nodal pathways, and of the left atrial substrate in atrial fibrillation. However, the progress of catheter ablation and the impetus for additional research and development of new approaches and technologic advances requires further data on clinical indications, methodologic approach, complications, and long-term success rate in the real world.     

Long-Term Outcomes of CRT-PM Versus CRT-D Recipients

Objective: To compare the rates of all-cause mortality in recipients of cardiac resynchronization therapy devices without (CRT-PM) versus with defibrillator (CRT-D).
Methods: Between February 1999 and July 2004, 233 patients (mean age = 69 ± 8 years, 180 men) underwent implantation of CRT-PM or CRT-D devices. New York Heart Association (NYHA) heart failure functional class II was present in 11%, class III in 69%, and class IV in 20% of patients; mean left ventricle ejection fraction (LVEF) was 26.5 ± 6.5 %, 48% presented with idiopathic dilated cardiomyopathy and 49% with ischemic heart disease. Cox multiple variable regression analysis was performed in search of predictors of death.
Results: The clinical characteristics of the 117 CRT-PM and 116 CRT-D recipients were similar, except for LVEF (28.2 ± 6.2% vs 25.0 ± 6.5%, respectively; P < 0.001), and ischemic versus nonischemic etiology of heart failure (41% vs 56%, respectively P = 0.02). Over a mean follow-up of 58 ± 15 months, no significance difference in overall mortality rate was observed between the two study groups. Male sex, NYHA functional class IV, and atrial fibrillation at implant were significant predictors of death.
Conclusions: There was no difference in long-term survival rate among patients with CRT-D versus CRT-PM, although CRT-D more effectively lowered the sudden death rate. Male sex, NYHA functional class IV, and atrial fibrillation predicted the worst prognosis.     

Sleep Disordered Breathing and Arrhythmia Burden in Pacemaker Recipients

Background: Sleep disordered breathing (SDB), a common condition among patients with permanent pacemaker (PM), is associated with greater incidence of cardiac arrhythmias. Scarce availability of sleep laboratories and the high costs of nocturnal‐attended polysomnography limit the routine screening of patients with PM for SDB. We investigated whether a novel PM that utilizes variations in transthoracic impedance to record the fluctuations in breathing pattern and minute ventilation could be used to screen patients for SDB. Methods: Twenty patients who underwent dual‐chamber PM implantation were studied. The Talent 3 DR PM (SORIN Group Italy S.r.l., Milan, Italy) calculates apnea‐hypopnea index (AHI) by computing minute ventilation signal derived from transthoracic impedance measurements. Within a month after PM implantation, an in‐home respiratory monitoring was performed to evaluate the accuracy of PM‐derived AHI. Patients were followed for mean ± standard deviation, 487 ± 166 days. The PM was checked at each follow‐up visit to retrieve the information about recurrent arrhythmias. Results: Eleven patients were diagnosed with SDB by an in‐home respiratory monitoring. An AHI derived from an in‐home respiratory monitoring was similar to pacemaker‐derived AHI (27 ± 14 vs 16 ± 13 events/hour, P = 0.15). The cumulative incidence of cardiac arrhythmias, including atrial fibrillation, extrasystolic beats, sustained and nonsustained ventricular tachycardia, and supraventricular tachycardia was similar in patients with and without SDB. Conclusion: SDB is highly prevalent in patients with permanent pacemaker. Screening for SDB with Talent 3 DR PM may facilitate diagnosis and treatment of SDB. (PACE 2010; 33:1462–1466)     

Uncommon complication of endoscopic ureterolithotripsy: The stone granuloma

Endoscopic management of urolithiasis is one of the commonest urological procedures today. It is usually safe and effective but one of the possible complications is ureteral obstruction. Stone fragmentation after ballistic lithotripsy and ureteral wall perforation could explain the mechanism responsible for this occurrence. We report a case of stone granuloma, occurring after a ballistic ureterolithotripsy.     

Permanent Mechanical Catheter Ablation of an Accessory Pathway in a Child

Permanent mechanical ablation of an accessory atrioventricular pathway was observed in an infant during intracavitary electrophysiological mapping. The persistent lack of preexcitation was confirmed during a 15-month follow-up period.     

Low Energy Intracardiac Cardioversion of Persistent Atrial Fibrillation

The aims of the study were to verify the efficacy and safety of low energy internal Cardioversion (LEIC) in patients with persistent at rial fibrillation (AF) and to identify the factors affecting the at rial defihrillation threshold (ADT). Forty-nine patients with persistent (lasting ≥ 10 days) AF underwent LEIC. In each patient, two 6 Fr custom-made catheters with large active surface areas were positioned in the coronary sinus (cathode) and the lateral right wall (anode), respectively, for shock delivery, and a tetrapolar lead was placed in the fight ventricular apex for R wave synchronization. Truncated, biphasic (3 ms+3 ms). exponential shocks were used, beginning at 50 V and increasing in steps of 50 V until sinus rhythm had been restored. Mild sedation (diazepam 5 mg IV) was administered to 12 patients. Sinus rhythm was restored in all the subjects with mean voltage and energy levels of 352.0 ± 80.3 V and 8.2 ± 3.4 J, respectively. The ADT in patients pretreated with amiodarone (6.4 ± 1.8 J) was lower than that of patients who had not received any antiarrhythmic drugs (9.2 ± 3.7) (P = 0.04). No ventricular arrhythmias were induced by any of the atrial shocks, and no other complications were observed. During a mean follow-up of 162.9 ± 58.7 days, AF recurred in 21 (43%) patients; 71% of these occurred in the first week after Cardioversion. LEIC is effective in restoring sinus rhythm in patients with persistent AF. The technique seems to be safe and does not require general anesthesia or, in most cases, sedation. Patients pretreated with amiodarone have lower ADTs.