In this first systematic study of QoL in a Latin American pacemaker population, AQUAREL detected well-impaired health-related QoL scores in different groups of patients, particularly in those with Chagas disease. Heart failure, evaluated by functional class, was the strongest predictor of low QoL in pacemaker patients.

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Objective -This study was performed to observe the number of pacemakers that had never been reprogrammed after implantation, and the effect of optimised output programming on estimated longevity of pulse generators in patients with pacemaker Methods -Sixty patients with Teletronics Reflex pacemakers were evaluated in a pacemaker clinic, from the time of the beginning of its activities, in June 1998, until March 1999Electric pacing of the heart began around forty years ago and stands out as one of the major achievements in cardiac therapy in the 20th century, combining both physiologic knowledge and technologic advances in the treatment of potentially disabling and fatal bradyarrhythmias. Currently, about 400 thousands pacemakers are implanted every year world-wide 1 , and 50% of pacemaker recipients are still alive when the pulse generator lifespan is over, making them eligible for a new pulse generator. Therefore, the prolongation of the life of pulse generators has been considered desirable and cost-effective because it would postpone a second surgical intervention, eliminating the expense of new generators units 1,2 .Pacemaker longevity is defined as the interval between implantation and detection of the end of pulse generator life, which is determined by the energy consumption of the pulse generator and the deliverable capacity of its power source 3,4 . The deliverable capacity of the power source is fixed for a certain battery, but energy consumption depends on both fixed parameters and physiologic and programmable variables. Therefore, the determinants of the consuption are: programmable output parameters of the system (voltage and pulse width), the frequency and percentage of pacing, the lead impedance, and the static energy drain of the system. Although programming the pacing rate and AV interval can optimise the battery energy drain, the most important parameters that are available to optimise the longevity of a pacing system are stimulation voltage and pulse width 2 .Original settings programmed by the manufacturer are chosen to provide for a sufficient safety margin during the subacute period when stimulation thresholds typically rise. However, most leads used today enable stimulation with reduced output parameters of pacing, resulting in significant reduction in energy drain and, therefore, prolongation of pulse generator life. Thus, reprogramming a pacemaker after a subacute period, according to an obtained stimulation threshold, was a desirable practice recommended in most basic textbooks and by international guidelines 1,3-6 . However, the majority of pacemakers remain at the original programmed

A doença de Chagas é uma patologia endêmica, de larga distribuição nas Américas Central e do Sul. A doença é encontrada em 21 países deste continente, com cerca de16 a 18 milhões de pessoas infectadas e cem milhões em risco de adquiri-la 21 . A miocardite crônica fibrosante que ocorre na fase crônica da doença é responsável não só pela perda da função contrátil do miocárdio como também pelo ABSTRACTThe aim of this study was to compare Chagas and non-Chagas' disease patients using single or dual-chamber pacemaker in relation to the ejection fraction of the left ventricle, the ventricular stimulation threshold and the occurrence of ventricular arrhythmia. From January, 2001 to November, 2002, 45 Chagas' disease patients and 35 non-Chagas' disease patients, all pacemaker users, were evaluated considering clinical history, echocardiographic study, Holter monitoring and analysis of the pacemaker telemetry data. Chagas' disease patients were significantly younger, but both groups were similar when chest X-Ray variables and right ventricular stimulation threshold were analyzed. Chagas' disease patients had a lower left ventricular ejection fraction and more frequent ventricular arrhythmia during Holter monitoring. A positive correlation between the low ejection fraction of the left ventricle and the intensity of ventricular arrhythmia was observed. In conclusion, among pacemaker user patients, Chagas' disease is related to cardiac markers of worse prognosis. Key-words: Chagas' disease. Pacemaker. Arrhythmia. Telemetry.comprometimento do sistema de condução do coração, por variados tipos de arritmias e sua associação não rara com a morte súbita 13 . A importância do bloqueio atrioventricular na doença de Chagas foi reconhecida desde os estudos iniciais de Chagas e Villela 7 , constituindose ainda hoje uma das mais freqüentes indicações para implante de marcapasso no Brasil.

OBJECTIVETo translate, to make the cultural adaptation and to evaluate reproducibility and validity of the Portuguese version of the AQUAREL (Assessment of QUAlity of life and RELated events) questionnaire, which is a specifi c tool to assess quality of life in pacemaker patients. METHODSWe evaluated 202 pacemaker patients: 63 patients during the cross-cultural adaptation stage and 139 during the reproducibility and validity evaluation stages. The questionnaire translation was reviewed repeatedly until ≥85% of patients correctly understood the questions. Reproducibility of the fi nal version was tested in 69 patients in whom the interview was performed twice by the same researcher. Validity was checked by the correlation between scores obtained in AQUAREL domains and those obtained in SF36 domains, in the functional class and the distance walked in the six-minute test. RESULTSThe internal consistency of AQUAREL was adequate, with Cronbach's alpha coeffi cient varying between 0.59 and 0.85. Reproducibility was good, with high correlation coeffi cients (0.68-0.89) and random distribution of data in Bland and Altman plots, without systematic bias. A signifi cant association was observed among AQUAREL domains and those obtained in SF36 domains and the functional class (p<0.01), although significant correlations with the distance walked in the six-minute test were not found. CONCLUSIONThe Portuguese version of the AQUAREL questionnaire is easy and rapid to apply, and could be used as a specifi c questionnaire to assess quality of life in pacemaker patients.

In patients with standard pacing indications, RV apical pacing did not seem to affect RV systolic function, despite induction of electromechanical dyssynchrony.

This study aimed to evaluate the bioequivalence between two products containing Clozapine 100 mg (testing product: LifalClozapina® from Lifal -Industrial Pharmaceutical Laboratory of Alagoas S/A and the reference product: Leponex® from the Novartis Biociências S/A. Laboratories) in 40 volunteers. The study was open, randomized, cross-over type, in a state of equilibrium, with two periods (two sequences) in which volunteers were given, in each period, the testing formulation or the reference formulation. The relative bioavailability of the formulations following oral administration was evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from blood samples in a 24 hours period. The concentration of Clozapine was measured using an appropriate and valid analytical method. The pharmacokinetic measures used were: Cmin and Cmax, and ASCt. The mean differences (± SD) between reference and testing were: 0.1615 ± 0.3404 (ng/mL); -0.0969 ± 0.4131 (ng/mL); and 0.9143 ± 3.9941 (ng*h/mL). The confidence intervals for medium bioequivalence met the limits determined by the National Agency of Sanitary Surveillance (ANVISA) of 80 to 125%, and both medications were considered bioequivalent. Thus, the testing and reference products are considered interchangeable. RESUMO Este estudo teve por objetivo avaliar a bioequivalência entre dois produtos contendo Clozapina 100 mg (produto teste: LifalClozapina ® da Lifal -Laboratório Industrial Farmacêutico de Alagoas S/A. O produto referência: Leponex ® do Laboratório Novartis Biociências S/A.) em 40 voluntários. O estudo foi aberto, randomizado, do tipo cross-over, em estado de equilíbrio, com dois períodos (duas sequências), nos quais os voluntários receberam, em cada período, a formulação teste ou a formulação referência.A biodisponibilidade relativa das formulações seguidas à administração oral foi avaliada com base em comparações estatísticas de parâmetros farmacocinéticos relevantes obtidos de dados de amostra sanguínea dos voluntários, sendo as amostras coletadas em período de 24h. A concentração de Clozapina foi medida a partir de método analítico apropriado e válido. As medidas farmacocinéticas utilizadas foram: Cmin, Cmax e ASCt. As diferenças médias (± DP) entre referência e teste foram: 0,1615 ± 0,3404 (ng/ mL); -0,0969 ± 0,4131 (ng/mL) e 0,9143 ± 3,9941 (ng*h/mL). Os intervalos de confiança para biequivalência média atenderam aos limites determinados pela Agência Nacional de Vigilância Sanitária (ANVISA) de 80 a 125%, sendo os dois medicamentos Estudo comparativo de biodisponibilidade relativa entre duas formulações contendo Clozapina 100 mg em pacientes portadores de esquizofrenia

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