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Background: Transvenous implantable cardioverter-defibrillators (ICD) have been implanted in Poland since 1995. As the method spreads it is important to consider its long-term benefits and disadvantages., Aim: To assess survival, efficacy and complication rate in ICD patients, who received the device more than ten years earlier., Methods: Retrospective analysis of 60 ICD patients implanted between 1995-1999., Results: There were 42 (70%) males, mean age 50.6 ± 16.4 years. In 59 patients ICD was implanted for sudden cardiac death (SCD) secondary prevention. Thirty eight patients (34 M, 63.3%) had coronary artery disease (CAD). The CAD was diagnosed in 89.5% of males and 10.5% of females (p〈 0.0001). Mean follow-up time was 75.4 ± 34.7 months. During this time 22 patients died (37%, 19 M, 3 F). Three deaths were SCD. Mean one-year mortality was 6.7%. Deaths were more frequent among males: 45.2% vs 16.7%, p〈 0.005. In CAD mortality was higher than in non-CAD patients (50% vs 13.6%, p〈 0.005). Appropriate ICD discharges in the ventricular fibrillation (VF) zone occurred in 35 (58%) patients, and in ventricular tachycardia (VT) zone - in 26 (43%) patients. Mean intervention rate per year was 3.7 for VF and 0.6 for VT. Complications occurred in 27 (45%) patients and 5 (8%) of them had no ICD intervention during follow-up. In 5 patients more than one complication was diagnosed. There were inappropriate discharges in 15 (25%) patients, 11 (18%) had electrical storm, and ICD-related infections were noted in 3 (5%) patients. During the perioperative period, lead revisions were done in 4 patients; in 3 with discharges induced by T-wave oversensing and in one with lead dislocation. Four cases of lead failure occurred during follow-up, requiring new lead implantation. In 4 patients, electrical storm (3 patients) and supraventricular tachycardia with ICD discharges (1 patient) were treated with radiofrequency ablation. Only 10 (17%) patients did not demonstrate any ICD interventions or ICD-related complications., Conclusions: 1. ICD interventions caused by malignant ventricular arrhythmias occurred in 75% patients with the device implanted more than 10 years earlier. 2. Almost a half of the analysed population suffered from complications and side effects related to implanted ICD and they were present in 8% of subjects without ICD intervention. Neither ICD interventions nor device-related adverse events were recorded in 17% of patients.

Background: More than 20 randomized trials and 4 meta-analyses have been conducted on the use of prophylactic lidocaine in acute myocardial infarction (MI). The results suggest that lidocaine reduces ventricular fibrillation (VF) but increases mortality rates in acute MI., Methods and Results: Patients with ST-elevation MI who were examined <6 hours after symptom onset (n = 903) were randomly assigned to either lidocaine or no lidocaine and to either streptokinase and heparin or heparin alone. Lidocaine was given as 4 boluses of 50 mg each every 2 minutes, then an infusion of 3 mg/min for 12 hours, then 2 mg/min for 36 hours. We compared the incidence of in-hospital death and ventricular arrhythmias. We then performed a meta-analysis of prophylactic lidocaine in acute MI that included these and prior trial results. The rates of VF and death with and without lidocaine were calculated for each trial, then odds ratios (OR) with confidence intervals (CI) were calculated for the risk of these events overall with and without lidocaine. Patients given lidocaine in the randomized study had significantly less VF (2.0% vs 5.7% without lidocaine, P =.004) and a trend toward increased mortality rates (9.7% vs 7.0%, P =.145). Meta-analysis revealed nonsignificant trends toward reduced VF (OR 0.71, 95% CI 0.47 to 1. 09) and increased mortality rates (OR 1.12, 95% CI 0.91 to 1.36) with lidocaine., Conclusions: Lidocaine reduces VF but may adversely affect mortality rates. The routine use of prophylactic lidocaine in acute MI is not recommended.

In a double-blind, randomized, placebo cross-controlled trial the effectiveness and the adverse effects of two types of buccal tablets containing 5 mg nitroglycerin: Polnitrin produced by Warsaw Pharmaceutical Works POLFA and its analogue of foreign origin, were assessed. The third compared preparation was sublingual nitroglycerin in 0.5 mg tablets. The longest dissolution in the buccal cavity showed Polnitrin (mean 6.6 hours). Polnitrin significantly increased the resting heart rate during 3 hours, and during 6 hours at maximal effort. The foreign analogue decreased significantly the systolic pressure during 3 hours after application. No significant differences were noted in the effects on the basic haemodynamic parameters between the compared buccal tablets. Exercise tolerance and coronary reserve were assessed with repeated exercise tests on moving track (Marquette Case-12). Immediately after being stuck to the gum Polnitrin, its analogue and sublingual nitroglycerin significantly prolonged the marching time: total, till pain, and till ischaemia. After 6 hours the marching time till pain appearance was significantly longer after Polnitrin than after placebo or its analogue. Local adverse effects connected with the presence of the tablet in the oral vestibule may hamper the treatment with Polnitrin in some cases. The most frequent side effect were headaches which are known to occur usually after all nitrates.

Relative bioavailability of amiodarone was studied in 10 healthy volunteers after its 600 mg single dose administration. Mean values of individual maximal concentrations and time for reaching them did not significantly differ and were respectively 0.828 +/- 0.401 microgram/ml and 4.4 +/- 1.5 h for Amiodarone preparation Polfa and 0.541 +/- 0.207 microgram/ml and 5.2 +/- 1.6 h for Cordarone preparation. Bioavailability extent (EBA) of examined preparation was 120 per cent in comparison with the standard one. Amiodarone absorption from both preparations was slow and individually diversified. Absorption rate constant Ka did not statistically significant differ and was respectively 0.35 +/- 0.10 1/h and 0.49 +/- 0.35 1/h. Obtained data indicated that both preparations were biologically equivalent.

In 16 healthy males bioavailability of Mexicord (Polfa) was studied, in comparison with mexiletine of foreign made. Bioavailability extent (EBA) of Mexicord was over 99% in comparison with a standard drug. Comparative study of antiarrhythmic activity and side effects was performed in 32 patients with frequent ventricular premalure beats and nearly in a half of them resistant to antiarrhythmic agents. Mexicord was effective in 47% of treated patients, and side effects (most often nausea) were observed in 28% of patients, but only in 1 case therapy withdrawal was necessary. Statistical study proved a lack of significant differences in antiarrhythmic effectiveness and side effects between Mexicord (Polfa) and a drug of foreign made.

Bioequivalence of Sustonit tablets (2.6 and 6.5 mg) produced at WZF Polfa and Sustac tablets (2.6 and 6.5 mg) made by Krka (Yugoslavia) and WZF Polfa (Poland) was studied by means of the digital plethysmography. All the three drugs with the nitroglycerin content of 2.6 mg were found to be biologically equivalent. On the other hand, Sustonit (WZF Polfa) and Sustac (Krka) tablets with 6.5 mg nitroglycerin proved to possess better bioavailability than Sustac (6.5 mg) tablets produced previously at WZF Polfa.