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Trial II (trial + ii)
Selected AbstractsClinical Course and Implantable Cardioverter Defibrillator Therapy in Postinfarction Women with Severe Left Ventricular DysfunctionJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 12 2005Ph.D. , WOJCIECH ZAREBA M.D. Background: There are limited data regarding implantable cardioverter defibrillator (ICD) therapy in postinfarction women with severe left ventricular dysfunction. The aim of this study was to evaluate the risk of cardiac events and effects of ICD therapy in women as compared to men enrolled in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). Methods and Results: Among 1,232 patients enrolled in MADIT II, there were 192 (16%) women and 1,040 (84%) men. When compared to men, women had an increased frequency of NYHA class ,II (70 vs 63%; P = 0.067), hypertension (60% vs 52%; P = 0.047), diabetes (42% vs 34%; P = 0.027), and LBBB (25% vs 17%; P = 0.011), and less frequent CABG surgery (42% vs 60%; P < 0.001). The 2-year cumulative mortality in patients randomized to conventional therapy was not significantly different in women and men (30% and 20%, respectively; P = 0.19). Adjusting for relevant clinical covariates, the hazard ratios for ICD effectiveness were similar in women (0.57; 95% CI = 0.28,1.18; P = 0.132) and men (0.66; 95% CI = 0.48,0.91; P = 0.011). The risk of appropriate ICD therapy for VT/VF was lower in women than in men (hazard ratio = 0.60 for female vs male gender; 95% CI = 0.37,0.98; P = 0.039). Conclusions: MADIT II women had similar mortality and similar ICD effectiveness when compared to men. MADIT II women with ICDs had a lower risk of arrhythmic events with fewer episodes of ventricular tachycardia than men. [source] The Clinical Implications of Cumulative Right Ventricular Pacing in the Multicenter Automatic Defibrillator Trial IIJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 4 2005JONATHAN S. STEINBERG M.D. Introduction: This study was designed to assess whether right ventricular pacing in the implantable cardioverter defibrillator (ICD) arm of the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II was associated with an unfavorable outcome. Methods and Results: Data on the number of ventricular paced beats were available in 567 (76%) of 742 MADIT II patients with ICDs. The number of ventricular paced beats over the total number of beats showed a bimodal distribution with patients being predominantly paced or nonpaced. Therefore, patients were dichotomized at 0,50% and 51,100% of cumulative pacing with median pacing rate 0.2% and 95.6%, respectively. Endpoints included new or worsening heart failure, appropriate ICD therapy for VT/VF, and the combined endpoint of heart failure or death. Clinical features associated with frequent ventricular pacing included age ,65 years, advanced NYHA heart failure class, LVEF < 0.25, first degree AV and bundle branch block, and amiodarone use. During follow-up, 119 patients (21%) had new or worsened heart failure, 130 (23%) had new or worsened heart failure or death, and 142 (25%) had appropriate therapy for VT/VF. In comparison to patients with infrequent pacing, those with frequent pacing had significantly higher risk of new or worsened heart failure (hazard ratio = 1.93; P = 0.002) and VT/VF requiring ICD therapy (HR = 1.50; P = 0.02). Conclusions: Patients in MADIT II who were predominantly paced had a higher rate of new or worsened heart failure and were more likely to receive therapy for VT/VF. These results suggest the deleterious consequences of RV pacing, particularly in the setting of severe LV dysfunction. [source] Abnormal P-Wave Morphology Is a Predictor of Atrial Fibrillation Development and Cardiac Death in MADIT II PatientsANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 1 2010Fredrik Holmqvist M.D., Ph.D. Background: Several ECG-based approaches have been shown to add value when risk-stratifying patients with congestive heart failure, but little attention has been paid to the prognostic value of abnormal atrial depolarization in this context. The aim of this study was to noninvasively analyze the atrial depolarization phase to identify markers associated with increased risk of mortality, deterioration of heart failure, and development of atrial fibrillation (AF) in a high-risk population with advanced congestive heart failure and a history of acute myocardial infarction. Methods: Patients included in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) with sinus rhythm at baseline were studied (n = 802). Unfiltered and band-pass filtered signal-averaged P waves were analyzed to determine orthogonal P-wave morphology (prespecified types 1, 2, and 3/atypical), P-wave duration, and RMS20. The association between P-wave parameters and data on the clinical course and cardiac events during a mean follow-up of 20 months was analyzed. Results: P-wave duration was 139 ± 23 ms and the RMS20 was 1.9 ± 1.1 ,V. None of these parameters was significantly associated with poor cardiac outcome or AF development. After adjustment for clinical covariates, abnormal P-wave morphology was found to be independently predictive of nonsudden cardiac death (HR 2.66; 95% CI 1.41,5.04, P = 0.0027) and AF development (HR 1.75; 95% CI 1.10,2.79, P = 0.019). Conclusion: Abnormalities in P-wave morphology recorded from orthogonal leads in surface ECG are independently predictive of increased risk of nonsudden cardiac death and AF development in MADIT II patients. Ann Noninvasive Electrocardiol 2010;15(1):63,72 [source] Altered Interatrial Conduction Detected in MADIT II Patients Bound to Develop Atrial FibrillationANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 3 2009Fredrik Holmqvist M.D., Ph.D. Background: Changes in P-wave morphology have recently been shown to be associated with interatrial conduction route used, without noticeable changes of P-wave duration. This study aimed at exploring the association between P-wave morphology and future atrial fibrillation (AF) development in the Multicenter Automatic Defibrillator Trial II (MADIT II) population. Methods: Patients included in MADIT-II without a history of AF with sinus rhythm at baseline who developed AF during the study ("Pre-AF") were compared to matched controls without AF development ("No-AF"). Patients were followed for a mean of 20 months. A 10-minute high-resolution bipolar ECG recording was obtained at baseline. Signal-averaged P waves were analyzed to determine orthogonal P-wave morphology, P-wave duration, and RMS20. The P-wave morphology was subsequently classified into one of three predefined types using an automated algorithm. Results: Thirty patients (age 68 ± 7 years) who developed AF during MADIT-II were compared with 60 patients (age 68 ± 8 years) who did not. P-wave duration and RMS20 in the Pre-AF group was not significantly different from the No-AF group (143 ± 21 vs 139 ± 30 ms, P = 0.26, and 2.0 ± 1.3 vs 2.1 ± 1.0 ,V, P = 0.90). The distribution of P-wave morphologies was shifted away from Type 1 in the Pre-AF group when compared to the No-AF group (Type 1/2/3/atypical; 25/60/0/15% vs 10/63/10/17%, P = 0.04). Conclusions: This study is the first to describe changes in P-wave morphology in patients prior to AF development. The results indicate that abnormal interatrial conduction may play a role in AF development in patients with prior myocardial infarction and congestive heart failure. [source] Treatment development for systemic Tetrahymena sp. infection in guppies, Poecilia reticulata PetersJOURNAL OF FISH DISEASES, Issue 6 2010M Pimenta Leibowitz Abstract Antibacterial and antiparasitic agents and a cysteine protease inhibitor (E-64) were tested against Tetrahymena infection, a serious problem in guppy production worldwide. Chemicals were tested in vitro by a colorimetric assay for Tetrahymena survival. The most effective were niclosamide, albendazole and chloroquine, with 23%, 35% and 60% survival, respectively, following 2-h exposure to 100 ppm. Longer incubation periods resulted in greater reductions in survival. Niclosamide was further studied in vivo at different dosages, administered orally to Tetrahymena -infected guppies. Mortality rates were significantly lower in all treatment groups; in trial I, 30% and 33% mortality in 5 and 40 mg kg,1 niclosamide-fed fish vs. 59% mortality in controls; in trial II, 35%, 13% and 10% in 50, 100 and 200 mg kg,1 niclosamide-fed fish vs. 64% in controls. The effect of the cysteine protease inhibitor E64 was tested in tissue culture, by measuring histolytic activity of the parasite (Tet-NI) on a guppy-fin cell line, based on cell depletion. Tet-NI feeding activity was significantly reduced following pretreatment with E-64 relative to non-treated Tet-NI. E-64-pretreated Tet-NI was injected i.p. into guppies: recorded mortality rates were significantly lower (35%) than that in non-treated Tet-NI (60%), suggesting inhibition of the parasite's cysteine protease as a possible therapeutic approach. [source] Induced cross-protection in channel catfish, Ictalurus punctatus (Rafinesque), against different immobilization serotypes of Ichthyophthirius multifiliisJOURNAL OF FISH DISEASES, Issue 3 2006D-H Xu Abstract Channel catfish, Ictalurus punctatus (Rafinesque), were immunized with Ichthyophthirius multifiliis (Ich) theronts and trophonts, and the immune response and host protection against both homologous and heterologous serotypes of Ich were evaluated. Immunizations were done with two immobilization serotypes (ARS4 and ARS6) of live theronts by bath immersion (trial I) and with sonicated trophonts by intraperitoneal (i.p.) injection (trial II). Cutaneous and serum antibody titres against Ich following immunization were measured and survival of catfish was determined after theront challenge. Theronts were immobilized by the antiserum from fish immunized with homologous theronts or trophonts, but not by the serum of fish immunized with the heterologous serotype. Serum from fish immunized by immersion with live theronts showed higher enzyme-linked immunosorbent assay titres against both homologous and heterologous serotypes than fish immunized by i.p. injection of trophonts. Channel catfish immunized by immersion with live theronts or by i.p. injection with sonicated trophonts developed an immune response against Ich and provided cross-protection against challenge from both serotypes (ARS4 and ARS6) of the parasite. Sonicated trophont antigens in aqueous solution by i.p. injection could stimulate an immune response in fish, but the immunity was of short duration. [source] | ||||||||||