Pre-clinical and few clinical studies suggest that transplantation of autologous bone marrow mononuclear cells (BMNC) improves heart function in dilated cardiomyopathies. Our objective was to ...determine if intracoronary injection of autologous BMNC improves the left ventricular ejection fraction (LVEF) of patients with non-ischaemic dilated cardiomyopathy (NIDCM).
This study was a multicentre, randomized, double-blind, placebo controlled trial with a follow-up of 12 months. Patients with NIDCM and LVEF <35% were recruited at heart failure ambulatories in specialized hospitals around Brazil. One hundred and sixty subjects were randomized to intracoronary injection of BMNC or placebo (1:1). The primary endpoint was the difference in change of LVEF between BMNC and placebo groups as determined by echocardiography. One hundred and fifteen patients completed the study. Left ventricular ejection fraction decreased from 24.0% (21.6-26.3) to 19.9% (15.4-24.4) in the BMNC group and from 24.3% (22.1-26.5) to 22.1% (17.4-26.8) in the placebo group. There were no significant differences in changes between cell and placebo groups for left ventricular systolic and diastolic volumes and ejection fraction. Mortality rate was 20.37% in placebo and 21.31% in BMNC.
Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827.
Within the chronic obstructive pulmonary disease (COPD) spectrum, lung emphysema presents, as a primarily histopathologic feature, the destruction of pulmonary parenchyma and, accordingly, an ...increase in the airflow obstruction distal to the terminal bronchiole. Notwithstanding the significant advances in prevention and treatment of symptoms, no effective or curative therapy has been accomplished. In this context, cellular therapy with stem cells (SCs) arises as a new therapeutic approach, with a wide application potential. The purpose of this study is to evaluate the safety of SCs infusion procedure in patients with advanced COPD (stage IV dyspnea). After selection, patients underwent clinical examination and received granulocyte colony-stimulating factor, immediately prior to the bone marrow harvest. The bone marrow mononuclear cells (BMMC) were isolated and infused into a peripheral vein. The 12-month follow-up showed a significant improvement in the quality of life, as well as a clinical stable condition, which suggest a change in the natural process of the disease. Therefore, the proposed methodology in this study for BMMC cell therapy in sufferers of advanced COPD was demonstrated to be free of significant adverse effects. Although a larger sample and a greater follow-up period are needed, it is possible to infer that BMMC cell therapy introduces an unprecedented change in the course or in the natural history of emphysema, inhibiting or slowing the progression of disease. This clinical trial was registered with ClinicalTrials.gov (NCT01110252) and was approved by the Brazilian National Committee of Ethics in Research (registration no. 14764, CONEP report 233/2009).
Abstract Background Worsening in clinical and cardiac status has been noted after chronic right ventricular pacing, but it is uncertain whether atriobiventricular (BiVP) is preferable to atrio-right ...ventricular pacing (RVP). Conventional versus Multisite Pacing for BradyArrhythmia Therapy study (COMBAT) sought to compare BiVP versus RVP in patients with symptomatic heart failure (HF) and atrioventricular (AV) block. Methods and Results COMBAT is a prospective multicenter randomized double blind crossover study. Patients with New York Heart Association functional class (FC) II-IV, left ventricular ejection fraction (LVEF) <40%, and AV block as an indication for pacing were enrolled. All patients underwent biventricular system implantation and then were randomized to receive successively (group A) RVP-BiVP-RVP, or (group B) BiVP-RVP-BiVP. At the end of each 3-month crossover period, patients were evaluated according to Quality of Life (QoL), FC, echocardiographic parameters, 6-Minute Walk Test (6MWT), and peak oxygen consumption (VO2max ). Sixty patients were enrolled, and the mean follow-up period was 17.5 ± 10.7 months. There were significant improvements in QoL, FC, LVEF, and left ventricular end-systolic volume with BiVP compared with RVP. The effects of pacing mode on 6MWT and VO2max were not significantly different. Death occurred more frequently with RVP. Conclusion In patients with systolic HF and AV block requiring permanent ventricular pacing, BiVP is superior to RVP and should be considered the preferred pacing mode.
Na Antiguidade, uma particularidade dos povos semitas era a tendência a localizar no coração a dimensao espiritual do homem. Entre os gregos antigos, observa-se a mesma perspectiva cardiocêntrica, ...presente nos textos de Homero, Hesíodo e Ésquilo, que remetem a um universo de significados e açoes que têm como foco a pessoa na sua integridade.
Na Antiguidade, uma particularidade dos povos semitas era a tendência a localizar no coração a dimensao espiritual do homem. Entre os gregos antigos, observa-se a mesma perspectiva cardiocêntrica, ...presente nos textos de Homero, Hesíodo e Ésquilo, que remetem a um universo de significados e açoes que têm como foco a pessoa na sua integridade.
Na Antiguidade, uma particularidade dos povos semitas era a tendência a localizar no coração a dimensao espiritual do homem. Entre os gregos antigos, observa-se a mesma perspectiva cardiocêntrica, ...presente nos textos de Homero, Hesíodo e Ésquilo, que remetem a um universo de significados e açoes que têm como foco a pessoa na sua integridade.
Introduction: The cardiovascular system (CVS) is heavily influenced by the autonomic nervous system. Additionally, there is a functional alteration during the various stages of sleep. In nonrapid eye ...movement (NREM), a state of cardiovascular relaxation occurs during stages three and four. A large amount of rapid ocular movements is concentrated in rapid eye movement (REM) sleep. During this phase, fluctuations in arterial pressure (AP) and heart rate (HR) can be readily noted. Sleep disordered breathing (SDB) has been associated with cardiac rhythm disorders. Recently, cardiac rhythm disorder treatment with pacemaker (PM) highlighted a reduction in abnormal respiratory events during sleep.
Objective: Comparison of sleep parameters of patients using PM with a sleep rate (SR) algorithm based on its rate‐modulated capability during physical activity (Integrity™ PM with SR function on and off).
Methods: Twenty‐two patients (14 women, 8 men), implanted with an Integrity PM (St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA) with SR function for standard clinical indications, were evaluated utilizing a double‐blind protocol. The indication for pacing included sinus node disease (SND), atrium ventricular blockage (AVB), and atrial fibrillation (AF). Following randomization, half of our patients had SR function switched to “on” mode while the other half were on “off” mode. During the first stage of the protocol, all patients underwent two consecutive nights of polysomnographic sleep recordings (PSG). During the first night patients slept in the sleep lab only for adaptation purpose. PSG full recording was carried out in the subsequent night. At a later stage, the programing of SR functions was shifted to “on” or “off” modes. One week later, a third assessment was undertaken.
Results: Twelve patients (54%) showed sleep efficiency improvement (total sleeping time/recording time) with PM SR on. This group had the least effective sleep efficiency with PM off, if compared with the others who highlighted no change in this sleep parameter (72 ± 12 vs 81 ± 7%, P = 0.01, respectively). This first group displayed a lower latency for REM sleep than the last one (89 ± 55 vs 174 ± 107 minutes, P = 0.01, respectively). In 11 (50%) patients, the number per sleep hour of microarousals was reduced when PM SR was switched on. When we compared such findings to the group whose parameters had not changed, we noted that the first set of patients were sleepier (ESE: 9 ± 4 vs 5 ± 5, P = 0.04, respectively), and showed more microarousals with PM SR off (20 ± 14 vs 7 ± 5 microarousal/hour, P = 0.007).
Conclusion: In PM patients with sleep‐related issues, the SR function activation improved sleep both from a qualitative and quantitative perspective.
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