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1.
PLoS One ; 14(7): e0219966, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31314790

RESUMO

INTRODUCTION: The aim of this study was to investigate the predictors of long-term clinical outcome of heart failure (HF) patients who survived first year after initiation of cardiac resynchronization therapy (CRT). METHODS: This was a single-center observational cohort study of CRT patients implanted because of symptomatic HF with reduced ejection fraction between 2005 and 2013. Left ventricle (LV) diameters and ejection fraction, New York Heart Association (NYHA) class, and level of N-terminal fragment of pro-brain natriuretic peptide (NT-proBNP) were assessed at baseline and 12 months after CRT implantation. Their predictive power for long-term HF hospitalization and mortality, and cardiac and all-cause mortality was investigated. RESULTS: A total of 315 patients with left bundle branch block or intraventricular conduction delay who survived >1 year after CRT implantation were analyzed in the current study. During a follow-up period of 4.8±2.1 years from CRT implantation, 35.2% patients died from cardiac (19.3%) or non-cardiac (15.9%) causes. Post-CRT LV ejection fraction and LV end-systolic diameter (either 12-month value or the change from baseline) were equally predictive for clinical events. For NT-proBNP, however, the 12-month level was a stronger predictor than the change from baseline. Both reverse LV remodeling and 12-month level of NT-proBNP were independent and comparable predictors of CRT-related clinical outcome, while NT-proBNP response had the strongest association with all-cause mortality. When post-CRT relative change of LV end-systolic diameter and 12-month level of NT-proBNP (dichotomized at -12.3% and 1230 ng/L, respectively) were combined, subgroups of very-high and very-low risk patients were identified. CONCLUSION: The level of NT-proBNP and reverse LV remodeling at one year after CRT are independent and complementary predictors of future clinical events. Their combination may help to improve the risk stratification of CRT patients.

2.
Eur Heart J ; 40(26): 2121-2127, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31046090

RESUMO

AIMS: The very long-term outcome of patients who survive the first few years after receiving cardiac resynchronization therapy (CRT) has not been well described thus far. We aimed to provide long-term outcomes, especially with regard to the occurrence of sudden cardiac death (SCD), in CRT patients without (CRT-P) and with defibrillator (CRT-D). METHODS AND RESULTS: A total of 1775 patients, with ischaemic or non-ischaemic dilated cardiomyopathy, who were alive 5 years after CRT implantation, were enrolled in this multicentre European observational cohort study. Overall long-term mortality rates and specific causes of death were assessed, with a focus on late SCD. Over a mean follow-up of 30 months (interquartile range 10-42 months) beyond the first 5 years, we observed 473 deaths. The annual age-standardized mortality rates of CRT-D and CRT-P patients were 40.4 [95% confidence interval (CI) 35.3-45.5] and 97.2 (95% CI 85.5-109.9) per 1000 patient-years, respectively. The adjusted hazard ratio (HR) for all-cause mortality was 0.99 (95% CI 0.79-1.22). Twenty-nine patients in total died of late SCD (14 with CRT-P, 15 with CRT-D), corresponding to 6.1% of all causes of death in both device groups. Specific annual SCD rates were 8.5 and 5.8 per 1000 patient-years in CRT-P and CRT-D patients, respectively, with no significant difference between groups (adjusted HR 1.0, 95% CI 0.45-2.44). Death due to progressive heart failure represented the principal cause of death (42.8% in CRT-P patients and 52.6% among CRT-D recipients), whereas approximately one-third of deaths in both device groups were due to non-cardiovascular death. CONCLUSION: In this first description of very long-term outcomes among CRT recipients, progressive heart failure death still represented the most frequent cause of death in patients surviving the first 5 years after CRT implant. In contrast, SCD represents a very low proportion of late mortality irrespective of the presence of a defibrillator.

3.
Circ Arrhythm Electrophysiol ; 8(5): 1113-21, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26338831

RESUMO

BACKGROUND: Electric left ventricular lead position, assessed by the electric delay from the beginning of the QRS complex to the local LV electrogram (QLV), was found in previous studies to be a strong predictor of short-term response to cardiac resynchronization therapy. We hypothesized that suboptimum electric position of the left ventricular lead is associated with an excess of heart failure events and mortality. METHODS AND RESULTS: We analyzed the clinical outcome of patients with left bundle branch block or intraventricular conduction delay treated with cardiac resynchronization therapy at our institution during 9 years. Baseline clinical characteristics, QLV/QRS duration (QLV ratio) at cardiac resynchronization therapy implant, and data about heart failure hospitalization and mode of death were collected in 329 patients who were followed for a period of 3.3±1.9 years. Of them, 83 were hospitalized for heart failure and 83 died. Event rates for all-cause mortality, cardiac mortality, noncardiac mortality, heart failure mortality, and sudden death were 25.2%, 14.9%, 10.3%, 12.2%, and 2.1%, respectively. Patients with a QLV ratio ≤0.70 had significantly worse event-free survival for all study end points--hazard ratio, 1.6; 95% confidence interval, 1.0 to 2.4; P=0.05 for heart failure hospitalization; hazard ratio, 2.9; 95% confidence interval, 1.6 to 5.5; P=0.001 for heart failure mortality; hazard ratio, 1.8; 95% confidence interval, 1.1 to 2.7; P=0.01 for cardiac mortality; and hazard ratio, 2.1; 95% confidence interval, 1.2 to 3.7; P=0.01 for all-cause mortality. In multivariable analysis, QLV ratio ≤0.70 remained associated with all study end points. CONCLUSIONS: Electric left ventricular lead position in cardiac resynchronization therapy patients was a significant predictor of heart failure hospitalization and mortality.


Assuntos
Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/terapia , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Sistema de Condução Cardíaco/anormalidades , Ventrículos do Coração/fisiopatologia , Idoso , Arritmias Cardíacas/fisiopatologia , Síndrome de Brugada , Bloqueio de Ramo/fisiopatologia , Doença do Sistema de Condução Cardíaco , Feminino , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Retrospectivos , Taxa de Sobrevida
5.
J Cardiovasc Electrophysiol ; 25(8): 882-888, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24724625

RESUMO

BACKGROUND: The left ventricular (LV) lead local electrogram (EGM) delay from the beginning of the QRS complex (QLV) is considered a strong predictor of response to cardiac resynchronization therapy. We have developed a method for fast epicardial QLV mapping during video-thoracoscopic surgery to guide LV lead placement. METHODS: A three-port, video-thoracoscopic approach was used for LV free wall epicardial mapping and lead implantation. A decapolar electrophysiological catheter was introduced through one port and systematically attached to multiple accessible LV sites. The pacing lead was targeted to the site with maximum QLV. The LV free wall activation pattern was analyzed in 16 pre-specified anatomical segments. RESULTS: We implanted LV leads in 13 patients with LBBB or IVCD. The procedural and mapping times were 142 ± 39 minutes and 20 ± 9 minutes, respectively. A total of 15.0 ± 2.2 LV segments were mappable with variable spatial distribution of QLV-optimum. The QLV ratio (QLV/QRSd) at the optimum segment was significantly higher (by 0.17 ± 0.08, p < 0.00001) as compared to an empirical midventricular lateral segment. The LV lead was implanted at the optimum segment in 11 patients (at an adjacent segment in 2 patients) achieving a QLV ratio of 0.82 ± 0.09 (range 0.63-0.93) and 99.5 ± 0.6% match with intraprocedural mapping. CONCLUSION: Video-thoracoscopic LV lead implantation can be effectively and safely guided by epicardial QLV mapping. This strategy was highly successful in targeting the selected LV segment and resulted in significantly higher QLV ratios compared to an empirical midventricular lateral segment.


Assuntos
Bloqueio de Ramo/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Mapeamento Epicárdico , Ventrículos do Coração/cirurgia , Pericárdio/fisiopatologia , Cirurgia Torácica Vídeoassistida , Idoso , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/fisiopatologia , Terapia de Ressincronização Cardíaca/efeitos adversos , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Fatores de Tempo , Função Ventricular Esquerda , Pressão Ventricular
6.
BMC Cardiovasc Disord ; 12: 34, 2012 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-22607487

RESUMO

BACKGROUND: Considerable proportion of patients does not respond to the cardiac resynchronization therapy (CRT). This study investigated clinical relevance of left ventricular electrode local electrogram delay from the beginning of QRS (QLV). We hypothesized that longer QLV indicating more optimal lead placement in the late activated regions is associated with the higher probability of positive CRT response. METHODS: We conducted a retrospective, single-centre analysis of 161 consecutive patients with heart failure and LBBB or nonspecific intraventricular conduction delay (IVCD) treated with CRT. We routinely intend to implant the LV lead in a region with long QLV. Clinical response to CRT, left ventricular (LV) reverse remodelling (i.e. decrease in LV end-systolic diameter - LVESD ≥10%) and reduction in plasma level of NT-proBNP >30% at 12-month post-implant were the study endpoints. We analyzed association between pre-implant variables and the study endpoints. RESULTS: Clinical CRT response rate reached 58%, 84% and 92% in the lowest (≤105 ms), middle (106-130 ms) and the highest (>130 ms) QLV tertile (p < 0.0001), respectively. Longer QRS duration (p = 0.002), smaller LVESD and a non-ischemic cardiomyopathy (both p = 0.02) were also univariately associated with positive clinical CRT response. In a multivariate analysis, QLV remained the strongest predictor of clinical CRT response (p < 0.00001), followed by LVESD (p = 0.01) and etiology of LV dysfunction (p = 0.04). Comparable predictive power of QLV for LV reverse remodelling and NT-proBNP response rates was observed. CONCLUSION: LV lead position assessed by duration of the QLV interval was found the strongest independent predictor of beneficial clinical response to CRT.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Técnicas Eletrofisiológicas Cardíacas , Bloqueio Cardíaco/terapia , Insuficiência Cardíaca/terapia , Função Ventricular Esquerda , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Bloqueio de Ramo/fisiopatologia , Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca/efeitos adversos , Distribuição de Qui-Quadrado , República Tcheca , Desenho de Equipamento , Feminino , Bloqueio Cardíaco/sangue , Bloqueio Cardíaco/fisiopatologia , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/fisiopatologia , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Valor Preditivo dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Remodelação Ventricular
7.
Lancet ; 374(9692): 787-95, 2009 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-19717184

RESUMO

BACKGROUND: Otamixaban is an intravenous direct factor Xa inhibitor. We aimed to assess its efficacy and safety in non-ST-elevation acute coronary syndromes and to identify the optimum dose range for further assessment in a phase 3 study. METHODS: In this double-blind, phase 2 trial undertaken in 196 sites in 36 countries, 3241 patients with non-ST-elevation acute coronary syndromes were randomly assigned via a central, telephone-based interactive voice response system to one of five doses of otamixaban (0.08 mg/kg bolus followed by infusions of 0.035 [n=125], 0.070 [676], 0.105 [662], 0.140 [658], or 0.175 [671] mg/kg/h) or to a control of unfractionated heparin (60 IU/kg intravenous bolus followed by an infusion of 12 IU/kg/h) plus eptifibatide (180 microg/kg intravenous bolus followed by an infusion of 1.0-2.0 microg/kg/min [n=449]). Both investigators and patients were unaware of treatment allocation. Enrolment into the lowest dose group was stopped early at the recommendation of the Data Monitoring Committee. The primary efficacy endpoint was a composite of death, myocardial infarction, urgent revascularisation, or bailout glycoprotein IIb/IIIa inhibitor use up to 7 days. The primary safety endpoint was TIMI major or minor bleeding not related to coronary-artery bypass grafting. Efficacy analyses were by intention to treat; safety analyses were in treated patients. This study is registered with ClinicalTrials.gov, number NCT00317395. FINDINGS: Rates of the primary efficacy endpoint in the five otamixaban doses were 7.2% (nine of 125) with 0.035 mg/kg/h, 4.6% (31/676) with 0.070 mg/kg/h, 3.8% (25/662) with 0.105 mg/kg/h, 3.6% (24/658) with 0.140 mg/kg/h, and 4.3% (29/671) with 0.175 mg/kg/h (p=0.34 for trend). In the control group, the rate was 6.2% (28/449), yielding relative risks for the five otamixaban doses of 1.16 (95% CI 0.56-2.38), 0.74 (0.45-1.21), 0.61 (0.36-1.02), 0.58 (0.34-1.00), and 0.69 (0.42-1.15), respectively. Rates of the primary safety endpoint in the five otamixaban doses were 1.6% (two of 122), 1.6% (11/669), 3.1% (20/651), 3.4% (22/651), and 5.4% (36/664), respectively (p=0.0001 for trend); the rate in the control group was 2.7% (12/448). INTERPRETATION: In patients with non-ST-elevation acute coronary syndromes, otamixaban infusions of 0.100-0.140 mg/kg/h might reduce ischaemic events and have a safety profile similar to unfractionated heparin plus eptifibatide. Further testing in a phase 3 trial is warranted. FUNDING: Sanofi-Aventis.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Óxidos N-Cíclicos/uso terapêutico , Piridinas/uso terapêutico , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Idoso , Angioplastia Coronária com Balão , Anticoagulantes/uso terapêutico , Angiografia Coronária , Óxidos N-Cíclicos/farmacologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Quimioterapia Combinada , Eptifibatida , Feminino , Seguimentos , Hemorragia/induzido quimicamente , Heparina/uso terapêutico , Humanos , Infusões Intravenosas , Injeções Intravenosas , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Peptídeos/uso terapêutico , Inibidores da Agregação de Plaquetas/uso terapêutico , Piridinas/farmacologia , Segurança , Resultado do Tratamento
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