RESUMO
BACKGROUND: Poor health-related quality of life (QOL) is related to morbidity and mortality in coronary heart disease and ventricular arrhythmias as well as to mortality in patients with heart failure (HF) and atrial fibrillation (AF). This study examined the contributions of QOL to the prediction of 1-year hospitalization and mortality in patients with AF, independent of HF. METHODS: This study used the public use dataset from the NHLBI/NIH AFFIRM randomized clinical trial. Patients enrolled in the QOL substudy (N = 693) were randomly assigned to rate or rhythm control. QOL was assessed with the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and the Quality of Life Index-Cardiac Version (QLI-CV). Data were analyzed with logistic regression to predict 1-year hospitalization and Cox proportional hazards analysis to predict mortality. RESULTS: In the first year of participation in the study 37% (n = 256) were hospitalized; mortality was 14.3% (n = 93) with mean follow-up of 3.5 years. Patients' mean age was 69.8 ± 8.2 years, were largely male (62%), and white (93%). Patient histories included 70.8% hypertension, 38.2% coronary artery disease (CAD), and 23.7% HF. History of stroke, HF, rhythm control arm, lower SF-36 mental component scores (MCS), and lower SF-36 physical component scores (PCS) predicted hospitalization (P < 0.001). Diabetes, female gender, older age, CAD, hypertension, and lower PCS predicted mortality (P < 0.001). CONCLUSION: QOL adds meaningful information beyond traditional biomedical factors to the prediction of mortality and/or hospitalization of patients with AF. Interventions for improving QOL and helping patients adapt to AF treatments may decrease hospitalization and improve survival.
Assuntos
Fibrilação Atrial/mortalidade , Fibrilação Atrial/psicologia , Nível de Saúde , Mortalidade Hospitalar/tendências , Hospitalização/tendências , Qualidade de Vida/psicologia , Idoso , Fibrilação Atrial/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Resultado do TratamentoRESUMO
BACKGROUND: The objectives of this study were to present the rationale for the main aspects of the study design and describe the trial methodology for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). METHODS: Eligible candidates with mild visual field loss (automated perimetric mean deviation [PMD] -2 to -7 dB) were randomized to receive either acetazolamide or matching placebo tablets. Randomized participants were offered participation in a supervised dietary program. The primary outcome variable, PMD, was measured at 6 months. Additionally, cerebrospinal fluid from subjects and serum from study participants and matched controls were collected for genetic analysis and vitamin A studies. An ancillary optical coherence substudy was added to investigate the changes of papilledema in the optic nerve head and retina that correlate with Frisén grading, visual field deficits, and low-contrast visual acuity. RESULTS: The randomized trial entered 165 participants from March 17, 2010, through November 27, 2012, from the United States and Canada. The primary outcome (month 6) visits were successfully completed by June 15, 2013. Blood specimens were obtained from 165 controls without IIH to investigate vitamin A metabolism and genetic markers of potential risk factors for IIH. CONCLUSIONS: The IIHTT is the first randomized, double-masked placebo-controlled trial to study the effectiveness of medical treatment for patients with IIH.
Assuntos
Acetazolamida/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Pseudotumor Cerebral/tratamento farmacológico , Projetos de Pesquisa , Adolescente , Adulto , Pressão do Líquido Cefalorraquidiano/efeitos dos fármacos , Método Duplo-Cego , Feminino , Seguimentos , Fundo de Olho , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos da Percepção/complicações , Transtornos da Percepção/tratamento farmacológico , Pseudotumor Cerebral/complicações , Estudos Retrospectivos , Testes de Campo Visual , Campos Visuais/efeitos dos fármacos , Adulto JovemRESUMO
BACKGROUND: Little is known about predictors of mortality or hospitalization in women compared with men in patients with atrial fibrillation (AF). Although there are established gender differences in patients with coronary artery disease (CAD), differences have not been established in AF. OBJECTIVES: The aim of this study was to examine clinical and health-related quality of life (HRQOL) predictors of mortality and 1-year hospitalization in women compared with men with AF. METHODS: Limited-use data from the National Institutes of Health/National Heart, Lung, and Blood Institute Atrial Fibrillation Follow-up Investigation of Rhythm Management clinical trial provided the sample of 693 patients with AF, 262 women and 431 men. Clinical predictors examined were heart failure (HF), CAD, left ventricular ejection fraction, diabetes, stroke, and age. Predictors of HRQOL included overall HRQOL (Medical Outcomes Study Short Form-36 physical [PCS] and mental component scores) and cardiovascular HRQOL using Quality of Life Index-Cardiac Version. RESULTS: Mortality did not differ (women, 11.4%; men, 14.5%; χ(2)1 = 0.437, P = .509) according to gender, with mean 3.5-year follow-up. Different variables independently predicted mortality for women and men. For women, diabetes (hazard ratio [HR], 3.415; P = .003), HF (HR, 2.346; P = .027), stroke (HR, 2.41; P = .032), and age (HR, 1.117; P = .002), and for men, CAD (HR, 1.914; P = 02), age (HR, 1.103, P = < .001), worse PCS (HR, 1.089, P = .001), and worse Quality of Life Index-Cardiac Version score (HR, 1.402, P = .025) independently predicted mortality.One-year hospitalization (women, 38.9%; men, 36.4%) did not differ by gender (χ(2)1 = 0.914, P = .339). Different variables independently predicted 1-year hospitalization-for women: diabetes (odds ratio [OR], 2.359; P = .022), worse PCS (OR, 1.070; P = .003), and rhythm control trial arm (OR, 2.111; P = .006); for men: HF (OR, 2.072; P = .007), worse PCS (OR, 1.045; P = .019), living alone (OR, 1.913; P = .036), and rhythm control trial arm (OR, 2.113; P < .001). CONCLUSION: Only clinical status predicted mortality among women; HRQOL and clinical status predicted mortality among men. Both clinical and HRQOL variables predicted hospitalization for women and men. Increased monitoring of HRQOL and interventions designed to target the clinical and HRQOL predictors could impact mortality and hospitalization. Nursing interventions may prove effective for modifying most of the predictors of mortality and hospitalization for women and men with AF.
Assuntos
Fibrilação Atrial/mortalidade , Nível de Saúde , Hospitalização , Qualidade de Vida , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Fibrilação Atrial/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Fatores de Risco , Fatores SexuaisRESUMO
IMPORTANCE: Acetazolamide is commonly used to treat idiopathic intracranial hypertension (IIH), but there is insufficient information to establish an evidence base for its use. OBJECTIVE: To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, double-masked, placebo-controlled study of acetazolamide in 165 participants with IIH and mild visual loss who received a low-sodium weight-reduction diet. Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012 and followed up for 6 months (last visit in June 2013). All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation (PMD) between -2 dB and -7 dB. The mean age was 29 years and all but 4 participants were women. INTERVENTIONS: Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide (up to 4 g/d) or matching placebo for 6 months. MAIN OUTCOMES AND MEASURES: The planned primary outcome variable was the change in PMD from baseline to month 6 in the most affected eye, as measured by Humphrey Field Analyzer. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss. Secondary outcome variables included changes in papilledema grade, quality of life (Visual Function Questionnaire 25 [VFQ-25] and 36-Item Short Form Health Survey), headache disability, and weight at month 6. RESULTS: The mean improvement in PMD was greater with acetazolamide (1.43 dB, from -3.53 dB at baseline to -2.10 dB at month 6; n = 86) than with placebo (0.71 dB, from -3.53 dB to -2.82 dB; n = 79); the difference was 0.71 dB (95% CI, 0 to 1.43 dB; P = .050). Mean improvements in papilledema grade (acetazolamide: -1.31, from 2.76 to 1.45; placebo: -0.61, from 2.76 to 2.15; treatment effect, -0.70; 95% CI, -0.99 to -0.41; P < .001) and vision-related quality of life as measured by the National Eye Institute VFQ-25 (acetazolamide: 8.33, from 82.97 to 91.30; placebo: 1.98, from 82.97 to 84.95; treatment effect, 6.35; 95% CI, 2.22 to 10.47; P = .003) and its 10-item neuro-ophthalmic supplement (acetazolamide: 9.82, from 75.45 to 85.27; placebo: 1.59, from 75.45 to 77.04; treatment effect, 8.23; 95% CI, 3.89 to 12.56; P < .001) were also observed with acetazolamide. Participants assigned to acetazolamide also experienced a reduction in weight (acetazolamide: -7.50 kg, from 107.72 kg to 100.22 kg; placebo: -3.45 kg, from 107.72 kg to 104.27 kg; treatment effect, -4.05 kg, 95% CI, -6.27 to -1.83 kg; P < .001). CONCLUSIONS AND RELEVANCE: In patients with IIH and mild visual loss, the use of acetazolamide with a low-sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function. The clinical importance of this improvement remains to be determined. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01003639.
Assuntos
Acetazolamida/uso terapêutico , Inibidores da Anidrase Carbônica/uso terapêutico , Dieta Hipossódica , Pseudotumor Cerebral/tratamento farmacológico , Transtornos da Visão/tratamento farmacológico , Adulto , Terapia Combinada , Feminino , Humanos , Masculino , Pseudotumor Cerebral/complicações , Pseudotumor Cerebral/dietoterapia , Qualidade de Vida , Resultado do Tratamento , Transtornos da Visão/etiologia , Redução de PesoRESUMO
Significant mortality benefits have been documented in recipients of implantable cardioverter defibrillators (ICDs); however, the psychosocial distress created by the underlying arrhythmia and its potential treatments in patients and family members may be underappreciated by clinical care teams. The disentanglement of cardiac disease and device-related concerns is difficult. The majority of ICD patients and families successfully adjust to the ICD, but optimal care pathways may require additional psychosocial attention to all ICD patients and particularly those experiencing psychosocial distress. This state-of-the-science report was developed on the basis of an analysis and critique of existing science to (1) describe the psychological and quality-of-life outcomes after receipt of an ICD and describe related factors, such as patient characteristics; (2) describe the concerns and educational/informational needs of ICD patients and their family members; (3) outline the evidence that supports interventions for improving educational and psychological outcomes for ICD patients; (4) provide recommendations for clinical approaches for improving patient outcomes; and (5) identify priorities for future research in this area. The ultimate goal of this statement is to improve the precision of identification and care of psychosocial distress in ICD patients to maximize the derived benefit of the ICD.
Assuntos
American Heart Association , Desfibriladores Implantáveis/psicologia , Família/psicologia , Educação de Pacientes como Assunto/métodos , Guias de Prática Clínica como Assunto , Humanos , Guias de Prática Clínica como Assunto/normas , Resultado do Tratamento , Estados UnidosRESUMO
Despite improvements in cardiovascular implantable electronic device (CIED) design, application of timely infection control practices, and administration of antibiotic prophylaxis at the time of device placement, CIED infections continue to occur and can be life-threatening. This has prompted the study of all aspects of CIED infections. Recognizing the recent advances in our understanding of the epidemiology, risk factors, microbiology, management, and prevention of CIED infections, the American Heart Association commissioned this scientific statement to educate clinicians about CIED infections, provide explicit recommendations for the care of patients with suspected or established CIED infections, and highlight areas of needed research.
Assuntos
Cardiologia/normas , Desfibriladores Implantáveis/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/terapia , American Heart Association , Desfibriladores Implantáveis/estatística & dados numéricos , Endocardite/epidemiologia , Endocardite/terapia , Humanos , Marca-Passo Artificial/estatística & dados numéricos , Estados UnidosRESUMO
BACKGROUND: The most common location of out-of-hospital sudden cardiac arrest is the home, a situation in which emergency medical services are challenged to provide timely care. Consequently, home use of an automated external defibrillator (AED) might offer an opportunity to improve survival for patients at risk. METHODS: We randomly assigned 7001 patients with previous anterior-wall myocardial infarction who were not candidates for an implantable cardioverter-defibrillator to receive one of two responses to sudden cardiac arrest occurring at home: either the control response (calling emergency medical services and performing cardiopulmonary resuscitation [CPR]) or the use of an AED, followed by calling emergency medical services and performing CPR. The primary outcome was death from any cause. RESULTS: The median age of the patients was 62 years; 17% were women. The median follow-up was 37.3 months. Overall, 450 patients died: 228 of 3506 patients (6.5%) in the control group and 222 of 3495 patients (6.4%) in the AED group (hazard ratio, 0.97; 95% confidence interval, 0.81 to 1.17; P=0.77). Mortality did not differ significantly in major prespecified subgroups. Only 160 deaths (35.6%) were considered to be from sudden cardiac arrest from tachyarrhythmia. Of these deaths, 117 occurred at home; 58 at-home events were witnessed. AEDs were used in 32 patients. Of these patients, 14 received an appropriate shock, and 4 survived to hospital discharge. There were no documented inappropriate shocks. CONCLUSIONS: For survivors of anterior-wall myocardial infarction who were not candidates for implantation of a cardioverter-defibrillator, access to a home AED did not significantly improve overall survival, as compared with reliance on conventional resuscitation methods. (ClinicalTrials.gov number, NCT00047411 [ClinicalTrials.gov].).
Assuntos
Reanimação Cardiopulmonar , Desfibriladores , Parada Cardíaca/terapia , Assistência Domiciliar , Idoso , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Serviços Médicos de Emergência , Feminino , Parada Cardíaca/etiologia , Parada Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/complicaçõesRESUMO
BACKGROUND: Public access automatic external defibrillators (AEDs) can save lives, but most deaths from out-of-hospital sudden cardiac arrest occur at home. The Home Automatic External Defibrillator Trial (HAT) found no survival advantage for adding a home AED to cardiopulmonary resuscitation (CPR) training for 7,001 patients with a prior anterior wall myocardial infarction. Quality of life (QOL) outcomes for both the patient and spouse/companion were secondary end points. METHODS: A subset of 1,007 study patients and their spouse/companions was randomly selected for ascertainment of QOL by structured interview at baseline and 12 and 24 months after enrollment. The primary QOL measures were the Medical Outcomes Study 36-Item Short-Form psychological well-being (reflecting anxiety and depression) and vitality (reflecting energy and fatigue) subscales. RESULTS: For patients and spouse/companions, the psychological well-being and vitality scales did not differ significantly between those randomly assigned an AED plus CPR training and controls who received CPR training only. None of the other QOL measures collected showed a clinically and statistically significant difference between treatment groups. Patients in the AED group were more likely to report being extremely or quite a bit reassured by their treatment assignment. Spouse/companions in the AED group reported being less often nervous about the possibility of using AED/CPR treatment than those in the CPR group. CONCLUSIONS: Adding access to a home AED to CPR training did not affect QOL either for patients with a prior anterior myocardial infarction or their spouse/companion but did provide more reassurance to the patients without increasing anxiety for spouse/companions.
Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores , Qualidade de Vida/psicologia , Estresse Psicológico/etiologia , Idoso , Feminino , Amigos , Humanos , Masculino , Pessoa de Meia-Idade , CônjugesRESUMO
BACKGROUND: In the Mode Selection Trial (MOST) of 2,010 patients with sinus node dysfunction, dual-chamber-paced patients had less atrial fibrillation (AF) and heart failure and had slightly improved health-related quality of life (QOL) compared with rate modulated right ventricular-paced patients. Our objective was to assess the impact of AF on QOL within MOST. METHODS: We analyzed serial QOL measures (Short Form-36, Specific Activity Scale, time trade-off) in 3 groups: (1) those without AF; (2) those with paroxysmal AF (PAF), but not chronic AF (CAF); and (3) those with CAF. We carried forward the last known QOL before crossover for all subsequent time points in patients randomized to rate modulated right ventricular pacing who crossed over to dual-chamber pacing for severe pacemaker syndrome. RESULTS: Three hundred seventeen patients (15.8%) had AF in the year after implantation, 206 patients within 3 months (191 PAF, 15 CAF), and another 159 (124 PAF, 35 CAF) between 3 and 12 months. There were no significant differences among groups in individual Short Form-36 subscales or time trade-off scores at 12 months as compared with baseline or 3 months. Cardiovascular health status was better at 12 months as compared with baseline or 3 months in those without AF. CONCLUSIONS: Atrial fibrillation after pacemaker implantation in elderly patients with sick sinus syndrome was not a major determinant of QOL. However, there was a trend toward better cardiovascular functional status in patients without AF.
Assuntos
Fibrilação Atrial/terapia , Marca-Passo Artificial/psicologia , Qualidade de Vida/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Síndrome do Nó Sinusal/terapia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/psicologia , Estudos de Coortes , Estudos Cross-Over , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Desenho de Prótese , Síndrome do Nó Sinusal/psicologiaRESUMO
BACKGROUND: Epidemiologic, laboratory, animal, and clinical studies suggest that there is an association between Chlamydia pneumoniae infection and atherogenesis. We evaluated the efficacy of one year of azithromycin treatment for the secondary prevention of coronary events. METHODS: In this randomized, prospective trial, we assigned 4012 patients with documented stable coronary artery disease to receive either 600 mg of azithromycin or placebo weekly for one year. The participants were followed for a mean of 3.9 years at 28 clinical centers throughout the United States. RESULTS: The primary end point, a composite of death due to coronary heart disease, nonfatal myocardial infarction, coronary revascularization, or hospitalization for unstable angina, occurred in 446 of the participants who had been randomly assigned to receive azithromycin and 449 of those who had been randomly assigned to receive placebo. There was no significant risk reduction in the azithromycin group as compared with the placebo group with regard to the primary end point (risk reduction, 1 percent [95 percent confidence interval, -13 to 13 percent]). There were also no significant risk reductions with regard to any of the components of the primary end point, death from any cause, or stroke. The results did not differ when the participants were stratified according to sex, age, smoking status, presence or absence of diabetes mellitus, or C. pneumoniae serologic status at baseline. CONCLUSIONS: A one-year course of weekly azithromycin did not alter the risk of cardiac events among patients with stable coronary artery disease.
Assuntos
Antibacterianos/uso terapêutico , Azitromicina/uso terapêutico , Doença das Coronárias/tratamento farmacológico , Infarto do Miocárdio/prevenção & controle , Idoso , Antibacterianos/efeitos adversos , Azitromicina/efeitos adversos , Infecções por Chlamydophila/tratamento farmacológico , Chlamydophila pneumoniae , Doença das Coronárias/mortalidade , Doença das Coronárias/prevenção & controle , Método Duplo-Cego , Feminino , Perda Auditiva/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica , Estudos ProspectivosRESUMO
Most cardiac arrests occur in the home, where emergency medical services (EMS) systems are challenged to provide timely care. Because a large proportion of sudden cardiac arrests (SCAs) are due to ventricular tachycardia or ventricular fibrillation, home use of an automated external defibrillator (AED) might offer an opportunity to decrease mortality in those at risk. Predicting who will have a cardiac arrest in the general population is difficult. Individuals at high risk are usually easily identified and may become candidates for implantable cardioverter defibrillators. It is within the population at lower risk where home AEDs may be most useful. The purpose of the Home Automatic External Defibrillator Trial (HAT) is to test whether providing home access to an AED can improve survival in patients at modest risk of SCA, such as those surviving an anterior myocardial infarction but in whom implantable cardioverter defibrillator therapy is not deemed necessary. Between January 23, 2003, and October 20, 2005, 7001 patients were enrolled, with completion of follow-up scheduled for September 30, 2007. Randomization was conducted in a 1:1 fashion between control therapy, comprising the standard lay response to SCA (calling the EMS and performing cardiopulmonary resuscitation), and the use of an AED first, followed by calling the EMS and performing cardiopulmonary resuscitation. The primary end point is all-cause mortality. Secondary outcomes include survival from SCA (witnessed and unwitnessed, in home and out of home), incremental cost-effectiveness, and quality of life measures for both the patient and the spouse/companion. The results of the trial should be available in mid 2008.
Assuntos
Morte Súbita Cardíaca/prevenção & controle , Cardioversão Elétrica/métodos , Serviços de Assistência Domiciliar/normas , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Taquicardia Ventricular/terapia , Análise Custo-Benefício , Morte Súbita Cardíaca/etiologia , Cardioversão Elétrica/economia , Seguimentos , Serviços de Assistência Domiciliar/economia , Humanos , Educação de Pacientes como Assunto , Taquicardia Ventricular/complicaçõesRESUMO
BACKGROUND: Quality-of-life (QoL) instruments evaluate various aspects of physical, mental, and emotional health, but how these psychosocial characteristics impact long-term outcome after cardiac arrest and ventricular tachycardia (VT) is unknown. OBJECTIVE: The purpose of this study was to evaluate the relationship of baseline QoL scores with long-term survival of patients enrolled in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. METHODS: Formal QoL measures included SF-36 mental and physical components, Patient Concerns Checklist, and Ferrans and Powers Quality-of-Life Index-Cardiac Version. Multivariate Cox regression was used to assess the association of survival and these measures, adjusting for index arrhythmia type, gender, race, age, ejection fraction, history of congestive heart failure, antiarrhythmic therapy, and beta-blocker use. RESULTS: During mean follow-up of 546 +/- 356 days, 129 deaths occurred among 740 patients. Higher baseline SF-36 physical summary scores (P <.001), higher baseline QoL Index summary scores (P = .015), and lower baseline Patient Concerns Checklist summary scores (P = .047) were associated with longer survival, even after adjustment for clinical variables. When QoL measures were examined simultaneously, only the SF-36 physical summary score remained significant (P = .002). CONCLUSION: During recovery after sustained VT or cardiac arrest, formal baseline QoL assessment provides important prognostic information independent of traditional clinical data.
Assuntos
Parada Cardíaca/mortalidade , Parada Cardíaca/psicologia , Qualidade de Vida , Taquicardia Ventricular/mortalidade , Taquicardia Ventricular/psicologia , Idoso , Distribuição de Qui-Quadrado , Desfibriladores Implantáveis , Feminino , Parada Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fatores de Risco , Taquicardia Ventricular/terapiaRESUMO
BACKGROUND: Several randomized trials have compared atrial-based (dual-chamber or atrial) pacing with ventricular pacing in patients with bradycardia. No trial has shown a mortality reduction, and only 1 small trial suggested a reduction in stroke. The goal of this review was to determine whether atrial-based pacing prevents major cardiovascular events. METHODS AND RESULTS: A systematic review was performed of publications since 1980. For inclusion, trials had to compare an atrial-based with a ventricular-based pacing mode; use a randomized, controlled, parallel design; and have data on mortality, stroke, heart failure, or atrial fibrillation. Individual patient data were obtained from 5 of the 8 identified studies, representing 95% of patients in the 8 trials, and a total of 35 000 patient-years of follow-up. There was no significant heterogeneity among the results of the individual trials. There was no significant reduction in mortality (hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.87 to 1.03; P=0.19) or heart failure (HR, 0.89; 95% CI, 0.77 to 1.03; P=0.15) with atrial-based pacing. There was a significant reduction in atrial fibrillation (HR, 0.80; 95% CI, 0.72 to 0.89; P=0.00003) and a reduction in stroke that was of borderline significance (HR, 0.81; 95% CI, 0.67 to 0.99; P=0.035). There was no convincing evidence that any patient subgroup received special benefit from atrial-based pacing. CONCLUSIONS: Compared with ventricular pacing, the use of atrial-based pacing does not improve survival or reduce heart failure or cardiovascular death. However, atrial-based pacing reduces the incidence of atrial fibrillation and may modestly reduce stroke.
Assuntos
Fibrilação Atrial/prevenção & controle , Estimulação Cardíaca Artificial/métodos , Acidente Vascular Cerebral/prevenção & controle , Arritmias Cardíacas/terapia , Fibrilação Atrial/complicações , Átrios do Coração , Ventrículos do Coração , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Dual-chamber (atrioventricular) and single-chamber (ventricular) pacing are alternative treatment approaches for sinus-node dysfunction that causes clinically significant bradycardia. However, it is unknown which type of pacing results in the better outcome. METHODS: We randomly assigned a total of 2010 patients with sinus-node dysfunction to dual-chamber pacing (1014 patients) or ventricular pacing (996 patients) and followed them for a median of 33.1 months. The primary end point was death from any cause or nonfatal stroke. Secondary end points included the composite of death, stroke, or hospitalization for heart failure; atrial fibrillation; heart-failure score; the pacemaker syndrome; and the quality of life. RESULTS: The incidence of the primary end point did not differ significantly between the dual-chamber group (21.5 percent) and the ventricular-paced group (23.0 percent, P=0.48). In patients assigned to dual-chamber pacing, the risk of atrial fibrillation was lower (hazard ratio, 0.79; 95 percent confidence interval, 0.66 to 0.94; P=0.008), and heart-failure scores were better (P<0.001). The differences in the rates of hospitalization for heart failure and of death, stroke, or hospitalization for heart failure were not significant in unadjusted analyses but became marginally significant in adjusted analyses. Dual-chamber pacing resulted in a small but measurable increase in the quality of life, as compared with ventricular pacing. CONCLUSIONS: In sinus-node dysfunction, dual-chamber pacing does not improve stroke-free survival, as compared with ventricular pacing. However, dual-chamber pacing reduces the risk of atrial fibrillation, reduces signs and symptoms of heart failure, and slightly improves the quality of life. Overall, dual-chamber pacing offers significant improvement as compared with ventricular pacing.
Assuntos
Arritmia Sinusal/terapia , Estimulação Cardíaca Artificial/métodos , Idoso , Arritmia Sinusal/complicações , Fibrilação Atrial/etiologia , Estimulação Cardíaca Artificial/efeitos adversos , Intervalo Livre de Doença , Feminino , Insuficiência Cardíaca/etiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Marca-Passo Artificial/efeitos adversos , Qualidade de Vida , Acidente Vascular Cerebral/etiologia , Volume SistólicoRESUMO
BACKGROUND AND OBJECTIVE: The quality of life (QOL) of patients with ventricular dysrhythmias is well studied, but less is known about the QOL of their partners. This study describes the QOL of partners of patients with serious ventricular dysrhythmias enrolled in the Antiarrhythmics Versus Implantable Defibrillators trial. SUBJECTS AND METHODS: A convenience sample of 124 partners of patients randomized to antiarrhythmic drugs (n = 59) or an implantable cardioverter defibrillator (n = 65) in the Antiarrhythmics versus Implantable Defibrillators trial was obtained. The Short Form-36 and Quality of Life Index were assessed at baseline (postrandomization) and at 3-, 6-, and 12-month follow-up. RESULTS AND CONCLUSIONS: The mean age of the partners was 62 years. Most were white and female. Their mean Short Form-36 scores were comparable to a normative age group. Partner and participant mean Short Form-36 and Quality of Life Index scores correlated modestly (range 0.25-0.36). The physical summary scores of partners using the Short Form-36 declined over time, whereas their mental summary scores remained stable. Partner concerns related to death, dysrhythmia recurrence, and the impact of dysrhythmias on enjoyment of life lessened from baseline to 12 months. Concern about implantable cardioverter defibrillator function remained stable over time. Although the sample size of this study was relatively small and limited by missing data for some assessments, it is the largest prospective study of QOL in partners of patients with serious dysrhythmias. The results offer a foundation for future research of the partners of patients with serious dysrhythmias in terms of identifying their needs, offering support, and maximizing QOL.
Assuntos
Antiarrítmicos/uso terapêutico , Arritmias Cardíacas/tratamento farmacológico , Arritmias Cardíacas/terapia , Desfibriladores Implantáveis , Qualidade de Vida , Cônjuges/psicologia , Arritmias Cardíacas/psicologia , Feminino , Nível de Saúde , Humanos , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Fatores de TempoRESUMO
BACKGROUND: Compared with single-chamber ventricular pacing, dual-chamber pacing can reduce adverse events and, as a result, improve quality of life in patients paced for sick sinus syndrome. It is not clear, however, how these benefits compare with the increased cost of dual-chamber pacemakers. METHODS AND RESULTS: We used 4-year data from a 2010-patient, randomized trial to estimate the incremental cost-effectiveness of dual-chamber pacing compared with ventricular pacing and then projected these findings over the patients' lifetimes by using a Markov model that was calibrated to the first 5 years of in-trial data. To assess the stability of the findings, we performed 1000 bootstrap analyses and multiple sensitivity analyses. During the first 4 years of the trial, dual-chamber pacemakers increased quality-adjusted life expectancy by 0.013 year per subject at an incremental cost-effectiveness ratio of 53,000 dollars per quality-adjusted year of life gained. Over a lifetime, dual-chamber pacing was projected to increase quality-adjusted life expectancy by 0.14 year with an incremental cost-effectiveness ratio of approximately 6800 dollars per quality-adjusted year of life gained. In bootstrap analyses, dual-chamber pacing was cost-effective in 91.9% of simulations at a threshold of 50,000 dollars per quality-adjusted year of life and in 93.2% of simulations at a threshold of 100,000 dollars. Its cost-effectiveness ratio was also below this threshold in numerous sensitivity analyses that varied key estimates. CONCLUSIONS: For patients with sick sinus syndrome requiring pacing, dual-chamber pacing increases quality-adjusted life expectancy at a cost that is generally considered acceptable.
Assuntos
Estimulação Cardíaca Artificial/economia , Síndrome do Nó Sinusal/terapia , Idoso , Fibrilação Atrial/epidemiologia , Estimulação Cardíaca Artificial/métodos , Análise Custo-Benefício , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Cadeias de Markov , Mortalidade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Síndrome do Nó Sinusal/fisiopatologia , Nó Sinoatrial/fisiopatologia , Análise de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: Patient and physician preferences as well as cost favor an increasingly higher threshold for hospital admission for heart failure (HF) treatment. This trend risks masking the severity and prevalence of HF as hospitalization for HF may decrease. METHODS: Heart Failure Score (HFS) has 4 ordinal subscales assessing (1) HF symptoms, physical signs of left (2) and (3) right HF, and (4) therapy changes for HF. Heart Failure Score was calculated for 1257 of 2010 (63%) patients enrolled in the MOST trial in sinus node dysfunction, who survived and had complete first-year HFS data at 4 postpacemaker implant visits (1, 3, 6, and 12 months). Heart Failure Score was summed and ranged from 0 to 14, with lower scores representing less HF. RESULTS: There were 1257 patients (median age 74 years [interquartile range 68-79], 47% were women, 61% had hypertension, 20%, diabetes mellitus, and 23%, prior myocardial infarction). The median HFS accumulated during 1 year was 4 (interquartile range 1-8). Of patients with a benign first year, those with a higher HFS were more likely to die during subsequent follow-up compared with patients with lower HFS (hazard ratio 1.07, 95% CI 1.04-1.10 for each 1-point increase, P < .001). CONCLUSIONS: Increasing HFS is associated with an increased risk of mortality in mostly elderly patients without pre-existing HF. Heart Failure Score may be a useful surrogate HF end point for clinical trials.
Assuntos
Estimulação Cardíaca Artificial , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Hospitalização/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial , Prognóstico , Modelos de Riscos Proporcionais , Qualidade de VidaRESUMO
BACKGROUND: Dual-chamber pacemakers restore AV synchrony compared with ventricular pacemakers, but the effects on health-related quality of life (QOL) are uncertain. OBJECTIVES: The purpose of this study was to assess the effect of pacemaker implantation, clinical factors, and pacing mode on QOL. METHODS: The Mode Selection Trial (MOST) randomized 2,010 patients with sinus node dysfunction to rate-modulated right ventricular (VVIR) or dual-chamber (DDDR) pacing. A longitudinal analysis of serial QOL measures (Short Form-36 [SF-36], Specific Activity Scale, and time trade-off utility) was performed. In patients who crossed over from VVIR to DDDR because of severe pacemaker syndrome, the last known QOL prior to crossover was carried forward. RESULTS: Pacemaker implantation resulted in substantial improvement in almost all QOL measures. Subjects 75 years or older experienced significantly less improvement in functional status and physical component summary scores than did younger subjects. In longitudinal analyses of the effect of pacing mode on QOL, significant improvement in three SF-36 subscales was observed with DDDR pacing compared with VVIR pacing: role physical [62.8 points (95% confidence interval [CI] 60.2, 65.5) vs 56.4 (95% CI 53.7, 59.1)], role emotional [85.0 (95% CI 82.9, 87.0) vs 81.9 (95% CI 79.9, 84.0)], and vitality [51.8 (95% CI 50.3, 53.3) vs 49.3 (95% CI 47.8, 50.7)], but not in other SF-36 subscales, the Specific Activity Scale, or utilities. The gains in QOL were larger than the declines associated with 1 year of aging but smaller than those associated with heart failure. CONCLUSION: Pacemaker implantation improved health-related QOL. The mode selected was associated with much smaller, but significant, improvements in several domains, particularly role physical function.
Assuntos
Marca-Passo Artificial , Qualidade de Vida , Síndrome do Nó Sinusal/terapia , Idoso , Estimulação Cardíaca Artificial , Desenho de Equipamento , Feminino , Humanos , Estudos Longitudinais , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: Patients' views about participation in clinical trials have been explored using end-of-study questionnaires for various disease entities. However, little is known about why individuals with atrial fibrillation (AF) choose to participate in clinical trials or how they view their research experience. Understanding these perceptions should provide valuable information for future studies in developing methods to enhance enrollment, optimize adherence to therapies, and maximize patient retention. METHODS: The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study was a randomized trial of rate-control versus rhythm-control for the management of AF. This descriptive ancillary study used a 7-item questionnaire comprising closed and open-ended items that explored: (1) perceptions of benefits from participation, (2) motivation for enrolling, and (3) satisfaction with research staff and operations. RESULTS: A total of 741/1,032 participants (72%) at 34 of 213 participating AFFIRM sites responded, representing 18% of the 4,060 patients enrolled. The mean follow-up of these respondents was 3.8 +/- 1.1 years. Most respondents (91%) felt that they received enough information about AFFIRM before enrolling and that the results would benefit themselves (88%) and others (91%). Most respondents felt study participation improved awareness about AF (90%) and facilitated coordination of their healthcare (89%). Virtually all were satisfied with information received from AFFIRM personnel (96%), and most (98%) reported that they had received "good care." Responses were similar between randomization groups (rate-control or rhythm-control) and between those younger than 65 years and those 65 years or older. Participants in sinus rhythm at last follow-up were more likely to believe that their medical care in AFFIRM was better than what they would otherwise have received, and were more likely to perceive their treatment course as entailing fewer emergency room visits, hospitalizations, and doctor visits. Regularly scheduled appointments and ongoing availability of staff to answer questions appeared to increase participants' confidence and reduce anxiety. CONCLUSIONS: Patients enrolled in a long-term clinical trial for management of AF were overwhelmingly satisfied with participation.
Assuntos
Fibrilação Atrial/tratamento farmacológico , Ensaios Clínicos como Assunto , Satisfação do Paciente , Idoso , Feminino , Seguimentos , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To examine the changes in vision-specific and overall health-related quality of life (QOL) at 6 months in participants with idiopathic intracranial hypertension (IIH) and mild visual loss enrolled in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to determine the signs and symptoms of IIH that mediate the effect of acetazolamide on QOL. METHODS: We assessed QOL using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), the 10-Item NEI-VFQ-25 Neuro-Ophthalmic Supplement, and the 36-Item Short Form Health Survey (SF-36). We examined associations among changes in QOL measures over 6 months, treatment status, and changes in signs and symptoms using linear and structural equation models. RESULTS: Among the 165 participants with IIH (86 randomized to acetazolamide, 79 to placebo), beneficial effects of acetazolamide were seen on all QOL scales evaluated, as well as on the Near Activities (5.60 points, p = 0.03), Social Functioning (3.85 points, p = 0.04), and Mental Health (9.82, p = 0.04) subscales of the NEI-VFQ-25. Positive acetazolamide-related effects on QOL appeared to be primarily mediated by improvements in visual field, neck pain, pulsatile tinnitus, and dizziness/vertigo that outweighed the side effects of acetazolamide. CONCLUSIONS: The marked reductions in baseline QOL seen among patients with mild visual loss from IIH are improved by treatment with acetazolamide. When combined with acetazolamide-associated improvements in visual field and other aspects of IIH, our findings with respect to QOL provide further support from the IIHTT in favor of acetazolamide to augment a dietary intervention in the treatment of IIH with mild visual loss (clinicaltrials.gov: NCT01003639).