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1.
Am Heart J ; 218: 110-122, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31726314

RESUMO

BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. METHODS: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. RESULTS: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. CONCLUSIONS: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

2.
J Womens Health (Larchmt) ; 27(6): 808-814, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29741978

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a less invasive alternative approach to surgery. Individual randomized clinical trials evaluating the safety and efficacy of TAVR were mostly underpowered for conducting separate analyses for women and men. We pooled data from premarket TAVR clinical trials comparing short (30 days)- and long-term (∼2 years) outcomes by sex. METHODS: Patient-level data from the TAVR arms of six clinical trials were pooled (2515 patients). Random-effects models for time-to-event outcomes (odds ratios [ORs] for 30-day outcomes and hazard ratios [HRs] for complete follow-up for mortality, ischemic stroke, kidney injury, major bleeding, myocardial infarction, and device migration) and dichotomous outcomes (ORs for reintervention, rehospitalization, and pacemaker implantation) were then fit to directly compare outcomes between women and men. RESULTS: Overall, the pattern of individual comorbidities was more severe in men. There was no difference in mortality risk at 30 days (female-to-male OR = 1.00 [0.69-1.46]); however, at follow-up completion (∼2 years post-TAVR), women had a 24% lower mortality risk than men (HR = 0.76 [95% CI: 0.65-0.89]). Women also had a 30% lower risk of kidney injury at 30 days (OR = 0.70 [0.49-0.98]), which increased to 33% over the complete follow-up period (HR = 0.67 [0.51-0.87]). Major bleeding was more common in women compared to men at both 30 days (OR = 1.44 [1.19-1.76]) and long-term follow-up (HR = 1.22 [1.04-1.43]). For dichotomous outcomes, women had a 68% lower risk for reinterventions (OR = 0.32 [0.18-0.58]). We did not observe any difference in the risk of ischemic stroke, myocardial infarction, device migration, rehospitalizations, or pacemaker implantations between sexes. CONCLUSIONS: This patient-level data meta-analysis of six premarket clinical trials found that women who received TAVR had fewer comorbidities at baseline. Acute outcomes (30 day) with respect to mortality were similar. Women were observed to have a lower risk of kidney injury, but higher risk of major bleeding compared to men receiving TAVR at 30 days. At complete follow-up, statistically significant advantages for women emerged in improved survival and lower reintervention risk. No differences in ischemic stroke, pacemaker implantation, or rehospitalization were observed. That women are healthier at baseline and develop fewer postprocedural complications than men may explain their higher survival.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter/métodos , Lesão Renal Aguda/epidemiologia , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Ensaios Clínicos como Assunto , Comorbidade , Feminino , Humanos , Masculino , Hemorragia Pós-Operatória/epidemiologia , Fatores Sexuais , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
3.
Cardiol Rev ; 26(2): 73-81, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29053483

RESUMO

Transcatheter aortic valve replacement (TAVR) is a safe and effective therapy for aortic valve replacement in patients ineligible for or at high risk for surgery. However, outcomes after TAVR based on an individual's sex remain to be fully elucidated. We searched PUBMED and EMBASE using the keywords: "transcatheter aortic valve replacement," "transcatheter aortic valve implantation," "sex differences," "gender," "sex characteristics" and collected information on baseline features, procedural characteristics, and postprocedural outcomes in women. Inclusion/exclusion resulted in 23 publications. Women had less preexisting comorbidities than men. Most studies reported better survival in women (range of hazard ratio [95% CI] = 0.27 [0.09-0.84] to 0.91 [0.75-1.10]). At 30 days, women also had more vascular complications (6-20% vs 2-14%) and higher bleeding rates (10-44% vs 8-25%). Stroke rates were similar at 30 days (women, 1-7%; men, 1-5%). This literature review showed better survival in women than men after TAVR. However, women had more vascular complications and bleeding; stroke rates were similar. These findings may partly be explained by fewer baseline comorbidities in women. These results should be interpreted with caution as most measures only include unadjusted percentages.


Assuntos
Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Feminino , Humanos , Masculino , Fatores Sexuais , Resultado do Tratamento
4.
J Womens Health (Larchmt) ; 25(5): 428-30, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-27028582

RESUMO

When not enough women are included in many clinical trials, an information gap on medical device safety and effectiveness exists, which can make it difficult to detect sex-specific results. In this article we discuss potential reasons for the underrepresentation of women and the regulatory research conducted by the U.S. Food and Drug Administration (FDA) used in supporting regulatory decisions. We demonstrate that important differences in cardiovascular device performance between women and men exist. Furthermore, concrete steps are outlined on the possible ways these sex-specific results can be detected and how a recent FDA Action Plan and Guidance Document aim at encouraging female participation in clinical trials and the appropriate analysis thereof.


Assuntos
Terapia de Ressincronização Cardíaca , Ensaios Clínicos como Assunto , Qualidade de Produtos para o Consumidor , Aprovação de Equipamentos , Insuficiência Cardíaca/terapia , Seleção de Pacientes , Pesquisa Comparativa da Efetividade , Equipamentos e Provisões , Feminino , Experimentação Humana , Humanos , Estados Unidos , United States Food and Drug Administration , Saúde da Mulher
5.
J Cardiovasc Transl Res ; 9(1): 12-22, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26659647

RESUMO

An important treatment for patients with heart failure is cardiac resynchronization therapy (CRT). Even though only 20% of women were included in clinical trials for CRT, a benefit has been shown in recent studies for subgroups of women compared to their male counterparts. Given this low inclusion rate of women in clinical studies, professional society guideline-based CRT recommendations, such as those by the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS), may not truly represent the best treatment for women, especially since most of the reports that showed this greater benefit in women were published after the latest guidelines. Despite having research and multiple publications regarding sex-specific heart failure outcomes and response to CRT, the ACCF/AHA/HRS guidelines have not yet been updated to account for the recent information regarding the differences in benefit for women and men with similar patient characteristics. This review discusses the physiology behind CRT, sex-specific characteristics of heart failure, and cardiac electrophysiology and summarizes the current sex-specific literature to encourage consideration of CRT guidelines for women and men separately.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca/normas , Terapia de Ressincronização Cardíaca/normas , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Insuficiência Cardíaca/terapia , Desenho de Equipamento , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Guias de Prática Clínica como Assunto , Fatores Sexuais , Resultado do Tratamento
6.
Am J Cardiol ; 116(1): 79-84, 2015 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-25933736

RESUMO

Previous analyses have shown that there is lower mortality with cardiac resynchronization therapy defibrillators (CRT-D) in patients with left bundle branch block (LBBB) but demonstrated mixed results in patients without LBBB. We evaluated the comparative effectiveness of CRT-D versus standard implantable defibrillators (ICDs) separately in patients with LBBB and right bundle branch block (RBBB) using Medicare claims data. Medicare records from CRT-D and ICD recipients from 2002 to 2009 that were followed up for up to 48 months were analyzed. We used propensity scores to match patients with ICD to those with CRT-D. In LBBB, 1:1 matching with replacement resulted in 54,218 patients with CRT-D and 20,763 with ICD, and in RBBB, 1:1 matching resulted in 7,298 patients with CRT-D and 7,298 with ICD. In LBBB, CRT-D had a 12% lower risk of heart failure hospitalization or death (hazard ratio [HR] 0.88, 95% confidence interval 0.86 to 0.90) and 5% lower death risk (HR 0.95, 0.92 to 0.97) compared with ICD. In RBBB, CRT-D had a 15% higher risk of heart failure hospitalization or death (HR 1.15, 1.10 to 1.20) and 13% higher death risk (HR 1.13, 1.07 to 1.18). Sensitivity analysis revealed that accounting for covariates not captured in the Medicare database may lead to increased benefit with CRT-D in LBBB and no difference in RBBB. In conclusion, in a large Medicare population, CRT-D was associated with lower mortality in LBBB but higher mortality in RBBB. The absence of certain covariates, in particular those that determine treatment selection, may affect the results of comparative effectiveness studies using claims data.


Assuntos
Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca , Pesquisa Comparativa da Efetividade , Desfibriladores Implantáveis , Medicare , Idoso , Idoso de 80 Anos ou mais , Bloqueio de Ramo/mortalidade , Terapia de Ressincronização Cardíaca/métodos , Estudos de Coortes , Pesquisa Comparativa da Efetividade/métodos , Desfibriladores Implantáveis/efeitos adversos , Feminino , Seguimentos , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Estados Unidos
7.
J Womens Health (Larchmt) ; 24(4): 261-71, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25793483

RESUMO

BACKGROUND: Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies. METHODS: We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information. RESULTS: Ninety percent of the studies evaluated included ≤ 35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT. CONCLUSIONS: Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca/terapia , Qualidade de Vida , Fatores Sexuais , Idoso , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/mortalidade , Dispositivos de Terapia de Ressincronização Cardíaca/efeitos adversos , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Caracteres Sexuais , Taxa de Sobrevida , Resultado do Tratamento
8.
Circ Cardiovasc Qual Outcomes ; 8(2 Suppl 1): S4-11, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25714821

RESUMO

BACKGROUND: Women have been under-represented in trials of cardiac resynchronization therapy-defibrillators (CRT-D). Previous studies suggest that women benefit from CRT-D at shorter QRS duration than men and that there may be no benefit of CRT-D in patients without left bundle branch block (LBBB) regardless of patient sex. METHODS AND RESULTS: We compared sex-specific death risk in 75 079 patients with New York Heart Association class III or IV heart failure, reduced left ventricular ejection fraction, and prolonged QRS duration (≥120 ms) receiving either CRT-D or implantable cardioverter defibrillator in subgroups according to QRS morphology and 10-ms increments in QRS duration. We applied propensity score weighting to control for differences between treatments. Among patients with LBBB, women receiving CRT-D had a lower relative death risk than those receiving an implantable cardioverter-defibrillator (absolute difference, 11%; hazard ratio=0.74 [95% confidence interval, 0.68-0.81]). In men, the lower mortality with CRT-D versus implantable cardioverter defibrillator was less pronounced (absolute difference, 9%; hazard ratio=0.84 [0.79-0.89]; sex×device interaction P=0.025). In those without LBBB, the mortality difference was modest and did not differ between women and men (absolute difference, 3%; hazard ratio=0.88 [0.79-0.97] in women and absolute difference, 2%; hazard ratio=0.95 [0.91-0.998] in men; interaction P=0.17). In subgroups according to QRS duration, CRT-D was associated with better survival in both sexes with LBBB and QRS ≥130 ms, whereas there was no clear relation between QRS duration and survival in patients without LBBB regardless of patient sex. CONCLUSIONS: In a large real-world population CRT-D was associated with a lower mortality risk in both sexes with LBBB, although more pronounced among women. Only among those with LBBB, both sexes had better survival with longer QRS duration. The mortality differences in patients without LBBB were attenuated in both sexes.


Assuntos
Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca , Cardioversão Elétrica , Sistema de Condução Cardíaco/fisiopatologia , Insuficiência Cardíaca/terapia , Idoso , Idoso de 80 Anos ou mais , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/fisiopatologia , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/mortalidade , Dispositivos de Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/mortalidade , Feminino , Disparidades nos Níveis de Saúde , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pontuação de Propensão , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Fatores Sexuais , Volume Sistólico , Resultado do Tratamento , Estados Unidos , Função Ventricular Esquerda
10.
JAMA Intern Med ; 174(8): 1340-8, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25090172

RESUMO

IMPORTANCE: Women were underrepresented in cardiac resynchronization therapy (CRT) trials for heart failure (making up about 20% of enrollees). Combining individual patient data from multiple clinical trials would enable assessment of CRT benefit in women. OBJECTIVE: To evaluate whether women with left bundle branch block (LBBB) benefit from CRT-defibrillators (CRT-D) at a shorter QRS duration than men with LBBB do. DESIGN, SETTING, AND PARTICIPANTS: Individual patient data were pooled from 3 CRT-D vs implantable cardioverter defibrillator (ICD) trials (4076 patients) enrolling predominantly patients with New York Heart Association (NYHA) class II heart failure and follow-up to 3 years. The effect of CRT-D compared with ICD on outcomes was assessed using random effects Cox proportional hazards. MAIN OUTCOMES AND MEASURES: Time to heart failure event or death (primary) and death alone (secondary). RESULTS: Women benefited from CRT-D more than men. The main difference occurred in patients with LBBB and a QRS of 130 to 149 milliseconds. In this group, women had a 76% reduction in heart failure or death (absolute CRT-D to ICD difference, 23%; hazard ratio [HR], 0.24, [95% CI, 0.11-0.53]; P < .001) and a 76% reduction in death alone (absolute difference 9%; HR, 0.24, [95% CI, 0.06-0.89]; P = .03), while there was no significant benefit in men for heart failure or death (absolute difference 4%; HR, 0.85 [95% CI, 0.60-1.21]; P = .38) or death alone (absolute difference 2%; HR, 0.86 [95% CI, 0.49-1.52]; P = .60). Neither women nor men with LBBB benefited from CRT-D at QRS shorter than 130 milliseconds, while both sexes with LBBB benefited at QRS of 150 milliseconds or longer. CONCLUSIONS AND RELEVANCE: In this population of patients with primarily mild heart failure, women with LBBB benefited from CRT-D at a shorter QRS duration than men with LBBB. This is important because recent guidelines limit the class I indication for CRT-D to patients with LBBB and QRS of 150 milliseconds or longer. While guidelines do give a class IIa indication to patients with LBBB and a QRS of 120 to 149 milliseconds, the present findings are important to communicate because women are less likely to receive CRT-D than men are. This study exemplifies the potential public health and regulatory science value of combining data from multiple clinical trials submitted to the FDA.


Assuntos
Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca/métodos , Insuficiência Cardíaca/terapia , Idoso , Bloqueio de Ramo/mortalidade , Dispositivos de Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration
11.
J Am Coll Cardiol ; 64(9): 887-94, 2014 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-25169173

RESUMO

BACKGROUND: Prior studies have suggested that women have better outcomes than men after cardiac resynchronization therapy-defibrillator (CRT-D) implantation. OBJECTIVES: The purpose of this study was to compare mortality after CRT-D implantation by sex, QRS morphology, and duration. METHODS: Survival curves and covariate adjusted hazard ratios (HR) were used to assess mortality by sex in 31,892 CRT-D patients in the National Cardiovascular Data Registry (NCDR), implantable cardioverter defibrillator (ICD) registry between 2006 and 2009, with up to 5 years' follow-up (median 2.9 years, interquartile range: 2.0 to 3.9 years). Patients were grouped by QRS morphology and 10-ms increments in QRS duration. RESULTS: Among patients with left bundle branch block (LBBB), women had a 21% lower mortality risk than men (HR: 0.79; 95% CI: 0.74 to 0.84; p < 0.001); however, there was no sex difference in non-LBBB (HR: 0.95; 95% CI: 0.85 to 1.06; p = 0.37). Longer QRS duration was associated with better survival in both sexes with LBBB, but not in patients without LBBB. Compared with women with LBBB and QRS of 120 to 129 ms, women with LBBB and QRS of 140 to 149 ms had a 27% lower mortality (HR: 0.73; 95% CI: 0.60 to 0.88; p = 0.001); this difference was 18% in men (HR: 0.82; 95% CI: 0.71 to 0.93; p = 0.003). Mortality in LBBB and QRS of 150 ms or longer compared with those with LBBB and QRS of 120 to 129 ms was similar between sexes (HR: 0.61 to 0.68; p < 0.001 for women and HR: 0.58 to 0.66; p < 0.001 for men). Sex interactions within 10-ms groups were not significant. CONCLUSIONS: Among patients with LBBB who received CRT-D, mortality is lower in women than men. Additionally, longer QRS duration in LBBB is associated with better survival in both sexes. In contrast, there is no sex difference in patients without LBBB, regardless of QRS duration. Further studies should include a non-CRT comparator group to confirm these findings.


Assuntos
Terapia de Ressincronização Cardíaca/métodos , Desfibriladores Implantáveis , Fatores Sexuais , Idoso , Bloqueio de Ramo/complicações , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Sistema de Registros , Reprodutibilidade dos Testes , Risco , Resultado do Tratamento , Estados Unidos
12.
JACC Heart Fail ; 1(3): 237-44, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24621876

RESUMO

OBJECTIVES: The goal of this study was to test the hypothesis that in recipients of cardiac resynchronization therapy defibrillators (CRT-D), conventional left bundle branch block (LBBB) diagnosis predicts better survival in women than in men. BACKGROUND: New York Heart Association class I and II patients without LBBB do not benefit from CRT-D, and women have better survival after CRT-D than men. Separate analysis suggests that QRS duration thresholds for LBBB diagnosis differ according to sex, and conventional LBBB electrocardiographic criteria are falsely positive in men more frequently than in women. METHODS: We analyzed Medicare records from 144,642 CRT-D recipients between 2002 and 2008 that were followed up for up to 90 months. Medicare billing data were used to determine age, sex, race, and comorbidities. Hazard ratios (HRs) were calculated to assess if conventional LBBB diagnosis had different prognostic significance according to sex. RESULTS: In univariate analysis, LBBB was associated with a 31% reduction in death in women (HR: 0.69 [95% confidence interval (CI): 0.67 to 0.71]) but only a 16% reduction in death in men (HR: 0.84 [95% CI: 0.82 to 0.85]). In multivariable analyses controlling for comorbidities, LBBB was associated with a 26% reduction in death in women (HR: 0.74 [95% CI: 0.71 to 0.77]) and a 15% reduction in death in men (HR: 0.85 [95% CI: 0.83 to 0.87]). A significant interaction (p < 0.0001) between sex and LBBB was seen. CONCLUSIONS: LBBB diagnosis is associated with greater survival in women than in men receiving CRT-D, and this discrepancy is not explained by differences in measured comorbidities. Possible explanations for this difference include that LBBB may have different prognostic significance according to sex or that LBBB diagnosis is more often false-positive in men compared with women.


Assuntos
Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Fatores de Tempo
13.
Am J Cardiol ; 97(6): 792-7, 2006 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-16516578

RESUMO

Patients with chronic renal insufficiency (CRI) have higher rates of target vessel revascularization and mortality. The efficacy of sirolimus-eluting stents (SESs) to improve the clinical outcomes of these patients is unknown. We investigated the effect of SESs versus bare metal stents (BMSs) on outcomes of patients with CRI. Among the first 1,522 patients treated with SESs, 76 were identified with CRI and 1,446 without CRI. In-hospital and 1- and 6-month clinical outcomes were compared with 153 patients with CRI who were treated with BMSs. Patients with CRI were older, hypertensive, and diabetic and had more previous myocardial infarctions, revascularizations, and decreased left ventricular function (p <0.001). These patients had more saphenous vein graft lesions, were treated with more debulking devices (p <0.003), and had higher rates of in-hospital complications and mortality (p <0.001) compared with those without CRI. Among patients with CRI, treatment with SESs did not affect clinical outcomes at 1 month and was associated with lower incidences of target vessel revascularization (7.1% vs 22.1%, p = 0.02) at 6 months but did not affect other events, including mortality (16.7% vs 14.7% p = 0.89), compared with BMSs. However, treatment with SESs in patients without CRI was associated with significantly lower rates of major adverse cardiac events at 6 months (p <0.001). In conclusion, percutaneous coronary intervention with SESs in patients with CRI is associated with low rates of repeat revascularization compared with BMSs but has no effect on mortality at 6 months.


Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Insuficiência Renal Crônica/complicações , Sirolimo/administração & dosagem , Stents , Idoso , Antibacterianos/administração & dosagem , Estudos de Casos e Controles , Doença das Coronárias/complicações , Doença das Coronárias/mortalidade , Feminino , Seguimentos , Humanos , Imunossupressores/administração & dosagem , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
14.
Cardiovasc Revasc Med ; 6(2): 52-7, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-16263359

RESUMO

BACKGROUND: Intracoronary beta-radiation therapy reduces in-stent restenosis (ISR). We aimed to determine the safety and feasibility of intracoronary radiation therapy (IRT) utilizing tungsten (188W), a beta emitter. METHODS: A total of 30 patients with angiographic evidence of ISR in a previously treated native coronary artery underwent percutaneous coronary intervention (PCI; balloon angioplasty, ablation by atherectomy, or laser angioplasty). After the intervention, a noncentered delivery catheter with a side guide 0.014-in. wire carrying a tungsten (188W) coil, with an active length of 33 mm, was inserted. Patients were randomized to a radiation dose of 18, 22, or 25 Gy at 2 mm from the center of the source. Aspirin and Plavix, at 300 mg loading dose, were administered prior to intervention. Plavix 75 mg/day was prescribed for 6 months after the procedure. RESULTS: At 6 months follow-up, the overall binary angiographic restenosis rate was 18.8%. Target vessel revascularization (TVR) was 23% and target lesion revascularization related major adverse cardiac events (TLR-MACE) was 13.3%, without any intergroup differences. A comparison with the original Washington Radiation for In-stent restenosis Trial (WRIST) radiation cohort utilizing an 192Iridium source (prescription dose 15 Gy at 2 mm from the source) showed similar TVR and TLR-MACE rates of 30% and 18%, respectively. The TVR and TLR-MACE rates in the WRIST placebo cohort were 70% and 66%, respectively. CONCLUSIONS: Vascular brachytherapy with tungsten (188W) is feasible and safe. The 6-month clinical outcomes are similar to the original WRIST radiation group.


Assuntos
Braquiterapia/métodos , Oclusão de Enxerto Vascular/radioterapia , Radioisótopos/uso terapêutico , Stents , Tungstênio/uso terapêutico , Anti-Inflamatórios não Esteroides/administração & dosagem , Aspirina/administração & dosagem , Partículas beta/efeitos adversos , Partículas beta/uso terapêutico , Clopidogrel , Estudos de Coortes , Angiografia Coronária/métodos , Relação Dose-Resposta à Radiação , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Radioisótopos/efeitos adversos , Ticlopidina/administração & dosagem , Ticlopidina/análogos & derivados , Resultado do Tratamento , Tungstênio/efeitos adversos
15.
Catheter Cardiovasc Interv ; 65(2): 257-62, 2005 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-15864805

RESUMO

The Washington Radiation for In-Stent Restenosis Trial in Saphenous Vein Grafts (SVG WRIST) demonstrated safety and efficacy of intravascular radiation therapy (IRT) for the treatment of in-stent restenosis (ISR) in SVG at 12 months. In this study, we aimed to examine whether the safety and efficacy of IRT is durable up to 36 months. One hundred twenty patients with diffuse ISR in SVG underwent balloon angioplasty, laser or atherectomy ablation, and/or additional stenting. After successful intervention, patients were randomly assigned in a double-blind fashion to intravascular treatment with a ribbon containing either iridium (Ir)-192 (n = 60) or nonradioactive seeds (n = 60). The prescribed dose at 2 mm from the source was either 14 or 15 Gy in vessels 2.5-4.0 mm or 18 Gy in vessels > 4.0 mm in diameter. At 36 months, target lesion revascularization (TLR; 43% vs. 66%; P = 0.02) and target lesion revascularization-major adverse cardiac event (TLR-MACE; 49% vs. 71%; P = 0.02) rates continued to be lower in the IRT group, but both target vessel revascularization (TVR; 59% vs. 71%; P = 0.17) and TVR-MACE (63% vs. 77%; P = 0.11) rates were not. In SVG WRIST, patients with ISR treated with IRT had a marked reduction in the need for repeat TLR at 36 months, with sustained clinical benefit at 3 years despite late recurrences, which were more pronounced in the radiation group.


Assuntos
Cateterismo Periférico , Raios gama/uso terapêutico , Oclusão de Enxerto Vascular/radioterapia , Veia Safena/transplante , Stents , Idoso , Método Duplo-Cego , Feminino , Seguimentos , Oclusão de Enxerto Vascular/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia , Fatores de Tempo , Resultado do Tratamento
16.
J Invasive Cardiol ; 16(12): 688-91, 2004 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-15596870

RESUMO

Whether percutaneous coronary intervention (PCI) alone is safe in patients with moderate or severe aortic stenosis (AS) and coexisting coronary artery disease (CAD), and whether aortic valve replacement (AVR) can be deferred in patients with moderate AS by undergoing PCI alone is not known. We conducted a retrospective study of surgically inoperable patients with AS who underwent PCI (moderate AS, n = 28; and severe AS, n = 28) and compared to those with AVR (n = 55). The clinical characteristics, procedural complications, in-hospital and long-term clinical outcomes of PCI were compared. Baseline and procedural characteristics were similar except that lower age, hypertension, and renal impairment were seen in the AVR group. In-hospital complications were comparable among the 3 groups. Six-month and 1-year rates of myocardial infarction (MI), non-Q-wave MI, death and out-of-hospital death were similar between AVR and moderate AS patients (p = NS) and significantly high (p < 0.04) in patients with severe AS. On multivariate analysis, severe AS was the only significant predictor of 6-month and 1-year mortality. Our study suggests that PCI is safe in patients with moderate AS and coexisting CAD but is associated with poor outcomes in patients with severe AS.


Assuntos
Angioplastia Coronária com Balão , Estenose da Valva Aórtica/terapia , Doença da Artéria Coronariana/complicações , Idoso , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/patologia , Intervalo Livre de Doença , District of Columbia/epidemiologia , Feminino , Humanos , Masculino , Registros Médicos , Complicações Pós-Operatórias , Estudos Retrospectivos , Índice de Gravidade de Doença , Análise de Sobrevida
17.
Am J Cardiol ; 94(6): 786-9, 2004 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-15374790

RESUMO

Increases in both serum creatinine and creatine kinase-MB (CK-MB) after percutaneous coronary intervention are associated with increased risk for late adverse cardiovascular events. In 5,397 patients, the strength of the association of each with late events and the risk factors for each of these markers were compared. A postprocedural increase in creatinine was a more powerful predictor of late mortality than an increase in CK-MB. Risk factors for an increase in creatinine are similar to those for contrast-induced nephropathy, suggesting that vulnerability to such injury may identify patients with increased risk for late mortality.


Assuntos
Lesão Renal Aguda/sangue , Angioplastia Coronária com Balão , Doença das Coronárias/sangue , Doença das Coronárias/terapia , Creatina Quinase/sangue , Creatinina/sangue , Isoenzimas/sangue , Lesão Renal Aguda/etiologia , Lesão Renal Aguda/mortalidade , Idoso , Distribuição de Qui-Quadrado , Doença das Coronárias/complicações , Doença das Coronárias/mortalidade , Creatina Quinase Forma MB , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco
18.
J Am Coll Cardiol ; 44(1): 53-6, 2004 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-15234406

RESUMO

OBJECTIVES: We sought to examine saphenous vein graft (SVG) lesions that fail within the first year after operation. BACKGROUND: Saphenous vein grafts remain patent for approximately 10 years; however, up to 15% to 20% of SVGs become occluded within the first year. METHODS: We studied 100 patients who underwent percutaneous coronary intervention (PCI) for early (<1 year post-implantation) SVG failure lesions and compared them with a diabetes- and hypercholesterolemia-matched cohort of late SVG failures (>1 year). Coronary angiography and intravascular ultrasound images were analyzed. RESULTS: The majority of patients in both groups were males who presented with unstable angina; 36% were diabetic. Graft ages were 6.0 +/- 2.9 months and 105.4 +/- 50.8 months, respectively. The early SVG failure lesion location was more often ostial or proximal (62% vs. 42%, respectively). Early SVG failures were angiographically smaller than late failures (reference: 2.47 +/- 0.86 mm vs. 3.26 +/- 0.83 mm, p < 0.001) but had similar lesion lengths. Intravascular ultrasound showed that early failure lesions had smaller proximal and distal reference lumen areas (7.3 +/- 6.8 mm2 vs. 10.6 +/- 3.8 mm2, p = 0.026) and greater reference plaque burden than late failures (52.3% vs. 36.1%, p < 0.001). After PCI, 20.6% of early and 30.6% of late failure lesions had creatine kinase-myocardial band (CK-MB) greater than twice normal. CONCLUSIONS: Early SVG failure is mostly proximal or ostial, lesions appear focal, and early SVGs appear smaller than late SVGs. Intravascular ultrasound shows significant reference segment plaque burden, suggesting more severe, diffuse SVG disease.


Assuntos
Angiografia Coronária , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/etiologia , Veia Safena/transplante , Ultrassonografia de Intervenção , Idoso , Angioplastia Coronária com Balão , Biomarcadores/sangue , Velocidade do Fluxo Sanguíneo/fisiologia , Doença das Coronárias/diagnóstico , Doença das Coronárias/fisiopatologia , Doença das Coronárias/terapia , Creatina Quinase/sangue , Creatina Quinase Forma MB , Feminino , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Isoenzimas/sangue , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Veia Safena/diagnóstico por imagem , Veia Safena/imunologia , Estatística como Assunto , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular/fisiologia
19.
Catheter Cardiovasc Interv ; 62(2): 181-5, 2004 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-15170707

RESUMO

We aimed to study the consequences and late outcomes of patients who experienced peripheral vascular complications (PVCs) following percutaneous coronary interventions (PCI). A retrospective analysis of the medical records of 10,669 patients who underwent PCI and experienced PVC between 1995 and 2002 was conducted. One thousand ninety-six patients (10.27% of the study cohort) had PVC post-PCI. After PCI, patients with PVC had higher rates of in-hospital complications (P < 0.001) when compared to patients without PVC, including Q-wave myocardial infarction (MI; 1.2% vs. 0.3%), coronary artery bypass grafting (CABG; 3.8% vs. 0.6%), and death (4.0% vs. 1.0%). At 1-year follow-up, late complications of MI (37.4% vs. 25.4%), non-Q-wave MI (34.9% vs. 22.7%), death (12.9% vs. 5.9%), and CABG (5.7% vs. 4.5%) were higher (< 0.001) in patients with PVC compared to those without. Multivariate analysis identified PVC as a significant predictor of 1-year mortality (P = 0.045). This study underscores the need to make diligent efforts to minimize PVC and follow up these patients for future coronary events.


Assuntos
Angioplastia Coronária com Balão , Complicações Pós-Operatórias/etiologia , Doenças Vasculares/etiologia , Idoso , Ponte de Artéria Coronária , Doença das Coronárias/mortalidade , Doença das Coronárias/terapia , District of Columbia , Feminino , Seguimentos , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Complicações Pós-Operatórias/mortalidade , Valor Preditivo dos Testes , Estudos Retrospectivos , Estatística como Assunto , Tempo , Resultado do Tratamento , Doenças Vasculares/mortalidade
20.
Clin Cardiol ; 27(5): 291-4, 2004 May.
Artigo em Inglês | MEDLINE | ID: mdl-15188946

RESUMO

BACKGROUND: It remains controversial whether women have smaller coronary arteries than men because of a gender-specific trait, or whether the observed differences are primarily due to a difference in body size. Intravascular ultrasound (IVUS), with its ability to provide unique coronary images that allow precise measurement of arterial size in vivo, is ideally suited to address this issue. HYPOTHESIS: Female gender, independent of body size, is associated with smaller coronary artery size as measured by intracoronary ultrasound. METHODS: Intravascular ultrasound images of normal left main arteries were identified retrospectively from a single center database. Associations between demographic and clinical characteristics (including body size) and left main coronary dimensions were assessed with univariant and multivariate regression analyses. RESULTS: We identified 257 completely normal left main arteries. Mean left main arterial areas were smaller in women than in men (17.2 vs. 20.6 mm2, p < 0.001), as were mean luminal areas (14.0 vs. 16.7 mm2, p < 0.001). By multiple regression analysis, the independent predictors of left main lumen were body surface area (p < 0.001) and gender (p = 0. 003). CONCLUSIONS: Body surface area and gender are both independent predictors of coronary artery size, although body size has a greater influence than gender.


Assuntos
Superfície Corporal , Vasos Coronários/diagnóstico por imagem , Idoso , Antropometria , Endotélio Vascular/diagnóstico por imagem , Feminino , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Sexuais , Túnica Média/diagnóstico por imagem , Ultrassonografia de Intervenção
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