RESUMO
BACKGROUND: The subcutaneous implantable defibrillator (S-ICD) provides an alternative to the transvenous ICD for the prevention of sudden cardiac death, but has not been well studied in the most commonly treated transvenous ICD patient population, namely, primary prevention (PP) patients with left ventricular dysfunction. OBJECTIVE: The analyses in the present study were designed to compare clinical outcomes for PP patients with and without a reduced ejection fraction (EF) and secondary prevention (SP) patients implanted with the S-ICD. METHODS: All patients 18 years and older from the S-ICD IDE study and the EFFORTLESS Registry with available data as of November 18, 2013, were included (n = 856; mean follow-up duration 644 days). Outcomes were evaluated in 2 analyses: (1) comparing all PP patients (n = 603, 70.4%) with all SP patients (n = 253, 29.6%) and (2) comparing all PP patients with an EF ≤35% (n = 379) with those with an EF >35% (n = 149, 17.4%). RESULTS: No differences were observed in mortality, complications, inappropriate therapy, or ability to convert ventricular tachyarrhythmias between SP and PP patients. However, SP patients had a higher incidence of appropriate therapy than did PP patients (11.9% vs 5.0%; P = .0004). In the PP subanalysis, the cohort with an EF ≤35% had significantly older patients with more comorbidities and higher mortality (3.0% annually vs 0.0%). Despite these differences, device-related complications, conversion efficacy, and incidence of inappropriate shock therapies were not significantly different between PP subgroups. CONCLUSION: The S-ICD performs well in protecting patients with either PP or SP implant indications from sudden cardiac death. Within PP patients, device performance was independent of EF.
Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica , Taquicardia Ventricular , Disfunção Ventricular Esquerda , Adulto , Idoso , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/métodos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Prevenção Primária/métodos , Prevenção Primária/estatística & dados numéricos , Ajuste de Prótese , Sistema de Registros , Prevenção Secundária/métodos , Prevenção Secundária/estatística & dados numéricos , Volume Sistólico , Taquicardia Ventricular/mortalidade , Taquicardia Ventricular/terapia , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
Cardiovascular disease is a leading cause of death and disability in the United States. National programs, such as the National Cardiovascular Data Registry, facilitate assessments of the quality of care and outcomes for broad populations of patients with cardiovascular disease. This report provides data for 2014 from 4 National Cardiovascular Data Registry hospital quality programs: 1) CathPCI (Diagnostic Catheterization and Percutaneous Coronary Intervention) for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals); 2) ICD Registry for implantable cardioverter-defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION-GWTG (Acute Coronary Treatment and Intervention Outcomes Network-Get With The Guidelines) for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT (Improving Pediatric and Adult Congenital Treatment) for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients, characteristics of participating centers, and selected measures of processes and outcomes of care in these programs.
Assuntos
Síndrome Coronariana Aguda/terapia , Cardiologia/tendências , Desfibriladores Implantáveis/estatística & dados numéricos , Intervenção Coronária Percutânea/estatística & dados numéricos , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Contemporary patterns of use and outcomes of implantable cardioverter-defibrillators (ICDs) in community practice settings are not well characterized. We assessed temporal trends in patient characteristics and outcomes among older patients undergoing primary prevention ICD therapy in US hospitals between 2006 and 2010. METHODS AND RESULTS: Using the National Cardiovascular Data Registry's ICD Registry, we identified Medicare fee-for-service beneficiaries aged ≥65 years and older with left ventricular ejection fraction ≤35% who underwent primary prevention ICD implantation, including those receiving concomitant cardiac resynchronization therapy between 2006 and 2010 and could be matched to Medicare claims. Outcomes were mortality and hospitalization (all-cause and heart failure) at 180 days, and device-related complications. We used multivariable hierarchical logistic regression to assess temporal trends in outcomes accounting for changes in patient, physician, and hospital characteristics. The cohort included 117 100 patients. Between 2006 and 2010, only modest changes in patient characteristics were noted. Fewer single lead devices and more cardiac resynchronization therapy devices were used over time. Between 2006 and 2010, there were significant improvements in all outcomes, including 6-month all cause mortality (7.1% in 2006, 6.5% 2010; adjusted odds ratio, 0.88; 95% confidence interval, 0.82-0.95), 6-month rehospitalization (36.3% in 2006, 33.7% in 2010; adjusted odds ratio, 0.87; 95% confidence interval, 0.83-0.91), and device-related complications (5.8% in 2006, 4.8% in 2010; adjusted odds ratio, 0.80; 95% confidence interval, 0.74-0.88). CONCLUSIONS: The clinical characteristics of this national population of Medicare patients undergoing primary prevention ICD implantation were stable between 2006 and 2010. Simultaneous improvements in outcomes suggest meaningful advances in the care for this patient population.
Assuntos
Desfibriladores Implantáveis , Planos de Pagamento por Serviço Prestado/tendências , Insuficiência Cardíaca/terapia , Medicare/tendências , Prevenção Primária/tendências , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Modelos Logísticos , Masculino , Readmissão do Paciente/estatística & dados numéricos , Estudos Retrospectivos , Volume Sistólico/fisiologia , Taxa de Sobrevida , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: To better inform patients and physicians of the expected risk of adverse events and to assist hospitals' efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry. BACKGROUND: ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications. METHODS: We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume. RESULTS: Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics = 0.724 and 0.719, respectively). The risk score characterized patients into low- and-high risk subgroups for adverse events (≤10 points, 0.3%; ≥30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15). CONCLUSIONS: We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance.
Assuntos
Doenças Cardiovasculares/terapia , Bases de Dados Factuais , Desfibriladores Implantáveis/efeitos adversos , Hospitalização , Sistema de Registros , Relatório de Pesquisa , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco/métodos , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
Recently, the American College of Cardiology Foundation in collaboration with the Heart Rhythm Society published appropriate use criteria (AUC) for implantable cardioverter-defibrillators and cardiac resynchronization therapy. These criteria were developed to critically review clinical situations that may warrant implantation of an implantable cardioverter-defibrillator or cardiac resynchronization therapy device, and were based on a synthesis of practice guidelines and practical experience from a diverse group of clinicians. When the AUC was drafted, the writing committee recognized that some of the scenarios that were deemed "appropriate" or "may be appropriate" were discordant with the clinical requirements of many payers, including the Medicare National Coverage Determination (NCD). To charge Medicare for a procedure that is not covered by the NCD may be construed as fraud. Discordance between the guidelines, the AUC, and the NCD places clinicians in the difficult dilemma of trying to do the "right thing" for their patients, while recognizing that the "right thing" may not be covered by the payer or insurer. This commentary addresses these issues. Options for reconciling this disconnect are discussed, and recommendations to help clinicians provide the best care for their patients are offered.
Assuntos
American Heart Association , Terapia de Ressincronização Cardíaca/economia , Terapia de Ressincronização Cardíaca/normas , Cardiologia/economia , Doenças Cardiovasculares/terapia , Fidelidade a Diretrizes , Mecanismo de Reembolso/normas , Doenças Cardiovasculares/economia , Humanos , Estados UnidosRESUMO
OBJECTIVES: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD). BACKGROUND: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD. METHODS: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time. RESULTS: In 2011 ACTION Registry-GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented. CONCLUSIONS: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes.
Assuntos
Doenças Cardiovasculares/cirurgia , Fidelidade a Diretrizes , Intervenção Coronária Percutânea , Sistema de Registros , Humanos , Fatores de Risco , Estados UnidosRESUMO
BACKGROUND: The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). METHODS AND RESULTS: This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. CONCLUSIONS: The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
Assuntos
Desfibriladores Implantáveis , Taquicardia Ventricular/terapia , Adulto , Idoso , Estudos de Coortes , Segurança de Equipamentos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoAssuntos
Comitês Consultivos , Terapia de Ressincronização Cardíaca/normas , Desfibriladores Implantáveis , Insuficiência Cardíaca/terapia , Guias de Prática Clínica como Assunto/normas , Comitês Consultivos/organização & administração , American Heart Association/organização & administração , Diagnóstico por Imagem/normas , Ecocardiografia Doppler , Insuficiência Cardíaca/mortalidade , Humanos , Angiografia por Ressonância Magnética , Garantia da Qualidade dos Cuidados de Saúde , Sensibilidade e Especificidade , Estados UnidosRESUMO
Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care.
Assuntos
Pesquisa Biomédica/normas , Doenças Cardiovasculares , Sistemas Computadorizados de Registros Médicos/normas , Assistência ao Paciente/normas , Sistema de Registros/normas , Humanos , Estados UnidosAssuntos
Comitês Consultivos , American Heart Association , Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Terapia de Ressincronização Cardíaca/normas , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/terapia , Desfibriladores Implantáveis/estatística & dados numéricos , Desfibriladores Implantáveis/normas , Fidelidade a Diretrizes/estatística & dados numéricos , Fidelidade a Diretrizes/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Comorbidade , Técnicas de Diagnóstico Cardiovascular/normas , Técnicas de Diagnóstico Cardiovascular/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde , Humanos , Guias de Prática Clínica como Assunto , Estados Unidos , Revisão da Utilização de Recursos de Saúde/estatística & dados numéricosAssuntos
Arritmias Cardíacas/terapia , Desfibriladores Implantáveis/estatística & dados numéricos , Monitorização Fisiológica/métodos , Sistema de Registros , Adolescente , Idoso , Arritmias Cardíacas/mortalidade , Criança , Pré-Escolar , Eletrodos Implantados , Falha de Equipamento , Segurança de Equipamentos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Estados UnidosAssuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/normas , Sistema de Registros , Fatores Etários , Criança , Proteção da Criança , Desfibriladores Implantáveis/efeitos adversos , Desenho de Equipamento , Falha de Equipamento , Humanos , Medicare , Pediatria , Vigilância da População/métodos , Estados UnidosRESUMO
BACKGROUND: Implantable cardioverter defibrillator (ICD) implant testing based on the upper limit of vulnerability, or vulnerability testing, permits assessment of defibrillation safety margins without inducing ventricular fibrillation (VF) in most patients. Vulnerability testing requires that T-wave shocks be timed at the most vulnerable intervals of the cardiac cycle, defined as intervals at which the strongest shock induces VF. Our goal was to develop and test an automated method to select these timing intervals using ICD intracardiac electrograms (EGMs). METHODS: At ICD implant in 22 patients, we determined the range of the most vulnerable intervals by scanning the T wave with shocks. Simultaneously, EGMs were recorded for 351 pacing sequences used for measurement of timing intervals or T-wave shocks. EGMs were analyzed off-line using a novel automated method to identify a stable point near the maximum slope of the T wave in the far-field (shock) EGM. Fiducial timing points based both on the EGM and on the electrocardiogram (ECG) were used to predict the most vulnerable intervals. We compared the predicted most vulnerable to the measured most vulnerable intervals determined by T-shock scans. RESULTS: Automatically determined timing points from EGMs and operator-determined timing points from the surface ECG had comparable accuracy in identifying the measured most vulnerable intervals (91% EGM vs 86% ECG, P = NS). CONCLUSIONS: An automated method based on ICD EGMs identifies the most vulnerable intervals with accuracy comparable to the operator-performed, clinical method based on the surface ECG. This EGM method can be implemented efficiently in an ICD to automate vulnerability testing.
Assuntos
Desfibriladores Implantáveis , Diagnóstico por Computador/métodos , Eletrocardiografia/métodos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/prevenção & controle , Terapia Assistida por Computador/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoAssuntos
Desfibriladores Implantáveis/estatística & dados numéricos , Cardiopatias/terapia , Sistema de Registros/estatística & dados numéricos , Idoso , Desfibriladores Implantáveis/efeitos adversos , Feminino , Humanos , Masculino , Medicare/estatística & dados numéricos , Pessoa de Meia-Idade , Programas Nacionais de Saúde , Estados UnidosRESUMO
OBJECTIVES: The Atrial Therapy Efficacy and Safety Trial (ATTEST) was a prospective, randomized study to evaluate preventive pacing and antitachycardia pacing (ATP) in patients with symptomatic atrial fibrillation (AF) or atrial tachycardia (AT). BACKGROUND: The effect of the combination of atrial prevention and termination algorithms on AT/AF burden and frequency in pacemaker patients is unknown. METHODS: A DDDRP pacemaker (AT500, Medtronic Inc., Minneapolis, Minnesota) with three atrial preventive pacing algorithms and two ATP algorithms was implanted in 368 patients. Patients were randomized one-month post-implant to all prevention and ATP therapies ON or OFF and followed for three months. The OFF group had DDDR pacing at a lower programmed rate of 60 ppm. The AT/AF burden and frequency were determined from daily device counters in 324 patients treated according to protocol. RESULTS: In 17,018 episodes with stored electrograms, appropriate detection was confirmed in 17,004 (99.9%). The median percentage of atrial pacing was 98% in the ON group versus 75% in the OFF group (p < 0.001). Using device-defined criteria for successful termination, ATP terminated 8,590 (54%) of 15,789 treated episodes. The median AT/AF burden during the three-month study period was 4.2 h/month ON versus 1.1 h/month OFF (p = 0.20). The median AT/AF frequency was 1.3 episodes/month ON versus 1.2 episodes/month OFF (p = 0.65). System-related, complication-free survival at four months was 90.2% (Kaplan-Meier estimate). CONCLUSIONS: This DDDRP pacemaker is safe, has accurate AT/AF detection, and provides ATP with 54% efficacy as defined by the device. The atrial prevention and termination therapies combined did not reduce AT/AF burden or frequency in this patient population.
Assuntos
Fibrilação Atrial/terapia , Bradicardia/terapia , Estimulação Cardíaca Artificial , Átrios do Coração/patologia , Átrios do Coração/cirurgia , Idoso , Idoso de 80 Anos ou mais , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Bradicardia/diagnóstico , Estudos de Coortes , Cardioversão Elétrica , Eletrocardiografia , Segurança de Equipamentos , Feminino , Seguimentos , Ventrículos do Coração/patologia , Ventrículos do Coração/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Distribuição Aleatória , Estudos Retrospectivos , Análise de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
The tissue in the high intraatrial septum in the region of Bachmann's Bundle (BB) exhibits electrophysiological properties that differ from the right atrial appendage (RAA). As BB pacing emerges as an alternative to RAA pacing, the feasibility of using automatic capture recognition technology in this location should be examined. At implant, active-fixation leads were consecutively placed in the RAA, then the BB in 18 patients (55.5% men, mean age 77.1 +/- 9.1). There was no significant difference between BB and RAA in the average capture threshold (1.12 vs 1.77 V, P = 0.09), sensing threshold (3.85 vs 3.69 mV, P = 0.84), impedance (508 vs 529 Ohms, P = 0.64), evoked response (1.78 vs 1.67 mV, P = 0.83), and polarization (0.41 vs 0.46 mV, P = 0.84) between. The difference in tissue characteristics was not associated with a different evoked response measured by the ventricular capture recognition algorithm. Based on the analogous evoked response and polarization values, capture recognition technology designed for the atrium will most likely be applicable at both pacing sites.