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2.
Am Heart J ; 269: 25-34, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38072334

RESUMO

BACKGROUND: Objective data comparing the diagnostic performance of different ambulatory cardiac monitors (ACMs) are lacking. OBJECTIVES: To assess variation in monitoring strategy, clinical outcomes and healthcare utilization in patients undergoing ambulatory monitoring without a pre-existing arrhythmia diagnosis. METHODS: Using the full sample (100%) of Medicare claims data, we performed a retrospective cohort study of diagnostic-naïve patients who received first-time ACM in 2017 to 2018 and evaluated arrhythmia encounter diagnosis at 3-months, repeat ACM testing at 6 months, all-cause 90-day emergency department (ED) and inpatient utilization, and cost of different strategies: Holter; long-term continuous monitor (LTCM); non-continuous, event-based external ambulatory event monitor (AEM); and mobile cardiac telemetry (MCT). We secondarily performed a device-specific analysis by manufacturer, identified from unique claim modifier codes. RESULTS: ACMs were used in 287,789 patients (AEM = 10.3%; Holter = 53.8%; LTCM = 13.3%; MCT = 22.5%). Device-specific analysis showed that compared to Holter, AEM, MCT, or other LTCM manufacturers, a specific LTCM (ZioⓇ XT 14-day patch, iRhythm Technologies, San Francisco, CA) had the highest adjusted odds of diagnosis and lowest adjusted odds of ACM retesting. Findings were consistent for specific arrhythmia diagnoses of ventricular tachycardia, atrioventricular block, and paroxysmal atrial fibrillation. As a category, LTCM was associated with the lowest 1-year incremental health care expenditures (mean Δ$10,159), followed by Holter ($10,755), AEM ($11,462), and MCT ($12,532). CONCLUSIONS: There was large variation in diagnostic monitoring strategy. A specific LTCM was associated with the highest adjusted odds of a new arrhythmia diagnosis and lowest adjusted odds of repeat ACM testing. LTCM as a category had the lowest incremental acute care utilization. Different monitoring strategies may produce different results with respect to diagnosis and care.


Assuntos
Fibrilação Atrial , Eletrocardiografia Ambulatorial , Metacrilatos , Estados Unidos , Humanos , Idoso , Estudos Retrospectivos , Medicare , Fibrilação Atrial/diagnóstico , Gastos em Saúde , Aceitação pelo Paciente de Cuidados de Saúde
4.
Circ Arrhythm Electrophysiol ; 13(11): e007953, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33021815

RESUMO

The field of cardiac electrophysiology has been on the cutting edge of advanced digital technologies for many years. More recently, medical device development through traditional clinical trials has been supplemented by direct to consumer products with advancement of wearables and health care apps. The rapid growth of innovation along with the mega-data generated has created challenges and opportunities. This review summarizes the regulatory landscape, applications to clinical practice, opportunities for virtual clinical trials, the use of artificial intelligence to streamline and interpret data, and integration into the electronic medical records and medical practice. Preparation of the new generation of physicians, guidance and promotion by professional societies, and advancement of research in the interpretation and application of big data and the impact of digital technologies on health outcomes will help to advance the adoption and the future of digital health care.


Assuntos
Arritmias Cardíacas/diagnóstico , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Tecnologia de Sensoriamento Remoto , Smartphone , Telemedicina/instrumentação , Dispositivos Eletrônicos Vestíveis , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/terapia , Inteligência Artificial , Atitude do Pessoal de Saúde , Atitude Frente aos Computadores , Ensaios Clínicos como Assunto , Difusão de Inovações , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Aplicativos Móveis , Participação do Paciente , Valor Preditivo dos Testes , Prognóstico
6.
N Engl J Med ; 381(20): 1909-1917, 2019 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-31722151

RESUMO

BACKGROUND: Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown. METHODS: Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10. RESULTS: We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events. CONCLUSIONS: The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).


Assuntos
Fibrilação Atrial/diagnóstico , Eletrocardiografia/instrumentação , Aplicativos Móveis , Telemedicina/instrumentação , Dispositivos Eletrônicos Vestíveis , Adulto , Idoso , Algoritmos , Confidencialidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos
8.
Circulation ; 139(22): 2502-2512, 2019 05 28.
Artigo em Inglês | MEDLINE | ID: mdl-30880434

RESUMO

BACKGROUND: Device-detected atrial fibrillation (AF) is associated with increased risk of stroke; however, there are no clearly defined thresholds of AF burden at which to initiate oral anticoagulation (OAC). We sought to describe OAC prescription practice variation in response to new device-detected AF and the association with outcomes. METHODS: We performed a retrospective cohort study using data from the Veterans Health Administration linked to remote monitoring data that included day-level AF burden. We included patients with cardiac implantable electronic devices and remote monitoring from 2011 to 2014, CHA2DS2-VASc score ≥2, and no prior stroke or OAC receipt in the preceding 2 years. We determined the proportion of patients prescribed OAC within 90 days after new device-detected AF across a range of AF thresholds (≥6 minutes to >24 hours) and examined site variation in OAC prescription. We used multivariable Cox proportional hazards regressions to determine the association of OAC prescription with stroke by device-detected AF burden. RESULTS: Among 10 212 patients with cardiac implantable electronic devices, 4570 (45%), 3969 (39%), 3263 (32%), and 2469 (24%) had device-detected AF >6 minutes, >1 hour, >6 hours, and >24 hours, respectively. For device-detected AF >1 hour, 1712 patients met inclusion criteria (72±10 years; 1.5% female; CHA2DS2-VASc score 4.0±1.4; HAS-BLED score 2.6±1.1). The proportion receiving OAC varied based on device-detected AF burden (≥6 minutes: 272/2101 [13%]; >1 hour: 273/1712 [16%]; >6 hours: 263/1279 [21%]; >24 hours: 224/818 [27%]). Across 52 sites (N=1329 patients), there was substantial site-level variation in OAC prescription after device-detected AF >1 hour (median, 16%; range, 3%-67%; median odds ratio, 1.56 [95% credible interval, 1.49-1.71]). In adjusted models, OAC prescription after device-detected AF >24 hours was associated with reduced stroke risk (hazard ratio, 0.28; 95% CI, 0.10-0.81; P=0.02), although the propensity-adjusted model was significant when AF lasted at least 6 minutes. CONCLUSIONS: Among veterans with cardiac implantable electronic devices, device-detected AF is common. There is large practice variation in 90-day OAC initiation after new device-detected AF, with low rates of treatment overall, even for episodes that last >24 hours. The strongest association of OAC with reduction in stroke was observed after device-detected AF >24 hours. Randomized trials are needed to confirm these observational findings.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Desfibriladores Implantáveis , Marca-Passo Artificial , Padrões de Prática Médica/tendências , Tecnologia de Sensoriamento Remoto/métodos , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Dispositivos de Terapia de Ressincronização Cardíaca , Prescrições de Medicamentos , Uso de Medicamentos/tendências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , United States Department of Veterans Affairs
9.
Clin Cardiol ; 41(9): 1136-1143, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30098034

RESUMO

BACKGROUND: Atrial fibrillation (AF) is treated by many types of physician specialists, including primary care physicians (PCPs). Health plans have different policies for how patients encounter these providers, and these may affect selection of AF treatment strategy. HYPOTHESIS: We hypothesized that healthcare plans with PCP-gatekeeping to specialist access may be associated with different pharmacologic treatments for AF. METHODS: We performed a retrospective cohort study using a commercial pharmaceutical claims database. We utilized logistic regression models to compare odds of prescription of oral anticoagulant (OAC), non-vitamin K-dependent oral anticoagulant (NOAC), rate control, and rhythm control medications used to treat AF between patients with PCP-gated healthcare plans (eg, HMO, EPO, POS) and patients with non-PCP-gated healthcare plans (eg, PPO, CHDP, HDHP, comprehensive) between 2007 and 2012. We also calculated median time to receipt of therapy within 90 days of index AF diagnosis. RESULTS: We found similar odds of OAC prescription at 90 days following new AF diagnosis in patients with PCP-gated plans compared to those with non-PCP-gated plans (OR: OAC 1.01, P = 0.84; warfarin 1.05, P = 0.08). Relative odds were similar for rate control (1.17, P < 0.01) and rhythm control agents (0.93, P = 0.03). However, PCP-gated plan patients had slightly lower likelihood of being prescribed NOACs (0.82, P = 0.001) than non-gated plan patients. Elapsed time until receipt of medication was similar between PCP-gated and non-gated groups across drug classes. CONCLUSIONS: Pharmaceutical claims data do not suggest that PCP-gatekeeping by healthcare plans is a structural barrier to AF therapy, although it was associated with lower use of NOACs.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Prescrições de Medicamentos/estatística & dados numéricos , Seguro Saúde/estatística & dados numéricos , Tromboembolia/prevenção & controle , Administração Oral , Idoso , Fibrilação Atrial/complicações , Estudos de Coortes , Bases de Dados Factuais , Feminino , Humanos , Masculino , Estudos Retrospectivos , Tromboembolia/etiologia , Estados Unidos
10.
J Cardiovasc Electrophysiol ; 29(8): 1081-1088, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29864193

RESUMO

BACKGROUND: Cost-effectiveness or value of cardiovascular therapies may be undermined by unwarranted cost variation, particularly for heterogeneous procedures such as catheter ablation for atrial fibrillation (AF). We sought to characterize cost variation of AF ablation in the US healthcare system and the relationship between cost and outcomes. METHODS AND RESULTS: We performed a retrospective cohort study using data from the MarketScan® commercial claims and Medicare supplemental databases including patients who received an AF ablation from 2007 to 2011. We aggregated encounter cost, reflecting total payments received for the encounter, to the facility level to calculate median facility cost. We classified procedures as outpatient or inpatient and assessed for association between cost and 30-day and 1-year outcomes. The analysis cohort included 9,415 AF ablations (59±11 years; 28% female; 52% outpatient) occurring at 327 facilities, with large cost variation across facilities (median: $25,100; 25th percentile: $18,900, 75th percentile: $35,600, 95th percentile: $57,800). Among outpatient procedures, there was reduced healthcare utilization in higher cost quintiles with reductions in rehospitalization at 30-days (Quintile 1: 16.1%, Quintile 5: 8.8%, P < 0.001) and 1-year (Quintile 1: 34.8%, Quintile 5: 25.6%, P < 0.001), which remained significant in multivariate analysis. CONCLUSIONS: Although median costs of AF ablation are below amounts used in prior cost-effectiveness studies that demonstrated good value, large facility variation in cost suggests opportunities for cost reduction. However, for outpatient encounters, association of cost to modestly improved outcomes suggests cost containment strategies could have variable effects.


Assuntos
Fibrilação Atrial/economia , Ablação por Cateter/economia , Análise Custo-Benefício/métodos , Hospitalização/economia , Formulário de Reclamação de Seguro/economia , Medicare/economia , Idoso , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos/epidemiologia
11.
Circulation ; 137(20): e623-e644, 2018 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-29661944

RESUMO

Our understanding of the risk factors and complications of atrial fibrillation (AF) is based mostly on studies that have evaluated AF in a binary fashion (present or absent) and have not investigated AF burden. This scientific statement discusses the published literature and knowledge gaps related to methods of defining and measuring AF burden, the relationship of AF burden to cardiovascular and neurological outcomes, and the effect of lifestyle and risk factor modification on AF burden. Many studies examine outcomes by AF burden classified by AF type (paroxysmal versus nonparoxysmal); however, quantitatively, AF burden can be defined by longest duration, number of AF episodes during a monitoring period, and the proportion of time an individual is in AF during a monitoring period (expressed as a percentage). Current guidelines make identical recommendations for anticoagulation regardless of AF pattern or burden; however, a review of recent evidence suggests that higher AF burden is associated with higher risk of stroke. It is unclear whether the risk increases continuously or whether a threshold exists; if a threshold exists, it has not been defined. Higher burden of AF is also associated with higher prevalence and incidence of heart failure and higher risk of mortality, but not necessarily lower quality of life. A structured and comprehensive risk factor management program targeting risk factors, weight loss, and maintenance of a healthy weight appears to be effective in reducing AF burden. Despite this growing understanding of AF burden, research is needed into validation of definitions and measures of AF burden, determination of the threshold of AF burden that results in an increased risk of stroke that warrants anticoagulation, and discovery of the mechanisms underlying the weak temporal correlations of AF and stroke. Moreover, developments in monitoring technologies will likely change the landscape of long-term AF monitoring and could allow better definition of the significance of changes in AF burden over time.


Assuntos
Fibrilação Atrial/patologia , Fibrilação Atrial/complicações , Fibrilação Atrial/mortalidade , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/etiologia , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Qualidade de Vida , Fatores de Risco , Gestão de Riscos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia
12.
PLoS One ; 13(4): e0195088, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29649277

RESUMO

INTRODUCTION: As atrial fibrillation (AF) is often asymptomatic, it may remain undiagnosed until or even after development of complications, such as stroke. Consequently the observed prevalence of AF may underestimate total disease burden. METHODS: To estimate the prevalence of undiagnosed AF in the United States, we performed a retrospective cohort modeling study in working age (18-64) and elderly (≥65) people using commercial and Medicare administrative claims databases. We identified patients in years 2004-2010 with incident AF following an ischemic stroke. Using a back-calculation methodology, we estimated the prevalence of undiagnosed AF as the ratio of the number of post-stroke AF patients and the CHADS2-specific stroke probability for each patient, adjusting for age and gender composition based on United States census data. RESULTS: The estimated prevalence of AF (diagnosed and undiagnosed) was 3,873,900 (95%CI: 3,675,200-4,702,600) elderly and 1,457,100 (95%CI: 1,218,500-1,695,800) working age adults, representing 10.0% and 0.92% of the respective populations. Of these, 698,900 were undiagnosed: 535,400 (95%CI: 331,900-804,400) elderly and 163,500 (95%CI: 17,700-400,000) working age adults, representing 1.3% and 0.09% of the respective populations. Among all undiagnosed cases, 77% had a CHADS2 score ≥1, and 56% had CHADS2 score ≥2. CONCLUSIONS: Using a back-calculation approach, we estimate that the total AF prevalence in 2009 was 5.3 million of which 0.7 million (13.1% of AF cases) were undiagnosed. Over half of the modeled population with undiagnosed AF was at moderate to high risk of stroke.


Assuntos
Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Coleta de Dados , Acidente Vascular Cerebral/complicações , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Feminino , Humanos , Masculino , Medicare , Pessoa de Meia-Idade , Prevalência , Probabilidade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Estados Unidos , Adulto Jovem
13.
J Cardiovasc Electrophysiol ; 29(4): 526-536, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29436112

RESUMO

BACKGROUND: Although ablation with focal impulse and rotor modulation (FIRM), as an adjunct to pulmonary vein isolation (PVI), has been shown to decrease atrial fibrillation (AF) recurrence, cost-effectiveness has not been assessed. OBJECTIVE: We aimed to evaluate the cost effectiveness of FIRM-guided ablation when added to PVI in a mixed AF population. METHODS AND RESULTS: We used a Markov model to estimate the costs, quality-adjusted survival, and cost effectiveness of adding FIRM ablation to PVI. AF recurrence rates were based on 3-year data from the CONFIRM trial. Model inputs for event probabilities and utilities were obtained from literature review. Costs were based on Medicare reimbursement, wholesale acquisition costs, and literature review. Three-year total costs FIRM+PVI versus PVI alone were $27,686 versus $26,924. QALYs were 2.338 versus 2.316, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $34,452 per QALY gained. Most of the cost (65-81%) was related to the index ablation procedure. Lower AF recurrence generated cost offsets of $4,266, primarily due to a reduced need for medications and repeat ablation. Probabilistic sensitivity analysis demonstrated ICER below $100,000/QALY in 74% of simulations. CONCLUSION: Based on data from the CONFIRM study, the addition of FIRM to PVI does have the potential to be cost-effective due to higher quality-adjusted life years and lower follow-up costs. Value is sensitive to the incremental reduction in AF recurrence, and FIRM may have the greatest economic value in patients with greater AF symptom severity. Results from ongoing randomized trials will provide further clarity.


Assuntos
Potenciais de Ação , Fibrilação Atrial/economia , Fibrilação Atrial/cirurgia , Ablação por Cateter/economia , Custos de Cuidados de Saúde , Frequência Cardíaca , Veias Pulmonares/cirurgia , Idoso , Antiarrítmicos/economia , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Análise Custo-Benefício , Custos de Medicamentos , Técnicas Eletrofisiológicas Cardíacas/economia , Feminino , Custos Hospitalares , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Veias Pulmonares/fisiopatologia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Recidiva , Reoperação/economia , Fatores de Tempo , Resultado do Tratamento
14.
Am Heart J ; 195: 50-59, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29224646

RESUMO

BACKGROUND: It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs). METHODS: We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC). RESULTS: In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, P<.001; NOAC: Military 24%, Private 19%, Medicare 17%, Other 17%, Medicaid 8%, P<.001). After adjustment for patient characteristics and facility, private, Medicaid, and other insurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription. CONCLUSIONS: In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Seguro Saúde , Sistema de Registros , Acidente Vascular Cerebral/prevenção & controle , Varfarina/administração & dosagem , Administração Oral , Idoso , Anticoagulantes , Fibrilação Atrial/complicações , Cardiologia , Feminino , Humanos , Masculino , Estudos Prospectivos , Estados Unidos
16.
Artigo em Inglês | MEDLINE | ID: mdl-28196927

RESUMO

BACKGROUND: In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified. METHODS AND RESULTS: We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different. CONCLUSIONS: After implantable cardioverter-defibrillator shock, related HCU was common, with 1 in 3 shock events followed by outpatient HCU and 1 in 7 followed by hospitalization. Use of invasive cardiovascular procedures was substantial, even after inappropriate shocks, which comprised 38% of all shocks. Implantable cardioverter-defibrillator shocks seem to trigger a cascade of health care. Strategies to reduce shocks could result in cost savings.


Assuntos
Arritmias Cardíacas/economia , Arritmias Cardíacas/terapia , Desfibriladores Implantáveis/economia , Cardioversão Elétrica/economia , Falha de Equipamento/economia , Custos de Cuidados de Saúde , Gastos em Saúde , Recursos em Saúde/economia , Avaliação de Processos em Cuidados de Saúde/economia , Demandas Administrativas em Assistência à Saúde/economia , Idoso , Assistência Ambulatorial/economia , Arritmias Cardíacas/diagnóstico , Bases de Dados Factuais , Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/estatística & dados numéricos , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/estatística & dados numéricos , Feminino , Recursos em Saúde/estatística & dados numéricos , Custos Hospitalares , Humanos , Masculino , Medicare Part B/economia , Pessoa de Meia-Idade , Admissão do Paciente/economia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Procedimentos Desnecessários/economia
17.
JACC Clin Electrophysiol ; 3(1): 20-28, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-29759690

RESUMO

OBJECTIVES: This study sought to define the characteristics and risks of death of patients receiving a physician-designated secondary prevention implantable cardioverter-defibrillator (ICD) in contemporary clinical practice. BACKGROUND: Data on utilization and outcomes of ICDs for the secondary prevention of sudden cardiac death (SCD) are limited. METHODS: Patients enrolled in the National Cardiovascular Data Registry's (NCDR) ICD Registry from 2006 to 2009 with a physician-designated secondary prevention indication for ICD implantation were identified and linked to the Social Security Death Master File. Those patients with a history either of tachycardic arrest or sustained ventricular tachycardia (SCD/VT) or of syncope without SCD/VT were included. Kaplan-Meier survival analysis was used to assess mortality. Cox proportional hazards survival modeling was used to assess the risk of death in these groups, adjusting for patient characteristics. RESULTS: In the study cohort of 46,685 patients (mean age 66 ± 14 years, 73.5% male, 85% white), 78% had SCD/VT and 22% had syncope. Overall mortality was 10.4% at 1 year and 16.4% at 2 years. Compared with patients having SCD/VT, the adjusted hazard of death at 1 year was lower in the patients having syncope (hazard ratio: 0.89; 95% confidence interval: 0.83 to 0.96) but was not significantly different by 2 years (hazard ratio: 0.96; 95% confidence interval: 0.90 to 1.01). CONCLUSIONS: Nearly 9 of 10 patients receiving a secondary prevention ICD in clinical practice are alive 1 year after implantation. The risk of death varies by indication and is highest among patients who survive SCD or sustained VT in the first year after device implantation.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Prevenção Secundária/métodos , Idoso , Idoso de 80 Anos ou mais , Desfibriladores Implantáveis , Desenho de Equipamento , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Qualidade de Vida , Resultado do Tratamento
18.
Circ Heart Fail ; 9(6)2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27296396

RESUMO

BACKGROUND: Atrial fibrillation is common in patients with heart failure, but outcomes of patients with both conditions who receive cardiac resynchronization therapy with defibrillator (CRT-D) compared with an implantable cardioverter-defibrillator (ICD) alone are unclear. METHODS AND RESULTS: Using the National Cardiovascular Data Registry's ICD Registry linked with Medicare claims, we identified 8951 patients with atrial fibrillation who were eligible for CRT-D and underwent first-time device implantation for primary prevention between April 2006 and December 2009. We used Cox proportional hazards models and inverse probability-weighted estimates to compare outcomes with CRT-D versus ICD alone. Cumulative incidence of mortality (744 [33%] for ICD; 1893 [32%] for CRT-D) and readmission (1788 [76%] for ICD; 4611 [76%] for CRT-D) within 3 years and complications within 90 days were similar between groups. After inverse weighting for the probability of receiving CRT-D, risks of mortality (hazard ratio, 0.83; 95% confidence interval, 0.75-0.92), all-cause readmission (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92), and heart failure readmission (hazard ratio, 0.68; 95% confidence interval, 0.62-0.76) were lower with CRT-D compared with ICD alone. There was no significant difference in the 90-day complication rate (hazard ratio, 0.88; 95% confidence interval, 0.60-1.29). We observed hospital-level variation in the use of CRT-D among patients with atrial fibrillation. CONCLUSIONS: Among eligible patients with heart failure and atrial fibrillation, CRT-D was associated with lower risks of mortality, all-cause readmission, and heart failure readmission, as well as with a similar risk of complications compared with ICD alone.


Assuntos
Fibrilação Atrial/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Insuficiência Cardíaca/terapia , Prevenção Primária/instrumentação , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/fisiopatologia , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/mortalidade , Distribuição de Qui-Quadrado , Pesquisa Comparativa da Efetividade , Morte Súbita Cardíaca/etiologia , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/mortalidade , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Medicare , Readmissão do Paciente , Pontuação de Propensão , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
19.
Artigo em Inglês | MEDLINE | ID: mdl-27307517

RESUMO

BACKGROUND: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data. METHODS AND RESULTS: We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. CONCLUSIONS: Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Análise Custo-Benefício , Intervenção Coronária Percutânea/economia , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/economia , Dabigatrana/administração & dosagem , Dabigatrana/economia , Árvores de Decisões , Feminino , Humanos , Masculino , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Dispositivo para Oclusão Septal/economia , Acidente Vascular Cerebral/prevenção & controle , Taxa de Sobrevida , Varfarina/administração & dosagem , Varfarina/economia
20.
Am J Cardiol ; 117(9): 1455-62, 2016 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-26996767

RESUMO

Several randomized trials and decision analysis models have found that remote monitoring may reduce health care utilization and expenditures in patients with cardiac implantable electronic devices (CIEDs), compared with in-office monitoring. However, little is known about the generalizability of these findings to unselected populations in clinical practice. To compare health care utilization and expenditures associated with remote monitoring and in-office monitoring in patients with CIEDs, we used Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases. We selected patients newly implanted with an implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillator (CRT-D), or permanent pacemaker (PPM), in 2009, who had continuous health plan enrollment 2 years after implantation. Generalized linear models and propensity score matching were used to adjust for confounders and estimate differences in health care utilization and expenditures in patients with remote or in-office monitoring. We identified 1,127; 427; and 1,295 pairs of patients with a similar propensity for receiving an ICD, CRT-D, or PPM, respectively. Remotely monitored patients with ICDs experienced fewer emergency department visits resulting in discharge (p = 0.050). Remote monitoring was associated with lower health care expenditures in office visits among patients with PPMs (p = 0.025) and CRT-Ds (p = 0.006) and lower total inpatient and outpatient expenditures in patients with ICDs (p <0.0001). In conclusion, remote monitoring of patients with CIEDs may be associated with reductions in health care utilization and expenditures compared with exclusive in-office care.


Assuntos
Assistência Ambulatorial/estatística & dados numéricos , Desfibriladores Implantáveis , Gastos em Saúde , Hospitalização/estatística & dados numéricos , Marca-Passo Artificial , Consulta Remota/economia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/economia , Estudos de Coortes , Serviço Hospitalar de Emergência/economia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Hospitalização/economia , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/economia , Pontuação de Propensão , Tecnologia de Sensoriamento Remoto/economia , Adulto Jovem
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