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2.
Value Health ; 24(7): 930-938, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34243836

RESUMO

OBJECTIVES: To model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England. METHODS: A decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk. RESULTS: The antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries. CONCLUSIONS: The absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections.


Assuntos
Antibioticoprofilaxia/economia , Análise Custo-Benefício , Controle de Infecções , Marca-Passo Artificial/microbiologia , Árvores de Decisões , Europa (Continente) , Humanos
3.
Europace ; 23(23 Suppl 4): iv33-iv44, 2021 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-34160600

RESUMO

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems.


Assuntos
Desfibriladores Implantáveis , Infecções Relacionadas à Prótese , Antibacterianos/uso terapêutico , Análise Custo-Benefício , Desfibriladores Implantáveis/efeitos adversos , Eletrônica , Humanos , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/prevenção & controle
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
5.
Circ Arrhythm Electrophysiol ; 13(10): e008503, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32915063

RESUMO

BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.


Assuntos
Antibacterianos/economia , Antibioticoprofilaxia/economia , Dispositivos de Terapia de Ressincronização Cardíaca/economia , Desfibriladores Implantáveis/economia , Custos de Medicamentos , Implantação de Prótese/economia , Infecções Relacionadas à Prótese/economia , Implantes Absorvíveis/economia , Antibacterianos/uso terapêutico , Dispositivos de Terapia de Ressincronização Cardíaca/efeitos adversos , Tomada de Decisão Clínica , Redução de Custos , Análise Custo-Benefício , Árvores de Decisões , Desfibriladores Implantáveis/efeitos adversos , Humanos , Modelos Econômicos , Estudos Multicêntricos como Assunto , Implantação de Prótese/efeitos adversos , Implantação de Prótese/instrumentação , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/prevenção & controle , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
6.
Circ Arrhythm Electrophysiol ; 13(5): e008280, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32281393

RESUMO

BACKGROUND: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system. METHODS: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets. RESULTS: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P<0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P=0.004). Quality of life was reduced (P=0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage. CONCLUSIONS: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.


Assuntos
Antibacterianos/economia , Antibacterianos/uso terapêutico , Antibioticoprofilaxia/economia , Desfibriladores Implantáveis/economia , Custos de Cuidados de Saúde , Recursos em Saúde/economia , Marca-Passo Artificial/economia , Infecções Relacionadas à Prótese/economia , Infecções Relacionadas à Prótese/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , Antibioticoprofilaxia/efeitos adversos , Causas de Morte , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/economia , Custos de Medicamentos , Planos de Pagamento por Serviço Prestado/economia , Feminino , Gastos em Saúde , Custos Hospitalares , Humanos , Tempo de Internação/economia , Masculino , Medicare/economia , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Readmissão do Paciente/economia , Estudos Prospectivos , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/mortalidade , Qualidade de Vida , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
7.
J Cardiovasc Electrophysiol ; 31(5): 1182-1186, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32108406

RESUMO

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in patients with medically refractory heart failure and wide QRS duration. While much is known about predictors of left ventricular (LV) remodeling after CRT implantation and short-term mortality, limited data exist on long-term outcomes after CRT placement. METHODS: We retrospectively reviewed all patients undergoing CRT implantation at our center between 2003 and 2008 and examined mortality using institutional electronic records, social security death index, and online obituary search. We included only patients with preimplant echoes with LV ejection fraction (LVEF) 35% or below. Variable selection was performed using stepwise regression and models were compared using goodness-of-fit criteria. A final model was validated with the bootstrap regression method. RESULTS: Out of the 877 CRT patients undergoing implantation during this time, 287 (32.7%) survived longer than 10 years. Significant (P < .05) predictors of survival in our multivariate model were age, left ventricular diastolic diameter, sex, presence of nonischemic vs ischemic cardiomyopathy, QRS duration, atrial fibrillation, BNP levels, and creatinine levels at the time of CRT implantation. A model using the odds ratios from these variables had a receiver operating curve with an area under the curve score of 0.816 (standard error, 0.019) at predicting survival or freedom from LVAD or heart transplant for longer than 10 years after CRT implantation. The specificity for factors 3 or above and 5 or above was 68% and 77%, respectively. CONCLUSION: A large proportion of patients are still alive 10 years after CRT implantation. Variables at the time of CRT implant can help provide prognostic information to patients and electrophysiologists to determine the long-term benefit and survival of patients after CRT implantation.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca/terapia , Idoso , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/mortalidade , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Sobreviventes , Fatores de Tempo , Resultado do Tratamento
10.
Europace ; 16(10): 1490-5, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25087154

RESUMO

AIMS: Infections of cardiac implantable electronic devices (CIEDs) are infrequent but carry significant morbidity and mortality. We aimed to assess risk factors for 1-year mortality among patients with CIED infection and to evaluate if the type of infection and the presence of vegetation affect survival. METHODS AND RESULTS: We reviewed records of all patients with infected CIEDs who underwent transvenous lead extraction at our tertiary care centre between 2002 and 2008. Patients who presented with infection involving the device pocket were classified as 'pocket infection', and those who presented with bacteraemia with or without vegetation and a pocket that looked benign were classified as 'endovascular infection' (EVI). One-year mortality was examined using the social security death index. Five hundred and two patients were identified (68.5 ± 15 years); 289 (58%) had pocket infection and 213 (42%) had EVI. One-year mortality rate was 20%. Using multivariable Cox regression model, EVI was associated with significantly higher 1-year mortality (hazard ratio 2.1, P-value 0.0008). Among patients with EVI, 100 patients had vegetation on transoesophageal echo; however, there was no difference in 1-year mortality between patients with EVI and vegetation compared with patients with EVI and no vegetation (27, 27 vs. 40, 35%; P-value 0.188). Risk factors for 1-year mortality among patients with EVI included renal failure, worse functional class, and bleeding requiring transfusion. The presence of vegetation was not associated with increased 1-year mortality. CONCLUSION: One-year mortality is higher among patients with EVI compared with patients with pocket infection; this increased mortality does not seem to be related to the presence of vegetations.


Assuntos
Desfibriladores Implantáveis , Marca-Passo Artificial , Infecções Relacionadas à Prótese/mortalidade , Idoso , Remoção de Dispositivo , Ecocardiografia Transesofagiana , Contaminação de Equipamentos , Feminino , Humanos , Masculino , Infecções Relacionadas à Prótese/diagnóstico por imagem , Fatores de Risco , Taxa de Sobrevida
11.
Heart Rhythm ; 11(3): 404-11, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24291414

RESUMO

BACKGROUND: An arteriovenous (AV) fistula is an infrequently reported complication of transvenous lead extraction (TLE), but may be under-recognized. OBJECTIVE: To determine the incidence, management, and outcomes of the AV fistula complicating TLE. METHODS: All TLE procedures from July 2001 to December 2012 were reviewed. RESULTS: Of 2471 patients who underwent TLE, the AV fistula occurred in 8 (0.3%; 6 pacemaker and 2 implantable cardioverter-defibrillator) procedures. Patients who developed an AV fistula had longer lead implant duration (11.8 [interquartile range 7.7] vs 5.2 [interquartile range 7.0] years) and were more likely to have required a powered sheath (8 of 8 [100%] vs 1392 of 2463 [56.5%]) compared to those who did not. Other procedural and demographic details did not discriminate. All patients had a continuous bruit along the anterior chest wall. Catheter angiography was more sensitive (100%) than computed tomography (75%) or ultrasound (25%) for confirming the diagnosis and identifying the vessels involved. One fistula closed spontaneously, while others were closed with covered stents (4) or surgical glue (1). One attempt at closure failed, and one was diagnosed postmortem. Mortality related to the AV fistula was 3 of 8 (37.5%). Patients who died all had structural heart disease. In the 5 patients with normal hearts, the AV fistula was well tolerated for up to 2 years. CONCLUSIONS: An AV fistula is an infrequent, though possibly under-recognized, complication of TLE. It requires a high index of suspicion for early diagnosis, may present late, and may be associated with significant morbidity and mortality in patients with structural heart disease.


Assuntos
Fístula Arteriovenosa/etiologia , Fístula Arteriovenosa/terapia , Remoção de Dispositivo , Eletrodos Implantados , Marca-Passo Artificial , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Fístula Arteriovenosa/mortalidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Resultado do Tratamento
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