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Objective: Cryoballoon ablation for pulmonary vein isolation is a time-efficient procedure that can alleviate stress on electrophysiology lab resources. This analysis modeled the impact of cryoballoon ablation on electrophysiology lab operation using data from Latin America. Methods: Data from centers in Argentina, Mexico, Colombia, and Chile of the were used as inputs for an electrophysiology lab efficiency simulation model. The model used the assumption that either two (today's electrophysiology lab operations) or three (including electrophysiology lab operational changes) cryoballoon ablation procedures could be performed per day. The endpoints were the percentage of days that resulted in 1) overtime and 2) time left for an extra non-ablation electrophysiology procedure. Results: Data from a total of 232 procedures from six Latin American centers were included in the analysis. The average electrophysiology lab occupancy time for all procedures in Latin America was 132 ± 62 minutes. In the Current Scenario (two procedures per day), 7.4% of simulated days resulted in overtime, and 81.4% had enough time for an extra electrophysiology procedure. In the Enhanced Productivity Scenario (three procedures per day), 16.4% of days used overtime, while 67.4% allowed time for an extra non-ablation electrophysiology procedure. Conclusions: Using real-world, Latin American-specific data, we found that with operational changes, three ablation procedures could feasibly be performed daily, leaving time for an extra electrophysiology procedure on more than half of days. Thus, use of cryoballoon ablation is an effective tool to enhance electrophysiology lab efficiency in resource-constrained regions such as Latin America.
Objetivos: La ablación con criobalón para el aislamiento de venas pulmonares es un procedimiento que ahorra tiempo y puede ahorrar recursos del laboratorio de electrofisiología. Este análisis modeló el impacto de la ablación con criobalón en el funcionamiento del laboratorio de electrofisiología utilizando datos de América Latina. Métodos: Los datos de los centros de Argentina, México, Colombia y Chile del se utilizaron como datos de entrada para un modelo de simulación de la eficiencia del laboratorio de electrofisiología. El modelo partió del supuesto de que se podían realizar dos (operaciones actuales del laboratorio de electrofisiología) o tres (incluidos los cambios operativos del laboratorio de electrofisiología) procedimientos de ablación con criobalón por día. Los criterios de valoración eran el porcentaje de días en los que se producían 1) horas extraordinarias y 2) tiempo restante para un procedimiento electrofisiológico adicional no relacionado con la ablación. Resultados: Se incluyeron en el análisis los datos un total de 232 procedimientos de seis centros latinoamericanos. El tiempo medio de ocupación del laboratorio de electrofisiología para todos los procedimientos en Latinoamérica fue de 132 ± 62 minutos. En el escenario actual (dos procedimientos por día), el 7,4% de los días simulados resultaron en horas extras, y el 81,4% tuvo tiempo suficiente para un procedimiento de electrofisiología adicional. En el escenario de productividad mejorada (tres procedimientos por día), el 16,4% de los días utilizó horas extraordinarias, mientras que el 67,4% dispuso de tiempo suficiente para un procedimiento electrofisiológico extra sin ablación. Conclusiones: Utilizando datos del mundo real específicos de América Latina, descubrimos que, aplicando cambios operativos, es factible realizar tres procedimientos de ablación al día, lo que deja tiempo para un procedimiento de electrofisiología adicional en más de la mitad de los días. Por lo tanto, el uso de la ablación con criobalón es una herramienta eficaz para mejorar la eficiencia de los laboratorios de electrofisiología en regiones con recursos limitados como América Latina.
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Fibrilación Atrial , Criocirugía , Venas Pulmonares , Sistema de Registros , Humanos , Criocirugía/métodos , Venas Pulmonares/cirugía , Fibrilación Atrial/cirugía , América Latina , Factores de TiempoRESUMEN
BACKGROUND: Cryoballoon ablation for treatment of atrial fibrillation (AF) reduces procedure times, but limited data is available about its impact on electrophysiology (EP) lab efficiency in Central and Eastern Europe (CEE). Using CEE-specific procedure data, the present study modeled cryoballoon ablation procedures on EP lab resource consumption to improve efficiency. METHODS: A discrete event simulation model was developed to assess EP efficiency with cryoballoon ablation. Model inputs were taken from CEE sites within the Cryo Global Registry, namely Czech Republic, Hungary, Poland, Serbia, and Slovakia. The main endpoints were percentage of days that resulted in overtime and percentage of days with time for one extra simple EP procedure. Use of the 'figure of 8' (Fo8) closure technique to reduce procedure time was also examined. RESULTS: The mean lab occupancy time across all CEE sites was 133 ± 47 minutes (min: 104 minutes, max:181 minutes). Cryoballoon ablation in the base-case scenario resulted in 14.6% of days with overtime and 64.8% of days with time for an extra simple EP procedure. Use of the Fo8 closure technique enhanced these values to 5.5% and 85.3%, respectively. Model endpoints were most sensitive to changes in lab occupancy times and overtime start time. CONCLUSIONS: In this CEE-specific analysis of EP lab efficiency it was found that 3 cryoballoon ablation procedures could be performed in 1 lab day, leaving time for a 4th simple EP procedure on most days. As such, use cryoballoon ablation for PVI is an effective way to improve EP lab efficiency.
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INTRODUCTION: Three randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective. METHODS: Individual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis. RESULTS: First-line cryoablation is dominant, meaning it results in lower costs (-2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of 23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive â¼ 1.2 ablation procedures over a lifetime horizon. CONCLUSION: First-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.
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Antiarrítmicos , Fibrilación Atrial , Análisis Costo-Beneficio , Criocirugía , Costos de los Medicamentos , Cadenas de Markov , Modelos Económicos , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/economía , Fibrilación Atrial/terapia , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/fisiopatología , Humanos , Criocirugía/economía , Criocirugía/efectos adversos , Dinamarca , Antiarrítmicos/uso terapéutico , Antiarrítmicos/economía , Resultado del Tratamiento , Factores de Tiempo , Masculino , Femenino , Persona de Mediana Edad , Técnicas de Apoyo para la Decisión , Anciano , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Ahorro de Costo , Árboles de DecisiónRESUMEN
INTRODUCTION: Three recent randomised controlled trials have demonstrated that pulmonary vein isolation as an initial rhythm control strategy with cryoablation reduces atrial arrhythmia recurrence in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drug (AAD) therapy. The aim of this study was to evaluate the cost-effectiveness of first-line cryoablation compared with first-line AADs for treating symptomatic PAF in an English National Health Service (NHS) setting. METHODS: Individual patient-level data from 703 participants with PAF enrolled into Cryo-FIRST (Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation), STOP AF First (Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation) and EARLY-AF (Early Aggressive Invasive Intervention for Atrial Fibrillation) were used to derive the parameters applied in the cost-effectiveness model (CEM). The CEM comprised a hybrid decision tree and Markov structure. The decision tree had a 1-year time horizon and was used to inform the initial health state allocation in the first cycle of the Markov model (40-year time horizon; 3-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3.5% per year. Model outcomes were generated using probabilistic sensitivity analysis. RESULTS: The results estimated that cryoablation would yield more QALYs (+0.17) and higher costs (+£641) per patient over a lifetime than AADs. This produced an incremental cost-effectiveness ratio of £3783 per QALY gained. Independent of initial treatment, individuals were expected to receive ~1.2 ablations over a lifetime. There was a 45% relative reduction in time spent in AF health states for those initially treated with cryoablation. DISCUSSION: AF rhythm control with first-line cryoablation is cost effective compared with first-line AADs in an English NHS setting.
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Fibrilación Atrial , Criocirugía , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Análisis Costo-Beneficio , Medicina Estatal , Antiarrítmicos/efectos adversos , Criocirugía/efectos adversos , Criocirugía/métodosRESUMEN
Aim: Catheter ablation is used to treat symptomatic atrial fibrillation (AF) and is performed using either cryoballoon (CB) or radiofrequency (RF) ablation. There is limited real world data of CB and RF in the US as healthcare codes are agnostic of energy modality. An alternative method is to analyze patients' electronic health records (EHRs) using Optum's EHR database. Objective: To determine the feasibility of using patients' EHRs with natural language processing (NLP) to distinguish CB versus RF ablation procedures. Data Source: Optum® de-identified EHR dataset, Optum® Cardiac Ablation NLP Table. Methods: This was a retrospective analysis of existing de-identified EHR data. Medical codes were used to create an ablation validation table. Frequency analysis was used to assess ablation procedures and their associated note terms. Two cohorts were created (1) index procedures, (2) multiple procedures. Possible note term combinations included (1) cryoablation (2) radiofrequency (3) ablation, or (4) both. Results: Of the 40,810 validated cardiac ablations, 3777 (9%) index ablation procedures had available and matching NLP note terms. Of these, 22% (n = 844) were classified as ablation, 27% (n = 1016) as cryoablation, 49% (n = 1855) as radiofrequency ablation, and 1.6% (n = 62) as both. In the multiple procedures analysis, 5691 (14%) procedures had matching note terms. 24% (n = 1362) were classified as ablation, 27% as cryoablation, 47% as radiofrequency ablation, and 2% as both. Conclusion: NLP has potential to evaluate the frequency of cardiac ablation by type, however, for this to be a reliable real-world data source, mandatory data entry by providers and standardized electronic health reporting must occur.
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Fibrilación Atrial , Ablación por Catéter , Humanos , Resultado del Tratamiento , Catéteres Cardíacos , Estudios Retrospectivos , Registros Electrónicos de Salud , Procesamiento de Lenguaje Natural , Fibrilación Atrial/cirugía , Ablación por Catéter/métodosRESUMEN
BACKGROUND: The EARLY-AF (NCT02825979), STOP AF First (NCT03118518), and Cryo-FIRST (NCT01803438) randomised controlled trials (RCTs) demonstrated that cryoballoon pulmonary vein isolation reduces atrial fibrillation (AF) recurrence compared with antiarrhythmic drugs (AADs) in patients with symptomatic paroxysmal atrial fibrillation (PAF). The present study developed a cost-effectiveness model (CEM) of first-line cryoablation compared with first-line AADs for PAF, from the Canadian health care payer's perspective. METHODS: Data from the 3 RCTs were analysed to estimate key CEM parameters. The model structure used a decision tree for the first 12 months and a Markov model with a 3-month cycle length for the remaining lifetime time horizon. Costs were set at 2023 Canadian dollars, health benefits were expressed as quality-adjusted life years (QALYs), and both were discounted 3% annually. Probabilistic sensitivity analysis (PSA) considered parameter uncertainty. RESULTS: The statistical analysis estimated that first-line cryoablation generates a 47% reduction (P < 0.001) in the rate of AF recurrence, a 73% reduction in the rate of subsequent ablation (P < 0.001), and a 4.3% (P = 0.025) increase in health-related quality of life, compared with first-line AADs. The PSA indicates that an individual treated with first-line cryoablation accrues less costs (-$3,862) and more QALYs (0.19) compared with first-line AADs. Cryoablation is cost-saving in 98.4% of PSA iterations and has a 99.9% probability of being cost-effective at a cost-effectiveness threshold of $50,000 per QALY gained. Cost-effectiveness results were robust to changes in key model parameters. CONCLUSIONS: First-line cryoballoon ablation is cost-effective when compared with AADs for patients with symptomatic PAF.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Análisis Costo-Beneficio , Antiarrítmicos/uso terapéutico , Ablación por Catéter/métodos , Canadá/epidemiología , Resultado del Tratamiento , RecurrenciaRESUMEN
Background: Three recent randomized controlled trials have demonstrated that, as an initial rhythm control strategy, first-line cryoballoon ablation (cryoablation) reduces atrial arrhythmia recurrence compared with antiarrhythmic drugs (AADs) in patients with symptomatic paroxysmal atrial fibrillation (PAF). Objective: The study sought to evaluate the cost-effectiveness of first-line cryoablation compared with first-line AADs for treating symptomatic PAF from a U.S. Medicare payer perspective. Methods: Individual patient-level data from 703 participants with PAF enrolled into the Cryo-FIRST (NCT01803438), STOP AF First (NCT03118518), and EARLY-AF (NCT02825979) trials were used to derive parameters for the cost-effectiveness model. The cost-effectiveness model used a hybrid decision tree and Markov structure. The decision tree had a 1-year time horizon and was used to inform the initial health state allocation in the first cycle of the Markov model. The Markov model used a 40-year time horizon (3-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Results: Cryoablation was estimated to yield higher QALYs (+0.17) and higher costs (+$4274) per patient over a 40-year time horizon than AADs. Ultimately, this produced an average incremental cost-effectiveness ratio of $24,637 per QALY gained. Independent of initial treatment, individuals were expected to receive â¼1.2 ablations over a lifetime. There was a 45% relative reduction in time spent in atrial fibrillation health states for those initially treated with cryoablation compared with AADs. Conclusion: Initial rhythm control with first-line cryoballoon ablation is highly cost-effective compared with first-line AADs from a U.S. Medicare payer perspective.
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BACKGROUND: Rates of early mortality and complications after catheter ablation (CA) of atrial fibrillation (AF) vary across health care settings. OBJECTIVE: The purpose of this study was to identify the rate and predictors of early mortality (within 30 days) after CA in the inpatient and outpatient settings. METHODS: Using the Medicare Fee for Service database, we analyzed 122,289 patients who underwent CA for treatment of AF between 2016 and 2019 to define 30-day mortality in both inpatients and outpatients. Odds of adjusted mortality were assessed with several methods, including inverse probability of treatment weighting. RESULTS: Mean age was 71.9 ± 6.7 years, 44% were women, and mean CHA2DS2-VASc score was 3.2 ± 1.7. Overall, 82% underwent AF ablation as an outpatient. Mortality rate 30 days after CA was 0.6%, with inpatients accounting for 71.5% of deaths (P <.001). Early mortality rates were 0.2% for outpatient procedures and 2.4% for inpatient procedures. The prevalence of comorbidities was significantly higher in patients with early mortality. Patients with early mortality had significantly higher rates of postprocedural complications. After adjustment, inpatient ablation was significantly associated with early mortality (adjusted odds ratio [aOR] 3.81; 95% confidence interval [CI] 2.87-5.08; P <.001). Hospitals with high overall ablation volume had 31% lower odds of early mortality (highest vs lowest tertile: aOR 0.69; 95% CI 0.56-0.86; P <.001). CONCLUSION: AF ablation conducted in the inpatient setting is associated with a higher rate of early mortality compared with outpatient AF ablation. Comorbidities are associated with enhanced risk of early mortality. High overall ablation volume is associated with a lower risk of early mortality.
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Fibrilación Atrial , Ablación por Catéter , Anciano , Femenino , Humanos , Masculino , Fibrilación Atrial/mortalidad , Ablación por Catéter/métodos , Pacientes Internos , Medicare , Pacientes Ambulatorios , Medición de Riesgo/métodos , Factores de Riesgo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: To identify the most frequently used atrial fibrillation-specific quality of life (QoL) instruments across atrial fibrillation (AF) ablation studies and to perform a systematic review of the most frequently used instrument's measurement properties. This study uses quality of life instruments as an overarching term for any patient reported outcome measure that assesses a person's health related well-being, functional status, and disease related symptoms. METHODS: A literature mapping exercise was undergone to identify the most frequently used AF-specific QoL instruments across AF ablation studies published from 2016 to 2021. A systematic review of the most frequently used AF QoL instruments identified from the mapping exercise was performed using the COSMIN guidelines for systematic reviews of patient-reported outcome measurements. A systematic search was conducted in Ovid MEDLINE, Ovid Embase, Ovid PsycINFO, EBSCO CINAHL, and Cochrane CENTRAL. The search used variations of the keywords "atrial fibrillation", "quality of life", and "catheter ablation". RESULTS: Forty-five instruments were identified via the literature mapping exercise. After excluding non-patient reported outcome instruments, non-AF specific instruments, and instruments appearing only once, six instruments were identified: AF Effect on QualiTy-of-Life (AFEQT), AF Severity Scale, Minnesota Living with Heart Failure Instrument, AF Quality of Life Instrument, Arrhythmia Specific instrument in Tachycardia and Arrhythmia (ASTA), and SCL (Arrhythmia Symptom Checklist, Frequency and Severity). A systematic review of these six AF-specific health related QoL instruments was performed. We screened 3221 articles and 17 studies were eligible for inclusion. Using the COSMIN guidelines, ASTA and AFEQT had the best ratings across measurement properties with both instruments having good ratings for instrument development and internal consistency. However, none of the 17 included articles assessed measurement error and cross-cultural validity. CONCLUSIONS: AFEQT and ASTA had the strongest measurement properties but not all measurement properties were assessed. Considering the large number of indeterminate and insufficient ratings, future research should focus on cross-cultural validation, measurement error, responsiveness, and interpretability. This review summarizes the current evidence for AF QoL instruments across AF ablation studies and outlines areas for future research.
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Fibrilación Atrial , Calidad de Vida , Humanos , Atención a la Salud , Medición de Resultados Informados por el PacienteRESUMEN
BACKGROUND: The volume of atrial fibrillation (AF) catheter ablation procedures has increased to address the growing patient population with AF; however, the impact of cryoballoon ablation on electrophysiology (EP) lab throughput is under-studied when treating patients with persistent AF (PsAF). OBJECTIVE: To assess EP lab utilization associated with cryoballoon ablation for the treatment of patients with PsAF and to evaluate mechanisms that optimize hospital resources. METHODS: Procedural data derived from the STOP Persistent AF trial were input into a discrete event simulation to assess EP lab utilization during AF ablation procedures. Patient and physician delays and lab occupancy times were modeled in a nominal and efficient EP lab setting over 1000 days. Accounting for variation in procedural times, we evaluated the number of days in which preplanned pulmonary vein isolation (PVI) cases resulted in overtime or excess time for non-ablation EP cases within a given lab day. A sensitivity analysis determined the parameters that most strongly influenced EP lab throughput. RESULTS: Lab occupancy times for the Nominal Use (NU) case included 165 procedures, and the High-Efficiency Use (HEU) case was derived from 69 procedures conducted at sites with faster procedure times than average. The HEU case had shorter lab occupancy times than the NU case (158 ± 32 minutes vs 188 ± 51 minutes, respectively). In the NU case, a total of 2000 procedures were conducted, with 28 lab days (2.8%) extending into overtime and 900 lab days (90%) exhibiting excess time for a non-ablation EP case. In the HEU case, a total of 3000 procedures were conducted, with 87 lab days (8.7%) extending into overtime and 635 lab days (63.5%) exhibiting excess time for a non-ablation EP case. The model was most sensitive to lab occupancy duration and the time of day that overtime started. CONCLUSIONS: Cryoballoon ablation for the treatment of patients with PsAF confers EP lab efficiencies that can support 3 PVI cases in a lab day.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Electrofisiología , Estudios de Seguimiento , Humanos , Venas Pulmonares/cirugía , Recurrencia , Resultado del TratamientoRESUMEN
OBJECTIVES: Intrathecal drug delivery (ITDD) devices have been shown to be a clinically effective and cost-effective option for the management of cancer pain and recommended for use in England. The aim of this study is to assess the impact of the 2015 NHS England Clinical Commissioning Policy on the uptake of ITDD pumps for the management of cancer pain or if there is an ongoing unmet need for this intervention in England. MATERIALS AND METHODS: Hospital Episode Statistics (HES) were obtained for all patients undergoing ITDD for the management of cancer pain between 2014 and January 2020. In addition, HES were utilized to estimate the number of patients with cancer potentially eligible for ITDD pump during the same period. RESULTS: The number of patients with cancer and those potentially suitable to receive an ITDD for the management of cancer pain have increased year on year since 2014. This increase has not been matched by an uptake in the provision of ITDD. Conservative estimates suggest that at least 8000 people with cancer pain would be eligible for ITDD; 458 patients received an intervention for pain management between April 2018 and March 2019 and only 30 ITDD pumps were implanted in that same period. CONCLUSIONS: We observed a substantial gap between the need and provision of ITDD for patients with refractory cancer pain in England despite the recommendation for the use of ITDD for this patient population. In addition, we present suggestions for improvement of access to and provision of ITDD in England.