Economic Considerations of Cardiovascular Implantable Electronic Devices for The Treatment of Heart Failure.

PURPOSE OF REVIEW: Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10 years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions. RECENT FINDINGS: In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10 years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold.

Impact of Atrial Fibrillation Burden on Health Care Costs and Utilization.

BACKGROUND: Integrating patient-specific cardiac implantable electronic device (CIED)-detected atrial fibrillation (AF) burden with measures of health care cost and utilization allows for an accurate assessment of the AF-related impact on health care use. OBJECTIVES: The goal of this study was to assess the incremental cost of device-recognized AF vs no AF; compare relative costs of paroxysmal atrial fibrillation (pAF), persistent atrial fibrillation (PeAF), and permanent atrial fibrillation (PermAF) AF; and evaluate rates and sources of health care utilization between cohorts. METHODS: Using the de-identified Optum Clinformatics U.S. claims database (2015-2020) linked with the Medtronic CareLink database, CIED patients were identified who transmitted data ≥6 months postimplantation. Annualized per-patient costs in follow-up were analyzed from insurance claims and adjusted to 2020 U.S. dollars. Costs and rates of health care utilization were compared between patients with no AF and those with device-recognized pAF, PeAF, and PermAF. Analyses were adjusted for geographical region, insurance type, CHA2DS2-VASc score, and implantation year. RESULTS: Of 21,391 patients (mean age 72.9 ± 10.9 years; 56.3% male) analyzed, 7,798 (36.5%) had device-recognized AF. The incremental annualized increased cost in those with AF was $12,789 ± $161,749 per patient, driven by increased rates of health care encounters, adverse clinical events associated with AF, and AF-specific interventions. Among those with AF, PeAF was associated with the highest cost, driven by increased rates of inpatient and outpatient hospitalization encounters, heart failure hospitalizations, and AF-specific interventions. CONCLUSIONS: Presence of device-recognized AF was associated with increased health care cost. Among those with AF, patients with PeAF had the highest health care costs. Mechanisms for cost differentials include both disease-specific consequences and physician-directed interventions.

Comparative Effectiveness of Implantable Defibrillators for Asymptomatic Brugada Syndrome: A Decision-Analytic Model.

Background Optimal management of asymptomatic Brugada syndrome (BrS) with spontaneous type I electrocardiographic pattern is uncertain. Methods and Results We developed an individual-level simulation comprising 2 000 000 average-risk individuals with asymptomatic BrS and spontaneous type I electrocardiographic pattern. We compared (1) observation, (2) electrophysiologic study (EPS)-guided implantable cardioverter-defibrillator (ICD), and (3) upfront ICD, each using either subcutaneous or transvenous ICD, resulting in 6 strategies tested. The primary outcome was quality-adjusted life years (QALYs), with cardiac deaths (arrest or procedural-related) as a secondary outcome. We varied BrS diagnosis age and underlying arrest rate. We assessed cost-effectiveness at $100 000/QALY. Compared with observation, EPS-guided subcutaneous ICD resulted in 0.35 QALY gain/individual and 4130 cardiac deaths avoided/100 000 individuals, and EPS-guided transvenous ICD resulted in 0.26 QALY gain and 3390 cardiac deaths avoided. Compared with observation, upfront ICD reduced cardiac deaths by a greater margin (subcutaneous ICD, 8950; transvenous ICD, 6050), but only subcutaneous ICD improved QALYs (subcutaneous ICD, 0.25 QALY gain; transvenous ICD, 0.01 QALY loss), and complications were higher. ICD-based strategies were more effective at younger ages and higher arrest rates (eg, using subcutaneous devices, upfront ICD was the most effective strategy at ages 20-39.4 years and arrest rates >1.37%/year; EPS-guided ICD was the most effective strategy at ages 39.5-51.3 years and arrest rates 0.47%-1.37%/year, and observation was the most effective strategy at ages >51.3 years and arrest rates <0.47%/year). EPS-guided subcutaneous ICD was cost-effective ($80 508/QALY). Conclusions Device-based approaches (with or without EPS risk stratification) can be more effective than observation among selected patients with asymptomatic BrS. BrS management should be tailored to patient characteristics.

Impact of insurance status on ICD implantation practice patterns: Insights from the NCDR ICD registry.

BACKGROUND: Whether insurance status influences practice patterns in implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) defibrillators, when indicated, is not known. METHODS AND RESULTS: We analyzed the NCDR ICD Registry to evaluate associations of insurance status with guidelines-based receipt of CRT, as well as device-type, complication rates, and use of optimal medical therapy defined by guidelines. Among 798,028 patients with de novo ICD implants, we included only patients < 65 years (those older have Medicare) and excluded those admitted before 2006 (n=1,835) or with insurance coverage other than Medicare, Medicaid or private insurance (n=25,695) leaving 286,556 for analysis. Inverse probability of treatment weighting was used to control for imbalances between groups. Mean age was 53 years, 29% were female. Patients with private insurance and Medicare were more likely to receive CRT-D when indicated (79.6%, OR 1.19 95% CI 1.09-1.28, P <.001 and 78.5%, OR 1.11 95% CI 1.01-1.21 P = .03, respectively) compared to the uninsured (76.7%). The uninsured were also more likely than other groups to receive a single-chamber device. Complication rates did not differ. Uninsured patients were, however, more likely to receive optimal medical therapy, particularly in the subgroup receiving the implant for primary prevention. CONCLUSIONS: In propensity-weighted analysis, uninsured patients are less likely to receive CRT when indicated but more likely to be receiving optimal medical therapy at discharge. Reasons for differences in device implantation practices based on insurance status require further study.

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation.

Importance: Little is known about the association between industry payments and medical device selection. Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D). Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated. Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation. Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation. Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D. Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

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.

Cost-Effectiveness of Implantable Cardioverter-Defibrillators in Children with Cardiac Conditions Associated with Risk for Sudden Cardiac Death.

Children at high risk for sudden cardiac death (SCD) receive implantable cardioverter-defibrillators (ICD) for prevention, but the cost effectiveness of ICDs in children at intermediate risk is unclear. Our objective was to create a cost-effectiveness model to compare costs and outcomes in children at risk of SCD, with and without ICD. Utilizing hypertrophic cardiomyopathy as the proxy disease, a theoretical cohort of 8150 children was followed for 69 years. Model inputs were derived from the literature, with an incremental cost-effectiveness ratio (ICER) willingness-to-pay threshold of $100,000/quality-adjusted life year (QALY) used to delineate cost effectiveness. Outcomes included prevalence of severe neurological morbidity (SNM), SCD, cost, and QALYs. In children at intermediate risk of SCD (4-6% over 5 years), ICD resulted in 56 fewer cases of SNM, 2686 fewer deaths. In children at high risk (> 6% over 5 years), ICD placement resulted in 74 fewer cases of SNM and 3663 fewer deaths from cardiac causes. The costs of ICD were higher, but placement was cost effective with an ICER of $3009 per QALY in intermediate risk children, but ICD therapy was a dominant strategy in high-risk children. Sensitivity analysis demonstrated ICD placement was cost-effective until the annual probability of SCD was < 0.22%. The model was robust over a wide range of values. For children at risk of SCD, prophylactic ICD implantation is cost effective, resulting in improved outcomes and increased QALYs, despite increased costs. These findings highlight the economic benefits of ICD utilization in this population.

Burden of recurrent syncope and injuries and the usefulness of implantable cardiac monitors: insights from a nationwide longitudinal cohort analysis.

Aim: The study assesses the burden and costs of recurring unexplained syncope and injuries and the effectiveness of implantable loop recorders. Methods: The English national hospital database (Hospital Episode Statistics) was retrospectively analyzed. Results: 12,002 patients were identified with repeated syncope hospitalizations. 25% of patients were hospitalized at least once again for syncope, 9% of the patients were hospitalized at least once for an injury, causing substantial costs. In the second analysis: 10,902 patients implanted with an implantable cardiac monitor were tracked. By year 3, hospitalizations due to syncope had dropped by 60% versus pre-implantable cardiac monitor (ICM) levels. Conclusion: This study shows a high rate of recurrent syncope admissions and a parallel burden of hospitalizations for injuries. Use of an ICM appears to reduce syncope hospitalizations.

Trends in utilization and spending on remote monitoring of pacemakers and implantable cardioverter-defibrillators among Medicare beneficiaries.

BACKGROUND: National trends and costs associated with remote and in-office interrogations of pacemakers and implantable cardioverter-defibrillators (ICDs) have not been previously described. OBJECTIVE: The purpose of this study was to evaluate utilization and Medicare spending for remote monitoring and in-office interrogations for pacemakers and ICDs. METHODS: We performed a retrospective cohort study of claims and spending for remote and in-office interrogations of pacemakers and ICDs for Medicare fee-for-service beneficiaries from 2012 to 2015. Aggregate and per-beneficiary claims and spending were calculated for each device type. RESULTS: Among all patients, 41.9% were female and the mean age was 78.3 years. From 2012 to 2015, remote monitoring utilization increased sharply. Aggregate professional remote monitoring claims for pacemakers increased by 61.3% and for ICDs by 5.6%, with an increase in technical claims (combined for pacemakers and ICDs) of 32.8%. Spending on all remote and in-office interrogations for these devices totaled $160 million per year, with remote costs increasing nearly 25% from $45.4 million in 2012 to $56.7 million in 2015. At the beneficiary level, remote interrogations increased for pacemakers from 0.6 to 0.9 per year, and for ICDs from 1.3 to 1.4 per year, whereas in-office interrogations decreased from 2.8 to 2.7 per year and from 3.0 to 2.9 per year, respectively. Beneficiary-level analysis revealed increased expenditures on remote interrogation offset by decreases in in-office expenditures, with total annual spending decreasing by $2 and $5 per beneficiary, respectively. CONCLUSION: Remote monitoring utilization increased substantially from 2012 to 2015, whereas annual costs per beneficiary decreased.

Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.

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.

Cost-effectiveness of in-home automated external defibrillators for children with cardiac conditions associated with risk of sudden cardiac death.

BACKGROUND: Children at high risk for sudden cardiac death (SCD) (>6% over 5 years) receive an implantable cardioverter-defibrillator (ICD), but no guidelines are available for those at lower risk. For children at intermediate risk for SCD (4%-6% over 5 years), the utility and cost-effectiveness of in-home automated external defibrillators (AEDs) are unclear. OBJECTIVE: The purpose of this study was to assess the cost-effectiveness of in-home AED for children at intermediate risk for SCD. METHODS: Using hypertrophic cardiomyopathy (HCM) as the proxy disease, a theoretical cohort of 1550 ten-year-old children with HCM was followed for 69 years. Baseline annual risk of SCD was 0.8%. Outcomes were SCD, severe neurologic morbidity (SNM), cost, and quality-adjusted life-years (QALYs). Model inputs were derived from the literature, with a willingness-to-pay threshold of $100,000 per QALY. RESULTS: Among children at intermediate risk for SCD, in-home AED resulted in 31 fewer cases of SCD but 3 more cases of SNM. There were 319 QALYs gained. Although costs were higher by $28 million, the incremental cost-effectiveness ratio was $86,458, which is below the willingness-to-pay threshold. CONCLUSION: For children at intermediate risk for SCD and HCM, in-home AED is cost-effective, resulting in fewer deaths and increased QALYS for a cost below the willingness-to-pay threshold. These findings highlight the economic benefits of in-home AED use in this population.

Cost-effectiveness analysis of implantable cardiac devices in patients with systolic heart failure: a US perspective using real world data.

Aims: Heart failure with reduced ejection fraction (HFrEF) has a substantial impact on costs and patients' quality-of-life. This study aimed to estimate the cost-effectiveness of implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P), cardiac resynchronization therapy defibrillators (CRT-D), and optimal pharmacologic therapy (OPT) in patients with HFrEF, from a US payer perspective.Materials and methods: The analyses were conducted by adapting the UK-based cost-effectiveness analyses (CEA) to the US payer perspective by incorporating real world evidence (RWE) on baseline hospitalization risk and Medicare-specific costs. The CEA was based on regression equations estimated from data from 13 randomized clinical trials (n = 12,638). Risk equations were used to predict all-cause mortality, hospitalization rates, health-related quality-of-life, and device-specific treatment effects (vs. OPT). These equations included the following prognostic characteristics: age, QRS duration, New York Heart Association (NYHA) class, ischemic etiology, and left bundle branch block (LBBB). Baseline hospitalization rates were calibrated based on RWE from Truven Health Analytics MarketScan data (2009-2014). A US payer perspective, lifetime time horizon, and 3% discount rates for costs and outcomes were used. Benefits were expressed as quality-adjusted life-years (QALYs). Incremental cost-effectiveness analysis was conducted for 24 sub-groups based on LBBB status, QRS duration, and NYHA class.Results: Results of the analyses show that CRT-D was the most cost-effective treatment at a $100,000/QALY threshold in 14 of the 16 sub-groups for which it is indicated. Results were most sensitive to changes in estimates of hospitalization costs.Limitations: Study limitations include small sample sizes for NYHA I and IV sub-groups and lack of data availability for duration of treatment effect.Conclusions: CRT-D has higher greater cost-effectiveness across more sub-groups in the indicated patient populations against as compared to OPT, ICD, and CRT-P, from a US payer perspective.

Cost-effectiveness of ablation of ventricular tachycardia in ischaemic cardiomyopathy: limitations in the trial evidence base.

Objective: Catheter ablation is an important treatment for ventricular tachycardia (VT) that reduces the frequency of episodes of VT. We sought to evaluate the cost-effectiveness of catheter ablation versus antiarrhythmic drug (AAD) therapy. Methods: A decision-analytic Markov model was used to calculate the costs and health outcomes of catheter ablation or AAD treatment of VT for a hypothetical cohort of patients with ischaemic cardiomyopathy and an implantable cardioverter-defibrillator. The health states and input parameters of the model were informed by patient-reported health-related quality of life (HRQL) data using randomised clinical trial (RCT)-level evidence wherever possible. Costs were calculated from a 2018 UK perspective. Results: Catheter ablation versus AAD therapy had an incremental cost-effectiveness ratio (ICER) of £144 150 (€161 448) per quality-adjusted life-year gained, over a 5-year time horizon. This ICER was driven by small differences in patient-reported HRQL between AAD therapy and catheter ablation. However, only three of six RCTs had measured patient-reported HRQL, and when this was done, it was assessed infrequently. Using probabilistic sensitivity analyses, the likelihood of catheter ablation being cost-effective was only 11%, assuming a willingness-to-pay threshold of £30 000 used by the UK's National Institute for Health and Care Excellence. Conclusion: Catheter ablation of VT is unlikely to be cost-effective compared with AAD therapy based on the current randomised trial evidence. However, better designed studies incorporating detailed and more frequent quality of life assessments are needed to provide more robust and informed cost-effectiveness analyses.

Costs and complications associated with transvenous lead reoperation in cardiac implantable electronic devices.

BACKGROUND: Cardiac implantable electronic device transvenous (TV) lead reoperations are projected to increase, and robust economic data are needed to assess the resulting financial impact and the cost-effectiveness of prevention and treatment strategies. This study estimates Medicare costs, and describes patterns of complications, in patients who underwent TV lead reoperation. METHODS AND RESULTS: Medicare data (2010-2014) were used to identify patients who underwent TV lead reoperation. Cumulative costs to Medicare, and rates of infection and mechanical complications were calculated from 180 days before, to 180 days after, lead reoperation. Multivariate analysis was used to estimate adjusted costs, and to examine the impact of complications on medical resource use and costs. There were 1691 patients, 63.2% of whom underwent inpatient lead reoperation. Overall, the mean age was 78.2 years, 39.6% were female, and 92.3% were white. The mean cumulative cost was $36 199 (95% confidence interval [CI], $31 864-$40 535) for TV lead repositioning, $27 701 (95% CI, $19 869-$35 534) for repair, and $54 442 (95% CI, $51 651-$57 233) for removal. Underlying infection was associated with increased odds of inpatient reoperation and of lead removal, as well as longer length of stay and higher costs. CONCLUSIONS: The economic consequences of TV lead reoperation are substantial. Strategies aimed at reducing reoperation, particularly lead removal, are likely to result in considerable cost offsets.

Wearable cardioverter-defibrillators in pediatric cardiomyopathy: A cost-utility analysis.

BACKGROUND: Dilated cardiomyopathy (DCM) is the most common cardiomyopathy in children. Patients with severe cardiac dysfunction are thought to be at risk of sudden cardiac arrest (SCA). After diagnosis, a period of medical optimization is recommended before permanent implantable cardioverter-defibrillator (ICD) implantation. Wearable cardioverter-defibrillators (WCDs) provide an option for arrhythmia protection as an outpatient during this optimization. OBJECTIVE: The purpose of this study was to determine the strategy that optimizes cost and survival during medical optimization of a patient with DCM before ICD placement. METHODS: A Markov state transition model was constructed for the 3 clinical approaches to compare costs, clinical outcomes, and quality of life: (1) "Inpatient," (2) "Home-WCD," and (3) "Home-No WCD." Transitional probabilities, costs, and utility metrics were extracted from the existing literature. Cost-effectiveness was assessed comparing each paradigm's incremental cost-effectiveness ratio against a societal willingness-to-pay threshold of $50,000 per quality-adjusted life year. RESULTS: The cost-utility analysis illustrated that Home-WCD met the willingness-to-pay threshold with an incremental cost-effectiveness ratio of $20,103 per quality-adjusted life year and 4 mortalities prevented per 100 patients as compared with Home-No WCD. One-way sensitivity analyses demonstrated that Home-No WCD became the most cost-effective solution when the probability of SCA fell below 0.2% per week, the probability of SCA survival with a WCD fell below 9.8%, or the probability of SCA survival with Home-No WCD quadrupled from base-case assumptions. CONCLUSION: Based on the existing literature probabilities of SCA in pediatric patients with DCM undergoing medical optimization before ICD implantation, sending a patient home with a WCD may be a cost-effective strategy.

The predictors and economic burden of early-, mid- and late-onset cardiac implantable electronic device infections: a retrospective cohort study in Ontario, Canada.

The rate of cardiac implantable electronic device (CIED) infection is increasing with time. We sought to determine the predictors, relative mortality, and cost burden of early-, mid- and late-onset CIED infections. We conducted a retrospective cohort study of all CIED implantations in Ontario, Canada between April 2013 and March 2016. The procedures and infections were identified in validated, population-wide health-care databases. Infection onset was categorized as early (0-30 days), mid (31-182 days) and late (183-365 days). Cox proportional hazards regression was used to assess the mortality impact of CIED infections, with infection modelled as a time-varying covariate. A generalized linear model with a log-link and γ distribution was used to compare health-care system costs by infection status. Among 17 584 patients undergoing CIED implantation, 215 (1.2%) developed an infection, including 88 early, 85 mid, and 42 late infections. The adjusted hazard ratio (aHR) of death was higher for patients with early (aHR 2.9, 95% CI 1.7-4.9), mid (aHR 3.3, 95% CI 1.9-5.7) and late (aHR 19.9, 95% CI 9.9-40.2) infections. Total mean 1-year health costs were highest for late-onset (mean Can$113 778), followed by mid-onset (mean Can$85 302), and then early-onset (Can$75 415) infections; costs for uninfected patients were Can$25 631. After accounting for patient and procedure characteristics, there was a significant increase in costs associated with early- (rate ratio (RR) 3.1, 95% CI 2.3-4.1), mid- (RR 2.8, 95% CI 2.4-3.3) and late- (RR 4.7, 95% CI 3.6-6.2) onset infections. In summary, CIED infections carry a tremendous clinical and economic burden, and this burden is disproportionately high for late-onset infections.

Cost and Outcomes of Implantable Cardiac Electronic Device Infections in Victoria, Australia.

BACKGROUND: Implantable cardiac electronic device (ICED) infections are associated with significant morbidity, mortality and cost. The aim of this study was to perform the first analysis for the cost of ICED infection in Australia. Secondary aims were to provide an update on the incidence, burden and outcomes of ICED infections and an analysis of the hospital ICD-10 codes used for ICED infection admissions. METHODS: We performed a retrospective study of ICED implantations and infections in the Barwon Health region (BH) and the state of Victoria (Vic) from January 2010 to December 2015 inclusive. RESULTS: Sensitivity of ICD-10 code T82.7 was 63.4% (95% CI 46.9-77.8) and specificity was 14.5% (95% CI 9.9-21.1). Infection rates were 1.4 admissions/100,000 persons/year (SD 0.7) in BH and estimated to be 7.9 admissions/100,000 persons/year (95% CI 6.8-9.0) in Vic. Average cost of infection was $670,334/year in BH and estimated to be $14,879,979/year in Vic. CONCLUSION: Rates of ICED infection are decreasing in Victoria. Infections are associated with significant morbidity and cost.

Potential Bias Associated with Modeling the Effectiveness of Healthcare Interventions in Reducing Mortality Using an Overall Hazard Ratio.

BACKGROUND: Clinical trials often report intervention efficacy in terms of the reduction in all-cause mortality between the treatment and control arms (i.e., an overall hazard ratio [oHR]) instead of the reduction in disease-specific mortality (i.e., a disease-specific hazard ratio [dsHR]). Using oHR to reduce all-cause mortality beyond the time horizon of the trial may introduce bias if the relative proportion of other-cause mortality increases with age. We sought to quantify this oHR extrapolation bias and propose a new approach to overcome this bias. METHODS: We simulated a hypothetical cohort of patients with a generic disease that increased background mortality by a constant additive disease-specific rate. We quantified the bias in terms of the percentage change in life expectancy gains with the intervention under an oHR compared with a dsHR approach as a function of the cohort start age, the disease-specific mortality rate, dsHR, and the duration of the intervention's effect. We then quantified the bias in a cost-effectiveness analysis (CEA) of implantable cardioverter-defibrillators based on efficacy estimates from a clinical trial. RESULTS: For a cohort of 50-year-old patients with a disease-specific mortality of 0.05, a dsHR of 0.5, a calculated oHR of 0.55, and a lifetime duration of effect, the bias was 28%. We varied these key parameters over wide ranges and the resulting bias ranged between 3 and 140%. In the CEA, the use of oHR as the intervention's effectiveness overestimated quality-adjusted life expectancy by 9% and costs by 3%, biasing the incremental cost-effectiveness ratio by - 6%. CONCLUSIONS: The use of an oHR approach to model the intervention's effectiveness beyond the time horizon of the trial overestimates its benefits. In CEAs, this bias could decrease the cost of a QALY, overestimating interventions' cost effectiveness.