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.

Cost-effectiveness analysis of leadless cardiac resynchronization therapy.

BACKGROUND: The Wireless Stimulation Endocardially for CRT (WiSE-CRT) system is a novel technology used to treat patients with dyssynchronous heart failure (HF) by providing leadless cardiac resynchronization therapy (CRT). Observational studies have demonstrated its safety and efficacy profile, however, the treatment cost-effectiveness has not previously been examined. METHODS: A cost-effectiveness evaluation of the WiSE-CRT System was performed using a cohort-based economic model adopting a "proportion in state" structure. In addition to the primary analysis, scenario analyses and sensitivity analyses were performed to test for uncertainty in input parameters. Outcomes were quantified in terms of quality-adjusted life year (QALY) differences. RESULTS: The primary analysis demonstrated that treatment with the WiSE-CRT system is likely to be cost-effective over a lifetime horizon at a QALY reimbursement threshold of £20 000, with a net monetary benefit (NMB) of £3781 per QALY. Cost-effectiveness declines at time horizons shorter than 10 years. Sensitivity analyses demonstrated that average system battery life had the largest impact on potential cost-effectiveness. CONCLUSION: Within the model limitations, these findings support the use of WiSE-CRT in indicated patients from an economic standpoint. However, improving battery technology should be prioritized to maximize cost-effectiveness in times when health services are under significant financial pressures.

Clinical and economic impact of multipoint left ventricular pacing: A comparative analysis from the Italian registry on multipoint pacing in cardiac resynchronization therapy (IRON-MPP).

INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.

Frequency of in-hospital adverse outcomes and cost utilization associated with cardiac resynchronization therapy defibrillator implantation in the United States.

BACKGROUND: The utilization of cardiac resynchronization therapy defibrillator (CRT-D) has increased significantly, since its initial approval for use in selected patients with heart failure. Limited data exist as for current trends in implant-related in-hospital complications and cost utilization. The aim of our study was to examine in-hospital complication rates associated with CRT-D and their trends over the last decade. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we estimated 378 248 CRT-D procedures from 2003 to 2012. We investigated common complications, including mechanical, cardiovascular, pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with CRT-D, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. Mechanical complications (5.9%) were the commonest, followed by cardiovascular (3.6%), respiratory failure (2.4%), and pneumothorax (1.5%). Age (≥65 years), female gender (OR, 95% CI; P value) (1.08, 1.03-1.13; 0.001), and the Charlson score ≥3 (1.52, 1.45-1.60; <0.001) were significantly associated with increased mortality/complications. CONCLUSIONS: The overall complication rate in patients undergoing CRT-D has been increasing in the last decade. Age (≥65), female sex, and the Charlson score ≥3 were associated with higher complications. In patients who underwent CRT-D implantation, postoperative complications were associated with significant increases in cost.

Statistics on the use of cardiac electronic devices and interventional electrophysiological procedures in Africa from 2011 to 2016: report of the Pan African Society of Cardiology (PASCAR) Cardiac Arrhythmias and Pacing Task Forces.

Aims: To provide comprehensive information on the access and use of cardiac implantable electronic devices (CIED) and catheter ablation procedures in Africa. Methods and results: The Pan-African Society of Cardiology (PASCAR) collected data on invasive management of cardiac arrhythmias from 2011 to 2016 from 31 African countries. A specific template was completed by physicians, and additional information obtained from industry. Information on health care systems, demographics, economics, procedure rates, and specific training programs was collected. Considerable heterogeneity in the access to arrhythmia care was observed across Africa. Eight of the 31 countries surveyed (26%) did not perform pacemaker implantations. The median pacemaker implantation rate was 2.66 per million population per country (range: 0.14-233 per million population). Implantable cardioverter-defibrillator and cardiac resynchronization therapy were performed in 12/31 (39%) and 15/31 (48%) countries respectively, mostly by visiting teams. Electrophysiological studies, including complex catheter ablations were performed in all countries from Maghreb, but only one sub-Saharan African country (South Africa). Marked variation in cost (up to 1000-fold) was observed across countries with an inverse correlation between implant rates and the procedure fees standardized to the gross domestic product per capita. Lack of economic resources and facilities, high cost of procedures, deficiency of trained physicians, and non-existent fellowship programs were the main drivers of under-utilization of interventional cardiac arrhythmia care. Conclusion: There is limited access to CIED and ablation procedures in Africa. A quarter of countries did not have pacemaker implantation services, and catheter ablations were only available in one country in sub-Saharan Africa.

Battery longevity of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators: technical, clinical and economic aspects. An expert review paper from EHRA.

In recent years an extension of devices longevity has been obtained for implantable cardioverter-defibrillators (ICDs), including ICDs for cardiac resynchronization therapy (CRT-D) through improved battery chemistry and device technology and this implies important clinical benefits (reduced need for device replacements and associated complications, particularly infections), as well as economic benefits, in line with patient preferences and needs. From a clinical point of view, the availability of this improvement in technology allows to better tune the choice of the device to be implanted, taking into account that the reasons supporting the value of an extended device longevity as a clinical priority may differ according to the clinical setting (purely electrical diseases or left ventricular dysfunction/heart failure, respectively). From an economic point of view, extension of device longevity may have an important impact in reducing long-term costs of device therapy, with substantial daily savings in favour of devices with extended longevity, up to 30%, depending on clinical scenarios. In studies based on projections, an extension of device longevity allowed to calculate that the cost per day of ICDs may be substantially reduced, and this allows to overcome the frequent perception of ICD and CRT-D devices as treatments with unaffordable costs and to overturn the misconception that up-front costs are the only metric with which to value device treatments. In view of its clinical and economic value, device longevity should be a determining factor in device choice by physicians and healthcare commissioners and should be appropriately considered and valued in comparative tenders.

The economic impact of battery longevity in implantable cardioverter-defibrillators for cardiac resynchronization therapy: the hospital and healthcare system perspectives.

AIMS: Patients receiving cardiac resynchronization therapy defibrillators (CRT-Ds) are likely to undergo one or more device replacements, mainly for battery depletion. We assessed the economic impact of battery depletion on the overall cost of CRT-D treatment from the perspectives of the healthcare system and the hospital. We also compared devices of different generations and from different manufacturers in terms of therapy cost. METHODS AND RESULTS: We analysed data on 1792 CRT-Ds implanted in 1399 patients in 9 Italian centres. We calculated the replacement probability and the total therapy cost over 6 years, stratified by device generation and manufacturer. Public tariffs from diagnosis-related groups were used together with device prices and hospitalization costs. Generators were from 3 manufacturers: Boston Scientific (667, 37%), Medtronic (973, 54%), and St Jude Medical (152, 9%). The replacement probability at 6 years was 83 and 68% for earlier- and recent-generation devices, respectively. The need for replacement increased total therapy costs by more than 50% over the initial implantation cost for hospitals and by more than 30% for healthcare system. The improved longevity of recent-generation CRT-Ds reduced the therapy cost by ∼6% in both perspectives. Among recent-generation CRT-Ds, the replacement probability of devices from different manufacturers ranged from 12 to 70%. Consequently, the maximum difference in therapy cost between manufacturers was 40% for hospitals and 19% for the healthcare system. CONCLUSIONS: Differences in CRT-D longevity strongly affect the overall therapy cost. While the use of recent-generation devices has reduced the cost, significant differences exist among currently available systems.

A Decade of Information on the Use of Cardiac Implantable Electronic Devices and Interventional Electrophysiological Procedures in the European Society of Cardiology Countries: 2017 Report from the European Heart Rhythm Association.

AIMS: The aim of this analysis was to provide comprehensive information on invasive cardiac arrhythmia therapies in the European Society of Cardiology (ESC) area over the past 10 years. METHODS AND RESULTS: The European Heart Rhythm Association (EHRA) has collected data on invasive arrhythmia therapies since 2008. This year 53 of the 56 ESC member countries provided data for the EHRA White Book. Here we present updated data on procedure rates together with information on demographics, economy, vital statistics, local healthcare systems and training activities. Considerable heterogeneity in the access to invasive arrhythmia therapies still exists across the five geographical ESC regions. In 2016, the device implantation rates per million population were 3-6 times higher in the Western region than in the non-European and Eastern ESC member countries. Catheter ablation activity was highest in the Western countries followed by the Northern and Southern areas. In the non-European countries, atrial fibrillation ablation rate was more than tenfold lower than in the European countries. On the other hand, the growth rate over the past ten years was highest in the non-European and Eastern countries. In some Eastern European countries with relative low gross domestic product the procedure rates exceeded the average values. CONCLUSION: It was encouraging to note that during the past decade the growth in invasive arrhythmia therapies was greatest in the areas historically with relatively low activity. Nevertheless, there is substantial disparity and continued efforts are needed to improve harmonization of cardiac arrhythmia therapies in the ESC area.

Cost-Effectiveness of Adding Cardiac Resynchronization Therapy to an Implantable Cardioverter-Defibrillator Among Patients With Mild Heart Failure.

BACKGROUND: Cardiac resynchronization therapy (CRT) reduces mortality and heart failure hospitalizations in patients with mild heart failure. OBJECTIVE: To estimate the cost-effectiveness of adding CRT to an implantable cardioverter-defibrillator (CRT-D) compared with implantable cardioverter-defibrillator (ICD) alone among patients with left ventricular systolic dysfunction, prolonged intraventricular conduction, and mild heart failure. DESIGN: Markov decision model. DATA SOURCES: Clinical trials, clinical registries, claims data from Centers for Medicare & Medicaid Services, and Centers for Disease Control and Prevention life tables. TARGET POPULATION: Patients aged 65 years or older with a left ventricular ejection fraction (LVEF) of 30% or less, QRS duration of 120 milliseconds or more, and New York Heart Association (NYHA) class I or II symptoms. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: CRT-D or ICD alone. OUTCOME MEASURES: Life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). RESULTS OF BASE-CASE ANALYSIS: Use of CRT-D increased life expectancy (9.8 years versus 8.8 years), QALYs (8.6 years versus 7.6 years), and costs ($286 500 versus $228 600), yielding a cost per QALY gained of $61 700. RESULTS OF SENSITIVITY ANALYSES: The cost-effectiveness of CRT-D was most dependent on the degree of mortality reduction: When the risk ratio for death was 0.95, the ICER increased to $119 600 per QALY. More expensive CRT-D devices, shorter CRT-D battery life, and older age also made the cost-effectiveness of CRT-D less favorable. LIMITATIONS: The estimated mortality reduction for CRT-D was largely based on a single trial. Data on patients with NYHA class I symptoms were limited. The cost-effectiveness of CRT-D in patients with NYHA class I symptoms remains uncertain. CONCLUSION: In patients with an LVEF of 30% or less, QRS duration of 120 milliseconds or more, and NYHA class II symptoms, CRT-D appears to be economically attractive relative to ICD alone when a reduction in mortality is expected. PRIMARY FUNDING SOURCE: National Institutes of Health, University of Copenhagen, U.S. Department of Veterans Affairs.

Impact of haematoma after pacemaker and CRT device implantation on hospitalization costs, length of stay, and mortality: a population-based study.

AIMS: Pocket haematoma is a common complication following pacemaker implantation. Impact of this complication on post-procedural outcomes has previously not been systematically studied. We sought to identify the incidence of pocket haematoma after a de novo pacemaker and cardiac resynchronization therapy (CRT) device implantation and evaluate its impact on the hospital outcomes using a large all-payer national inpatient database. METHODS AND RESULTS: Data from Nationwide Inpatient Sample 2010 was queried to identify all primary implantations of single chamber, dual chamber pacemakers, and biventricular devices during the year 2010 using the appropriate ICD-9 codes. Patients who experienced a procedure-related haematoma during the hospital stay were identified. Of a total of 78,751 primary pacemaker implantations in the year 2010, 1677 (2.1%) of the implantations were complicated by a pocket haematoma. Higher age groups, more complex pacemaker types (BiV > dual chamber > single chamber), and comorbidities such as congestive heart failure and coagulopathy were associated with an increased risk of pocket haematoma formation post-pacemaker implantation. Patients who developed a pocket haematoma had a longer length of stay (8.7 vs. 4.8 days, P < 0.001), higher hospitalization costs ($48,815 vs. $34,324, P < 0.001) and higher in-hospital mortality (2.0 vs. 0.7%, P < 0.001) compared with patients who did not develop a haematoma. CONCLUSIONS: Haematoma is a relatively common complication associated with pacemaker implantation; however, it adversely impacts in-hospital outcomes.

Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association.

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation.

Hospitalization rates and associated cost analysis of cardiac resynchronization therapy with an implantable defibrillator and quadripolar vs. bipolar left ventricular leads: a comparative effectiveness study.

AIMS: This study compares, from a prospective, observational, non-randomized registry, the post-implant hospitalization rates and associated healthcare resource utilization of cardiac resynchronization therapy-defibrillator (CRT-D) patients with quadripolar (QUAD) vs. bipolar (BIP) left ventricular (LV) leads. METHODS AND RESULTS: Between January 2009 and December 2012, 193 consecutive patients receiving de novo CRT-D implants with either a QUAD (n = 116) or a BIP (n = 77) LV lead were enrolled at implant and followed until July 2013 at a single-centre, university hospital. Post-implant hospitalizations related to heart failure (HF) or LV lead surgical revision and associated payer costs were identified using ICD-9-CM diagnosis and procedure codes. Italian national reimbursement rates were determined. Propensity scores were estimated using a logistic regression model based upon 11 pre-implant baseline characteristics and were used to derive a 1 : 1 matched cohort of QUAD (n = 77) and BIP (n = 77) patients. Hospitalization rates for the two groups were compared using negative binomial regression and associated payer costs were compared using non-parametric bootstrapping (×10 000) and one-sided hypothesis test. Hospitalization rates of the QUAD group [0.15/ patient (pt)-year] were lower than those of the BIP group (0.32/ pt-year); the incidence rate ratio was 0.46, P = 0.04. The hospitalization costs for the QUAD group (434 ± 128 €/pt-year) were lower than those for the BIP group (1136 ± 362 €/pt-year). The average difference was 718 €/pt-year, P = 0.016. CONCLUSIONS: In this comparative effectiveness assessment of well-matched groups of CRT-D patients with quadripolar and bipolar LV leads, QUAD patients experienced a lower rate of hospitalizations for HF and LV lead surgical revision, and a lower cost burden. This has important implications for LV pacing lead choice.

Cardiac resynchronisation therapy in patients with atrioventricular nodal disease and reduced ejection fraction - can we afford it?

BACKGROUND: Recent pacing guidelines from the European Society of Cardiology recommend cardiac resynchronisation therapy (CRT) in patients with an atrioventricular (AV) nodal pacing indication and reduced ejection fraction (EF). However, concerns over added expenditure may limit its widespread implementation. We investigate the potential incremental cost of biventricular over right ventricular pacing if such a practice was adopted. METHODS: Retrospective analysis was performed of devices implanted over eight years. The database was analysed for device type, pacing indication and EF. Cost analysis was performed. RESULTS: 1751 devices were implanted over eight years at an averaged cost of AUD$1,369,125 per year. 172 with CRT were excluded. 25.4 (11.6%) patients per year had an EF≤50% and AV nodal disease. 18.4 were in sinus rhythm (SR) and 7.0 in atrial fibrillation (AF). Of these, 13.5 (6.2%) had EF≤45% (9.9 SR, 3.6 AF) and 8.2 (3.8%) had EF≤35% (5.6 SR, 2.6 AF). Based on an incremental cost of $4,000 per device, if all patients with EF≤50% received CRT, the total cost increment per year equates to $73,500 for SR patients or $101,500 if AF patients were included. In patients with EF≤35% and EF≤45%, this amounts to $22,500 and $39,500 per year for SR patients respectively or $33,000 and $54,000 per year if AF patients were included. Depending on the EF and rhythm, this represents a 1.6% to 7.4% increase per year in the pacing budget for an increased patient population of between 2.6% (EF≤35% in SR) to 11.6% (EF≤50%). CONCLUSION: A small proportion of additional patients will qualify for CRT based on the chosen cut-off and rhythm. Although the individual incremental cost for biventricular over right ventricular pacing is high in patients with AV nodal disease and reduced EF, overall this represents at most, a modest increase in the total pacing budget.

Estimating incremental cost-effectiveness ratios and their confidence intervals with different terminating events for survival time and costs.

Cost-effectiveness analysis (CEA) is an important component of the economic evaluation of new treatment options. In many clinical and observational studies of costs, censored data pose challenges to the CEA. We consider a special situation where the terminating events for the survival time and costs are different. Traditional methods for statistical inference offer no means for dealing with censored data in these circumstances. To address this gap, we propose a new method for deriving the confidence interval for the incremental cost-effectiveness ratio. The simulation studies and real data example show that our method performs very well for some practical settings, revealing a great potential for application to actual settings in which terminating events for the survival time and costs differ.

On the underutilization of cardiac resynchronization therapy.

Cardiac resynchronization therapy (CRT) is an exciting therapy that can treat patients with systolic heart failure and left ventricular dysfunction who have a wide QRS complex. Indications for its use have been refined and expanded based on recent clinical data and guidelines, yet the rate of new CRT implants in the United States has not changed much over the past 8 years. Many patients receiving implantable cardioverter-defibrillators can benefit from, but are not receiving, appropriately-indicated CRT devices. We summarize data on CRT use, discuss reasons for probable underutilization, and provide recommendations for augmenting proper and effective use of this highly beneficial therapy.

Cost-effectiveness of cardiac resynchronization therapy in the MADIT-CRT trial.

BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT) trial demonstrated that cardiac resynchronization therapy (CRT) when added to the implantable cardiac defibrillator (ICD) reduces risk of heart failure or death in minimally symptomatic patients with reduced cardiac ejection fraction and wide QRS complex. OBJECTIVES: To evaluate 4-year cost-effectiveness of CRT-ICD compared to ICD alone using MADIT-CRT data. RESEARCH DESIGN: Patients enrolled in the trial were randomized to implantation of either ICD or CRT-ICD in a 2:3 ratio, with up to 4-year follow-up period. Cost-effectiveness analyses were conducted, and sensitivity analyses by age, gender, and left bundle branch block (LBBB) conduction pattern were performed. SUBJECTS: A total of 1,271 patients with ICD or CRT-ICD (US centers only) who reported healthcare utilization and health-related quality of life data. MEASURES: We used the EQ-5D (US weights) to assess patient HRQOL and translated utilization data to costs using national Medicare reimbursement rates. RESULTS: Average 4-year healthcare expenditures in CRT-ICD patients were higher than costs of ICD patients ($62,600 vs 57,050, P = 0.015), mainly due to the device and implant-related costs. The incremental cost-effectiveness ratio of CRT-ICD compared to ICD was $58,330/quality-adjusted life years (QALY) saved. The cost effectiveness improved with longer time horizon and for the LBBB subgroup ($7,320/QALY), with no cost-effectiveness benefit being evident in the non-LBBB group. CONCLUSIONS: In minimally symptomatic patients with low ejection fraction and LBBB, CRT-ICD is cost effective within 4-year horizon when compared to ICD-only.

Cardiac resynchronization therapy in pacemaker-dependent patients with left ventricular dysfunction.

AIMS: Heart failure and left ventricular (LV) systolic dysfunction (LVSD) are common in patients with permanent pacemakers. The aim was to determine if cardiac resynchronization therapy (CRT) at the time of pulse generator replacement (PGR) is of benefit in patients with unavoidable RV pacing and LVSD. METHODS AND RESULTS: Fifty patients with unavoidable RV pacing, LVSD, and mild or no symptoms of heart failure, listed for PGR were randomized 1 : 1 to either standard RV-PGR (comparator) or CRT. The primary endpoint was the difference in change in LV ejection fraction (LVEF) between RV-PGR and CRT groups from baseline to 6 months. Secondary endpoints included peak oxygen consumption, quality of life, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. At 6 months there was a difference in change in median (interquartile range) LVEF [9 (6-12) vs. -1.5 (-4.5 to -0.8)%; P < 0.0001] between the CRT and RV-PGR arms. There were also improvements in exercise capacity (P = 0.007), quality of life (P = 0.03), and NT-proBNP (P = 0.007) in those randomized to CRT. After 809 (729-880) days, 17 patients had died or been hospitalized (6 in CRT group and 11 in the comparator RV-PGR group) and two patients in the RV-PGR arm had required CRT for deteriorating heart failure. Patients with standard RV-PGR had more days in hospital during follow-up than those in the CRT group [4 (2-7) vs. 11 (6-16) days; P = 0.047]. CONCLUSION: Performing CRT in pacemaker patients with unavoidable RV pacing and LVSD but without severe symptoms of heart failure, at the time of PGR, improves cardiac function, exercise capacity, quality of life, and NT-pro-BNP levels.

Impact of extending device longevity on the long-term costs of implantable cardioverter-defibrillator therapy: a modelling study with a 15-year time horizon.

AIMS: To determine the long-term costs of extending device longevity in four patient populations requiring a single-chamber implantable cardioverter-defibrillator (ICD) or requiring cardiac resynchronization therapy with defibrillation (CRT-D) device over a 15-year time window. METHODS AND RESULTS: We considered patient populations with an accepted indication for a single-chamber ICD for prevention of sudden cardiac death in the context of preserved (Population A) or impaired (Population B) left ventricular function; or with indication for a CRT-D device in the context of heart failure in New York Heart Association class II (Population C) or III (Population D). Expected patient survival and a cost analysis, including the cost of complications, was undertaken from a hospital perspective. Extended device longevity of 5 vs. 9 years for ICDs (Populations A and B); 4 vs. 7 years for CRT-Ds (Populations C and D) were considered. Over a 15-year time horizon, total, yearly, and per diem savings, per patient, from extending ICD longevity to 9 years were €10 926.91, €728.46, and €1.99 for Population A, and €7661.32, €510.75, and €1.40 for Population B. Total, yearly, and per diem savings from extending CRT-D longevity to 7 years were €13 630.38, €908.69, and €2.49 for Population C, and €10 968.29, €731.22, and €2.00 for Population D. Avoidance of a generator replacement amounted up to 46.6-62.5% of the saving. CONCLUSION: Extending device longevity has an important effect on the long-term cost of device therapy, both for ICD and CRT-D. This has important implications for device choice.

Cost-effectiveness analysis of cardiac resynchronization therapy in patients with NYHA I and NYHA II heart failure in Spain.

OBJECTIVES: The aim of the study was to combine clinical results from the European Cohort of the REVERSE study and costs associated with the addition of cardiac resynchronization therapy (CRT) to optimal medical therapy (OMT) in patients with mild symptomatic (NYHA I-II) or asymptomatic left ventricular dysfunction and markers of cardiac dyssynchrony in Spain. METHODS: A Markov model was developed with CRT + OMT (CRT-ON) versus OMT only (CRT-OFF) based on a retrospective cost-effectiveness analysis. Raw data was derived from literature and expert opinion, reflecting clinical and economic consequences of patient's management in Spain. Time horizon was 10 years. Both costs (euro 2010) and effects were discounted at 3 percent per annum. RESULTS: CRT-ON showed higher total costs than CRT-OFF; however, CRT reduced the length of hospitalization in ICU by 94 percent (0.006 versus 0.091 days) and general ward in by 34 percent (0.705 versus 1.076 days). Surviving CRT-ON patients (88.2 percent versus 77.5 percent) remained in better functional class longer, and they achieved an improvement of 0.9 life years (LYGs) and 0.77 years quality-adjusted life years (QALYs). CRT-ON proved to be cost-effective after 6 years, except for the 7th year due to battery depletion. At 10 years, the results were €18,431 per LYG and €21,500 per QALY gained. Probabilistic sensitivity analysis showed CRT-ON was cost-effective in 75.4 percent of the cases at 10 years. CONCLUSIONS: The use of CRT added to OMT represents an efficient use of resources in patients suffering from heart failure in NYHA functional classes I and II.

Critical appraisal of costly therapy modalities for heart failure in a developing country.

Contemporaneous challenges in heart failure management include strategies to rationally use health economic resources and relative donor shortage to adequately offer electric devices (cardiac resynchronization therapy [CRT] and implantable cardioverter defibrillators [ICD]), ventricular assist devices (VADs) and heart transplant, respectively. These issues are particularly important in countries with middle-income rates and limited structured heart transplant centers, such as Brazil. Use of CRT and ICDs need to follow strict guidelines, further customized to public financial health conditions. Experience with VADs in is the early days in Brazil and will require extreme caution to allocate health public resources to develop VAD programs in highly selected centers. Chagas' disease is epidemiologically important in Brazil; outcomes of patients with Chagas' on electric devices are unclear while these patients fare better post-transplant than non-Chagas' patients. Thus, heart transplant remains an attractive option regarding both favorable outcomes and resource allocation for advanced heart failure patients in Brazil.