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.

Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer.

AIMS: Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices. METHODS AND RESULTS: We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion. CONCLUSION: The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers.

Durable staged hybrid ablation with thoracoscopic and percutaneous approach for treatment of long-standing atrial fibrillation: a 30-month assessment with continuous monitoring.

OBJECTIVES: Electrophysiologic and surgical procedures to treat stand-alone atrial fibrillation (AF) have recently evolved, but disappointing results in patients with long-standing persistent (LSP) AF have challenged the durability of these procedures. METHODS: Lone AF patients (n = 36) with either LSP-AF (n = 28) or persistent AF (n = 8) were prospectively enrolled in the study and consecutively treated by thoracoscopic ablation followed by electrophysiologic evaluation 30 days afterward. Mean left atrial dimension was 50.3 ± 5.5 mm, and average AF duration was 72.8 months (range, 7-240 months). The thoracoscopic procedure was a right monolateral approach to create a box lesion using a temperature-controlled radiofrequency device with suction adherence. A continuous rhythm monitoring device was implanted at the end of the operation. RESULTS: Thoracoscopic ablation was successfully completed without morbidity or mortality and without any intensive care unit stay. Intraoperative exit and entrance block was achieved in 100% and 88.8% (32/36) of patients, respectively. At 33 ± 2 days after the operation, an electrophysiologic study confirmed entry-exit block in 83.3% (30/36) whereas pulmonary vein reconnections were observed in 16.7% (6/36) of patients. Additional transcatheter lesions were performed in 61.1% (22/36) of patients. At a mean follow-up of 30 months (range, 1-58 months), 91.6% (33/36) of patients are in sinus rhythm with 77.7% (28/36) of these patients off antiarrhythmic drugs and 88.8% (32/36) free of warfarin. Long-term incidence of left atrial flutter was 0%. CONCLUSIONS: The combination of a surgical box lesion and transcatheter ablation in a hybrid approach provided excellent durable clinical outcomes in patients with LSP-AF.

Prospective assessment of integrating the existing emergency medical system with automated external defibrillators fully operated by volunteers and laypersons for out-of-hospital cardiac arrest: the Brescia Early Defibrillation Study (BEDS).

AIMS: There are few data on the outcomes of cardiac arrest (CA) victims when the defibrillation capability of broad rural and urban territories is fully operated by volunteers and laypersons. METHODS AND RESULTS: In this study, we investigated whether a programme based on diffuse deployment of automated external defibrillators (AEDs) operated by 2186 trained volunteers and laypersons across the County of Brescia, Italy (area: 4826 km(2); population: 1 112 628), would safely and effectively impact the current survival among victims of out-of-hospital CA. Forty-nine AEDs were added to the former emergency medical system that uses manual EDs in the emergency department of 10 county hospitals and in five medically equipped ambulances. The primary endpoint was survival free of neurological impairment at 1-year follow-up. Data were analysed in 692 victims before and in 702 victims after the deployment of the AEDs. Survival increased from 0.9% (95% CI 0.4-1.8%) in the historical cohort to 3.0% (95% CI 1.7-4.3%) (P=0.0015), despite similar intervals from dispatch to arrival at the site of collapse [median (quartile range): 7 (4) min vs. 6 (6) min]. Increase of survival was noted both in the urban [from 1.4% (95% CI 0.4-3.4 %) to 4.0% (95% CI 2.0-6.9 %), P=0.024] and in the rural territory [from 0.5% (95% CI 0.1-1.6%) to 2.5% (95% CI 1.3-4.2%), P=0.013]. The additional costs per quality-adjusted life year saved amounted to euro39 388 (95% CI euro16 731-49 329) during the start-up phase of the study and to euro23 661 (95% CI euro10 327-35 528) at steady state. CONCLUSION: Diffuse implementation of AEDs fully operated by trained volunteers and laypersons within a broad and unselected environment proved safe and was associated with a significantly higher long-term survival of CA victims.

[Economic impact of cardiac resynchronization therapy in patients with heart failure. Available evidence and evaluation of the CRT-Eucomed model for analysis of cost-effectiveness]. / L'impatto economico della terapia di resincronizzazione in pazienti con scompenso cardiaco. Evidenze disponibili e valutazione del modello CRT-Eucomed per l'analisi del rapporto costo-efficacia.

Several clinical trials show that cardiac resynchronization therapy (CRT) in patients with moderate-severe heart failure increases survival, improves quality of life and reduces hospital admissions. The high cost of this new technology, incurred by health organizations at the moment of the implant, requires to assess whether its use is economically rational for the Italian Health Service. The paper summarizes evidences of the impact of CRT on the use of hospital resources and on quality of life, and presents a model to calculate incremental costs per quality adjusted life years (QALYs) gained in patients with moderate-severe heart failure treated with optimal medical therapy. The model is based on efficacy data drawn from clinical trials and on other information concerning the Italian context collected and validated by a team of experts from Assobiomedica and the Italian Federation of Cardiology. The model estimates that the incremental cost per QALY gained attributable to CRT is Euro 63,225 if all effects (years of life gained, increased quality of life and reduction of hospital costs) are censored at the end of the first year after the implant and Euro 21,720 if all effects are censored at the end of the third year. Cost-effectiveness of CRT is thus strongly dependent upon the duration of its effects: longer benefits of the therapy compensate initial costs and thus make the technology more cost-effective. In order to get better estimates of the economic profile of CRT it is required to collect more precise data from routine practice on survival, quality of life and hospital resources. The model presented can be easily adapted to take into account new evidence and to calculate cost per QALY gained in regional and local contexts.