Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing.

AIMS: Reactive atrial-based anti-tachycardia pacing (rATP) in pacemakers (PMs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been reported to prevent progression of atrial fibrillation, and this reduced progression is expected to decrease the risk of complications such as stroke and heart failure (HF). This study aimed to assess the cost-effectiveness of rATP in PMs and CRT-Ds in the Japanese public health insurance system. METHODS AND RESULTS: We developed a Markov model comprising five states: bradycardia, post-stroke, mild HF, severe HF, and death. For devices with rATP and control devices without rATP, we compared the incremental cost-effectiveness ratio (ICER) from the payer's perspective. Costs were estimated from healthcare resource utilisation data in a Japanese claims database. We evaluated model uncertainty by analysing two scenarios for each device. The ICER was 763 729 JPY/QALY (5616 EUR/QALY) for PMs and 1,393 280 JPY/QALY (10 245 EUR/QALY) for CRT-Ds. In all scenarios, ICERs were below 5 million JPY/QALY (36 765 EUR/QALY), supporting robustness of the results. CONCLUSION: According to a willingness to pay threshold of 5 million JPY/QALY, the devices with rATP were cost-effective compared with control devices without rATP, showing that the higher reimbursement price of the functional categories with rATP is justified from a healthcare economic perspective.

Current Medical Technology Reimbursement System in Japan.

OBJECTIVES: The process for reimbursement of medical technologies in Japan is complex, and to date, it has not been well described overall. This article aims to provide an overview of the reimbursement system for medical technologies in Japan, including the reimbursement application process and the payment decision making. METHODS: Conduct review for relevant health policy and regulation and gather opinion from the key stakeholders. RESULTS: The Japanese functional category listing system for the reimbursement of medical technologies is a unique fee-for-service payment system, and the timing for the listing is dependent on the application category. A key positive aspect of the current system is the level of transparency and the predictable pathway for reimbursement of new medical technologies. Conversely, the current reimbursement process may not capture the true extent of the innovation of new technologies, especially when creating a new functional category and/or a new medical procedure coding. CONCLUSIONS: There are potential areas where changes could improve access, efficiencies, and value, such as the price revision system based on the market survey, the foreign average price assessment, and the health technology assessment system. These additions and modifications in policy and regulation of reimbursement will help facilitate the effective and efficient access to new innovative medical technologies within the context of a sustainable and affordable National Health Insurance system in Japan.

Cost-effective analysis of automated programming optimization in cardiac resynchronization therapy: Holistic Markov modelling.

BACKGROUND: Automated optimization algorithm (AdaptivCRT; Medtronic, Mounds View, MN, USA) allowing automated optimization of cardiac resynchronization therapy (CRT), has been introduced. However, little is known concerning its cost-effectiveness. This study aims to evaluate the potential economic benefits of AdaptivCRT of CRT. METHODS: Markov modelling was informed by empirical data sourced from the AdaptivCRT Clinical Trial. Published meta-analyses were used to derive the impact of increasing response to hospitalization and mortality risks. Response was assessed via the clinical composite score. RESULTS: Deterministic results suggested a mean survival of 10.97 years with adaptive algorithms against 10.5 years without (+0.47 in favour of novel algorithms). Heart failure hospitalization costs were modelled to ¥1,382,753 (US $12,686) with novel devices against ¥1,524,747 (US $13,989) with previous technology models. Sensitivity analyses show CRT with Adaptive algorithm was projected to provide cost savings in all scenarios. CONCLUSIONS: The use of AdaptivCRT was projected to improve average patient survival and avoid costs in a Japanese healthcare setting.

Non-invasive assessment of arterial stiffness in appropriate-for-gestational age newborn infants.

BACKGROUND: Quantitative information about the elastic properties of the large arteries can be obtained by determination of the pressure and the pulsatile changes of arterial diameter. OBJECTIVE: To study the stiffness of major branches (common carotid artery; CCA, abdominal aorta; AA and femoral artery; FA) in newborn infants. STUDY DESIGN: The arterial stiffness index (SI) values were measured with a phase locked loop ultrasound technique to estimate the arterial systolic and diastolic diameters and their correlation with blood pressure. SUBJECTS: We studied 62 appropriate-for-gestational age infants (between 30 and 41 weeks of gestation at birth) including 33 preterm infants. RESULTS: The systolic and diastolic diameters of the CCA, AA and FA, as well as the SI, increased with the gestational age at birth. In the SI of the FA, there was considerable variation in the individual values for a given gestational age at birth. The gestational age associated increase in stiffness was statistically significant only in the CCA and the AA. Although the mechanical properties of the FA were significantly influenced by physical activities during the active waking and quiet sleeping states, the calculated SI values were less vulnerable to these activities in the central arteries. CONCLUSION: These results indicate that the SI of the FA (peripheral muscular artery) is modified appreciably by vasoactive stimuli. The mechanical properties of the deeper elastic arteries in newborn infants provide sufficiently reliable information about changes caused by development.

Evaluation of cardiac function of the fetus by inferior vena cava diameter pulse waveform.

BACKGROUND: The diameter pulse waveforms (DPWs) are known to reflect the pressure waveforms at the target vessel. Our purpose was to clarify the usefulness of DPWs recorded noninvasively from the fetal inferior vena cava (IVC) for detecting cardiac function. METHODS: A paired ultrasonic phase-locked echo tracking system was used to follow the movement of diametrically opposite points of the IVC. RESULTS: We studied 90 healthy fetuses (20-40 weeks, normal group) and 21 fetuses with cardiac abnormalities. The 4 component (A, X, V, and Y) waves of the DPW were identified. In the normal group, there was an increase in the depth of X and Y descents with advancing gestation. The 21 fetuses with suspected cardiac dysfunction were divided into normal and cardiac dysfunction subgroups, according to the values of fractional shortening and preload index. Of these, 11 fetuses with cardiac dysfunction had significantly higher incidence of shallow X nadir (P < .001) than the remaining 10 fetuses with normal cardiac function. CONCLUSION: The DPW analysis in the fetal IVC proved useful for detecting fetal cardiac dysfunction in utero.

Uteroplacental circulation, preeclampsia, and maternal abdominal aortic stiffness in normal and compromised pregnancies.

A study of 82 normal and 60 compromised pregnant women who were identified by uterine artery Doppler flow waveform systolic/diastolic ratio >95th percentile (increased peripheral resistance) was carried out to examine the elastic properties of the maternal abdominal aorta (AA). An aortic stiffness index (SI) was measured between 18 and 40 weeks at four-weekly intervals with a phase-locked loop ultrasound technique to estimate the aortic systolic and diastolic diameters and their correlation with blood pressure. In the normal group, the aortic systolic and diastolic diameters, as well as the SI, increased with the maternal age. In the compromised group, aortic diameter and blood pressure were normal, but the SI during the early second trimester was increased. Twenty-two women from the compromised group with an SI above the 95th percentile for their age had a significantly higher prevalence of preeclampsia in comparison with women with a normal SI (P<0.001). The aortic SI was significantly higher in severe than in mild preeclampsia. This study demonstrates that stiffness of the AA is increased in pregnant women with preeclampsia and that a progressive increase of the SI in serial studies is associated with severity of the disease. Aberrant hemodynamic adaptation in preeclampsia seems to include increased stiffness of the larger artery besides high resistance in small peripheral arteries.

Normal and abnormal diameter pulse waveforms in the fetal inferior vena cava.

OBJECTIVES: To study the diameter pulse waveforms (DPWs) recorded noninvasively from the fetal inferior vena cava (IVC) in human fetuses. METHODS: We studied 90 normal fetuses (20 to 40 weeks), ten fetuses with abnormalities of cardiac structure, and seven fetuses with arrhythmia. A paired ultrasonic phase-locked echo tracking system was used to follow the movement of diametrically opposite points of the IVC. RESULTS: The four component (A, X, V, Y) waves of the DPW were identified. In the normal group, there was an increase in the depth of X and Y nadirs. The abnormal group was divided into two subgroups. In 12 fetuses (five pulmonary stenosis, seven arrhythmia) there was a high pulsatile pattern with deep nadir from the A peak to X trough so that the pulsatility of the waveform appeared increased. The cause of the high pulsatility was due to a marked change of intraatrial pressure. In five fetuses with tricuspid regurgitation, this change was shallow and the pulsatility appeared reduced. Clinical outcome was significantly worse in the low pulsatile subgroup. CONCLUSION: The low pulsatility waveform may indicate depressed myocardial function. Measuring the DPW provides a simple method for obtaining important information about fetal cardiac performance.