Background: The cost-effectiveness of sodium-glucose cotransporter 2 (SGLT2) inhibitors for chronic kidney disease (CKD) has not been evaluated in Japan, so we analyzed the cost-effectiveness of ...dapagliflozin, an SGLT2 inhibitor, for CKD stages 3a and 3b.Methods and Results: We used the Markov model for CKD to assess the costs and benefits associated with and without dapagliflozin from a health system perspective. We estimated the incremental cost-effectiveness ratio (ICER), expressed as per quality-adjusted life-years (QALYs). An ICER <5 million Japanese yen (JPY)/QALY was judged to be cost-effective. The effect of dapagliflozin on renal and cardiovascular events was based on published clinical trials. In patients with CKD stage 3a, the ICER of dapagliflozin over standard treatment was 4.03 million JPY/QALY gained. With a cost-effectiveness threshold of 5 million JPY/QALY gained, the cost-effectiveness probability of dapagliflozin over standard treatment was 52.6%. In patients with CKD stage 3b, the ICER of dapagliflozin over standard treatment was 0.12 million JPY/QALY gained. The cost-effectiveness probability of dapagliflozin over standard treatment was 75.2%.Conclusions: The results seemed to show acceptable cost-effectiveness when dapagliflozin was used for CKD stage 3b. On the other hand, cost-effectiveness of dapagliflozin for CKD stage 3a was ambiguous, and further validation is needed.
Background:Because the early diagnosis of subclinical cardiac sarcoidosis (CS) remains difficult, we developed a deep learning algorithm to distinguish CS patients from healthy subjects using ...echocardiographic movies.Methods and Results:Among the patients who underwent echocardiography from January 2015 to December 2019, we chose 151 echocardiographic movies from 50 CS patients and 151 from 149 healthy subjects. We trained two 3D convolutional neural networks (3D-CNN) to identify CS patients using a dataset of 212 echocardiographic movies with and without a transfer learning method (Pretrained algorithm and Non-pretrained algorithm). On an independent set of 41 echocardiographic movies, the area under the receiver-operating characteristic curve (AUC) of the Pretrained algorithm was greater than that of Non-pretrained algorithm (0.842, 95% confidence interval (CI): 0.722–0.962 vs. 0.724, 95% CI: 0.566–0.882, P=0.253). The AUC from the interpretation of the same set of 41 echocardiographic movies by 5 cardiologists was not significantly different from that of the Pretrained algorithm (0.855, 95% CI: 0.735–0.975 vs. 0.842, 95% CI: 0.722–0.962, P=0.885). A sensitivity map demonstrated that the Pretrained algorithm focused on the area of the mitral valve.Conclusions:A 3D-CNN with a transfer learning method may be a promising tool for detecting CS using an echocardiographic movie.
Background:Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) ...for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction MI, and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.Conclusions:Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).
The development of deep learning technology has enabled machines to achieve high-level accuracy in interpreting medical images. While many previous studies have examined the detection of pulmonary ...nodules in chest X-rays using deep learning, the application of this technology to heart failure remains rare. In this paper, we investigated the performance of a deep learning algorithm in terms of diagnosing heart failure using images obtained from chest X-rays. We used 952 chest X-ray images from a labeled database published by the National Institutes of Health. Two cardiologists verified and relabeled a total of 260 "normal" and 378 "heart failure" images, with the remainder being discarded because they had been incorrectly labeled. Data augmentation and transfer learning were used to obtain an accuracy of 82% in diagnosing heart failure using the chest X-ray images. Furthermore, heatmap imaging allowed us to visualize decisions made by the machine. Deep learning can thus help support the diagnosis of heart failure using chest X-ray images.
Background:The addition of eicosapentaenoic acid (EPA) to statin therapy has been shown to reduce cardiovascular events. This study examined the cost-effectiveness of EPA plus statin (EPA+statin) ...combination therapy compared with statin monotherapy for primary and secondary prevention of cardiovascular disease (CVD) in Japan.Methods and Results:A Markov model was applied to assess the costs and benefits associated with EPA+statin combination therapy over a projected 30-year period from the perspective of a public healthcare funder in Japan. The incremental cost-effectiveness ratio (ICER), expressed as quality-adjusted life-years (QALY), was estimated for primary prevention and secondary prevention of CVD in patients with hypercholesterolemia. Impact on survival and number of events were based on the Japan EPA Lipid Intervention Study. Sensitivity analyses examined the influence of various input parameters on costs and outcomes of treatment. ICER was ¥29.6 million per QALY gained in primary prevention and ¥5.5 million per QALY gained in secondary prevention. The probabilities that EPA+statin combination therapy would be cost-effective compared with statin monotherapy were 39% in primary prevention and 49% in secondary prevention at a cost-effectiveness threshold of ¥5 million per QALY gained. Sensitivity analyses showed that EPA was cost-effective in secondary prevention.Conclusions:EPA+statin combination therapy showed acceptable cost-effectiveness for secondary prevention, but not primary prevention, of CVD in patients with hypercholesterolemia in Japan.
Background:The cost-effectiveness of percutaneous coronary intervention (PCI) for ischemic heart disease is undetermined in Japan. The aim of this study was to analyze the cost-effectiveness of PCI ...compared with medical therapy for ST-elevation myocardial infarction (STEMI) and angina pectoris (AP) in Japan.Methods and Results:We used Markov models for STEMI and AP to assess the costs and benefits associated with PCI or medical therapy from a health system perspective. We estimated the incremental cost-effectiveness ratio (ICER), expressed as quality-adjusted life-years (QALY), and ICER <¥5 m per QALY gained was judged to be cost-effective. The impact of PCI on cardiovascular events was based on previous publications. In STEMI patients, the ICER of PCI over medical treatment was ¥0.97 m per QALY gained. The cost-effectiveness probability of PCI was 99.9%. In AP patients, the ICER of fractional flow reserve (FFR)-guided PCI over medical treatment was ¥4.63 m per QALY gained. The cost-effectiveness probability of PCI was 50.4%. The ICER of FFR-guided PCI for asymptomatic patients was ¥23 m per QALY gained.Conclusions:In STEMI patients, PCI was cost-effective compared with medical therapy. In AP patients, FFR-guided PCI for symptomatic patients could be cost-effective compared with medical therapy. FFR-guided PCI for asymptomatic patients with myocardial ischemia was not cost-effective.
Fractional flow reserve (FFR) is often used to evaluate the physiological severity of intermediate coronary stenoses, but less-invasive assessment methods are desirable. We evaluated the feasibility ...of angiographic FFR (angioFFR) calculated from two projections acquired simultaneously by a biplane C-arm system and angioFFR calculated from two projections acquired independently by one plane of the same biplane C-arm system. AngioFFR was validated against FFR in terms of detection of hemodynamically relevant coronary artery stenoses. Twenty-two Patients who underwent angiography and FFR for coronary artery disease were included. We used a non-commercial prototype to calculate biplane angioFFR for 22 vessels (19 LAD, 1 LCx, 2 RCA) and single plane angioFFR for 17 of the same 22 vessels. FFR < 0.8 was measured in 8 vessels. The Pearson correlation coefficients with FFR were 0.55 for single plane angioFFR and 0.61 for biplane angioFFR and the diagnostic accuracies were 88% (95% CI 73–100%) for single plane angioFFR and 86% (95% CI 72–100%) for biplane angioFFR. Bland–Altman plots revealed that compared with FFR, the limits of agreement for single plane angioFFR were – 0.07 to 0.19 (mean difference 0.06,
p
= 0.002) and the limits of agreement for biplane FFR were – 0.09 to 0.15 (mean difference 0.03,
p
= 0.03). In conclusion, angioFFR calculated from single or biplane acquisitions by a biplane C-arm is feasible and may evolve to a tool for less invasive imaging-based assessment of myocardial ischemia.
•We examined the cost effectiveness of transcatheter aortic valve implantation (TAVI) in Japan.•TAVI had good cost effectiveness for inoperable patients vs. medical therapy.•TAVI had low cost ...effectiveness for operable patients vs. surgery.
Transcatheter aortic valve implantation (TAVI) is a less invasive treatment for elderly patients with aortic stenosis. However, the cost of TAVI is a major issue. This study analyzed the cost effectiveness of TAVI in Japan.
We developed an economic model to evaluate the quality-adjusted life years (QALYs) and costs of TAVI, surgical aortic valve replacement (SAVR), and medical therapy over a 10-year time horizon from the perspective of Japanese public healthcare payers. The first model compared transapical or transfemoral TAVI with Sapien valve implantation and medical therapy in inoperable patients. The second model compared transfemoral TAVI with Sapien XT valve implantation and SAVR in operable patients with intermediate surgical risk. We assumed a cost-effectiveness threshold of 5,000,000yen per QALY, and assessed the cost-effectiveness probability with 100,000 simulations. We performed a broad sensitivity analysis to assess the effect of uncertainty on our results.
Among inoperable patients, the incremental cost-effectiveness ratio for TAVI compared with medical therapy was 3,918,808yen per QALY. In operable patients, the incremental cost-effectiveness ratio for TAVI compared with SAVR was 7,523,821yen per QALY. The cost-effectiveness probability of TAVI was 60% for inoperable patients and 46% for operable patients. Among inoperable patients, the cost-effective threshold of TAVI was <7,759,085yen. Among operable patients, the cost-effective threshold of TAVI was <5,427,439yen.
This study suggests that TAVI has good cost effectiveness for inoperable patients, but not for operable patients.
Background: The addition of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to statin therapy reduces the rate of cardiovascular events. This study examined the cost-effectiveness ...of PCSK9 inhibitor+statin compared with standard therapy (statin monotherapy) in the treatment of triple-vessel coronary artery disease (CAD) in Japan. Methods and Results: A Markov model was applied to assess the costs and benefits associated with PCSK9 inhibitor+statin over a projected 30-year period from the perspective of a public healthcare payer in Japan. The incremental cost-effectiveness ratio (ICER), expressed as the quality-adjusted life-years (QALYs), was estimated. The effects on survival and numbers of events were based on the FOURIER trial and the CREDO Kyoto registry. The ICER of PCSK9 inhibitor+statin over standard therapy was 13.5 million (95% confidence interval 7.6–23.5 million) Japanese Yen (JPY) per QALY gained for triple-vessel CAD. The probability of the cost-effectiveness of PCSK9 inhibitor+statin vs. standard therapy was 0.0008% at a cost-effectiveness threshold of 5 million JPY. In patients with poorly controlled familial hypercholesterolemia (FH) with triple-vessel CAD, the ICER was 3.4 million JPY per QALY gained. Conclusions: PCSK9 inhibitor plus statin did not show good cost-effectiveness for triple-vessel CAD; however, it showed good cost-effectiveness for patients with triple-vessel CAD and poorly controlled FH in Japan.
Distal radius fracture (DRF) is very common worldwide. In particular, aging countries have numerous patients with DRF, resulting in an urgent need for active preventive measures. As few ...epidemiological studies have investigated DRF in Japan, we aimed to identify the epidemiological characteristics of patients of all ages with DRF in Japan.
This descriptive epidemiologic study analyzed data obtained from clinical information of patients diagnosed with DRF from January 1, 2011, to December 31, 2020, at a prefectural hospital in Hokkaido, Japan. We calculated the crude and age-adjusted annual incidences of DRF and described the age-specific incidence, injury characteristics (injury location and cause, seasonal differences, and fracture classification), and 1- and 5-year mortality rates.
A total of 258 patients with DRF were identified, of which 190 (73.6%) were female and the mean age (standard deviation) was 67.0 (21.5) years. The crude annual incidence of DRF ranged from 158.0 to 272.6 per 100,000 population/year, and the age-adjusted incidence among female patients demonstrated a significant decreasing trend during 2011-2020 (Poisson regression analysis; p = 0.043). The age-specific incidence differed by sex, with peaks at 10-14 years for males and 75-79 years for females. The most common cause of injury was a simple fall in patients > 15 year of age and sports injuries in patients ≤ 15 years of age. DRFs were most frequently sustained outdoors and were more common in the winter season. In patients > 15 years of age, the proportions of AO/OTA fracture types A, B, and C were 78.7% (184/234), 1.7% (4/234), and 19.6% (46/234), respectively, and 29.1% (68/234) of patients received surgical treatment for DRF. The 1- and 5-year mortality rates were 2.8% and 11.9%, respectively.
Our findings were mostly consistent with previous global studies. Although the crude annual incidence of DRF was relatively high because of recent population aging, the age-adjusted annual incidence among female patients showed a significant decreasing trend during this decade.
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