Epidemiology of distal radius fracture: a regional population-based study in Japan.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Cost-Effectiveness of Dapagliflozin for Chronic Kidney Disease in Japan.

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.

Agreement between single plane and biplane derived angiographic fractional flow reserve in patients with intermediate coronary artery stenosis.

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.

Deep Learning Algorithm to Detect Cardiac Sarcoidosis From Echocardiographic Movies.

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.

Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent　- A Randomized Comparison Through 5 Years in Japan.

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).

Association between the ratio of serum n-3 to n-6 polyunsaturated fatty acids and acute coronary syndrome in non-obese patients with coronary risk factor: a multicenter cross-sectional study.

BACKGROUND: Previous studies have reported that being overweight, obese, or underweight is a risk factor for ischemic cardiovascular disease (CVD); however, CVD also occurs in subjects with ideal body mass index (BMI). Recently, the balance of n-3/n-6 polyunsaturated fatty acids (PUFAs) has received attention as a risk marker for CVD but, so far, no study has been conducted that investigates the association between BMI and the balance of n-3/n-6 PUFAs for CVD risk. METHODS: We evaluated the association between n-3/n-6 PUFA ratio and acute coronary syndrome (ACS) in three BMI-based groups (< 25: low BMI, 25-27.5: moderate BMI, and ≥ 27.5: high BMI) that included 1666 patients who visited the cardiovascular medicine departments of five hospitals located in urban areas in Japan. RESULTS: The prevalence of ACS events was 9.2, 7.3, and 10.3% in the low, moderate, and high BMI groups, respectively. We analyzed the relationship between ACS events and several factors, including docosahexaenoic acid/arachidonic acid (DHA/AA) ratio by multivariate logistic analyses. In the low BMI group, a history of smoking (odds ratio [OR]: 2.47, 95% confidence interval [CI]: 1.40-4.35) and low DHA/AA ratio (OR: 0.30, 95% CI: 0.12-0.74) strongly predicted ACS. These associations were also present in the moderate BMI group but the magnitude of the association was much weaker (ORs are 1.47 [95% CI: 0.54-4.01] for smoking and 0.63 [95% CI: 0.13-3.10] for DHA/AA). In the high BMI group, the association of DHA/AA (OR: 1.98, 95% CI: 0.48-8.24) was reversed and only high HbA1c (OR: 1.46, 95% CI: 1.03-2.08) strongly predicted ACS. The interaction test for OR estimates (two degrees of freedom) showed moderate evidence for reverse DHA/AA ratio-ACS associations among the BMI groups (P = 0.091). CONCLUSIONS: DHA/AA ratio may be a useful marker for risk stratification of ACS, especially in non-obese patients.

Efficacy of Fractional Flow Reserve-Guided Percutaneous Cornary Intervention for Patients with Angina Pectoris.

Evaluation of hemodynamic parameters, such as fractional flow reserve (FFR), is recommended before percutaneous coronary intervention (PCI) for patients with angina pectoris (AP). However, the advantage of FFR-guided PCI has not been fully established. This study was performed to confirm whether FFR-guided PCI improves the prognosis compared with other treatments. Multiple databases were searched for studies published from 2000 to 2018, and a network meta-analysis (NMA) was performed to compare outcomes of FFR-guided PCI, non-FFR-guided PCI, coronary artery bypass grafting (CABG), and medical treatment (MT) for AP based on estimated odds ratios (ORs). The study included 18,093 patients from 15 randomized controlled trials (RCTs). No evidence of inconsistency was observed among the studies. The NMA showed that the all-cause mortality of FFR-guided PCI was not significantly different from that of the other treatment groups (CABG: OR, 1.1; 95% confidence interval [CI], 0.67-1.7; non-FFR-guided PCI: OR, 0.85; 95% CI, 0.53-1.4; and MT: OR, 0.83; 95% CI, 0.52-1.3). The NMA for the composite of all-cause mortality and myocardial infarction, which included 15,454 patients from 12 RCTs, showed that FFR-guided PCI significantly reduced the composite outcome compared with non-FFR-guided PCI and MT (non-FFR-guided PCI: OR, 0.66; 95% CI, 0.46-0.95 and MT: OR, 0.66; 95% CI, 0.46-0.95). Although FFR-guided PCI for AP did not show significant prognostic improvement compared with non-FFR-guided PCI, CABG, and MT, FFR-guided PCI may significantly reduce the composite of all-cause mortality and myocardial infarction compared with non-FFR-guided PCI and MT.

Balloon Valvuloplasty to Treat Adult Symptomatic Pulmonary Valve Stenosis with Sequential Follow-Up Using Cardiac Magnetic Resonance Imaging in Combination with Echocardiography.

Pulmonary valve stenosis (PVS) accounts for approximately 10% of all congenital heart defects. Echocardiography and right heart catheterization are the gold standards for diagnosis of PVS and for assessing disease severity and responsiveness to treatment.Recently, cardiac magnetic resonance imaging (cMRI) has been established as an important tool to comprehensively evaluate cardiac structure and function; however, research into the usefulness of cMRI for PVS management is limited. Here, we describe a case of a 59-year-old female with isolated, severe PVS who was successfully treated with balloon pulmonary valvuloplasty (BPV) followed by sequential cMRI at 1 and 12 months. Exertional dyspnea and elevated plasma BNP concentration were observed 1 month after BPV; however, echocardiographic findings did not indicate recurrent stenosis or increased pulmonary valve regurgitation but an increase in mitral E/e'. cMRI demonstrated improved systolic forward flow and RV function with enlargement of LV volume, and the rapid increase in LV preload might be associated with the transient deterioration in symptoms and BNP level, which both gradually improved within 3 months after BPV. cMRI further depicted that a reduced RV mass index and increased RV cardiac output were achieved gradually during the follow-up period.In conclusion, cMRI in combination with echocardiography was sufficiently informative to follow-up this PVS patient both before and after BPV. cMRI is easily reproducible in adult patients; therefore, cMRI should be recommended for long-term follow-up in adult PVS patients.

Novel Balloon Pulmonary Angioplasty Technique for Chronic Thromboembolic Pulmonary Hypertension.

This study aimed to clarify the usefulness of the Ikari-curve left (IL) guiding catheter for balloon pulmonary angioplasty (BPA).The current BPA strategy for chronic thromboembolic pulmonary hypertension is dilation of as many branches as possible to normalize hemodynamics and oxygenation. The shape of the guiding catheter is a major factor in achieving this. However, conventional guiding catheters are difficult to introduce into particular branches. The IL guiding catheter may be suitable; however, its utility remains unclear.We retrospectively analyzed 202 consecutive BPA sessions of 40 patients from November 2016 to October 2019 and divided these sessions into two groups: the IL group where the IL guiding catheter was used and the non-IL group where other catheters were utilized. The occurrence of lung injury was determined by the presence of bloody sputum. We compared the rates of successful introduction into target vessels and assessed for the occurrence of lung injury.The average age of enrolled patients was 60.3 ± 14.4 years, with females comprising 65%. There were 99 sessions in the IL group. The median treated branches per session differed between the 2 groups (IL group: 15 versus non-IL group: 10, P < 0.05). The occurrence of lung injury was lower in the IL group (4.0% versus 11.7%, P = 0.07). The IL group had more successful vessel insertions than the non-IL group (78.8% versus 42.7%, P < 0.01).The IL guiding catheter may be introduced into branches that cannot be accessed by conventional guiding catheters.

Diagnosing Heart Failure from Chest X-Ray Images Using Deep Learning.

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.

Erratum: Diagnosing Heart Failure from Chest X-Ray Images Using Deep Learning.

An error appeared in the article entitled "Diagnosing Heart Failure from Chest X-Ray Images Using Deep Learning" by Takuya Matsumoto, Satoshi Kodera, Hiroki Shinohara, Hirotaka Ieki, Toshihiro Yamaguchi, Yasutomi Higashikuni, Arihiro Kiyosue, Kaoru Ito, Jiro Ando, Eiki Takimoto, Hiroshi Akazawa, Hiroyuki Morita, Issei Komuro (Vol. 61, No. 4, 781-786, 2020). The Figure 5on page 784 should be replaced by the following figure.

Cost-Effectiveness of Percutaneous Coronary Intervention Compared With Medical Therapy for Ischemic Heart Disease 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.

Overview of the 83rd Annual Scientific Meeting of the Japanese Circulation Society　- Renaissance of Cardiology for the Creation of Future Medicine.

The 83rdAnnual Scientific Meeting of the Japanese Circulation Society was held in Yokohama, Japan, on March 29-31, 2019, just as the cherry blossoms came into full bloom. Because the environment around cardiovascular healthcare is rapidly changing, it becomes highly important to make a breakthrough at the dawn of a new era. The main theme of this meeting was "Renaissance of Cardiology for the Creation of Future Medicine". The meeting benefited from the participation of 18,825 people, and there were in-depth and extensive discussions at every session, focusing on topics covering clinical and basic research, medical care provision system, human resource development, and public awareness in cardiovascular medicine. The meeting was completed with great success, and we greatly appreciate the tremendous cooperation and support from all affiliates.

Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Worsening of Mitral Regurgitation by Balloon Aortic Valvuloplasty for Severe Aortic Stenosis.

A 91-year-old woman was admitted to our hospital for treatment of congestive heart failure with severe aortic stenosis. After admission, she developed a high fever due to pneumonia and worsened heart failure. We could not perform transcatheter aortic valve implantation (TAVI) because of active infection; therefore, retrograde balloon aortic valvuloplasty (BAV) was urgently performed. A complete atrioventricular block and severe functional mitral regurgitation appeared suddenly after BAV in the absence of mechanical disorders. Her condition improved after several days in our intensive care unit. Pacemaker implantation and TAVI were then performed, and the patient was discharged from our hospital. MR could sometimes exacerbate after BAV in clinical practice; therefore, we set out to report this case.

Short-Term and Long-Term Efficacy of Drug-Coated Balloon for In-Stent Restenosis in Hemodialysis Patients with Coronary Artery Disease.

The efficacy of drug-coated balloons (DCB) for in-stent restenosis (ISR) in hemodialysis (HD) patients remains unclear.We retrospectively evaluated 153 consecutive patients who underwent DCB for ISR with follow-ups for up to 3 years after the procedure between February 2014 and June 2017. Patients were divided into an HD group (n = 39) and a non-HD group (n = 114). The primary endpoint was target lesion revascularization (TLR). The secondary endpoints were all revascularizations and major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and cerebral infarction. Kaplan-Meier curves of survival free from TLR were compared between the two groups. We also performed propensity score matching and then compared the two matched groups (n = 27 in each group). The acute procedure success rate was similar for the two groups (100% versus 99.1%, P = 0.56). The incidence of TLR was higher in the HD group than in the non-HD group (41.0% versus 9.6%, P < 0.0001). The rate of revascularizations and MACE combined was significantly higher in the HD group than in the non-HD group (64.1% versus 17.5%, P < 0.0001). Kaplan-Meier analyses showed that survival free from TLR was significantly lower in the HD group than in the non-HD group both before and after propensity score matching (P < 0.0001 and P = 0.005, respectively; log-rank test).Contrary to the similar acute procedure success, recurrent ISR and MACE occurred more frequently in HD patients than in non-HD patients after DCB, which indicates poorer long-term efficacy of DCB in HD patients.

Cost-Effectiveness of Statin Plus Eicosapentaenoic Acid Combination Therapy for Cardiovascular Disease Prevention in Japanese Patients With Hypercholesterolemia　- An Analysis Based on the Japan Eicosapentaenoic Acid Lipid Intervention Study (JELIS).

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.

Cost-Effectiveness of PCSK9 Inhibitor Plus Statin in Patients With Triple-Vessel Coronary Artery Disease in Japan.

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.

Influence of Flap Thickness on Nipple Projection After Nipple Reconstruction Using a Modified Star Flap.

BACKGROUND: In nipple reconstruction, the width, length, and thickness of modified star flaps are concerns for long-term reconstructed nipple projection. However, the flap's projection has not been analyzed, based on its thickness. The aim of the present study was to investigate how flap thickness in a modified star flap influences the resulting reconstructed nipple and achieves an appropriate flap width in design. METHODS: Sixty-three patients who underwent nipple reconstruction using a modified star flap following implant-based breast reconstruction between August 2014 and July 2016 were included in this case-controlled study. The length of laterally diverging flaps was 1.5 times their width. The thickness of each flap was measured using ultrasonography, and the average thickness was defined as the flap thickness. We investigated the correlation between the resulting reconstructed nipple and flap thickness, and the difference of the change in the reconstructed nipple projection after using a thin or thick flap. RESULTS: The average flap thickness was 3.8 ± 1.7 (range 2.5-6.0) mm. There was a significant, linear correlation between the flap thickness and resulting reconstructed nipple projection (ß = 0.853, p < 0.01). Furthermore, the difference between the thin and thick flaps in the resulting reconstructed nipple projection was significant (p < 0.01). CONCLUSION: Measuring the flap thickness preoperatively may allow surgeons to achieve an appropriate flap width; otherwise, alternative methods for higher projection might be used. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Coronary Artery Aneurysm Caused by a Stent Fracture.

Coronary stent fracture (SF) is rare as a complication of percutaneous coronary intervention (PCI), and its adverse events are increasingly being recognized with the development in devices of PCI. The major adverse events caused by SFs are in-stent restenosis due to neointimal overgrowth caused by poor drug delivery.1,2) A coronary artery aneurysm (CAA) is a rare complication of SF, but may lead to lethal events such as acute coronary syndrome or rupture of the CAA further leading to cardiac tamponade.3-5) However, the management of CAAs is controversial with or without SF.6) Herein, we report a case of a CAA caused by an SF and discuss the management of CAA complicated with SF, along with a literature review. We suggest that surgical treatment should be considered the higher-priority strategy in the cases of CAA with SF as compared to CAA without SF.