Treatment strategy modification and its implication on the medical cost of fractional flow reserve-guided percutaneous coronary intervention in Japan.

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) could improve outcome compared with angiography-guided PCI. However, the economic impact of FFR-guided PCI remains largely unknown in the medical system in Japan. We evaluated the impact of treatment strategy modification by FFR measurement on the direct medical cost using a model analysis with a decision tree model in Japan. METHODS: For the clinical parameters set in the model, the findings from CVIT-DEFER registry were adopted. Cost parameters were considered on the assumption that coronary angiography, FFR measurement, and the treatment are performed at Diagnosis Procedure combination (DPC) hospitals, and the costs were calculated based on the medical fee reimbursement systems in Japan. RESULTS: The probability of deferral of PCI in patients who were allocated to PCI based on coronary angiography was set as 90.1% based on the CVIT-DEFER registry. In the model analysis, the cost of tests was increased by 185,660 JPY per patient by the addition of FFR measurement, but the cost of treatment with PCI was reduced by 561,425 JPY per patient, and the entire cost of treatment was reduced by 322,675 JPY, resulting in the expected reduction in the total expected medical cost by 137,015 JPY per patient. CONCLUSION: Under contemporary Japanese practice, FFR-guided PCI has potential to reduce the medical cost by effective reassessment of coronary stenosis and reducing inappropriate application of PCI.

Multislice computed tomography assessment of everolimus-eluting Absorb bioresorbable scaffolds in comparison with metallic drug-eluting stents from the ABSORB Japan randomised trial.

AIMS: Blooming artefacts limit accurate coronary assessment by multislice computed tomography (MSCT) in metallic stents. We sought to investigate whether bioresorbable vascular scaffolds (BVS) could be better assessed by MSCT. METHODS AND RESULTS: Among 400 patients in the randomised ABSORB Japan trial, a pre-specified MSCT substudy was performed in 98 patients (103 lesions) in the BVS arm and 49 patients (49 lesions) in the cobalt-chromium everolimus-eluting stent (CoCr-EES) arm at 13 months prior to follow-up angiography. The assessability of BVS by MSCT was superior to that of CoCr-EES (94% versus 67%, p<0.001). Blooming artefacts were the main reason CoCr-EES could not be analysed (29%), while marker artefacts precluded analysis in 1.1% of BVS. In the CoCr-EES arm, non-assessable lesions were more prevalent in segments with 2.5 mm stents compared to 3.0 or 3.5 mm stents (75.0% versus 23.5%, p=0.01), while in the BVS arm image quality was good regardless of the diameter. The in-device minimal lumen diameter by MSCT was smaller than that by QCA with a difference of 0.61 mm in the CoCr-EES arm, vs. only 0.026 mm in the BVS arm. CONCLUSIONS: The feasibility of MSCT assessment of BVS-treated lesions was greater than that for lesions with CoCr-EES.

Cardiovascular Outcomes in Patients With Previous Myocardial Infarction and Mild Diabetes Mellitus Following Treatment With Pioglitazone: Reports of a Randomised Trial From The Japan Working Group for the Assessment Whether Pioglitazone Protects DM Patients Against Re-Infarction (PPAR Study).

BACKGROUND: Secondary prevention in patients with myocardial infarction (MI) is critically important to prevent ischaemic heart failure and reduce social burden. Pioglitazone improves vascular dysfunction and prevents coronary atherosclerosis, mainly via anti-inflammatory and antiatherogenic effects by enhancing adiponectin production in addition to antihyperglycemic effects, thus suggesting that pioglitazone attenuates cardiovascular events in patients with mild (HbA1c levels < 6·5%) diabetes mellitus (DM). Therefore, we evaluated the effects of pioglitazone on cardiovascular events in patients with both previous MI and mild DM. METHODS: In this multicentre, prospective, randomised, open, blinded-endpoint trial, we randomly assigned 630 patients with mild DM with a history of MI to undergo either DM therapy with (pioglitazone group) or without (control group) pioglitazone. DM was diagnosed using the 75-g oral glucose tolerance test, and mild DM was defined if HbA1c level was < 6·5%. The primary endpoint was the composite of cardiovascular death and hospitalisation caused by acute MI, unstable angina, coronary revascularisation (including percutaneous coronary intervention and cardiac bypass surgery), and stroke. FINDINGS: HbA1C levels were 5·9 and 5·8% (p = 0·71) at baseline and 6·0 and 5·8% (p < 0·01) at 2 years for the control and pioglitazone groups, respectively.The primary endpoint was observed in 14·2% and 14·1% patients in the control and pioglitazone groups during two years (95% confidential interval (CI):0.662-1·526, p = 0·98), respectively; the incidence of MI and cerebral infarction was 0·3% and 2·2% (95%CI: 0·786-32·415, p = 0·09) and 1·0% and 0·3% (95%CI: 0·051-3·662, p = 0·44), respectively. Post-hoc analyses of the 7-year observation period showed that these trends were comparable (21·9% and 19·2% in the control and pioglitazone groups, 95%CI: 0.618-1·237, p = 0·45). INTERPRETATION: Pioglitazone could not reduce the occurrence of cardiovascular events in patients with mild DM and previous MI.

Impact of Institutional and Operator Volume on Short-Term Outcomes of Percutaneous Coronary Intervention: A Report From the Japanese Nationwide Registry.

OBJECTIVES: The aim of this study was to assess the volume-outcome relationship for PCI within the nationwide registration system in Japan. BACKGROUND: The effect of site and operator case load for percutaneous coronary intervention (PCI) on outcomes has not been investigated thoroughly in non-Western regions. METHODS: In the present study, PCI procedural data recorded between January 2014 and December 2015 in the Japanese PCI registry, a nationwide registration system, were analyzed. Institutions and operators were categorized into deciles based on the number of PCIs performed per year. Odds ratios (ORs) for in-hospital mortality and the composite endpoint (in-hospital death and periprocedural complications) were estimated for each decile (with the lowest volume group as a reference group). RESULTS: A total of 323,322 PCIs (at 625 hospitals [median PCI cases/year: 216; quartiles: 121 to 332] by 4,211 operators [median PCI cases/year: 28; quartiles: 10 to 56]) were analyzed, of which 2,959 patients (0.9%) and 7,205 patients (2.2%) experienced in-hospital mortality and the composite endpoint after PCI, respectively. The adjusted risk for in-hospital mortality and the composite endpoint was significantly higher in hospitals included in the lowest decile (<150 PCIs/year); the risk remained consistently low across the remaining deciles. Contrastingly, no significant volume-outcome relationship was observed between operator volume and outcomes. A similar trend was observed when the analysis was confined to emergency/urgent PCI cases. CONCLUSIONS: In contemporary Japanese PCI practice, lower institutional volume was related inversely to in-hospital outcomes, but the association of annual operator volume with outcomes was less clear.

Automated assessment of myocardial viability after acute myocardial infarction by global longitudinal peak strain on low-dose dobutamine stress echocardiography.

BACKGROUND: Low-dose dobutamine stress echocardiography (DSE) assesses myocardial viability at the early stage of acute myocardial infarction (AMI), but its assessment is subjective and variable. Automated function image (AFI) determines global longitudinal peak strain (GLPS) based on tissue tracking technique. The ability of GLPS obtained by AFI during dobutamine stress to assess myocardial viability after AMI was investigated. METHODS AND RESULTS: Low-dose DSE at day 3 in 23 consecutive patients with AMI was performed using Vivid 7 (GE Healthcare). Segmental longitudinal peak strain with AFI and obtained GLPS was analyzed. Wall motion score index (WMSI) by echocardiography 1 month later was determined. In 18 patients, left ventriculography was also performed at 3.2±1.5 months later to obtain left ventricular ejection fraction (LVEF) and regional wall motion (RWM, SD/chord). GLPS was improved during dobutamine infusion at 10 µg · kg(-1) · min(-1) (-12.9 ± 3.5% to -15.2 ± 3.6%, P=0.0004). GLPS during dobutamine stress showed good correlations with follow-up WMSI (R=0.47, P=0.02), with peak CK-MB (R = 0.52, P=0.01), with RWM (R = -0.48, P=0.04), and with LVEF (R = -0.54, P=0.02), whereas GLPS at baseline showed no correlations with them. Averaged segmental peak strain at baseline and during stress were correlated with follow-up WMSI (R = 0.50 and 0.43, respectively), but not with LVEF. CONCLUSIONS: GLPS during dobutamine stress determined by AFI is a promising, objective index to assess myocardial viability on the early stage of AMI.

Comparison of orifice area by transthoracic three-dimensional Doppler echocardiography versus proximal isovelocity surface area (PISA) method for assessment of mitral regurgitation.

Effective regurgitant orifice area is a useful index of the severity of mitral regurgitation (MR). The calculation of regurgitant orifice area using the proximal isovelocity surface area (PISA) method has some technical limitations. Three-dimensional reconstruction of the MR jet was performed using the Live 3D system on a Sonos 7500 to measure regurgitant orifice area directly in 109 cases of MR. Regurgitant orifice area was also measured by quantitative 2-dimensional echocardiography and by the PISA method. To analyze the shape of the regurgitant orifice, the ratio of the long axis to the short axis of the orifice (the L/S ratio) was calculated. Regurgitant orifice area on 3-dimensional echocardiography showed an almost identical correlation with that obtained by quantitative echocardiography (r = 0.91, p <0.0001, slope = 0.97) regardless of the L/S ratio. It was also significantly correlated with orifice area obtained using the PISA method (r = 0.93, p <0.0001). However, orifice area on 3-dimensional echocardiography was significantly larger than that obtained using the PISA method in the whole study group and in the 62 cases of MR with L/S ratios >1.5, whereas the correlation was almost identical in cases of MR with L/S ratios < or =1.5. Orifice area obtained using the PISA method also underestimated that obtained by quantitative echocardiography in cases of MR with L/S ratios >1.5. Three-dimensional echocardiography provided robust values independent of the eccentricity of the MR jet or of cardiac rhythm. In conclusion, the direct measurement of the regurgitant orifice area of MR with 3-dimensional Doppler echocardiography could be a promising method to overcome the limitations of the PISA method, especially in cases of MR with elliptic orifice shapes.