Cost reduction associated with transradial access in percutaneous coronary intervention: A report from a Japanese nationwide registry.

Background: Percutaneous coronary intervention (PCI) is increasingly performed via transradial access (TRA). This study aimed to investigate the clinical and economic benefits of TRA compared with transfemoral access (TFA) under universal healthcare coverage system in Japan. Methods: A total of 36,153 patients (acute coronary syndrome [ACS], 15,266; stable ischemic heart disease [SIHD], 20,052) across 714 institutions in the Japanese nationwide PCI registry (J-PCI) in 2015 were analyzed (mean age 69.9 ± 11.1 years and 23.6% female). Cost was defined as the total amount of healthcare resources used to care for the patient during hospitalization. Propensity score matching analysis was conducted to balance the baseline characteristics of patients undergoing TRA and TFA. Findings: The median total cost of PCI was JPY 1,341,176 (interquartile range, 959,052), with higher expenses for ACS (JPY 1,772,116 [1,117,107]) compared with SIHD (JPY 1,119,153 [540,440]) patients. Most patients underwent PCI via TRA (73.8%), and after propensity score matching, TRA was associated with a reduced risk of in-hospital death and bleeding (0.88% vs. 1.91% [P < 0.0001] and 2.18% vs. 4.53% [P < 0.0001] in ACS, and 0.10% vs. 0.28% [P = 0.070] and 0.53% vs. 1.72% [P < 0.0001] in SIHD, respectively), which led to lower costs in both ACS (JPY 1,699,279 [1,164,554] for TRA vs. JPY 1,931,255 [1,070,222] for TFA; P < 0.0001), and SIHD (JPY 1,102,352 [505,904] for TRA vs. JPY 1,311,525 [706,450] for TFA; P < 0.0001) patients. Interpretation: In this direct cost analysis of a nationwide registry, the use of TRA was associated with cost saving for both ACS and SIHD patients. Funding: This study was funded by the Japan Society for the Promotion of Science (grant nos. 20H03915, 16H05215, 16KK0186, 20K22883, and 21K08064), Japan Agency for Medical Research and Development [AMED] (grant number 16lk1010004h0002), and the National Clinical Database. The J-PCI registry is led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics.

Variation in in-hospital mortality and its association with percutaneous coronary intervention-related bleeding complications: A report from nationwide registry in Japan.

Large-scale registries have demonstrated that in-hospital mortality after percutaneous coronary intervention (PCI) varies widely across institutions. However, whether this variation is related to major procedural complications (e.g., bleeding) is unclear. In this study, institutional variation in in-hospital mortality and its association with PCI-related bleeding complications were investigated. We analyzed 388,866 procedures at 718 hospitals performed from 2017 to 2018, using data from a nationwide PCI registry in Japan. Hospitals were stratified into quintiles according to risk-adjusted in-hospital mortality (very low, low, medium, high, and very high). Incidence of bleeding complications, defined as procedure-related bleeding events that required a blood transfusion, and in-hospital mortality in patients who developed bleeding complications were calculated for each quintile. Overall, 4,048 (1.04%) in-hospital deaths and 1,535 (0.39%) bleeding complications occurred. Among patients with bleeding complications, 270 (17.6%) died during hospitalization. In-hospital mortality ranged from 0.22% to 2.46% in very low to very high mortality hospitals. The rate of bleeding complications varied modestly from 0.27% to 0.57% (odds ratio, 1.95; 95% confidence interval, 1.58-2.39). However, mortality after bleeding complications markedly increased by quintile and was 6-fold higher in very high mortality hospitals than very low mortality hospitals (29.0% vs. 4.8%; odds ratio, 12.2; 95% confidence interval, 6.90-21.7). In conclusion, institutional variation in in-hospital mortality after PCI was associated with procedure-related bleeding complications, and this variation was largely driven by differences in mortality after bleeding complications rather than difference in their incidence. These findings underscore the importance of efforts toward reducing not only bleeding complications but also, even more importantly, subsequent mortality once they have occurred.

Discordance in the diagnostic assessment of vulnerable plaques between radiofrequency intravascular ultrasound versus optical coherence tomography among patients with acute myocardial infarction: insights from the IBIS-4 study.

We aimed to evaluate the diagnostic agreement between radiofrequency (RF) intravascular ultrasound (IVUS) and optical coherence tomography (OCT) for thin-cap fibroatheroma (TCFA) in non-infarct-related coronary arteries (non-IRA) in patients with ST-segment elevation myocardial infarction (STEMI). In the Integrated Biomarker Imaging Study (IBIS-4), 103 STEMI patients underwent OCT and RF-IVUS imaging of non-IRA after successful primary percutaneous coronary intervention and at 13-month follow-up. A coronary lesion was defined as a segment with ≥ 3 consecutive frames (≈1.2 mm) with plaque burden ≥ 40% as assessed by grayscale IVUS. RF-IVUS-derived TCFA was defined as a lesion with > 10% confluent necrotic core abutting to the lumen in > 10% of the circumference. OCT-TCFA was defined by a minimum cap thickness < 65 µm. The two modalities were matched based on anatomical landmarks using a dedicated matching software. Using grayscale IVUS, we identified 276 lesions at baseline (N = 146) and follow-up (N = 130). Using RF-IVUS, 208 lesions (75.4%) were classified as TCFA. Among them, OCT identified 14 (6.7%) TCFA, 60 (28.8%) thick-cap fibroatheroma (ThCFA), and 134 (64.4%) non-fibroatheroma. All OCT-TCFA (n = 14) were confirmed as RF-TCFA. The concordance rate between RF-IVUS and OCT for TCFA diagnosis was 29.7%. The reasons for discordance were: OCT-ThCFA (25.8%); OCT-fibrous plaque (34.0%); attenuation due to calcium (23.2%); attenuation due to macrophage (10.3%); no significant attenuation (6.7%). There was a notable discordance in the diagnostic assessment of TCFA between RF-IVUS and OCT. The majority of RF-derived TCFA were not categorized as fibroatheroma using OCT, while all OCT-TCFA were classified as TCFA by RF-IVUS.ClinicalTrials.gov Identifier NCT00962416.

Quantitative Assessment of Acute Regurgitation Following TAVR: A Multicenter Pooled Analysis of 2,258 Valves.

OBJECTIVES: The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves. BACKGROUND: Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed. METHODS: Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core laboratory using video densitometry. Results of quantitative regurgitation are shown as percentages. The valves evaluated were the ACURATE (n = 115), Centera (n = 11), CoreValve (n = 532), Direct Flow Medical (n = 21), Evolut PRO (n = 95), Evolut R (n = 295), Inovare (n = 4), Lotus (n = 546), Lotus Edge (n = 3), SAPIEN XT (n = 239), and SAPIEN 3 (n = 397). For the main analysis, only valves with more than 50 procedures (7 types) were used. RESULTS: The Lotus valve had the lowest mean regurgitation (3.5 ± 4.4%), followed by Evolut PRO (7.4 ± 6.5%), SAPIEN 3 (7.6 ± 7.1%), Evolut R (7.9 ± 7.4%), SAPIEN XT (8.8 ± 7.5%), ACURATE (9.6 ± 9.2%) and CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). The only valves that statistically differed from all their counterparts were Lotus (as the lowest regurgitation) and CoreValve (the highest). The proportion of patients presenting with moderate or severe regurgitation followed the same ranking order: Lotus (2.2%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE (11.3%), and CoreValve (30.1%) (chi-square p < 0.001). CONCLUSIONS: In this pooled analysis stemming from daily clinical practice, the Lotus valve was shown to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core laboratory (nonsponsored) in a real-world cohort of patients using a quantitative technique.

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.

Variability in the measurement of minimum fibrous cap thickness and reproducibility of fibroatheroma classification by optical coherence tomography using manual versus semi-automatic assessment.

AIMS: The minimum fibrous cap thickness (FCT) is considered a major criterion of coronary plaque vulnerability according to autopsy studies. We aimed to assess the reproducibility in the measurement of the optical coherence tomography (OCT)-detected minimum FCT and the agreement in the classification of thin-cap fibroatheroma (TCFA), by a software-based semi-automatic method compared with the manual method. METHODS AND RESULTS: A total of 50 frames with fibroatheromas (FA) were randomly selected from the Integrated Biomarker Imaging Study-4 (IBIS-4). Two experienced OCT analysts independently measured the minimum FCT at two different time points, manually and by three different semi-automatic software-based algorithms, based on the assessment of light intensity along the axial scan line. A TCFA was defined as an FA with minimum FCT <65 µm. The inter- and intra-observer reproducibility of the manual measurement of the minimum FCT was moderate with an intra-class correlation coefficient (ICC) of 0.71 and 0.79, respectively. The corresponding ICCs by either one of the three semi-automatic algorithms were 0.99. When categorising FA according to the minimum FCT based on the manual assessment, the inter- and intra-observer agreement was poor (κ=0.23) and moderate (κ=0.50), respectively. In contrast, the semi-automatic assessment showed perfect agreement for both inter- and intra-observer assessments (κ=0.90-1.00 and 1.00, respectively). CONCLUSIONS: While semi-automatic assessment of FCT and TCFA classification was associated with excellent reproducibility and agreement, manual measurements were associated with a moderate reproducibility and agreement in the quantification of FCT and classification of TCFA.