Right ventricular free wall longitudinal strain assessment using offline speckle tracking in COVID-19 patients requiring intensive medical care.

PURPOSE: The purpose of this study was to evaluate and confirm the prognostic utility of comprehensive transthoracic echocardiography (TTE) using offline myocardial strain analyses in a Japanese coronavirus disease (COVID-19) cohort hospitalized in intensive care units. METHODS: We performed a retrospective analysis of 90 consecutive adult patients with COVID-19 who underwent clinically indicated standard two-dimensional TTE in intensive care wards. Patients on extracorporeal membrane oxygenation (ECMO) at the time of TTE were excluded. Biventricular strain assessments using vendor-independent offline speckle tracking analysis were performed. Patients with inadequate TTE image quality were also excluded. RESULTS: Among the 90 COVID-19 patients, 15 (17%) patients required venovenous or venoarterial ECMO. There were 25 (28%) in-hospital deaths. A composite event, defined as the combination of in-hospital mortality and subsequent initiation of ECMO, occurred in 32 patients. Multivariate logistic regression for composite events indicated that right ventricular free wall longitudinal strain (RV-FWLS) and mechanical ventilation at the time of TTE were independent risk factors for composite events (p = 0.01, odds ratio [OR] 1.09, 95% confidence interval [CI] 1.01-1.18; p = 0.04, OR 3.24, 95% CI 1.03-10.20). Cumulative survival probability plots generated using the Kaplan-Meier method for composite events with log-rank tests revealed a significant difference between subgroups divided by the cutoff value of RV-FWLS (p < 0.001). CONCLUSION: Offline measurement of RV-FWLS may be a potent predictor of worse outcomes in COVID-19 requiring intensive care. Larger multicenter prospective studies are needed.

Clinical and Economic Evaluation of Impella Treatment for Fulminant Myocarditis　- A Preliminary Retrospective Cohort Study in Japan.

BACKGROUND: Fulminant myocarditis (FM) is rare but has an extremely poor prognosis. Impella, a catheter-based heart pump, is a new therapeutic strategy, but reports regarding its health economics are lacking.Methods and Results: This retrospective cohort study compared Impella treatment (Group I) with existing treatments (Group E) using medical data collected from October 2017 to September 2021, with a 1-year analysis period. Cost-effectiveness indices were life-years (LY; effect index) and medical fee amount (cost index). Results were validated using probabilistic sensitivity analysis. The incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted LY (QALY) and medical costs. Each group included 7 patients, and more than half (57.1%) received combined Impella plus extracorporeal membrane oxygenation. There was no significant difference between Groups I and E in 1-year mortality rates (28.6% vs. 57.1%, respectively) or LY (mean [±SD] 163.1±128.3 vs. 107.8±127.3 days, respectively), but mortality risk was significantly lower in Group I than Group E (95% confidence interval 0.02-0.96; P<0.05). Compared with Group E, Group I had higher total costs (9,270,597±4,121,875 vs. 6,397,466±3,801,364 JPY/year; P=0.20) and higher cost-effectiveness (32,443,987±14,742,966 vs. 92,637,756±98,225,604 JPY/LY; P=0.74), which was confirmed in the sensitivity analysis. ICER probability distribution showed 23.2% and 51.5% reductions below 5 million and 10 million JPY/QALY, respectively. CONCLUSIONS: Impella treatment is more cost-effective than conventional FM treatments. Large-scale studies are needed to validate the added effects and increasing costs.

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.

Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese association of cardiovascular intervention and therapeutics-update 2022.

Fractional flow reserve and instantaneous wave-free ratio are widely accepted and recommended in Western and Japanese guidelines for appropriate percutaneous coronary intervention. There are, however, many differences in clinical situations between Japan and Western countries. Therefore, the Task Force on coronary physiology of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has proposed an expert consensus document to summarize current evidence and suggest the practical use of physiological lesion assessment in Japan.

Expert consensus statement for quantitative measurement and morphological assessment of optical coherence tomography: update 2022.

In this updated expert consensus document, the methods for the quantitative measurement and morphological assessment of optical coherence tomography (OCT)/optical frequency domain imaging images (OFDI) are briefly summarized. The focus is on the clinical application and the clinical evidence of OCT/OFDI to guide percutaneous coronary interventions.

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.

Correction to: Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese Association of Cardiovascular Intervention and Therapeutics.

In the original publication of the article, author group affiliation was published incorrectly. The correct affiliation for author group is given in this correction.

Clinical expert consensus document on standards for measurements and assessment of intravascular ultrasound from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Intravascular ultrasound (IVUS) provides precise anatomic information in coronary arteries including quantitative measurements and morphological assessment. To standardize the IVUS analysis in the current era, this expert consensus document summarizes the methods of measurements and assessment of IVUS images.

Expert consensus statement for quantitative measurement and morphological assessment of optical coherence tomography.

In this document, the methods for the quantitative measurement and morphological assessment of optical coherence tomography (OCT)/optical frequency domain imaging images (OFDI) are briefly summarized. The focus is on the clinical application of OCT/OFDI to guide percutaneous coronary interventions.

Primary Percutaneous Coronary Intervention in Elderly Patients With Acute Myocardial Infarction　- An Analysis From a Japanese Nationwide Claim-Based Database.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) is strongly recommended by guidelines for patients presenting with acute myocardial infarction (AMI), but its applications in elderly patients are less clear.Methods and Results:The JROAD-DPC is a Japanese nationwide registry for patients with cardiovascular diseases combined with an administrative claim-based database. Among 2,369,165 records from 2012 to 2015, data for 115,407 AMI patients were extracted for this study. Elderly patients (≥75 years) comprised 45,645 subjects (39.6%), and received pPCI less frequently (62.2%) than younger patients (79.2%, P<0.001). Clinical variables such as higher age, female sex, higher Killip class, and renal dysfunction, but not functional status on admission, were predictors of non-application of pPCI. Endpoint 30-day mortality increased with aging, and was significantly higher in elderly patients (10.7%) than in younger patients (3.8%, P<0.001). Indeed, pPCI was independently associated with lower 30-day mortality only in subgroups of patients aged ≥60 years. Propensity score-matching analysis confirmed a similar reduction in endpoint 30-day mortality with pPCI in elderly patients. Duration of hospitalization was significantly shorter and functional ability on discharge was significantly better in elderly patients who underwent pPCI. CONCLUSIONS: Elderly patients with AMI underwent pPCI less frequently, but it was consistently associated with better clinical outcome in these patients. Our findings support the proactive application of pPCI for elderly AMI patients when they are eligible for an invasive strategy.

Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese Association of Cardiovascular Intervention and Therapeutics.

In this document, the background, concept, and current evidence are briefly summarized. The focus is on the clinical application of physiological lesion assessment from a practical standpoint for facilities that do not have ample experience. Finally, the characteristics of new resting indexes are summarized.

Evaluation of coronary arterial calcification - Ex-vivo assessment by optical frequency domain imaging.

AIMS: The purpose of this study was to determine the diagnostic ability of optical frequency domain imaging (OFDI) to carry out quantitative and qualitative evaluation of coronary calcification in comparing with ex vivo human autopsy heart specimens. METHODS: Analysis was carried out in 25 coronary artery specimen obtained from 16 cadavers that were imaged ex-vivo imaging by OFDI and intravascular ultrasound (IVUS). Of 235 cross-sections obtained for histologic evaluation, 149 were classified as showing calcified plaques, and in this group a comparison between histology versus co-registered images by OFDI and IVUS was performed. RESULTS: Maximum thickness of calcification measured by OFDI was well correlated with histology (rs = 0.70, p < 0.0001) whereas IVUS was not useful for quantitative analysis because of the presence of acoustic shadows occurring behind calcifications. Furthermore qualitative evaluation could be carried out using OFDI, for calcifications with vague or invisible outer borders by OFDI had lipid contents (lipid pool or histologic necrotic core) more frequently as compared to those with a clear outer border (79% vs. 24%, p < 0.0001). We also found that calcified nodules, a well-recognized thrombogenic substrate, demonstrated atypical appearance in OFDI, showing irregular surfaces with high attenuation. CONCLUSION: OFDI demonstrated a greater ability than IVUS to provide quantitative and qualitative evaluation of coronary arterial calcification. Precise recognition of calcified plaque morphology by OFDI may serve to determine the treatment strategy of patients having atherosclerotic coronary disease.

Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS).

BACKGROUND: Clinical data of sirolimus-eluting stent (SES) implantation are under investigation in Japan. METHODS AND RESULTS: The CYPHER stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 +/-10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 +/-0.58 mm and 72.0 +/-16.1%. The 8-month late loss was 0.20 +/-0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR. CONCLUSIONS: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety.