Circulation Reports
Online ISSN : 2434-0790
Advance online publication
Showing 1-21 articles out of 21 articles from Advance online publication
  • Teruhiko Imamura, Masakazu Hori, Takatoshi Koi, Takuya Fukui, Akira Os ...
    Type: ORIGINAL ARTICLE
    Subject Area: Heart Failure
    Article ID: CR-21-0130
    Published: December 03, 2021
    [Advance publication] Released: December 03, 2021
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    Background:The relationship between body posture and lung fluid level has not been quantified thus far. Remote dielectric sensing (ReDSTM) is a recently introduced non-invasive electromagnetic-based technology to quantify lung fluid percentage.

    Methods and Results:ReDS values were measured at different body postures (i.e., sitting, supine, and supine with legs elevated) in a healthy volunteer cohort (n=16; median age 39 years, 69% men, median [interquartile range {IQR}] body mass index 23.3 kg/m2[21.0–26.2 kg/m2]). In the sitting position, the median ReDS value was 27% (IQR 25–29%). The ReDS value increased significantly in the supine position (median 28%; IQR 27–30%; P=0.009), and increased further upon leg elevation (median 29%; IQR 28–32%; P=0.001).

    Conclusions:In this proof-of-concept study, the relationship between body posture and lung fluid level was quantitatively validated in a healthy cohort.

  • Junichi Sugiura, Tsunenari Soeda, Atsushi Kyodo, Takuya Nakamura, Akih ...
    Type: ORIGINAL ARTICLE
    Subject Area: Imaging
    Article ID: CR-21-0147
    Published: December 03, 2021
    [Advance publication] Released: December 03, 2021
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    Supplementary material

    Background:The aim of this study was to evaluate optical coherence tomography (OCT)-detected lipid-rich coronary plaques (LRCPs) with coronary computed tomography angiography (CCTA) 10 months after optimal medical therapy (OMT).

    Methods and Results:Baseline OCT detected 28 LRCPs in non-culprit lesions. High-risk plaque features (HRPFs), such as positive remodeling, very low attenuation plaques, napkin-ring sign, and spotty calcification, were observed in 67.9%, 67.9%, 21.4%, and 64.3% of LRCPs, respectively, at the 10-month follow-up CCTA. Lesions with ≥3 HRPFs were defined as high-risk LRCPs (n=12); the remaining were defined as low-risk LRCPs (n=16). The maximum lipid arc on baseline OCT was larger in high- than low-risk LRCPs (221±62° vs. 179±44°, respectively; P=0.04). Receiver operating characteristic curve analysis indicated that a maximum lipid arc >154° on baseline OCT was the optimal cut-off value to predict high-risk LRCPs 10 months after OMT. Patients with high-risk LRCPs had worse clinical outcomes, defined as a composite of cardiac death, target lesion-related myocardial infarction, and target lesion-related revascularization, during follow-up than those with low-risk LRCPs (33.3% vs. 0%; P=0.01).

    Conclusions:A high-risk LRCP at follow-up CCTA was correlated with a larger maximum lipid arc on baseline OCT. Further aggressive treatment for patients with large LRCPs may reduce vulnerable plaque features and prevent future cardiac events.

  • Junji Yamaguchi, Risako Chiba, Hiroaki Komuro, Kensuke Ihara, Kosuke N ...
    Type: ORIGINAL ARTICLE
    Subject Area: Ischemic Heart Disease
    Article ID: CR-21-0100
    Published: December 01, 2021
    [Advance publication] Released: December 01, 2021
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    Supplementary material

    Background:Previous studies showed that hydroxyapatite electret (HAE) accelerates the regeneration of vascular endothelial cells and angiogenesis. This study investigated the effects of HAE in myocardial infarction (MI) model mice.

    Methods and Results:MI was induced in mice by ligating the left anterior descending artery. Immediately after ligation, HAE, non-polarized hydroxyapatite (HAN), or water (control) was injected into the infarct border myocardium. Functional and histological analyses were performed 2 weeks later. Echocardiography revealed that HAE injection preserved left ventricular systolic function and the wall thickness of the scar, whereas HAN-injected mice had impaired cardiac function and thinning of the wall, similar to control mice. Histological assessment showed that HAE injection significantly attenuated the length of the scar lesion. There was significant accumulation of CD31-positive cells and increased expression of vascular endothelial growth factor (Vegf), intercellular adhesion molecule-1 (Icam1), vascular cell adhesion molecule-1 (Vcam1), hypoxia-inducible factor-1α (Hif1a), and C-X-C motif chemokine ligand 12 (Cxcl12) genes in the infarct border zone of HAE-injected mice. These effects were not induced by HAN injection. Anti-VEGFR2 antibody canceled the beneficial effect of HAE. In vitro experiments in a human cardiovascular endothelial cell line showed that HAE dose-dependently increasedVEGFAexpression.

    Conclusions:Local injection of HAE attenuated infarct size and improved cardiac function after MI, probably due to angiogenesis. The electric charge of HAE may stimulate angiogenesis via HIF1α-CXCL12/VEGF signaling.

  • Noriko Fukue, Mari Ishida, Makiko Taniyama, Natsuko Mukai-Yatagai, Tak ...
    Type: BRIEF REPORT
    Article ID: CR-21-0111
    Published: November 30, 2021
    [Advance publication] Released: November 30, 2021
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    Supplementary material

    Background:Various issues, such as gender diversity and overwork, need to be considered in cardiovascular workplaces. Here, we report the results of 2 questionnaire surveys conducted among members of the Chugoku branch of the Japanese Circulation Society.

    Methods and Results:The first questionnaire was posted to all 194 female members in 2018. Of the 73 respondents, 61.6% reported feeling that it would be difficult to continue in cardiovascular care. The second questionnaire was completed by participants of the Chugoku Regional Meeting in 2019. Of the 133 respondents, 42.4% reported difficulties continuing in cardiovascular care. Respondents reporting difficulties had a significantly lower mean age, a higher frequency of day and night shifts, and a higher rate of working >80 h/week than respondents who did not report such difficulties. In logistic regression analysis, working >80 h/week was the only independent factor associated with difficulties continuing in cardiovascular care (odds ratio 4.16; 95% confidence interval 1.46–11.9; P=0.008). Although 47.4% of respondents worked >960 h overtime per year (considered a risk factor for death from overwork), 59.6% of these respondents reported being satisfied with their current situation.

    Conclusions:In the Chugoku region, the work-life balance of medical personnel engaged in cardiovascular care has not been sufficiently secured. In order to promote diverse human resources, we need to recognize the current situation and continue to take countermeasures.

  • Anwar Ahmed Salim, Shin Kawasoe, Takuro Kubozono, Satoko Ojima, Takeko ...
    Type: ORIGINAL ARTICLE
    Subject Area: Epidemiology
    Article ID: CR-21-0139
    Published: November 20, 2021
    [Advance publication] Released: November 20, 2021
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    Background:Body mass index (BMI) and the waist-to-height ratio (WHtR) are widely used anthropometric indices of obesity to predict cardiovascular risks. However, the usefulness of combining WHtR and BMI values to predict hypertension risk by sex has not been well elucidated.

    Methods and Results:This cohort study enrolled 45,921 participants (mean [±SD] age 53.8±10.5 years; 47.0% men) without hypertension from among those undergoing annual health checkups. Participants were divided into 4 categories based on median BMI and WHtR values, and the 5-year incidence of hypertension was assessed for both sexes using logistic regression analysis. Mean (±SD) BMI and WHtR values were 23.5±3.1 kg/m2and 0.50±0.05, respectively, in men and 22.4±3.3 kg/m2and 0.53±0.06, respectively, in women. Among the women, those with high BMI and low WHtR had an increased risk of hypertension compared with those with low BMI and low WHtR (odds ratio [OR] 1.37, P<0.001); however, the same result was not found in men (OR 1.14, P=0.080). In both sexes, the incidence of hypertension was higher among participants with low BMI and high WHtR than among those with low BMI and low WHtR (men: OR 1.26, P<0.001; women: OR 1.15, P=0.048).

    Conclusions:Using WHtR and BMI together provides a better hypertension risk assessment. Among men, those with a high BMI had no increased hypertension risk when WHtR was low.

  • Masakazu Hori, Teruhiko Imamura, Nikhil Narang, Koichiro Kinugawa
    Type: ORIGINAL ARTICLE
    Subject Area: Heart Failure
    Article ID: CR-21-0132
    Published: November 18, 2021
    [Advance publication] Released: November 18, 2021
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    Background:Clinical outcomes of adaptive servo-ventilation (ASV) therapy have not been rigorously assessed. Optimal device settings ascertained by a pressure ramp test may increase the utility of ASV therapy.

    Methods and Results:Patients with congestive heart failure (CHF) who underwent ASV therapy were prospectively included in the study. Patients in the ramp test group underwent a pressure ramp test, during which the end-expiratory pressure was optimized to maximize cardiac output (assessed using the AESCLONE mini). The control group consisted of age-matched patients who received ASV therapy with a default pressure 5 cmH2O. The primary endpoint was a composite of all-cause death and heart failure recurrence, and was compared between the 2 groups. Of a total of 37 patients, 11 each were included in the ramp test and control groups. Median patient age was 73 years (interquartile range 59–75 years) and 16 were men. There were no significant differences in baseline characteristics between the 2 groups. In the ramp test group, end-expiratory pressure was optimized between 2 and 5 cmH2O in each patient. The 2-year incidence of the primary endpoint tended to be lower in the ramp test than control group (0% vs. 59%; P=0.080).

    Conclusions:Pressure ramp testing may be a promising strategy to optimize device pressure settings in patients with CHF undergoing ASV therapy. Larger-scale trials are needed to validate our findings.

  • Ryota Kaichi, Kyohei Marume, Michikazu Nakai, Masanobu Ishii, Soshiro ...
    Type: ORIGINAL ARTICLE
    Subject Area: Medical Economy
    Article ID: CR-21-0134
    Published: November 17, 2021
    [Advance publication] Released: November 17, 2021
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    Supplementary material

    Background:Left ventricular ejection fraction (LVEF) is a basic clinical index that determines the heart failure (HF) treatment strategy. We aimed to evaluate the association between hospitalization costs for HF patient and LVEF in an advanced aging society in a region in Japan.

    Methods and Results:Consecutive HF patients admitted to Miyazaki Prefectural Nobeoka Hospital between January 2015 and March 2018 were included in the study. The 346 HF patients (mean age 78 years) were divided into 2 groups: HF with reduced ejection fraction (HFrEF; LVEF <40%; n=129) and HF with preserved ejection fraction (HFpEF; LVEF ≥40%; n=217). Median hospitalization costs (in 2017 US dollars) were higher in the HFrEF than HFpEF group, but the difference was not statistically significant (&#36;7,128 vs. &#36;6,580; P=0.189). However, in older adults (age ≥75 years; n=252), median hospitalization costs were significantly higher in the HFrEF than HFpEF group (&#36;7,240 vs. &#36;6,471; P=0.014), and LVEF was an independent factor of hospitalization costs (β=−0.0301, P=0.006). Median hospitalization costs were significantly lower in the older than younger HFpEF group (&#36;6,471 vs. &#36;7,250; P=0.011), but there was no significant difference in costs between the older and younger HFrEF groups (&#36;7,240 vs. &#36;6,760; P=0.351).

    Conclusions:The relationship between LVEF and hospitalization costs became more pronounced with age, and LVEF was a negative independent factor for hospitalization costs in the older population.

  • Tetsufumi Motokawa, Satoshi Ikeda, Yuki Ueno, Masamichi Eguchi, Takako ...
    Type: ORIGINAL ARTICLE
    Subject Area: Epidemiology
    Article ID: CR-21-0140
    Published: November 16, 2021
    [Advance publication] Released: November 16, 2021
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    Background:Despite the beneficial effects ofBCR-ABL1tyrosine kinase inhibitors (TKIs) in the treatment of chronic myeloid leukemia (CML), they may also cause adverse events (AEs), especially cardiovascular toxicity. The incidence of TKI-induced AEs may vary among ethnic groups, and there is little specific information for Japanese patients.

    Methods and Results:Sixty-nine consecutive patients who were started on treatment with dasatinib (n=25) or imatinib (n=44) for CML or gastrointestinal stromal tumor (GIST) between December 2008 and December 2019 were retrospectively recruited to the study. We determined the prevalence of AEs through October 2020 and compared the incidence of AEs between the 2 drugs. Baseline characteristics were comparable between the 2 groups. However, compared with the imatinib-treated group, the dasatinib-treated group had a higher incidence of congestive heart failure (CHF; 20.0% vs. 2.3%; P=0.04), pleural effusion (48% vs. 20.5%; P=0.03), pericardial effusion (24% vs. 4.6%; P=0.02), QT prolongation (4 vs. 0 patients; P=0.02), and pulmonary hypertension (3 vs. 0 patients; P=0.04). In the dasatinib-treated group, CHF tended to be associated with tricuspid valve regurgitation pressure gradient, and pleural effusion was observed in all patients. All-cause mortality and other cardiovascular events did not differ significantly between the 2 groups.

    Conclusions:Cardiotoxic AEs occurred more frequently in Japanese patients with CML and GIST treated with dasatinib than imatinib.

  • Teruhiko Imamura, Makiko Nakamura
    Type: LETTER TO THE EDITOR
    Article ID: CR-21-0120
    Published: November 11, 2021
    [Advance publication] Released: November 11, 2021
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  • Kensaku Nishihira, Yoshisato Shibata, Koichi Kaikita
    Type: IMAGES IN CARDIOVASCULAR MEDICINE
    Article ID: CR-21-0127
    Published: November 11, 2021
    [Advance publication] Released: November 11, 2021
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    Supplementary material
  • Yuri Ochi, Toru Kubo, Yuichi Baba, Naohito Yamasaki, Hiroaki Kitaoka
    Type: AUTHOR’S REPLY
    Article ID: CR-21-0141
    Published: November 11, 2021
    [Advance publication] Released: November 11, 2021
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  • Mayu Nishio, Kiyoshi Kume, Keiji Hirooka, Satoshi Nakatani
    Type: IMAGES IN CARDIOVASCULAR MEDICINE
    Article ID: CR-21-0136
    Published: November 10, 2021
    [Advance publication] Released: November 10, 2021
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    Supplementary material
  • Reimi Goya, Masao Takemoto, Eiji Nyuta, Yoshibumi Antoku, Arisa Yamagu ...
    Type: ORIGINAL ARTICLE
    Subject Area: Arrhythmia/Electrophysiology
    Article ID: CR-21-0105
    Published: November 09, 2021
    [Advance publication] Released: November 09, 2021
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    Background:Hemostasis at the femoral venous access site after cryoballoon ablation (CA) for atrial fibrillation (AF) is often prolonged because of aggressive anticoagulation and the use of 15-Fr-caliber sheaths. The Nepcell STM(NC) is a newly developed hemostatic pad made of fibrosed calcium alginate extracted from natural seaweed. The calcium ions from the NC accelerate the clotting cascade. This single-center randomized clinical trial assessed the efficacy and safety of the NC in patients undergoing CA for AF.

    Methods and Results:In all, 62 patients undergoing CA for non-valvular paroxysmal AF were randomly assigned to either the NC or control group. The primary endpoints of this study were time to hemostasis, internal hemorrhage, and rebleeding. Secondary endpoints were the length of hospital stay (LOS) and vascular complications at 1 month. The time to hemostasis was significantly shorter in NC than control group (mean [±SD] 377±216 vs. 505±241 s; P=0.031). The frequency of internal hemorrhaging (6% vs. 37%; P=0.003) and rebleeding (0% vs. 13%; P=0.033) was lower in the NC than control group, contributing to a decreased LOS in the NC group (3.56±0.67 vs. 4.23±0.73 days; P<0.001). There were no NC-related vascular complications at the 1-month echographic examination.

    Conclusions:The use of NC was associated with a shorter hemostasis time and fewer bleeding complications in patients undergoing CA for AF, leading to a shorter LOS.

  • Yu-ki Nishimura, Sho-ichi Kubokawa, Ryu-ichiro Imai, Yoko Nakaoka, Koj ...
    Type: ORIGINAL ARTICLE
    Subject Area: Myocardial Disease
    Article ID: CR-21-0090
    Published: November 06, 2021
    [Advance publication] Released: November 06, 2021
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    Background:Takotsubo syndrome (TTS) in the very elderly is poorly understood. We sought to clarify the characteristics of octogenarians and nonagenarians with TTS.

    Methods and Results:From 148 patients with TTS who underwent coronary angiography, 68 very elderly patients aged ≥80 years (octogenarians/nonagenarians) were compared with 80 younger patients aged ≤79 years. Emotional triggers of TTS were less frequent (7% vs. 19%; P=0.043), whereas physical triggers were more frequent (69% vs. 46%; P=0.005), in octogenarians/nonagenarians than in patients aged ≤79 years. As initial clues to the diagnosis, electrocardiogram changes were more frequent (71% vs. 46%; P=0.003) and chest pain and/or dyspnea were less common (25% vs. 51%; P=0.001) in octogenarians/nonagenarians than in patients aged ≤79 years. Twenty-nine patients had acute heart failure (AHF) as a complication. AHF was more frequently found in octogenarians/nonagenarians than in patients aged ≤79 years (29% vs. 11%, respectively; P=0.006). Cardiac death occurred in 2 octogenarians/nonagenarians; non-cardiac death occurred in 3 octogenarians/nonagenarians and in 2 patients aged ≤79 years.

    Conclusions:Emotional triggers of TTS were infrequent in octogenarians/nonagenarians with TTS. AHF was common and there was significant in-hospital all-cause mortality among octogenarians/nonagenarians.

  • Hiroshi Yonekura
    Type: IMAGES IN CARDIOVASCULAR MEDICINE
    Article ID: CR-21-0137
    Published: November 06, 2021
    [Advance publication] Released: November 06, 2021
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    Supplementary material
  • Masatsugu Nozoe, Shinki Nishioka, Keiji Oi, Nobuhiro Suematsu, Toru Ku ...
    Type: ORIGINAL ARTICLE
    Subject Area: Cardiovascular Intervention
    Article ID: CR-21-0129
    Published: November 05, 2021
    [Advance publication] Released: November 05, 2021
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    Background:The presence of a calcified nodule (CN) is associated with unfavorable clinical outcomes after percutaneous coronary intervention (PCI). This study clarified the optimal management of CNs by reassessing the PCI strategy in association with patient background characteristics and clinical outcomes.

    Methods and Results:Among 5,332 consecutive PCI cases managed using intra-coronary imaging, CNs were found in 167 lesions (3.1%). CNs were predominantly located at the proximal or mid-right coronary artery (RCA; 62%). More than half presented clinically as acute coronary syndrome (ACS; 56%). All-cause mortality and the target lesion revascularization (TLR) rate at 1 year were 13% and 23%, respectively. Multivariate analysis revealed that hemodialysis, diabetes, and ACS were independent risk factors for all-cause death, whereas hemodialysis and RCA location were independent risk factors for TLR. Regarding the PCI strategy, not using rotational atherectomy (RA) was significantly associated with restenosis, whereas placing a drug-eluting stent (DES) was not.

    Conclusions:Both hemodialysis and RCA location were strong predictors of poor outcomes after PCI for CN. Because not using RA was significantly associated with restenosis, it may be better to use RA whenever possible.

  • Tomohiro Kawasaki, Taichi Okonogi, Hisashi Koga, Yoshiya Orita, Kyoko ...
    Type: ORIGINAL ARTICLE
    Subject Area: Imaging
    Article ID: CR-21-0093
    Published: October 29, 2021
    [Advance publication] Released: October 29, 2021
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    Supplementary material

    Background:The optimal site for measuring computed tomography (CT)-derived fractional flow reserve (FFRCT) to detect significant coronary artery disease (CAD) remains unknown. We investigated how diagnostic performance changes with FFRCTmeasurement site.

    Methods and Results:The diagnostic performance of FFRCT, measured 1–2 cm distal to the stenosis vs. a far-distal site, in detecting significant CAD with invasive fractional flow reserve ≤0.8 was evaluated in 254 diseased vessels from 146 patients with stable or suspected CAD diagnosed by coronary CT angiography. Receiver operating characteristic curve analysis revealed a significantly larger area under the curve for FFRCTmeasured 1–2 cm distal to the stenosis than at a far-distal site (0.829 vs. 0.791, respectively; P=0.0305). The rate of reclassification of positive FFRCTwas 19% for measurements made 1–2 cm distal to the stenosis, and diagnostic accuracy for FFRCT0.71–0.80 improved from 36% to 58% (P=0.0052). Vessel-based diagnostic accuracy of FFRCT1–2 cm distal to the stenosis and at a far-distal site was 75% and 65%, respectively (P<0.0001), with corresponding sensitivity of 87% and 94% (P=0.0039), specificity of 60% and 29% (P<0.0001), a positive predictive value of 73% and 62% (P=0.028), and a negative predictive value of 78% and 79% (P=0.958).

    Conclusions:Our data suggest measuring FFRCT1–2 cm distal to the stenosis has better diagnostic performance for detecting physiologically significant CAD.

  • Toshiki Kaihara, Martijn Scherrenberg, Maarten Falter, Ines Frederix, ...
    Type: STATEMENT / OPINION
    Article ID: CR-21-0126
    Published: October 29, 2021
    [Advance publication] Released: October 29, 2021
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    Cardiac rehabilitation (CR) is a well-known intervention for the secondary prevention of cardiovascular diseases. However, in Japan, the outpatient CR participation rate is estimated to be very low. Cardiac telerehabilitation (CTR) can be defined as a remote CR program using digital health technology to support it. Evidence regarding the use of CTR has been accumulated, and the COVID-19 pandemic has accelerated the need for CTR. Japan has sufficient potential to benefit from CTR because, nationally, digital literacy is high and the infrastructure for telemedicine is developed. To overcome several barriers, evidence of CTR in Japan, well-educated multidisciplinary CTR teams, a good combination of center-based CR and CTR, and sophisticated systems including social insurance and adequate legislation need to be developed immediately. CTR has the potential to increase the low CR participation rate in Japan. CTR also has many different effects that not only cardiologists, but also paramedics who engage in CTR, have to be aware of.

  • Yusuke Okadome, Jun Morinaga, Hirotaka Fukami, Kota Hori, Teruhiko Ito ...
    Type: ORIGINAL ARTICLE
    Subject Area: Critical Care
    Article ID: CR-21-0043
    Published: October 27, 2021
    [Advance publication] Released: October 27, 2021
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    Supplementary material

    Background:Patients with cardiogenic shock due to acute myocardial infarction (AMI) can rapidly undergo veno-arterial extracorporeal membrane oxygenation (VA-ECMO) therapy to recover cardiac output and decrease mortality. However, the clinical indicators predictive of mortality in these patients remain unknown.

    Methods and Results:We conducted a single-center retrospective cohort study targeting AMI patients undergoing VA-ECMO. All 63 patients undergoing VA-ECMO for AMI at the Japanese Red Cross Kumamoto Hospital between January 1, 2010 and June 30, 2020 were enrolled. An exploratory analysis was conducted using a survival tree model and variables selected in a univariate Cox proportional hazard model. The median survival time from the start of VA-ECMO was 6.3 days, and 77.8% (n=49) of patients died. Survival analysis divided patients into 3 groups based on 2 parameters at the initial medical examination: Group 1, patients with neither hyperglycemia (blood glucose ≥213 mg/dL) nor thrombocytopenia (platelets ≤145,100/μL); Group 2, patients with hyperglycemia; and Group 3, patients with hyperglycemia plus thrombocytopenia. Relative to Group 1, the risk of in-hospital mortality was significantly increased in Group 2 (hazard ratio [HR] 2.25; 95% confidence interval [CI] 1.13–4.46), and that risk further increased in Group 3 (HR 7.60; 95% CI 3.21–17.95).

    Conclusions:Hyperglycemia plus thrombocytopenia on initial medical examination combinatorially increase the risk of mortality in patients with cardiogenic shock due to AMI undergoing VA-ECMO.

  • Yuji Nishimoto, Ryosuke Hara, Ryoji Taniguchi, Masanao Toma, Yukihito ...
    Type: IMAGES IN CARDIOVASCULAR MEDICINE
    Article ID: CR-21-0119
    Published: October 22, 2021
    [Advance publication] Released: October 22, 2021
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  • Yusuke Sato, Kazushi Urasawa, Tetsuji Morishita, Michinao Tan, Naoki H ...
    Type: PROTOCOL PAPER
    Article ID: CR-21-0097
    Published: October 20, 2021
    [Advance publication] Released: October 20, 2021
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    Supplementary material

    Background:Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT).

    Methods and Results:The HOTFOOT study is a multicenter prospective randomized open blinded-endpoint trial that is to be conducted at 10 trial centers in Japan between February 2021 and February 2022. This study will enroll 140 patients with CLTI receiving successful EVT. Eligible participants will be allocated 1 : 1 to either the EVT+HBOT or EVT group; participants in the EVT+HBOT group will receive 30 HBOT sessions. The primary outcome is the time to complete wound healing over the 6-month follow-up. Secondary outcomes during the 6-month follow-up are the proportion of patients who achieved complete wound healing, freedom from major lower-limb amputation, amputation-free survival, and freedom from target lesion reintervention.

    Conclusions:This study is expects to assess whether HBOT, in combination with successful EVT, can improve lower-limb outcomes in CLTI patients.

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