Faculty Profiles - Hirai Kenta

Papers - Hirai Kenta

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Eight-Year Outcomes of Cardiosphere-Derived Cells in Single Ventricle Congenital Heart Disease Reviewed

Kenta Hirai, Ryusuke Sawada, Tomohiro Hayashi, Toru Araki, Naomi Nakagawa, Maiko Kondo, Kenji Yasuda, Takuya Hirata, Tomoyuki Sato, Yuki Nakatsuka, Michihiro Yoshida, Shingo Kasahara, Kenji Baba, Hidemasa Oh

2024.11

Pulmonary Flow Management by Combination Therapy of Hemostatic Clipping and Balloon Angioplasty for Right Ventricular-Pulmonary Artery Shunt in Hypoplastic Left Heart Syndrome. Reviewed International journal

Yusuke Shigemitsu, Maiko Kondo, Yoshihiko Kurita, Yosuke Fukushima, Yuya Kawamoto, Kenta Hirai, Mayuko Hara, Tomoyuki Kanazawa, Tatsuo Iwasaki, Shingo Kasahara, Koichi Kataoka, Hirokazu Tsukahara, Kenji Baba

Pediatric cardiology 2024.7

Language：English Publishing type：Research paper (scientific journal)

Controlling pulmonary blood flow in patients who have undergone Norwood palliation, especially early postoperatively, is challenging due to a change in the balance of systemic and pulmonary vascular resistance. We applied a combination therapy of clipping and balloon angioplasty for right ventricle-pulmonary artery (RV-PA) shunt to control pulmonary blood flow, but the influence of the combination therapy on the PA condition is uncertain. Retrospectively analysis was conducted of all infants with hypoplastic left heart syndrome who had undergone Norwood palliation with RV-PA shunt at Okayama University Hospital from January 2008 to September 2022. A total of 50 consecutive patients underwent Norwood palliation with RV-PA shunt in this study period. Of them, 29 patients underwent RV-PA shunt flow clipping, and the remaining 21 had unclipped RV-PA shunt. Twenty-three patients underwent balloon angioplasty for RV-PA shunt with clips. After balloon angioplasty, oxygen saturation significantly increased from 69 (59-76)% to 80 (72-86)% (p < 0.001), and the narrowest portion of the clipped conduit significantly improved from 2.8 (1.8-3.4) to 3.8 (2.9-4.6) mm (p < 0.001). In cardiac catheterizations prior to Bidirectional cavo-pulmonary shunt (BCPS), there were no significant differences in pulmonary-to-systemic flow ratio (Qp/Qs), ventricular end-diastolic pressure, Nakata index, arterial saturation, mean pulmonary artery pressure and pulmonary vascular resistance index. On the other hand, in Cardiac catheterizations prior to Fontan, Nakata index was larger in the clipped group (p = 0.02). There was no statistically significant difference in the 5-year survival between the two groups (clipped group 96%, unclipped group 74%, log-rank test: p = 0.13). At least, our combination therapy of clipping and balloon angioplasty for RV-PA shunt did not negatively impact PA growth. Although there is a trend toward better but not statistically significant difference in outcomes in the clipped group compared to the non-clipped group, this treatment strategy may play an important role in improving outcomes in hypoplastic left heart syndrome.

DOI： 10.1007/s00246-024-03579-6

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Initial trial of three‑lead wearable electrocardiogram monitoring in a full marathon. Reviewed

Kenta Hirai, Noriko Sakano, Susumu Oozawa, Daiki Ousaka, Yosuke Kuroko, Shingo Kasahara

Journal of cardiology cases 30 ( 1 ) 24 - 28 2024.7

Authorship：Lead author,　Corresponding author Language：English Publishing type：Research paper (scientific journal)

UNLABELLED: Sudden cardiac arrest during exercise can occur without prior warning signs at rest, highlighting the importance of monitoring for its prevention. To detect the signs of ischemic heart disease, including coronary artery anomalies, ST changes must be detected using three‑lead electrocardiograms (ECGs) corresponding to each region of the three coronary artery branches. We conducted ECG monitoring of five runners during a marathon using a wearable three‑lead ECG device (e-skin ECG; Xenoma Inc., Tokyo, Japan). Data without noise or artifacts were successfully collected for one of five runners during the entire marathon. Within the initial hour of the marathon, poor electrode adhesion to the skin hindered the data collection for the remaining four runners, which resulted in significantly decreased acquisition rate compared with the first hour (86.7 ± 13.4 % to 37.3 ± 36.9 %, p = 0.028). Couplets of premature ventricular contractions with clear ECG waveforms in the three leads were detected in one runner during the marathon. Further device improvements are necessary to enable marathon runners to obtain ECGs efficiently without affecting their performance. This study also demonstrated the potential applications of three‑lead wearable ECG monitoring for other short-duration sports and remote home-based cardiac rehabilitation. LEARNING OBJECTIVE: This is an initial trial of a three‑lead wearable electrocardiogram (ECG) monitoring device during a full marathon. ECG data were obtained with low noise and artifacts during the first hour of the marathon; however, the data acquisition rate decreased in the middle and late stages owing to poor electrode adhesion. This study demonstrated the possibility of applying wearable ECG monitoring during short-term exercise and cardiac rehabilitation to detect warning signs and prevent sudden cardiac arrest.

DOI： 10.1016/j.jccase.2024.03.004

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Intravenous infusion of cardiac progenitor cells in animal models of single ventricular physiology. Reviewed International journal

Takuya Goto, Daiki Ousaka, Kenta Hirai, Yasuhiro Kotani, Shingo Kasahara

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 64 ( 4 ) 2023.10

Language：English Publishing type：Research paper (scientific journal)

OBJECTIVES: The goal of this study was to identify the practical applications of intravenous cell therapy for single-ventricle physiology (SVP) by establishing experimental SVP models. METHODS: An SVP with a three-stage palliation was constructed in an acute swine model without cardiopulmonary bypass. A modified Blalock-Taussig (MBT) shunt was created using an aortopulmonary shunt with the superior and inferior venae cavae (SVC and IVC, respectively) connected to the left atrium (n = 10). A bidirectional cavopulmonary shunt (BCPS) was constructed using a graft between the IVC and the left atrium with an SVC cavopulmonary connection (n = 10). The SVC and the IVC were connected to the pulmonary artery to establish a total cavopulmonary connection (TCPC, n = 10). The survival times of half of the animal models were studied. The other half and the biventricular sham control (n = 5) were injected intravenously with cardiosphere-derived cells (CDCs), and the cardiac retention of CDCs was assessed after 2 h. RESULTS: All SVP models died within 20 h. Perioperative mortality was higher in the BCPS group because of lower oxygen saturation (P < 0.001). Cardiac retention of intravenously delivered CDCs, as detected by magnetic resonance imaging and histologic analysis, was significantly higher in the modified Blalock-Taussig and BCPS groups than in the TCPC group (P < 0.01). CONCLUSIONS: Without the total right heart exclusion, stage-specific SVP models can be functionally constructed in pigs with stable outcomes. Intravenous CDC injections may be applicable in patients with SVP before TCPC completion, given that the initial lung trafficking is efficiently bypassed and sufficient systemic blood flow is supplied from the single ventricle.

DOI： 10.1093/ejcts/ezad304

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Exercise-Induced Ischemic ST-Segment Elevation in Anomalous Origin of the Right Coronary Artery From the Left Sinus of Valsalva With an Intramural Course and Blocked Coronary Bypass Reviewed

Kenta Hirai, Daiki Ousaka, Yosuke Kuroko, Shingo Kasahara

Cureus 2022.12

Vascular occlusion with 0.035-inch hydrogel expandable coils in congenital heart diseases and vascular anomalies. Reviewed International journal

Kenji Baba, Maiko Kondo, Takahiro Eitoku, Yusuke Shigemitsu, Kenta Hirai, Shinichi Otsuki, Tomoyuki Kanazawa, Tatsuo Iwasaki, Toshihiro Iguchi, Norihisa Toh, Yasuhiro Kotani, Shingo Kasahara

Journal of cardiology 80 ( 3 ) 249 - 254 2022.9

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: We present our experience with transcatheter vascular occlusion using 0.035-inch hydrogel expandable coils, which has been reported only in a few cases in the pediatric cardiology fields. METHODS: This study is a retrospective analysis of all patients who underwent transcatheter embolization with 0.035-inch hydrogel coils at the Department of Pediatrics, Okayama University Hospital, between October 2018 and September 2020. RESULTS: Twenty patients with a median age of 5.1 years (0.05-26.0 years) and a median weight of 13.8 kg (3.0-56.8 kg) were included. A total of fifty-four 0.035-inch hydrogel coils, including 35 Azur 35 and nineteen Azur CX 35 coils (Terumo, Tokyo, Japan), were successfully deployed in 22 target vessels. The target vessels consisted of 10 aortopulmonary collaterals, 8 veno-venous collaterals, and 4 pulmonary arteriovenous malformations. We achieved technical success in all the target vessels. In total, the mean target vessel diameter was 4.4 mm, the mean number of 0.035-inch hydrogel coils was 2.5 per vessel. The mean device to vessel ratio was 1.6 for the anchor coil and 1.2 for the additional coil. Post-implantation angiograms revealed that the primary occlusion rate was 18/22 (82%). There were no periprocedural complications. CONCLUSIONS: The 0.035-inch hydrogel expandable coils are effective and safe in patients with congenital heart disease and vascular anomalies. These occlusion devices could be valuable options for interventional pediatric cardiologists.

DOI： 10.1016/j.jjcc.2022.04.005

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Stepwise Treatment for Heterotaxy Syndrome and Functional Single Ventricle Complicated by Infra-Cardiac Total Anomalous Pulmonary Venous Connection with Ductus Venosus Stent Placement and Subsequent Occlusion. Reviewed International journal

Yuki Imai, Kenji Baba, Shinichi Otsuki, Maiko Kondo, Takahiro Eitoku, Yusuke Shigemitsu, Yosuke Fukushima, Kenta Hirai, Tatsuo Iwasaki, Tomoyuki Kanazawa, Yasuhiro Kotani, Shingo Kasahara

Pediatric cardiology 43 ( 4 ) 756 - 763 2022.4

Language：English Publishing type：Research paper (scientific journal)

Even today, when the surgical outcome of congenital heart disease in the neonatal period has improved, the prognosis for heterotaxy syndrome and functional single ventricle complicated with total anomalous pulmonary venous connection (TAPVC), especially the infra-cardiac type, is catastrophic. We describe a strategy that combines percutaneous ductus venosus (DV) stent placement and occlusion after TAPVC repair to ensure survival from initial surgery to bidirectional cavopulmonary shunt (BCPS) procedure and facilitate subsequent treatment. Three consecutive patients with heterotaxy syndrome and functional single ventricle complicated by infra-cardiac TAPVC treated with our own strategy were retrospectively studied. In two infants, DV stent placement was performed on the day of birth. In one case at 11 days of age. The risk of pulmonary vein obstruction was reduced, and on-pump surgery, including TAPVC repair, was performed on a standby basis. Since the rapid increase in hepatic enzymes occurred on postoperative day 0 to 1 in all cases, percutaneous stent occlusion was performed until postoperative day 3. The procedure improved liver function. One patient died due to severe atrioventricular valve regurgitation, one case underwent BCPS, and one patient was waiting to undergo. DV stent placement can avoid TAPVC repair in the early neonatal period. After TAPVC repair, the portosystemic shunt remained, resulting in hepatic dysfunction, but this could be improved by stent and vertical vein occlusion. A series of stepwise treatments can be useful to help such critically ill infants survive the high-risk neonatal period and achieve good BCPS circulation.

DOI： 10.1007/s00246-021-02782-z

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Initial evaluation of a novel electrocardiography sensor-embedded fabric wear during a full marathon. Reviewed

Daiki Ousaka, Kenta Hirai, Noriko Sakano, Mizuki Morita, Madoka Haruna, Kazuya Hirano, Takahiro Yamane, Akira Teraoka, Kazuo Sanou, Susumu Oozawa, Shingo Kasahara

Heart and vessels 37 ( 3 ) 443 - 450 2022.3

Language：English Publishing type：Research paper (scientific journal)

Sudden cardiac accident (SCA) during a marathon is a concern due to the popularity of the sport. Preventive strategies, such as cardiac screening and deployment of automated external defibrillators have controversial cost-effectiveness. We investigated the feasibility of use of a new electrocardiography (ECG) sensor-embedded fabric wear (SFW) during a marathon as a novel preventive strategy against SCA. Twenty healthy volunteers participated in a full marathon race. They were equipped with a SFW hitoe® with a transmitter connected via Bluetooth to a standard smartphone for continuous ECG recording. All data were stored in a smartphone and used to analyze the data acquisition rate. The adequate data acquisition rate was > 90% in 13, 30-90% in 3, and < 10% in 4 runners. All of 4 runners with poorly recorded data were female. Inadequate data acquisition was significantly associated with the early phase of the race compared with the mid phase (P = 0.007). Except for 3 runners with poor heart rate data, automated software calculation was significantly associated with manual analysis for both the mean (P < 0.001) and maximum (P = 0.014) heart rate. We tested the feasibility of continuously recording cardiac data during a marathon using a new ECG sensor-embedded wearable device. Although data from 65% of runners were adequately recorded, female runners and the early phase of the race tended to have poor data acquisition. Further improvements in device ergonomics and software are necessary to improve ability to detect abnormal ECGs that may precede SCA.

DOI： 10.1007/s00380-021-01939-3

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Trial of Sportswear Type ECG Sensor Device for Cardiac Safety Management during Marathon Running Reviewed

Takahiro Yamane, Kazuya Hirano, Kenta Hirai, Daiki Ousaka, Noriko Sakano, Mizuki Morita, Susumu Oozawa, Shingo Kasahara

ADVANCED BIOMEDICAL ENGINEERING 11 151 - 161 2022

Language：English Publishing type：Research paper (scientific journal) Publisher：JAPANESE SOC MEDICAL & BIOLOGICAL ENGINEERING

Cardiac arrest has been reported during participation in several sports. Of these sports, marathon running is a particularly popular sport but imposes high cardiac load. Indeed, its popularity has been growing worldwide. Risk of cardiac arrest during marathon races is also expected to increase. Several studies have recorded electrocardiographic (ECG) information during marathon races to protect athletes from cardiac arrest. Although evaluable ECG data have been obtained and analyzed, cost-effectiveness of the system, data quality, and clinical significance remain inadequate. This report is the first to describe an economical electrocardiograph built into a T-shirt for use during marathon race. Twenty healthy runners aged 20 to 59 years (mean 36 years) wore the ECG device while running. The ECG data were monitored and analyzed to assess the observed frequencies of specified arrhythmias and the sections of the marathon in which the arrhythmias occurred. Of the ECG data obtained from 14 runners who completed the full marathon, six ECG datasets were evaluable. In some runners, there was inadequate contact between the electrode and body surface or poor Bluetooth connection between the ECG wireless transmitter and smartphone. Regarding arrhythmia analysis, all evaluable data that were analyzed showed some rhythm fluctuations. In conclusion, this economical T-shirt type ECG sensor provided evaluable ECG data during marathon races, although the evaluable rate was not high. The data were used to analyze specified arrhythmias, but some difficulties were encountered. The ECG sensor did not function properly because of a system error. The ECG sensor was not adequately moistened to record ECGs accurately. Moreover, some runners chose an unsuitable shirt size, which impaired the stability and strength of the electrode-skin contact. These shortcomings produced noise in the ECG data, which made it difficult to analyze arrhythmias. The next step will be to solve these problems and acquire data from a large number of runners.

DOI： 10.14326/abe.11.151

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Outcomes of Right Ventricular Outflow Tract Reconstruction in Children: Retrospective Comparison Between Bovine Jugular Vein and Expanded Polytetrafluoroethylene Conduits. Reviewed International journal

Kenta Hirai, Kenji Baba, Takuya Goto, Daiki Ousaka, Maiko Kondo, Takahiro Eitoku, Yasuhiro Kotani, Shingo Kasahara, Shinichi Ohtsuki, Hirokazu Tsukahara

Pediatric cardiology 42 ( 1 ) 100 - 108 2021.1

Authorship：Lead author Language：English Publishing type：Research paper (scientific journal)

Bovine jugular vein (BJV) and expanded polytetrafluoroethylene (ePTFE) conduits have been described as alternatives to the homograft for right ventricular outflow tract (RVOT) reconstruction. This study compared RVOT reconstructions using BJV and ePTFE conduits performed in a single institution. The valve functions and outcomes of patients aged < 18 years who underwent primary RVOT reconstruction with a BJV or ePTFE conduit between 2013 and 2017 were retrospectively investigated. 44 patients (20 and 24 with BJV and ePTFE conduits, respectively) met the inclusion criteria. The mean follow-up time was 4.5 ± 1.5 years. No significant differences in peak RVOT velocity (1.8 ± 0.9 m/s vs 2.1 ± 0.9 m/s, P = 0.27), branch pulmonary stenosis (P = 0.50), or pulmonary regurgitation (P = 0.44) were found between the BJV and ePTFE conduit groups, respectively. Aneurysmal dilatation of the conduit was observed in 25.0% of the patients in the BJV conduit group but not in the ePTFE conduit group (P = 0.011). All the cases with aneurysmal dilatation of the BJV conduit were complicated with branch pulmonary stenosis up to 3.0 m/s (P = 0.004). No conduit infections occurred during the follow-up period, and no significant difference in conduit replacement (20.0% vs 8.3%, P = 0.43) was found between the BJV and ePTFE conduit groups, respectively. The outcomes of the RVOT reconstructions with BJV and ePTFE conduits were clinically satisfactory. Aneurysmal dilatation was found in the BJV conduit cases, with branch pulmonary stenosis as the risk factor.

DOI： 10.1007/s00246-020-02458-0

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Cardiosphere-derived exosomal microRNAs for myocardial repair in pediatric dilated cardiomyopathy. Reviewed International journal

Kenta Hirai, Daiki Ousaka, Yosuke Fukushima, Maiko Kondo, Takahiro Eitoku, Yusuke Shigemitsu, Mayuko Hara, Kenji Baba, Tatsuo Iwasaki, Shingo Kasahara, Shinichi Ohtsuki, Hidemasa Oh

Science translational medicine 12 ( 573 ) 2020.12

Authorship：Lead author Language：English Publishing type：Research paper (scientific journal)

Although cardiosphere-derived cells (CDCs) improve cardiac function and outcomes in patients with single ventricle physiology, little is known about their safety and therapeutic benefit in children with dilated cardiomyopathy (DCM). We aimed to determine the safety and efficacy of CDCs in a porcine model of DCM and translate the preclinical results into this patient population. A swine model of DCM using intracoronary injection of microspheres created cardiac dysfunction. Forty pigs were randomized as preclinical validation of the delivery method and CDC doses, and CDC-secreted exosome (CDCex)-mediated cardiac repair was analyzed. A phase 1 safety cohort enrolled five pediatric patients with DCM and reduced ejection fraction to receive CDC infusion. The primary endpoint was to assess safety, and the secondary outcome measure was change in cardiac function. Improved cardiac function and reduced myocardial fibrosis were noted in animals treated with CDCs compared with placebo. These functional benefits were mediated via CDCex that were highly enriched with proangiogenic and cardioprotective microRNAs (miRNAs), whereas isolated CDCex did not recapitulate these reparative effects. One-year follow-up of safety lead-in stage was completed with favorable profile and preliminary efficacy outcomes. Increased CDCex-derived miR-146a-5p expression was associated with the reduction in myocardial fibrosis via suppression of proinflammatory cytokines and transcripts. Collectively, intracoronary CDC administration is safe and improves cardiac function through CDCex in a porcine model of DCM. The safety lead-in results in patients provide a translational framework for further studies of randomized trials and CDCex-derived miRNAs as potential paracrine mediators underlying this therapeutic strategy.

DOI： 10.1126/scitranslmed.abb3336

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Balloon atrial septostomy in hypoplastic left heart syndrome with restrictive atrial septum. Reviewed International journal

Yosuke Fukushima, Kenji Baba, Maiko Kondo, Yoshihiko Kurita, Takahiro Eitoku, Yusuke Shigemitsu, Kenta Hirai, Hirokazu Tsukahara, Tatsuo Iwasaki, Shingo Kasahara, Yasuhiro Kotani, Shinichi Otsuki

Pediatrics international : official journal of the Japan Pediatric Society 61 ( 4 ) 339 - 344 2019.4

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: Rashkind balloon atrial septostomy (BAS) can be challenging in infants with hypoplastic left heart syndrome (HLHS) and small atrial septal defect (ASD). METHODS: We retrospectively reviewed all infants with HLHS who underwent surgery and BAS between January 2006 and December 2015. The infants were divided into three groups: no BAS; catheter BAS; and open AS. Infants who underwent catheter BAS were divided into two groups based on atrial septal anatomy: standard and complex. RESULTS: Of the 70 patients, 57 (81%) underwent Glenn surgery. Subsequently, a significant difference in survival was observed: 86% (44/51), 91% (10/11), and 25% (2/8) in the no BAS, catheter BAS, and open AS groups, respectively (P = 0.0002). No significant difference was seen between the no BAS and the catheter BAS groups (P = 1.0). In the 56 patients who underwent catheterization after surgery, no intergroup differences in mean pulmonary artery pressure, pulmonary vascular resistance, or pulmonary artery index were found. We classified catheter BAS into standard (n = 5) and complex (n = 5) based on ASD location, and septum thickness. All patients in the standard group underwent complete Rashkind BAS, but in the complex group, only one patient underwent complete Rashkind BAS, with the remaining requiring initial static BAS (P = 0.048). Following septostomy, ASD size, ASD flow, and percutaneous oxygen saturation (SpO2 ) were not significantly different between the two groups. CONCLUSIONS: Catheter BAS is effective in infants with HLHS and a restrictive atrial septum. Infants with standard or complex atrial septum can achieve equivalent outcomes despite more patients often requiring static BAS.

DOI： 10.1111/ped.13716

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Prenatal Diagnosis of a Huge Ventriculocoronary Fistula in Pulmonary Atresia with Intact Ventricular Septum Reviewed

Maiko Kondo, Kenji Baba, Yoshihiko Kurita, Takahiro Eitoku, Yusuke Shigemitsu, Yousuke Fukushima, Kenta Hirai, Shingo Kasahara, Tatsuo Iwasaki, Shin-ichi Ohtsuki

Journal of Pediatric Cardiology and Cardiac Surgery 2018.7

Impact of Cardiac Progenitor Cells on Heart Failure and Survival in Single Ventricle Congenital Heart Disease. Reviewed International journal

Toshikazu Sano, Daiki Ousaka, Takuya Goto, Shuta Ishigami, Kenta Hirai, Shingo Kasahara, Shinichi Ohtsuki, Shunji Sano, Hidemasa Oh

Circulation research 122 ( 7 ) 994 - 1005 2018.3

Language：English Publishing type：Research paper (scientific journal)

RATIONALE: Intracoronary administration of cardiosphere-derived cells (CDCs) in patients with single ventricles resulted in a short-term improvement in cardiac function. OBJECTIVE: To test the hypothesis that CDC infusion is associated with improved cardiac function and reduced mortality in patients with heart failure. METHODS AND RESULTS: We evaluated the effectiveness of CDCs using an integrated cohort study in 101 patients with single ventricles, including 41 patients who received CDC infusion and 60 controls treated with staged palliation alone. Heart failure with preserved ejection fraction (EF) or reduced EF was stratified by the cardiac function after surgical reconstruction. The main outcome measure was to evaluate the magnitude of improvement in cardiac function and all-cause mortality at 2 years. Animal studies were conducted to clarify the underlying mechanisms of heart failure with preserved EF and heart failure with reduced EF phenotypes. At 2 years, CDC infusion increased ventricular function (stage 2: +8.4±10.0% versus +1.6±6.4%, P=0.03; stage 3: +7.9±7.5% versus -1.1±5.5%, P<0.001) compared with controls. In all available follow-up data, survival did not differ between the 2 groups (log-rank P=0.225), whereas overall patients treated by CDCs had lower incidences of late failure (P=0.022), adverse events (P=0.013), and catheter intervention (P=0.005) compared with controls. CDC infusion was associated with a lower risk of adverse events (hazard ratio, 0.411; 95% CI, 0.179-0.942; P=0.036). Notably, CDC infusion reduced mortality (P=0.038) and late complications (P<0.05) in patients with heart failure with reduced EF but not with heart failure with preserved EF. CDC-treated rats significantly reversed myocardial fibrosis with differential collagen deposition and inflammatory responses between the heart failure phenotypes. CONCLUSIONS: CDC administration in patients with single ventricles showed favorable effects on ventricular function and was associated with reduced late complications except for all-cause mortality after staged procedures. Patients with heart failure with reduced EF but not heart failure with preserved EF treated by CDCs resulted in significant improvement in clinical outcome. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01273857 and NCT01829750.

DOI： 10.1161/CIRCRESAHA.117.312311

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Transcoronary cell infusion with the stop-flow technique in children with single-ventricle physiology. Reviewed International journal

Takahiro Eitoku, Kenji Baba, Maiko Kondou, Yoshihiko Kurita, Yousuke Fukushima, Kenta Hirai, Shinichi Ohtsuki, Shuta Ishigami, Shunji Sano, Hidemasa Oh

Pediatrics international : official journal of the Japan Pediatric Society 60 ( 3 ) 240 - 246 2018.3

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: Almost all reports on cardiac regeneration therapy have referred to adults, and only a few have focused on transcoronary infusion of cardiac progenitor cells using the stop-flow technique in children. METHODS: Intracoronary autologous cardiosphere-derived cell (CDC) transfer was conducted at Okayama University as a phase 1 clinical trial for seven patients with hypoplastic left heart syndrome between January 2011 and December 2012, and as a phase 2 clinical trial for 34 patients with single-ventricle physiology between July 2013 and March 2015. RESULTS: A total of 41 patients with single-ventricle physiology underwent transcoronary infusion of CDC with the stop-flow technique. The median age was 33 months (range, 5-70 months) and the median weight was 10.1 kg (range, 4.1-16.0 kg). Transient adverse events occurred during the procedure, including ST-segment elevation or depression, hypotension, bradycardia, and coronary artery vasospasm. All patients completely recovered. There were no major procedure-related adverse events. In this study, transcoronary infusion of CDC using the stop-flow technique was successfully completed in all patients. CONCLUSION: Transcoronary infusion of CDC using the stop-flow technique in children is a feasible and safe procedure.

DOI： 10.1111/ped.13485

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Prominent Eustachian valve in a preterm infant causing cyanosis. Reviewed International journal

Kei Tamai, Misao Kageyama, Akihito Takeuchi, Makoto Nakamura, Kenta Hirai

Pediatrics international : official journal of the Japan Pediatric Society 60 ( 3 ) 311 - 313 2018.3

Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology: The PERSEUS (Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease) Randomized Phase 2 Trial. Reviewed International journal

Shuta Ishigami, Shinichi Ohtsuki, Takahiro Eitoku, Daiki Ousaka, Maiko Kondo, Yoshihiko Kurita, Kenta Hirai, Yosuke Fukushima, Kenji Baba, Takuya Goto, Naohiro Horio, Junko Kobayashi, Yosuke Kuroko, Yasuhiro Kotani, Sadahiko Arai, Tatsuo Iwasaki, Shuhei Sato, Shingo Kasahara, Shunji Sano, Hidemasa Oh

Circulation research 120 ( 7 ) 1162 - 1173 2017.3

Language：English Publishing type：Research paper (scientific journal)

RATIONALE: Patients with single ventricle physiology are at high risk of mortality resulting from ventricular dysfunction. The preliminary results of the phase 1 trial showed that cardiosphere-derived cells (CDCs) may be effective against congenital heart failure. OBJECTIVE: To determine whether intracoronary delivery of autologous CDCs improves cardiac function in patients with single ventricle physiology. METHODS AND RESULTS: We conducted a phase 2 randomized controlled study to assign in a 1:1 ratio 41 patients who had single ventricle physiology undergoing stage 2 or 3 palliation to receive intracoronary infusion of CDCs 4 to 9 weeks after surgery or staged reconstruction alone (study A). The primary outcome measure was to assess improvement in cardiac function at 3-month follow-up. Four months after palliation, controls had an alternative option to receive late CDC infusion on request (study B). Secondary outcomes included ventricular function, heart failure status, somatic growth, and health-related quality of life after a 12-month observation. At 3 months, the absolute changes in ventricular function were significantly greater in the CDC-treated group than in the controls (+6.4% [SD, 5.5] versus +1.3% [SD, 3.7]; P=0.003). In study B, a late CDC infusion in 17 controls increased the ventricular function at 3 months compared with that at baseline (38.8% [SD, 7.7] versus 34.8% [SD, 7.4]; P<0.0001). At 1 year, overall CDC infusion was associated with improved ventricular function (41.4% [SD, 6.6] versus 35.0% [SD, 8.2]; P<0.0001) and volumes (P<0.001), somatic growth (P<0.0001) with increased trophic factors production, such as insulin-like growth factor-1 and hepatocyte growth factor, and quality of life, along with a reduced heart failure status (P<0.0001) and cardiac fibrosis (P=0.014) relative to baseline. CONCLUSIONS: Intracoronary infusion of CDCs after staged palliation favorably affected cardiac function by reverse remodeling in patients with single ventricle physiology. This impact may improve heart failure status, somatic growth, and quality of life in patients and reduce parenting stress for their families. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01829750.

DOI： 10.1161/CIRCRESAHA.116.310253

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Onset of polyarticular juvenile idiopathic arthritis with both anti-cyclic citrullinated peptide antibodies and rheumatoid factor in a 3-year-old girl. Reviewed International journal

Kozo Yasui, Sonoko Sakata, Hideaki Ochi, Shinji Itamura, Kenta Hirai, Mieko Takenaka, Osamu Mitani, Kazunori Ogawa, Kuniaki Iyoda

Pediatric rheumatology online journal 10 ( 1 ) 41 - 41 2012.12

Language：English Publishing type：Research paper (scientific journal)

This report describes 3 year old girl with the unusual presentation of polyarticular juvenile idiopathic arthritis (JIA) with anti-cyclic citrullinated peptide (anti-CCP) antibodies and a positive rheumatoid factor (RF). She was initially treated with a nonsteroidal anti-inflammatory drug (NSAID; ibuprofen) followed by methotrexate (MTX, 10 mg/m2/week) and prednisolone (0.25 mg/kg/day), but these treatments were ineffective. Administration of tocilizumab, a humanized antihuman interleukin-6 receptor monoclonal antibody, promptly improved her clinical manifestations, and she has been in complete remission (DAS28 <2.6) without bone erosion and/or destruction. Positivity for both antibodies (anti-CCP and RF) can forecast the severity of JIA (radiographic bone destruction). In such cases the administration of biologic remissive therapy may be prudent early in the disease course.

DOI： 10.1186/1546-0096-10-41

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Papers - Hirai Kenta