start-ver=1.4
cd-journal=joma
no-vol=
cd-vols=
no-issue=
article-no=
start-page=
end-page=
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2025
dt-pub=20250506
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Outcomes of ultra-high-pressure balloon angioplasty for congenital heart disease in single-center experience
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=Angioplasty using ultra-high-pressure (UHP) balloons may successfully treat stenotic lesions refractory to high-pressure dilation. The use of UHP balloons in patients with congenital heart disease is mostly for dilation of the pulmonary artery, and there have been few reports on the effectiveness and safety of balloons for other sites. We retrospectively evaluated the efficacy and safety of the ultra-high-pressure balloon angioplasty (UHP-BA) for stenotic lesions in patients with congenital heart disease between January 2020 and December 2022 at Okayama University Hospital. A total of 78 UHP-BAs were performed in 44 patients, with a median age of 6.6 years and a median weight of 17.6 kg. The balloon types used in the UHP-BAs were Yoroi? and Conquest?. UHP-BA performed 39 procedures for the pulmonary artery (PA), 24 for fenestration, 8 for SVC, 4 for shunt, and three for others. The lesion-specific acute procedural success rates for PA, Fontan fenestration, SVC, and shunt were 77%, 75%, 88%, and 75%, respectively. A complication of UHP-BA occurred in 3.8% (3/78). Two of the three patients had pulmonary hemorrhage, and the remaining patients had pulmonary artery embolization due to the migration of a thrombus. There were no fatal complications. Balloon dilation with UHP balloons was safe and effective not only for pulmonary artery stenotic lesions but also for SVC, Fontan fenestration, shunt, and other dilation sites in patients with congenital heart disease.
en-copyright=
kn-copyright=
en-aut-name=KondoMaiko
en-aut-sei=Kondo
en-aut-mei=Maiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=KuritaYoshihiko
en-aut-sei=Kurita
en-aut-mei=Yoshihiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=FukushimaYosuke
en-aut-sei=Fukushima
en-aut-mei=Yosuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=ShigemitsuYusuke
en-aut-sei=Shigemitsu
en-aut-mei=Yusuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=HiraiKenta
en-aut-sei=Hirai
en-aut-mei=Kenta
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=KawamotoYuya
en-aut-sei=Kawamoto
en-aut-mei=Yuya
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=HaraMayuko
en-aut-sei=Hara
en-aut-mei=Mayuko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=KanazawaTomoyuki
en-aut-sei=Kanazawa
en-aut-mei=Tomoyuki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=IwasakiTatsuo
en-aut-sei=Iwasaki
en-aut-mei=Tatsuo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=KotaniYasuhiro
en-aut-sei=Kotani
en-aut-mei=Yasuhiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=KasaharaShingo
en-aut-sei=Kasahara
en-aut-mei=Shingo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=TsukaharaHirokazu
en-aut-sei=Tsukahara
en-aut-mei=Hirokazu
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
en-aut-name=BabaKenji
en-aut-sei=Baba
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=13
ORCID=
affil-num=1
en-affil=Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
kn-affil=
affil-num=2
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=3
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=4
en-affil=Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
kn-affil=
affil-num=5
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=6
en-affil=Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
kn-affil=
affil-num=7
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=8
en-affil=Department of Pediatric Anesthesiology, Okayama University Hospital
kn-affil=
affil-num=9
en-affil=Department of Pediatric Anesthesiology, Okayama University Hospital
kn-affil=
affil-num=10
en-affil=Department of Cardiovascular Surgery, Okayama University Hospital
kn-affil=
affil-num=11
en-affil=Department of Cardiovascular Surgery, Okayama University Hospital
kn-affil=
affil-num=12
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=13
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
en-keyword=Ultra-high-pressure balloon
kn-keyword=Ultra-high-pressure balloon
en-keyword=Balloon angioplasty
kn-keyword=Balloon angioplasty
en-keyword=Congenital heart disease
kn-keyword=Congenital heart disease
END
start-ver=1.4
cd-journal=joma
no-vol=13
cd-vols=
no-issue=22
article-no=
start-page=e038137
end-page=
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2024
dt-pub=20241119
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Eight-Year Outcomes of Cardiosphere-Derived Cells in Single Ventricle Congenital Heart Disease
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=Background: Cardiosphere]derived cell (CDC) infusion was associated with better clinical outcomes at 2?years in patients with single ventricle heart disease. The current study investigates time]to]event outcomes at 8?years.
Methods and Results: This cohort enrolled patients with single ventricles who underwent stage 2 or stage 3 palliation from January 2011 to January 2015 at 8 centers in Japan. The primary outcomes were time]dependent CDC treatment effects on death and late complications during 8?years of follow]up, assessed by restricted mean survival time. Among 93 patients enrolled (mean age, 2.3}1.3?years; 56% men), 40 received CDC infusion. Overall survival for CDC]treated versus control patients did not differ at 8?years (hazard ratio [HR], 0.60 [95% CI, 0.21?1.77]; P=0.35). Treatment effect had nonproportional hazards for death favoring CDCs at 4?years (restricted mean survival time difference +0.33?years [95% CI, 0.01?0.66]; P=0.043). In patients with heart failure with reduced ejection fraction, CDC treatment effect on survival was greater over 8?years (restricted mean survival time difference +1.58?years [95% CI, 0.05?3.12]; P=0.043). Compared with control participants, CDC]treated patients showed lower incidences of late failure (HR, 0.45 [95% CI, 0.21?0.93]; P=0.027) and adverse events (subdistribution HR, 0.50 [95% CI, 0.27?0.94]; P=0.036) at 8?years.
Conclusions: By 8?years, CDC infusion was associated with lower hazards of late failure and adverse events in single ventricle heart disease. CDC treatment effect on survival was notable by 4?years and showed a durable clinical benefit in patients with heart failure with reduced ejection fraction over 8?years.
Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01273857 and NCT01829750.
en-copyright=
kn-copyright=
en-aut-name=HiraiKenta
en-aut-sei=Hirai
en-aut-mei=Kenta
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=SawadaRyusuke
en-aut-sei=Sawada
en-aut-mei=Ryusuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=HayashiTomohiro
en-aut-sei=Hayashi
en-aut-mei=Tomohiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=ArakiToru
en-aut-sei=Araki
en-aut-mei=Toru
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=NakagawaNaomi
en-aut-sei=Nakagawa
en-aut-mei=Naomi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=KondoMaiko
en-aut-sei=Kondo
en-aut-mei=Maiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=YasudaKenji
en-aut-sei=Yasuda
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=HirataTakuya
en-aut-sei=Hirata
en-aut-mei=Takuya
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=SatoTomoyuki
en-aut-sei=Sato
en-aut-mei=Tomoyuki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=NakatsukaYuki
en-aut-sei=Nakatsuka
en-aut-mei=Yuki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=YoshidaMichihiro
en-aut-sei=Yoshida
en-aut-mei=Michihiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=KasaharaShingo
en-aut-sei=Kasahara
en-aut-mei=Shingo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
en-aut-name=BabaKenji
en-aut-sei=Baba
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=13
ORCID=
en-aut-name=OhHidemasa
en-aut-sei=Oh
en-aut-mei=Hidemasa
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=14
ORCID=
en-aut-name=the TICAP/PERSEUS Study Group
en-aut-sei=the TICAP/PERSEUS Study Group
en-aut-mei=
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=15
ORCID=
affil-num=1
en-affil=Department of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=2
en-affil=Department of Pharmacology Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=3
en-affil=Department of Pediatrics Kurashiki Central Hospital
kn-affil=
affil-num=4
en-affil=Department of Pediatrics National Hospital Organization Fukuyama Medical Center
kn-affil=
affil-num=5
en-affil=Department of Pediatric Cardiology Hiroshima City Hiroshima Citizens Hospital
kn-affil=
affil-num=6
en-affil=Department of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=7
en-affil=Department of Pediatrics Shimane University Faculty of Medicine
kn-affil=
affil-num=8
en-affil=Department of Pediatrics Kyoto University Graduate School of Medicine
kn-affil=
affil-num=9
en-affil=Department of Pediatrics Jichi Medical University
kn-affil=
affil-num=10
en-affil=Department of Data Science, Center for Innovative Clinical Medicine Okayama University Hospital
kn-affil=
affil-num=11
en-affil=Department of Data Science, Center for Innovative Clinical Medicine Okayama University Hospital
kn-affil=
affil-num=12
en-affil=Department of Cardiovascular Surgery Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=13
en-affil=Department of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=14
en-affil=Department of Regenerative Medicine, Center for Innovative Clinical Medicine Okayama University Hospital
kn-affil=
affil-num=15
en-affil=
kn-affil=
en-keyword=cardiosphere
kn-keyword=cardiosphere
en-keyword=heart failure
kn-keyword=heart failure
en-keyword=restricted mean survival time
kn-keyword=restricted mean survival time
en-keyword=single ventricle
kn-keyword=single ventricle
en-keyword=survival
kn-keyword=survival
END
start-ver=1.4
cd-journal=joma
no-vol=
cd-vols=
no-issue=
article-no=
start-page=
end-page=
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2024
dt-pub=20240719
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Pulmonary Flow Management by Combination Therapy of Hemostatic Clipping and Balloon Angioplasty for Right Ventricular-Pulmonary Artery Shunt in Hypoplastic Left Heart Syndrome
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=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.
en-copyright=
kn-copyright=
en-aut-name=ShigemitsuYusuke
en-aut-sei=Shigemitsu
en-aut-mei=Yusuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=KondoMaiko
en-aut-sei=Kondo
en-aut-mei=Maiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=KuritaYoshihiko
en-aut-sei=Kurita
en-aut-mei=Yoshihiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=FukushimaYosuke
en-aut-sei=Fukushima
en-aut-mei=Yosuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=KawamotoYuya
en-aut-sei=Kawamoto
en-aut-mei=Yuya
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=HiraiKenta
en-aut-sei=Hirai
en-aut-mei=Kenta
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=HaraMayuko
en-aut-sei=Hara
en-aut-mei=Mayuko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=KanazawaTomoyuki
en-aut-sei=Kanazawa
en-aut-mei=Tomoyuki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=IwasakiTatsuo
en-aut-sei=Iwasaki
en-aut-mei=Tatsuo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=KasaharaShingo
en-aut-sei=Kasahara
en-aut-mei=Shingo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=KataokaKoichi
en-aut-sei=Kataoka
en-aut-mei=Koichi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=TsukaharaHirokazu
en-aut-sei=Tsukahara
en-aut-mei=Hirokazu
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
en-aut-name=BabaKenji
en-aut-sei=Baba
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=13
ORCID=
affil-num=1
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=2
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=3
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=4
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=5
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=6
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=7
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=8
en-affil=Department of Pediatric Anesthesiology, Okayama University Hospital
kn-affil=
affil-num=9
en-affil=Department of Pediatric Anesthesiology, Okayama University Hospital
kn-affil=
affil-num=10
en-affil=Department of Pediatric Anesthesiology, Okayama University Hospital
kn-affil=
affil-num=11
en-affil=Department of Cardiovascular Surgery, Okayama University Hospital
kn-affil=
affil-num=12
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
affil-num=13
en-affil=Department of Pediatrics, Okayama University Hospital
kn-affil=
en-keyword=Hypoplastic left heart syndrome
kn-keyword=Hypoplastic left heart syndrome
en-keyword=Norwood palliation
kn-keyword=Norwood palliation
en-keyword=Balloon angioplasty
kn-keyword=Balloon angioplasty
en-keyword=Congenital heart disease
kn-keyword=Congenital heart disease
END
start-ver=1.4
cd-journal=joma
no-vol=12
cd-vols=
no-issue=573
article-no=
start-page=eabb3336
end-page=
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2020
dt-pub=20201209
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Cardiosphere-derived exosomal microRNAs for myocardial repair in pediatric dilated cardiomyopathy
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=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.
en-copyright=
kn-copyright=
en-aut-name=HiraiKenta
en-aut-sei=Hirai
en-aut-mei=Kenta
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=OusakaDaiki
en-aut-sei=Ousaka
en-aut-mei=Daiki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=FukushimaYosuke
en-aut-sei=Fukushima
en-aut-mei=Yosuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=KondoMaiko
en-aut-sei=Kondo
en-aut-mei=Maiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=EitokuTakahiro
en-aut-sei=Eitoku
en-aut-mei=Takahiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=ShigemitsuYusuke
en-aut-sei=Shigemitsu
en-aut-mei=Yusuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=HaraMayuko
en-aut-sei=Hara
en-aut-mei=Mayuko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=BabaKenji
en-aut-sei=Baba
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=IwasakiTatsuo
en-aut-sei=Iwasaki
en-aut-mei=Tatsuo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=KasaharaShingo
en-aut-sei=Kasahara
en-aut-mei=Shingo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=OhtsukiShinichi
en-aut-sei=Ohtsuki
en-aut-mei=Shinichi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=OhHidemasa
en-aut-sei=Oh
en-aut-mei=Hidemasa
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
affil-num=1
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=2
en-affil=Department of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=3
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=4
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=5
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=6
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=7
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=8
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=9
en-affil=Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=10
en-affil=Department of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=11
en-affil=Department of Pediatric Cardiology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=12
en-affil=Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital
kn-affil=
END
start-ver=1.4
cd-journal=joma
no-vol=116
cd-vols=
no-issue=4
article-no=
start-page=653
end-page=664
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2015
dt-pub=201502
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Intracoronary Autologous Cardiac Progenitor Cell Transfer in Patients With Hypoplastic Left Heart Syndrome (TICAP) : A Prospective Phase 1 Controlled Trial
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract= RATIONALE:
Hypoplastic left heart syndrome (HLHS) remains a lethal congenital cardiac defect. Recent studies have suggested that intracoronary administration of autologous cardiosphere-derived cells (CDCs) may improve ventricular function.
OBJECTIVE:
The aim of this study was to test whether intracoronary delivery of CDCs is feasible and safe in patients with hypoplastic left heart syndrome.
METHODS AND RESULTS:
Between January 5, 2011, and January 16, 2012, 14 patients (1.8}1.5 years) were prospectively assigned to receive intracoronary infusion of autologous CDCs 33.4}8.1 days after staged procedures (n=7), followed by 7 controls with standard palliation alone. The primary end point was to assess the safety, and the secondary end point included the preliminary efficacy to verify the right ventricular ejection fraction improvements between baseline and 3 months. Manufacturing and intracoronary delivery of CDCs were feasible, and no serious adverse events were reported within the 18-month follow-up. Patients treated with CDCs showed right ventricular ejection fraction improvement from baseline to 3-month follow-up (46.9%}4.6% to 52.1%}2.4%; P=0.008). Compared with controls at 18 months, cardiac MRI analysis of CDC-treated patients showed a higher right ventricular ejection fraction (31.5%}6.8% versus 40.4%}7.6%; P=0.049), improved somatic growth (P=0.0005), reduced heart failure status (P=0.003), and lower incidence of coil occlusion for collaterals (P=0.007).
CONCLUSIONS:
Intracoronary infusion of autologous CDCs seems to be feasible and safe in children with hypoplastic left heart syndrome after staged surgery. Large phase 2 trials are warranted to examine the potential effects of cardiac function improvements and the long-term benefits of clinical outcomes.
en-copyright=
kn-copyright=
en-aut-name=IshigamiShuta
en-aut-sei=Ishigami
en-aut-mei=Shuta
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=OhtsukiShinichi
en-aut-sei=Ohtsuki
en-aut-mei=Shinichi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=TaruiSuguru
en-aut-sei=Tarui
en-aut-mei=Suguru
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=OusakaDaiki
en-aut-sei=Ousaka
en-aut-mei=Daiki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=EitokuTakahiro
en-aut-sei=Eitoku
en-aut-mei=Takahiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=KondoMaiko
en-aut-sei=Kondo
en-aut-mei=Maiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=OkuyamaMichihiro
en-aut-sei=Okuyama
en-aut-mei=Michihiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=KobayashiJunko
en-aut-sei=Kobayashi
en-aut-mei=Junko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=BabaKenji
en-aut-sei=Baba
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=AraiSadahiko
en-aut-sei=Arai
en-aut-mei=Sadahiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=KawabataTakuya
en-aut-sei=Kawabata
en-aut-mei=Takuya
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=YoshizumiKo
en-aut-sei=Yoshizumi
en-aut-mei=Ko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
en-aut-name=TateishiAtsushi
en-aut-sei=Tateishi
en-aut-mei=Atsushi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=13
ORCID=
en-aut-name=KurokoYosuke
en-aut-sei=Kuroko
en-aut-mei=Yosuke
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=14
ORCID=
en-aut-name=IwasakiTatsuo
en-aut-sei=Iwasaki
en-aut-mei=Tatsuo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=15
ORCID=
en-aut-name=SatoShuhei
en-aut-sei=Sato
en-aut-mei=Shuhei
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=16
ORCID=
en-aut-name=KasaharaShingo
en-aut-sei=Kasahara
en-aut-mei=Shingo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=17
ORCID=
en-aut-name=SanoShunji
en-aut-sei=Sano
en-aut-mei=Shunji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=18
ORCID=
en-aut-name=OhHidemasa
en-aut-sei=Oh
en-aut-mei=Hidemasa
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=19
ORCID=
affil-num=1
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=2
en-affil=Departments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=3
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=4
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=5
en-affil=Departments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=6
en-affil=Departments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=7
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=8
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=9
en-affil=Departments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=10
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=11
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=12
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=13
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=14
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=15
en-affil=Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=16
en-affil=Department of Radilogy, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=17
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=18
en-affil=Departments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=19
en-affil=Department of Regeneraive Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital
kn-affil=
en-keyword=cell therapy
kn-keyword=cell therapy
en-keyword=congenital heart disease
kn-keyword=congenital heart disease
en-keyword=hypoplastic left heart syndrome
kn-keyword=hypoplastic left heart syndrome
en-keyword=stem cells
kn-keyword=stem cells
END
start-ver=1.4
cd-journal=joma
no-vol=81
cd-vols=
no-issue=5
article-no=
start-page=837
end-page=842
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2013
dt-pub=201304
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Usefulness of balloon angioplasty for the right ventricle-pulmonary artery shunt with the modified norwood procedure
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=Objective We sought to evaluate the efficacy of balloon angioplasty (BA) for severely desaturated patients due to a stenotic right ventricle (RV) to pulmonary artery (PA) shunt following modified Norwood procedure. Methods Of 87 patients who underwent a Norwood procedure with the RV-PA shunt between February 1998 through March 2010, 22 (25%) patients underwent BA. The efficacy of BA was assessed by angiographic measurement of the changes in the internal diameters of the stenotic portions of the shunt, changes in arterial saturation and clinical outcomes. Results BA was performed for stenotic RV-PA shunts following stage I palliation (n = 17, 77%), or those placed as an additional blood source (n = 5, 23%, 3 patients awaiting biventricular repair, 2 patients following stage II palliation). The location of the BA was at the distal anastomosis in 12 (54.5%), proximal anastomosis in 21 (95.4%) and in the mid-portion of the shunt in 11 (50%) cases. The diameters of these three shunt portions were measured from the anteriorposterior and lateral angiographic images, increasing significantly after BA (p < 0.0001) in all. Arterial saturation significantly improved after BA in all cases (66.5 +/- 4.3% to 79.4 +/- 3.4%, p < 0.0001). Freedom from reintervention was 100%. All patients underwent subsequent elective planned surgery at an appropriate age with no mortality. Conclusions A BA-alone strategy for a stenotic RV-PA shunt was effective for all three shunt portions, minimizing shunt-related premature surgical intervention.
en-copyright=
kn-copyright=
en-aut-name=OhnoNaoki
en-aut-sei=Ohno
en-aut-mei=Naoki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=OhtsukiShinichi
en-aut-sei=Ohtsuki
en-aut-mei=Shinichi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=KataokaKoichi
en-aut-sei=Kataoka
en-aut-mei=Koichi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=BabaKenji
en-aut-sei=Baba
en-aut-mei=Kenji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=OkamotoYoshio
en-aut-sei=Okamoto
en-aut-mei=Yoshio
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=KondoMaiko
en-aut-sei=Kondo
en-aut-mei=Maiko
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=SanoShunji
en-aut-sei=Sano
en-aut-mei=Shunji
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=KasaharaShingo
en-aut-sei=Kasahara
en-aut-mei=Shingo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=HonjoOsami
en-aut-sei=Honjo
en-aut-mei=Osami
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=MorishimaTsuneo
en-aut-sei=Morishima
en-aut-mei=Tsuneo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
affil-num=1
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
affil-num=2
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
affil-num=3
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
affil-num=4
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
affil-num=5
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
affil-num=6
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
affil-num=7
en-affil=
kn-affil=Okayama Univ, Dept Cardiovasc Surg, Grad Sch Med Dent & Pharmaceut Sci
affil-num=8
en-affil=
kn-affil=Okayama Univ, Dept Cardiovasc Surg, Grad Sch Med Dent & Pharmaceut Sci
affil-num=9
en-affil=
kn-affil=Okayama Univ, Dept Cardiovasc Surg, Grad Sch Med Dent & Pharmaceut Sci
affil-num=10
en-affil=
kn-affil=Okayama Univ, Dept Pediat, Grad Sch Med Dent & Pharmaceut Sci
en-keyword=balloon angioplasty
kn-keyword=balloon angioplasty
en-keyword=rv-pa shunt
kn-keyword=rv-pa shunt
en-keyword=hypoplastic left heart syndrome
kn-keyword=hypoplastic left heart syndrome
en-keyword=Norwood
kn-keyword=Norwood
END