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?