Lippincott Williams & WilkinsActa Medica Okayama0009733011642015Intracoronary Autologous Cardiac Progenitor Cell Transfer in Patients With Hypoplastic Left Heart Syndrome (TICAP) : A Prospective Phase 1 Controlled Trial653664ENShutaIshigamiDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesShinichiOhtsukiDepartments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesSuguruTaruiDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesDaikiOusakaDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesTakahiroEitokuDepartments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesMaikoKondoDepartments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesMichihiroOkuyamaDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesJunkoKobayashiDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesKenjiBabaDepartments of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesSadahikoAraiDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesTakuyaKawabataDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesKoYoshizumiDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesAtsushiTateishiDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesYosukeKurokoDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesTatsuoIwasakiDepartment of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesShuheiSatoDepartment of Radilogy, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesShingoKasaharaDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesShunjiSanoDepartments of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical SciencesHidemasaOhDepartment of Regeneraive Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital 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.No potential conflict of interest relevant to this article was reported.Acta Medica Okayama1522-19468152013Usefulness of balloon angioplasty for the right ventricle-pulmonary artery shunt with the modified norwood procedure837842ENNaokiOhnoShinichiOhtsukiKoichiKataokaKenjiBabaYoshioOkamotoMaikoKondoShunjiSanoShingoKasaharaOsamiHonjoTsuneoMorishimaObjective 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.No potential conflict of interest relevant to this article was reported.