PDF(Pubmed)
Abstract：
UNASSIGNED: The Atrial Flow Regulator (AFR; Occlutech) can be used to create interatrial communication with a predetermined diameter in various pathophysiological settings. In the pediatric population, the experience is limited to a few case reports. We aim to report the initial single-center experience of AFR implantation in children with congenital and acquired heart disease.
UNASSIGNED: From December 2021 to June 2023, we enrolled 10 patients (aged 6 months-16 years). Indications to treatment were: left ventricular systolic dysfunction (n = 6), restrictive cardiomyopathy with pulmonary hypertension (n = 2), postoperative right ventricle dysfunction after surgical repair of a native Tetralogy of Fallot in a 12-year-old child (n = 1), and failure Fontan (n = 1). AFR implantation was successfully performed in all patients. Transseptal puncture was needed in 8 cases; in the other 2 cases, preexisting patent foramen ovale and fenestrated atrial septal defect were used. Balloon predilation was performed in 9 cases. An 8 mm device was implanted in all cases. The mean time of the procedure was 50 minutes, the median fluoroscopy time was 17 minutes, and median radiation exposure dose was 2.3 Gy × cm2.
UNASSIGNED: No complications were reported during the procedure. Three patients died during the follow-up: 1 due to sepsis (16 days after the procedure), 1 due to disease progression (8 months after), and 1 due to failure of ECMO decannulation 7 days after the atrial venting. In the remaining patients, a reduction of LA dilation, postcapillary pulmonary hypertension, and heart failure symptoms were observed.
UNASSIGNED: AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.
UNASSIGNED: From December 2021 to June 2023, we enrolled 10 patients (aged 6 months-16 years). Indications to treatment were: left ventricular systolic dysfunction (n = 6), restrictive cardiomyopathy with pulmonary hypertension (n = 2), postoperative right ventricle dysfunction after surgical repair of a native Tetralogy of Fallot in a 12-year-old child (n = 1), and failure Fontan (n = 1). AFR implantation was successfully performed in all patients. Transseptal puncture was needed in 8 cases; in the other 2 cases, preexisting patent foramen ovale and fenestrated atrial septal defect were used. Balloon predilation was performed in 9 cases. An 8 mm device was implanted in all cases. The mean time of the procedure was 50 minutes, the median fluoroscopy time was 17 minutes, and median radiation exposure dose was 2.3 Gy × cm2.
UNASSIGNED: No complications were reported during the procedure. Three patients died during the follow-up: 1 due to sepsis (16 days after the procedure), 1 due to disease progression (8 months after), and 1 due to failure of ECMO decannulation 7 days after the atrial venting. In the remaining patients, a reduction of LA dilation, postcapillary pulmonary hypertension, and heart failure symptoms were observed.
UNASSIGNED: AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.
摘要：
■心房流量调节器（AFR;Occlutech）可用于在各种病理生理设置中创建具有预定直径的心房连通。在儿科人群中，经验仅限于少数病例报告。我们旨在报告先天性和后天性心脏病患儿AFR植入的初始单中心经验。
■从2021年12月到2023年6月，我们招募了10名患者（年龄6个月-16岁）。治疗适应症为：左心室收缩功能障碍（n=6），限制性心肌病伴肺动脉高压（n=2），一名12岁儿童（n=1）的原发性法洛四联症手术修复后右心室功能障碍，和失败Fontan(n=1)。所有患者均成功进行了AFR植入。8例需要进行房间隔穿刺；在其他2例中，使用先前存在的卵圆孔未闭和有孔的房间隔缺损。9例进行了球囊预扩张。在所有情况下植入8mm装置。手术的平均时间是50分钟,中位透视时间为17分钟,中位辐射暴露剂量为2.3Gy×cm2。
■术中无并发症报告。3例患者在随访期间死亡：1例由于败血症（手术后16天），1由于疾病进展（8个月后），1是由于心房通气后7天ECMO拔管失败。在剩下的病人中，LA扩张的减少，毛细血管后肺动脉高压，观察心力衰竭症状。
■AFR在儿童和危重环境中是安全可行的，允许右/左腔卸载和改善血流动力学和症状。
■从2021年12月到2023年6月，我们招募了10名患者（年龄6个月-16岁）。治疗适应症为：左心室收缩功能障碍（n=6），限制性心肌病伴肺动脉高压（n=2），一名12岁儿童（n=1）的原发性法洛四联症手术修复后右心室功能障碍，和失败Fontan(n=1)。所有患者均成功进行了AFR植入。8例需要进行房间隔穿刺；在其他2例中，使用先前存在的卵圆孔未闭和有孔的房间隔缺损。9例进行了球囊预扩张。在所有情况下植入8mm装置。手术的平均时间是50分钟,中位透视时间为17分钟,中位辐射暴露剂量为2.3Gy×cm2。
■术中无并发症报告。3例患者在随访期间死亡：1例由于败血症（手术后16天），1由于疾病进展（8个月后），1是由于心房通气后7天ECMO拔管失败。在剩下的病人中，LA扩张的减少，毛细血管后肺动脉高压，观察心力衰竭症状。
■AFR在儿童和危重环境中是安全可行的，允许右/左腔卸载和改善血流动力学和症状。
