Castaldi Biagio, Cuppini Elena, Sirico Domenico, Cattapan Irene, Fumanelli Jennifer, Pozza Alice, Di Salvo Giovanni
Department for Women's and Children's Health, University Hospital of Padova, Pediatric and Congenital Cardiology Unit, Via Nicolò Giustiniani 2, 35128 Padova, Italy.
J Soc Cardiovasc Angiogr Interv. 2023 Dec 4;2(6Part B):101209. doi: 10.1016/j.jscai.2023.101209. eCollection 2023 Nov-Dec.
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.
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 × cm.
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.
AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.
心房血流调节器（AFR；Occlutech公司）可用于在各种病理生理情况下创建具有预定直径的房间隔交通。在儿科人群中，相关经验仅限于少数病例报告。我们旨在报告儿童先天性和后天性心脏病患者植入AFR的单中心初步经验。
2021年12月至2023年6月，我们纳入了10例患者（年龄6个月至16岁）。治疗指征为：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岁儿童法洛四联症手术修复术后右心室功能障碍（n = 1）以及功能性单心室（n = 1）。所有患者均成功植入AFR。8例患者需要经房间隔穿刺；另外2例患者利用了现有的卵圆孔未闭和多孔房间隔缺损。9例患者进行了球囊预扩张。所有病例均植入8毫米装置。手术平均时间为50分钟，透视时间中位数为17分钟，辐射暴露剂量中位数为2.3 Gy×cm。
手术过程中未报告并发症。3例患者在随访期间死亡：1例死于败血症（术后16天），1例死于疾病进展（术后8个月），1例死于心房减压术后7天体外膜肺氧合（ECMO）撤管失败。在其余患者中，观察到左心房扩张、毛细血管后肺动脉高压和心力衰竭症状有所减轻。
AFR在儿童及危急情况下是安全可行的，可减轻右/左心腔负荷，改善血流动力学和症状。
