Haddad Raymond N, Khraiche Diala, Bonnet Damien, Meot Mathilde, Malekzadeh-Milani Sophie
M3C-Necker, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Université de Paris, Paris, France.
Front Pediatr. 2021 Mar 11;9:641742. doi: 10.3389/fped.2021.641742. eCollection 2021.
To evaluate safety, efficacy, and technical advantages of Amplatzer™ Trevisio™ intravascular delivery system (ATIDS) in percutaneous atrial septal defect (ASD) closure in children. The Trevisio™ is a novel delivery system designed for accurate and facilitated implantation of Amplatzer™ devices. There are no published clinical reports so far. During September 2020, 9 children with anatomically challenging ASDs underwent attempted transcatheter closure using ATIDS to deliver Amplatzer™ Septal occluders (ASO). All interventions were performed under general anesthesia, trans-esophageal echocardiography (TOE), and fluoroscopic guidance. Standard safety, immediate, and 60-days outcomes were prospectively assessed. The median age was 8.1 (5.1-16.9) years and the median bodyweight was 30 (18-63) kg. Six patients had isolated secundum-type ASDs with absent anterosuperior rims including one with an aneurysmal septum. Three patients had unclassical defects associated with complex congenital heart anomalies. Eight devices were delivered from the femoral vein and the jugular vein was accessed in one patient with interrupted inferior caval vein and azygos continuation. All implantations were successful. The shape, position, and orientation of the ASO were identical before and after release on TOE and fluoroscopy. There was no device embolization or serious complication following closure. Complete shunt closure was confirmed on follow-up. We report the first clinical experience with ATIDS in transcatheter ASD pediatric closures. Safety and efficacy were witnessed in our case-series. The major advantage of reduced-tension deployment and reliable precision in device positioning is highly beneficial in challenging anatomies and unusual access.
评估Amplatzer™ Trevisio™血管内输送系统（ATIDS）在儿童经皮房间隔缺损（ASD）封堵术中的安全性、有效性和技术优势。Trevisio™是一种新型输送系统，专为准确、便捷地植入Amplatzer™装置而设计。目前尚无已发表的临床报告。2020年9月，9例解剖结构具有挑战性的ASD患儿尝试使用ATIDS输送Amplatzer™房间隔封堵器（ASO）进行经导管封堵。所有干预均在全身麻醉、经食管超声心动图（TOE）和荧光透视引导下进行。前瞻性评估标准安全性、即时和60天结局。中位年龄为8.1（5.1 - 16.9）岁，中位体重为30（18 - 63）kg。6例患者为单纯继发孔型ASD，无前上缘，其中1例伴有房间隔瘤。3例患者有与复杂先天性心脏畸形相关的非典型缺损。8枚封堵器经股静脉输送，1例下腔静脉中断、奇静脉延续的患者经颈静脉途径。所有植入均成功。TOE和荧光透视显示，ASO释放前后的形状、位置和方向相同。封堵后无器械栓塞或严重并发症。随访证实分流完全关闭。我们报告了ATIDS在小儿经导管ASD封堵术中的首例临床经验。我们的病例系列证实了其安全性和有效性。在具有挑战性的解剖结构和不寻常的入路中，降低张力释放和可靠的器械定位精度的主要优势非常有益。
