Transcatheter closure of perimembranous ventricular septal defects using the new amplatzer membranous VSD occluder - Results of the US phase I trial

被引:178
作者
Fu, YC
Bass, J
Amin, Z
Radtke, W
Cheatham, JP
Hellenbrand, WE
Balzer, D
Cao, QL
Hijazi, ZM
机构
[1] Univ Chicago, Comer Childrens Hosp, Pediat Cardiol Sect, Dept Pediat,Pritzker Sch Med, Chicago, IL 60637 USA
[2] Univ Minnesota, Div Pediat Cardiol, Minneapolis, MN USA
[3] Univ Nebraska Creighton Univ, Childrens Hosp Omaha, Joint Div Pediat Cardiol, Omaha, NE USA
[4] MUSC Childrens Hosp, Pediat Cardiol Sect, Charleston, SC USA
[5] Childrens Hosp Pittsburgh, Pittsburgh, PA 15213 USA
[6] Columbus Childrens Hosp, Dept Pediat, Pediat Cardiol Sect, Columbus, OH USA
[7] Columbia Univ, Dept Pediat, Pediat Cardiol Sect, New York, NY 10027 USA
[8] St Louis Childrens Hosp, Dept Pediat, Pediat Cardiol Sect, St Louis, MO 63178 USA
关键词
D O I
10.1016/j.jacc.2005.09.028
中图分类号
R5 [内科学];
学科分类号
1002 [临床医学]; 100201 [内科学];
摘要
OBJECTIVES This phase I study attempted to report the initial safety and efficacy results of transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using the new Amplatzer Membranous VSD Occluder (AGA Medical Corp., Golden Valley, Minnesota) in the U.S. BACKGROUND The most common congenital heart disease is PmVSD. Surgical repair is widely accepted, but still carries a small but definite risk of morbidity and mortality. METHODS Between October 2003 and August 2004, a total of 35 patients with PmVSD underwent an attempt of transcatheter closure under transesophageal and/or intracardiac echocardiographic guidance. The median age was 7.7 years (range, 1.2 to 54.4 years) and median weight was 25 kg (range, 8.3 to 110 kg). The median Qp/Qs ratio was 1.8 (range, 1 to 4), and the median VSD size as assessed by echocardiography was 7 mm (range, 4 to 15 mm). RESULTS The attempt to place a device was successful in 32 patients (91%). The median device size used was 10 mm (range, 6 to 16 mm). The Complete Closure rates by echocardiography at 10 min (transesophageal/intracardiac), 24 h, 1 month, and 6 months (transthoracic) were 47% (15/32), 63% (20/32), 78% (25/32), and 96% (27/28), respectively. The median fluoroscopy time was 36 min (range, 14 to 191 min), and the median total procedure time was 121 min (range, 67 to 276 min). Three patients (8.6%) had serious adverse events of complete heart block, peri-hepatic bleeding, and rupture of tricuspid valve chordae tendineae. No other patient encountered serious adverse events during the follow-up. CONCLUSIONS Transcatheter closure of a PmVSD is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials to assess the long-term safety and efficacy.
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页码:319 / 325
页数:7
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