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CLINICAL RESEARCH: TRANSCATHETER CLOSURE OF CONGENITAL DEFECT

Transcatheter Closure of Perimembranous Ventricular Septal Defects Using the New Amplatzer Membranous VSD Occluder

Results of the U.S. Phase I Trial

Yun-Ching Fu, MD, PhD^_*, John Bass, MD, FACC, Zahid Amin, MD, FACC, Wolfgang Radtke, MD, FACC, John P. Cheatham, MD, FACC^||, William E. Hellenbrand, MD, FACC^¶, David Balzer, MD, FACC^#, Qi-Ling Cao, MD^_* and Ziyad M. Hijazi, MD, MPH, FACC^_*,_*

^_* Section of Pediatric Cardiology, Department of Pediatrics, University of Chicago Comer Children’s Hospital, Pritzker School of Medicine, Chicago, Illinois
Division of Pediatric Cardiology, University of Minnesota, Minneapolis, Minnesota
Joint Division of Pediatric Cardiology, University of Nebraska/Creighton University, Children’s Hospital of Omaha, Omaha, Nebraska
Section of Pediatric Cardiology, MUSC Children’s Hospital, Charleston, South Carolina, and Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania
^|| Section of Pediatric Cardiology, Department of Pediatrics, Columbus Children’s Hospital, Columbus, Ohio
^¶ Section of Pediatric Cardiology, Department of Pediatrics, Columbia University, New York, New York
^# Section of Pediatric Cardiology, Department of Pediatrics, St. Louis Children’s Hospital, St. Louis, Missouri

Manuscript received March 22, 2005; revised manuscript received August 20, 2005, accepted September 8, 2005.

^_* Reprint requests and correspondence: Dr. Ziyad M. Hijazi, Section of Pediatric Cardiology, University of Chicago Comer Children’s Hospital, 5841 South Maryland Avenue, MC4051, Chicago, Illinois 60637. (Email: zhijazi{at}peds.bsd.uchicago.edu).

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.

Abbreviations and Acronyms   AR = aortic regurgitation   ICE = intracardiac echocardiography   PmVSD = perimembranous ventricular septal defect   TEE = transesophageal echocardiography   TTE = transthoracic echocardiography

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