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(Circulation. 1999;100:320-328.)
© 1999 American Heart Association, Inc.

Basic Science Reports

New Device for Closure of Muscular Ventricular Septal Defects in a Canine Model

Presented at the 70th Scientific Sessions of the American Heart Association, November 9–12, 1997, and published in abstract form (Circulation. 1997;96[suppl I]:I-373).

Zahid Amin, MD; Xiaoping Gu, MD; James M. Berry, RDMS; John L. Bass, MD; Jack L. Titus, MD; Myra Urness, MS; Young-Min Han, MD; Kurt Amplatz, MD

From the Department of Cardiology, Northwestern University, Children's Memorial Medical Center, Chicago, Ill (Z.A.), and the Department of Cardiovascular Radiology, Pathology and Pediatric Cardiology, University of Minnesota, Minneapolis, Minn (X.G., J.M.B., J.L.B., J.L.T., M.U., Y.-M.H., K.A.).

Correspondence to Zahid Amin, MD, Medical College of Georgia, Division of Pediatric Cardiology, 1120 15th St, BAA 800 W, Augusta, GA 30912. E-mail zamin{at}mail.mcg.edu

Background—Repair of muscular ventricular septal defects (MVSDs) has always been challenging to the surgeon. Long-term morbidity and mortality are significantly increased if the defects are closed via left ventriculotomy or if they are associated with other complex congenital anomalies. The purpose of this study was to close MVSDs with the Amplatz ventricular septal defect device. This device is constructed from 0.004-in nitinol wire mesh filled with polyester fibers. It is retrievable, repositionable, self-centering, and of low profile.

Methods and Results—MVSDs were created with the help of a sharp punch in 10 dogs. The location of the defects was anterior muscular (n=3), midmuscular (n=3), apical (n=3), and inlet muscular (n=1). The diameter of the defects ranged from 6 to 14 mm. All defects were closed in the catheterization laboratory. The device was placed with the help of transesophageal echocardiography and fluoroscopy. A 7F sheath was used to deploy the device from the right ventricular side in 8 and the left ventricular side in 2 dogs. Placement was successful in all animals. The complete closure rate was 30% (3/10) immediately after placement and 100% at 1-week follow-up. Pathological examination of the heart revealed complete endothelialization of the device in dogs killed after 3 months.

Conclusions—The Amplatz ventricular septal defect device appears highly efficacious in closing MVSDs. The advantages include a small delivery sheath, complete retrievability before release, and the fact that it is self-centering and self-expanding, thereby making it an attractive option in smaller children.

Key Words: catheterization • heart defects, congenital • heart septal defects • surgery

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