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CLINICAL RESEARCH: CONGENITAL HEART DISEASE

Device Closure Rates of Simple Atrial Septal Defects Optimized by the STARFlex Device

Department of Cardiology, Children’s Hospital Boston, and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.

Manuscript received October 25, 2005; revised manuscript received March 7, 2006, accepted March 16, 2006.

^_* Reprint requests and correspondence: Dr. Alan W. Nugent, Children’s Hospital Heart Center, 6621 Fannin MC 19345-C, Houston, Texas 77030-2399. (Email: awnugent{at}texaschildrenshospital.org).

OBJECTIVES: This study sought to review the outcomes of 3 generations of closure devices for secundum atrial septal defects (ASDs) at a single institution.

BACKGROUND: Transcatheter closure of ASDs is now increasingly performed with devices that have been modified over time to improve performance.

METHODS: A review of prospective clinical trials of Clamshell (C.R. Bard Inc., Murray Hill, New Jersey), CardioSEAL (NMT Medical Inc., Boston, Massachusetts), and STARFlex (NMT Medical Inc.) closure devices for simple ASDs was performed. The entry criteria for these trials were age 2 years, isolated secundum ASD, evidence of right ventricular volume overload, and maximum stretched diameter varying from 20 to 25 mm. Successful outcomes were defined as no more than small residual leak (2 mm) with absence of a severe complication or the need for an additional device or surgery.

RESULTS: A total of 72 Clamshell, 30 CardioSEAL, and 42 STARFlex devices were placed in uncomplicated ASDs. Each device modification resulted in improved closure rates, with the STARFlex device achieving a 93% complete closure rate with a device/stretched diameter ratio significantly smaller than with the other devices (p = 0.001). Severe complications occurred in 5 Clamshell, 1 CardioSEAL, and 0 STARFlex cases. Successful outcomes increased for each generation of device (79%, 93%, and 98% respectively, p = 0.009). There have been no long-term complications for either the CardioSEAL or the STARFlex devices.

CONCLUSIONS: Modifications in 3 generations of devices have resulted in improved results for percutaneous ASD closure.

Abbreviations and Acronyms   ASD = atrial septal defect   TEE = transesophageal echocardiogram   TTE = transthoracic echocardiogram

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