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J Thorac Cardiovasc Surg 2009;137:1339-1341
© 2009 The American Association for Thoracic Surgery

Invited Commentary

Discussion

The first 300 words of the full text of this article appear below.

Dr Carl L. Backer (Chicago, Ill). I want to congratulate Dr DiBardino and colleagues at Children's Hospital Boston for their very clever idea of mining the MAUDE database to determine the incidence of adverse events involving the Amplatzer septal occluder device. I first became aware of this database at the AATS in Toronto in 2004 when Richard Jonas debated Andrew Reddington about this very topic. A brief look at that MAUDE database is quite an eye-opener.

This is a very timely presentation and an important analysis. The issue of device closure was the first paper at the STS in the Plenary Session this year. In that paper, Dr Tara Karamlou also mined a database, the Nationwide Inpatient Sample and ICD-9 procedure and diagnosis codes. She discovered an increased incidence of ASD closure mostly due to a sudden and dramatic rise in percutaneous closure beginning in the year 2001.

The comparison of the MAUDE database to the STS database clearly demonstrates the importance of our own congenital database. When I debated this topic at the ACC 3 years ago, the cardiologists complained that there is no MAUDE database for surgeons. The STS database is our answer to that issue.

I have three questions for you, and they relate to your numerator and your denominator.

My first question relates to the numerator in your analysis. There were 223 adverse events and 17 deaths related to the Amplatzer device. At the AATS meeting in 2006, when we had a similar discussion, I asked this audience how many people had taken Amplatzer devices out of various parts of the body; nearly everyone in the room raised their hand. Is it possible that the MAUDE database might only be capturing the tip of the iceberg, and how confident are you in your numerator?

Dr . . . [Full Text of this Article]






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