Rebuttal: Response to a letter about the cardioseal device

Abstract

Rebuttal: Response to a Letter About the CardioSeal Device TO THE EDITOR I welcome this controversy from my esteemed colleagues. As members of the Editorial Board for Catheterization and Cardiovascular Interventions, we are asked to provide editorials that demonstrate our opinion about a topic raised by the articles published. The purpose is to flush out the details and nuances beyond the data that can be described in a paper.My observation is that interventional cardiologists are not preselected for timid qualities. The authors of these letters have strong opinions about the devices described for ASD or PFO closure. As an experienced operator, I have my own opinions which I expressed in the editorial, suggesting that, ''The CardioSeal/Starflex device should be graciously retired.'' I'm glad to see that my comments stimulated this discussion. It raises questions that all operators can think about when they are trying to decide what equipment is best for their patients.Perhaps I was too subtle in my editorial so that my friends who wrote these letters did not completely understand my points. Let me summarize them here:1. The CardioSeal/Starflex device is not an adequate self centering device and is not an optimal ASD closure device. In most operators' experience, the Amplatzer device is much more effective for closing ASDs. 2. As for closure of PFOs, all of the devices are being used off label without FDA approval. We should make every effort to enroll appropriate patients in the randomized trials for stroke or migraine. 3. There is a 20% incidence of thrombus on the CardioSeal device at 2-4 weeks post implantation. 4. There is a 3% stroke or embolic event rate when the CardioSeal is used for PFO closures. Perhaps some of these emboli are due to atherosclerotic disease, perhaps not. It is impossible to know, but the fact that there is a high frequency of documented thrombus on the device makes me more suspicious that the device is the source of emboli rather than the ascending aorta. 5. The CardioSeal/Starflex is a poor PFO closure device. If the tunnel is long, the arms of the umbrella often force the PFO to open more than it was before. This might explain some of the alleged 35% residual shunt rate in the MIST Trial. 6. The company that makes this device and sponsored the MIST trial, NMT, is suing the original cardiology principal investigator, Peter Wilmshurst, in an effort to silence his criticisms. In my 35 years in academic medicine, I've never heard of such an egregious attempt to suppress scientific dialogue. Perhaps with a new CEO now at NMT, they will drop this self-detrimental lawsuit. Until the 6 month echo data for frequency and severity of residual shunts is clarified from the MIST trail, we will be left with uncertainty about this device. This has lead to the assumption from the neurology community that PFO closure does not reduce migraine frequency and inhibits their interest in entering patients into ongoing clinical trials. Until the effectiveness for complete closure with the CardioSeal is known...