Unit of Vascular Neurosurgery, Hospital Universitario Río Hortega, Valladolid, Spain
We appreciate the interest raised by our article,1 although the major concerns expressed in this letter indicate a worrisome misunderstanding of our proposal.
The PUFS study sustained the US Food and Drug Administration approval of flow diverter devices (FDD) for specific giant and complex carotid aneurysms,2 even though this prescription is now overwhelmed by many. Other studies were published later, most of which corroborated the initial indication as the best for these devices, at the same time that they advised about the risks and unpredictability related to their use.3
The authors state that we have thrown data on both the Silk and Pipeline embolization devices as if they were identical. Our analysis was conceived for the entire neurovascular surgery community, not just for the endovascular (as we ourselves are practicing endo- and exovascular neurovascular surgery), and also not only in the United States, but also in Europe and other countries. For this reason, we included series using Pipeline and Silk, which are the 2 FDD commercially available worldwide, although they are not identical. As a matter of fact, differences between the 2 devices in terms of adverse effects and closure rates were defined in our analysis and can be clearly outlined without effort.
What is important to stress is that, for those aneurysms that can be treated with more controlled and predictable instruments (such as clips and coils), it is advisable to keep caution when indicating new devices still under investigation. More classic techniques have demonstrated their usefulness in a large set of reports since long ago until the present.4-7 What we really believe is that an “unfounded statement that may affect patient care” is to obviate all the uncertainty about FDD just because these devices are new, attractive, and easy to use.
It is finally impressive and fills us with envy that the authors are able to reduce the complex problem of aneurysms into a single solution: FDD for all aneurysms except ruptured. We wish them good luck with their policy. In our practice, we discuss each case individually to offer the best particular solution (endo- or exovascular) related to the patient's characteristics, the clinical history, and the aneurysm characteristics. The authors seem to be concerned about the disservice that our study could entail for the patients. We can only answer that, in our opinion, the best way to help our patients is to apply the evidence-based medicine in daily practice, considering the whole armamentarium of techniques to offer the best one adjusted to each single patient.
The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.
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3. Withers K, Carolan-Rees G, Dale M. Pipeline™ embolization device for the treatment of complex intracranial aneurysms: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2013;11(1):5–13.
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