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Dear Sir, I attended the one‐day symposium on “Cutting‐Edge and Future technology in Ischemic and Hemorrhagic Stroke” at the Congress of Neurological Surgeons 2014, Boston, MA, USA. I expected to learn about the advances in treatment of cerebro‐vascular accidents and “cures” for ischemic and hemorrhagic strokes. Instead, presenters focused on “the ways to place and navigate ‘off‐label’ devices such as wires, coils, balloon catheters, pipelines, and stents in the complex vasculatures of the brain in patients worldwide.” The subject was presented as the modern achievements of nano‐technology, necessitating the wide acceptance of the new era of cutting‐edge of endovascular technology. In some of the presented cases, young patients with brain aneurysms received multiple stents, pipelines, and coils. The use of these devices was advocated by many endovascular interventionalists as “first choice approach” that might replace the conventionally utilized surgical clipping and vascular reconstruction. The presenting interventionalists admitted to the poor obliteration rates of brain aneurysms and the years of “steep learning curve” in the use of these devices.[3‐6] In fact, with the use of “pipelines and coils” for giant aneurysms, the authors reported complications in more than 50% of cases. Following the European example, many US hospitals nationwide have been using “off‐label” devices for two decades. Such devices have been presented to patients as the “first choice” and sometimes the “only choice” that replaced the standard of care surgical aneurysm clipping and vascular reconstruction. In recent medical and surgical history, the large‐scale nationwide use of off‐label devices is unique to endovascular surgery. Modern medicine and regulatory authorities had allowed such a practice to flourish, despite awareness of the inferior results to the standard of care obtained by surgical techniques. The situation makes it difficult for patients to make informed decisions, since many patients see us as sacred medical and surgical care givers. Adopting cutting‐edge technology should not lead to acceptance of inferior results. It is truly surprising in 2014, to witness the industry‐led medical management for, based on the assumption that “open surgery” is “old and bad” and needs to be replaced with high tech procedures. Of note, surgical clipping is currently performed through “mini open” technique with short length of stay.

surgical neurology international

How has the nationwide use of off-label experimental endovascular devices been allowed for two decades as first choice and sometimes the only alternative to conventional standard and advanced surgical techniques?