Technological Innovation and Standards of Care: Do They Ever Intersect?

Look around you. We are literally “surrounded” by innovation, less-invasive endovascular techniques and devices… “New paradigms” emerge every couple of years, perhaps more often! Many such new technologies and therapies can be classified as disruptive (see VDM editor’s corners from the September/October 2005 and November/December 2005 issues). They tend to emerge rapidly as new options or alternatives to traditional standards of care. Enthusiasts are quick to proclaim that a new standard of care has arrived! But, has it really…? The article “Most Thoracic Aneurysms and Thoracic Aortic Aneurysms are Best Treated Open” by Safi et al. speaks to these issues and constitutes a good case in point. Traditional open surgery for treatment of TAAs is being challenged by newly-developed less invasive techniques and devices for endovascular exclusion — instead of surgical reconstruction. These are very exciting developments, no doubt! But have they risen yet to the level of “standard-of-care”? Do we have enough scientific evidence on safety and efficacy, and on durability, to substantiate such claims? The answer is obviously “NO!” to at least two of the questions or issues. This is not to say that present-day advances are not promising and exciting, because they surely are! However, as shown by Safi et al., it is clearly premature to state that endograft repair has now replaced open surgery and become the new standard. It may do so one day soon, but not yet. This discussion brings up another significant issue: how is it that a therapy or treatment approach becomes the standard of care for a particular clinical problem or condition? And what is required for a new therapy or concept to replace the old standard? As VDM readers may already suspect, there are no clear answers or definitions in any of these areas. This is particularly intriguing when considering that most of the standards we have all lived with (and by) during the majority of our professional lives evolved much before the emergence of evidence-based medicine. In the end, I must confess to playing the devil’s advocate, since I am a “card-carrying endo-enthusiast” myself. However, the truth be told, it is really incumbent upon all of us involved in the testing and clinical introduction of new technologies to become “crusaders” for clarity and honesty, and to call things what they are. After all, aren’t the terms “innovation” and “standard of care” contradictory? Isn’t innovation’s main job to improve upon — and change — existing standards of care?

Frank J. Criado