Austin, TX and Towson, MD – Questions about unnecessary stent procedures have reared their head again, this time in Texas. The Texas Medical Boardalleges that Austin/El Paso interventional cardiologist Dr Samuel J DeMaio failed to meet the standard of care in his treatment of nine patients.
According to a Complaint filed by the Board on August 17, 2010 , DeMaio committed a number of standard-of-care violations by placing multiple stents in areas of insignificant or moderate disease; performing multiple angiograms in patients who were asymptomatic and had normal stress tests; unnecessarily implanting an ICD in two patients; failing to adequately inform patients of risks; and failing to obtain informed consent for the off-label use of a device in one patient.
Although, underappreciated by most people except vascular proceduralists-management of vascular access sites is the most important part of any percutaneous intervention. The reliable and consistently successful management of vascular access sites significantly reduces the morbidity associated with complex high volume work. Endovascular Today has a very detailed article describing the currently available products
This is the eighth year that I have had the privilege of writing the annual Overview of Vascular Closure in Endovascular Today. There were a number of developments in the past year, including new device approvals and changes in existing closure platforms. Vascular closure continues to grow toward the eventual billion- dollar mark, as an ever-expanding range of endovascular procedures drives the need for more efficient closure at the end of procedures. In addition, a changing reimbursement landscape, with slowly increasing adoption of outpatient interventions in the United States, will likely drive vascular closure device (VCD) use (as well as increasing transradial interventions). Although the intellectual property space is narrowing, a number of creative concepts are being explored, some of which will be covered in this edition of our annual overview.
I will review the existing technologies, discuss new devices receiving US Food and Drug Administration (FDA) clearance, and touch on some not-yet-ready for market platforms. I continue to find it useful, for both new readers as well as those familiar with the classification system, to show the various technologies classified by category (Figures 1 through 7); this time, I have included FDA-approved devices as well as some in various stages of development. This classification system, first introduced in Endovascular Today, provides a conceptual framework to allow comparison of VCDs and to anticipate the potential strengths and weaknesses of each device. I will review select items from the past year’s medical literature and will expound on fluoroscopy-guided access (see What Should Fluoroscopic Guidance Really Entail?).