Editorial: A New Beginning and Ending?

Abstract

(J Interven Cardiol 2011;24:491–492)

Greetings from Detroit Michigan! I am thrilled to announce that after 21 years, I have changed employment and am now located at the Detroit Medical Center (DMC) Cardiovascular Institute (CVI). My current position is Vice President of Clinical and Academic Affairs of DMC CVI, and Professor of Medicine at Wayne State University, and of course Editor of the Journal of Interventional Cardiology. These past few weeks have been an exciting transition for me. It is wonderful working with cutting edge technology, brilliant physicians and scientists, and it is actually fun to be in downtown Detroit which finally seems to be undergoing a slow resurrection.

In my new position, I am responsible for quality initiatives. In order to assure that DMC is at the forefront of becoming an Accountable Care Organization, we thoroughly review every complication in cardiac patients. Thus within days of my arrival, I was confronted with reviewing a case of a complication I had never seen in my 25 years as an interventional cardiologist—marked shortening, deformation and accordion of the Ion coronary stent which was recently released in the United States.¹ In order to better understand the case, I described this situation to interventional cardiologists at a national meeting in Chicago. My colleagues responded that they had also heard of cases where the Ion stent had shortened, and I was directed to Abbott Laboratories who was conducting bench testing of longitudinal strength in coronary stents.²

I think the readers will agree that the images of our case demonstrating shortening of approximately 35–40% are striking. We believe that accordion of the stent caused technical difficulties in rewiring the vessel and ultimately stent thrombosis, thus is of serious concern. Although recent reports from Europe noted this phenomenon in the Element and Omega stents (similar family of stent designs), to my knowledge this is the first published case in the stent approved in the United States, the Ion stent.

In this issue of the Journal of Interventional Cardiology is also the scientific bench testing conducted by engineers of a competing stent manufacturer in response to the above physician observations.² Although this study was performed by a different stent manufacturer, the results showing that the Element family of stents (including the Omega and Ion) may shorten up to 46% under the force that an interventional cardiologist may exert to advance a post-dilation balloon or intravascular ultrasound device is very disturbing. Although this shortening phenomenon may just require an additional stent to ensure adequate coverage of the lesion, in our case it appeared that the stent may have deformed and involuted, further compromising the lumen and preventing additional device interventions.

The Food and Drug Administration as well as Boston Scientific are aware of this issue and investigation is ongoing. Furthermore, it will be discussed in detail at the Trans-catheter Therapeutics (TCT) conference in early November 2011. Hopefully, there will soon be new recommendations regarding the use of stents of this particular design for our community of interventional cardiologists. Until further data are available, our institution will use the Ion stent cautiously, and only when alternatives are unavailable for the size under consideration.