The Midei/St. Joseph Medical Center Litigation: A Primer – How did coronary artery stents evolve?

This post was authored by Sharon Stabile and posted to The Eye Opener on June 10th, 2010.

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As was recently announced, we are beginning a series of articles on the medicine and law relating to the class action lawsuit (in which we, together with The Murphy Firm and the Law Offices of Peter Angelos represent the plaintiffs) against St. Joseph Medical Center. Today’s installment is presented in an effort to provide a basic comprehension of , among other things, the concepts of angioplasty and angiography, which we believe is needed to have an understanding of the medical terms, devices and techniques at the core of this litigation. Where we believe useful, we are providing you with links to sample videos of the terms and concepts we will be discussing.

According to Angioplasty.org,  in 1964, a vascular radiologist, Dr. Charles T. Dotter at the University of Oregon, introduced to the world a groundbreaking technique that opened blocked human arteries.  By using multiple catheters of increasing diameters, Dr. Dotter demonstrated how blocked human arteries could be remolded and opened.  Doctors had been able to see dye flowing through arteries since the late 1950′s using technology known as radiographic angiography (a test that uses an injection of a liquid dye to make the arteries easily visible on X-rays).  Using angiography, Dr. Dotter was able to visually demonstrate his remarkable technique.   The technique became known as transluminal angioplasty.  

It was not until around 1980 that Dr. Dotter’s transluminal angioplasty technique gained acceptance in the US. Reported complications, difficulty reproducing results, and philosophical resistence plagued this medical pioneer. In the meantime, a young German physician working in Switzerland named Andreas Gruentzig  began experimenting with adding a balloon to the Dotter multiple catheter prototype. He practiced inflating a small balloon on one catheter to achieve the same result. After successful animal experimentation, Dr. Gruentzig presented his study results to the American Heart Association (AHA) in 1976. While generally rebuffed following his presentation, he gained the interest of another physician by the name of Richard Myler from San Francisco.Together they formed a collaboration and performed the first human coronary balloon angioplasty in 1977, and in 1980 were widely applauded by the AHA on their results.

Dr. Gruentzig did it right!  He established the PTCA registry at the National Heart, Lung, and Blood Institute to gather and share data that resulted in continued technical improvement.  The data revealed some arterial walls were weakened after balloon inflation later rupturing; some would collapse immediately after deflation; and 30% of all treated arteries would eventually close.  These findings guided scientists and physicians toward the development and implantation of the first human coronary artery metal scaffold stent in 1986.  This device was not approved in the US until 1994 and was called the Palmaz-Schatz stent.

The stent evolution from the early 80′s to the mid 90′s had produced more flexible and easier to insert devices with far less complications.  However, follow-up studies found that within 6 months the arteries became blocked again in 25% of all cases.  The re-blocking became known as restenosis, which was caused by scar tissue forming over the stent. It was later determined that this ‘restenosis’ was the body’s response to the stent itself and not a recurrence of arterial disease.

Various stent devices emerged in an effort to better these results and reduce restenosis.  Continual evolving of bare metal stents (BMS)  and the  introduction of new drug eluding stents (DES) were placed into clinical trials worldwide.  More was being learned about the biology of restenosis and how particular medicines could interrupt the formation of stent-associated scarring.

In a coming article, we will be discussing the coronary stent, which is the device at the center of this litigation.

Contributed to and edited by: Brian Nash

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