ANGIOPLASTIES
Promises that have failed over the years! "Without taking care of the root cause of the illness, how can the problem be solved."
In the last 25 years or so every time a new angioplasty procedure came, the heart patients were given promises of a lifetime cure. Press conferences would be arranged to tell the press that the ultimate cure had come and there would be no heart patients left in the country! General population, an optimist, expecting that the new scientific inventions would probably wash away all their sorrows, believed the doctors. History has witnessed that every time these promises have failed! First came the ballooning or PTCA (Percutaneous Transluminal Coronary Angioplasty) in the middle of eighties. The promises failed within a few years. The cardiologists in the heart hospitals reluctantly agreed that this procedure was not so good as promised. When the stent came, it was promised that only one percent of the cases would have problems. People soon forgot the last failure of the promise! Now the same cardiologists who performed millions of stent implantations with the above promise, again admit that the results are very bad. About 50% of the stents implanted failed within six months! Then came the drug elluting stent or drug coated stent. Instant publicity led to the belief that now there would be no problems left. The optimistic heart patients emptied their pockets in the hope that they would be now completely cured. The promises seem to be failing again! The FDA of USA has started issuing warnings. Guess... what may be the next step...?
One third of patients with coronary artery disease (CAD) will undergo coronary artery angioplasty (PTCA) and stenting.
The primary problem with PTCA is "restenosis" which is a closing of the coronary artery following balloon dilatation. Approximately 30% of all coronary arteries begin to close up after angioplasty. Stents were created to address this complications. But they are also failing.
In 1994 the first stent approved for use in the United States was called the Palmarz-Schatz. While the Palmarz-Schatz stent eliminated many of the complications of PTCA, restenosis still remained a problem, occurring around six months, post-PTCA, in about 25% of the cases.
Why was this happening despite the presence of a stent? The issue came down to the injury to the coronary artery wall caused by the PTCA procedure itself. In essence, the body's response to the balloon expansion of the blocked artery was to grow smooth muscle cells at the PTCA site in an attempt to repair what it saw as an injury. It became clear that a mechanical device alone was not going to solve the biological response of the body. In the 1990's researchers began looking to pharmacological coatings on the stents to interrupt the restenosis process. The first attempts were unsuccessful. However, by 2002 two new pharmacological agents were developed to improve the effectiveness of coated stents.
The first was a drug called sirolimus, which is found in the soil of Easter Island. It is used with the Cypher stent (manufactured by Johnson and Johnson). The second was a drug called paclitaxel. It is used with the Taxus stent (manufactured by Boston Scientific). Both of these stents, Cypher and Taxus, are called drug-eluting stents.
On April 23,2003 the FDA approved the Cypher stent for use in the United States.
However, by June 2003 the FDA issued a warning to physicians regarding possible clotting complications with the Cypher stent.
In October 29,2003 the FDA issued a second warning on the Cypher stent regarding possible "adverse events." Specifically, the FDA had received more than 290 reports of clotting between one to 30 days of using the Cypher stent.
In more than 60 of these reports, use of Cypher stent was associated with death of the patient.
What does this mean in terms of increased risk to patients undergoing PTCA? It appears that the Cypher stent is not going to solve the problem.
Without taking care of the root cause of the illness, how can the problem be solved? Just trying to provide a temporary relief to the symptoms by forcing open the clogged tubes is bound to result in restenosis.
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This article is written by Dr. Bimal Chhajer (Heart Caring Expert)
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