ACVP Managment Corner: Anniversaries, Birthdays, Stents and the Internet

In 1978, Dr. Gruentzig performed the first PTCA cases in the United States with Dr. Richard Myler in San Francisco and Dr. Simon Stertzer in New York. If you currently work in a cath lab, chances are you have heard of Dr. Gruentzig, who unfortunately died in a plane crash in October 1985. Yet with all due respect to Drs. Myler and Stertzer, it is uncertain that you are familiar with their names, a conclusion I draw based on a recent and unscientific survey of the cath lab staff at The University of Kansas Hospital in Kansas City. The average age of the nursing and technical team is just a little over 30, which means that most of the team was not born or were very young when the first PTCA was performed 30 years ago. Even one of the interventional fellows in our lab was only three when the first case was performed, so it is understandable that some individuals might not be familiar with pioneer names like Myler, Stertzer and Sones. When bare-metal stents were introduced in 1994, most of the cath lab team were just entering their teens, and by the time these individuals entered the field, at around 24 years of age, 2 million angioplasties had already been performed. Yet by the time the first drug-eluting stents (DES) were introduced in 2003, most cath lab professionals were probably well-established in their lab career. To put it all into perspective, The University of Kansas Hospital cath lab team, like many in the country, has never lived in a world without coronary angiography and interventions. Even though they weren't around 30 years ago at the beginning of interventional procedures, these professionals will still be able to share tales about life in the cath lab during an era when interventional procedures used only bare-metal stents and then, of course, the introduction of DES. History First-Hand Once bare-metal stents were introduced into cath labs in 1994, many of the problems associated with acute closure of arteries immediately following angioplasty were eliminated. Fewer cases had to be sent directly to the operating room for bypass surgery. Arteries still had a 30% chance of restenosis, but with the introduction of DES in 2003, this problem promised to be dramatically lessened. In 2002 and 2003, DES were the hot topic, not only in medical circles, but with the government, payors and the public. In 2002, virtually every medical and cardiovascular administrative meeting had a special section dealing with the issue of DES and the finances associated with this new advancement. It boiled down to a triple threat for hospitals: surgical case loads might be further eroded, increased stent costs would hurt cath lab profit margins and fewer redo cases in the cath lab would affect volumes. Seminar presenters made the case that DES would almost immediately receive Medicare approval once the FDA approved its use, but noted that extensive work with the other payors in a market would have to take place in order to be paid. It was felt that just because the FDA and Medicare had approved this device, it was not likely payment would follow immediately, and when it did, it would not completely cover the cost of a single DES, let alone multiple stents or the infamous full metal jackets. During these special sessions, spreadsheets were distributed, and once the calculations were made by each facility, accountants themselves were having chest pain. The initial estimate of the financial impact for The University of Kansas Hospital's cath lab was in excess of $1.5 million. This figure was later revised downward because of lack of sufficient availability of the DES product to meet market demands. Confusion and product shortages plagued the manufacturer for some time, leading to visits around the country by corporate leaders who apologized and explained first-hand many of the issues hindering distribution. Drug-eluting stents were also receiving lots of attention in the media, with many television interviews and print articles, not to mention the commercials that touted the benefits of drug-coated stents, done long before the stents were actually released into the market. Almost every cath lab patient wanted to know if they were going to get one of those drug stents? At this time, many were dismayed that DES had not yet been cleared by the FDA. It was not uncommon for patients to delay their procedures until DES were released and available. Yet there were launch problems with the new stents. When in April of 2003 the FDA cleared their use, there were no DES, at least not for every lab, and in fact, it wasn't until June 2003 that our lab at The University of Kansas Hospital had DES. Even then, overall supply and sizes were limited. What many believe happened was that the company had been playing a guessing game as to when they would receive FDA clearance. Based on their best guess, the manufacturer produced what they thought was sufficient product, taking into consideration the projected shelf life of the stents. Unfortunately, when the company was given the go-ahead to release the stents, the FDA shortened its shelf life by half, leaving the manufacturer with stents that were going to expire literally days after the official clearance data. The Stent Wars Immediately prior to the introduction of DES, there were several companies that were producing bare-metal stents. Cath labs that were using product from a manufacturer other than the first DES supplier found themselves at the end or near the back of the distribution chain. Right or wrong, the DES supplier argued that they had to take care of their best customers first. Many labs complained and to their credit, the company began to supply product to all labs as availability dictated. One of the biggest problems, and perhaps the best argument that labs in the lower part of the food chain used to get DES, was the fact that many patients, having been influenced by the publicity and advertisements, were demanding DES and even threatening to take legal action against physicians and hospitals if bare-metal stents were used instead. Imagine patients today taking legal action against a physician and hospital if a physician didn't use DES! Today, if you go on the internet and do a search for heart stents or drug-eluting stents, you will find almost no clinical information. Instead, what you will see are a host of links that will take you to attorneys' websites where you will see statements like, If you or a member of your family has been injured or died as a result of a drug-eluting stent, you may have a legal case. Contact our office for a free evaluation of your case. Seems like we have come full circle in just a few years. What will the future hold as the percentage of patients getting DES drops along with the overall stent volume? Several things are already happening all over the country. All involve even more careful consideration of stent selection, bare metal versus drug-eluting. Patient drug compliance issues are being carefully considered along with surgery as an important option for cath lab interventions. Even more interesting, physicians around the country are being cautioned not to say too much to the media in response to continued interest in DES, since many lawyers feel that any answer may be incorrect. Most interesting is when you ask one of the interventionalists if they would have a DES deployed in their artery, there is always a very long pause before an answer. Fortunately for the patient having an intervention, cardiologists go through this same thought process, and ask and answer the bare metal vs. DES question for each case they see in the lab. As a result, DES usage in the cath lab at The University of Kansas Hospital has dropped from 82% to 61% during quarter(Q) 4 of 2005 through Q3 of 2006, and industry sources suggest this is not an uncommon trend. A note about the author. John Florio was not only involved in cath labs when interventions started, he was there when the only available option for individuals with coronary artery disease was surgery. He was at The Cleveland Clinic in the late 1960's, when the first coronary artery bypass procedures were performed. He also worked directly for F. Mason Sones, Jr., one of the pioneers in the field of coronary angiography. You may gather from this that Mr. Florio is old and this article is to the best of his recollection. It should also be noted that he has not escaped ravages of heart disease and he is a frequent flyer in the cath lab at The University of Kansas Hospital, where he has had stents placed. They were all bare metal. John can be contacted at jflorio (at) kumc. edu

NULL