Views from the TCT: The Transcatheter Cardiovascular Therapeutics Meeting, held October 16-21, 2005

Hospitals today are strapped for cash and often times, one of the first things to go is staff education. In my hospital alone there were twenty-two staff educators in 1992; today there are two. Hemodynamics, EKG, ACLS and emergency cardiac drugs are about the only classes offered to cath lab staff. Fortunately, eight years ago, with support from one of our cardiac physicians (thank you, Dr. Peck), our department started sending two staff to a major educational event each year. This year, it was my turn to go to a major conference. I live and work in Podunk, Michigan (what a new interventional cardiologist called my cath lab when he first arrived). We are one hundred and fifty miles east of Chicago, one hundred and fifty miles west of Detroit, a few miles south of the North Pole and a few miles north of the Equator. I work in what I feel is a typical mid-level diagnostic/interventional cath lab in a typical middle-class American city. Like many other working cath labs, we don't have the reputation of Lenox Hill, Washington Heart, Cleveland Clinic, Mayo Clinic, or Scripps, but we are known in our region as being an excellent hospital. Our lab sees over 6,000 a year, with a staff of twenty-three men and women manning five labs. We see emergencies, diagnostic, interventional and some research cases, just like hundreds or possibly thousands of other cath labs around this country. My first interventional exposure was in the fall of 1978 when I assisted in our first angioplasty. The surgeon and anesthesiologist were in the control room and surgical staff in the hallway all of us knowing that we were going to kill the patient. In the 1980s, I was assisting in peripheral and renal angioplasties. Working in the 1980s meant learning to perform arterial access (1982), learning suturing techniques and becoming more than just a person holding a wire in my hand. In 1992, I assisted in my hospital’s first carotid angioplasty. When I attended the nurse/technologist sessions of TCT, I noticed something interesting. I once read that in 1985 there were approximately 1,600 cath labs in the U.S., and in 1995, there were almost 4,000. Today I don’t have the count, but I know it is over 5,000. In light of these thoughts, I observed the number of staff present at the opening of the nurse/technologist conference and was disappointed. I observed what must have been well over 10,000 cardiologists, but counted only 500 or fewer nurses and technologists present. Discounting the number of directors, managers, educators and research staff present, I felt saddened that there really weren't enough working staff represented to experience this great learning experience. I was fortunate to meet two young ladies from Lewiston, Maine (my hometown) who had been in the cath lab for two years. They were enthusiastic, eager to learn, overwhelmed by the amount of information presented and reminded me of myself 30 years ago going to my first American Heart Association meeting completely over my head and not knowing it. It made me wonder, how many present really made up the core of the experienced cath lab workers? How many would take back to their hospitals information that could help them understand cardiology just a little bit more? Despite these thoughts, I left TCT with a sense of gratification, feeling that I had learned a great deal and now had more of a sense of what I might be expecting during the next five years in cardiology. I'm sharing my experience because I felt too few dedicated fellow cath lab staff had the opportunity to experience TCT. The conference began Sunday, October 16th and lasted until October 21, Friday afternoon. It was a week of lectures, live case presentations and reviews of all the trials and studies currently going on in the cardiology field. Attending TCT was an opportunity to listen to the greats of modern cardiology. Hearing and seeing Drs. Leon, Stone, Ellis, Serruys, King, Grines, Tierstein and on and on (and on some more) was a fantastic learning experience. Dr. Colombo performed a live procedure from Milan, and then I was able to see him live and in-person in a small lecture room at six in the evening, showing his enthusiasm for the field in his talk on coronary wire use for chronic total occlusions (CTOs). It was amazing, truly amazing. I was overwhelmed by the magnitude of TCT’s program. I was lucky because my fellow attendee and Borgess staff member was Terry Adlam, RCIS, RT(R), who had previously been to TCT. We have worked together in the lab for over twenty years. We enjoy cardiology and have the same interest in the field, so it was very helpful to map out our educational strategy together. TCT is so large that educational opportunities are restricted by only two things your interests and your time. Courses, presentations, lectures and live cases started at eight in the morning and lasted till ten in the evening. The course options were so varied as to satisfy anyone’s interests. I met one of our interventional cardiologists on Wednesday night. He said that he had spent his whole time in the main arena, listening to lecturers and watching live cases. I saw another physician who was pursuing peripheral cases and lectures. My personal interests included stents and cardiac intervention, as well as what is on the cardiac horizon. Terry and I broke our time down into two parts: pens and courses. The pen part meant vendors. What were they selling? How would it affect our workplace? How easy was any individual device to use? We distilled the course section into three parts. Part one was looking at the current status of stents. How good were they? Were there any real problems showing up in the results of long-term stent use? Part two meant the interventional arena and seeing presentations on the current areas of interest in the field. Part three was finding out what new procedure(s) I might be seeing in Podunk, Michigan in the next few years. I had arrived on Sunday and after putting my luggage in my room, had gone to Sunday’s how-to workshops. Updates on Current Device Options was a lecture on closure devices. Many closure devices were displayed and reviewed, which surprised me. I didn't realize that so many had come out in the last five years. The lecture ended with the moderator saying that while there were many closure devices on the market, none had proven to be wildly successful, and the reason was that if there was a perfect closure device, then we’d all be using it. My cath lab sees over six thousand patients a year, and we very seldom pull a sheath. We haven’t needed to pull sheaths in years. We don’t even pull balloon pumps. Our cardiac floor nurses pull their patients’ sheaths, even balloon pump sheaths and balloons. Over the past few years, we have tried numerous devices, but had been dissatisfied with our complication rate. Even though the complication rate was low, it was still more than manual compression. Furthermore, when a complication did occur, it was usually a major adverse event. Monday morning was the official opening of TCT and vendor booths didn’t open until the afternoon. Terry and I made the vendors’ exhibition our afternoon adventure. Finding the perfect pen was part of the vendor adventure. A pen that is different, totally cool, feels great in the hand and more importantly, one that no one else in our cath lab has in their possession. The pen that makes a physician leave his office and come half way across the city to pull it out of your pocket because he found out (through a staff squealer) that you’d taken it when he wasn’t looking. The pen that was abducted and then ransomed with a photocopy of the abducted pen on the schedule board. Due to new government restrictions on gifts, however, there were no show-quality pens at this year’s TCT. If you like specialty-flavored coffee, then you would have enjoyed the many coffee bars available. More importantly, we did receive many helpful hints on current and future products and that was truly our primary purpose, so in effect, our pens adventure was successful. I was surprised by the number of vendors present. Patches, seals, staples, stitches, gels, powders were the flavors of the day. There were a least a dozen closure device companies selling their closure products. Terry and I went to their booths, listened to their spiel, and played with their devices, all the while trying to figure out, why so many devices? Why Sunday’s special session on closure devices? What was driving this plethora of closure devices? Was there a possibility of one of these devices coming back into our lab? I thought of the many times I had heard the phrases cost savings and early ambulation, yet we still weren’t seeing these devices in my lab. I decided that a possible reason for the new push was a new influx of patient surveys. Hospitals now seem to be driven by customer surveys. Staff bonuses are given to us quarterly, based on customer satisfaction surveys. We have had one bonus in the last two years. Patients just plain don’t like lying immobile. Surveys say that patients would rather take their chances on a closure device and be up and about in under two hours, than be in bed for four to eight hours. Private rooms and quick ambulation makes patients happy and contented, itself a reason for closure devices. As a matter of fact, I hadn’t been back from TCT more than a week before I saw a Perclose representative at the desk to the cath lab. Those of us who haven’t dealt with these devices better get ready, because they are on their way. Other noticeable interventional devices in the vendor area were intravascular ultrasound devices and devices for crossing chronic occluded arteries. Most lectures and live cases I attended focused on this year’s interventional direction [the theme was left main and chronic total occlusions (CTOs)] and these devices were needed for optimal success. Patent foraman ovale (PFO) closure devices also caught my eye. These are occlusive devices that close openings in the atrial septal wall. Terry and I went to as many courses as could be found during the daytime. We also went to evening sessions offered by Cordis, Boston Scientific and Terumo (on biolimus, a new drug stent coating). I was impressed by Cordis’ presentation. I thought they gave a fair view of the current status of stents without name-calling. One of the lecturers even gave praise to the Taxus stent. I applaud such a balanced presentation. Putting it in extremely simple terms, the Cypher stent had a 4% restenosis rate to the Taxus 6% restenosis rate. It was publicized and acknowledged that essentially both are good stents, able to satisfy the needs of today’s patients. There was talk of the sticking issue with the Taxus stent. Dr. Stone mentioned that all Taxus stents should be deployed at 16 atm with a 4-5 second delay between deflating the balloon and removing the balloon from the area of the stent (this is to allow for full balloon fold collapse). The biggest challenge brought up for both stents was late stent thrombosis. Both seem to have issues with sudden late stent closure due to thrombus formation. No reasons were finalized or cause determined for this problem, and no obvious solutions were made available, but concern was shown by all moderators. A new stent coming out by Terumo using a coating called biolimus may have answers. This stent is still in clinical trials, but so far it is looking very promising. The chemical biolimus dissipates away from the stent in 30 days, has a lower restenosis rate than siroliumus (Cypher) and has a zero late thrombotic history. Watch out there may soon be a new drug-eluting stent contender on the block. You may recall the second part of my course strategy was to check out current frontiers in modern interventional cardiology. What new areas of cardiology might I be seeing in the near future? At Boston Scientific’s Taxus evening session, a moderator presented a case and then asked the audience for a show of hands regarding how many would attempt left main stenting and how many would opt for surgery. Out of the hundreds of physicians present, a handful raised their hands in support of stenting. Not many, to be sure, but probably more than would have raised their hands a year ago. In 1974, Dr. Gruentzig performed his first angioplasty on a human. In 1977, his work was accepted by the American Heart Association when he presented four cases. In 1978, he assisted Dr. Myler in San Francisco in the first U.S. angioplasty. Cardiologists at the time were hesitant to take on this new technology. Even though my facility started angioplasties that same year, it still took one of our cardiologists four years from that first case before he himself attempted his first angioplasty. However, modern-day interventional cardiologists are determined to keep patients from the surgeon and an area that has been held out as being a no-no area for stenting has been the left main. However, left mains are no longer being held at arm’s length. Even with some TCT reports of left main restenosis of up to thirty-eight percent, physicians are willing to push the envelope to a new level. Patients are also willing to take the chance rather than going under the knife. As a result, making sure to have complete stent apposition was strongly advocated during live case demonstrations and by the lecturers. Complete stent apposition means serious emphasis on using devices to guarantee full stent deployment. The best chance of improving stent success was the use of intravascular ultrasound (IVUS). Galaxy and Volcano are known to all of us as our intravascular ultrasound devices. Now there are more vendors selling their own versions of a better diagnostic tool. Of all the IVUS devices presented, I found Boston Scientific’s new Galaxy to be a dream for staff operation and thought to myself that the company had done their homework in preparing for this new cardiology frontier. Those few hands that were raised by cardiologists deciding to stent the left main made me think back to 1978 and assisting in my first angioplasty. We were the fifth hospital in the country to attempt this method of relieving a patient of chest discomfort. The failure rate was much higher in 1978 than today, yet patients willingly put themselves in our hands rather than going into surgery. Today our failure rate is less than 6% (using Taxus and Cypher restenosis data). We have done over fifty left main cases in our institution with few complications. I feel safe in saying that it is just a matter of time before left main stenting is no longer considered unique in the cath lab and is dealt with as any other coronary artery. Will there be a learning curve? Sure. Will there be more complications? Certainly. However, patients would rather take their chances in the lab than go to surgery. I have three stents in my heart and I certainly would not say no to a left main stent, if that question were put to me. All I ask is that they have the intravascular ultrasound nearby for a look at complete stent apposition. Devices for crossing chronic total occlusions were also abundant. Complex devices needing six-thousand pound magnets placed on both sides of the patient (Stereotaxis) and specialty coronary wires competed for space with closure devices in the vendor arena. I listened to vendors talking about melding computed tomography (CT) results with angiograms, and using lasers, micro-forceps and other methods for crossing long, closed vessels. However, I think our gold standard is still going to be wires, but we now have to learn new terms for speaking about them. Before CTOs became our new word of the day, we spoke about wires using terms like soft, extra-support, super soft, medium support and hydrophilic-coated. Now we’ll be calling out for 3, 6, 12, 22 or 24, which indicate the grams of force necessary to make the tip of the wire start to bend. A physician may start with a 3 gram wire, and if unable to find an opening through a total occlusion, then switch to a stiffer and stiffer wire (the bigger the number, the stiffer the wire) in order to cross an obstruction. Recent interest in opening closed vessels due to the fact that patients have shown dramatic improvement in cardiac function, even in vessels that have been closed for over ten years. As live cases, these interventions lasted longer and were more technically challenging than a normally planned intervention. They consumed lab time, but I can see cath labs becoming more willing to take the chance and help those special patients that have no other choice for quality of life improvement. As vendors go, those offering PFO closure devices were not numerous or colorful but their products were intriguing. I wrote about these devices five years ago in Invasive Cardiology for Cath Lab Personnel (edited by Sandy Watson). At the time, I wrote that the major indication in adults was to assist or relieve conditions of stroke and transient ischemic attacks. I thought these devices were primarily for children, and in my lab, we don't deal with infants or children. I felt that there were too few adult patients in the area to support its use; no physicians were even interested except to send the patient to surgery. In addition, these devices seemed complicated to use, time-consuming and definitely required a certain number of patients to gain competency. I felt that this device would never come into my lab for these reasons and had no interest in devices to close septal holes. I didn't give these devices their due. They have come a long way in the past five years. TCT speakers focused on an aspect of PFO devices that may very well bring them into my lab. They estimated that as many as eighty percent of all migraines are related to atrial septal defects (ASDs). Repairing ASDs has been shown to dramatically decrease or eliminate migraines altogether. That changes the face of ASD closure devices. Moderators believed that within the next five years these devices may be as common a feature in the typical interventional cath lab as our current use of stents. A final note What I learned at TCT was that, sadly, millions upon millions are being spent producing better medical devices. Millions are being spent by hospitals in acquiring new labs and equipment. Patients are demanding the best that medicine has available. Millions are spent on advertisement by hospitals to show their latest modern marvels to the public. Something’s gotta give and that, sadly, is staff education. Too many hospitals depend on the manufacturer to educate the staff, and too few staff are getting the opportunity to be educated by individuals notable in their field, as at TCT. For myself, I feel that I’ve come away from TCT with a good sense of the direction cardiology will take during the next few years. We are going to see more and more acceptance of left main repair. In five years, it will be just another vessel to repair. Repairing totally chronically closed arteries will also become an accepted form of patient care. Like the Rotoblator, it will be a procedure that is going to be performed, but not regularly. Procedure complexity, greater chances of complications and time (cath lab, staff and interventionalist) will more than likely keep it that way. Finally, septal wall closure devices are different. If research can show without any problem that the repair of an atrial septal wall will dramatically decrease migraines, then we who work in adult labs are going to have to learn the other side of the heart.

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