Washington, D.C. recently hosted interventional cardiology’s annual Transcatheter Cardiovascular Therapeutics 2001 meeting (Sept. 11-16, 2001). With the arrival of approximately 25 percent of the normal 10,000 participants, the meeting began promptly with great enthusiasm bright and early on Sept. 11.
As the day’s events tragically unfolded, TCT attendees were resolved to salvage some value, albeit from a dramatically shortened meeting. The meeting subsequently concluded on the evening of Sept. 12, canceling many of the key conference elements — live cases, main sessions, late-breaking clinical trials — as well as the exhibits.
With a full year of research, development, clinical trials and experience with new devices, the cardiologists were eagerly anticipating this year’s meeting, as the pace of change continues unabated in this medical specialty. While Medtronic, Guidant, Boston Scientific, GE, Siemens, Philips and other major suppliers of drugs and devices to this group presently enjoy strong market positions, they fully appreciate that their futures are not guaranteed — just ask J&J Cordis (formerly holder of 80 percent+ market share in coronary stents in the U.S.) how far and fast a company can fall in this market.
In the spirit of moving forward, here are some of the relevant trends presently changing the field of interventional cardiovascular medicine.
Drug-eluding stents
The early results from clinical trials of drug-coated stents were announced just before and after the TCT meeting, and in-stent restenosis appears almost non-existent in this new therapy. Multiple combinations of drug and stent designs are showing distinct results, with the best indicating almost no restenosis — truly an eye-opener to everyone involved. Obviously, this gives great impetus to larger and more definitive clinical trials, but the door is now wide open for this therapeutic combination to enter the market in a huge way. Patients stand to benefit the most from this development, as the need for repeat procedures may be dramatically lessened. The drugs supplied on the stent serve to directly treat the site of mechanical injury from the stent implantation, much like treating a child’s cut finger with antibiotic cream and a Band-Aid. Both are simple and effective. We’ll be learning more on this topic quickly over the next year, but if in the future you are in need of a stent, ask for the new version.
Physiologic lesion assessment
It’s not just the image of a lesion anymore — at least that is the message that researchers in this specialty are pursuing. X-ray angiography and intravascular ultrasound are the workhorse imaging modalities used to diagnose and treat cardiovascular disease in the interventional world. (Note: More on MRI and CT later). The new question is whether all lesions require treatment, as some may have little or no effect on the local circulation of blood supplied to the heart muscle.
The challenge is to isolate and evaluate the effect of any lesion on the cardiovascular system — and only treat the lesions demonstrated to have a critical effect on the current or future progression of the disease. The tools to accomplish this include pressure and flow measurement devices, in combination with the physical appearance of the lesion itself.
Fractional flow reserve appears to be the significant variable that researchers are testing, and results are continually encouraging. However, the impact on the everyday clinical world is less conducive to this proposed treatment protocol. The dilemma is simple — an M.D. must evaluate and potentially leave a visible, significant lesion untreated. This protocol will require substantial evidence and conviction that the normal established treatment (stent, etc.) poses more harm than potential good from non-treatment. Don’t hold your breath for this one, though subsequent developments may eventually tilt the scales in favor of this additional diagnostic step.
Vulnerable plaque
As individuals, many of us want to know our risk for heart problems, especially as we drive by the fast-food places that now mark the landscape worldwide. EBCT (only from Imatron, which GE announced in September it plans to acquire) has been on a solo journey since the 1980s, and seems to be carving a niche for itself in cardiac screening. While a white-hot debate rages on medical and scientific fronts, consumers and investors (in cardiac screening centers) are voting with their wallets. This service has struck a nerve, and we should expect these centers on more street corners soon. The longer-term future of these centers is anyone’s guess — go ahead, we’re probably all equally wrong on this one.
In mainstream cardiology, CT and MRI are quietly (loudly at some meetings, though) developing substantial capability in an unlikely location — the radiology department. These capabilities are targeted at routine diagnostic angiography and echocardiography, based on the benefits of higher resolution images, non-invasive and lower cost procedures. This is a powerful currency, albeit in the hands of the radiologist, at least for now. The early adopters are now moving beyond research into tests of clinical protocols for patient management — we should expect a blizzard of publications over the next year, but ultimately the responsible physicians, mainly cardiologists, will weigh in, heavily, with their own orders for systems and equipment, probably staffed with radiologists.
Doug Orr, president of J&M Group (Ridgefield, Conn.), consults with medical device companies in strategy and business development for emerging growth markets, notably radiology and cardiology. Comments and suggestions can be sent to [email protected].
