Letter from the Editor

Some Thoughts on Evaluating New Equipment and Devices in the Cardiac Cath Lab

Morton Kern, MD
Morton Kern, MD
If you’ve worked in a cath lab for any length of time, I’m sure you’ve heard the following comments:
I just went to a meeting and I saw the greatest device…Let’s get it!
What happened to the device I wanted to get last month?
Why do we never get the latest devices in our lab?
How do cath lab administrators and physicians balance the desires, needs, and costs in the quest to use new and potentially better cath lab devices? This dilemma exists in all cath labs with regard to trying to satisfy the physician’s desires, administrative costs, and best patient care.
Ideally, a new technology (e.g., cath lab equipment/devices) should always provide an advantage to the patient, lab, and hospital at a reasonable cost. There are enumerable examples of new devices/therapies helping patients, such as drug-eluting stents, vascular closure devices, new contrast media, and glycoprotein receptor blockers, to name just a few. These new technologies provided benefit with an additional cost, which was felt to be justified. However, there are probably as many devices that are perceived not to provide appropriate benefit when considering the cost involved. Consider the low usage of intravascular ultrasound (IVUS), pressure-wires and automatic contrast injectors.
How is benefit demonstrated? Clinical benefit is demonstrated by data that shows the patient will have better outcomes over time, fewer complications, less discomfort and few re-hospitalizations. Benefit to the hospital is demonstrated by reduced procedural and equipment costs, especially the labor involved in clinical care. Benefit to the physician encompasses the two prior benefits plus the benefit of enhanced practice experience and a marketing opportunity drawing patient referrals by publicizing the use of the most modern and possibly best device. Without clinical data demonstrating benefit, all devices should be considered as investigational for use in patients. Recall all of the interventional procedures that we once used, which after the data were available, fell out of favor (e.g., DCA, laser, intra-arterial streptokinase). How should a lab approach the purportedly improved version of an existing device that offers the same benefit but is easier or safer to use? This one is a no-brainer: get it, provided it acts like it should, and the cost is not unreasonable. Why use an older version of x device, which is hard to work and may have worse results? Spend a little to get a lot seems a rational approach.
What are the perceived obstacles to getting new technology into the lab? From a physician view, the company representatives are doing a vigorous job in promoting the device by educating the physician users, staff and ancillary personnel on the use and problems of a device. In some labs with a physician director, the doctors agree to evaluate a device over a short timeframe, and if acceptable in terms of benefit, the device is ordered and stocked. Of course, the technical staff needs to be trained and become familiar with the device, but this is rarely an obstacle.
In labs without a physician director, the nurse director receives input from physicians and vendors. He/she discusses the device and its potential with the physicians, and an evaluation is then scheduled. However, without a physician champion or overwhelmingly important clinical use, this process may take months or longer. While a new device with obvious clinical benefit is always fast-tracked, it is the less dramatic but equally important me-too-but-improved device that requires attention. For example, new and better arterial closure devices should not take months (or years) to come into daily use if the device is user-friendly, the clinical data strong and the cost reasonable. Likewise, for new (and presumed improved) catheters, syringes, injection devices, and importantly, pharmacologic agents, this approach should not be delayed.
What is the main reason for delay in getting new technology in such labs? The cath lab director, while trying to hold down costs, can be overwhelmed by the number of vendors trying to have their device utilized. The paperwork associated with new devices contributes to the delay. Finally, some of the many physicians in a lab do not want the use a new technology. They resist change for change’s sake.
What are the advantages of the new technology beyond the patient’s clinical benefits? Laboratories (physicians, staff, administrators) who embrace new technology find they are thought-leaders to industry, market leaders, and high-visibility, forward-thinking institutions. New technology provides institutional opportunities to share the direct benefits with more patients who may not be aware of the advantages of such technology. Hospitals can receive the spin-off benefits of more patients using their facility that embraces new technology.
Are there disadvantages to using new technology? The most obvious disadvantage is the cost of a new device, which may not be reimbursed or involved with a cost-pass through. Another disadvantage is dealing with only marginal clinical benefits and encountering late adverse responses which initially were not identified or anticipated. In such a case, widespread physician acceptance would not be forthcoming, resulting in the acquisition of the new device and its cost without any return on the institution’s investment.
Finally, on a personal note, the introduction of new technology into a cath lab requires some guidelines for the industry representatives and cath lab staff. First, all cath lab personal should be familiar with what the device does and how it works. Secondly, no person other than paid staff members should handle the device in the lab (or during set-up) to reduce error and liability. Third, the industry representative can demonstrate in a dry lab fashion, but in the clinical arena must not touch the device or the patient. Meaning NO GLOVES for non-team members. Finally, concentrate the experience with a new device in a small team and then expand the experience to the remaining lab team members. Track the experience with a new device and share the information with all users and eventually consumers.
New technology is a double-edged sword, but in the last 20 years, has moved interventional cardiology forward faster than all other areas of medicine during this century. Let’s keep our minds open to ways to do things better.