Clinical Editor's Corner

What’s Your Approach to New Technology? Early Adopter or Prisoner of Tribal Customs?

MORTON KERN, MD Clinical Editor Professor of Medicine Associate Chief Cardiology University of California Irvine Orange, California
MORTON KERN, MD Clinical Editor Professor of Medicine Associate Chief Cardiology University of California Irvine Orange, California
Technology and new information come to the cath lab nearly every month. The use of new stents and techniques in percutaneous coronary intervention (PCI) (for example, bifurcation management or thrombus aspiration methods) continues to evolve. Years of studies supporting various approaches encourage each one’s incorporation into the lab when associated with better outcomes. If such a straightforward application of technology is related to better patient outcomes and supported by excellent studies, why then are simple technologies like intravascular ultrasound (IVUS) and fractional flow reserve (FFR) not put into daily practice? Let’s review what both IVUS and FFR do for our patients (a discussion of these technologies is also the topic of this month’s “Ask the Clinical Instructor” by Todd Ginapp, EMT-P, RCIS, FSICP). After two decades of studies and tens of thousands of patient applications, IVUS tells us that what we see by angiography is not always what we get with regard to presence of disease, vessel size, extent of calcium and adequate deployment of a stent. This anatomic advance in seeing coronary artery disease and accuracy of stent placement continues to be confirmed by computed tomographic angiography (CTA), optical coherence tomography (OCT) and FFR. Further studies emphasizing that technology like FFR can help us overcome the limitations of the angiogram are abundant. Correlative studies demonstrating the poor predictive value of an angiogram for physiology related to blood flow and ischemia are the impetus for stress testing. The numerous well-performed studies on IVUS and FFR technology support their common usage to help us make the best decisions to provide superior outcomes over those using angiography alone. A recent multi-vessel FFR-guided PCI study (FAME) presented at TCT last month showed significant reduction in adverse events when compared to angio-guided PCI alone. What are some of the obstacles to the use of (relatively) new technology or techniques in the cath lab? One obstacle is the physician’s acceptance of the techniques as important and clinically valuable when weighed against his/her ability to perform the technique in a timely manner, obtain the correct information and be reimbursed for the effort. There are three types of mindsets held by users of new technology: early adopters, late adopters and “never” adopters. The first group has no qualms about trying out new things, putting them into practice, overcoming the problems that may be encountered and moving them into their patient care plan for better outcomes. Some physicians are the “wait and see” type. Considerable time and studies must transpire before they adopt a new technique. These late adopters are more conservative and less self-assured, but when they are convinced of the value of a technique, they correctly apply the technology to the patient’s benefit. Lastly, there are the “never” adopters. These physicians learn one way to do things and that’s the way it will stay regardless of the data, technology and peer influence. These physicians will not change until the procedure, equipment or clinical indication are obsolete and absent from the lab. Some physicians refuse to believe the data even after years of favorable large studies. For the adjunctive techniques used for interventions, recent studies continue to support what is widely known: 1. IVUS demonstrates accurate vessel size, composition and stent apposition. 2. FFR-guided interventions are better than those with angiography alone (see FAME study, discussed below). Younger physicians appear to have greater exposure to the theory and practice of IVUS and FFR, and therefore are more readily inclined to be early adopters and use the technology. Some of the older physicians are technologically late adopters to many new techniques, especially those with minimal reimbursement, which are often negatively perceived. Use of these techniques is limited, rarely entering their routine despite having strong supporting data. Some interventional cardiologists fall into the “never” adopter group, especially with regard to the extra effort it might take. Some physicians argue that the procedures take too much time for the value of the information related to the patient’s care. Another obstacle to the use of IVUS and FFR is the belief that reimbursements are poor and that the resulting information does not justify the time and effort. CMS reimbursement data does not bear this out any longer. It is true that physician reimbursement is at best modest, but hospital costs are generally a pass through. It is unfortunate that the patient is considered secondarily in a judging whether this procedure should be performed or not. The next obstacle to the use of new technology in the lab is “tribal custom.” Each cath lab (tribe) has a history, standard of behavior, customary way of doing things to set up the room, perform interventions and share information, all of which make up part of their individual tribal customs. Each lab has a tribal leader (nurse and/or physician) and set of tribal elders who influence how a lab functions. Of course, input from the practitioners influences the tribal customs. It is not unheard of to have a physician ask for an IVUS or FFR procedure and then hear from the tribe that “it’s too late to start that,” “the equipment’s not turned on,” “it will take too long,” and “the main person who does that procedure is out today.” In most labs, the tribe’s wishes can trump the adopter if they wish. Overcoming tribal custom is a matter of education and desire of the tribe and its leaders to do the best for the patient and the physician. What are the objections the tribe must overcome? “The IVUS/FFR takes too long to set up.” Many labs now can have integrated systems, overcoming the objection to the set-up time. Machines can be set up early in the day, turned on, warmed up, plugged in and catheters placed nearby, ready to use. Mixing adenosine takes time, but IV adenosine ordered early in the day can be in the lab ready to use on short notice. Future, integrated IVUS/FFR systems, available in 2009, will eliminate the large consoles. The needed information will be displayed on the monitors in front of the physicians. The concept of “plug and play” will become routine within the cath lab and obviate the set-up time altogether. Time-saving and accuracy will overcome staff reticence. Through better training, the knowledgeable tribe will convert disinterest or disbelief into realized value of the information for best care. I believe technology obstruction by the tribe is truly a minority behavior, however. Most cath lab staff understand the techniques and value of IVUS and FFR, and can become highly proficient. The limiting factor to technology use is really not those working within the lab, but rather the adopters. Most cath lab staff should be comfortable and knowledgeable enough about the setup, pitfalls and value of these techniques to convey their enthusiasm about helping their patients and physicians with these cases. Physician adopters can be easily assisted by labs that have a background in moving technology forward. FAME and Technology I would like to highlight what I thought was one of the most important applications of technology presented at the TCT meeting this October. Despite my bias toward physiologic approaches to coronary intervention, the FAME study, which stands for “Fractional flow reserve versus Angiography for Multivessel Evaluation,” truly demonstrated better outcomes obtained with the adjunctive FFR modality. The principal investigator was Nico H.J. Pijls of Catharina Hospital, Eindhoven, The Netherlands, and the pioneer of the FFR concept. The study tested whether FFR-guided PCI in multi-vessel disease would be superior to angiography-guided intervention alone. Twenty U.S. and European cardiovascular centers randomized 1,005 patients who had at least two major vessel stenoses of > 50%. The patients who had left main disease, previous bypass surgery, acute ST-elevation myocardial infarction or extreme tortuous and calcified arteries were excluded. In the FFR-guided group, only those lesions with FFR values ≤ 0.80 were treated, while the other non-physiologically significant lesions were treated medically. All patients were followed for one year. Primary endpoints included composite of death, myocardial infarction and repeat revascularization. Secondary endpoints were individual components of major adverse cardiac events (MACE), functional class, use of anti-anginal drugs, quality of life, contrast usage, procedure time and cost. Four hundred ninety-six (496) patients were randomized to angiography and 509 patients to PCI. There were no differences between groups with regard to clinical, angiographic or procedural characteristics. Results showed major differences favoring the FFR-guided approach, with fewer stents needed per patient (2.7 ± 1.2 for the angio group and 1.9 ± 1.3 for the FFR group, p