Where Do We Go From Here? What advances in catheter-based therapies mean to cath labs and their staff

We are dramatically changing the way we approach the treatment of cardiovascular disease. Practitioners and patients alike demand progressively less invasive treatments, with better results. For some this is simply a matter of convenience, but in looking at the bigger picture, there is tremendous promise in the potential to treat the previously untreatable patients with previously untreatable conditions. This applies to every patient along the spectrum, from the premature newborn with a heart defect to the elderly patient with severe cardiomyopathy in need of valve replacement. When we look at those who are at highest risk we can see that the difference between performing procedures through a 3-millimeter arterial puncture and a 6-centimeter chest incision is, in many ways, immeasurable. The day is coming closer when we can dismiss a patient’s fear of having their chest cracked open and their heart stopped for a procedure with a simple wave of the hand, saying that’s how they used to do it in the old days. This leaves us with the question, what do the advances in catheter-based therapeutics mean to catheterization laboratories and their staff? The advances in the field of non-invasive imaging, and specifically computed tomography (CT) angiography, may soon make strictly diagnostic angiograms a rarity, but as more and more catheter-based treatments are developed, any volume decrease from the loss of clean caths will be replaced with procedures which previously fell under the realm of surgical repairs. The cath lab has, primarily through the advances in available technology, moved to the forefront of the interventional field and redefined the term anatomic treatment, moving it off of the surgeon’s table and into the medical practitioner’s lap. Over time, the function of the catheterization laboratory as a department will evolve, as all things do. The diagnostic portion of the lab’s duties will gradually fade back into the sphere of radiology and the scope of the cath lab’s practice will reach deeper into the realm of the surgery department. This should not be tainted by territoriality or squabbles about who is taking business from whom, but instead give us an opportunity to work together in the best interests of patients, practitioners, and our facility. We are all essentially working in a paradox where levels of specialization increase, yet the borders between these distinctive fields are beginning to dissolve. It has become commonplace in many labs today to have a cardiologist and a vascular surgeon performing the same procedures in adjoining suites, and the expectation in these facilities is that the lab be stocked and the staff be trained appropriately for both types of physicians’ needs. As the walls that separate the practice of the surgeon in the OR from that of the interventionalist in the cath lab begin to crumble, our practice as cath lab staff must compensate by becoming stronger. Both the level of complexity and skill required to perform these procedures rises daily, making it difficult to distinguish a catheterization suite from a surgical suite. ¹ In some labs, such as those that routinely perform rhythm-management device insertions, they are one and the same. While we may not have the luxury of absolute independence in determining the destiny of our field, it is up to the cath lab staff to define what an invasive cardiovascular professional is and does. Certification by, and membership in, our professional societies provides without question great support to achieve this goal, but it is not wholly sufficient. Comprehensive training is required. Dr. Morton Kern touched on this in his initial letter as the Clinical Editor of Cath Lab Digest. As the procedures we perform become more and more complex, the expectation for lab staff to understand the mechanism of the devices being used is higher. Just as the catheterization department is coming into its own right, we too are moving out of the shadow of the traditional radiology technician performing imaging studies or surgical technician handing off instruments. In many labs, the scrubber plays an active role in device implantation, deployment, and complication management. In addition to the duties of the staff member scrubbed in to assist the physician, those staff that comprise the rest of the team, both in the recording and circulating positions, must know not only the intricacies of procedure, but also be responsible for critical care-level monitoring, management and assessment of the patient. We are fortunate to work in a field where continuing education is always available, and in our specialty in particular, we have numerous opportunities to develop a strong working knowledge of the cutting-edge technology with which we work. Cath lab professionals directly and indirectly interact with several professional societies which pepper the calendar with conferences. We are supported by zealous industry representatives that offer in-house training sessions at a moment’s notice; and we have our own dedicated periodicals, such as Cath Lab Digest, which now offers both an online newsletter and online CEUs in a variety of cath lab-specific topics. As we make this move forward in the level of our practice, one area we cannot neglect is our sterile technique. Simply put, sterility is a must. Anything that is being implanted into the body should be done so under sterile conditions. This goes beyond rhythm management devices to include stents, valvuloplasty rings, congenital defect repair devices, and even vascular closure devices. The days of assuming catheterization is a clean procedure, not a sterile procedure are over. According to the Infection Control Guidelines for the Cath Lab released last fall by the Society for CV Angiography and Interventions Executive Committee, 18% of patients were found to have positive blood cultures following angiography. While these infections were generally sub-clinical (less than 1% showed signs or symptoms of infection requiring treatment), there has been case studies that report both intracoronary stent and vascular closure device infections. ¹ The significance of this data, even in the case of sub-clinical infections, is in the demonstration that the pathway for infection is adequately established with our current methods of practice. The CLIC Guidelines even go so far as to recommend routine antibiotic prophylaxis following vascular closure device implantation in diabetic patients. Anything implanted into the body has the potential to be a vector for infection until it is fully endothelialized, and an unintended consequence of the immunosuppressant qualities of drug-eluting stents is that they take longer to endothelialize than their bare metal counterparts (at least 3 months for sirolimus and 6 months for paclitaxel-eluting stents). ⁴ Consideration of the CLIC data, coupled with the challenge caused by these long endothelialization times, puts us in a difficult position. While the CLIC committee guidelines continue to recommend aseptic technique for simple diagnostic studies, in most labs a diagnostic procedure can quickly transform into the implantation of a stent with little more than a cine-run’s notice. As mentioned earlier, the quantity of purely diagnostic procedures is likely to fall, and the line between a catheterization suite and a surgical suite is becoming more of a blur with each new intervention we perform. With more implantations occurring, and nosocomial infections perpetually rising in frequency and severity, the natural conclusion is that stricter infection control is the proper course. It seems like the lab has been caught in a tide of change and a load of responsibility rests on our shoulders, but it may be of some comfort to know that we are not the only ones aboard this boat. Physicians have seen the storm on the horizon and some are struggling to figure out what these changes will mean for their futures. Hospitals, as a whole, are there as well. They face uncertainty, but not only in terms of logistics. In the case of those whose revenues are largely dependent upon their volume of high-dollar heart surgeries, there is a cloud of worry around their financial outlooks. Since we are all in the same boat, all three groups are presented with similar choices. In the evolutionary process there are only three options number one: stay ahead of the changes, making yourself and your professional practice competitive, nimble, and viable; number two: let yourself get swept up in the tides of change and just see where the tumble of the current takes you; or the dreaded option number three: fail to adapt and ultimately become extinct. In order to achieve success and survive what has the potential to become turbulent seas, everyone involved must be prepared to adapt to our new world, even if this world is one where heart or vascular surgery becomes a treatment used only as a last resort. Bruce Lytle, MD, referred to an industrial era for cardiac surgery following the advent of coronary artery bypass grafting and prosthetic valve implantation/valvuloplasty procedures. It was an era that had profound impact not only on the treatment of heart disease but on the medical infrastructure as a whole. ⁵ We stand today on the brink of another such era. Martin B. Leon, MD, the founder of the Transcatheter Cardiovascular Therapeutics (TCT) conference, said the goal was to create an intervention that was safe, predictable, generally applied to most patients and definitive. ³ Thanks in large part to drug-eluting coronary stents, which currently make up greater than 90% of interventional procedures, restenosis rates have fallen well below 10%, bringing us closer to a true definitive therapy. ³ Dr. Leon believes we are slowly erasing the durability advantage of CABG and each day we come closer to fulfilling the promise inherent in those goals. The blizzard of ongoing clinical trials may ultimately show that in many patient populations, percutaneous coronary interventions are superior to bypass surgery when comparing risks versus benefits. Even before the completion of the current clinical trials, present estimates indicate that there are three times as many PCI procedures versus CABG surgeries in the United States, and the gap is widening, with an expected 30% reduction in CABG surgeries over the next 3-5 years.³ In the battle for control of territory in cardiovascular procedures, it is unlikely that we will find a clear-cut winner, which further increases the need for integration in the roles of the surgeon and the physician. In his presentation, entitled Is Cardiac Surgery Dead? during the 2006 New Era Cardiac Care Conference, Dr. Lytle predicted that the anatomic treatment of cardiovascular disease has a bright future, but the proportion of patients whose treatment includes a median sternotomy and cardiopulmonary bypass is likely to decline. Once the dominant breed in the field of cardiac intervention, heart surgeons are finding themselves faced with the possibility that in the foreseeable future traditionally performed cardiac surgery will… (be) unlikely to support the same industry that it has in the past. ⁵ Columbia University College of Physicians is one of the first schools in the country to recognize this and has created a revolutionary Cardiac Treatment Specialist fellowship program where physicians are trained in both cardiothoracic surgery and interventional cardiology, sharing their time between the cath lab and the operating room. The intention is to create a hybrid-trained cardiac treatment specialist able to manage anatomic cardiac disease by use of all available modalities.6 Matthew Williams, MD, the first fellow in this pilot program, has met with numerous challenges, including, but not limited to, certification, ‘turf battles,’ reimbursement and establishment of hospital privileges. ⁶ As is often the case with those that feel threatened by change, some level of resistance is to be expected. Despite the opposition faced by Dr. Williams and Columbia, their foresight will certainly give them the advantage in the coming years when others are scrambling to stay up to date. The final group to tackle these obstacles are the facilities in which we work. As lab staff and physicians progress out from the shadows, so too must the mindset of the hospital administrators. Forward thinking is the only thing that will be able to prevent the further financial decay of many hospitals and keep them alive in this new era. The cath lab can no longer be dismissed as an extension of the radiology department, and the fiscal promise inherent in the area of percutaneous interventions and procedures needs to be recognized. Drug-eluting stents have created a multi-billion industry practically overnight, and while the specific growth in that market may predictably slow, this clearly demonstrates the potential for percutaneous interventions as a whole. When this is coupled with the potential fruits of laboring in the fields of cardiac electrophysiology and endocardial repair procedures, the disadvantage of less reimbursement versus cardiac surgery will be erased by the explosion in volume of these procedures. As with each preceding industry revolution, those who are unprepared for the future eventually become extinct. If hospitals do not invest in the development of their labs, and the employees of those labs, they too will be left behind. More and more procedures are being performed on an elective basis, and in large, multi-center cities, the physicians will schedule their procedures, especially the more complex and likely more profitable ones, at the institutions where a forward-thinking environment is nurtured. As reimbursement catches up to the increasing complexity of catheter-based interventions, hospitals will begin to realize a substantial return on their investments. Failure to embrace this new technology may eventually lead to a settling out and concentrating effect. The good employees with the higher skill levels will leave for better-paying, more technically challenging positions and leave behind less progressive physicians, facilities, and co-workers. The physicians will take their high-dollar business elsewhere, and only the run-of-the-mill and likely lower-reimbursing procedures will be performed. The facility then has less money to spend on new equipment, and less money to pay their workers. You end up with a lab filled with lesser-motivated staff that becomes progressively overworked and burnt out as more staff leaves. The lab as a whole becomes less productive, feeding into a vicious cycle of generating less revenue, getting paid less than their peers in other nearby facilities, and hospitals finding themselves unable retain qualified personnel or to recruit strong new prospects. To quote Dr. Kern, those who embrace new technologies find they are thought-leaders in the industry and subsequently become market leaders and high visibility, forward-thinking institutions…Hospitals can receive the spin-off benefits of more patients using a facility that embraces new technology. ² The days ahead are full of questions, challenges, and possibilities for the field of cardiovascular care. While we may not have the ultimate responsibility in how our facility prepares for the future, or how the physicians with whom we work focus their practice, we need to keep our eyes forward, looking towards tomorrow. We are the wheels that keep the system in motion and it is the catheterization laboratory staff that has the opportunity to effect the greatest amount of change in the overall direction of our professional practice. Education is the key to preparation, and we must embrace it. We must understand the new technologies we have available to us, even if the physicians do not. Likewise the enforcement of stricter standards, both upon the physical lab and upon ourselves, will establish the right precedent, instill professionalism and help us earn the respect we deserve for the jobs we do. And finally, with the full support of proactive hospital administrations, we will have the ability to take control of the chaos and move confidently, and most of all, successfully, forward into the future of cardiovascular medicine. Author Michael Arnold can be contacted at michael.arnold@tucsonhearthospital.com

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