The Cardiac Cath Lab in Evolution

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 The GE Innova digital cardiac cath lab is coupled with the Mac-Lab hemodynamic monitoring system and the Centricity Cardiology image and data management system.

Cardiac catheterization labs across the country are evolving. Changes in types and volumes of procedures combined with an increasingly competitive environment and reimbursement cuts are forcing cath labs to adapt and fine-tune their management strategies. What brings success? Diversifying into EP and peripheral vascular procedures, tightly managing and even consigning pricey inventory such as drug-eluting stents, cross-training staff, and ensuring high flexibility.


The cath lab then and now



The initial purpose of the cath lab—evaluation and diagnosis of coronary artery disease—has been supplanted by interventional procedures since the onset of drug-eluting stents and statins. Since the advent of coronary stenting, a greater percentage of patients’ coronaries are remaining open, translating into fewer repeat procedures. What’s more, cardiologists are getting into the cardiac cath business on their own and launching joint-venture operations. The upshot for many sites, says Katrina Dunn, cath lab manager at Methodist-DeBakey Heart Center in Houston, is that the bread-and-butter business of the cardiac cath lab is in a state of decline. Plus, regulations and declining reimbursement are taking their tolls in the cath lab. “Our margins are much narrower than they used to be. We have to stay on top of the cath lab from the business perspective,” says Eileen Wimsatt, director of cardiac cath lab and electrophysiology (EP) lab at Inova Heart and Vascular Institute in Falls Church, Va.

If you take a closer look at the cath lab in terms of procedure volume, in 2006, about 4.21 million studies were performed in 1,970 sites, reflecting growth of just 2 percent annually, according to market research firm IMV. Of these cath lab cases, 89 percent were cardiac-related and 11 percent were non-cardiac applications. But despite the flattening in the number of procedures, capital budgets are increasing at a faster pace. From 2003 to 2006, the average device budget per cath lab surged about 18 percent per year to $1.8 million. Also, the proportion of sites with capital budgets of more than $1.5 million has increased from 14 percent in 2000 to 30 percent in 2006, as hospitals invest in new technology such as flat-panel digital detectors, according to IMV. The typical cath lab is used by an average of 10.8 cardiologists and 3.6 cardiology groups.

So how are smart cath labs handling these changes? They’re employing a variety of strategies from investing in a broader array of imaging equipment to facilitate EP and peripheral vascular work and optimizing IT solutions to cross-training staff as well as exploring high-tech inventory management tools like radiofrequency identification technology (RFID).


A complicated arena


The cath lab at Methodist-DeBakey Heart Center is a microcosm of its peers nationwide. Its procedure mix has changed from 75 percent coronary evaluations, 20 percent EP studies and 5 percent peripheral vascular work to 45 percent coronary exams, 40 percent EP work and 15 percent peripheral vascular over the course of a few years. One hitch associated with EP procedures is time. EP cases take much longer than standard coronary cases—often by a factor of two. A diagnostic EP case is a two-hour procedure, and a complex interventional procedure can last between three and five hours. In comparison, a diagnostic coronary case is a 30- to 45-minute procedure, and interventional cases last between 60 and 90 minutes.

But the challenges of EP aren’t the only factor complicating the cath business. Two satellite hospitals have opened cardiac cath labs and usually retain the straightforward, non-complex cases, so Methodist-DeBakey patients tend to be more complex with greater co-morbidity than in the past. Patient length of stay is longer. Ultimately, the volume of EP and peripheral vascular work has not offset the loss of coronary procedures, says Dunn, and it requires more resources to complete fewer cases.

One survival mechanism for the cath lab is to change its imaging arsenal. “We used to take a cookie cutter approach to imaging equipment, with each lab a clone of the others. Now, we need equipment that supports peripheral vascular, EP and coronary procedures,” explains Dunn. The center’s eight cath labs are outfitted with a variety of Siemens Medical Solutions imaging equipment. Two labs are outfitted with the Axiom Artis dTC, a 30 x40 cm large plate system that facilitates imaging of the carotids and peripheral vascular anatomy. Two labs house Siemens bi-plane systems and provide the flexibility to handle both diagnostic and interventional procedures and EP operations. The remaining four rooms are equipped with the Axiom Artis dFC, a universal angiography system.

Inventory management is evolving as well. “An EP ablation catheter is as expensive as a drug-eluting stent,” Dunn points out. The key difference for bean counters is that vendors allow labs to consign drug-eluting stents, so they need not be counted as inventory. Dunn is working on similar arrangements with catheter vendors, but so far, only one of the hospital’s five vendors has agreed to the consignment arrangement. One potential fix is RFID technology that would allow the lab to easily track and manage its inventory. “It’s pretty pricey,” admits Dunn, “but could help us better manage inventory and limit overstocking.” In addition, the radio trackers minimize loss. Another piece of the management puzzle is staff. Methodist-DeBakey Heart Center aggressively promotes cross-training for EP, rewarding staff who complete the curriculum with a $2,000 bonus. Cross-training increases flexibility among staffing and allows the site to supplement its procedure load with additional EP cases.


The business growth model


PinnacleHealth in Harrisburg, Penn., operates a high-volume cardiac cath business, performing nearly 5,000 procedures annually in its seven suites. Like other cardiac cath labs across the country, PinnacleHealth is facing declining coronary case volumes. The primary reason for the tough environment is a static patient load; area cath labs are competing for the same patients. And patients are not turning to the cath lab as fast as in the past. That may be because preventative measures are working and helping some patients delay coronary stenting. In addition, recent research promotes medical management over stenting for some patients.

The hospital does have a key advantage; it participates in a considerable amount of clinical research. Research keeps us on the cutting edge, says Director of Invasive Cardiology Kate Acquaviva. For example, PinnacleHealth had its feet in the peripheral vascular business earlier than many of its colleagues, so as coronary volume dropped, peripheral vascular work helped fill the gaps. The ticket to success in the current environment, says Acquaviva, is to maintain or grow other businesses like peripheral vascular procedures or EP work.

The equipment mix at PinnacleHealth reflects the changing procedure mix. Two of the hospital’s five cath labs are outfitted with GE Healthcare Innova 3100 digital cardiovascular imaging systems, which can accommodate both peripheral vascular and traditional coronary catheterization procedures. The hospital plans to upgrade a third room to the Innova 3100 by the end of the year. Two EP suites rely on GE Biplane Advantx LCLP and Advantx LC+, and the remaining cardiac cath labs use Advantx LC, enabling flexibility in the changing market. Another ticket to maximum flexibility is a clinical ladder program that cross-trains staff across coronary, peripheral vascular and EP work.

The hospital uses a streamlined, proactive approach to handle its large cardiac cath inventory. “We do keep a lot of equipment on hand, particularly new technologies,” says Acquaviva. Consignment is the first option with equipment, and most vendors are accommodating the hospital’s needs. “Sometimes our high volumes allow us to take advantage of special buys and bulk purchases to trim inventory costs,” adds Acquaviva.

Other fixes center on education. Two recent research trials have sent mixed messages to patients and primary-care physicians, says Acquaviva. The first advocated medical management over stenting for some treatable blockages. The second questioned the benefits of drug-eluting stents over bare metal stents. Consequently, some patients are putting off elective catheterization, which affects volume. Hospitals need to launch a cohesive educational campaign that explains the drawbacks and benefits of various options, says Acquaviva.


Small site, major challenges


Johns Hopkins University Bayview Medical Center in Baltimore, Md., houses a single cardiac cath lab and one EP lab and has effectively countered national trends in declining volume cath lab volume. In fact, in the last three years, volumes have increased—particularly this year with the opening of the EP lab.

The small site not only contends with typical challenges, but also faces other hurdles. For example, the medical center does not offer an open heart surgical option, so some patients are transferred to The Johns Hopkins Hospital for cardiac cath procedures. The cath labs at the downtown center are equipped with an array of cardiovascular x-ray systems including the Infinix DP-i/FD2 from Toshiba America Medical Systems and can handle both diagnostic and interventional angioplasty procedures. (Current regulations prohibit sites without surgical backup from performing interventional angioplasty.)

Despite the challenges, the center has increased cath lab volumes in the last few years. We attribute volume increases to the new EP lab and successful marketing of the service, says Cardiac Cath Lab Manager Martha McDowell. The cath suites at the downtown hospital are taking a slightly different tactic and focusing on growing a peripheral vascular program. The dual-plane Toshiba system can readily accommodate the hospital’s fledgling vascular program.

Managing the complicated and ever-increasing inventory of stents and catheters presents another challenge. Stent technology changes constantly, and science has not yet embraced bare metal over drug-eluting stents or vice versa, forcing the lab to maintain a complete inventory. “We try to secure stents on consignment, but that can be problematic as the cath lab focuses on emergent rather than routine procedures. In addition, one type of drug-eluting stents has a very short expiration date,” explains McDowell.

On the EP side, the lab consigns ablation catheters, which are shipped to the hospital for the day of the scheduled procedure.

Bayview employs a variety of technology and processes to streamline inventory management and ensure billing compliance. “First, because we have a small staff we can designate a single person to touch the probe to the product in each case. Second, we complete an audit within 24 hours of every case, which serves two purposes. It catches any errors and provides a basis for training and education,” explains McDowell.


The new facility


Inova Heart and Vascular Institute opened three years ago in Falls Church, Va., with seven dedicated catheterization labs, three dedicated EP rooms and a combination cath and EP room. Rooms are equipped with a variety of Philips Medical Systems Allura Xper FD 10 and FD 20 cardiovascular x-ray systems, including single and bi-plane systems and a single plane FD 10 that accommodates both EP and cath procedures.

One of the main changes since the institute opened its doors, says Wimsatt, is the tremendous increase in peripheral vascular work. “Our peripheral vascular volume has increased almost 200 percent, mainly due to a partnership with area cardiovascular surgeons.” Interventional work is also on the rise as new x-ray systems offer improved maneuverability and dexterity to facilitate lesion access. Wimsatt says a thorough, site-based cross-training program helps Inova Heart manage the evolving procedure mix.

The regulatory front presents other challenges. The Centers for Medicare & Medicaid Services (CMS) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) have adopted major changes in documentation requirements, says Wimsatt. The cath lab turns to its IT staff to create and update templates and dropdown menus in its documentation system. For example, when CMS instituted new criteria for implantable cardioverter defibrillators (ICDs), IT created a dropdown list to prompt physicians and ensure regulatory compliance.

Inventory management remains a challenge. On the front end, the documentation system tracks used inventory, but the lab lacks an automated system to record incoming items. “Staff has to stay on top of inventory,” states Wimsatt, “but I’m not convinced an automated system would significantly improve management.”


A sneak peek into the cath lab of the future


Look for a relaxing of interventional angioplasty criteria, says McDowell. The C-Port-E research project demonstrated the viability of angioplasty in hospitals without open heart surgical backup. The next step is to approve interventional angioplasty in hospitals such as Johns Hopkins Bayview Medical Center.

  • Vulnerable plaque assessment. Imaging technology and clinical know-how aren’t quite ready for prime time, says Dunn. But the cath lab could play a role in diagnosing and treating patients with vulnerable plaque.
  • Tackling total occlusion. New systems such as Siemens Axiom Artis dFC Magnetic Navigation (developed in partnership with Sterotaxis Inc.) provide access to conventionally inaccessible places. “It will open up new procedures,” predicts Dunn.
  • Cardiac CT. PinnacleHealth plans to place a 64-slice CT scanner in its cath lab. “Some sites indicate that cardiac CT can decrease cath lab volume, but we expect coronary, peripheral vascular and EP work to increase because the scanner will find previously undetected blockages,” explains Acquaviva. The Pennsylvania cath lab also may offer as triple abdominal aortic aneurysm (AAA) procedures in the future, and it plans to explore the research potential of percutaneous surgical procedures such as mitral valve replacement.


Smart management



Cardiac cath labs are changing. Conventional cath procedures are down, and competition and regulation are up. Smart labs are adapting by diversifying into EP and peripheral vascular work, cross-training staff, keeping close tabs on and consigning inventory and proactively planning for future developments.