Future Vision: How Will Today’s Trends Shape Tomorrow’s PCI Toolbox?

Interventional cardiology has come light years since the advent of bare-metal stents and directional atherectomy in the late 1980s. The next decade promises an even wilder ride, driven by the increasing complexity of diseases and co-morbidities, the graying of the American population, the seismic move from fee-for-service to a risk-bearing, performance-based payment model and much more. What trends are expected to have the greatest impact, and which tools will evolve to help the field manage the transformation?

Inside a cath lab, the “final frontier” for interventional cardiology—chronic total occlusion—is being conquered by a physician in blue scrubs and a head-mounted virtual reality display. Thanks to 3D projections from a coronary computed tomography (CT) angiogram that fill his field of vision, the interventionalist is able to clearly visualize the patient’s occluded coronary segment and verify the direction of the guidewire snaking through the distal vessels. This vivid optical reconstruction—virtually putting the physician inside the blocked artery—allows him to restore blood flow to the vessel by implanting stents in a safer, faster, more accurate way than ever before.

It will probably be years before this scene, which actually played out at the Institute of Cardiology in Warsaw, Poland, last year, becomes a cath lab fixture. There’s little question, though, that virtual reality has the ability to remake the field. “It would be immensely helpful if we could actually see how a stent is deploying within a vessel and covering branches, or if we could see a 3D reconstruction of how a valve is fitting into the patient’s aorta,” ventures Jordan Safirstein, MD, director of transradial intervention and assistant director of the cath lab at Morristown Medical Center in New Jersey. “Right now, OCT [optical coherence tomography] provides wonderful imagery for us, but virtual reality has the potential to take the technology to a new level.”

Chronic total occlusion is just one of a growing number of anatomically complex conditions—left main coronary artery disease, bifurcations and microvascular disease are others—that are pushing interventional cardiology in significant new directions. At a time when the clinical practice landscape is being reconfigured by the Medicare Access & CHIP Reauthorization Act (MACRA), appropriate use criteria (AUC) and new bundled payment models, trends like radial access and same-day discharge will continue to intensify. Used in just 1 percent of percutaneous coronary interventions (PCIs) in 2008 in the United States, radial access has since grown to around 30 percent and is expected to become the predominant vascular access site over the next decade, propelled by studies linking it to lower bleeding rates and reduced hospital stays and associated costs. “Radial access is part of the adoption of safer, more efficient care strategies,” notes Sunil Rao, MD, associate professor of medicine at the Duke Clinical Research Institute and outgoing chair of the quality committee for the Society for Cardiovascular Angiography and Interventions (SCAI), who authored one of those studies. “Hospitals are realizing in an era of one-lump payment for procedure and length of stay, if they can reduce complications and get patients out faster they can reserve these beds for cases of advanced heart failure, pneumonia and the like.”

Closely linked to radial access is same-day discharge following PCI. “As we move into a capitated environment, there will be growing pressure from payers and health systems to perform complete revascularizations in a single session, whenever possible,” maintains Herb Aronow, MD, MPH, director of interventional cardiology at Lifespan Cardiovascular Institute in Rhode Island. Rao, who has co-written several papers on same-day discharge since 2011, predicts that the widening interest in “same-day” he sees from clinicians and administrators will help it grow well beyond its current 16 percent penetration rate in the years ahead (JAMA 2011;306[13]:1461-7; JACC Cardiovasc Interv 2013;6[2]:99-112; JAMA Cardiol 1[2]:216-23). Medical centers that currently use the practice, he notes, typically require four to six hours of observation following PCI and discharge the same day only if the patient is stable and doesn’t need prolonged anticoagulation or antiplatelet therapy.

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Technology as the great enabler

Same-day and radial access are points on an even broader trend line known as minimally invasive intervention. Transcatheter aortic valve replacement (TAVR) is a perfect case-in-point. At one time performed only on patients at the highest risk for open-chest surgery, the success of percutaneous valve replacement has opened the door to moderate-risk patients, and low-risk trials are underway.

“Patients prefer a less invasive way of being treated,” says  Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at Mount Sinai Hospital in New York. “And through improved guidewire and catheter technologies and better visualization in the cath lab and noninvasive imaging before it, we’re able to handle very complex procedures that previously required referring patients for bypass surgery.”

Safirstein suggests that the shift to less invasive in the years ahead could augur big changes in how patients are sedated. “Maybe we can do some or even a majority of valve replacement procedures in a less surgical environment with the patient awake,” he posits, “getting them out even sooner.”

For disruptive changes like these to flourish, however, the consensus is that technology must serve as the great enabler. Stents have been more than equal to the challenge, amazing some with their ongoing inventiveness through bioresorbable polymers, high-pressure balloons with thinner walls and miniaturized stents that don’t need to be advanced over a guidewire because the stent is the guidewire. Tests are underway on stents with dissolving microelectronics for patient monitoring and the delivery of drugs on demand. The evolution in design is expected to continue not just for stents, but for atherectomy, where the relatively new orbital device is drawing growing interest at the same time the old standby, rotational atherectomy, is being updated to make it more user-friendly.

Imaging and other tools for assessing lesion severity also will continue to build on their explosive growth of the past decade with the emphasis on noninvasive testing and eliminating any gap between test and diagnosis. Paving the way are fractional flow reserve (FFR), already an indispensable tool for many cath labs in determining whether to treat a lesion, and intravascular ultrasound (IVUS) for understanding the nature of the blockage. The real future, as many experts see it, could be FFR-CT, which uses CT imaging data to assess whether a coronary artery blockage is hemodynamically significant. If it’s not, the patient could avoid an unnecessary catheterization procedure. Technology is also beginning to integrate FFR and OCT for lesion mapping and provide visual guidance for stent selection and deployment.

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Paying for value instead of volume

As cardiologists look to the future, however, they’re well aware that technology is not the only drummer to which they’ll march. There’s the less flashy but still hugely powerful pay-for-performance model that’s emerging—one that rewards providers for improved quality and outcomes and puts a premium on data reporting, benchmarking, risk management and team-based care. As American College of Cardiology (ACC) President Richard Chazal, MD, puts it, “Technology tells us what we can do, but data and outcomes research tell us whether or not we should do it.” Pointing to the profound impact MACRA and AUC are already having on how medicine is practiced, Chazal adds, “I believe our principal investment will not be so much in hardware-type technology, but in our ability to harvest, analyze and act upon data.”

National registries like ACC’s National Cardiovascular Data Registry, which captures reams of clinical data and converts it into AUCs and other practice guidelines, and mobile tools like SCAI’s AUC calculator, a downloadable app for smartphones, tablets and laptops that allows physicians to assess the prudence of revascularization on a patient-by-patient basis, are windows into this data-fueled future. “There will be a lot more awareness of public reporting of data and documenting why the procedures we’re doing are appropriate,” acknowledges John P. Reilly, MD, vice chair of the Department of Cardiology at Ochsner Medical Center in New Orleans. “And that’s an area where we haven’t done a good enough job in the past.”

Another quality-based trend that will prompt cardiologists to rethink how they practice is team-based care. Hitting the quality and performance targets being set by Medicare and other payers will require more integrated patient care models. “Especially in cases like structural heart disease and TAVR, you need the input of not just surgeons and the heart team but nurses, technologists and others involved in making decisions at different points of the patient’s care,” points out Mehran. A novel addition to that team might even be “scribes,” as Aronow sees it, to help manage documentation requirements and “reorient the provider away from the computer screen and toward the patient once again.” Nevertheless, a look into the future convinces him that “much work on cost-effectiveness and cost-utility will be needed to guide medical decision-making.”