The Siemens Artis one
Angiography System,
a floor-mounted system
that covers a broad range
of procedures, was FDA
approved in May 2014.

Special procedure rooms: will TAVR shift to the cath lab?

March 02, 2015

by Lisa Chamoff, Contributing Reporter

Special procedure rooms are coming into their own, driven by both innovation and the need to justify costs that has come to be a dominant trend driving change in the health care landscape. For example, transcatheter aortic-valve replacement (TAVR) is generally done in a hybrid operating room, but the conventional wisdom is that the open-heart surgery alternative will eventually migrate into the cardiac catheterization lab, resulting in a substantial cost savings.

A small study published in the August 2014 issue of JACC Cardiovascular Interventions looked at 142 patients, 70 who underwent TAVR with the Edwards Sapien valve in a cath lab, and 72 who had the procedure performed in a hybrid OR. According to the paper, all procedures in the cath lab were successful, with one patient intubated, while three patients in the hybrid OR had a procedure- related death. There was no significant difference between the two groups in mortality at 30 days, and both 30 day stroke/ transient ischemic attack and moderate or severe paravalvular leak were similar. Procedure room time, length of stay and costs were all lower in the cath lab procedures, by close to $10,000.

“The NCD (national coverage determination) has been firm in saying that the procedures should be done by a heart team consisting of a surgeon and a cardiologist,” says Dr. David Holmes, a past president of the American College of Cardiology and professor of medicine in cardiovascular disease at the Mayo Clinic. “NCD doesn’t say…it needs to be done in the cath lab and it doesn’t say it has to be done in the OR. The majority are still done in OR by virtue of the fact that the catheters are large in size. As the catheters get smaller and smaller, it gets more feasible to do these in catheterization laboratories.”

Holmes notes that if a facility were to perform TAVR in the cath lab, it would need a very good system to handle emergencies that require bypass surgery. “They need to be an expert center with an expert heart team,” Holmes says. “Not any facility in a small town someplace can get started.”

Tom Watson, a clinical analyst at MD Buyline with more than 35 years of experience in the field of cardiovascular medicine, agrees. He notes that it’s a generally accepted belief that less risky TAVR procedures will evolve into the more traditional cath lab, much like what happened with balloon angioplasty years ago.

“I believe it would still be limited to facilities that are capable of doing open-heart surgery valve replacements,” Watson says. “I think we’re still several years away from that becoming a reality, but that’s a very common theory.”

There are still concerns with post-TAVR issues, such as leaking due to the positioning of the valves, and techniques with 3-D ultrasound have had to be perfected. There is a long list of requirements a facility has to meet before it can be considered for approval for a TAVR program, Watson says.

According to the Centers for Medicare and Medicaid services, TAVR must be performed in a hospital with the appropriate infrastructure including, but not limited to: an on-site heart valve surgery program; a cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging system with flat-panel fluoroscopy; noninvasive imaging such as echocardiography, vascular ultrasound, computed tomography, and magnetic resonance; sufficient space, in a sterile environment, to accommodate equipment for cases with and without complications; and a post-procedure intensive care facility with staff experienced in managing patients who have undergone open-heart valve procedures.

There are also qualifications for hospitals with and without TAVR experience that include a minimum number of aortic valve replacements and catheterizations previously performed and physicians that have performed those procedures a minimum number of times.

“Initially, and rightly so, it was suggested that less than 100 facilities will have the procedure in general,” Watson says. But if a facility is not ready to do TAVR today, there are things it can do, at a smaller cost and a lower barrier in terms of staff training and knowledge, to move toward the ultimate goal of being able to provide care that is safe. “Some facilities have moved ahead with the technology to prepare when things open up. You can purchase the imaging foundation without expending a tremendous amount of money beyond what you would purchase for a typical diagnostic/ interventional system in order to be prepared for TAVR, if you choose,” Watson says. In addition, there are technical innovations that are paving the way to making it easier for institutions to handle the challenges of the procedure.

“Technological advances are being made almost every six months,” says Morton Kern, chief of medicine at the VA Long Beach Healthcare System in California and Last year, for example, Medtronic got FDA approval for its self-expanding transcatheter CoreValve System, after studies showed clinical outcomes at one year with the CoreValve System were superior to open-heart surgery.

The valves themselves are undergoing renovations as well, reducing aortic regurgitation with skirt-like structure on the bottom and with better retractability for repositioning, according to Kern. But there are those who are less than enthusiastic about moving TAVR to the cath lab.

Niels Bakker, marketing manager for Philips, isn’t so sure the room has the best setup for a procedure like TAVR, which needs more flexible positioning of imaging equipment and higher sterility for transapical access. “When we first started hybrid ORs, we just used cath lab equipment and placed them in an OR environment,” Bakker says. “The positioning capabilities of cath lab systems are not optimal for a hybrid OR, so Philips developed dedicated hybrid OR solutions like the FlexMove that give higher flexibility… I think the hybrid OR is still a very valid proposition if you look at the broad spectrum of new SHD procedures emerging.”

New imaging products
There are other new imaging products that promise to accelerate the trend to reducing cost and improving patient care in special procedure rooms.

In general for TAVR procedures, multimodality imaging is important. To that end, last year Philips released a second version of its EchoNavigator, which first came to the market in 2013. The new version fuses live X-ray and 3-D cardiac ultrasound imaging, or echocardiography, during structural heart disease procedures.

Previously, the EchoNavigator oriented echo and X-ray in the same projection, but the images were still side by side, says Bakker of Philips. The second release actually fuses the two images together in real time. “Echo allows you to see the soft tissue anatomy that you are treating and the X-ray gives you an excellent view on your devices,” Bakker says. “Fusing the images makes it easier.”

At last year’s RSNA, Toshiba released its Infinix 4DCT, which overlays real-time CT images over fluoroscopic images. David Sloop, director of Toshiba’s X-ray vascular business unit, says the technology improves the workflow of oncology and cardiac procedures, allowing physicians to plan, treat and verify in one place, rather than transferring patients to the CT lab and dragging out procedure times.

“Often in the regular lab, doctors can’t see the smaller tumors,” Sloop says. “They have to take patient off the gurney and bring them to the CT lab, or use a CT image from a day or two ago. Now, they can do all that in one room.”

The Infinix 4DCT system is FDA cleared with the Infinix Elite and Aquilion ONE ViSION Edition configuration, as well as for use with the Aquilion PRIME CT system. Also last year, Toshiba released the Infinix Essential value system for interventional cardiology. The system has a slim, off-center C-arm design, allowing steep angulations for optimized vessel profiling during cardiac interventions.

For other cardiovascular procedures, Siemens received FDA approval in May 2014 for its Artis one Angiography System, a floor-mounted system that covers a broad range of procedures, including revascularization of peripheral vessel occlusions, diagnostic or minimally invasive angiographic treatment of narrowed coronary arteries, and pacemaker implantations. Rob Dewey, senior director of marketing for angiography imaging systems at Siemens Healthcare, says this addresses a trend of the broadening of cardiologists’ procedure mix from cardiac to the peripheral system.

“It really takes to heart this marriage of cardiac and peripheral vascular procedures,” Dewey says. Dewey says the system has a more intuitive user interface that allows the person using it to keep their eyes on the display, driving everything from a menu-driven approach on the screen. Additionally, new tools for cardiac imaging include HeartSweep, which uses dual-axis rotational angiography to image the entire heart in a single C-arm movement, instead of multiple acquisitions from different projections, which the company says has the potential to speed up procedures and reduce the amount of contrast needed. The Clearstent Live application, which was previously available on Siemens’ premium systems, such as the Artis Q and the Artis Q.zen, helps physicians more precisely position stents by freezing movement in the area of operation.

Dewey also emphasizes the system’s small footprint — 269 square feet, compared to the standard 484 square feet taken up by ceiling-mounted systems, as well as the ability to cover patients up to 6-feet- 10-inches tall without repositioning them.

Radiation risks
Using this equipment in the close confines of a cath lab, does raise concerns about radiation dose. Dr. Charles Chambers, an interventional cardiologist who serves as director of the cath lab at Penn State Hershey Medical Center and president of the Society for Cardiovascular Angiography and Interventions, says cardiologists are becoming increasingly more aware of the risks of radiation and need to continually keep dose in mind for the safety of the patient.

“You need to make sure the right procedure is done with the right equipment for the right patient,” Chambers says. Chambers says other modalities may be used to reduce the need for fluoroscopic imaging. Physicians, for example, can use intra-cardiac echo and intra-vascular echo to assist in the imaging of coronary arteries or heart valves, reducing radiation during a cardiac catheterization.

A study by the Cleveland Clinic published in August of last year looked at reducing the default fluoroscopic frame rate and a greater use of low-dose acquisition in diagnostic catheterization (DC) and percutaneous interventions (PCI). By reducing the default fluoroscopic frame rate from 10 to 7.5 frames per second and increasing the emphasis on the use of low-dose acquisition starting in 2013, there was a marked reduction in air kerma rates for both DC and PCI compared to the previous year — a median of 625 milligray in 2013 versus 798 milligray in 2012 for DC and a median of 1675 milligray in 2013 compared to 2463 milligray in 2012 for PCI.

New technology has shown fairly definitive improvement in the amount of radiation expended to show high-quality diagnostic images, says Watson of MD Byline. Some vendors have two levels of systems, one that has a traditional imaging package with very good traditional dose management software and a new generation that is the same core technology, but with further enhancements, such as improved X ray tubes and/or new detectors, coupled with new processing software for even more advanced dose management, dose reduction capabilities.

Less invasive thanks to imaging
Imaging is also helping to decrease the need for invasive procedures. Dr. James Min, who specializes in the diagnosis of coronary heart disease with multi-detector CT angiography at Weill Cornell Medical College, notes that at the end of last year, the FDA approved marketing of the HeartFlow FFR-CT software, which allows physicians to non-invasively evaluate blood flow in the coronary arteries of patients with signs and symptoms of coronary artery disease. Before, the patient would have to undergo an invasive procedure that entails running a wire through the coronary artery and measuring pressure before and after the blockage. With the new software, a 64-slice CT angiogram is sent to the company, called HeartFlow, and they use it to calculate fractional flow reserve.

“Diagnostic accuracy is so much higher that I think it will become the standard of care,” Min says. “You have the anatomic as well as the physiological importance of these plaques. That’s a game changer.”

DOTmed Registered Special Procedures/Cath-Angio March 2015 Companies