by
Lisa Chamoff, Contributing Reporter | March 02, 2015
From the March 2015 issue of HealthCare Business News magazine
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.
