A CMS registry established in 2012 for transcatheter heart valve procedures has provided physicians and researchers with real-world data on outcomes and patient safety, allowing providers to benchmark themselves against their peers across the nation and enabling industry and regulators to conduct well-informed post-market surveillance.
But do the time and resources that it takes to enter data into the registry constitute a burden for providers?
Nobody doubts that the registry, which is managed by the Society of Thoracic Surgeons and the American College of Cardiology, provides valuable data from tens of thousands of patients who have undergone the procedure and has informed a number of studies. But Mike Mussallem, CEO of devicemaker Edwards Lifesciences Corp., is concerned that efforts like the TVT registry are a drag on providers' resources.
“It's a burden on the system. Right now, it's tough on hospitals. In addition to the fees they pay, they have to have staff to manually fill out multiple data fields,” Mussallem said during an interview at the American College of Cardiology's Annual Scientific Session and Expo in Chicago on Sunday.
Participation in the registry is required for providers seeking Medicare payment for transcatheter heart valve procedures. Edwards produces the SAPIEN 3 Transcatheter Heart Valve, which is currently approved for use on patients for whom open-heart surgery would be too risky.
An evidence-development requirement such as a registry often means there are still questions about a device's clinical effectiveness. The registry currently includes 428 participating facilities in 48 states, the District of Columbia and Puerto Rico.
Many hospitals hire a data manager to facilitate data collection and submission, though approaches to this process vary, according to the registry's website. Providers pay an initial fee of $25,000 to join the registry in their first year, then pay an annual fee of $10,000 in subsequent years.
Mussallem estimated that it takes hospitals three to four times longer to enter data than it does to complete the procedure, because much of the data isn't streamed directly from the electronic health record. He said Edwards is very supportive of the registry “broadly and philosophically” in that it allows the industry to collect real-world data, but the company is concerned about whether it's a sustainable model for providers.
“We think, ultimately, if we want these kinds of registries to be used more broadly, we need to find ways to get the benefit of them with a little less burden,” Mussallem said.
But physicians who spoke to Modern Healthcare downplayed his estimate of how long data entry takes and argued that the benefit of real-time data outweighs the burden of resources.
“There is a burden, but I think that that's a necessary evil to maintain the integrity and the efficacy of the procedure,” said Dr. Mauricio Cohen, an interventional cardiologist and director of the Cardiac Catheterization Laboratory at the University of Miami Hospital.
Cohen and his colleagues perform between 100 and 120 transcatheter aortic valve replacement procedures a year, or a little more than two a week. He said the University of Miami has one person assigned to manage the resulting data and liaise with the registry.
For most patients, the procedure takes about 45 minutes. Dr. Frederick Grover, vice chairman of the steering committee for the registry, said his data manager at the University of Colorado Hospital has determined that it takes between 45 minutes and an hour to input all the relevant information, which can include a variety of indicators, such as time in the ICU, length of stay and whether the patient was discharged to a rehabilitation facility or nursing home.
Grover said he's heard some complaints about the data burden, and that STS and ACC are cognizant of it and could eliminate or modify some of the fields as the registry evolves. The registry committee has discussed streamlining data from electronic health records, though at the moment that can be tricky if the EHR data fields don't match up with the registry's fields.
Nonetheless, Grover said hospitals shouldn't be shy about spending resources on quality improvement.
“For this type of a new thing we're looking at, new technology, we don't want to miss something,” Grover said. “We try to pick up early signals of potential issues of technology that hasn't been out that long.”
Grover's comments are timely given the recent recall of Abbott Laboratories' MitraClip system, a transcatheter mitral valve repair device that also requires TVT registry participation. Complications from use of the MitraClip were not reported through the registry, but rather directly to Abbott.
The registry has already informed a number of studies, including one presented at the ACC conference that found that higher-volume TAVR sites had better outcomes. This “learning curve” has been found in other surgeries as well, and could suggest that TAVR procedures should be limited to a small number of high-volume sites.
“It's exciting to envision a future in which a registry that is as large and robust as the TVT registry can serve as a platform for simple, pragmatic, randomized trials,” said Dr. Patrick O'Gara, an STS trustee and director of clinical cardiology at Brigham and Women's Hospital, during a roundtable about the registry at the society's annual meeting earlier this year.
Edwards Lifesciences rival Medtronic, which produces the CoreValue TAVR device, did not respond to a request for comment.