US TAVR Cases Pass a Quarter Million, Surpassing Surgery: Key Trends

Details from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry on more than a quarter of a million TAVR-treated patients, collected over the span of 9 years, show not only gains but also areas for improvement as the procedure’s use has skyrocketed.

The trove of data were published online yesterday as a state-of-the-art review in the Journal of the American College of Cardiology.

“It gives everyone really the raw data from 276,000 patients. It gives it on an annual basis so that people can for themselves look at the trends. So it’s transparent that way,” lead author John D. Carroll, MD (University of Colorado School of Medicine, Aurora), told TCTMD. Also, in supplementary materials, the results are broken down into the risk categories that have shaped clinical trial design, regulatory approval, and now real-world practice: low, intermediate, and high.

A group that had been on his mind, said Carroll, is “those patients we predominately treated early on who were at high prohibitive risk and they didn’t have great 1-year outcomes—are they doing better now? Have the improvements in experience and technology and processes of care translated into these people doing better than they did?”

The answer not only for hard endpoints but also quality of life “was a resounding yes, and that’s very reassuring,” he stressed.

Wayne Batchelor, MD (Inova Heart & Vascular Institute, Falls Church, VA), who serves on the TVT Registry’s steering committee but didn’t take part in the current analysis, stressed the breadth of the data set and the project’s collaborative approach.

“What we’re testing is not just the device. What we’re testing is the multidisciplinary heart team and the success of that really complex method of working up the patients, getting them seen, having multiple specialties bring to bear their expertise on the ultimate outcome,” said Batchelor.

He drew attention to the “sheer volume” of TAVR cases it contains, noting: “It’s just incredible to me.”

Carroll, too, pointed out that the number of people undergoing any form of aortic valve replacement—transcatheter or surgical—grew by 94% from 2012 to 2019, reaching nearly 131,000 that year. Thanks to greater disease awareness but also an aging population, he said, “more people are being treated.”

“TAVR has become the dominant form of valve replacement in the US in a pretty short period of time. That’s historic. That’s just mind boggling,” Carroll observed. “And it’s a success story. It’s improvement in patient care, treating more patients. And everyone has contributed. Certainly, the medical device companies deserve huge credit for their ability to design these devices and to do the clinical trials that have really moved the evidence base along. So I do really think it is something we all should be proud of.”

Batchelor agreed that TAVR’s evolution is “one of the most successful stories in cardiology in the last decade.”

Among the many dramatic shifts in this field is TAVR’s extension to intermediate-risk patients in 2016 and low-risk patients in 2019. This report offers a first glimpse at how these changes are playing out—last year, the registry tracked 8,395 patients deemed low risk by their heart teams. It also details the growing body of evidence on valve-in-valve cases, as well as evolutions in adjunctive technologies like cerebral protection.

Keeping tabs on outcomes across the risk spectrum will be key, said Batchelor. “There’s no room for error in the low-risk group. We’re going to have to show that as we make these forays into the low-risk cohorts, that over the long term we’re doing as well as historically SAVR has done. Because it’s going to be easy to do these patients, but the expectations on outcome—the bar is going to be set so much higher for those folks.”

Both he and Carroll pointed to areas that need work: pacemaker and stroke rates are still too high, and there are stark racial/ethnic imbalances in who gets treatment. “Where I think we have to just really do a deeper dive,” said Batchelor, “is into understanding how these treatment disparities play out, why they’re there. And now that we’re so successful, we’ve got to make sure the success is spread across our broader community in a more equitable fashion.”

COVID-19 also looms, with immediate impact on the STS/ACC Registry itself as well as potential long-term effects on valve health and interventions.

A Peek at the Trends

Between 2011 and 2019, the TVT Registry tracked 276,316 patients who underwent TAVR. Fully 49 US states are captured in the current analysis, as are the District of Columbia and Puerto Rico. In 2020, Wyoming saw its first site open, bringing TAVR’s reach to all 50 states and more than 700 participating centers. Not captured are procedures at military hospitals and the Veterans Affairs medical system.

Annual TAVR volumes grew each year since 2011, exceeding isolated SAVR in 2015-2016. By 2019, TAVR outnumbered all SAVR, at 72,991 versus 57,626 cases.

Femoral access use had risen to 95.3% by the end of the study period, hospital stays had shortened to a median of 2 days, and 90.3% of patients were discharged home.

In-hospital mortality dropped over time, from 5.7% in 2012 to 1.3% in 2019, while 30-day mortality decreased from 7.5% to 2.5%. One-year mortality, using Centers for Medicare & Medicaid Services (CMS) data, decreased from 26.4% in 2012 to 13.7% in 2017, though Carroll emphasized the difficulty in getting full long-term follow-up in the US healthcare system.

In less-promising news, the 30-day pacemaker rate remained at 10.8% in 2019, just 0.1% lower than it had been at the launch of the database. As the proportions of intermediate- and low-risk patients have grown, “you’d think we’d have a major fall in pacemaker need, and there just hasn’t been,” Carroll said, adding that he’s not sure what the solution is.

Stroke, too, continued to be an issue, showing a “small, slow, downward trend,” the researchers report, with an in-hospital rate of 1.6% and 30-day rate of 2.3%.

Additionally, racial/ethnic gaps persisted. Despite undergoing a higher absolute number of procedures in 2019 versus 2012, the relative proportion of Black and Hispanic individuals held steady at around 4% and 2% of TAVR cases, respectively, far lower than would be expected based on US demographics.

“So the demographics are extremely consistent—it’s remarkable,” Batchelor said, noting that the reasons for these disparities aren’t known but likely are complex. Interestingly, a “cursory look at the mitral data” from the TVT Registry, he added, doesn’t show the same patterns.

Variations in aortic valve disease prevalence wouldn’t be large enough to produce differences across race/ethnicity, he explained. Possible culprits—likely overlapping—are access to primary care, referral for further testing, and bias at a treatment level, as well as insurance, socioeconomic factors, cultural beliefs, and patient preferences. There is also some evidence that Black patients are less likely to present with “typical” symptoms, Batchelor continued. “And finally the stark truth is that life expectancy is about 4 to 5 years less for African Americans than for Caucasians—so you actually have to live long to get aortic stenosis. We have no idea to what extent life expectancy plays into this.”

Batchelor’s own research has touched on these issues, and he stressed another factor that has emerged in treatment disparities: rurality. For example, a study led by Abdulla A. Damluji, MD, PhD, MPH (Inova Heart & Vascular Institute), with Batchelor as senior author, showed sevenfold lower TAVR utilization for Florida patients who lived in areas with the lowest population density.

COVID-19 a Challenge

COVID-19, however, may hamper efforts at data collection. Starting in February 2020, the pandemic had “an impact on all programs, [with] most only performing TAVR with urgent clinical implications,” Carroll et al write in their report, noting that it “has impaired submission of data from some sites in 2020.”

In response, the STS/ACC TVT Registry has thus far held two webinars—“Rebooting Your Valve Program Post-COVID” and “The COVID Pandemic and Clinical Trials in New Transcatheter Treatments for Valvular Heart Disease.”

CMS has already announced it will not hold hospitals and physicians responsible for meeting volume requirements mandated for reimbursement for a range of procedures, including TAVR.

Researchers are now gathering data from the second and third quarters of 2020 on not only TAVR but also transcatheter mitral repair and replacement, said Carroll. “Will we see major decrements in volumes of patients being treated? We think so. Will we see shifts in who’s being treated? Will it be much more sick patients, and outcomes therefore look worse, or not?”

Batchelor, for his part, suggested that as the pandemic drags on, TAVR might see ill effects similar to those of the “missing STEMIs” if people delay care.

Lastly, said Batchelor, it will be important to study the intersection between COVID-19 and TAVR outcomes. More universal testing prior to procedures has enabled operators to know their patients’ COVID-19 status beforehand and adjust practices as needed. But there may be unexpected long-term implications, he explained. “We all know that COVID itself presents potentially a hypercoagulable state and can produce myocarditis and cardiomyopathies. So we’re just going to have to see how all that plays out and how that might intersect with valvular heart disease, especially mitral valve regurgitation over time.”