The number of transcatheter aortic valve replacement (TAVR) procedures exceeded all forms of surgical aortic valve replacement (SAVR) in the U.S. for the first time in 2019, while TAVR’s mortality and stroke rates continued to fall since the first approval in 2011.
This is according to an analysis of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT) from 2011 through 2019, which collected data on 276,316 patients undergoing TAVR at sites in the U.S.
The findings were published by the University of Colorado School of Medicine’s John Carroll, MD, and colleagues simultaneously in the latest issues of the Journal of the American College of Cardiology and The Annals of Thoracic Surgery.
TAVR volumes have increased every year since initial U.S. Food and Drug Administration (FDA) approval for inoperable or extreme risk patients in 2011, the researchers said, with subsequent approvals for high-risk in 2012, intermediate risk in 2016 and most recently, low-risk patients in 2019.
As of 2020, TAVR is performed in all U.S. states, with 715 U.S. sites recorded in August, the researchers added. The 2019 data were collected from hospitals in 49 states, two sites in the District of Columbia and two in Puerto Rico, though did not include military hospitals and the Veterans Authority medical system which has eight TAVR programs.
Following the low-surgical-risk indication approval in 2019, TAVR exceeded all forms of SAVR for the first time, with 72,991 procedures versus 57,626. Of the TAVR procedures in 2019, 8,395 were in the low-risk group.
While popularity of the procedure has continued to grow, outcomes have continued to improve. For instance, the 30-day mortality rate associated with TAVR fell from 7.2% in 2011 to 2.5% in 2019. Incidence of stroke at 30 days has also started to decrease, the researchers said, dropping from around 2.75% to 2.3%.
However, pacemaker need at 30 days is largely the same, from 10.9% in the early days to 10.8% in 2019, peaking in between at 15.1% in 2015. The researchers called the still-high pacemaker rates “perplexing” given the inclusion of large numbers of patients in the intermediate-risk category (32,697 in 2019). Pacemaker rates are related to patient risk category, they said.
“This issue is clinically problematic, given the short hospital (length of stay) after TAVR and an increasing proportion of patients require a pacemaker after hospital discharge, during which time, there is some risk of sudden death and other complications due to conduction system block,” Carroll and colleagues noted.
There was also a persistent under-representation of Black people, who made up just 3.98% of the overall population, compared to white people, who made up 92.82% of the total.
An accompanying press statement said the finding will stimulate further research into its possible causes ranging from barriers to health care access to differences in the prevalence of disease.
Other minority groups were underrepresented, including those of Hispanic or Latino ethnicity (4.70%), Asian (1.34%), Native American/Alaskan native (0.29%), and Native Hawaiian/Pacific Islander (0.17%).
Overall, the registry analysis shows major real-world trends in the TAVR patient population as its broad use continues to grow, Carroll said in the press statement.
“The data on outcomes after TAVR document a substantial improvement in quality of care in the last nine years,” he said.
In the study, the researchers added that they expect further growth of TAVR use with recovery of the health care system in the “new world of COVID-19.”
Carroll J, Mack M, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2020;76:2492-516.