More than 276,000 U.S. patients have undergone a TAVR procedure since the approval of the first TAVR device in 2011, with outcomes improving over time, according to a review paper simultaneously published Nov. 16 in the Journal of the American College of Cardiology and the Annals of Thoracic Surgery.

John D. Carroll, MD, FACC, et al., used data from the STS/ACC TVT Registry to examine year-by-year data from hospitals performing TAVR. Specifically, the researchers looked at procedure volumes and characteristics, patient characteristics, and outcomes for all TAVR procedures at active TAVR sites from 2011 through 2019. TAVR patients were categorized into three subgroups based on traditional SAVR risk – high or extreme risk, intermediate risk and low risk – to reflect trends as approved indications expanded over time to increasingly lower-risk patients. The researchers defined early TAVR experience as patients treated from late 2011 through 2013, which was compared to current TAVR experience, defined as patients treated in 2019.

Results showed that TAVR volumes have increased each year. In 2019, 72,991 TAVR procedures were performed, exceeding the 57,626 SAVR procedures performed. This coincided with the U.S. Food and Drug Administration (FDA) approval of TAVR for low-risk patients. In 2019, sites performed an average of 84 TAVR procedures, with 161 sites performing fewer than 50 cases. In the early TAVR period, 57.1% of TAVR procedures used femoral artery access, compared with 95.3% in 2019. Alternative access approaches also changed over time, with transapical and direct aortic approaches being the most common in the early TAVR period, compared with the axillary-subclavian in 2019.

The age of patients undergoing TAVR has decreased, from a median of 84 years immediately after FDA approval to a median of 80 years in 2019. Males accounted for 56% of TAVR patients in 2019, a shift from the early TAVR period when there was a nearly equal male/female distribution of patients. For all years, TAVR patients were predominantly white, with a persistent underrepresentation of Black patients. Between 2011 and 2018, high-risk patients were the largest cohort undergoing TAVR. In 2019, intermediate-risk patients were the largest cohort and low-risk patients made up 11.5% of all TAVR cases.

Regarding outcomes, in-hospital mortality has decreased from 5.4% in the early TAVR period to 1.3% in 2019, while 30-day mortality has decreased from 7.2% to 2.5%. In-hospital and 30-day stroke rates also have decreased. Pacemaker implantation rates within 30 days have not changed significantly over time. The median length of stay also has declined from seven to two days.

According to the researchers, the STS/ACC TVT Registry offers a "comprehensive observational warehouse of patient-level data" that provides insight into the state of TAVR in the U.S. They note that one-year outcomes have steadily improved over time and conclude that "further growth is expected with recovery of the health care system" after the COVID-19 pandemic.

"The STS/ACC TVT Registry allows us to see major trends occurring in the real-world TAVR patient population, including a rapid growth in both the number of hospital sites performing TAVR and case volume as we treat a broader spectrum of patients," said Carroll, who is chair of the STS/ACC TVT Registry Steering Committee. "We have also seen TAVR become the leading choice for aortic valve replacement compared to the open surgical approach. Furthermore, the data on outcomes after TAVR document a substantial improvement in quality of care in the last nine years."

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, COVID-19 Hub, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Cardiac Surgery and Arrhythmias

Keywords: Aortic Valve, Hospital Mortality, Thoracic Surgery, COVID-19, Transcatheter Aortic Valve Replacement, Femoral Artery, Length of Stay, severe acute respiratory syndrome coronavirus 2, Heart Valve Prosthesis, Registries, Pandemics, Cardiology, Stroke, STS/ACC TVT Registry, National Cardiovascular Data Registries

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