Since the approval of the first transcatheter aortic valve replacement (TAVR) device in 2011, more than 276,000 patients have undergone a TAVR procedure in the United States. According to a report from The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry, volumes have increased every year and in 2019 TAVR exceeded all forms of surgical aortic valve replacement (SAVR) for the first time. In addition, over time the 30-day mortality and stroke rates have decreased, while pacemaker need remains largely unchanged. The full report was published in the Journal of the American College of Cardiology and The Annals of Thoracic Surgery simultaneously.
"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. We have also seen TAVR become the leading choice for aortic valve replacement compared to the open surgical approach," said John D. Carroll, MD, Chair of the STS/ACC TVT Registry Steering Committee and the lead author on the report. "Furthermore, the data on outcomes after TAVR document a substantial improvement in quality of care in the last nine years."
Since the first TAVR device approval, access has been extended from patients considered inoperable or at extreme risk (2011), at high-risk (2012), intermediate-risk (2016) and low-risk (2019) for SAVR. Researchers examined data in the STS/ACC TVT Registry for all TAVR procedures performed at sites active through 2019. An early TAVR experience was defined as patients treated from late 2011 through 2013 and was compared to current TAVR experience, which was defined as patients treated in 2019.
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Data in 2019 are from hospitals located in 49 U.S. states, as well as two sites in the District of Columbia and two sites in Puerto Rico. In August 2020 there were 715 U.S. TAVR sites. As of the opening of a site in Wyoming in 2020 TAVR programs exist in all 50 states. The only U.S. TAVR sites not included in the STS/ACC TVT Registry are those in military hospitals and the Veterans Authority (VA) medical system: as of mid-2019 there were eight VA TAVR programs.
The annual volume of TAVR has increased each year and in 2019 TAVR volume (72,991) exceeded all forms of SAVR (57,626), coinciding with the U.S. Food and Drug Administration (FDA) approval of TAVR for low-risk patients. The number of TAVR procedures performed per site varies, but as the number of sites performing TAVR has increased, the total annual volume has increased. In 2019 sites performed 84 TAVR procedures on average with 161 sites performing less than 50 cases. An expert consensus document published by stakeholders--including the ACC and STS--included a recommendation of a 50-case annual threshold minimum for sites performing TAVR.