The volume of transcatheter aortic valve implantation (TAVI) procedures in the USA exceeded surgical valve replacement for the first time in 2019, data from The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry, published today, have revealed.
The registry data confirms that since the first TAVI device was approved in the country in 2011, TAVI procedures have increased year-on-year, 30-day mortality and stroke rates have decreased, while pacemaker need has remained 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 [TAVI] 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, 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 TAVI 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—surgical aortic valve replacement. Researchers examined data in the STS/ACC TVT Registry for all TAVI procedures performed at sites active through 2019. An early TAVI experience was defined as patients treated from late 2011 through 2013 and was compared to current TAVI experience, which was defined as patients treated in 2019.
Data in 2019 are from hospitals located in 49 US states, as well as two sites in the District of Columbia and two sites in Puerto Rico. In August 2020 there were 715 US TAVI sites. As of the opening of a site in Wyoming in 2020 TAVR programmes exist in all 50 states. The only US TAVI 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 TAVI programs.
The annual volume of TAVI has increased each year and in 2019 TAVR volume (72,991) exceeded all forms of SAVR (57,626), coinciding with the US Food and Drug Administration (FDA) approval of TAVI for low-risk patients. The number of TAVI procedures performed per site varies, but as the number of sites performing TAVI has increased, the total annual volume has increased. In 2019 sites performed 84 TAVI 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 TAVI.
Data showed the median age of patients undergoing TAVI has slightly gone down from early TAVI experiences. In 2019 mostly males (56%) underwent TAVI, a shift away from the early TAVI period when there was a nearly equal male/female distribution of patients undergoing the procedure. For all years, patients undergoing TAVI were predominantly white with the persistence of under-representation of black patients, based on overall US demographics, at 4% despite the substantial growth of sites offering TAVI. This finding will stimulate further research into its possible causes ranging from barriers to health care access to differences in the prevalence of disease, ACC and STS said. From 2011 through to 2018 extreme and high-risk patients remain the largest cohort undergoing TAVI, but in 2019 intermediate-risk was the largest cohort. In 2019, the first year TAVR was FDA-approved for low-risk patients, this population made up 11.5% of all TAVI patients and had a median age of 75.
In the early TAVI period with very large vascular sheaths required for the first-generation TAVI delivery catheters, only 57.1% of TAVI procedures used femoral artery access. By the current TAVI period in 2019, femoral access accounted for 95.3% of vascular access sites for the procedure. In 2019 the axillary-subclavian was the most commonly used alternative access approach, a shift from the use of transapical and direct aortic approaches that were the common alternative access point in the early TAVI period.
The median length of stay for patients has declined from seven days to two days for all patients over the course of the report. For patients assessed as low-risk, the median length of stay in 2019 was only one-day—an overnight hospital stay—with some patients discharged the same day. In the early TAVI period, most patients were discharged to another care facility. In 2019 90.3% of patients were discharged home, while 6.6% were discharged to a rehabilitation or extended care facility and 2.45% to a nursing home. Researchers also found a steady and dramatic shift in mortality from the early TAVI period to 2019. In-hospital mortality fell from 5.4% to 1.3% and 30-day mortality decreased from 7.2% to 2.5%. In-hospital and 30-day stroke rates also fell from the early TAVI period to the current TAVI period. However, the 30-day pacemaker implantation rate has remained largely the same. The in-hospital rate has fallen in the context of the shorter length of stay at the hospit