TAVI expands the population of treatable AS, does not cut in SAVR

Surgical volumes have not declined significantly, despite the dramatic growth in the use of the catheter procedure in recent years.

Not only is TAVI bringing aortic valve replacement (AVR) to a wider range of U.S. patients with severe symptomatic aortic stenosis, it has also performed better over time, according to an analysis from the National Inpatient Sample.

The number of patients treated with TAVI increased from just 6,470 in 2012 to 57,155 in 2018, with the procedure surpassing surgery in terms of the share of all AVRs during this period. TAVI accounted for 11.1% of AVRs in 2012 and 58.0% at the end of the study period, report lead author Katherine Clark, MD, MBA (Yale University School of Medicine, New Haven, CT) and her colleagues. colleagues in a research letter recently published online in the American Heart Journal.

But SAVR volumes did not decline much during TAVI’s growth, with 44,117 surgical replacements completed in 2008 and 41,455 in 2018.

It’s “pretty encouraging,” Clark told TCTMD. “This suggests that we are reaching an increased number of patients with severe aortic stenosis and that we are having a significant impact on a larger patient population.”

Additionally, there have been reductions in in-hospital mortality, length of stay, and procedural costs associated with TAVI over time. “It achieves the three-fold goal of healthcare: outcomes have improved, costs and resource use have declined, and access to this technology has expanded to a wider population,” Clark said.

Yet, commented Benjamin Wessler, MD (Tufts Medical Center, Boston, MA), another key finding is that there are persistent racial / ethnic disparities in access to TAVI and SAVR, despite some gains over the years. study period.

“The treatment of white patients dominates the national landscape, and I think if [Clark et al] identify a modest increase in the number of Hispanic patients being treated, I really think the observation is that there is a profound under-treatment of under-represented minorities in this space, ”he said, calling for more research into the underlying reasons.

Clark recognized that “we still have a lot of work to do, but the needle is definitely going in the right direction.”

National trends

From the first TAVI device has been approved in the United States in 2011 – the Sapien valve (Edwards Lifesciences) – the procedure took off, with indications expanding from inoperable patients to patients at moderate and then low surgical risk.

Regarding the national sample of inpatients, Clark et al set out to examine how the AVR landscape has changed since then. The analysis included 208,500 admissions for TAVI between 2011 and 2018 and 540,775 admissions for SAVR (with concomitant acts in 12.5%) between 2008 and 2018.

The total volume of AVR procedures increased from 58,120 in 2012 to 98,610 in 2018 (P

On average, patients undergoing TAVI were much older than those undergoing surgery (mean age 80.1 versus 68.9), although the age was lower for the transcatheter approach over time. Most of the patients, regardless of the type of AVR, were males (53.7% for TAVI and 65.7% for SAVR) and white (87.0% for TAVI and 83.8% for SAVR). The proportion of Hispanic patients undergoing TAVI increased from 2.4% in 2012 to 5.6% in 2018 (P

Socioeconomic status and geographic region did not have a strong association with AVR use. Medicare was the primary payer for TAVI (90.0%) and SAVR (65.4%), although this number declined slightly over time for the catheter procedure.

Both procedures were performed primarily in large teaching hospitals in urban areas throughout the study period, but they were increasingly performed in small and medium-sized hospitals over the years.

From 2012 to 2018, the proportion of patients discharged home increased for TAVI (64.2% to 86.1%), with a smaller variation for SAVR (68.7% versus 76.0%). The median length of stay increased from 6 to 2 days for TAVI (P

Hospital mortality was overall lower with TAVI than with SAVR (1.9% vs 2.7%) and decreased more during the study with the transcatheter approach (from 4.5% to 1, 4%) than with surgery (2.7% to 2.2%). The authors caution, however, that “mortality was not adjusted between groups, so differences in indications between procedures, which are more extensive for SAVR than for TAVR, may have affected mortality. observed and length of stay. [differences]. “

Total hospital costs have also declined over time for TAVI, from a median of $ 61,508 in 2012 to $ 47,642 in 2018, while remaining relatively stable for SAVR; the costs of the transcatheter and the surgical treatment were approximately equal at the end of the study period.

What is behind the improvements in TAVI?

Clark et al state that the positive trends in TAVI results are likely related to multiple factors, “including an optimized valve design with improved hemodynamics, improved operator skills and procedural training, as well as decreased perioperative complications ”. The lower costs, they continue, “can potentially be attributed to a shorter length of stay and fewer perioperative complications. The inclusion of low-risk patients also likely contributes to improving in-hospital mortality and lowering the total cost; However, a more in-depth understanding is needed regarding the durability of the TAVR valve as the indications develop.

Wessler also attributed the gains in TAVI to improvements in performing the procedure and changes in the types of patients treated. “We are better at providing this procedure to patients in terms of the success of the procedure and the care systems to move patients through the hospital safely,” he explained. “Plus, the patients who are treated now are generally less sick than they were in 2011, and that’s when the surgical risk, or procedural risk profile, has decreased as [TAVI] has been available for a larger number of patients based on clinical trial data.

The fact that SAVR volumes have not declined significantly despite a rapid increase in TAVI use is not particularly surprising, Wessler commented, as other studies have shown stabilization of SAVR levels. “There are several patients. . . that are optimized with an open technique, and this cohort will persist over the years, ”he said, pointing to younger patients, those with bicuspid valves and those who also require coronary bypass surgery. “And I also believe that as there is increased recognition of the need to identify, refer and treat symptomatic aortic stenosis, the rates of surgical AVR will be sustained.”

In the end, Clark said: “We hope that the use and adoption of TAVR will continue to grow as we have shown that even over a relatively short period of time, the use of TAVR has had a dramatic impact on common cardiovascular disease, allowing a considerable number increased number of patients who may obtain aortic valve replacement.

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