‘Concerning’ Trends Seen in Aortic Stenosis-Related Mortality: CDC WONDER

NEW ORLEANS, LA—Small, but notable, increases in US death rates related to aortic stenosis (AS) in middle-aged adults have followed in the wake of TAVI’s regulatory expansion to lower-risk patients, according to a new analysis.

After the US Food and Drug Administration approved TAVI for patients at low surgical risk in 2019, AS-related mortality increased by a relative 1.75% through 2023 among patients aged 45 to 74 years, said Sameer Hirji, MD, MPH (Mass General Brigham, Boston, MA), who presented the findings from the CDC WONDER database at the 2026 Society of Thoracic Surgeons (STS) Annual Meeting.

Researchers say their findings, though based on death certificate data, are illuminating given the adoption of TAVI across the surgical risk spectrum and other research hinting at a concerning rise in postprocedural mortality in recent years.

“There’s a lot of interest in early intervention [and] in early screening,” Hirji told TCTMD. Right now, he said, there is limited data evaluating the population-level impact of those early interventions and screening practices.

These new findings are “pretty concerning, because maybe we are not screening enough people or they’re not even asymptomatic and they don’t meet the criteria for intervention,” Hirji explained. “Maybe we should be more aggressive towards challenging them for symptoms . . . to see [if] actually they should fit criteria or not.”  

STS President Vinay Badhwar, MD (West Virginia University, Morgantown), who spoke following the presentation, said the analysis may set off alarm bells. “Usually when we introduce a new therapy, one would expect to see mortality decrease. You’re showing the absolute opposite,” he said.

There are limitations to the data—including missing information on treatments and the role AS played in death, a potential lag in charting, and the effect of the COVID-19 pandemic on outcomes—that affect the reliability of the findings, Hirji acknowledged.

“There’s a lot of . . . plausible explanations [for the results],” he said.

Badhwar noted that it’s possible TAVI may enabled better identification of patients with symptomatic, severe AS. “But if it’s not and it’s actually the treatment that’s resulting in the mortality, we have a problem,” he added.

Commenting on the analysis for TCTMD, David J. Cohen, MD (Cardiovascular Research Foundation, New York, NY, and St. Francis Hospital and Heart Center, Roslyn, NY), who has previously sought to understand the prevalence of aortic stenosis nationwide, said the data have too many limitations to draw strong conclusions.

There is research showing that use of echocardiography has increased over the last decade, he said, adding that it makes sense that more patients are being diagnosed with AS and even dying with the disease noted in their charts.

“If we’re diagnosing aortic stenosis, then people are going to list it on the death certificate—at least as a contributory factor,” Cohen said. “If there’s a signal here at all, some of it could be due to more screening—of people identifying asymptomatic disease or moderate disease and it showing up in the medical record.”

CDC WONDER Findings

The current study used the CDC WONDER registry to locate death certificates that listed AS among the causes of death between 1999 and 2023.

AS-related mortality remained mostly steady until about 2019, when it rose from 3.33 to 3.57 deaths per 100,000 people in 2023, representing an average relative increase of 1.75%. In the cohort of decedents aged 75 and older, AS-related mortality slowly declined from 112.3 deaths per 100,000 people in 2012, when the FDA first approved TAVI, to 104.1 in 2023. This represented a relative 0.71% average decrease (P = 0.014).

Trends were similar when stratified by sex, with men maintaining higher death rates throughout the timeline than women in both the older and younger cohorts. Looking by race, mortality rates were consistently higher among those who identified as white compared with African American and other. Geographically, AS-related mortality was slightly higher after 2012 in the West and Midwest regions compared with the Northeast and South.

The location of death also changed before and after TAVI was approved, with more deaths recorded at home in both younger and older adults.

Usually when we introduce a new therapy, one would expect to see mortality decrease. Vinay Badhwar

All the trends observed are “something to be cautious [about] as we expand TAVR technologies and especially in the current setting of the [National Coverage Determination] approvals for outcomes and surgeon involvement,” Hirji concluded.

As for the increase in AS-related mortality after the expansion of TAVI into lower-risk patients, Hirji said there could be several explanations.

“There likely could be a delayed intervention,” he said, noting that some deaths may be related to those with moderate AS or moderate-severe AS who may be waiting to qualify for valve replacement. “There could be underscreening of asymptomatic patients, underdiagnosis, and also system-level barriers, which include cost, insurance, or number of heart centers within the vicinity.”

Because of all the aforementioned challenges with the database, Hirji added, “these findings are hypothesis-generating at best.”

Too Many Limitations

For Cohen, the effect of the COVID-19 pandemic on mortality in this population is also too large to discount.

“What did we change about the way we’re treating patients with aortic stenosis that’s making them die more often starting in 2019?” Cohen asked. “The implication of this study seems to be that something, or things, changed in 2019/2020 that is driving these trends. . . . The COVID pandemic happened in 2020, and multiple studies have found that cardiac event rates have remained elevated even though the pandemic has passed.”

The implication of this study seems to be that something, or things, changed in 2019/2020 that is driving these trends. David Cohen

Dhaval Kolte, MD, PhD (Massachusetts General Hospital and Harvard Medical School, Boston), who was not involved in the study, felt similarly.

“When you think about aortic stenosis-related mortality, these types of data as well as claims data obviously cannot distinguish between the severity of the aortic stenosis,” he told TCTMD. “Especially when you are using multiple causes of death and aortic stenosis is listed as one out of the 20 things, it’s hard to know if the mortality has anything to do with aortic stenosis.”

Drawing conclusions about TAVR approvals and their effect on mortality is “hard,” Kolte added. “The question certainly is an important one as it relates to . . . underdiagnosis and treatment, But I think one would need much higher quality data to understand that.”