TAVR Approval Linked to Increased Aortic Stenosis Deaths: Study

Findings suggest physicians may have hesitated to recommend TAVR in the early years after its introduction, delaying potentially life-saving interventions.

A new study presented at this year’s Society of Thoracic Surgeons annual meeting suggests that deaths linked to heart valve failure have increased over the past six years, with researchers warning that delays in receiving life-saving care may be a contributing factor.

The findings center on transcatheter aortic valve replacement, or TAVR, a minimally invasive procedure used to treat aortic stenosis, a serious heart valve condition that narrows the aortic valve and restricts blood flow from the heart to the rest of the body. For decades, patients relied on open heart surgery as the only effective treatment, until the U.S. Food and Drug Administration approved TAVR in 2011, offering a less invasive alternative for those facing the life threatening disease.

During TAVR, doctors thread a catheter through a blood vessel, typically in the groin, expand a balloon and implant a replacement valve, allowing many individuals to avoid open-heart surgery and recover more quickly. However, the researchers who presented this data said long wait times and other barriers are preventing many patients from receiving the procedure in time, potentially increasing the risk of fatal outcomes.

While TAVR has expanded treatment access, studies have also raised concerns about complications, linking the procedure to risks such as stroke, bleeding and vascular injuries. In January, Japanese researchers showed TAVR may lead to the destruction of healthy red blood cells, with an increase in reports of hemolytic anemia and other complications following the procedure.

Additional research published in 2024 linked balloon-expandable valve replacement following TAVR to an increased likelihood of valve dysfunction and a higher death risk, as those valves were four times more likely to fail or experience blood leaks.

For the new study, researchers from Brigham and Women’s Hospital in Boston, conducted a national study examining data from the U.S. Centers For Disease Control and Prevention’s WONDER study. Led by Dr. Sameer Hirji, the team included data on deaths from 1992 to 2023 where aortic stenosis was listed as an underlying cause or contributing factor.

The findings indicated death rates from aortic stenosis decreased from 1999 to 2005 and then held stable until 2019. However, death rates from 2019 to 2023 increased moderately among people 45 to 74 years old, from 3.33 per 100,000 in 2019 to 3.57 per 100,000 in 2023.

Researchers identified several factors that may be contributing to the rise in deaths among those with aortic stenosis.

One major concern is limited access to TAVR. Many hospitals lack the capacity to perform the procedure and have struggled to keep pace with growing demand.

As a result, patients often face extended wait times. Those delays can prove dangerous, increasing the risk of death while remaining on waiting lists, and worsening outcomes for individuals whose valve disease has significantly progressed by the time they finally undergo the procedure.

The research team noted that as the medical field was shifting from routine open-heart surgeries to less invasive procedures, there may have been many delays in aortic stenosis diagnoses. Some doctors may have been unsure about the proper timing for intervention, especially among younger or asymptomatic patients.

Conclusions showed that data was consistent among all patients spanning sex, race and geography, with researchers warning that this demands “urgent evaluation” of screening practices, improved diagnosis and equal access to both surgical and less invasive procedures.

These findings are considered preliminary until published in a peer-reviewed journal.

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