Concerning Rise in Younger Patients Getting TAVR, Despite Dearth of Data

A review of nationwide data on TAVR recipients in the United States shows that more and more patients under age 65 have been receiving the procedure in the last few years despite little evidence on how those valves will perform over the long term in younger, intermediate-risk groups.

"What I'm concerned about is that we're not doing a very good job of communicating benefits and harms to patients,” Art Sedrakyan, MD, PhD (Weill Cornell Medicine, New York, NY), told TCTMD. “In a complex situation like this, that communication might not even be based on numbers because the numbers are not there. We don't know how long these valves are going to last and we don't have data beyond 5 years.” Even data out to 5 years is sparse, he added, coming from “just a few” trials.

Sedrakyan and colleagues report the new data in a research letter published online July 23, 2018, in JAMA.

Looking at the National Inpatient Sample (NIS), they found that the total number of TAVR procedures increased from 1,531 in 2012 to 5,567 in 2015. Although surgical aortic valve replacements (SAVRs) still far outweighed TAVR in younger patients, the proportion of AVRs that were TAVR increased across all age groups during those years. Among those age 55 and younger, the percentage more than doubled from 1.2% to 3.5%, and among those 56 to 65 years it nearly tripled from 2.5% to 7.3%. Whereas 27 patients age 55 and younger were listed as TAVR recipients in the NIS in 2012, the number was 87 in 2015. Likewise, among those age 56 to 65, the number increased from 71 to 250.

Sedrakyan said fully 4,000 patients under age 65 received TAVR through 2015, a number he said is likely to grow as high as 8,000 or more by the end of 2018.

Data Needed to Avoid Past Device Missteps

To TCTMD, Sedrakyan said the lack of evidence on longitudinal durability of bioprosthetic TAVR valves is troubling and calls to mind a similar situation that occurred with articular surface replacement (ASR) hip resurfacing, which was once marketed toward young, active patients needing hip replacement surgery. The metal-on-metal construction was supposed to be an alternative to metal-on-plastic or ceramic hip replacement, and based on belief of durability they were implanted in tens of thousands of patients. But within 7 or 8 years, Sedrakyan said, complications began to mount, the hips began to fail, and “these were shown to be the worst performing implants. Almost every single one of them had to be removed within 10 years.” In some patients, the ASR implants also were found to release microscopic amounts of metal ions that caused metallosis—a type of metal poisoning linked to a cascade of symptoms.

"If we end up with every single young TAVR patient needing a reoperation, just as an extreme example, it's double what we thought it was going to cost society, particularly Medicare,” Sedrakyan noted. In the research letter, he and his colleagues say registries and trials are needed to collect longer-term follow-up data and to compare TAVR with mechanical valves in younger patients.

“Start now, as soon as possible, with mechanical valve controls and plan for follow-up beyond 10 years,” he said. “We might still end up with a large number receiving TAVR, but in time we will [accumulate] the data and also be able to leverage real-world evidence and continuously update patients and doctors about the options.”

Sedrakyan added that patients, their families, and physicians also may be too quick to believe that valve-in-valve procedures can fix the problem when TAVR valves begin to fail.

“They need to think about the risks, because patients who are under 65 now may be looking at having this again not only once but maybe twice in the future at a later age when the risks are higher,” he said.