Why surgery, not TAVR, remains the best treatment for some AS patients
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Transcatheter aortic valve replacement (TAVR) is starting to be used more and more to treat patients with severe aortic stenosis who are under the age of 70 and present with bicuspid aortic valves (BAVs).
However, according to a new commentary published in The Annals of Thoracic Surgery, TAVR has not been proven to be the best choice for these patients, and there are many times when surgical aortic valve replacement (SAVR) should be considered first.[1]
D. Craig Miller, MD, a professor of cardiovascular surgery with Stanford University, wrote the editorial, noting that that physicians need to stop automatically turning to TAVR when SAVR may be a safer, more effective treatment option.
To help make his point, he examined data from a recent analysis on this topic that was also published in The Annals of Thoracic Surgery.[2] The study included more than 11,000 patients with a BAV who underwent aortic valve replacement from 2018 to 2022. The median age was 70 years old, 64.5% of patients were men and the median follow-up periods were 2.6 years for the SAVR group and 2.4 years for the TAVR group.
Overall, SAVR was associated with superior long-term outcomes for patients with a BAV when compared to TAVR. This included a lower 30-day new stroke rate (2% vs. 2.5%) and a much lower rate of patients requiring a permanent pacemaker after treatment (2.3% vs. 12.4%).
“Until more controlled evidence has been accumulated and analyzed, BAV patients under 70 with a reasonable life expectancy should not be offered TAVR as a first choice,” Miller wrote. “If the BAV patient is under 65-70, then an open surgical or robotic mechanical AVR should also be considered as an alternative option. For now, there is a concern that the heart team and the shared decision making framework has devolved to be ineffective in the U.S., or perhaps the surgeons who must see these patients pursuant to the Medicare national coverage decision are not standing their ground … With all due respect for shared decision making and honoring patient autonomy, physicians in good conscience cannot continue to allow patients to make decisions which threaten their welfare and life expectancy.”
Are care teams too reliant on valve-in-valve TAVR?
Miller also touched on the ongoing trend of patients who require aortic valve replacement receiving a tissue bioprosthesis instead of a “proven mechanical surgical valve.” He believes a primary driver of this shift is the “theoretical, very attractive hope” that valve-in-valve TAVR can occur whenever a patient with a bioprosthesis encounters an issue. However, he said, valve-in-valve TAVR is intended to be used when patients are inoperable or face especially high risks if treated with surgery—it is not to be treated as a failsafe that clinicians can turn to at the first sign of any problem.
“Unfortunately, this valve-in-valve TAVR rescue notion has still not been rigorously proven to be effective,” Miller wrote. “This strategy may not prove to be the alluring panacea some believe, but actually sophistry.”
He added that valve-in-valve TAVR has been linked to “an alarming penalty in life expectancy” that is not seen with redo open SAVR procedures.
More research is still necessary
Miller closed his editorial by pushing for more research. He emphasized that the U.S. Food and Drug Administration should lead in this area and work to see that more randomized controlled trials are performed.
“In the interim, we all must put the patients’ welfare ahead of our egos and resist intense industry lobbying and marketing hype to do what is most prudent,” Miller concluded. “Keep your seatbelt fastened, more will be revealed.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.