TAVR for moderate aortic stenosis, HFrEF may improve quality of life
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Key takeaways:
- TAVR did not improve a composite of clinical endpoints in patients with moderate aortic stenosis and HFrEF.
- However, TAVR improved quality of life at 1 year compared with surveillance.
WASHINGTON — In patients with moderate aortic stenosis and HF with reduced ejection fraction, transcatheter aortic valve replacement did not improve clinical outcomes but may raise quality of life vs. clinical surveillance, data show.
For the TAVR UNLOAD trial, presented at TCT 2024 and simultaneously published in the Journal of the American College of Cardiology, Nicolas M. Van Mieghem, MD, PhD, and colleagues randomly assigned 178 patients (mean age, 78 years; 20.8% women) with moderate aortic stenosis and HFrEF to TAVR with a balloon-expandable valve (Sapien 3, Edwards Lifesciences) or clinical aortic stenosis surveillance.
“Heart failure with reduced ejection fraction requires medical neurohormonal modulation and afterload reduction,” Van Mieghem said during a press conference. “So the rationale [for this trial] was, so if we treat moderate aortic stenosis, this may represent a complementary target for additional afterload reduction on top of guideline-directed medical therapy.”
The primary endpoint, expressed as a win ratio, was the hierarchical occurrence of all-cause death, disabling stroke, disease-related hospitalizations and HF equivalents and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at longest follow-up.
At a median follow-up of 23 months, there were more wins for the TAVR group than for the control group (47.6% vs. 36.6%), but the win ratio was not significant (win ratio = 1.31; 95% CI, 0.91-1.88; P = .14), Van Mieghem said during the press conference.
However, at 1 year as opposed to longest follow-up, KCCQ overall summary score improved more in the TAVR group than in the control group (12.8 points vs. 3.2 points; P = .018), he said, noting that was the original primary endpoint, but it was changed to at longest follow-up due to logistical difficulties.
“If we would have stuck to the 1-year [KCCQ] endpoint, then we would have seen a win ratio of 1.55, with a P value of .032,” Van Mieghem said during the press conference. “But we had to change the sample size due to slow enrollment and other issues such as the COVID-19 pandemic.”
During the study period, 43% of the control group underwent TAVR, most because they progressed to severe aortic stenosis, Van Mieghem said.
The improvement in KCCQ was immediate in the TAVR group and gradual in the control group, the latter resulting from patients progressing to severe aortic stenosis and receiving TAVR, he said.
“If we censor the patients [from the control group] who underwent TAVR, then I think the clinical picture becomes clearer,” Van Mieghem said during the press conference. “You see an immediate and consistent improvement in quality of life in the TAVR arm, and no improvement in the clinical surveillance arm.”
There were no differences between the groups in major adverse cardiac and cerebrovascular events (HR = 0.83; 95% CI, 0.56-1.24; P = .36) or in all-cause death (HR = 0.98; 95% CI, 0.61-1.56), he said.
“There are two other large trials on this topic ... that introduce the concept of cardiac damage, rather than ejection fraction, to phenotype these patients, and those trials will be eagerly awaited in the forthcoming years,” Van Mieghem said during the press conference.
During a discussant presentation after the results were presented, JoAnn Lindenfeld, MD, FHFSA, professor of medicine and Samuel S. Riven, MD Director in Heart Failure and Heart Transplantation at Vanderbilt University Medical Center, said the results are “the beginning of a change in the way we address these patients.
“This is a population that sees the doctor a lot and has a lot of comorbidities,” she said. “Adding a big surveillance regimen is not what they want to see. The study ... is going to give me data to ask my interventional colleagues to proceed earlier. Because the procedure is safe and there are no downstream safety issues, there was a huge rate of development of [worse] aortic stenosis, so they need careful follow-up, but these patients are elderly and frail. Clinical follow-up is difficult and costly for them. They hate the dobutamine stress test. Just from a practical matter, I think that early intervention is going to be good for these patients to reduce afterload.”
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Perspective
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The key message here is that it does appear beneficial to consider doing TAVR on patients with moderate aortic stenosis and HFrEF. Two reasons that came out were that the TAVR group did better on the KCCQ score and reported symptomatic improvements, and that in the surveillance group, by 2 to 3 years, the majority of patients either underwent TAVR or expired. The researchers showed that performing TAVR in this population was very safe, so we should probably be moving to earlier TAVR for them.
Another benefit to doing TAVR in this population is that it allows clinicians to be more aggressive with guideline-directed medical therapy for HF, which can lower BP, which is a concern for patients with aortic stenosis.
For patients with moderate aortic stenosis but not HFrEF, we are still looking for studies to provide good data on them.
Other studies presented at this session highlighted effects of aortic stenosis such as cardiac fibrosis that maybe we had not appreciated. Even if the aortic stenosis is not symptomatic, there is still an effect on the heart and the left ventricle. That is another reason that we maybe should move to doing TAVR on patients with moderate aortic stenosis, even if they don’t have HFrEF or symptoms.
These results are going to encourage thinking about a heart team approach for these patients. During the session, there was discussion of making it a IIb recommendation — may be considered — in the guidelines. We should see more movement toward doing TAVR in patients with moderate aortic stenosis, particularly those that have HFrEF and are symptomatic.
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Van Mieghem NM, et al. Late-breaking clinical trials: Session I, in collaboration with The New England Journal of Medicine. Presented at: TCT Scientific Symposium; Oct. 27-30, 2024; Washington, D.C. (hybrid meeting).
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