VIVA: Outcomes not different with TAVR vs. surgery in those with small aortic annuli
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Key takeaways:
- Women comprised 93% of patients with severe aortic stenosis and small aortic annuli.
- Results showed no difference in hemodynamic or clinical outcomes between transcatheter or surgical aortic valve replacement.
SAN FRANCISCO — Among patients with severe aortic stenosis and small aortic annuli, treatment with transcatheter or surgical aortic valve replacement yielded similar early and late hemodynamic and clinical outcomes in the VIVA trial.
“The results of this trial suggest that these two treatments are a valid alternative for treating patients with aortic stenosis and small aortic annulus,” Josep Rodés-Cabau, MD, PhD, director of catheterization and interventional laboratories at the Quebec Heart and Lung Institute, Laval University, Quebec City, said during a press conference at TCT 2023.
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Current guidelines recommend TAVR and surgical AVR for treatment of aortic stenosis in older adults. However, aortic annular size, prosthetic valve hemodynamics and gender are not taken into consideration in the current recommendations, Rodés-Cabau said. Data have suggested superior prosthetic valve performance with TAVR in patients with small aortic annuli and improved outcomes after TAVR in women, many of whom have small aortic annuli, Rodés-Cabau said.
The VIVA trial was conducted to compare hemodynamic and clinical outcomes between TAVR and surgical AVR in patients with small aortic annuli. The prospective, randomized trial included 151 patients at 15 centers. All had severe aortic stenosis and small aortic annuli (mean diameter < 23 mm). The mean age was 75 years, median Society of Thoracic Surgeons score was 2.5% and median annulus diameter was 21.1 mm. Women comprised 93% of patients enrolled.
“The vast majority of low- to intermediate-risk patients with aortic stenosis exhibiting the anatomic feature of small aortic annulus were women. To the best of my knowledge, this is the first trial enrolling more than 90% of patients that are women in the heart valve field,” Rodés-Cabau said.
Researchers reported no differences in the primary outcome of severe prosthesis-patient mismatch or moderate to severe aortic regurgitation at 60 days, which was reported in 5.6% of patients randomly assigned to undergo TAVR compared with 10.3% assigned to surgical AVR (P = .3).
“In this challenging population ... there was no evidence of contemporary TAVR superiority vs. surgical AVR regarding valve hemodynamic outcomes as evaluated by Doppler echocardiography, with relatively low rates of severe prosthesis-patient mismatch in both groups [and rates were] much lower than those we expected,” Rodés-Cabau said.
At 30 days, mortality occurred in 1.3% of those assigned TAVR compared with 1.4% of those assigned surgical AVR (P = 1) and stroke occurred in 0% compared with 2.7%, respectively (P = .24).
After a median follow-up of 2 years, those who underwent TAVR or surgical AVR did not have significantly different rates of mortality (9.1% vs. 8.1%; P = .89), stroke (3.9% vs. 4.1%; P = .95) and cardiac rehospitalization (19.5% vs. 20.3%; P = .8).
Reference:
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Rodés-Cabau, J. Late-breaking clinical trials: Session III, in collaboration with the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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