In women with small aortic annuli, TAVR with self-expanding valve has better hemodynamics
Click Here to Manage Email Alerts
Key takeaways:
- In women with small aortic annuli who underwent TAVR, a self-expanding valve conferred better 1-year hemodynamic outcomes vs. a balloon-expandable valve.
- There were no differences in 1-year clinical outcomes.
In women with severe aortic stenosis and small aortic annuli who underwent transcatheter aortic valve replacement, a self-expanding valve was linked with better hemodynamic outcomes vs. a balloon-expandable valve at 1 year.
There were no differences between the groups in clinical outcomes at 1 year, according to new data from the SMART trial presented by Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, at EuroPCR.
As Healio previously reported, in the main results of SMART, patients assigned to TAVR with a self-expanding valve (Evolut Pro, Evolut Pro+ or Evolut FX, Medtronic) had similar clinical outcomes and better hemodynamic outcomes at 1 year compared with those assigned to TAVR with a balloon-expandable valve (Sapien 3 or Sapien 3 Ultra, Edwards Lifesciences). Mehran presented the 1-year results of the trial’s female patients, who made up 87% of the cohort.
“Most of these patients were women, often underrepresented in clinical trials,” Mehran said during a presentation. “Therefore, we evaluated clinical and hemodynamic outcomes in women from the SMART trial in a prespecified analysis.”
The cohort included 621 women who had a mean age of 80 years, a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 3.4% and a mean aortic annulus area of 379 mm2.
At 1 year, there was no difference between the groups in the primary composite clinical outcome of death, disabling stroke or HF rehospitalization (self-expanding group, 9.4%; balloon-expandable group, 11.8%; absolute difference, –2.3 percentage points; 95% CI, –7.5 to 2.5; P = .35), Mehran said during the presentation.
The primary valve performance outcome of bioprosthetic valve dysfunction, which was powered for superiority in women, was lower in the self-expanding group at 1 year (8.4% vs. 41.8%; difference, –33.4 percentage points; 95% CI, –40.4 to –26.4; P < .001), she said, noting the self-expanding group also had less hemodynamic structural valve dysfunction and nonstructural valve dysfunction (P < .001 for both).
At 1 year, effective orifice area was higher in the self-expanding group (1.97 cm2 vs. 1.49 cm2, P < .001) and mean gradient was lower (7.7 mm Hg vs. 15.8 mm Hg; P < .001), Mehran said.
The self-expanding group had fewer cases of mild or moderate aortic regurgitation at 1 year (12.3% vs. 18.8%; P = .04), she said, noting there were no cases of severe aortic regurgitation in either group.
In addition, she said, the self-expanding group was more likely to have no patient-prosthesis mismatch at 1 year (88.8% vs. 62.6%; P < .001).
Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire Ordinal Outcome improved to a greater extent in the self-expanding group at 1 year (P = .037), whereas NYHA HF classification was similar in both groups at 1 year (P = .281), Mehran said.
“Compared to a balloon-expandable valve, the Evolut self-expanding valve was associated with significantly less bioprosthetic valve dysfunction, less patient-prosthesis mismatch, less total aortic regurgitation and [greater improvement in] quality of life in women with aortic stenosis and a small annulus,” Mehran said during the presentation. “Long-term follow-up is needed to assess the impact of differences in bioprosthetic valve dysfunction and hemodynamic endpoints on clinical outcomes.”
For more information:
Roxana Mehran, MD, can be reached at roxana.mehran@mountsinai.org; X (Twitter): @drroxmehran.
Collapse
Mehran R, et al. Late-breaking trials: TAVI head-to-head. Presented at: EuroPCR; May 14-17, 2024; Paris.
Click Here to Manage Email Alerts