SMART trial reaffirms hemodynamic superiority of TAVR self-increasing valve

Extra analysis from the SMall Annuli Randomized To Evolut or SAPIEN (SMART) look demonstrated clinical non-inferiority of self-increasing valves (SEV) versus balloon-expandable valves (BEV) in aortic stenosis sufferers present process transcatheter aortic valve replace (TAVR) and confirmed valve efficiency superiority over time in step with hemodynamics.

Information additionally confirmed identical sure ends up in two age groups (< or ≥ 80 years old). The late-breaking results were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions.

Patients with aortic stenosis (AS) and small aortic annuli (SAA), typically female and underrepresented in clinical trials, are at risk for impaired valvular hemodynamics, or blood flow, and associated adverse cardiovascular outcomes following TAVR. The underrepresentation of women in research and the severity of the condition creates a call for more clinical data.

The SMART trial is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of SEV versus BEV in TAVR patients with symptomatic severe AS and SAA.

Eligible patients had an aortic valve annulus area of less than or equal to 430 mm² by CT and suitable anatomy for transfemoral TAVR with an Evolut PRO/PRO+/FX or a SAPIEN 3/3 Ultra valve. The co-primary endpoints were: a clinical outcome composite of mortality, disabling stroke, or heart failure rehospitalization; and a valve function composite of bioprosthetic valve dysfunction (BVD) through 12 months.

A total of 716 patients (87% women, mean age 80 years) were treated at 83 sites. The SMART trial met both primary endpoints. Compared with BEV, the supra-annular SEV demonstrated non-inferior clinical outcomes and superior valve performance as measured by multiple definitions of bioprosthetic valve dysfunction (BVD) as well as by standard hemodynamics (doppler velocity index [DVI], effective orifice area [EOA], severe prosthesis‐patient mismatch [PPM], mean gradient >20 mmHg) at one twelve months. As an further analysis, the hemodynamics over time were evaluated and stumbled on to be identical between cohorts at baseline and liked SEV compared to BEV at all follow-up time aspects through 12 months (p<0.001).

The implications were additionally consistent in sufferers with age < or ≥ 80 years. BEV had a BVD dissimilarity of 39.8% for sufferers < 80 years used, and a BVD dissimilarity of 27.1% for sufferers ≥ 80 years used (both p<0.001).

“The SMART trial is the ideally suited, most rigorous trial so a ways to randomize sufferers the utilization of the two most broadly broken-down TAVR devices, and the ideally suited TAVR trial to enroll largely females. We’re enraged to reiterate our previously introduced findings in front of the interventional heart specialist neighborhood with our further analysis,” mentioned Howard C. Herrmann, MD, FACC, MSCAI, John W. Bryfogle Professor of Cardiovascular Remedy and Surgical treatment, Health Machine Director and Portion Chief of Interventional Cardiology, Perelman School of Remedy on the College of Pennsylvania, and lead creator of the look.

“This confirms the hemodynamic superiority of self-increasing supra-annular valves, which allow for elevated alternatives and improved decision-making for clinicians. It used to be additionally really helpful to query that this medication choice produced identical sure results for the more tantalizing younger patient inhabitants.”

Longer-time duration follow-up of the SMART trial is ongoing.

More details:
“Self-Increasing Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Limited Aortic Annuli: Extra Outcomes from the SMART Trial” Friday, Would possibly perhaps 3, 2024; 2: 38-2: 45 PM PT, scai.org/scai-2024-scientific-sessions