In patients undergoing valve-in-valve TAVR, use of an intra-annular self-expanding valve resulted in a 30-day mean transvalvular gradient of 10.6 mmHg compared to 12.3 mmHg with a supra-annular self-expanding valve, showing no significant difference (p=0.44).
Observational (n=100)
Yes
Does an intra-annular self-expanding valve compared to a supra-annular self-expanding valve improve 30-day mean transvalvular gradient in patients undergoing Valve-in-Valve TAVR?
Valve-in-valve TAVR using an intra-annular self-expanding valve demonstrated similar 30-day hemodynamic performance compared to a supra-annular self-expanding valve.
Effect estimate: p=0.44 (no significant difference)
Absolute Event Rate: 10.6% vs 12.3%
p-value: p=0.44
ABSTRACT Background A limitation of Valve‐in‐Valve (VIV) transcatheter aortic valve replacement (TAVR) is patient‐prosthesis mismatch (PPM), which is associated with worse quality of life and heart failure hospitalizations. As such, strategies to avoid PPM are desired. We compared the clinical and hemodynamic results of VIV TAVR with intra‐annular self‐expanding valves (IA SEV, Navitor, Abbott Vascular) versus supra‐annular self‐expanding valves (SA SEV, Evolut, Medtronic). Aims To evaluate the hemodynamics and clinical outcomes of self‐expanding valve platforms for VIV TAVR. Methods Patients were treated at two sites. The primary endpoint was the 30‐day mean transvalvular gradient. Secondary endpoints included 30‐day effective orifice area (EOA); and key clinical events including major vascular complication, coronary obstruction, 30‐day all‐cause mortality, stroke, need for reintervention, and new requirement of permanent pacemaker. A linear effects model was fit to adjust for factors related to PPM including surgical valve true inner dimension (TID), balloon post‐dilation, body surface area, and etiology of surgical valve failure. Results Consecutive patients who underwent VIV TAVR with IA SEV ( n = 48) and SA SEV ( n = 52) are reported; 42% were women, the mean age was 79.2 ± 6.7 years, and the mean STS Predicted Risk of Mortality was 6.0 ± 4.1%. The mean surgical valve TID was 21.5 ± 1.5 mm. At 30 days, there was no difference in mean transvalvular gradient in IA SEV (10.6 ± 3.6 mmHg) and SA SEV (12.3 ± 6.9, p = 0.44). EOA was slightly larger in IA SEV (1.69 ± 0.6 cm 2 ) than in SA SEV (1.40 ± 0.5 cm 2 , p = 0.04) in the unadjusted analysis. After adjustment, there was no significant effect of IA SEV versus SA SEV ( p = 0.28), surgical valve true inner diameter ( p = 0.79), or balloon post‐dilation ( p = 0.37) on gradient. A subset of IA SEV patients who underwent bioprosthetic valve fracture ( n = 5) experienced no annular injury, valve leaflet injury, or valve dysfunction at 30 days. Conclusions VIV TAVR using an IA SEV was safe in this case series with no difference in hemodynamics between IA SEV and SA SEV. These findings provide support for prospective evaluations of an IA SEV for VIV TAVR.
Saxon et al. (Mon,) conducted a observational in Patients with failed bioprosthetic aortic valves undergoing valve-in-valve transcatheter aortic valve replacement (VIV TAVR), mean age 79.2 years, 42% female, mean STS Predicted Risk of Mortality 6.0% (n=100). Intra-annular self-expanding valve (Navitor, Abbott Vascular) vs. Supra-annular self-expanding valve (Evolut, Medtronic) was evaluated on 30-day mean transvalvular gradient (mmHg) (p=0.44 (no significant difference), p=0.44). In patients undergoing valve-in-valve TAVR, use of an intra-annular self-expanding valve resulted in a 30-day mean transvalvular gradient of 10.6 mmHg compared to 12.3 mmHg with a supra-annular self-expanding valve, showing no significant difference (p=0.44).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: