Key result
Same-volume double-tap post-dilatation linked to ~11-point higher median mid-portion THV expansion.
Why the study?
Transcatheter heart valve underexpansion is associated with hemodynamic valve deterioration, and double-inflation using the delivery balloon with unchanged volume (double-tap) may improve valve expansion after TAVR with SAPIEN-3 Ultra RESILIA valves while minimising complication risk.
Does post-dilatation using the delivery balloon with unchanged volume (double-tap) improve transcatheter heart valve expansion and deformation in patients undergoing TAVR with SAPIEN-3 Ultra RESILIA valves for severe native aortic stenosis?
Observational (n=113)
No
Does post-dilatation using the delivery balloon with unchanged volume (double-tap) improve transcatheter heart valve expansion and deformation in patients undergoing TAVR with SAPIEN-3 Ultra RESILIA valves for severe native aortic stenosis?
Routine same-volume double-tap post-dilatation of SAPIEN-3 Ultra RESILIA valves during TAVR significantly improves transcatheter heart valve expansion and reduces frame deformation, particularly in the mid-portion and among patients with bicuspid anatomy or higher calcium burden.
Double-tap post-dilatation was associated with greater THV expansion; hypothesis-generating and requires RCTs before routine adoption.
Background Transcatheter heart valve (THV) underexpansion is associated with hemodynamic valve deterioration. Double-inflation of balloon-expandable valves using the delivery balloon with unchanged volume (double-tap) may improve THV expansion, whilst minimising the risk of complications. Aim To evaluate the efficacy of double-tap after transcatheter aortic valve replacement (TAVR) with SAPIEN-3 Ultra RESILIA (S3UR) valves. Methods This observational study included consecutive patients who underwent TAVR for severe native aortic stenosis and had same-volume double-tap. Patients were included from a single high-volume centre from November 2024 to September 2025. We excluded patients with prior TAVR or surgical aortic valve replacement, severe left ventricular outflow tract or annular calcium, or aortic regurgitation as the indication for TAVR. THV expansion and deformation were assessed fluoroscopically before and after double-tap (after appropriate calibration). Expansion (%) = ((Pi x [THV diameter divided by 2]2) divided by nominal THV area) x 100. Deformation index = (area at THV inflow + outflow) divided by (2 x area at narrowest). Thirty-day clinical outcomes were reported. Results Of 113 patients who underwent TAVR with same-volume double-tap (mean age: 79.3±7.3 years, 26.5% female, 13.3% bicuspid anatomy), the median THV expansion before double-tap, at the inflow, mid-portion and outflow was 88.6% (IQR: 86.4-90.4%), 80.1% (IQR: 77.3-82.3%) and 90.1% (IQR: 88.4-90.0%) respectively, and after double-tap increased to 96.4% (IQR: 94.6-98.4%), 90.8% (IQR: 88.6-92.0%) and 97.6% (IQR: 96.2-99.0%) (all P<0.001). The largest increase in expansion following double-tap occurred in the THV mid-portion (median: 10.6% [IQR: 9.9–11.6%]) (Figures). Multivariable predictors of the extent of minimum expansion improvement following double-tap were bicuspid anatomy (median increase with bicuspid vs. tricuspid: 11.7% [IQR: 11.2-12.8%] vs. 10.6% [9.7-11.4%], coefficient 0.27 [95% confidence interval (CI): 0.08-0.45] P=0.005) and aortic valve calcium volume >median (385mm3) (median increase with calcium volume >385mm3 vs. </= 385mm3: 11.1% [IQR: 10.0-12.1%] vs 10.4% [IQR: 9.8-11.2%], coefficient 0.19 [95% CI: 0.00-0.38] P=0.046). Even though pre-dilatation was undertaken in 60% of patients, this did not mitigate the benefit of double tap on THV expansion (median increase in minimum expansion with vs. without pre-dilatation: 11.1% [IQR: 10.0-12.1%] vs. 10.3% [IQR: 9.4-11.0%], coefficient 0.11 [95% CI: -0.09 to 0.30] P=0.278). The median THV deformation index decreased from 1.05 (IQR: 1.04-1.07) to 1.03 (IQR: 1.02-1.04) after double-tap (P<0.001). Thirty-day mortality rate was 0.9%. Conclusion Routine double-tap post-dilatation of balloon-expandable valves appears safe, and improves THV expansion and frame deformation. Bicuspid anatomy and aortic valve calcium burden were associated with the extent of expansion improvement after double-tap.
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Maznyczka et al. (2026) conducted an observational in Severe native aortic stenosis (n=113). Same-volume post-dilatation (double-tap) using the delivery balloon vs. Pre-double-tap baseline was evaluated on Transcatheter heart valve (THV) mid-portion expansion (Median increase 10.6%, p=<0.001). Same-volume double-tap post-dilatation increased median THV expansion at the inflow (88.6% to 96.4%), mid-portion (80.1% to 90.8%), and outflow (90.1% to 97.6%) (all P<0.001).
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