Impact of prolonged balloon inflation on valve expansion and early clinical outcomes following contemporary balloon-expandable transcatheter aortic valve implantation.
Cardaioli F, Fovino L, et al. • EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology • 2026
Prolonged balloon inflation (8 seconds) during SAPIEN 3 Ultra RESILIA deployment was associated with favourable valve expansion, haemodynamic results, and a favourable safety profile, consistent with values reported in double-tap series, and may be a simple alternative to routine double-tap in selected patients if confirmed in larger studies.
Key Findings
Results
Prolonged balloon inflation produced complete valve expansion at the inflow and outflow levels, with only mild underexpansion at the midframe level.
Single-centre study of 84 consecutive patients with native tricuspid aortic stenosis treated with the SAPIEN 3 Ultra RESILIA valve using an 8-second prolonged inflation strategy.
Expansion was assessed by fluoroscopy at multiple frame levels and compared with three validated reference standards.
Midframe underexpansion was mild (98.5±1.3%) when manufacturer-defined nominal values were used as the reference.
Results
Expansion with prolonged inflation was similar or higher than previously published double-tap data for the 23, 26, and 29 mm valves, but lower for the 20 mm valve.
The comparison with published double-tap data was descriptive, not a direct head-to-head analysis.
Expansion values for the 23, 26, and 29 mm sizes were consistently similar or higher.
Lower expansion was observed for the 20 mm size.
Results
Procedural and early clinical outcomes were favourable, with 100% device success and no stroke at 30 days.
Outcomes at 30 days were adjudicated per Valve Academic Research Consortium 3 criteria.
Device success was achieved in all cases.
Permanent pacemaker implantation occurred in 6% of patients.
Results
Haemodynamic performance at 30 days was favourable, with low gradients and no moderate or severe paravalvular leak.
Mean transvalvular gradient was 9.2 mmHg (interquartile range 7.0-10.3) at 30 days.
No patients had moderate or severe paravalvular leak.
Results
The study population was a relatively low-risk, older cohort.
84 patients were included, mean age 78.8 years, 58% male.
Median Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.9%.
Conclusions
The authors conclude that prolonged balloon inflation may be a simple alternative to routine double-tap if confirmed in larger studies.
Results were consistent with values reported in double-tap series.
Routine post-dilatation (double-tap) has been proposed to optimise expansion but may increase procedural complexity.
The study is single-centre with a small sample and a descriptive comparison with historical data, so confirmation is needed.
What This Means
When a replacement heart valve is implanted through a catheter (TAVI) to treat a narrowed aortic valve, balloon-expandable valves are opened by inflating a balloon. If the valve does not open fully, it might not work as well or last as long. One approach to fix this is a second balloon inflation (the 'double-tap'), but that adds steps and complexity to the procedure. This study looked at a simpler alternative: holding the balloon inflated for longer (8 seconds) during the initial deployment.
Researchers examined 84 patients treated at one centre with a specific modern valve (SAPIEN 3 Ultra RESILIA). X-ray imaging showed the valves expanded fully at the top and bottom ends, and almost fully in the middle (about 98.5% of the expected size). For most valve sizes, expansion was similar or better than that reported in earlier studies of the double-tap technique, though the smallest (20 mm) valves expanded less. All procedures were successful, no patient had a stroke within 30 days, 6% needed a pacemaker, and blood flow across the valve was good with no moderate or severe leakage around it.
This research suggests that prolonged balloon inflation could be a simple way to achieve good valve expansion and results. However, the study was small, done at one centre, and compared with other studies' data rather than directly with a double-tap group, and it followed patients only for 30 days. Larger studies are needed before conclusions can be drawn about whether it can replace routine double-tap.
Cardaioli F, Fovino L, Fabris T, Masiero G, Panza A, Napodano M, et al.. (2026). Impact of prolonged balloon inflation on valve expansion and early clinical outcomes following contemporary balloon-expandable transcatheter aortic valve implantation.. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. https://doi.org/10.4244/EIJ-D-26-00494