Routine post-dilatation at nominal volume to optimise the expansion of balloon-expandable valves: the DOUBLE-TAP...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Incomplete expansion of balloon-expandable transcatheter heart valves (THVs) can occur after TAVI.
• Ad hoc post-dilatation is a common but unevaluated treatment for THV underexpansion.
• Routine post-dilatation with the original balloon (double-tap) may improve THV expansion safely.

Purpose of the Study:

• To assess the safety and efficacy of routine double-tap after balloon-expandable TAVI.
• To evaluate the impact of double-tap on THV expansion in patients receiving the SAPIEN 3 Ultra valve.

Main Methods:

• Prospective inclusion of patients undergoing TAVI with SAPIEN 3 Ultra (S3U) valves.
• Exclusion of patients with severe annular or subannular calcification.
• Fluoroscopic analysis to measure THV cross-sectional area before and after double-tap; 30-day clinical outcomes documented.

Main Results:

• Routine double-tap was performed in 102 patients, all showing some underexpansion initially.
• Significant increases in THV expansion were observed across various S3U valve sizes (e.g., 9.9% for 23 mm, p<0.001).
• No stroke or cardiovascular mortality occurred within 30 days.

Conclusions:

• Routine double-tap effectively improved THV expansion in patients with favorable anatomy undergoing TAVI.
• The strategy demonstrated no immediate safety concerns.
• Long-term effects on THV function, hemodynamics, and durability require further investigation.