Redo-TAVI with SAPIEN 3 in SAPIEN XT or SAPIEN 3 - impact of pre- and post-dilatation on final THV expansion

Area of Science:

• Cardiovascular interventions
• Medical device engineering
• Interventional cardiology

Background:

• Redo-transcatheter aortic valve implantation (TAVI) involves implanting a new valve within a previously implanted one.
• Balloon-expandable transcatheter heart valves (THVs) carry a risk of underexpansion when used in redo-TAVI procedures.
• Underexpansion can negatively impact THV performance and patient outcomes.

Purpose of the Study:

• To evaluate the effect of pre- and post-dilatation on the expansion of balloon-expandable THVs during redo-TAVI.
• To compare the expansion of SAPIEN 3 THVs implanted within SAPIEN XT or SAPIEN 3 failed valves.

Main Methods:

• Benchtop redo-TAVI simulations using 23 mm SAPIEN XT and SAPIEN 3 as index valves.
• Implantation of a 23 mm SAPIEN 3 THV within the index valves.
• Application of pre- and/or post-dilatation using a 23 mm non-compliant balloon.
• Assessment of THV expansion via microcomputed tomography (micro-CT) and hydrodynamic testing.

Main Results:

• Without dilatation, the redo-SAPIEN 3 THV was significantly underexpanded within both SAPIEN XT and SAPIEN 3.
• Pre- and post-dilatation improved redo-THV expansion, with an additive effect.
• Only SAPIEN 3 in SAPIEN 3 with both pre- and post-dilatation achieved nominal expansion.
• Underexpanded valves showed worse leaflet pinwheeling, despite acceptable hydrodynamic performance.

Conclusions:

• Full expansion of a 23 mm SAPIEN 3 THV in a redo-TAVI procedure is achievable within a SAPIEN 3 valve using both pre- and post-dilatation.
• SAPIEN 3 THVs implanted within SAPIEN XT valves remained underexpanded even with dilatation.
• CT assessment of THV expansion and the judicious use of pre-/post-dilatation are crucial in redo-TAVI.