Transcatheter valve replacement: new concepts for microsurgery inside the heart

Area of Science:

• Cardiovascular Surgery
• Medical Device Innovation
• Interventional Cardiology

Background:

• Transcatheter aortic valve implantation (TAVI) is a significant advancement but faces complications like paravalvular leakage and embolization.
• Safe removal of calcified valves is crucial for improving TAVI outcomes, mirroring open surgical procedures.

Purpose of the Study:

• To analyze a novel stapler-based device for aortic valve resection and implantation (StapAVR).
• To evaluate a new approach for pulmonary valve isolation using a pump-integrated chamber (PVIC) without extracorporeal circulation.

Main Methods:

• The StapAVR was tested in an artificial aortic valve debris model, assessing debris visualization and procedural times.
• The PVIC prototype was evaluated in porcine in vitro and in vivo models, monitoring hemodynamic stability during valve isolation.

Main Results:

• StapAVR valve resection and implantation were feasible, with debris visualization aiding analysis. Debris distribution varied by position, highlighting the need for emboli management.
• The PVIC enabled 21 minutes of stable pulmonary valve isolation in vivo, supporting potential for bulky calcification removal and stent implantation.

Conclusions:

• The StapAVR shows potential for safe valve resection and subsequent stent implantation.
• The PVIC system demonstrated sustained hemodynamic function, offering a viable option for valve isolation during TAVI procedures.
• Further prototype improvements are ongoing, but these concepts present promising future applications for TAVI.