Percutaneous left atrial appendage closure with a novel self-modelizing device: a pre-clinical feasibility study

Area of Science:

• Cardiovascular Research
• Medical Device Technology
• Animal Models in Research

Background:

• The left atrial appendage (LAA) is a common source of emboli in conditions like atrial fibrillation.
• Effective LAA occlusion is crucial for preventing stroke.
• New device technologies are needed to improve LAA occlusion safety and efficacy.

Purpose of the Study:

• To evaluate the feasibility and safety of a novel left atrial appendage (LAA) occluder device.
• To assess the device's performance in achieving LAA closure and its long-term integration.
• To determine the biocompatibility and potential complications associated with the LAA occluder.

Main Methods:

• Implantation of the LAA occluder in twelve pigs under TEE and fluoroscopic guidance.
• Assessment of device placement and immediate closure via TEE.
• Macroscopic evaluation of explanted hearts after six weeks to assess device integration and tissue response.

Main Results:

• Successful LAA closure was achieved in 8/10 pigs immediately post-implantation, and in all pigs after six weeks.
• The device demonstrated ease of deployment and excellent adaptation to LAA tissue.
• Macroscopic examination revealed secure device integration, benign healing, and no thrombus formation or significant inflammation. Minor device loop penetration occurred without adverse effects.

Conclusions:

• The Occlutech® LAA occluder is feasible and safe for LAA occlusion.
• The device achieves complete and durable LAA closure with a favorable safety profile.
• The study supports the potential of this device for clinical application in stroke prevention.