A novel method to create atrial septal defect using a cutting balloon in piglets

Area of Science:

• Cardiovascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• Atrial septal defects (ASDs) are commonly treated surgically or with device closure.
• Minimally invasive techniques for ASD creation are continuously being explored.
• Existing methods may have limitations in specific patient populations or procedural scenarios.

Purpose of the Study:

• To introduce and evaluate a novel method for creating atrial septal defects (ASDs).
• To assess the feasibility of combining a cutting balloon catheter with static balloon dilation for ASD creation.
• To determine the size and hemodynamic significance of ASDs created using this new technique.

Main Methods:

• A novel approach involving a 3- or 4-blade cutting balloon catheter was employed.
• The cutting balloon was used in conjunction with conventional static balloon dilation.
• Radially directed surgical cuts were made in the atrial septum and subsequently enlarged.
• Balloon angioplasty was utilized to expand the created defects.

Main Results:

• The combined technique successfully created atrial septal defects.
• The resulting defects ranged in size from 3 to 8 mm.
• Hemodynamic assessment showed a mean Qp/Qs ratio of 1.96/L, indicating significant left-to-right shunting.

Conclusions:

• This new method offers a viable approach for creating atrial septal defects.
• The combination of cutting balloon and static balloon dilation provides controlled enlargement of septal defects.
• The created defects achieve a size and hemodynamic profile suitable for further intervention or study.