Transapical access closure: the TA PLUG device

Area of Science:

• Cardiovascular Interventions
• Medical Device Technology
• Surgical Access Site Closure

Background:

• Percutaneous closure of large transapical (TA) access sites after transcatheter aortic valve implantation (TAVI) remains a significant clinical challenge.
• Current methods for managing large apical access sites are often invasive or suboptimal.

Purpose of the Study:

• To evaluate the feasibility and safety of the TA PLUG device for true-percutaneous closure of large-calibre apical access.
• To assess the hemostatic and anchoring capabilities of the TA PLUG in an acute animal model.

Main Methods:

• The TA PLUG, a self-sealing closure device, was implanted in six pigs following simulated large apical access.
• Hemostasis, bleeding rates, and device anchoring under hemodynamic stress were assessed.
• A feasibility study involving pull-force measurements was also conducted.

Main Results:

• Successful deployment and immediate complete hemostasis were achieved in most cases.
• No leaks or device dislodgement occurred during a 5-hour observation period or under hemodynamic stress.
• Device migration was observed at a force of 3.3 ± 0.5 N; post-mortem analysis showed no myocardial damage and a zero renal embolic index.

Conclusions:

• True-percutaneous closure of large left ventricular apex access is feasible using the TA PLUG device.
• The TA PLUG demonstrates immediate hemostasis and reliable acute anchoring.
• This represents the first report of a true-percutaneous closure device for large-bore TAVI access.