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Transapical access closure: the TA PLUG device.

Henriette Brinks¹, Fabian Nietlispach, Volkhard Göber

¹Department of Cardiovascular Surgery, Swiss Cardiovascular Centre, University Hospital of Bern, Bern, Switzerland.

Interactive Cardiovascular and Thoracic Surgery

|July 12, 2013

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The TA PLUG device offers a true-percutaneous solution for closing large transapical access sites after transcatheter aortic valve implantation. This novel device achieves immediate hemostasis and secure anchoring in acute animal studies.

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.

Keywords:

Apex Closure device Percutaneous Sutureless Transapical Transcatheter Transcatheter aortic valve implantation

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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.