First-in-man evaluation of the transapical APICA ASCTM access and closure device: the initial 10 patients
Selected in European Journal of Cardio-Thoracic Surgery by Rylski
Johannes Blumensteina, Joerg Kempferta, Arnaud Van Lindena, Mani Arsalana, Sina K. Schmidta, Helge Mollmannb, Won-Keun Kima,b, Vinod Thouranic and Thomas Walthera
Eur J Cardiothorac Surg (2013) 44 (6): 1057-1062
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Transfemoral (TF) access to transcatheter aortic valve implantation (TAVI) is usually considered to be less invasive than transapical (TA) route. However, TF access is limited in patients with peripheral vascular disease and may be associated with a higher incidence of vascular complications compared with the TA approach. Therefore, the authors developed a novel apical access and closure device (titanium coil + closure cap) to facilitate the TA approach.
- Ten patients underwent TAVI via TA route using a novel stabilization and closure device
- The titanium coil and closure cap provided in all patients sufficient sealing without bleeding throughout and after the procedure
- There was no left ventricular function change in discharge echocardiography
- All 10 patients were alive at 30 days.
The TA access offers multiple advantages when compared with TF-TAVI approach. The independence of the sheath diameter, no vascular complications, short distance between access and implantation sites, etc. are the main benefits. However, many centers follow a TF first strategy, since the TA approach is assessed to be more invasive than the TF approach. The authors presented a novel technology enabling an easy and repeatable access to the inside of the heart via TA route. This is an important milestone to a fully percutaneous TA approach, which may be used in the future for TAVI and endovascular aortic repair without skin incision.