Image: The Apica ASC system (Photo courtesy of Apica Cardiovascular).
A new surgical platform allows the delivery of aortic and mitral valves through the chest wall and the apex of the beating heart.
The Access, Stabilization, and Closure (ASC) system, in conjunction with minimally invasive surgical (MIS) techniques is used to deliver large-bore therapeutic devices into the beating heart of patients with structural heart disease, via the cardiac apex. The system both seals and stabilizes the tissue of the access site during therapeutic device delivery, minimizing loss of blood from, or induction of air to the beating heart. On completion of the therapeutic treatment, it standardizes apical access and closure, leading to safer heart operations, decreased procedure time, and reduced technical challenges associated with transapical access and closure.
A multicenter clinical trial conducted in Germany of the ASC system demonstrated an excellent safety profile with 100% technical success, superior ease-of-use for surgeons, and reductions in both blood loss and operative time. Follow-up assessments of patients showed that the system provided robust closure, with no postoperative apical bleeding complications and no degradation of left ventricular function. The ASC system is a product of Apica Cardiovascular (Galway, Ireland), and has received the European community CE marking of approval.
“Clinically, the Apica ASC System is easy to use, standardizing apical access and closure. Its ‘sutureless’ access coil minimizes both rib spreading and patient pain, providing a dry access site with no peri-sheath bleeding,” said Prof. Thomas Walther, MD, of the Kerckhoff Klinik (Hamburg, Germany), who participated in the device’s clinical study. “Apical closure was reliable, rapid, and completely dry, demonstrating a reduction in operative times, blood loss, use of blood products and apical access site complications.”
“Apica has provided an excellent example of how a new medical device, which was initially conceived and developed overseas, could be brought to Ireland and developed here so that it can be made available for export to treat patients globally,” said James Greene, CEO of Apica Cardiovascular.
The transapical transcatheter aortic valve implantation (TAVI) approach is used for patients whose arteries are too small or too diseased for the transfemoral approach. The delivery system is designed for replacement valve implantation via the apex of the heart, which is reached through a small incision made between the ribs just below the left nipple. It is then expanded using a balloon to fit across the stenotic aortic valve, holding it open permanently.