A Universal Delivery System for Percutaneous Heart Valve Implantation

• Published in: Annals of biomedical engineering Vol. 44; no. 9; pp. 2683 - 2694
• Main Authors: Bartosch, Marco, Peters, Heiner, Spriestersbach, Hendrik, O h-Ici, Darach, Berger, Felix, Schmitt, Boris
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.09.2016; Springer Nature B.V
• Subjects: Access routes; Animals; Biochemistry; Biological and Medical Physics; Biomedical and Life Sciences; Biomedical Engineering and Bioengineering; Biomedicine; Biophysics; Cardiac Catheterization - instrumentation; Cardiac Catheterization - methods; Classical Mechanics; Delivery systems; Feasibility studies; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Heart valves; Humans; Implantation; Medical instruments; Polymers; Prostheses; Pulmonary Valve - surgery; Rigidity; Sheep; Stents; Surgical implants; Valves; TPVI; Stent implantation; Tissue engineered heart valve implantation; Transcatheter implantation; TAVI; Pulmonary valve implantation
• ISSN: 0090-6964; 1573-9686; 1573-9686
• DOI: 10.1007/s10439-016-1561-2

Transcatheter heart valve implantation is an emerging technology and an alternative to surgical valve replacement. Most existing systems consist of valves sewn into balloon-expandable stents with a delivery catheter functioning with the specific valve only. The aim of this study was to develop a universally applicable delivery system (DS) for plane stents, valves sewn into both balloon-expandable and self-expandable stents and feasible for use with different access routes. A DS was designed and manufactured in five different diameters. The requirements were derived from the implants, the implantation technique and the cardiovascular geometry of the experimental sheep. The combination of a self-expandable Nitinol stent and a jugular access point represented the major challenge as both flexibility and rigidity of the DS were required. To fulfill these contradicting mechanical properties the sheaths were comprised of a soft outer polymer tube with a stainless steel coiled spring inside. Tissue-engineered and pericardial pulmonary valves were implanted. Also polymeric and balloon-expandable stents were delivered to various positions in the vascular system. The initial success rate was 70.5%. After refinement of the DS, a success rate of 83.3% was achieved with the remaining failed implantations resulting from inadequate sizes of the prostheses.