This article describes the human implantation of the 3F Therapeutics Enable Sutureless Aortic Heart Valve├óÔÇŞ╦İ (3F-TESAHV), performed on 13 January 2005 in the Department of Cardiovascular Surgery and Transplantology at Jagiellonian University in Krakow, Poland.
The purpose of this feasibility human clinical trial was to validate and verify the design of the 3F-TESAHV after aortic valve replacement (AVR) in humans. The primary focus of the study was to evaluate ease of use, safety, efficacy and incidence of complications attributable to the valve.
The 3F-TESAHV consists of a self-expanding nitinol stent covered with a polyester cloth and a scalloped polyester ring (see Figure 1). The valve leaflet material is comprised of equine pericardium, treated with a low concentration, buffered glutaraldehyde solution. The valve design also incorporates a reinforced sewing cuff and commissural attachment tabs, which are constructed using a woven polyester material.
The valve is designed in standard sizes of 19mm, 21mm, 23mm, 25mm, 27mm and 29mm for implantation in the aortic position. The valve has been designed for sutureless implantation, thereby eliminating the requirement for the surgeon to suture the valve into the aortic annulus and reducing the time associated with the AVR procedure. The 3F-TESAHV can be implanted in a very short time (less than three minutes based on experimental studies in animals and less then one minute based on first human implant), resulting in a much shorter time for the patient to be under cardiopulmonary bypass (CPB). For patients who have certain conditions that increase risk for open heart surgery, minimal time under CPB is desirable.
Material and Methods
A 76-year-old male with predominant aortic valve stenosis was enrolled in January 2005 to the feasibility human clinical study in the Department of Cardiovascular Surgery and Transplantology at Jagiellonian University.
The patient met all inclusion and exclusion criteria and underwent standardised procedures for AVR, with follow-up intervals being performed in accordance with the requirements of the clinical investigation plan. Echocardiography (ECG) was performed pre-operatively, post-operatively at hospital discharge and three to six months after surgery. Standard blood tests were performed at the time of follow-up.