FIRST NORTH AMERICAN EXPERIENCE WITH THE ENGAGER SELF-EXPANDING TRANSCATHETER AORTIC VALVE: INSIGHTS FROM THE LONDON HEALTH SCIENCE CENTRE HEART TEAM

Abstract

BackgroundThe second-generation Engager valve consists of bovine pericardial leaflets mounted on a self-expandable frame. The device is specifically designed with anatomic orientation capabilities for accurate position and implantation by transapical access. The aim of this study was to report the initial North American experience with the Engager self-expanding transcatheter aortic valve implantation (TAVI).MethodsTransapical-TAVI with the Engager bioprosthesis was performed in a hybrid operating room under general anesthesia and transesophageal echocardiography guidance as complementary imaging tool. Clinical and echocardiographic data were prospectively gathered.ResultsA total of 4 patients (mean age of 80±6 years, logistic EuroSCORE of 19±8% and STS-score of 5±1%) were included. Reasons for refusing surgical aortic valve replacement where either previous coronary artery bypass grafting with adherent grafts, porcelain aorta, or age/frailty. The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to surgery or major procedure-related complications. Engager implantation resulted in significant reduction of mean transvalvular gradient (50±18 mmHg to 15±6 mmHg, P=0.012). Pacemaker implantation was necessary in 1 patient. Hospital discharge occurred at a mean of 5±2 days and none of the patients showed paravalvular regurgitation at discharge echocardiogram.ConclusionTransapical Engager valve implantation was safe and effective for the treatment of elderly patients with aortic stenosis at high surgical risk. The anatomic orientation and anchoring within the native leaflets can avoid coronary obstruction, and allow optimal hemodynamic performance and avoidance of paravalvular regurgitation. BackgroundThe second-generation Engager valve consists of bovine pericardial leaflets mounted on a self-expandable frame. The device is specifically designed with anatomic orientation capabilities for accurate position and implantation by transapical access. The aim of this study was to report the initial North American experience with the Engager self-expanding transcatheter aortic valve implantation (TAVI). The second-generation Engager valve consists of bovine pericardial leaflets mounted on a self-expandable frame. The device is specifically designed with anatomic orientation capabilities for accurate position and implantation by transapical access. The aim of this study was to report the initial North American experience with the Engager self-expanding transcatheter aortic valve implantation (TAVI). MethodsTransapical-TAVI with the Engager bioprosthesis was performed in a hybrid operating room under general anesthesia and transesophageal echocardiography guidance as complementary imaging tool. Clinical and echocardiographic data were prospectively gathered. Transapical-TAVI with the Engager bioprosthesis was performed in a hybrid operating room under general anesthesia and transesophageal echocardiography guidance as complementary imaging tool. Clinical and echocardiographic data were prospectively gathered. ResultsA total of 4 patients (mean age of 80±6 years, logistic EuroSCORE of 19±8% and STS-score of 5±1%) were included. Reasons for refusing surgical aortic valve replacement where either previous coronary artery bypass grafting with adherent grafts, porcelain aorta, or age/frailty. The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to surgery or major procedure-related complications. Engager implantation resulted in significant reduction of mean transvalvular gradient (50±18 mmHg to 15±6 mmHg, P=0.012). Pacemaker implantation was necessary in 1 patient. Hospital discharge occurred at a mean of 5±2 days and none of the patients showed paravalvular regurgitation at discharge echocardiogram. A total of 4 patients (mean age of 80±6 years, logistic EuroSCORE of 19±8% and STS-score of 5±1%) were included. Reasons for refusing surgical aortic valve replacement where either previous coronary artery bypass grafting with adherent grafts, porcelain aorta, or age/frailty. The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to surgery or major procedure-related complications. Engager implantation resulted in significant reduction of mean transvalvular gradient (50±18 mmHg to 15±6 mmHg, P=0.012). Pacemaker implantation was necessary in 1 patient. Hospital discharge occurred at a mean of 5±2 days and none of the patients showed paravalvular regurgitation at discharge echocardiogram. ConclusionTransapical Engager valve implantation was safe and effective for the treatment of elderly patients with aortic stenosis at high surgical risk. The anatomic orientation and anchoring within the native leaflets can avoid coronary obstruction, and allow optimal hemodynamic performance and avoidance of paravalvular regurgitation. Transapical Engager valve implantation was safe and effective for the treatment of elderly patients with aortic stenosis at high surgical risk. The anatomic orientation and anchoring within the native leaflets can avoid coronary obstruction, and allow optimal hemodynamic performance and avoidance of paravalvular regurgitation.