Purpose: Optimal TAVI results require accurate valve positioning, possibly including anatomically correct orientation and secure fixation within the aortic annulus, thereby potentially decreasing paravalvular regurgitation. The new Engager system captures the native leaflets for sealing and allows for tactile feedback during anatomically correct placement of the valve. We report the safety and performance evaluations of the Engager system, an investigational device currently without CE marking, in patients with severe aortic valve stenosis at high or extreme risk for surgical aortic valve replacement (AVR).
Methods: An interim analysis was performed on the initial 61 patients from four sites in Germany who were enrolled from September 2011 through May 2012. Inclusion criteria comprised severe aortic stenosis by echocardiography, NYHA ≥ II, Logistic EuroSCORE I ≥ 20% or contraindication to surgical AVR. Patients were evaluated at 24 to 48 hours post-procedure, at hospital discharge, at 30 days, and at 6 months. Follow-up is planned annually through 5 years.
Results: The baseline characteristics for the initial 61 patients in the study were: mean age 81.9 ± 4.4 years, 62.3% female, 88.5% NYHA III/IV, 52.5% CAD, and 49.2% PVD. For all of the attempted implantations (n=60), the Engager prosthesis was positioned in the correct anatomical position (100%) without conversions to surgery, second valve implantation, device malposition, aortic annular rupture, or coronary obstruction. At 30 days, the rates of all-cause mortality and major apical access site complications were 9.9% and 8.4%, respectively. Based on echocardiographic fi ndings at 30 days, average mean gradient was 11.5 ± 5.0 mmHg, and no patient experienced greater than trace paravalvular regurgitation. All-cause mortality, hemodynamic performance, and change in NYHA functional classifi cation at 6 months will be reported in the presentation.
Conclusions: Early postoperative results support implantation success and valve safety. Analyses for 6-month outcomes are underway and will be provided in the conference presentation.