First 30-day results of the Engager European pivotal trial support the safety and performance of the Engager transapical aortic valve system (Medtronic) in patients with severe aortic valve stenosis at high risk for surgical aortic valve replacement. Hendrick Treede, University Heart Center Hamburg, Hamburg, Germany, presented data at a Late-breaking trials session of the European Association for Cardio-Thoracic Surgery annual meeting (EACTS, Barcelona, Spain, 27−31 October).
The investigational device, pending CE mark approval, “consist of a nitinol frame that is self-expanding, it has a supra-annular valve function and achieves true anatomical alignment by control arms that fix the natural leaflets between the control arms and the lower stent part,” said Treede. “The control arms also provide tactile feedback and secure device during deployment.” This design contributes to reduce the incidence of paravulvar leak, commented Treede.
From September 2011 to May 2012, 61 patients (mean age 81.9±4.4 years, 62% female) with severe aortic stenosis were enrolled, 60 were implanted with the Engager system at four German centres. Eighty nine per cent presented NYHA class III or IV, 53% had coronary artery disease and 49% had peripheral vascular disease. Primary endpoints of the study are all-cause mortality at 30 days following implant and intention to treat analysis.
Treede told delegates that the device was deployed in the correct anatomical position and the delivery system was successfully retrieved in all patients. There were no major procedurial complications related to annulus rupture, valve embolization, conversion to surgery, need for a second valve, coronary obstruction or device malposition. At 30 days follow-up, the rate of all-cause mortality was 9.9% (6 patients) and one case of stroke was reported. Nine patients were implanted with pacemakers due to third-degree atrioventricular block post-implant and seven received pacemakers for other reasons.
Treede also reported that, according to an independent Echo Core Lab evaluation, out of 37 patients followed up at 30 days there were no cases of mild, moderate or severe paravulvar leak and 24% presented trace of paravulvar leak. “The low incidence of paravulvar leak is consistent with the design intent of the valve,” said Treede.
“This multicenter study confirms that transapical implantation of the Engager valve can be performed with a high degree of technical success,” said Treede. “The valve performs as intended with a positive risk/benefit for patients with symptomatic aortic stenosis who are at high or extreme risk for surgical aortic valve replacement.”