First-in-Human Case of Transfemoral CardiAQ Mitral Valve Implantation.

Abstract

Major advancements have been made in transcatheter aortic and pulmonary valve implantation during the past decade. However, transcatheter mitral valve implantation (TMVI) poses different challenges because of the complexity of the mitral valve apparatus. Although several companies are attempting to develop transcatheter approaches for mitral valve repair, these technologies may have limited applicability because of the heterogeneous nature of the disease and, to date, this strategy has had a difficult time demonstrating the efficacy that is equivalent to surgical approaches. In this report, we describe the first-in-human percutaneous transfemoral-TMVI, which was performed at Rigshospitalet in Copenhagen, Denmark on June 12, 2012 using a dedicated device. An 86-year-old male with symptomatic mitral regurgitation (MR) was referred for interventional treatment. Transesophageal echocardiography showed severe MR (grade, 3+ to 4) because of mitral annular dilatation and a severely restricted posterior mitral leaflet in a dilated left ventricle (LV) with ejection fraction 40%. The patient was declined for mitral valve surgery (Society of Thoracic Surgeons score, 31.9%) and for MitraClip treatment because of a too large systolic coaptation gap. An informed consent from the patient and approval from the Danish National Board of Health were obtained for this first-in-human TMVI procedure using the first-generation CardiAQ valve (CardiAQ Valve Technologies, Irvine, CA; Figure 1). Figure 1. CardiAQ prosthesis consists of a self-expanding nitinol frame, which has 3 leaflets of bovine pericardial tissue and is covered with a polytetrafluoroethylene membrane to minimize paravalvular leakage. The frame design features 2 sets of opposing left ventricular anchors and allows for annular attachment without radial force. The frame engages and preserves the native subvalvular apparatus and features a 40-mm anchoring region and a 30-mm inflow region. A , First-generation device, as used in the first-in-human transfemoral CardiAQ case. B , Second-generation device, which offers improved load distribution, optimized flow properties …