EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology | 2019
First-in-human experience of a new-generation transfemoral transcatheter aortic valve for the treatment of severe aortic regurgitation: the J-Valve transfemoral system.
Abstract
Introduction Transcatheter aortic valve implantation (TAVI) is now well established in the contemporary management of severe aortic stenosis (AS) with a multitude of valve designs available. The transapical (TA) J-ValveTM system (JC Medical Inc., Burlingame, CA, USA) has previously been shown to be effective for the treatment of both severe AS and aortic regurgitation (AR)1,2. The J-Valve transcatheter aortic valve consists of the valve and three U-shaped “anchor rings” (Figure 1A) and is deployed in a two-step process. The transfemoral (TF) valve is delivered by an 18 Fr steerable delivery system (Figure 1B). First, the anchor rings are opened above the native valve and are retracted (TA) or advanced (TF) into the valve apparatus allowing automatic anatomic alignment in the aortic sinuses and clasping of the native valve leaflets (Figure 1C). This can be visualised on fluoroscopy. Once positioned, the self-expanding valve is then deployed within the anchor rings and secures the native valve leaflets (Figure 1D). The valve, which is not recapturable, is currently available in three sizes (Figure 1E). We present the firstin-human experience of the TF J-Valve system for the treatment of severe AR. Methods A 42-year-old male with prior subaortic membrane repair presented with recurrent heart failure hospitalisations due to severe AR (New York Heart Association [NYHA] Class IV) and high diuretic requirements. Echocardiography revealed normal left ventricular (LV) systolic function, an LV end-diastolic diameter of 66 mm and a non-calcified tricuspid aortic valve with severe AR (Figure 2A). Invasive cardiac catheterisation revealed normal coronary arteries and raised LV end-diastolic pressure of 35 mmHg. The patient had multiple comorbidities including morbid obesity (BMI >50 kg/m2), diabetes and stage IV chronic kidney disease (eGFR 29 ml/min per 1.73 m2). The Society of Thoracic Surgeons (STS) predicted risk of mortality was 7.8% and the patient was deemed at prohibitive risk for surgical aortic valve replacement or TA TAVI by the multidisciplinary Heart Team. Preoperative valve sizing with computed tomography was not optimal due to elevated body mass index and attempts to reduce contrast load to lower the risk of acute kidney injury; therefore, intraoperative transoesophageal echocardiography (TEE) was performed to confirm sizing. TEE is not required for deployment of the valve.