The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

INTERVENTIONS FOR VALVULAR DISEASE AND HEART FAILURE

First-in-human experience of a new-generation transfemoral transcatheter aortic valve for the treatment of severe aortic regurgitation: the J-Valve transfemoral system

EuroIntervention 2019;14:e1553-e1555 published online November 2018. DOI: 10.4244/EIJ-D-18-00935

Centre for Heart Valve Innovation, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada

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-Valve™ 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 first-in-human experience of the TF J-Valve system for the treatment of severe AR.

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Figure 1. Transfemoral J-Valve system. A) Valve consisting of bovine pericardial leaflets within a nitinol stent frame deployed within a nitinol anchor ring. B) J-Valve steerable transfemoral delivery system. Outer diameter of 18 Fr with minimal femoral access diameter of 5.5 mm. C) Illustration of anchor ring deployment within native valve cusps with anatomic alignment and leaflet grasping. D) Deployment of self-expanding J-Valve within anchor ring. E) Valve sizing chart. A 31 mm valve is also in development.

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