The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.
OBJECTIVES
We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR).


BACKGROUND
Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism.


METHODS
The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled.


RESULTS
Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up.


CONCLUSIONS
The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.
['Silaschi|Miriam|M|0000-0001-7293-5516', 'Conradi|Lenard|L|', 'Wendler|Olaf|O|', 'Schlingloff|Friederike|F|', 'Kappert|Utz|U|', 'Rastan|Ardawan J|AJ|', 'Baumbach|Hardy|H|', 'Holzhey|David|D|', 'Eichinger|Walter|W|', 'Bader|Ralf|R|', 'Treede|Hendrik|H|']
D000368:Aged D000369:Aged, 80 and over D001021:Aortic Valve D001022:Aortic Valve Insufficiency D005260:Female D006350:Heart Valve Prosthesis D006801:Humans D008297:Male D011358:Product Surveillance, Postmarketing D011446:Prospective Studies D011474:Prosthesis Design D020127:Recovery of Function D012042:Registries D018570:Risk Assessment D012307:Risk Factors D013997:Time Factors D065467:Transcatheter Aortic Valve Replacement D016896:Treatment Outcome
transapical aortic regurgitation TAVI