The JUPITER registry: One‐year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation

• Published in: Catheterization and cardiovascular interventions Vol. 91; no. 7; pp. 1345 - 1351
• Main Authors: Silaschi, Miriam, Conradi, Lenard, Wendler, Olaf, Schlingloff, Friederike, Kappert, Utz, Rastan, Ardawan J, Baumbach, Hardy, Holzhey, David, Eichinger, Walter, Bader, Ralf, Treede, Hendrik
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.06.2018
• Subjects: aortic regurgitation; Aortic stenosis; Aortic valve; Electrocardiography; Embolization; Implantation; Regurgitation; Safety; Stenosis; Surgery; TAVI; transapical; transapical; aortic regurgitation; TAVI
• DOI: 10.1002/ccd.27370
• ISSN: 1522-1946

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.