The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation
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The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. / Silaschi, Miriam; Conradi, Lenard; Wendler, Olaf; Schlingloff, Friederike; Kappert, Utz; Rastan, Ardawan J; Baumbach, Hardy; Holzhey, David; Eichinger, Walter; Bader, Ralf; Treede, Hendrik.
in: CATHETER CARDIO INTE, Jahrgang 91, Nr. 7, 06.2018, S. 1345-1351.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation
AU - Silaschi, Miriam
AU - Conradi, Lenard
AU - Wendler, Olaf
AU - Schlingloff, Friederike
AU - Kappert, Utz
AU - Rastan, Ardawan J
AU - Baumbach, Hardy
AU - Holzhey, David
AU - Eichinger, Walter
AU - Bader, Ralf
AU - Treede, Hendrik
N1 - © 2017 Wiley Periodicals, Inc.
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Insufficiency/diagnostic imaging
KW - Female
KW - Heart Valve Prosthesis
KW - Humans
KW - Male
KW - Product Surveillance, Postmarketing
KW - Prospective Studies
KW - Prosthesis Design
KW - Recovery of Function
KW - Registries
KW - Risk Assessment
KW - Risk Factors
KW - Time Factors
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
U2 - 10.1002/ccd.27370
DO - 10.1002/ccd.27370
M3 - SCORING: Journal article
C2 - 29171730
VL - 91
SP - 1345
EP - 1351
JO - CATHETER CARDIO INTE
JF - CATHETER CARDIO INTE
SN - 1522-1946
IS - 7
ER -