Miriam Silaschi1, Hendrik Treede2, Ardawan J Rastan3, Hardy Baumbach4, Friedhelm Beyersdorf5, Utz Kappert6, Walter Eichinger7, Florian Rüter8, Thomas L de Kroon9, Rüdiger Lange10, Stephan Ensminger11, Olaf Wendler12. 1. Department of Cardiothoracic Surgery, King's College Hospital London, London, UK. 2. Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. 3. Department of Cardiac Surgery, Center of Cardiovascular Diseases Rotenburg a. d. Fulda, Rotenburg, Germany. 4. Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany. 5. Department of Cardiovascular Surgery Freiburg, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany. 6. Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany. 7. Department of Cardiovascular Surgery, Klinikum Bogenhausen, Munich, Germany. 8. Department of Cardiac Surgery, University Hospital Basel, Basel, Switzerland. 9. Department of Cardiothoracic Surgery, St. Antonius Hospital, Nieuwegein, Netherlands. 10. Department of Cardiovascular Surgery, German Heart Center Munich at Technische Universität München, Munich, Germany. 11. Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany. 12. Department of Cardiothoracic Surgery, King's College Hospital London, London, UK olaf.wendler@nhs.net.
Abstract
OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. METHODS: The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. RESULTS: The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. CONCLUSIONS: In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.
OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. METHODS: The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. RESULTS: The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. CONCLUSIONS: In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.
Authors: Simon C Y Chow; Randolph H L Wong; Gary S H Cheung; Alex P W Lee; Henry K L Chui; Kent C Y So; Eugene B Wu Journal: J Cardiothorac Surg Date: 2020-07-29 Impact factor: 1.637
Authors: Adriaan W Schneider; Mark G Hazekamp; Michel I M Versteegh; Arend de Weger; Eduard R Holman; Robert J M Klautz; Eline F Bruggemans; Jerry Braun Journal: Eur J Cardiothorac Surg Date: 2019-12-01 Impact factor: 4.191