Moritz Seiffert1, Ralf Bader2, Utz Kappert3, Ardawan Rastan4, Stephan Krapf5, Sabine Bleiziffer6, Steffen Hofmann7, Martin Arnold8, Klaus Kallenbach9, Lenard Conradi10, Friederike Schlingloff2, Manuel Wilbring3, Ulrich Schäfer2, Patrick Diemert10, Hendrik Treede10. 1. Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. Electronic address: m.seiffert@uke.de. 2. Departments of Cardiac Surgery and Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. 3. Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany. 4. Department of Cardiovascular Surgery, Cardiovascular Center Rotenburg, Rotenburg a.d. Fulda, Germany. 5. Department of Cardiothoracic Surgery, Klinikum Augsburg, Augsburg, Germany. 6. Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany. 7. Department of Cardiac Surgery, Schüchtermann Klinik Bad Rothenfelde, Bad Rothenfelde, Germany. 8. Department of Cardiology, University Hospital Erlangen, Erlangen, Germany. 9. Department of Cardiac Surgery, University Hospital Heidelberg, Heidelberg, Germany. 10. Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
Abstract
OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.
OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS:Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.
Authors: Jayendrakumar S Patel; Samir R Kapadia; Lourdes Prieto; E Murat Tuzcu; Amar Krishnaswamy Journal: Curr Treat Options Cardiovasc Med Date: 2015-11
Authors: Brandon M Jones; Amar Krishnaswamy; E Murat Tuzcu; Stephanie Mick; Wael A Jaber; Lars G Svensson; Samir R Kapadia Journal: Nat Rev Cardiol Date: 2017-07-06 Impact factor: 32.419