Oliver Husser1, Costanza Pellegrini2, Thorsten Kessler2, Christof Burgdorf2, Hannah Thaller2, N Patrick Mayr3, Ilka Ott2, Albert M Kasel2, Heribert Schunkert4, Adnan Kastrati4, Christian Hengstenberg5. 1. Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany. Electronic address: oliver.husser@gmail.com. 2. Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany. 3. Deutsches Herzzentrum München, Institut für Anästhesiologie, Technische Universität München, Munich, Germany. 4. Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 5. Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: christian.hengstenberg@gmail.com.
Abstract
OBJECTIVES: Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria. BACKGROUND: Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited. METHODS: A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days. RESULTS: The mean age was 81.0 ± 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed. CONCLUSIONS: We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor.
OBJECTIVES: Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria. BACKGROUND: Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited. METHODS: A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days. RESULTS: The mean age was 81.0 ± 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed. CONCLUSIONS: We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor.
Authors: Sabine Bleiziffer; Johan Bosmans; Stephen Brecker; Ulrich Gerckens; Peter Wenaweser; Corrado Tamburino; Axel Linke Journal: Clin Res Cardiol Date: 2017-05-08 Impact factor: 5.460
Authors: Costanza Pellegrini; Tobias Rheude; Teresa Trenkwalder; N Patrick Mayr; Michael Joner; Adnan Kastrati; Heribert Schunkert; Oliver Husser; Christian Hengstenberg Journal: Clin Res Cardiol Date: 2019-05-02 Impact factor: 5.460