Rüdiger Lange1, Andreas Beckmann2, Till Neumann3, Markus Krane4, Marcus-André Deutsch5, Sandra Landwehr6, Joachim Kötting6, Armin Welz7, Ralf Zahn8, Jochen Cremer9, Hans R Figulla10, Gerhard Schuler11, David M Holzhey11, Anne-Kathrin Funkat11, Gerd Heusch12, Stefan Sack13, Miralem Pasic14, Thomas Meinertz15, Thomas Walther16, Karl-Heinz Kuck17, Friedhelm Beyersdorf18, Michael Böhm19, Helge Möllmann20, Christian W Hamm20, Friedrich W Mohr11. 1. Department of Cardiovascular Surgery, German Heart Center, Technische Universität München (TUM), Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: lange@dhm.mhn.de. 2. Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie [DGTHG], Berlin, Germany. 3. Department of Cardiology, West German Heart Center Essen, Essen, Germany. 4. Department of Cardiovascular Surgery, German Heart Center, Technische Universität München (TUM), Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 5. Department of Cardiovascular Surgery, German Heart Center, Technische Universität München (TUM), Munich, Germany. 6. BQS-Institute, Düsseldorf, Germany. 7. Department of Cardiac Surgery, University Hospital Bonn, Bonn, Germany. 8. Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen, Germany. 9. Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Kiel, Germany. 10. Department of Internal Medicine I, University Heart Center Jena, Jena, Germany. 11. Leipzig Heart Center, University of Leipzig, Leipzig, Germany. 12. Institute of Pathophysiology, University of Essen Medical School, West German Heart and Vascular Center Essen, Germany. 13. Department of Cardiology, Klinikum Muenchen Schwabing, Munich, Germany. 14. Department of Cardiac Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany. 15. Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. 16. Department of Cardiac Surgery, Kerckhoff-Klinik, Bad Nauheim, Germany. 17. Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. 18. Department of Cardiac Surgery, Heart Center Freiburg University, Freiburg, Germany. 19. Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany. 20. Department of Cardiology, Kerckhoff-Klinik, Bad Nauheim, Germany.
Abstract
OBJECTIVES: This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). BACKGROUND: Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. METHODS: In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. RESULTS: Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. CONCLUSIONS: TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits.
OBJECTIVES: This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). BACKGROUND: Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. METHODS: In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. RESULTS: Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. CONCLUSIONS: TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits.
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