Thomas Walther1, Christian W Hamm2, Gerhard Schuler3, Alexander Berkowitsch2, Joachim Kötting4, Norman Mangner3, Harald Mudra5, Andreas Beckmann6, Jochen Cremer7, Armin Welz8, Rüdiger Lange9, Karl-Heinz Kuck10, Friedrich W Mohr11, Helge Möllmann2. 1. Kerckhoff Herzzentrum, Abteilung Herzchirurgie, Bad Nauheim, Germany. Electronic address: t.walther@kerckhoff-klinik.de. 2. Kerckhoff Herzzentrum, Abteilung Kardiologie, Bad Nauheim, Germany. 3. Herzzentrum Leipzig, Abteilung Kardiologie, Leipzig, Germany. 4. BQS Institute, Düsseldorf, Germany. 5. Städtisches Klinikum Munich, Klinikum Neuperlach, Department of Cardiology/Pneumology, Munich, Germany. 6. Deutsche Gesellschaft für Thorax-, Herz-, und Gefässchirurgie, Berlin, Germany. 7. Universität Kiel, Abteilung für Herzchirurgie, Kiel, Germany. 8. Universität Bonn, Abteilung Herzchirurgie, Bonn, Germany. 9. Deutsches Herzzentrum München, Abteilung Herzchirurgie, München, Germany. 10. St. Georg Krankenhaus, Abteilung Kardiologie, Hamburg, Germany. 11. Herzzentrum Leipzig, Abteilung Herzchirurgie, Leipzig, Germany.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. OBJECTIVES: TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). METHODS: From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. RESULTS: Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. CONCLUSIONS: The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. OBJECTIVES: TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). METHODS: From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. RESULTS: Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. CONCLUSIONS: The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients.
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Authors: Susheel Kodali; Vinod H Thourani; Jonathon White; S Chris Malaisrie; Scott Lim; Kevin L Greason; Mathew Williams; Mayra Guerrero; Andrew C Eisenhauer; Samir Kapadia; Dean J Kereiakes; Howard C Herrmann; Vasilis Babaliaros; Wilson Y Szeto; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; Jonathon Leipsic; Philipp Blanke; Brian K Whisenant; Rakesh M Suri; Raj R Makkar; Girma M Ayele; Lars G Svensson; John G Webb; Michael J Mack; Craig R Smith; Martin B Leon Journal: Eur Heart J Date: 2016-03-31 Impact factor: 29.983