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TAVR Outcomes in Germany | Journal Scan
Study Questions:
What is the complication rate of transcatheter aortic valve replacement (TAVR) in Germany?
Methods:
This prospective registry examined 15,964 TAVR procedures performed in Germany between 2011 and 2013, and evaluated rates of severe vital complications (SVC; this included death on day of intervention, conversion to sternotomy, acute percutaneous coronary intervention, requirement for mechanical support, cardiac tamponade, aortic dissection, annular rupture) and technical complications (TCO; this included valve repositioning or retrieval, valve-in-valve implantation, embolization of device, paravalvular leak closure).
Results:
Mean age was 81 years and 46% were male; median Society of Thoracic Surgeons (STS) score was 5.0. Overall in-hospital mortality was 5.2%, with no significant change during the time of the study (5.9%, 5.0%, and 4.9% for 2011, 2012, and 2013, respectively; p = 0.08). Overall SVC was 5.0%, and decreased during each of these years (6.8%, 4.9%, and 3.9%; p < 0001). Variables independently associated with SVC were female gender, baseline New York Heart Association (NYHA) class IV symptoms, ejection fraction <30%, preprocedural inotropes, arterial vascular disease, greater calcification, and more severe aortic stenosis (p < 0.05 for each). TCO occurred overall in 4.7% of patients, with a significant decrease during each of these years (5.3%, 5.0%, and 1.1%; p = 0.003). Patients who experienced SVC had a hospital mortality rate of 40.8%, while those with TCO had a hospital mortality rate of 17.1%.
Conclusions:
The rates of SVC and TCO are low, and significantly decreased between 2011 and 2013. Nevertheless, the rate of hospital mortality did not significantly change during this period.
Perspective:
The results of this large registry highlight the importance of experience in TAVR, as there was a significant decrease in complications (both SVC and TCO) between 2011 and 2013. As large numbers of TAVR procedures have been performed in Germany since 2008, these data largely avoid early TAVR experience, and yet still demonstrate this improvement, with a particularly large magnitude of improvement with TCO. It is disappointing that the improved rate of complications did not translate to improved overall mortality, especially as there was a significant regression of patient risk, as measured by the STS score during this period (5.2, 5.0, and 4.9 for 2011, 2012, and 2013; p < 0.001). This lack of improved mortality is puzzling, and may merit further study in this large registry. This study also identified 20 significant independent predictors of mortality, which are an important addition to current literature as we seek to improve our ability to identify which patients may or may not benefit from TAVR.
Keywords: Transcatheter Aortic Valve Replacement, Hospital Mortality, Aortic Aneurysm, Aortic Valve Stenosis, Cardiac Tamponade, Percutaneous Coronary Intervention, Sternotomy, Heart Valve Diseases, Treatment Outcome, Cardiac Surgical Procedures, Surgeons, Registries, Prospective Studies
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