1Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland; 2Atos Praxisklinik Zentrum für Gefäßerkrankungen und Präventivmedizin Heidelberg, Deutschland
Background. Patients with atrial fibrillation (AF) and Evaluated Heartvalves, Rheumatic or Artificial (EHRA) type 1 valvular heart disease (VHD) are often underrepresented or excluded in large randomized controlled trials. Thus, there is a paucity of studies focusing on the particular challenges of patients with AF and VHD.
Aim. This study aimed to create real-world evidence for the prevalence and characteristics of patients with EHRA Type 1 heart disease presenting to an emergency department (ED).
Methods. In this single-center retrospective observational sub-study, data from the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) was screened for the prevalence of EHRA type 1 valvular heart disease. The HERA-FIB project included 10.222 patients presenting consecutively to the ED of the University Hospital Heidelberg from June 2009 to March 2020. A structured follow-up was performed with a mean follow-up at 23 months (IQR 12-35). In this observational study, patient treatment remained on the discretion of treating physicians. The trial was approved by the local ethics committee and registered at ClinicalTrials.gov Identifier: NCT05995561.
Results. Overall 2.2% of patients in the HERA-FIB collective were classified as EHRA Type 1. In this subgroup 44.1% had a mechanical aortic valve prothesis, 27.0% a mechanical mitral valve prothesis and the rest was divided between other mechanical and or biological valve prothesis and isolated mitral valve stenosis. At discharge most (92.1%) EHRA Type 1 patients received anticoagulation whereas only 79.8% non-EHRA type 1 patients received anticoagulation (p<0.0001). Median INR at presentation was higher in the EHRA type 1 subgroup (2.47 vs. 1.14, p<0.0001). During the follow-up, there were higher rates of all-cause mortality and major bleeding events according to ISTH criteria in patients with EHRA type 1 (30.0% vs. 21.1% p=0.0012 and 18.2% vs 5.6%, p <0.0001). The hazard ratio (HR) for a major bleeding event was 9.58 (95% CI: 5.21-16.62) for EHRA type 1 patients. There were no major differences for strokes and myocardial infarction upon follow-up (2.7% vs 3.3% p=0.6505 and 2.7% vs 4.4% p=0.2524).
Conclusions. Data from this sub-study of HERA-FIB gives insights into the specifics of EHRA type 1 VHD patients in a real-world collective of patients presenting to an ED. Major bleeding remains critically high in patients with EHRA type 1 VHD. Further analysis are required to identify relevant subgroups and risk factors among patients with EHRA type 1 VHD.