The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
Study Type
OBSERVATIONAL
Enrollment
198
Robert Bosch KH Stuttgart
Stuttgart, Germany
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months
a composite endpoint of * Myocardial infarction until discharge * Stroke until discharge * Mortality until discharge * Endocarditis of the replaced / reconstructed valve until 6 months
Time frame: from intervention up to 6 months postoperative
Comparison of mortality at different timepoints in postoperative course
Incidence of mortality until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of myocardial infarction (MI) at different timepoints in postoperative course
Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of stroke at different timepoints in postoperative course
Incidence of stroke until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course
Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course
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Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of atrial fibrillation valve at different timepoints in postoperative course
Incidence of atrial fibrillation until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of renal failure at different timepoints in postoperative course
Incidence of renal failure until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of pneumonia at different timepoints in postoperative course
Incidence of pneumonia until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of mediastinitis at different timepoints in postoperative course
Incidence of mediastinitis until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of bleeding at different timepoints in postoperative course
Incidence of bleeding until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Rate of adverse events
valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related
Time frame: until 6 months postop
Length of intensive care unit stay
Number of days the patient has to stay in intensive care unit after intervention
Time frame: until discharge (approximately 10 days postoperative)
Length of hospital stay
Number of days the patient has to stay in hospital
Time frame: until discharge (approximately 10 days postoperative)
Intraoperative handling of the suture material
Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment
Time frame: intraoperative
Course of Health Status
EQ-5D is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"
Time frame: until 6 months postoperative
Employment status
The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment
Time frame: preoperative and 6 months postoperative