Aortic Valve Stenosis
Conditions
Keywords
elective surgery, minimally invasive surgery, cardiac valve reconstruction, cardiac valve replacement
Brief summary
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
Interventions
None listed
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an elective primary open or minimal invasive surgery for a single or multiple cardiac valve reconstruction or / and replacement. * Age ≥18 years * Written informed consent
Exclusion criteria
* Patients undergoing an elective primary cardiac valve reconstruction or / and replacement in combination with a coronary arterial bypass graft surgery. * Emergency surgery * Pregnancy * Infective endocarditis * Previous cardiac surgical intervention * Known immunodeficiency or immunosuppression * Participation or planned participation in another cardiovascular study before study follow-up is completed. * Inability to give informed consent due to mental condition, mental retardation, or language barrier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months | from intervention up to 6 months postoperative | a composite endpoint of * Myocardial infarction until discharge * Stroke until discharge * Mortality until discharge * Endocarditis of the replaced / reconstructed valve until 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of myocardial infarction (MI) at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop |
| Comparison of stroke at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of stroke until discharge, 30 days and 6 months postop |
| Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop |
| Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop |
| Comparison of atrial fibrillation valve at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of atrial fibrillation until discharge, 30 days and 6 months postop |
| Comparison of renal failure at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of renal failure until discharge, 30 days and 6 months postop |
| Comparison of pneumonia at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of pneumonia until discharge, 30 days and 6 months postop |
| Comparison of mortality at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of mortality until discharge, 30 days and 6 months postop |
| Comparison of bleeding at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of bleeding until discharge, 30 days and 6 months postop |
| Rate of adverse events | until 6 months postop | valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related |
| Length of intensive care unit stay | until discharge (approximately 10 days postoperative) | Number of days the patient has to stay in intensive care unit after intervention |
| Length of hospital stay | until discharge (approximately 10 days postoperative) | Number of days the patient has to stay in hospital |
| Intraoperative handling of the suture material | intraoperative | Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment |
| Course of Health Status | until 6 months postoperative | 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 |
| Employment status | preoperative and 6 months postoperative | The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment |
| Comparison of mediastinitis at different timepoints in postoperative course | until discharge (approximately 10 days postoperative), 30 days and 6 months postop | Incidence of mediastinitis until discharge, 30 days and 6 months postop |
Countries
Germany, Spain
Outcome results
None listed