Aortic Valve Stenosis, Cardiac Valve Insufficiency, Coronary Artery Disease
Conditions
Keywords
Median Sternotomy, Partial Sternotomy, Coronary Artery Bypass Grafting (CABG), Cardiac Valve Replacement, Cardiac Valve Reconstruction
Brief summary
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the OPTICABG as well as in the PREMIVALVE study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. OPTICABG patients were followed up 3 months after surgery and PREMIVALVE patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.
Interventions
DEVICESternum Closure after Cardiac Surgery
Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set. * PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set. * Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent * Age ≥18 years
Exclusion criteria
* OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection | up to 6 months after surgery | Combination of: * Incidence of sternum instability * Incidence of sternum dehiscence * Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of sternum dehiscence | up to 6 months after surgery | Number of patients presenting with dehiscence of the sternum after sternal closure with Steelex® Sternum Set |
| Incidence of superficial and deep sternal wound infection | up to 6 months after surgery | Number of patients presenting with superficial and deep sternal wound infection according to CDC classification after sternal closure with Steelex® Sternum Set |
| Incidence of other cardiac and cerebral complications | up to 6 months after surgery | Number of patients presenting with other cardiac and cerebral complications such as stroke, myocardial infarction, death, as well as mediastinitis after sternal closure with Steelex® Sternum Set |
| Incidence of suture related complications | up to 6 months after surgery | Number of patients presenting with suture related complications (e.g. wire breakage) after sternal closure with Steelex® Sternum Set |
| Incidence of sternum instability | up to 6 months after surgery | Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set |
| 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 |
| Health Status measured with EQ-5D-5L Score | up to 6 months after surgery | EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. |
| Intraoperative handling of the Steelex® Sternum Set | at time of surgery | the handling is examined using a survey, which will be answered and filled out prospectively and anonymously once by all involved cardiac surgeons |
| Length of hospital stay | until discharge (approximately 10 days postoperative) | Number of days the patient has to stay in hospital |
Countries
Germany, Spain
Outcome results
None listed