I35.0 I35.1 I34.0 I34.1 I05.0 I07.0 I07.1 I35.2 I07.2 I05.2
Conditions
Interventions
Group 1: Axillary - In order to put the patient into a so-called "circulatory arrest", the patient must be connected to a heart-lung machine (HLM) so that the body's own organs can continue to be supp
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patients with valvular insufficiency or stenosis scheduled for minimally invasive surgery via anterolateral minithoracotomy 2. patients suitable for both femoral and axillary cannulation of the heart-lung machine (i.e., no relevant calcifications of the iliac leg vessels and the aorta, sufficient vascular diameter)
Exclusion criteria
Exclusion criteria: 1. vascular access site that is anatomically unsuitable for cannulation in the femoral or axillary artery 2. patients with vascular calcifications 3. higher grade stenoses in the para-aortic vessels 4. pre-interventional complications at the vascular access site (before the actual minimally invasive valve replacement/reconstruction procedure) 5. unstable active bleeding or bleeding diathesis or significant unmanageable anemia 6. lack of capacity of the patient to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Manifest stroke (confirmed by imaging or nontransient, manifest new neurologic deficit) within 7 days postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| - Transient ischemic attack - Severe delirium (CAM-ICU score based) - Seizures generalized and focal - Delayed awakening response (NIH stroke scale) - Survival rate at 1 and 2 years - Rate of access site or access-related hemorrhage - Rate of wound healing failure in the cannulation site - Aortic dissection - Postoperative ventilation duration - Mean NIH Stroke Scale at 3 and 7 days postoperatively | — |
Countries
Germany
Contacts
Public ContactFarhad Bakhtiary
Universitätsklinikum Bonn
Outcome results
None listed