Femoral or axillary cannulation of the heart-lung machine in minimally invasive heart valve surgery.
- Conditions
- Mitral stenosisI35.0I34.0I35.1I34.1I05.0I07.0I07.1I35.2I07.2
- Registration Number
- DRKS00030486
- Lead Sponsor
- niversitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 820
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)
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Manifest stroke (confirmed by imaging or nontransient, manifest new neurologic deficit) within 7 days postoperatively
- Secondary Outcome Measures
Name Time Method - Transient ischemic attack<br>- Severe delirium (CAM-ICU score based)<br>- Seizures generalized and focal<br>- Delayed awakening response (NIH stroke scale)<br>- Survival rate at 1 and 2 years<br>- Rate of access site or access-related hemorrhage <br>- Rate of wound healing failure in the cannulation site <br>- Aortic dissection<br>- Postoperative ventilation duration<br>- Mean NIH Stroke Scale at 3 and 7 days postoperatively