Effectivity of RIPC in Outcomes of TAVI Procedure
Conditions
Brief summary
We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the TAVI setting to reduce post-procedural myocardial damage and improve patient outcome. Accordingly, we aim to investigate whether RIPC can be introduced as an integral part of the TAVI procedure, in order to reduce post-procedural myocardial damage and potentially improve patient outcome.
Detailed description
Transcatheter aortic valve implantation (TAVI) is associated to myocardial injury, defined as post-procedural cardiac troponin (cTn) elevation. Earlier experiences have shown that myocardial damage can be encountered in a percentage of patients that varies from 1.5% to 17%, depending on the access route (transfemoral and transapical, respectively). The degree of rise in cTn after TAVI emerged as an independent predictor of mortality. Remote ischaemic preconditioning (RIPC) consists of brief episodes of ischaemia applied to remote organs or tissues and has shown to result in a significant reduction in postoperative troponin levels in cardiac and non-cardiac surgery patients. Lately, growing evidence suggests that post-procedural troponin decreases due to RIPC application protocols protocols and is associated with improved outcome. The patients will be divided into two Groups. In Group 1, RIPS will be induced with three cycles of Inflation of a blood-pressure cuff on the left arm to 200 mmHg for 5 min., followed by 5 min. of reperfusion while the cuff is deflated. In controls (Group 2), the cuff will be placed around the left arm without being inflated.
Interventions
OTHERwithout RIPC
the cuff will be placed around the left arm without being inflated
PROCEDURERIPC
RIPC will be induced with three cycles of inflation of a blood-pressure cuff on the left arm to 200 mm Hg for 5 min, followed by 5 min of reperfusion while cuff deflated
Sponsors
Institut für Pharmakologie und Präventive Medizin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Indication for elective TAVI following Heart Team discussion * Stable hemodynamic conditions without circulatory support or catecholamines
Exclusion criteria
* Myocardial infarction at least 3 months before enrollment * Stroke/TIA at least 3 months before enrollment * Severe chronic kidney disease (defined as a baseline serum creatinine of \> 1.5 mg/dl or an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2 ) * PCI at least 3 months before enrollment * Abnormal (\>99th percentile of laboratory cut-off) baseline values of biomarkers of myocardial ischemia (i.e. TnT, CK-MB) * Abnormal NSE values at baseline (local laboratory cut-off values)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT | 72 hours after intervention | Change in cardiac troponine T (cTnT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-procedural myocardial injury | 72 hours after intervention | defined by the geometric mean (95% CI) of the area under the curve (AUC) for CK-MB |
| Post-procedural acute kidney injury | 72 hours after intervention | defined according to the VARC 2 criteria |
| Post-procedural brain injury | 72 hours after intervention | defined by the geometric mean (95% CI) of the area under the curve (AUC) for NSE |
| composite of major adverse cardiac and cerebrovascular events | discharge, at 30 days and at 1 year | including death, postoperative myocardial infarction and cerebrovascular accident or stroke |
Countries
Germany
Outcome results
None listed