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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
the cuff will be placed around the left arm without being inflated
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
Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie
Dortmund, Germany
Evangelisches Klinikum Niederrhein, Kardiologie
Duisburg, Germany
Klinikum Karlsruhe
Karlsruhe, Germany
post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT
Change in cardiac troponine T (cTnT)
Time frame: 72 hours after intervention
Post-procedural myocardial injury
defined by the geometric mean (95% CI) of the area under the curve (AUC) for CK-MB
Time frame: 72 hours after intervention
Post-procedural acute kidney injury
defined according to the VARC 2 criteria
Time frame: 72 hours after intervention
Post-procedural brain injury
defined by the geometric mean (95% CI) of the area under the curve (AUC) for NSE
Time frame: 72 hours after intervention
composite of major adverse cardiac and cerebrovascular events
including death, postoperative myocardial infarction and cerebrovascular accident or stroke
Time frame: discharge, at 30 days and at 1 year
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