Effectivity of RIPC in Outcomes of TAVI Procedure Clinical Trial
Official title:
The CARE-TAVI Study: Cardioprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Transcatheter Aortic Valve Implantation
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)