Aortic Valve Stenosis Clinical Trial
Official title:
Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry
There is limited experience for the balloon expandable THV (transcatheter heart valve) on the
need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results
of a small case series published by Wendler et. al. to examine hard endpoints such as the
incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a
multicenter registry.
We aim to compare the implantation of balloon expandable transcatheter heart valves with or
without predilation with respect to procedural outcomes (VARC2).
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty
(BAV) is usually performed under rapid right ventricular pacing (burst >180 bpm) with the
induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation is
aiming at facilitating the crossing of the aortic annulus, accurate valve positioning and
does also provide information on the anatomy of the valve complex. However, BAV has been
shown to have a number of potentially detrimental effects, such as:
- Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral,
and renal ischemia.
- In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac
depression after rapid pacing is observed and may result in hemodynamic failure and
systemic inflammatory response syndrome (SIRS). Both are associated with a high
periprocedural mortality.
- BAV has been identified as a major source of thrombotic and valvular material and
increases the risk for coronary obstruction with subsequent myocardial infarction and
stroke.
- The local trauma in the left-ventricular outflow tract caused by BAV may potentially
contribute to aortic root rupture.
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