Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT)

Institut für Pharmakologie und Präventive Medizin

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Procedure: without BAV

Procedure: BAV

Study type

Observational

Funder types

NETWORK

Identifiers

NCT02127580

EASE-IT

Details and patient eligibility

About

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).

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with an indication for TAVI as to the Edwards THV IFU
Eligible for TABI with AND without BAV
Signed informed consent

Exclusion criteria

Logistic EuroSCORE I >50%
Mitral or tricuspid valvular insufficiency (> grade II)
Previous aortic valve replacement
Uncontrolled atrial fibrillation
Left ventricular or atrial thrombus by echocardiography
Recent cerebrovascular event (within the last 3 months)
High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)