Comparison of Conscious Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Aortic valve stenosis is the most common valvular heart disease in the developed world,
affecting 3,9% of population over 70 years of age. If untreated it carries a poor prognosis,
leading to heart failure and death in 2 years after first symptom presentation. Treatment of
choice for severe aortic stenosis is surgical aortic valve replacement. A new treatment
option for severe aortic stenosis emerged in the last decade - Transcatheter Aortic Valve
Replacement (TAVR). This minimally invasive method was formerly reserved for high risk
patients deemed unfit for surgical aortic valve replacement. Increasing use throughout the
developed world and recent studies have established TAVR as a safe and viable treatment
option also for intermediate-risk patients. TAVR not only enables a less aggressive surgical
approach, but also a less invasive type of anaesthesia. Anaesthesiologists are trying to
modify the type of anaesthesia in the way of minimally invasive approach, aiming to improve
the overall outcome.
TAVR can be performed under general anaesthesia or conscious sedation (CS). From the start,
TAVR was performed solely under general anaesthesia. Over time the procedure became routine
and the anaesthesiologists started to commonly decide for CS. Many US and European
retrospective studies have established CS to be a safe and compelling method of anaesthetic
care for TAVR procedures with a favorable perioperative course, less complications, shorter
intensive care unit and in-hospital stay and lower early mortality, when performed by an
experienced anaesthesia team. There are many anaesthesia agents currently accepted for CS in
everyday anaesthesia practice. Presently, reliable data from studies comparing different
agents for CS for TAVR procedures is scarce. Most of it comes from retrospective
nonrandomized trials. Propofol is a popular anaesthetic agent for CS. According to current
studies, it is a safe anaesthetic agent with favorable pharmacokinetic and pharmacodynamic
profiles with quite low incidence of side effects. In recent years, dexmedetomidine has been
commonly used for CS having analgesic properties inclusive of its anaesthetic properties. In
addition, dexmedetomidine is associated with a lesser degree of respiratory depression as to
other anaesthetic agents. Patient comfort is also believed to be improved with
dexmedetomidine. Studies comparing outcomes of CS with propofol versus dexmedetomidine for
different non-cardiac and interventional procedures showed benefits of dexmedetomidine, owing
to its analgesic properties and preferable respiratory parameters.
The aim of this study is to compare the outcome of patients undergoing TAVR under CS with
dexmedetomidine against those undergoing TAVR under CS with propofol. With the results the
investigators aim to aid in defining the optimal anaesthetic agent for CS for TAVR and
possibly other interventional cardiology procedures.