Conscious Sedation for Transcatheter Aortic Valve Implantation
Status:
Recruiting
Trial end date:
2025-11-15
Target enrollment:
Participant gender:
Summary
Aortic valve stenosis is the heart valve disease with the highest prevalence among the
elderly, and may lead to heart failure. Until recently, the only definitive treatment was
surgical replacement (SAVR). However, the increased risk associated with the surgical
procedure excluded patients with multiple co-morbidities. As the population is aging and more
and more patients may present with aortic stenosis, the need of a less invasive approach has
emerged. Transcatheter Aortic Valve Replacement (TAVR) offered an alternative therapy for
these high risk patients. This new method has seen worldwide acceptance, has been proven very
beneficial for these patients, and therefore its indications have been expanded to
intermediate risk patients, as well. Until recently, general anesthesia was the primary
anesthetic technique for TAVR, but conscious sedation or monitored anesthesia care (MAC) is
gaining more and more popularity lately. Our knowledge regarding the comparison between
general anesthesia and MAC in TAVR procedures is derived mainly from observational studies
and few randomized trials. MAC seems to be associated with less inotropic drug usage, shorter
procedural times, shorter intensive care unit (ICU) and hospital length of stay. However,
according to published data, there were no differences in 30-day mortality and complications
between these two techniques.
Even less are known about the most suitable anesthetic agent for MAC during TAVR. Many drugs
have been used, with propofol and dexmedetomidine being the most popular. However, there are
only few comparative studies and their results are not conclusive.
This study compares MAC under propofol and MAC under dexmedetomidine for TAVR in order to
examine which method of conscious sedation comes with more beneficial postoperative outcomes
for the patients.