Key result
This study is a protocol for a prospective observational trial to compare reactive oxygen species generation and 3-month clinical outcomes between TAVR and SAVR in 24 patients; no results are reported.
Why the study?
Does TAVR compared to SAVR alter the generation of reactive oxygen species in patients with severe aortic stenosis?
Observational (n=24)
Does TAVR compared to SAVR alter the generation of reactive oxygen species in patients with severe aortic stenosis?
This protocol describes a prospective observational study to evaluate whether reactive oxygen species generation differs between TAVR and SAVR and correlates with short-term clinical outcomes.
Answers are grounded in this paper and cite their sources.
Leaves open whether TAVR alters ROS generation versus SAVR; this small observational protocol is hypothesis-generating.
Background: Myocardial ischemia and reperfusion injury mediated by reactive oxygen species (ROS) related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. The generation of ROS and its clinical impact in patients undergoing transcatheter aortic valve replacement (TAVR) have not been studied. Methods/Design: This is a prospective observational study that will compare the generation of ROS between 12 consecutive patients undergoing TAVR and 12 patients undergoing isolated surgical aortic valve replacement (SAVR) and will determine whether any potential differences are related to the 3-month composite endpoints of cardiovascular mortality, myocardial infarction, stroke, major bleeding or life threatening bleeding. Peripheral blood will be taken immediately before aortic intervention, at the completion of the procedure, 6-8 hours after the procedure, and 24 hours after the procedure for measurements of ROS. Clinical follow-up at 3 months post discharge will be undertaken either in the outpatient clinic or by telephone. Discussion: This study will determine changes in the levels of ROS in patients undergoing TAVR and identify whether any potential changes are correlated with clinical outcomes. Trial registration: ClinicalTrials.gov identifier: NCT02841917; registered on December 29, 2015. Ethics: The study protocol has been approved by the RES Committee North West Liverpool East (IRAS Project ID: 206946). Informed consent: Signed informed consent will be obtained from each patient who wishes to participate in this study.
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Mahmoudi et al. (2016) conducted an observational in severe aortic stenosis (n=24). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on Generation of reactive oxygen species (ROS) and its relation to a 3-month composite of cardiovascular mortality, myocardial infarction, stroke, major bleeding, or life-threatening bleeding. This study is a protocol for a prospective observational trial to compare reactive oxygen species generation and 3-month clinical outcomes between TAVR and SAVR in 24 patients; no results are reported.
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