Myocardial Protection Clinical Trial
Official title:
Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.
Thru the last 20 years it has been a discussion witch solution that gives the best myocardial
protection during cardiac arrest by heart operations.
- It has been a tendency that a blood based cardioplegia gives a better protection bye
long ischemic times but it has not been possible too conclude in this matter.
- The investigators have two groups of cardioplegia, the blood based and, the crystalloid
based cardioplegia.
- It has been done a lot of studies to see what kind of cardioplegia that gives the best
myocardial protection. Different temperature, different amount and content, retrograde
or antegrade or both, contentiously and further on have been tested without a clear
conclusion.
- The investigators decided to make a study with a cohort of patients as homogenous as
possible with a cross clamp time around 70 min.
- Adult patients' with a severe aortic stenoses without any other significant heart
disease was included in our prospective randomised study.
- Patients with additional significant coronary artery disease (≥ 50% stenoses) were
excluded from the study.
- The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the
myocardial damage.
Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia.
To day we normally used a blood or crystalloid based solutions. It has been published a lot
of papers comparing the too groups with different results. To our knowledge no prospective,
randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on
the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve
replacement on patients without additional significant coronary artery disease.
Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without
significant coronary artery stenoses or other significant concomitant heart valve disease
were included in the study. They were given antegrade cold blood or cold crystalloid
cardioplegia delivered through the coronary Ostia every 20 min throughout the period of
aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.
Published 2010 in the journal of thoracic and cardiovascular surgery.
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