De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but \<2+ TR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
Ziekenhuis Oost-Limburg (General Hospital Genk)
Genk, Belgium
RECRUITINGcombination of all-cause mortality or heart failure hospitalisation
Time frame: at 12 months post-surgery
RV function & geometry
volumes and ejection fraction Assessed by cardiac ultrasound and MRI
Time frame: 3, 6, 12 and 18 months
Quality of Life
Change at follow-up, measured by SF-36 \& Minnesota Living with Heart Failure scale.
Time frame: 6, 12 and 18 months
Duration of Hospital and ICU stay
Time frame: postoperative phase
All-Cause Mortality
Time frame: at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure
Time frame: at 3, 6, 12 and 18 months post-surgery
progressive TR > 2+ post-surgery
Time frame: 3, 6, 12 and 18 months
cardiovascular mortality
Time frame: at 3, 6, 12 and 18 months post-surgery
Exercise Tolerance
Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)
Time frame: 6, 12 and 18 months
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