Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients. The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Percutaneous mitral repair will be performed using the MitraClip system.
All mitral valve surgeries will be performed either via sternotomy or right thoracotomy, and with cardioplegic arrest and cardiopulmonary bypass. Mitral valve repair may include annuloplasty and adjunctive procedures as determined by the operating surgeon. For mitral valve replacement, the choice of mitral valve prosthesis will be left at the surgeon's discretion.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
RECRUITINGMortality rate
All-cause mortality. Death from cardiovascular and non-cardiovascular causes.
Time frame: Within 12 months of intervention
Rate of myocardial infarction
These will be defined according to the Fourth Universal Definition of Myocardial Infarction
Time frame: Within 12 months of intervention
Rate of Stroke
1\) New, acute focal neurological deficit thought to be of vascular origin with signs or symptoms lasting \> 24 h and confirmed by a neurologist or 2) new, focal neurological deficit lasting \> 24 h with imaging evidence of cerebral infarction or intracerebral hemorrhage.
Time frame: Within 12 months of intervention
Hospitalization rate for congestive heart failure
Admission to hospital with congestive heart failure exacerbation being the primary reason for admission. Congestive heart failure exacerbation is defined as 1) evidence of fluid overload and elevated filling pressures (for example, a central venous pressure \> 8mmHg and/or a pulmonary capillary wedge pressure \> 18mmHg) and/or 2) new decrease in cardiac output (for example, cardiac index \< 2.2 L/min/m2) and end-organ perfusion (measured by one or more of: urine output \< 20mL/hr, lactate \>= 2.0, mixed venous oxygen saturation \< 70%).
Time frame: Within 12 months of intervention
Change in indexed left atrial volume
Time frame: Within 6 and12 months of intervention
Degree of left ventricular remodeling
Quantified by the change in left ventricular end systolic volume index
Time frame: Within 6 and12 months of intervention
Presence of recurrent MR ≥2+
Defined as a regurgitant volume of 30-44 ml, a right ventricular ejection fraction of 30-39%, or an effective regurgitant orifice area of 20-29 mm2
Time frame: Within 6 and12 months of intervention
Rate of mitral valve re-intervention
Time frame: Within12 months of intervention
Number of Participants with worsening in heart failure symptoms
+1 NYHA Class
Time frame: Within 6 and12 months of intervention
Cumulative hospital days
Time frame: Within 12-months of intervention
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