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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous mitral repair | Experimental | Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair. |
|
| Mitral valve surgery | Active Comparator | Surgical mitral valve surgery +/- coronary artery bypass grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous mitral valve repair | Procedure | Percutaneous mitral repair will be performed using the MitraClip system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | All-cause mortality. Death from cardiovascular and non-cardiovascular causes. | Within 12 months of intervention |
| Rate of myocardial infarction | These will be defined according to the Fourth Universal Definition of Myocardial Infarction | 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. | 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%). | Within 12 months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in indexed left atrial volume | Within 6 and12 months of intervention | |
| Degree of left ventricular remodeling | Quantified by the change in left ventricular end systolic volume index | Within 6 and12 months of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Chan, MD, MPH | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| D012092 | Replantation |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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Prospective randomized trial
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| Surgical mitral valve repair/replacement | Procedure | 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. |
|
| 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 | Within 6 and12 months of intervention |
| Rate of mitral valve re-intervention | Within12 months of intervention |
| Number of Participants with worsening in heart failure symptoms | +1 NYHA Class | Within 6 and12 months of intervention |
| Cumulative hospital days | Within 12-months of intervention |
| D017202 |
| Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |