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The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.
The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients.
The reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of MR when performed without mitral valve surgery in patients with symptomatic ventricular dilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Papillary Muscle Sling Group | Experimental | Participants in the papillary muscle sling group will receive the sling technique performed in conjunction with their standard of care (SOC) Coronary Artery Bypass Grafting (CABG) surgery. |
|
| Controls Group | Active Comparator | Participants in the control group will receive their SOC CABG surgery only, without any additional intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papillary Muscle Sling | Device | The sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular function as assessed by LVEF | Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram | Baseline, up to 5 years |
| Change in left ventricular volume | End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram. | Baseline, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | Rate of reported mortality rate will be evaluated. | 5 years |
| Number of Major Adverse Cardiac Events (MACE) | MACE is defined as a composite of clinical events comprised of death, stroke, worsening heart failure defined as +1 New York Heart Association (NYHA) class, Congestive Heart Failure (CHF) hospitalization and mitral valve intervention as evaluated by treating physician |
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Inclusion Criteria:
Patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Lamelas, MD | University of Miami | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24364086 | Background | Lamelas J, Mihos C, Santana O. Surgical technique: papillary muscle sling for functional mitral regurgitation during minimally invasive valve surgery. Heart Surg Forum. 2013 Oct;16(5):E295-7. doi: 10.1532/hsf98.2013209. | |
| 23545430 | Background | Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):496-9. doi: 10.1016/j.jtcvs.2013.03.006. Epub 2013 Mar 29. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D009202 | Cardiomyopathies |
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| CABG surgery | Procedure | Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery |
|
| 5 years |
| Percentage of participants at each FMR severity grade | Functional Mitral Regurgitation (FMR) severity is graded on a scale of 1 to 4 with 1 = none, 2 =mild, 3 = moderate and 4 =severe. This outcome will report the percentage of participants with reported none, mild, moderate or severe mitral regurgitation as assessed via echocardiogram by treating physician. | Baseline, up to 5 years |
| Change in MLHF Questionnaire Score | Minnesota Living with Heart Failure (MLHF) is a 21-item questionnaire with a total score ranging from 0 (indicating heart failure has no affect to life) to 105 (indicating the greatest affect to life). | Baseline, up to 5 years |
| Change in Functional Status as assessed by 6MWT | Functional status will be assessed as the distance reached in meters via the 6-minute Walk Test (6MWT). | Baseline, up to 5 years |
| All Cause Readmission Rate | All cause readmission rate will be calculated for any case throughout the duration of study participation. | 5 years |
| Heart Failure Readmission Rate | Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation. | 5 years |
| Incidence of Mitral Leaflet Tenting | Mitral Leaflet tenting will be evaluated using echocardiographic imaging. | 5 years |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |