IMPROVE-FMR: Improving Mitral Repair for Functional Mitral Regurgitation
Study Details
Study Description
Brief Summary
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though widely adopted, durability of the repair is less, as 58% of the patients present with recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA failure, but research indicates that some geometric indices might be strong predictors. The investigators are interested in testing the hypothesis that, elevated lateral inter-papillary muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the first part of this study, the study team will measure lateral IPMS before surgery, and relate to post-surgery FMR severity at discharge/30 days, 6 months and 12 months.
A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is expected to improve the durability of UMA. In the second part of this study, the investigators will perform PMA and UMA together and determine if FMR severity is reduced at discharge/30 days, 6 months and 12 months.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Functional mitral regurgitation (FMR) is a common heart valve lesion that is observed in patients suffering for cardiomyopathies. Timely surgical repair of FMR can reduce volume overload and potentially improve cardiac function. Durable surgical techniques for FMR repair are lacking. Undersizing mitral annuloplasty (UMA) is the current technique of choice, but its durability is quite poor. Thirty five percent of the repairs fail within one year and 58% fail within 2 years.
One of the probable mechanisms causing UMA failure is elevated lateral inter-papillary muscle separation (IPMS). The study investigators are interested in understanding if the extent of lateral IPMS has a direct impact on the failure rates of UMA at 1 year post surgery. Secondly, the investigators are interested in determining if patients with elevated lateral IPMS benefit from papillary muscle approximation (PMA) along with UMA.
The investigators are interested in determining the best way to correct functional mitral regurgitation, as there is currently not one technique that is established to better than the other. The most common repair technique is called undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Another more recent technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. In this research study, the study team is investigating whether they can identify those patients who will benefit from one repair over another.
The primary objective of this protocol is to investigate if pre-operative IPMS is predictive of FMR severity at 12 months after UMA to repair FMR. Furthermore, whether a cut-off value of pre-operative inter-papillary muscle separation can be established to predict patients who might have failure of UMA.
The secondary objective of this protocol is to investigate if adding PMA to UMA is an effective technique in reducing recurrence of FMR at 12 months post-procedure.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: UMA (Group 1) Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA). |
Procedure: Undersizing Mitral Annuloplasty
Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size.
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Other: UMA + PMA (Group 2) Participants in the UMA + PMA group will receive an undersizing mitral annuloplasty (UMA) with papillary muscle approximation (PMA). |
Procedure: Undersizing Mitral Annuloplasty
Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size.
Procedure: Papillary Muscle Approximation
One or two 4-0 pledgeted sutures are used to draw the two papillary muscle tips together to reduce the inter papillary muscle separation (IPMS) before undergoing undersizing mitral annuloplasty.
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No Intervention: Retrospectively identified patients Retrospectively identified patients, who already underwent the standard of care surgery for the lesion of interest at Emory, within 6 months (± 1 month) after the date of their surgery, and are suitable for recruitment to the study for their post-operative research. |
Outcome Measures
Primary Outcome Measures
- Change in FMR Severity [Pre-Intervention, Post-Intervention (30 Days), Post-Intervention (6 Months), Post-Intervention (12 Months)]
Severity of mitral regurgitation measured using cardiac echocardiography and/or MRI (per physician's discretion).
Secondary Outcome Measures
- Mortality Rate [Post-Intervention (Up to 20 Days), Post-Intervention (Month 6), Post-Intervention (Month 12)]
The number of participants who are deceased will be collected throughout the study at discharge and planned follow up visits.
- Number of Major Adverse Cardiac Events (MACE) [Duration of Study (6 Years)]
MACE is defined as a composite of clinical events comprised of the following: Death Stroke Worsening heart failure (+1 New York Heart Association (NYHA) class) Congestive heart failure (CHF) hospitalization Mitral valve re-intervention
- Change in Quality of Life Scale Score [Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)]
Participants will be asked to measure their perceived quality of life on a scale from 0 to 100 where 0 indicates "worst imaginable health state" and 100 indicates "best imaginable health state".
- Change in Minnesota Living with Heart Failure (MLHF) Questionnaire Score [Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)]
The Minnesota Living with Heart Failure Questionnaire is a 21 item questionnaire that asks participants to describe how much their heart failure has affected life during the past month (4 weeks). Participants are asked if their heart failure prevented them from living as they want when completing daily tasks. Responses are rated on a scale from 0 to 5; 0 represents "no", 1 represents "very little" and 5 represents "very much" on a continuum. The MLHF score is obtained by summing the subjects responses. A minimum score is 0 indicating no affect to life and a maximum score is 105 indicating the greatest affect to life.
- Change in Functional Status assessed by 6-Minute Walk Test (6MWT) [Baseline, Post-intervention (Month 6), Post-Intervention (Month 12)]
Functional status will be measured by a 6-minute walk test, which assesses the distance walked (in feet) on a flat, hard surface in a period of 6 minutes (the 6MWD). The test is used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease. Optimal reference equations from healthy population-based samples using standardized 6MWT methods are not yet available. A low 6MWD is nonspecific and nondiagnostic. When the 6MWD is reduced, a thorough search for the cause of the impairment is warranted.
- All Cause Readmission Rate [Post Surgery (Up to 30 Days)]
Readmission rate will be calculated for any cause within the first 30 days following surgery throughout the duration of the study.
- Heart Failure Readmission Rate [Post Surgery (Up to 30 Days)]
Readmission rate will be calculated for heart failure after 30 days following surgery throughout the duration of the study. Classification of readmission as heart failure related requires at least 2 out of the following signs and symptoms of acute decompensated heart failure: Dyspnea felt related to HF Treatment with intravenous diuretic, vasodilator or inotropic therapy X ray evidence of pulmonary edema or pulmonary vascular congestion Rales on physical exam Pulmonary capillary wedge pressure (PCWP) or LVEDP > 18mm Hg
- Change in Left Ventricular Volume [Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)]
Change in left ventricular volume at 6 and 12 months post intervention compared to baseline as measured by echocardiogram
- Change in Left Ventricular Volume [Baseline, Post-Intervention (Month 12)]
Change in left ventricular volume at 12 months post intervention compared to baseline as measured by cardiac MRI
- Change in Left Ventricular Mass [Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)]
Change in left ventricular mass at 6 and 12 months post intervention compared to baseline as measured by echocardiogram.
- Change in Left Ventricular Mass [Baseline, Post-Intervention (Month 12)]
Change in left ventricular mass at 12 months post intervention compared to baseline as measured by cardiac MRI.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mitral regurgitation of moderate or greater severity, as defined by the guidelines of the American society of echocardiography (via a transthoracic echo)
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Cardiomyopathy of ischemic or non-ischemic origins, with or without the need for coronary revascularization
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Able to sign informed consent and release of medical information forms
Exclusion Criteria:
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Any evidence of structural (chordal or leaflet) mitral lesions
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Prior mitral valve repair
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Contraindication for cardiopulmonary bypass
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Clinical signs of cardiogenic shock at the time of randomization
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ST-segment elevation myocardial infarction within 14 days prior to inclusion in this study
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Congenital heart disease, except patent foramen ovale (PFO) or atrial septal defect (ASD)
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Chronic renal insufficiency defined by creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
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Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
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Pregnancy at the time of randomization
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
2 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
3 | Emory St. Joseph's Hospital | Atlanta | Georgia | United States | 30342 |
Sponsors and Collaborators
- Emory University
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Sai Muralidhar Padala, PhD, Emory University
Study Documents (Full-Text)
None provided.More Information
Publications
- Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro DA, Ailawadi G, Dagenais F, Gardner TJ, O'Gara PT, Michler RE, Kron IL; CTSN. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014 Jan 2;370(1):23-32. doi: 10.1056/NEJMoa1312808. Epub 2013 Nov 18.
- Kalra K, Wang Q, McIver BV, Shi W, Guyton RA, Sun W, Sarin EL, Thourani VH, Padala M. Temporal changes in interpapillary muscle dynamics as an active indicator of mitral valve and left ventricular interaction in ischemic mitral regurgitation. J Am Coll Cardiol. 2014 Nov 4;64(18):1867-79. doi: 10.1016/j.jacc.2014.07.988. Epub 2014 Oct 27.
- Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6.
- Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ Jr, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3.
- IRB00097939
- 1R01HL133667-01A1