MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2018 |
| Start Date: | January 2017 |
| End Date: | December 2020 |
| Contact: | Seth Uretsky, MD |
| Email: | seth.uretsky@atlantichealth.org |
| Phone: | 9739715597 |
Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study
Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the
severity of mitral regurgitation is central to determining which patients are appropriate for
correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is
made, patients are considered appropriate for mitral valve surgery in almost all clinical
circumstances. However, there is a significant mortality and morbidity associated with mitral
valve surgery The most common diagnostic tool to assess the severity of MR is
echocardiography. Several studies have shown that echocardiography parameters used to
quantify and qualify MR have high inter-observer and intra-observer variability, calling the
accuracy of these parameters into question. Furthermore, studies have shown that there is a
significant degree of discordance between echocardiography and MRI when assessing MR,
particularly among patients referred for mitral valve surgery. In a recent study,
quantification of mitral regurgitant volume MRI was found to be more accurate than
echocardiography in patients who underwent mitral valve surgery. All 38 patients who
underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA
guidelines based on echocardiographic findings. However, more than 2/3rds of patients who
underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose
this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients
undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and
healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post
surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.
repair according to MR severity by MRI.
severity of mitral regurgitation is central to determining which patients are appropriate for
correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is
made, patients are considered appropriate for mitral valve surgery in almost all clinical
circumstances. However, there is a significant mortality and morbidity associated with mitral
valve surgery The most common diagnostic tool to assess the severity of MR is
echocardiography. Several studies have shown that echocardiography parameters used to
quantify and qualify MR have high inter-observer and intra-observer variability, calling the
accuracy of these parameters into question. Furthermore, studies have shown that there is a
significant degree of discordance between echocardiography and MRI when assessing MR,
particularly among patients referred for mitral valve surgery. In a recent study,
quantification of mitral regurgitant volume MRI was found to be more accurate than
echocardiography in patients who underwent mitral valve surgery. All 38 patients who
underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA
guidelines based on echocardiographic findings. However, more than 2/3rds of patients who
underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose
this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients
undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and
healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post
surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.
repair according to MR severity by MRI.
Mitral regurgitation is a common disease which can lead to heart failure and death if left
untreated. The only known therapy for mitral regurgitation is correction of the mitral valve,
most commonly performed by surgical repair or replacement. According the STS database, there
were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has
been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA
guidelines for the management of mitral valve disease, quantifying the severity of mitral
regurgitation is central to determining which patients are appropriate for correction of
their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made,
patients are considered appropriate for mitral valve surgery in almost all clinical
circumstances. However, there is a significant mortality and morbidity associated with mitral
valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for
replacement. This data does not take into account long-term mortality and morbidity from
re-operation and life-long anti-coagulation as well as changes in quality of life.
The most common diagnostic tool to assess the severity of MR is echocardiography. Several
studies have shown that echocardiography parameters used to quantify and qualify MR have high
inter-observer and intra-observer variability, calling the accuracy of these parameters into
question. Furthermore, studies have shown that there is a significant degree of discordance
between echocardiography and MRI when assessing MR, particularly among patients referred for
mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was
found to be more accurate than echocardiography in patients who underwent mitral valve
surgery. All 38 patients who underwent mitral valve surgery in this study were deemed
appropriate according the ACC/AHA guidelines based on echocardiographic findings. However,
more than 2/3rds of patients who underwent mitral valve surgery in this study did not have
severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the
severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral
valve surgery on quality of life and healthcare costs in the context of MR severity by MRI,
3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the
likelihood of valve replacement vs. repair according to MR severity by MRI.
untreated. The only known therapy for mitral regurgitation is correction of the mitral valve,
most commonly performed by surgical repair or replacement. According the STS database, there
were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has
been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA
guidelines for the management of mitral valve disease, quantifying the severity of mitral
regurgitation is central to determining which patients are appropriate for correction of
their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made,
patients are considered appropriate for mitral valve surgery in almost all clinical
circumstances. However, there is a significant mortality and morbidity associated with mitral
valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for
replacement. This data does not take into account long-term mortality and morbidity from
re-operation and life-long anti-coagulation as well as changes in quality of life.
The most common diagnostic tool to assess the severity of MR is echocardiography. Several
studies have shown that echocardiography parameters used to quantify and qualify MR have high
inter-observer and intra-observer variability, calling the accuracy of these parameters into
question. Furthermore, studies have shown that there is a significant degree of discordance
between echocardiography and MRI when assessing MR, particularly among patients referred for
mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was
found to be more accurate than echocardiography in patients who underwent mitral valve
surgery. All 38 patients who underwent mitral valve surgery in this study were deemed
appropriate according the ACC/AHA guidelines based on echocardiographic findings. However,
more than 2/3rds of patients who underwent mitral valve surgery in this study did not have
severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the
severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral
valve surgery on quality of life and healthcare costs in the context of MR severity by MRI,
3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the
likelihood of valve replacement vs. repair according to MR severity by MRI.
Inclusion Criteria:
- Age 18 years and older.
- Able to give informed consent.
- Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within
30 days.
- Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA
guidelines for the management of valvular heart disease.
Exclusion Criteria:
- Secondary mitral regurgitation.
- Have a device which is not compatible with MRI
- Claustrophobia preventing MRI.
- Concomitant CABG, other valve surgery, or other cardiac surgery.
- Atrial fibrillation or other substantial arrhythmia that would substantially degrade
MRI image acquisition.
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