Patients with severe symptomatic mitral valve regurgitation who are not good surgical candidates now have an option for mitral valve repair – the MitraClip® delivery system. It's one of several treatment options available for advanced heart failure.
The University of Kansas Health System is among just a few organizations in the region offering the transcatheter mitral valve repair (TMVr) for treatment of degenerative mitral valve regurgitation. TMVr is indicated for reduction of significant symptomatic mitral regurgitation caused by a degenerative mitral valve. Many patients with this diagnosis have a reasonable life expectancy but are high surgical risks because of advanced age, left ventricle dysfunction or other comorbidities. Healthier patients would undergo robotic or open surgical repair.
TMVr is contraindicated in patients who cannot tolerate procedural anticoagulation or postprocedural antiplatelet regimen, and in those with active endocarditis of the mitral valve, rheumatic mitral valve disease or evidence of intracardiac, inferior vena cave or femoral venousthrombus.
Percutaneous access, short recovery
Mitral insufficiency, or leaky mitral valve, is one of the most prevalent valve problems in the heart failure community. TMVr is safe and offers a new option for improving symptoms of heart failure, such as shortness of breath, for extending quality of life and for reducing heart failure-related hospitalizations.
Via femoral access, we reach the mitral valve by performing a transseptal puncture. We then clip or tether the two leaflets together with the MitraClip. The procedure takes about 90 minutes on average, with a 2- to 3-day hospital stay and recovery time of about a week. Data shows the procedure can result in a 73% reduction in the hospitalization rate for heart failure (1). MitraClip is the only nonsurgical device used for mitral insufficiency reduction that is FDA approved.
COAPT trial also available
The University of Kansas Health System is participating in Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) for functional mitral insufficiency. The purpose of this study is to confirm the safety and effectiveness of the MitraClip system for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip system for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation.
COAPT trial details
Those interested in participating in the trial can contact interventional cardiologist Mark Wiley, MD, principal investigator, at mawiley@kumc.edu , or Tilitha Shawgo, RN, MS, trial coordinator, at 913-588-9720 or tshawgo@kumc.edu
Inclusion criteria
- Symptomatic functional MR (≥ 3+) due to cardiomyopathy of either ischemic or nonischemic etiology
- Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
- Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or corrected BNP ≥ 300 pg/mL or corrected NT-proBNP ≥ 1500 pg/mL
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- Surgery will not be offered as a treatment option, and medical therapy is the intended therapy for the subject
- Left ventricular ejection fraction (LVEF) is ≥ 20% and ≤ 50%
- Left ventricular end systolic dimension (LVESD) is ≤ 70 mm
Exclusion criteria
- Untreated clinically significant coronary artery disease requiring revasulcarization
- Coronary artery bypass grafting (CABG) within prior 30 days
- Percutaneous coronary intervention within prior 30 days
- Tricuspid valve disease requiring surgery
- Aortic valve disease requiring surgery
- Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- Cerebrovascular accident within prior 30 days
- Severe symptomatic carotid stenosis (> 70% by ultrasound)
- Carotid surgery within prior 30 days
- Mitral valve orifice area < 4.0 cm2
- Leaflet anatomy that may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
Coordinated care is critical
If you think your patient is too sick to be evaluated for mitral valve intervention, we ask you to reconsider. We will be happy to work with you to explore both medical and surgical options for improving your patient's quality of life. We will strive to coordinate closely with you, based on your comfort level. This is especially true when the patient is located remotely.
1Reduction in the Rate of Hospitalizations for Heart Failure. (2016). Retrieved Dec. 1, 2016, from https://mitraclip.com/hcp/safety_profile.