Mitral regurgitation (MR) places an extra burden on your heart and lungs, and your heart may have to work harder to function normally. The mitral valve is a heart valve that lies between the left atrium and left ventricle. The valve opens and closes to ensure that blood flows in only one direction. In mitral regurgitation, the valve does not close completely and blood leaks backward (regurgitates) into the left atrium.1 The more open the valve remains, the more blood regurgitates and the more severe the problem.
In some cases, you may have MR but not experience any symptoms. In other cases, you may experience symptoms such as1,2:
Fatigue or inability to exercise
Dry, hacking cough (often worse when lying down)
SHORTNESS OF BREATH
Swollen feet or ankles
If you are experiencing any of these symptoms, talk to your doctor to receive a thorough examination and proper diagnosis. You should also promptly seek treatment if you notice that your symptoms are getting worse — for example, if the swelling in your feet and ankles has increased or if you find it more difficult to perform daily activities such as walking up the stairs.
Mitral regurgitation places an extra burden on your heart and lungs. Over time, some people may develop an enlarged heart because it has to work harder to pump blood through the body. If it is not treated, mitral regurgitation can cause other, more serious problems with your heart, such as heart failure. This is a condition that occurs when your heart can’t pump enough blood to meet the needs of your body.1
Treatment for mitral regurgitation depends on how severe your condition is, and if it’s getting worse.1,2 The goal of treatment is to improve your heart’s function while minimizing your symptoms and avoiding future complications.
Medications may be prescribed to help manage symptoms of mitral regurgitation, such as diuretics for fluid buildup in the legs and lungs. However, these medications only treat the symptoms and do not address the underlying problem with your mitral valve that is causing your disease.
MITRAL VALVE SURGERY
Considered the most effective long-term treatment for mitral regurgitation, surgery gives you the greatest probability for a safe and effective solution over time. Several surgical procedures are available to repair or replace the mitral valve, including traditional open-heart surgery (with an incision over the chest and sternum), minimally invasive surgery that does not involve opening the chest, and less invasive robotic and transcatheter procedures.
SURGICAL MITRAL VALVE REPAIR
If mitral valve repair is an option for you, a surgical technique called an annuloplasty may be performed. This procedure typically involves the implantation of a device to tighten or replace the ring around the mitral valve (annulus) so that the valve leaflets can close properly. When needed, other techniques may be used to repair the valve.
TRANSCATHETER MITRAL VALVE REPAIR (TMVr)
TMVr with MitraClip™ therapy, is a less invasive procedure that may be an option for patients with severe mitral regurgitation. Unlike surgery, this procedure does not require chest incisions and temporarily stopping the heart. In this procedure, a clip will be implanted onto the center of your mitral valve. This reduces mitral regurgitation, and the valve continues to open and close on either side of the clip, allowing blood to flow through.
The information provided is not intended for medical diagnosis or treatment or as a substitute for professional advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.
MAT-2007301 v2.0 | Item approved for U.S. use only.
- Mayo Clinic. Mitral valve regurgitation. Accessed August 18, 2020.
- Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2017;135(25):e1159-e1195.
MITRACLIP CLIP DELIVERY SYSTEMS
INDICATION FOR USE
- The MitraClip™ NTR/XTR System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
- The MitraClip™ NTR/XTR System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
The MitraClip™ NTR/XTR System is contraindicated in patients with the following conditions:
- Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
- Active endocarditis of the mitral valve
- Rheumatic mitral valve disease
- Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
- DO NOT use MitraClip™ outside of the labeled indication.
- The MitraClip™ Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g., transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
- Read all instructions carefully. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip™ System to avoid user injury.
- Use of the MitraClip™ should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.
- The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device or other serious injury or death.
- Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.
- Note the product “Use by” date specified on the package.
- Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.
- Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
- Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
- 30-day STS predicted operative mortality risk score of
- ≥8% for patients deemed likely to undergo mitral valve replacement or
- ≥6% for patients deemed likely to undergo mitral valve repair
- Porcelain aorta or extensively calcified ascending aorta.
- Frailty (assessed by in-person cardiac surgeon consultation).
- Hostile chest
- Severe liver disease / cirrhosis (MELD Score > 12)
- Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
- Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery(IMA) at high risk of injury, etc.
- Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip® should be used only when criteria for clip suitability for DMR have been met.
- The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
- Secondary Mitral Regurgitation
- Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
- The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the
Death; Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding;
Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast
media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClipTM Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClipTM to the intended site; Failure to retrieve MitraClipTM System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClipTM Implant erosion, migration or malposition; MitraClipTM Implant thrombosis; MitraClipTM System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea / vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence