MITRACLIP FREQUENTLY ASKED QUESTIONS

  • How does my doctor determine if I have mitral regurgitation?

    To determine if you have degenerative mitral regurgitation and to assess the function and condition of your heart and mitral valve, your cardiologist may perform diagnostic evaluations including:

    • Listening to your heart with a stethoscope
    • Using an echocardiogram (ultrasound) to get a close look at your heart and mitral valve
    • Taking a chest x-ray to see the size and shape of your heart and evaluate your lungs
    • Evaluating you for symptoms of congestive heart failure (such as shortness of breath or fatigue) or other related heart conditions
  • What is transcatheter mitral valve repair (TMVr) and does it require open-heart surgery?

    TMVr is a minimally invasive procedure that may be an option for patients with primary (or degenerative) mitral regurgitation who are too sick for surgery. It is also an option for patients with heart failure and secondary (or functional) mitral regurgitation who have not responded to treatment. Unlike surgery, this procedure does not require opening the chest and temporarily stopping the heart. Instead, doctors access your heart through a vein in your leg to repair your mitral valve. MitraClip therapy is the only TMVr option to treat mitral regurgitation. Your cardiologist or TMVr heart team will determine if you are a candidate for MitraClip therapy.

  • How will my doctors decide if I am a candidate for the MitraClip procedure?

    You will be evaluated by a specially trained heart team at a MitraClip treating center, including a cardiac surgeon and a cardiologist, who will review your medical history and perform a variety of tests. There are several factors they will take into consideration when deciding whether or not you are too sick for open heart surgery, and therefore a possible candidate for MitraClip therapy, such as your age, frailty, and the condition of your heart.

  • What is the MitraClip device made of and how does it reduce mitral regurgitation?

    The MitraClip device is a small metal clip covered with a polyester fabric that is implanted on your mitral valve. The clip is inserted through a catheter, without the need to temporarily stop your heart.

    The MitraClip device treats mitral regurgitation by clipping together a small area of the mitral valve. The valve continues to open and close on either side of the clip. This allows blood to flow on both sides of the clip while reducing the flow of blood in the wrong direction. Watch an animation of the procedure to learn more.

  • How do I find a doctor who performs the MitraClip procedure?

    To find the nearest center offering TMVr with MitraClip therapy, go to our TMVr Finder page.

  • How should I prepare for my MitraClip procedure?

    In the days before your procedure, it is important that you:

    • Take all your prescribed medications
    • Tell your doctor if you are taking any other medications
    • Make sure your doctor knows of any allergies you have
    • Follow all instructions given to you by your doctor or nurse
  • What should I expect after my MitraClip procedure?

    The average hospital stay is two to three days. You should experience relief from your symptoms of mitral regurgitation soon after your procedure.

    Most patients will not need special assistance at home following discharge from the hospital, outside of ongoing needs for any unrelated health conditions. While in the hospital, you will be closely monitored and your doctor will perform various tests to evaluate your heart function.

    Following your procedure, you will receive an Implant Identification Card, which you must carry with you at all times. Show your Implant Identification Card if you report to an emergency room or if you require a magnetic resonance imaging (MRI) scan.

  • How long before I feel the effects of the MitraClip procedure?

    Clinical data from patients who underwent the MitraClip procedure demonstrate an immediate reduction of mitral regurgitation. You should experience significant improvement in your symptoms of mitral regurgitation and quality of life soon after your procedure. It is important to discuss what to expect following the procedure with your TMVr heart team.

  • Will I be able to feel the MitraClip implant in my heart?

    No, you will not be able to feel the implant.

  • Will I be prescribed any medications following the MitraClip procedure?

    You may be prescribed blood-thinning medications to help reduce the risk of developing a blood clot after the procedure. Your doctor or nurse will give you instructions about your medications before you leave the hospital.

  • Who should not have the MitraClip procedure?

    Your doctor may decide that the MitraClip procedure is not appropriate for you if you:

    • Cannot tolerate medications that thin the blood or prevent blood clots from forming
    • Have an active infection or inflammation of the mitral valve
    • Have mitral valve disease as a result of rheumatic fever
    • Have a blood clot in your heart or in the vessels that carry blood from the lower body to the heart

    Your doctor should discuss with you if you have any of these issues that would prevent you from having the MitraClip procedure. An evaluation of your heart will also confirm if your heart valve anatomy would allow for successful placement of the device.

AP2947626-WBU Rev. A

Important safety information

MITRACLIP DELIVERY SYSTEMS
INDICATION FOR USE

  • The MitraClip™ G4 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™ G4 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.

CONTRAINDICATIONS

The MitraClip™ G4 System is contraindicated in patients with the following conditions:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen
  • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity
  • Active endocarditis of the mitral valve
  • Rheumatic mitral valve disease
  • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

WARNINGS

  • DO NOT use MitraClip outside of the labeled indication.
  • The MitraClip™ G4 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. Use universal precautions for biohazards and sharps while handling the MitraClip™ G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
    • MitraClip™ G4 Implant erosion, migration or malposition
    • Failure to deliver MitraClip™ G4 Implant to the  intended site
    • Difficulty or failure to retrieve MitraClip™ G4 system components
  • 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.
  • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
  • For the Steerable Guide Catheter and Delivery Catheter only:
    • The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
    • The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
    • Failure to prepare the device as stated in these instructions and failure to handle the device with  care could lead to additional intervention or serious adverse event.
  • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or re-use may result in infections, malfunction of the device and other serious injury or death.
  • 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.

PRECAUTIONS

  • 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 calcifed 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 Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip™ should be used only when criteria for clip suitability for Primary 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 MitraClip™ G4 procedure.

  • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs
  • Vascular access complications which may require transfusion or vessel repair including:
    • wound dehiscence
    • catheter site reactions
    • Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
    • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion
    • Emboli (air thrombotic material, implant, device component)
    • Peripheral Nerve Injury
  • Lymphatic complications
  • Pericardial complications which may require additional intervention, including:
    • Pericardial effusion
    • Cardiac tamponade
    • Pericarditis
  • Cardiac complications which may require additional interventions or emergency cardiac surgery, including:
    • Cardiac perforation
    • Atrial septal defect
  • Mitral valve complications, which may complicate or prevent later surgical repair, including:
    • Chordal entanglement / rupture
    • Single Leaflet Device Attachment (SLDA)
    • Thrombosis
    • Dislodgement of previously implanted devices
    • Tissue damage
    • Mitral valve stenosis
    • Persistent or residual mitral regurgitation
    • Endocarditis
  • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias)
  • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina)
  • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism)
  • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
  • System organ failure:
    • Cardio-respiratory arrest
    • Worsening heart failure
    • Pulmonary congestion
    • Respiratory dysfunction / failure / atelectasis
    • Renal insufficiency or failure
    • Shock (including cardiogenic and anaphylactic)
  • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT))
  • Hypotension / hypertension
  • Infection including:
    • Urinary Tract Infection (UTI)
    • Pneumonia
    • Septicemia
  • Nausea / vomiting
  • Chest pain
  • Dyspnea
  • Edema
  • Fever or hyperthermia
  • Pain
  • Death
  • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications:
    • Skin injury or tissue changes due to exposure to  ionizing radiation
    • Esophageal irritation
    • Esophageal perforation
    • Gastrointestinal bleeding

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