EDUCATION FOR PATIENTS

STRUCTURAL HEART DISEASE: PATIENT INFORMATION

Heart disease is a broad topic—the sole purpose of hundreds of books and medical journals is to help inform physicians and patients about the details of various heart conditions. Here you will find information to help keep patients better informed.

VIDEOS

Treating Mitral Regurgitation with MitraClip™ THERAPY
Treating Cryptogenic Stroke with Amplatzer™ PFO Occluder

OFFER PATIENTS A DEEPER LOOK INTO THESE 3 HEART CONDITIONS

  • Mitral regurgitation (MR) is one of the most common heart valve diseases, affecting millions worldwide.

    Read more
  • Congenital defects refer to a problem with the structure of the heart that is present at birth.

    Read more
  • Heart failure is a condition in which the heart can't pump enough blood to meet the body’s needs.

    Read more

The information provided is not intended for medical diagnosis or treatment as a substitute for professional medical advice.  Consult with a physician or qualified healthcare provider for appropriate medical advices.

MAT-2004902 v2.0 | Item approved for U.S. use only

Important safety information
  • MitraClip

    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
  • Amplatzer PFO

    AMPLATZER™ PFO OCCLUDER
    INDICATION FOR USE


    The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

    CONTRAINDICATIONS

    • Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
    • Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.
    • Patients with anatomy in which the AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
    • Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
    • Patients with active endocarditis or other untreated infections.

    WARNINGS

    • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO Closure following standard of care.
    • Do not use this device if the sterile package is open or damaged.
    • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon.
    • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
    • Patients who are allergic to nickel can have an allergic reaction to this device.
    •  This device should be used only by physicians who are trained in standard transcatheter techniques. 
    •  Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
    • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
    • Ensure there is sufficient distance from the PFO to the aortic root or SVC (typically defined as 9 mm or greater as measured by echo). See Figure 6. and Figure 7. 

    PRECAUTIONS

    • The safety and effectiveness of the AMPLATZER™ PFO Occluder has not been established in patients (with):
      • Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
      • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
      • Unable to take antiplatelet therapy
      • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
      • Acute or recent (within 6 months) myocardial infarction or unstable angina
      • Left ventricular aneurysm or akinesis
      • Mitral valve stenosis or severe mitral regurgitation irrespective of etiology
      • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation 
      • Mitral or aortic valve vegetation or prosthesis
      • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
      • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
      • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
      • Uncontrolled hypertension or uncontrolled diabetes mellitus
      • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
      •  Arterial dissection as cause of stroke
      • Index stroke of poor outcome (modified Rankin score greater than 3)
      • Pregnancy at the time of implant
      •  Multi-organ failure
    • Use on or before the last day of the expiration month that is printed on the product packaging label.
    • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
    • The AMPLATZER™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
    • Store in a dry place.
    • Pregnancy – Minimize radiation exposure to the fetus and the mother.
    • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

    ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus; Allergic drug reaction; Allergic dye reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vessel perforation

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