The first step in determining whether your patient is suitable for MitraClip® therapy is to perform a transthoracic echocardiogram (TTE) of the mitral valve to assess anatomical suitability.
Download the quick reference guide, which includes all the recommended TTE images above and a standardized screening checklist to help ensure the Heart Team has everything they need to make the most informed decision about MitraClip® eligibility.
DOWNLOAD >The guideline supports frequent monitoring and performance of routine TTEs. TTEs are recommended in the initial evaluation of patients with known or suspected DMR and should be performed with any change in symptoms or physical examination findings.1
Asymptomatic patients with severe DMR and normal LV function should have TTEs performed every 6-12 months, and those with dilating LV even more frequently.1
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MitraClip® NT Clip Delivery System |
INDICATION FOR USE
The MitraClip® NT Clip Delivery 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.
CONTRAINDICATIONS
The MitraClip® NT Clip Delivery System is contraindicated in DMR patients with the following conditions:
WARNINGS
PRECAUTIONS
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip® NT procedure.
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; Death; 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, MitraClip® NT Device); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip® NT to the intended site; Failure to retrieve MitraClip® NT 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; MitraClip® NT erosion, migration or malposition; MitraClip® NT Device thrombosis; MitraClip® NT 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
Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.