This site is intended for U.S. healthcare professionals only.

Abbott U.S. Logo

MitraClip™ Frequently Asked Questions

  • Where can I refer a patient for the transcatheter mitral valve repair (TMVr) procedure?

    To find the nearest center offering TMVr with MitraClip therapy, go to our MitraClip Center locator tool.

  • Is the TMVr procedure included in the treatment guidelines?

    Yes. In December 2020, the ACC and AHA formally updated their clinical practice guideline for the management of patients with valvular heart disease.¹

    Learn more about the update here.

  • How many patients have been treated with MitraClip therapy?

    As of March 2019, more than 100,000 patients worldwide have been treated with MitraClip.*
    *Worldwide data as of March 2019, on file at Abbott.

  • Can the MitraClip procedure be used to treat patients with secondary (or functional) MR?

    Yes, MitraClip is indicated for both primary and secondary MR.

    • Patients with significant primary (or degenerative) mitral regurgitation (MR) who are unable to have surgery.

    • Patients with significant secondary MR and heart failure who remain symptomatic despite guideline-directed medical therapy.

  • What are the MitraClip devices made of?

    The implantable MitraClip devices feature cobalt-chromium construction and a polyester cover designed to promote tissue growth.

  • What should I expect after my primary (or degenerative) MR patient has undergone MitraClip therapy?

    The adjudicated EXPAND study reported MR reduction to ≤1+ maintained in 84.5% of patients (N=420) with primary (or degenerative) mitral regurgitation at 1 year2. The EXPAND study also showed a durable 1-year improvement in the quality of primary MR patients, with a 21.3 point increase in KCCQ-OS2. EXPAND demonstrated low hospitalization rate (12.2%) and low mortality rate (12.5%) at 1 year in primary MR patients2.

    Note: Health-related quality of life measured by Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score.

  • What clinical results have been observed in heart failure patients with secondary (or functional) MR?

    The COAPT™ trial showed a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone in patients of this type. For more information, click here.

  • Will my patient be prescribed short-term anticoagulation therapy following the procedure?

    Your patient may be prescribed short-term anticoagulation therapy following the procedure.

  • Can patients have an MRI if they have a MitraClip™ device?

    It is possible for patients to have a magnetic resonance imaging (MRI) scan performed. However, patients must inform their MRI facility and technician that they have a MitraClip™ device. After the procedure, patients will be given an implant card that describes what types of MRIs they will be able to receive. If the test can be performed, they may need to make certain adjustments to ensure patient safety.

MAT-2410455 v1.0 | Item approved for U.S. use only

References
  1. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/ American Heart Association Joint Committee on Clinical Practice Guidelines.” J Am Coll Cardiol. 2021; 77 (4) e25 -e197. 
  2. Kar S. Core-Lab Adjudicated Contemporary Clinical Outcomes at 1 Year with MitraClip™ (NTR/XTR) System from Global EXPAND Study. Data presented at TCT 2020.

REQUEST AN ABBOTT REP

Contact now
Important Safety Information

Rx Only
Important Safety Information

MITRACLIP™ CLIP DELIVERY SYSTEM

  • 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 regime; 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.

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 effuse on, 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.

 

+