Where can I refer a patient for the transcatheter mitral valve repair (TMVr) procedure?
How do I know if my patient is eligible to receive MitraClip® therapy?
You can refer your patient to a MitraClip® Center
, where a Heart Team will determine if they are eligible for MitraClip®
therapy based on the following criteria1
Degenerative mitral regurgitation (DMR)
- Also known as primary or organic MR, DMR is usually due to an anatomic abnormality of the mitral valve itself, including the leaflets, and/or the subvalvular apparatus, such as the chordae of papillary muscles
Significant mitral regurgitation (MR ≥ 3+)
Prohibitive risk criteria, including any of the following:
30-day Society of Thoracic Surgeons (STS) predicted operative mortality risk score of
- ≥8% (mitral valve replacement)
- ≥6% (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 at high risk of injury, etc.
Existing comorbidities do not preclude expected benefit of MR reduction to ≤2+
What are the preferred anatomic patient characteristics for the TMVr procedure?
For optimal results, several anatomic patient characteristics should be considered.1
When you refer your patient to a MitraClip® Center locator tool
, a Heart Team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, will confirm the following:
The primary regurgitant jet is noncommissural. If a secondary jet exists, it must be considered clinically insignificant
Mitral valve area ≥ 4.0 cm2
Minimal calcification in the grasping area
No leaflet cleft in the grasping area
Flail width < 15 mm and flail gap < 10 mm
LVEF > 20% or LVESD < 60 mm
Is TMVr contraindicated in any patients?
NT device is contraindicated in degenerative MR patients with the following conditions1
Patients who cannot tolerate procedural anticoagulation or postprocedural antiplatelet regimen
Active endocarditis of the mitral valve
Rheumatic mitral valve disease
Evidence of intracardiac, inferior vena cava (IVC), or femoral venous thrombus
Consult with a MitraClip® Center, where a Heart Team can confirm the eligibility of your patient.
Is the TMVr procedure included in treatment guidelines?
How many patients have been treated with the MitraClip® therapy?
In clinical studies, more than 1200 patients in the United States have been treated with the MitraClip® therapy, with 1-year follow-up in over 900 patients.1 Over 35,000 patients have been implanted with MitraClip® therapy worldwide.*
Can the MitraClip® NT device be used to treat patients with functional mitral regurgitation (FMR)?
In the United States, the MitraClip®
NT device is indicated for degenerative MR (primary MR) in select patients. However, there is a clinical trial for MitraClip®
therapy currently enrolling patients with functional MR. To learn more, visit COAPTtrial.com
and discuss enrollment with patients you believe may be appropriate candidates.
What is the MitraClip® NT device made of?
The implantable MitraClip® NT device is manufactured with a superelastic metal alloy (Nickel Titanium) and a polyester cover designed to promote tissue growth. These materials are commonly used in cardiovascular implants.
What should I expect after my patient has undergone MitraClip® therapy?
Real-world registry data showed consistent results to those seen in the clinical setting with 93% of patients (N = 564) achieving MR ≤ 2+ and nearly 64% of patients achieving MR ≤ 1+ immediately after treatment.3†
Real-world data also showed low rates of procedural complications (8%) and device-related adverse events (1.4%) after 30 days.3†
Will my patient be prescribed any medications following the MitraClip® procedure?
Your patient may be prescribed short-term anticoagulation therapy following the procedure.
- MitraClip Clip Delivery System Instructions for Use.
- Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):2438-2488.
- Sorajja P, Mack M, Vemulapalli S, et al. Initial Experience With Commercial Transcatheter Mitral Valve Repair in the United States. J Am Coll Cardiol. 2016;67(10):1129-1140.
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.
The MitraClip® NT Clip Delivery System is contraindicated in DMR 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® NT outside of the labeled indication. Treatment of non-prohibitive risk DMR patients should be conducted in accordance with standard hospital practices for surgical repair and replacement.
- MitraClip® NT is intended to reduce mitral regurgitation. The MitraClip® NT procedure is recommended to be performed when an experienced heart team has determined that reduction of MR to ≤2+ is reasonably expected following the MitraClip® NT. If MR reduction to ≤2+ is not achieved, the benefits of reduced symptoms and hospitalizations, improved quality of life, and reverse LV remodeling expected from MitraClip® NT may not occur.
- The MitraClip® NT Device 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® NT System to avoid user injury.
- Use of the MitraClip® NT 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.
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 >60mm. MitraClip® NT should be used only when criteria for clip suitability for DMR have been met.
- The major clinical benefits of MitraClip® NT are reduction of MR to ≤2+ resulting in reduced hospitalizations, improved quality of life, reverse LV remodeling and symptomatic relief in patients who have no other therapeutic option. No mortality benefit following MitraClip® NT therapy has been demonstrated.
- 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.
- The heart team may determine an in-person surgical consult is needed to complete the assessment of prohibitive risk. The experienced mitral valve surgeon and heart team should take into account the outcome of this surgical consult when making the final determination of patient risk status.
- For reasonable assurance of device effectiveness, pre-procedural evaluation of the mitral valve and underlying pathologic anatomy and procedural echocardiographic assessment are essential.
- Note the “Use by” date specified on the package.
- Inspect all product prior to use. DO NOT use if the package is opened or damaged, or if product is damaged.
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.