Explore Mitral Regurgitation Patient Types
Examples of Secondary Mitral Regurgitation (SMR) and Primary Mitral Regurgitation (PMR) Patients Suitable for MitraClip™ Therapy
SMR Patient Example:
John, 76
John is an entrepreneur and software engineer who still sits on the board of the start-up he founded in the early 2000s.
- During hospitalization for congestive heart failure (CHF), echocardiogram showed P2 flail with EF 55%
- Medications were optimized and patient was discharged
- 10 days after discharge, John was admitted for CHF
- The surgeon turned John down for surgery due to prior aortic valve replacement (AVR) and chronic kidney disease (CKD)
What makes JOHN a candidate for MitraClip?
- Secondary MR
- Guideline-directed medical therapy (GDMT) optimized
- P2 flail with ejection fraction (EF) 55%
SMR Patient Example:
Monica, 69
Monica is a retired teacher who remains active and social.
- Feeling chronic fatigue, weakness, dyspnea on exertion, and dizziness
- Echocardiogram and interventional cardiologist confirm a worsening of her mitral valve function with EF 35%
- Cardiologist concludes regurgitation in her mitral valve has progressed to 4+ and is compounded by pulmonary disease
- Despite compliance with guideline-directed medical therapy, her condition worsens
- Cardiologist recommends Monica for MitraClip therapy to correct her MR
What makes Monica a candidate for MitraClip?
- Secondary MR
- MR severity 4+
- Pulmonary disease
- GDMT optimized
- Left ventricular ejection fraction (LVEF) 35%
SMR Patient Example:
Dorothy, 81
Dorothy is a retired librarian who despite her age, continues to care for herself and complies with her GDMT and doctor appointments.
- Experiencing shortness of breath and low energy
- Her doctor concludes that MR is severe per transesophageal echocardiogram and enlists the evaluation of a valve team to determine appropriate intervention
- She does not require concomitant coronary artery bypass graft surgery (CABG)
- Given her worsening condition with congestive heart failure (CHF), advanced age, and poor left ventricular function (EF 25%), Dorothy is not recommended for surgical repair, her cardiologist recommends repair with MitraClip
What makes Dorothy a candidate for MitraClip?
- Secondary MR
- MR severity 4+
- GDMT optimized
- LVEF 25%
PMR Patient Example:
Sam, 80
Sam is an active retiree.
- Monitored for 20 years for moderate aortic stenosis (AS) and moderate MR and admitted several times for CHF
- An echocardiogram deemed his AS and MR were still moderate, though progressively worsening with an LVEF of 40%
- Sam underwent transcatheter aortic valve replacement
- 2 years later, his MR had become severe
- MitraClip procedure was performed
What makes Sam a candidate for MitraClip?
- Primary MR
- LVEF >20% or left ventricular end systolic dimension (LVESD) <60 mm
- A2-P2 prolapse
MitraClip, when used with maximally tolerated GDMT, is indicated for the treatment of symptomatic, moderate-to-severe or severe SMR in patients with1:
- MR ≥ Grade III per American Society of Echocardiography criteria
- AN LVEF ≥ 20% and ≤ 50%
- LVESD ≤ 70 mm
- Symptoms and MR severity that persist despite maximally tolerated GDMT
Check your patients for one or more of these symptoms1
- Marked limitations on physical activity
- Fatigue
- Shortness of breath
- Weight gain
- Edema
Your patients may have at least moderate-to-severe secondary (or functional) MR (grade 3+), which can be determined by echocardiogram.
Candidates for MitraClip therapy should be evaluated by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
MAT-2410455 v1.0 | Item approved for U.S. use only
- MitraClip™ Clip Delivery System Instructions for Use.
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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.