MitraClip (mitral clip) is a medical device used to treat

mitral valve regurgitation Mitral regurgitation (MR), also known as mitral insufficiency or mitral incompetence, is a form of valvular heart disease in which the mitral valve is insufficient and does not close properly when the heart pumps out blood. Section: Valvular Hea ...

for individuals who should not have open-heart surgery. It is implanted via a tri-axial transcatheter technique and involves

suturing A surgical suture, also known as a stitch or stitches, is a medical device used to hold body tissues together and approximate wound edges after an injury or surgery. Application generally involves using a needle with an attached length of threa ...

together the anterior and posterior

mitral valve The mitral valve (), also known as the bicuspid valve or left atrioventricular valve, is one of the four heart valves. It has two cusps or flaps and lies between the left atrium and the left ventricle of the heart. The heart valves are all one-w ...

leaflets.

Medical use and indications

MitraClip is used for patients with severe secondary mitral valve regurgitation that is refractory to medical therapy. Primary mitral regurgitation is usually due to an organic cause whereas secondary mitral regurgitation is due to a secondary ischemia or cardiomyopathy. Open-heart surgery remains the preferred treatment option when possible for primary mitral regurgitation, due to the effectiveness and long-term record of the procedure in reducing mitral valve regurgitation. Secondary Mitral regurgitation however can have different options in management as surgery has not been proven in clinical trials to be superior The indications for using MitraClip are as follows: # Those with symptomatic 3+ or 4+ Chronic Moderate-to-severe or severe Mitral Regurgitation are not candidates for surgery # New York Heart Association Functional Class III or IV # Favorable anatomy: Mitral Valve area greater than 4.0 centimeter squared, Minimal

Calcification Calcification is the accumulation of calcium salts in a body tissue. It normally occurs in the formation of bone, but calcium can be deposited abnormally in soft tissue,Miller, J. D. Cardiovascular calcification: Orbicular origins. ''Nature Mat ...

/no cleft in grasping area, Flail width less than 15mm, flail gap less than 10mm # At least 1+ year of life expectancy

Advantages

Compared to patients who need open heart surgery, patients who received mitral clip have less need for a

blood transfusion Blood transfusion is the process of transferring blood products into a person's circulation intravenously. Transfusions are used for various medical conditions to replace lost components of the blood. Early transfusions used whole blood, but mo ...

and have fewer ventilation days. When compared to the patient who has had open heart surgery, MitraClip was cheaper - approximately $2200 less per person - and the median stay in the hospital post mitral clip is 2.4 days.

Contraindications

# Patients who are unable to receive

anticoagulation Anticoagulants, commonly known as blood thinners, are chemical substances that prevent or reduce coagulation of blood, prolonging the clotting time. Some of them occur naturally in blood-eating animals such as leeches and mosquitoes, where the ...

or dual antiplatelet therapy # Active mitral valve

endocarditis Endocarditis is an inflammation of the inner layer of the heart, the endocardium. It usually involves the heart valves. Other structures that may be involved include the interventricular septum, the chordae tendineae, the mural endocardium, or the ...

# Mitral valve

rheumatic disease Rheumatism or rheumatic disorders are conditions causing chronic, often intermittent pain affecting the joints or connective tissue. Rheumatism does not designate any specific disorder, but covers at least 200 different conditions, including art ...

# Patient that has femoral venous,

Inferior vena cava The inferior vena cava is a large vein that carries the deoxygenated blood from the lower and middle body into the right atrium of the heart. It is formed by the joining of the right and the left common iliac veins, usually at the level of the ...

(IVC), intracardiac thrombus

Adverse effects and complications

The most common complication of transcatheter mitral valve repair is access site bleeding, although transfusion is generally required less often than with surgical mitral valve repair. Rare but serious complications can include infective endocarditis, mitral stenosis, and device embolization. In general, major adverse events in a 30-day post-procedural time period are significantly lower with a transcatheter versus surgical approach. In the EVEREST 2 Clinical Trial, new onset atrial fibrillation and

acute kidney failure Acute kidney injury (AKI), previously called acute renal failure (ARF), is a sudden decrease in kidney function that develops within 7 days, as shown by an increase in serum creatinine or a decrease in urine output, or both. Causes of AKI are cla ...

is higher in MitraClip group when compared to the surgical group

Barriers and disadvantages

Major obstacles of mitral clip include the novelty of the technology. As of 2016, there were only 75 centers in the US that were able to offer this technology. Each hospital needs skilled technicians and operators who know 2D and 3D Echo-cardiogram criteria for selecting mitral clip candidates, and who can assist with intraprocedural guidance when the mitral clip is installed. In addition, as of 2016, there is a lack of coverage of health insurance by Centers of Medicare and Medicaid Services. According to the EVEREST 2 Trial, 20% of patients who received MitraClip required surgical repair vs 2% who received open heart surgery. Overall surgical repair has more of a pronounced effect in reducing mitral regurgitation

Post Procedure

Patients will need dual anti-platelet therapy for 6 months or more. Within the next 6 months, patients will need antibiotics for endocarditis prophylaxis for dental and urological procedures.

History

In 1996,

Ottavio Alfieri Ottavio is the Italian form of Octavius. Its feminine given name version is Ottavia. Ottavio may refer to: Given name * Ottavio Cinquanta, the President of the International Skating Union * Ottavio Leoni, Italian painter * Ottavio Piccolomini, ( ...

proposed to Dr Mehmet Oz that the mitral valve only needed one suture to close a leak. Oz developed the idea to use a catheter to put one staple in and submitted the patent for MitraClip in 1997. He helped to create a start-up called Evalve Inc. in 1999, which later became a division of

Abbott Laboratories Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known dr ...

. The company's first chief executive officer was Ferolyn Powell. She grew Evalve Inc. until the Abbott acquisition in 2009, and led a trial of 600 patients that revealed those using MitraClip reduced their hospitalizations in half and deaths by 38 percent. MitraClip was first implanted in 2003, obtained

CE marking On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificatio ...

in Europe in 2008, and approved by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

in 2013. The FDA obligated the company to run post-marketing studies to confirm the safety and efficacy of the device. Two industry-funded RCTs of the MitraClip in patients with mitral regurgitation and heart failure demonstrated mixed results. Abbott expanded its MitraClip training process in 2016, after several instances of surgical complications.

References

{{Cardiac procedures Interventional cardiology Medical devices Valvular heart disease