MitraClip: Overcoming a Flow of Doubt to Help Thousands

Everyday Innovators: How MitraClip's "Eureka!" moment changed the world of possibility for heart failure care.

MitraClip: Overcoming a Flow of Doubt to Help Thousands
Products and Innovation | Dec. 10, 2020

If you're reading this story, you understand the logic fundamental to comprehension.

The words flow in one direction: Left to right, top to bottom.

Take that first sentence. Here it is again, this time in reverse:

.noisneherpmoc ot latnemadnuf cigol eht dnatsrednu uoy, yrots siht gnidear er’uoy fI.

Unless you're da Vinci (and you're likely not as the Italian Renaissance genius has been gone more than 500 years), it's confounding. Even with the clue above, it's difficult, slow and labored to see if we made a mistake flipping it. (We didn't. Check it.)

Now think for a minute about your heart.

Like language, it works best when blood flows in one direction. From the body, it enters the right atrium and travels down to the right ventricle to be pumped through the pulmonary artery to the lungs. Now, restocked with oxygen from the lungs, blood arrives in the left atrium and heads down to the left ventricle to be pumped up through the aorta to the rest of the body before making the trip back to the heart.

And, like language, it's a cycle that’s easy to understand — and it works well when it's going in that one direction.

But when a faulty valve lets blood flow backward, it can be life-threatening.

At the minimum, it makes breathing difficult.

And slow.

And labored.

Just like reading that reversed sentence above.

Enter MitraClip a master stroke of invention, delivered by necessity.

"The paradigm shift was actually made by an Italian surgeon in the middle of a heart operation," said cardiac surgeon Mehmet Oz, who holds a patent on MitraClip. "He needed some desperate hail Mary solution, and he just tacked the leaflets together and it worked."

Indeed it did.

But like blood flowing through a heart suffering from mitral regurgitation, the journey from concept to creation did not go directly forward from its "Eureka!" moment. Like many of the world's great breakthroughs, formalizing the device and procedure initially faced resistance from some of even the brightest medical minds.

"The biggest challenge to MitraClip's success, was the basic belief that it couldn’t be done," Oz said.

Abbott scientists and engineers were among the true believers, bringing monastic focus to years of perfecting the design of MitraClip and throughs trials — along with the occasional tribulation — to demonstrate its safety and effectiveness at reducing mitral regurgitation.

Because of Abbott's support, a MitraClip was proved worthy.

The simplicity of the solution holds the power to its elegant effectiveness. During a minimally invasive procedure, MitraClip is inserted via a catheter into the heart, where MitraClip is positioned to hold the leaflets of the mitral valve together, saving the patient from open-heart surgery and helping to keep blood flowing in the direction the body intended.

With more than 26 million people worldwide suffering from heart failure, most are not good candidates to survive open heart surgery to repair a leaky mitral valve due to their heart failure. Now, more than 100,000 people have benefited1 from the effects of this ingenious invention, lengthening and improving their lives by years.

It's positioned to help even more.

Since its launch, MitraClip is now on its fourth generation with approval in the U.S. and Europe along with other geographies. It also received an expanded indication from the U.S. Food and Drug Administration to treat secondary mitral regurgitation (MR).

To hear more from some of those directly involved in MitraClip’s creation as well as those directly benefitting from it, click the video above. They paint a picture Leonardo would be proud of.

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References

1Abbott data on file.
2The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others.

For U.S. important safety information on MitraClip™, visit: http://abbo.tt/MitraClipG4ISI

INFORMATION SAFETY INFORMATION

MITRACLIP CLIP DELIVERY SYSTEMS

INDICATION FOR USE
The MitraClip™ NTR/XTR 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™ NTR/XTR 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™ NTR/XTR System is contraindicated in 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

WARNINGS
DO NOT use MitraClip™ outside of the labeled indication.
The MitraClip™ Implant 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™ System to avoid user injury.
Use of the MitraClip™ 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.
Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.

PRECAUTIONS
Note the product “Use by” date specified on the package.
Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.
Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
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 > 60 mm. MitraClip® should be used only when criteria for clip suitability for DMR have been met.
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.
Secondary Mitral Regurgitation
Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClipTM procedure.
Death; 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; 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, MitraClipTM Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClipTM to the intended site; Failure to retrieve MitraClipTM 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; MitraClipTM Implant erosion, migration or malposition; MitraClipTM Implant thrombosis; MitraClipTM 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