What to Know Before a Heart Valve Repair

Here's what to expect from your heart valve repair so that you feel empowered about your options.

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Healthy Heart | Feb. 19, 2018

Minimally invasive heart valve repair procedures offer an important treatment option to repair a failing valve for patients who are not eligible for open heart surgery. If you or your loved one's doctor notices increasing symptoms that point to heart valve disease, such as shortness of breath and chest pain, it is important to weigh your options and understand how they can impact your health.

The right information can make you more comfortable with your choice for valve repair, so use this guide to have a productive discussion with your doctor about which treatment option is best for you.

Why a Heart Valve Repair May Be Necessary

The four valves of your heart (aortic, pulmonary, tricuspid and mitral) keep blood moving in the correct direction from one chamber to another. When the valves don't function properly, blood flow is disrupted, which can cause long-term damage.

In the case of the mitral valve, for example, the leaflets may not close entirely, allowing backflow of blood. This can result in a dangerous condition called mitral regurgitation (MR) — a leaky heart valve — and uncomfortable symptoms such as chest pain, shortness of breath and lightheadedness.

Left untreated, heart valve disease such as MR may lead to heart failure, which can be deadly.

Your doctor will likely consider a valve repair or replacement to avoid the valve's failure. Until recently, MR treatments have been limited to medications — which typically help with symptoms and may not address the underlying valve issue — and open-heart surgery, which is not a viable option for some patients because of advanced age or the presence of one or more additional diseases.

If you or your loved one doesn't need a total valve replacement or isn't a candidate for open-heart repair surgery, a minimally invasive valve repair procedure, called transcatheter valve repair, is available. It allows your doctor to repair the leaky mitral valve through a small incision in the leg, which is then used to guide a thin tube through a vein to reach your heart.

Discussing Transcatheter Valve Repair with Your Doctor

Before scheduling your procedure, make sure you have a clear understanding of what you can expect including:

  • Preparation, such as adjusting routine medications, fasting and arranging your hospital stay and ride home.
  • How to maximize your recovery, including diet adjustments and activity limitations.
  • How to reduce your pain and make daily tasks easier while you heal.
  • What to expect at follow up, including recovery time and other side effects of the procedure.
  • Who you should contact with any questions and phone numbers where you can reach them.
  • Financial costs, including those associated with the procedure, anesthesia, home care, follow-up office visits, insurance coverage and other expenses.

Preparing for Your Procedure

Before the procedure, your doctor will do a full physical and blood work, check your vital signs and review your current medications to make sure you are healthy enough for your repair procedure. Ask your doctor about any risks associated with the procedure or your condition. Make sure you understand if you need to stop eating or taking medications at a specific time before the procedure, as well.

During the Procedure

Because minimally invasive treatments eliminate the need for open-heart surgery or stopping the heart, your doctor only needs to make a small incision in the leg or groin to insert a catheter into a vein to reach the heart. The cardiologist then repairs the leak to allow better functionality.

For MR, your doctor may use MitraClip®, a clinically proven and minimally invasive treatment to repair a leaky mitral valve in people who are not eligible for open heart surgery. The procedure takes up to three hours and requires general anesthesia.

Since it's minimally invasive, recovery time is reduced to an average hospital stay of two days.

After the Repair

After the valve is repaired, your doctor will order testing and imaging to ensure success. You can generally resume a normal diet as soon as the next day. Let your nurses know if you have any unusual discomfort or pain.

You should also expect to take it easy for several days after you leave the hospital. Watch for signs of infection at the insertion site, like redness and warmth, increased pain or unusual drainage. Be sure to follow specific recovery instructions from your doctor. If you have any questions or concerns, don't hesitate to call your doctor to clarify.

Advancing Minimally Invasive Technology for Heart Valve Diseases

In addition to MR, Abbott is also innovating minimally invasive treatment for several other conditions, including for people with tricuspid valve regurgitation.

The company is studying the use of a similar clip-based technology, to treat patients with tricuspid regurgitation. A transcatheter clip-based tricuspid repair system* would treat tricuspid valves in need of repair.

Abbott is also studying a minimally invasive solution for total valve replacement of the mitral valve in the Tendyne trial**, because the need for a valve replacement is more common in older adults who are often at risk or not candidates for surgery.

Taking Charge of Your Own Heart Health

If you or your loved one is in need of a heart valve repair procedure, speak with your cardiologist about your options. Feeling empowered about all your options is key to your recovery, so be sure to get involved in decisions about your heart health.

*Pending CE mark. Neither approved nor available for sale.

**CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.

IMPORTANT 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.  MitraClipTM 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