Background Information:

What are the other Names for the Procedure?

• Transcatheter Edge to Edge Repair (TEER) - MitraClip

What is MitraClip Surgical Procedure?

• MitraClip Surgical Procedure is a procedure that is used to repair severe mitral valve regurgitation (leak)
• The procedure involves deploying a clip-like device to bring the mitral leaflets together to reduce regurgitation
• This device is deployed using specialized catheters that are advanced through a small incision (about 6-8mm) in the groin

What part of the Body does the Procedure involve?

The MitraClip Surgical Procedure involves the mitral valve, which is one of the main valves on the left side of the heart.

Why is the MitraClip Surgical Procedure Performed?

There could be a variety of reasons for performing a MitraClip Surgical Procedure. Some of these include:

• Flail mitral valve leaflets causing mitral regurgitation
• Mitral valve prolapse (MVP)
• Weakened heart muscle leading to stretching of the mitral leaflets causing regurgitation
• Heart attack that damages the mitral valve apparatus leading to mitral regurgitation
• In select cases, condition where the heart muscle is severely thickened (termed hypertrophic cardiomyopathy) causing mitral regurgitation

What are some Alternative Choices for the Procedure?

Some of the alternative choices for MitraClip Surgical Procedure include:

• Surgery to repair or replace the mitral valve
• Through select research trials, other TEER devices (PASCAL) or transcatheter mitral valve replacement can be used. These are only available through clinical research at select sites

What are the Recent Advances in the Procedure?

Some of the recent advances include newer generation of the MitraClip (G4) with larger sizes, both length and width, which expand the ability to treat more patients with difficult mitral valve conditions.

What is the Cost of performing the MitraClip Surgical Procedure?

The cost of the MitraClip Surgical Procedure depends on a variety of factors, such as the type of your health insurance, annual deductibles, co-pay requirements, out-of-network and in-network of your healthcare providers and healthcare facilities.

In many cases, an estimate may be provided before the procedure. The final amount depends upon the findings during the surgery/procedure and post-operative care that is necessary.

When do you need a Second Opinion, prior to the Procedure?

• It is normal for a patient to feel uncomfortable and confused with a sudden inflow of information regarding the MitraClip Surgical Procedure and what needs to be done
• If the patient needs further reassurance or a second opinion, a physician will almost always assist in recommending another physician
• Also, if the procedure involves multiple steps or has many alternatives, the patient may take a second opinion to understand and choose the best one. They can also choose to approach another physician independently

What are some Helpful Resources?

Http://www.mayoclinic.org (accessed on 10/26/2021)

http://www.mitraclip.com (accessed on 10/26/2021)

Prior to MitraClip Surgical Procedure:

How is the MitraClip Surgical Procedure Performed?

The MitraClip Surgical Procedure is performed in the following manner:

• The patient is brought to the specialized cardiac cath lab, also known as a hybrid operating room, and is placed under general anesthesia
• The groins are prepped, and antiseptic is applied
• The femoral vein is accessed with a needle and a plastic tube is inserted into the femoral vein. This tube is upsized to a large bore delivery catheter/sheath
• Specialized catheters are advanced through the vein to the right atrium
• An echocardiogram is performed by placing a probe in the food-pipe (trans-esophageal echocardiogram). This helps to direct the catheter from the right atrium to the left atrium by making a small puncture in the atrial septum
• Over a guide wire, the delivery sheath for the MitraClip is advanced into the left atrium. The MitraClip is then used to repair the diseased mitral valve
• The delivery system and catheter is then removed from the patient and the femoral access site is sutured

When the patient awakes from anesthesia, he/she is transferred to the recovery area. The patient is typically monitored overnight and discharged the next day.

Where is the Procedure Performed?

The MitraClip Surgical Procedure is performed in a specialized cardiac cath lab, also known as a hybrid operating room, which can be used to rescue the patient if needed.

Who Performs the Procedure?

The procedure is performed by an interventional cardiologist with special training.

How long will the Procedure take?

The MitraClip Surgical Procedure usually takes about 3-4 hours.

• Pre-procedure preparation takes about 1-2 hours and typically involves placing an IV and obtaining bloodwork
• Post-procedure recovery using takes about 1-2 hours, to recover from the effects of anesthesia. After about 6 hours of bed rest, patients are able to increase their activity levels

What do you need to tell your Physician before the Procedure?

It is very important to provide the following information to your healthcare provider. This enables your healthcare provider in assessing the risks for the procedure and helps avoid complications.

• Provide medical history such as diabetes, hypertension, heart disease, etc. (if any)
• Provide a complete list of medications you are currently, taking to your physician. This information is useful for a variety of reasons. For example, it can help your healthcare provider prevent complications due to a drug interaction
• If you are allergic to any specific medication or food items
• If you are taking blood thinners, such as aspirin, warfarin, herbal supplements, or any other such medications
• Any medical or family history of bleeding disorders or blood clots
• If you have ever been diagnosed with blood clots in your leg (deep vein thrombosis) or lung (embolism of lung)
• Any unusual effects of anesthesia from prior surgery
• A list of all previous surgical procedures you have undergone, like for example: Removal of appendix, gallbladder, or any other part, of your body; surgical repair of any body part, such as hernia repair, perforation of bowel wall, etc.

What Preparations are needed, prior to the Procedure?

The physician performing the procedure will evaluate the patient prior to the procedure and discuss the details with risks for complications and obtain his/her permission (termed informed consent).

• Some medications increase a person’s chances of bleeding and it may be recommended to discontinue them for a period of time, before the procedure is performed
• Blood tests may be performed to determine if there is a bleeding tendency or any other medical conditions that prevents the person from undergoing the procedure
• Blood work, glucose, and pregnancy tests (if applicable) will be undertaken per physician recommendations
• If anesthesia team is involved in the procedure, then they too will discuss details of anesthesia with risks for complications and obtain permission from the patient (informed consent)
• Avoid application of any deodorant or topical medicines on the area, prior to the procedure
• It is advisable to quit smoking and the use of any nicotine based products, for a while, before the procedure
• Consumption of alcoholic drinks must also be avoided for a period of time, as instructed
• Generally, the patient is required to be on fast (no solids or liquids) for at least 8 hours prior to the procedure
• Individuals with diabetes, hypertension, or other cardiac conditions, are required to discuss these (including medications taken) with their attending physician well in advance
• For individuals with diabetes, it is important that the blood sugar stays within the normal range; if not their diabetologist may have to control blood sugar by recommending insulin and/or a combination of oral medicines

Pregnant women and individuals with severe underlying sicknesses are advised not to undertake this procedure. Please consult with your healthcare provider to assess suitability for this procedure.

What is the Consent Process before the Procedure?

The physician will obtain permission for the MitraClip Surgical Procedure using an Informed Consent Form.

Consent for the Procedure: A “consent” is the approval to undergo a procedure. A consent form is signed after the risks and benefits of the procedure, and alternative treatment options, are discussed. This process is called informed consent.

In case of minors and individuals unable to give informed consent, the parent or legal guardian or next of kin can sign the consent for the procedure.

What Tests are needed, before the MitraClip Surgical Procedure?

The individual may have to undergo certain tests prior to the MitraClip Surgical Procedure, which may include:

• Blood and urine tests
• Imaging studies
• Transesophageal echocardiogram (TEE)
• Cardiac catheterization

The physician may suggest further tests depending on the health of the individual and their medical history.

What are some Questions for your Physician?

Some of the questions that you might ask your healthcare provider are as follows:

• What is a MitraClip Surgical Procedure?
• Why is this procedure necessary? How will it help?
• How soon should I get it done? Is it an emergency?
• Who are the medical personnel involved in this procedure?
• Where is the procedure performed? 
• What are the risks while performing the procedure?
• What are the complications that might take place during recovery?
• How long will it take to recover? When can I resume normal work?
• How many such procedures have you (the physician) performed?
• Are there any follow-up tests, periodic visits to the healthcare facility required, after the procedure?
• What are the costs involved?

During the MitraClip Surgical Procedure:

What kind of Anesthesia is given, during the Procedure?

Local anesthesia by injection and general anesthesia by injection and inhalation are administered for the procedure.

How much Blood will you lose, during the Procedure?

MitraClip Surgical Procedure is considered a minimally-invasive procedure. Typically, the blood loss is less than 50 ml.

What are the possible Risks and Complications during the MitraClip Surgical Procedure?

There are general factors that increase one’s risk of getting complications during the MitraClip procedure, which include:

• Obesity: Generally greater the degree of obesity, greater is the surgical risk
• Smoking: Longer the smoking history (in pack years smoked), greater the surgical risk
• Advancing age
• Poorly controlled diabetes, as evidenced by a high hemoglobin A1c and a high fasting glucose
• Poorly functioning kidney, as evidenced by increased BUN (blood urea nitrogen) and blood creatinine
• Poorly functioning liver, as evidenced by increased blood liver function tests
• Hypertension (increased blood pressure), especially if it is poorly controlled
• Poor nutritional status (malnutrition with mineral and vitamin deficiencies)
• Poor lung function, as evidenced by abnormal lung function tests
• History of bleeding disorders
• Poor immune system due to a variety of causes

Some of the possible risks and complications that may arise during a MitraClip procedure are:

• Infection
• Bleeding
• Injury to the neighboring structures
• Pain
• Discomfort
• Anesthetic complications
• Need for further procedures
• Pneumonia
• Blood clot formation, affecting blood supply to the buttocks and lower extremities
• Stroke
• Perforation of the heart chambers (rare)

What Post-Operative Care is needed at the Healthcare Facility after the MitraClip Surgical Procedure?

The patient is usually observed by a healthcare professional (usually a nurse) in the recovery area or PACU (post-anesthesia care unit), depending on the type of anesthesia that was given during the procedure. Also, the patient vital signs are monitored.

After the MitraClip Surgical Procedure:

What are the possible Risks and Complications after the MitraClip Surgical Procedure?

The risks and complications that may arise after the MitraClip Surgical Procedure include:

• Excessive bleeding that may sometimes require an additional surgical procedure
• Any symptom that causes uneasiness such as nausea and dehydration
• Low-grade fever

• Infection of the surgical wound

What is the Prognosis after the Surgery?

In many cases, the prognosis after a MitraClip Surgical Procedure is typically excellent. Most patients are discharged the next day.

When do you need to call your Physician?

Do contact your physician or call 911 (or your local emergency number) based on the seriousness of any of the following symptoms:

• Fever and chills
• Severe pain
• Shortness of breath
• Bleeding or fluid discharge from the surgical wound
• Nausea or vomiting
• Signs of infection
• Severe fatigue
• Dizziness

What Post-Operative Care is needed at Home after the MitraClip Surgical Procedure?

At home, the following post-operative care is recommended after a MitraClip Surgical Procedure:

• Use a heat pad or warm compress to relieve pain due to the incision
• Resume showering and keep the wound clean and dry. Gently wash the surgical wound with mild unscented soap. Avoid soaking in a bath tub or swimming until the surgical site has healed completely.
• Replace dressing after showering
• Take the prescribed medications following the procedure
• Avoid any strenuous activity for a period recommended by the physician
• Do not drive (post-procedure) for a period of 24 hours
• Avoid smoking or drinking alcohol post-procedure
• Continue old, prescribed medications after checking with your healthcare provider
• Avoid sex until complete healing has taken place (under advice by the physician)
• Do not sign any legal documents post-procedure for a period of 24 hours

How long does it normally take to fully recover, from the Procedure?

The time for recovery from the MitraClip Surgical Procedure is typically two days.

Additional Information:

What happens to tissue/samples (if any), taken during the Procedure?

The procedure does not involve the surgical removal of any tissue.

When should you expect results from the pathologist regarding tissue taken out, during the Procedure?

Since no tissue is removed during the procedure, a pathologist does not get involved in the care of the patient.

Who will you receive a Bill from, after the MitraClip Surgical Procedure?

It is important to note that the number of bills that the patient may receive depends on the arrangement the healthcare facility has with the physician and other healthcare providers.

Sometimes, the patient may get a single bill that includes the healthcare facility, and the consultant physician charges. Sometimes, the patient might get multiple bills depending on the healthcare provider involved. For instance, the patient may get a bill from:

• The outpatient facility or hospital
• The interventional cardiologist or cardiothoracic surgeon
• An anesthesiologist (if anesthesia was administered)
• A pathologist (if the tissue was sent for analysis)

The patient is advised to inquire and confirm the type of billing before the MitraClip Surgical Procedure is performed.