Background Information:

What are the other Names for the Procedure?

• TAVI (Transcatheter Aortic Valve Implantation)
• TAVR (Transcatheter Aortic Valve Replacement)
• Transcatheter Aortic Valve Implantation (TAVI)

What is Transcatheter Aortic Valve Replacement surgical procedure?

Transcatheter Aortic Valve Replacement (TAVR) procedure is a minimally-invasive procedure that is undertaken to replace a severely diseased aortic valve either due to narrowing (aortic stenosis) or leakage (aortic insufficiency) of the valve.

What part of the Body does the Procedure involve?

The Transcatheter Aortic Valve Replacement procedure is typically done via the groin approach using the femoral arteries (arteries of the leg).

• In some instances, the femoral arteries are too diseased or too small to use, hence, other arteries in the body may be used, such as the arm arteries (subclavian arteries) or neck arteries (carotid arteries)
• Very rarely, none of these approaches are viable, and so TAVR procedure is performed through a small, surgical hole made in the chest

Why is the Transcatheter Aortic Valve Replacement surgical procedure Performed?

• The Transcatheter Aortic Valve Replacement procedure is performed since it is a less invasive procedure with lesser morbidity and quicker recovery, especially among the elderly patients, who would otherwise not be able to tolerate an open heart surgery due to increased surgical risk
• However, not all patients may qualify and the decision is made in collaboration between an interventional cardiologist who specializes in TAVR, and a cardio-thoracic surgeon taking the best interest of the patient into consideration

What are the Alternative Choices for the Procedure?

Some of the alternative choices for the Transcatheter Aortic Valve Replacement procedure include:

• Open heart surgical aortic valve replacement
• Balloon aortic valvuloplasty: This is only a temporizing procedure done in severely ill patients, and does not lead to permanent treatment for the valve
• Medical therapy which is usually palliative

What are the Recent Advances in the Procedure?

Currently, Transcatheter Aortic Valve Replacement procedure is only commercially available for patients with severely narrowed aortic valves (or aortic stenosis). However, the recent advances in this procedure include:

• Early discharge to home after the procedure typically on the next day; sometimes, even on the same day
• Performance of the procedure with minimal sedation (awake patient)
• Decreased rates of pacemaker with the newer generation valves
• Availability of similar technology for patients with leaking aortic valves (aortic insufficiency), which are currently being researched and not commercially available

What is the Cost of performing the Transcatheter Aortic Valve Replacement surgical procedure?

The cost of the Transcatheter Aortic Valve Replacement 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 Procedure?

• It is normal for a patient to feel uncomfortable and confused by the information regarding Transcatheter Aortic Valve Replacement procedure and on what needs to be done
• If the patient needs further reassurance or a second opinion, a physician will almost always assist and also recommend another physician, if required
• They can also choose to approach another physician independently. Besides, if the procedure has many alternatives, the patient may take a second opinion to understand and choose the best one

What are some Helpful Resources?

http://www.newheartvalve.com (accessed on 10/15/2021)

http://www.dovemed.com (accessed on 10/15/2021)

http://www.mayoclinic.org (accessed on 10/15/2021)

http://www.thechristhospital.com (accessed on 10/15/2021)

Prior to Transcatheter Aortic Valve Replacement surgical procedure:

How is the Transcatheter Aortic Valve Replacement surgical procedure Performed?

The Transcatheter Aortic Valve Replacement 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 mild to moderate sedation is administered
• The groin area is prepped with antiseptic and local anesthesia is applied to the bilateral groins
• The femoral artery is accessed with a small needle and a plastic tube is placed in this artery. The contralateral femoral artery is similarly accessed, and a tube is placed as well
• The tube is upsized to a larger tube called a delivery sheath. Using a guide wire and a specialized catheter, the diseased aortic valve is crossed
• Over this wire, a slenderized bioprosthetic valve is advanced through the delivery sheath across the diseased valve
• A temporary pacemaker is then placed to rapidly pace the heart. Under rapid pacing, the slenderized valve is deployed
• Once the valve is deployed, the delivery system is removed from the patient, the groin sheaths are removed, and the hole in the arteries are sealed with sutures
• The temporary pacemaker wire is removed as well

The patient is then transferred to a step down unit and typically discharged home the next day after overnight observation.

Where is the Procedure Performed?

The Transcatheter Aortic Valve Replacement procedure is performed in a specialized cardiac cath lab (or hybrid operating room), as these procedure rooms are capable of performing open heart surgery, if needed, for rescuing the patient.

Who Performs the Procedure?

The surgical procedure is performed by two physicians - an interventional cardiologist with special training and a cardio-thoracic surgeon.

How long will the Procedure take?

The Transcatheter Aortic Valve Replacement procedure typically takes about two hours. 

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 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
• If you or your family members, have a history of bleeding disorders, or if there is a tendency to bleed more than normal
• If you have diabetes, high blood pressure, chest pains, or have previously suffered from a heart attack
• If you have ever been diagnosed with blood clots in your leg (deep vein thrombosis) or lung (embolism of lung)
• If you have a history of frequent bone fractures (this may affect bone-healing, if bones are involved as part of your procedure)
• If you have any unusual effects of local 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 may evaluate the individual’s medical history to gain a comprehensive knowledge of the overall health status of the patient including information related to the medications that are being currently taken
• Some medications, like blood thinners, 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
• Avoid application of any cosmetics, 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 surgery
• Consumption of alcoholic drinks must also be avoided for a period of time, as instructed
• The patient must avoid eating or drinking at least 8 hours prior to the surgical procedure, depending on when the procedure is arranged
• 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

What is the Consent Process before the Procedure?

The physician will obtain permission for the Transcatheter Aortic Valve Replacement 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 Transcatheter Aortic Valve Replacement surgical procedure?

Prior to a Transcatheter Aortic Valve Replacement procedure, the following tests may be performed:

• Echocardiogram
• Occasionally, an invasive echocardiogram, called trans-esophageal echocardiogram, may be necessary
• Cardiac catheterization and coronary angiography 
• CT-based angiogram of the chest, abdomen, and pelvis to help valve planting and for valve sizing (this is typically performed after an IV is placed and contrast is administered during the CT scan)
• Pulmonary function test (PFT), if needed, to determine suitability of lungs in case an open heart surgery is planned
• Blood tests, as required

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

What are some Questions for your Physician?

Some of the basic questions that you might ask your physician are as follows:

• What is a Transcatheter Aortic Valve Replacement procedure?
• Why is this procedure necessary? How will this procedure help?
• What does the procedure involve?
• How soon should I get it done? Is there an emergency?
• What choices do I have apart from an angioplasty?
• What are the other available and cost-effective surgical options?
• What are the risks involved?
• What are the possible complications that might take place during recovery?
• Are there any chances for the failure of this surgery?
• Will an angioplasty ensure that there shall be no future blockages, in the same artery?
• How long will it take to recover? When can I resume normal work?
• Do I have to follow any cardiac rehabilitation program post-surgery?
• How many such procedure have you (the physician) performed?
• Are there any lifestyle restrictions or modifications required, after the procedure is performed?
• Are there any follow-up tests, periodic visits to the healthcare facility required, after the procedure?
• Is there any medication that needs to be taken for life after the procedure?
• What are the costs involved?

During the Transcatheter Aortic Valve Replacement surgical procedure:

What kind of Anesthesia is given during the Procedure?

During the Transcatheter Aortic Valve Replacement procedure, the patient is given varying degrees of anesthesia depending on the difficulty of the procedure. Most procedures (90-95%) are done with moderate to deep sedation without involving general anesthesia.

How much Blood will you lose during the Procedure?

During the procedure, patients typically lose less than 50ml of blood.

What are the possible Risks and Complications during the Transcatheter Aortic Valve Replacement surgical procedure?

The possible risks or complications that may arise during the Transcatheter Aortic Valve Replacement procedure include:

• Stroke (about 1-2% possibility)
• Pacemaker placement (in between 10-15% of the cases)
• Bleeding from the spot where the catheter was inserted (in less than 5% of the cases)
• Arrhythmia, or irregular heartbeat
• Blood clot formations
• Heart attack
• Allergic reactions to the dye used for X-ray imaging
• Bleeding from the spot where the catheter was inserted
• Need for conversion to open heart surgery (that may occur in less than 1% of the cases)

There is also a lower than 1% chance of death from the procedure.

What Post-Operative care is needed at the Healthcare Facility after the Transcatheter Aortic Valve Replacement surgical procedure?

The following post-operative care may be considered at the healthcare facility:

• Management of the groin access site
• Resumption of blood thinners
• Monitoring of patients for development of a heart block; patients may need a pacemaker if a heart block occurs
• Echocardiogram
• IV antibiotics

After the Transcatheter Aortic Valve Replacement surgical procedure:

What are the possible Risks and Complications after the Transcatheter Aortic Valve Replacement surgical procedure?

Post Transcatheter Aortic Valve Replacement procedure, the following complications may arise:

• Bleeding from the procedure site (may be observed in less than 5% of the cases)
• Pacemaker requirement 
• Stroke (about 1-2% possibility)

What is the Prognosis after the Surgery?

The prognosis of successful Transcatheter Aortic Valve Replacement procedure is generally excellent with very little long-term side effects or complications noted.

When do you need to call your Physician?

Do contact your physician if you notice any of the following symptoms:

• Sudden chest pain
• Shortness of breath
• Dizziness
• Pain, swelling, bleeding or discharge from the point, where the catheter was inserted
• Fever

What Post-Operative care is needed at Home after the Transcatheter Aortic Valve Replacement surgical procedure?

At home, the following post-operative care is recommended, after the Transcatheter Aortic Valve Replacement procedure:

• Avoid any strenuous exercise or activities for a minimum period of 2 weeks
• Strictly adhere to, and complete the cardiac rehabilitation program suggested by the physician
• The spot, where the catheter was inserted, may be gently cleaned with warm water and soap
• Completely avoid non-prescribed medication
• Resume routine daily activities as early as possible (under supervision of your physician)
• Minimize use of stairs
• Strictly adhere to medication regimen the patient was discharged with

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

It takes about two to three days to completely recover from a Transcatheter Aortic Valve Replacement procedure. 

Additional Information:

What happens to tissue (if any taken out) after the Procedure?

There is no tissue taken out during the procedure.

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

There are no results expected from pathology as no tissue is taken out.

Who will you receive a Bill from after the Transcatheter Aortic Valve Replacement 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 hospital
• A cardiologist
• A radiologist (if radiological tests were performed during the procedure)
• Other assisting healthcare providers

The patient is advised to inquire and confirm the type of billing before the Transcatheter Aortic Valve Replacement procedure is performed.