Patent foramen ovale transcatheter repair

Overview

Catheter-based procedures are commonly employed for both diagnosis and treatment of cardiovascular issues, such as arterial blockages and heart attacks. In cases requiring the closure of a patent foramen ovale (PFO), a catheter is utilized to guide the placement of a permanent implant that seals the hole in the heart wall and prevents the flap from opening.

During a cardiac catheterization, a lengthy, slender, and flexible hollow tube (catheter) is gradually advanced into the heart. This catheter is inserted through a small incision, typically made in the inner thigh (groin area), into a large vein, allowing access to the heart. Various tests are conducted to assess the PFO and ensure the absence of any other defects.

Angiography, involving the injection of a specific dye followed by X-ray imaging, may be employed for a clearer view of the heart. Additionally, intracardiac echo (ICE), an ultrasound imaging technique, is used to visualize the defect and determine the appropriate size for the closure device. The ultrasound device is advanced to the heart through the vein. A special balloon on a catheter may also be inflated in the area of the hole to measure its size accurately before selecting the closure device.

The ICE enables the physician to observe the heart structures and blood flow during the gentle stretching of the hole with the balloon and the placement of the closure device to seal the defect. The PFO closure device is carefully maneuvered through the vein to the heart and specifically to the location of the heart wall defect. Once positioned correctly, the device is shaped to straddle each side of the hole and remains in the heart permanently to halt the abnormal blood flow between the atrial chambers. Subsequently, the catheter is removed, marking the completion of the procedure.

Types

There are two well-known devices for closing a small opening in the heart called a patent foramen ovale (PFO): the Amplatzer® PFO occluder and the GORE® CARDIOFORM septal occluder.

• Amplatzer® PFO: occluder has received approval from the FDA specifically for closing PFOs. However, other devices designed for closing different types of heart openings, like atrial or ventricular septal defects, can also be used for PFO closure.
• GORE® CARDIOFORM septal occluder: Consists of a nickel-titanium wire frame coated in a thin Gore-Tex membrane, a material used in heart surgery for over two decades. The device is inserted through a catheter and opens up to cover one side of the heart’s septum with two disks. The healthcare provider selects a device slightly larger than the PFO size, and over time, the patient’s tissue grows around the device.

Reasons for undergoing the procedure

While most cases of patent foramen ovales (PFOs) are asymptomatic and often don’t require intervention, they can pose a risk of complications, with stroke being a notable concern due to the potential for blood clot obstruction in the brain. Treatment decisions depend on individual factors; for those without stroke risk factors or a history of clot-related issues, observation may be sufficient. However, if problems such as strokes have occurred, various interventions may be considered. Options range from antiplatelet or anticoagulant medications to more invasive approaches like transcatheter repair or heart surgery, the choice of which depends on factors like overall health and the need for concurrent heart surgery.

Risk

Complications associated with the procedure are uncommon. Risk factors may vary based on factors such as the size of the defect, age, and other medical conditions. Potential risks include:

• Stroke
• Bleeding
• Infection
• Puncture of the heart
• Arrhythmias or abnormal heart rhythms
• Tears in the blood vessels surrounding the heart
• Detachment of the device, leading it to pass through the heart or blood vessels

There is also a possibility that the surgery may not effectively resolve the PFO. To understand the specific risks pertinent to your case, it is advisable to discuss them with your healthcare provider.

Procedure

Cardiac catheterization is a medical procedure involving the careful insertion of a thin, flexible tube called a catheter into the heart. Typically initiated through a small incision in the inner thigh (groin area), the catheter is advanced into the heart through a large vein. Throughout the procedure, healthcare professionals assess the patent foramen ovale (PFO) and conduct various tests to identify any additional issues. To enhance the visualization of the heart, angiography, a diagnostic imaging technique, may be employed, where a special dye is injected, followed by capturing motion X-ray images. Additionally, intracardiac echocardiography (ICE) may be used to obtain a clearer view of the heart defect and determine the appropriate size for a closure device.

To ensure precise sizing and placement of the closure device, ultrasonography equipment is advanced to the heart through the vein. A specific balloon on a catheter may be positioned at the hole, inflated to measure its size while gently stretching it. The ICE allows healthcare providers to view the heart’s internal architecture and blood flow during this process. The PFO closure device, designed to span both sides of the hole, is inserted into the vein and advanced to the heart, precisely placed at the heart wall defect. Once in position, the closure device is implanted permanently to block irregular blood flow between the atrial chambers. The procedure concludes with the removal of the catheter.

Before the procedure

To prepare for the upcoming procedure, take the following steps:

• Consultation with healthcare provider:
  Discuss preparation with your healthcare provider.
  Confirm if there are any eating/drinking restrictions and if you need to adjust medications.
• Additional tests may include:
  • Chest X-ray
  • Electrocardiogram (EKG) to evaluate heart rhythm.
  • Blood tests for overall health
  • Echocardiogram to examine heart structure and blood flow
  • Transcranial/transmitral Doppler to observe blood movement
  • Bubble study to check the PFO
• Pre-procedure grooming:
• Hair removal around the catheter insertion site might be required.

During the procedure

It’s important to have a discussion with your healthcare provider about what to expect during the procedure. The specific details of the process may vary depending on the type of echocardiography used by your healthcare provider. Typically, this procedure is performed by a team of experienced nurses and a cardiologist, usually in a specialized cardiac catheterization lab. The process includes:

• The patient will most likely receive anesthesia prior to the commencement of the procedure from a healthcare provider. Throughout the procedure, they will be in a state of deep and painless sleep.
• A short, flexible tube called a catheter is inserted by the healthcare provider into an artery located in the groin. There will be a small device within this tube.
• The healthcare provider may employ echocardiograms and X-rays to pinpoint the precise location of the tube.
• The healthcare provider inserts the tube through the blood vessel and into the PFO.
• The healthcare provider will plug the PFO’s hole and push the small devices out of the tube. After that, the device will be securely fixed.
• The healthcare provider will then remove the tube through the blood vessel.
• Bandage will be placed and the insertion site will be closed.
• The procedure will take around 2 hours.

After the procedure

Discuss what will happen following the procedure with the healthcare provider. In general, individuals can expect:

• The patient will stay in the recovery room for several hours.
• The medical team will be monitoring the vital signs closely. These consist of respiration, blood pressure, oxygen saturation, and heart rate.
• Following the procedure, the patient might need to lie flat for a few hours without bending their legs. This will lessen the chance of bleeding.
• A follow-up test, such as an echocardiography or electrocardiogram, may be ordered by the healthcare provider.
• To prevent blood clots, the healthcare provider may recommend medication. If necessary, the patient may get pain medication.
• The day after the surgery, the patient can be allowed to return home. Ensure they have a designated driver to get them home.

Home care procedure are as follows:

• Find out what medications the patient must take. To stop blood clots, the patient might need to take antibiotics or other medications briefly. As needed, use pain medication.
• The patient is able to promptly return to their regular activities. However, stay away from physically demanding tasks.
• The patient will have any staples or stitches taken out during a follow-up visit. Keep all of the follow-up appointments.

Following certain dental and medical procedures, the patient may be advised to take antibiotics for a period of time. This precautionary measure helps protect the heart valves from potential infections. If you have any questions or concerns about whether you need to take antibiotics, be sure to discuss this with your healthcare provider.

Outcome

Heart surgical techniques historically use safe closure devices that seamlessly integrate into the heart tissue within three to six months. Patients won’t feel the device, and it won’t interfere with daily activities or sensors, except for a slight reduction in magnetic resonance imaging (MRI) or computed tomography (CT) image clarity due to the wire frame on occluder devices. Patients should inform imaging technicians, carry an ID card, and follow up with a bubble study. Strict adherence to healthcare provider instructions on medication, physical activity, nutrition, and wound care is crucial. Promptly contact the healthcare provider for severe symptoms, fever, excessive bleeding, discharge, or unusual swelling.