Patent Foramen Ovale (PFO) Closure Devices Growth

 

Patent Foramen Ovale (PFO) Closure Devices

What is a Patent Foramen Ovale?

A patent foramen ovale (PFO) is a remnant from fetal circulation that failed to close after birth. In a fetus, blood passes through an opening called the foramen ovale that connects the right and left upper chambers of the heart (atria). This bypasses the fetus' developing lungs. After birth, increased blood pressure in the left atrium usually causes the foramen ovale to close. However, in about 25% of people, the opening fails to seal completely, leaving a PFO. Normally this does not cause issues, as the flap blocks the passage of blood between the atria with each heartbeat. However, a PFO may allow blood clots to bypass the lungs, which can lead to certain health problems.

Types of Patent Foramen Ovale (PFO) Closure Devices

There are several types of Patent Foramen Ovale (PFO) Closure Devices that can be used to close an abnormal opening without open heart surgery. Closure devices aim to help prevent complications by blocking blood clots from entering the left side of the heart and potentially causing a stroke. The two main types of closure devices are:

- Amplatzer PFO Occluder: The Amplatzer PFO Occluder was the first device approved by the FDA for percutaneous PFO closure. It consists of a nitinol mesh disk that conforms to the defect size. The disk has "pins" or "anchors" that grab the septum to help secure it in place.

- Helex Septal Occluder: The Helex Septal Occluder is another type of PFO closure device. Like the Amplatzer, it uses nitinol wire mesh and "pins" or "anchors" to close and secure the opening. However, it has a lower profile delivery system designed for easier use.

- Other Devices: There are a few other PFO closure devices available such as the CardioSEAL Septal Occluder and the Gore Cardioform Septal Occluder. These devices work in a similar way using nitinol mesh and anchors but may have small design differences from the Amplatzer and Helex occluders.

How are Patent Foramen Ovale (PFO) Closure Devices Implanted?

PFO closure using a percutaneous device is generally an outpatient procedure performed under local anesthesia. The patient is monitored to ensure they are comfortable. The doctor first inserts an IV line to deliver medications. They then make a small incision in the groin area to access the femoral vein. A catheter is threaded through the vein and guided to the heart under X-ray visualization.

Once in place, the cardiologist evaluates the PFO size and chooses the appropriately sized closure device. They then collapse and load the device via the catheter. Using the catheter's steering mechanism, the device is carefully guided through the cardiac septum and deployed across the defect. Deployment anchors one side first then the other to secure it shut. Following deployment, several tests are done to check for leaks or residual shunting. The catheter is then removed, and pressure is applied to the insertion site to stop any bleeding. The whole procedure typically takes 30-60 minutes.

Recovery from PFO Closure

Most patients can resume normal activity within a few days after a PFO closure. However, vigorous exercise or heavy lifting should be avoided for about a week to allow the implant site to heal. Patients may feel some soreness at the groin insertion site, which is normal. Bruising or small hematomas also occasionally occur but resolve within the first 1-2 weeks.

It's important not to get the insertion site wet during initial healing. Showers are generally fine after 2-3 days but baths should be avoided for up to 2 weeks. The closure device does not require any special care but patients will need to take aspirin for 6 months as instructed to prevent clot formation. Follow-up visits allow the cardiologist to monitor device positioning and closure success using imaging tests like echocardiograms or MRIs. Full recovery is usually within 4 weeks.

Effectiveness of Patent Foramen Ovale (PFO) Closure Devices

Studies show that properly implanted PFO closure devices are very effective at eliminating right-to-left shunting and preventing recurrent stroke in selected patients. One landmark study found the risk of recurrent stroke after PFO closure with the Amplatzer device dropped over 90% compared to medical management alone. Other research confirms closure significantly lowers the risk of further brain lesions, migraine headaches, and heart-related issues like paradoxical embolism.

Proper patient selection is important for achieving these promising results. Guidelines recommend considering closure for cryptogenic stroke patients under 60 years old with at least one moderate/large shunt detected. For older patients or those with smaller shunts, medical management alone may be just as effective. Long term studies continue to monitor device performance and help refine criteria to optimize outcomes. Overall, PFO closure provides an important treatment option for preventing future complications in appropriately selected patients.

 

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About Author:

Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191)