Patent Foramen Ovale (Pfo) Closure Devices Remnant From The Fetal Circulation That Usually Closes At Birth

Introduction

A Patent Foramen Ovale (PFO) is a flap-like opening between the two upper chambers of the heart. It is a remnant from the fetal circulation that usually closes at birth. However, in about 25% of the general population, it remains open or patent. While a PFO is usually harmless, in some cases it can allow blood clots to pass from the right side of the heart to the left side and travel to the brain, causing a stroke. PFO closure devices are minimally invasive implants used to close a PFO and prevent future strokes.

Types of PFO Closure Devices

There are multiple types of PFO closure devices approved by the FDA for closing PFOs and reducing the risk of stroke. Some of the common devices include:

- Amplatzer PFO Occluder: Made by Abbott, this was the first FDA approved PFO closure device in 2001. It is a self-expanding nitinol mesh device that is deployed via a catheter through the femoral or jugular vein.

- GORE Cardioform Septal Occluder: Manufactured by W.L. Gore and Associates, it was approved in 2015. Similar to the Amplatzer device, it is a nitinol mesh structure that is compacted inside a delivery catheter.

- Figulla Flex II Occluder: Made by Occlutech, this device received FDA approval in 2020. It has flexible nitinol wires and polyester fabric to allow maximal adaptation to a patient's anatomy.

- Cera PFO Occluder: This device by Cardinal Health uses low-profile silicone material for soft, flexible closure of the PFO channel. It gained FDA approval in 2022.

How PFO Closure Devices Work

All Patent Foramen Ovale (PFO) Closure Devices closure devices are implanted using a minimally invasive catheter procedure. Under light anesthesia, a thin catheter is inserted through a small incision in the groin or neck and guided to the heart under fluoroscopic guidance. The compressed closure device is passed through the catheter and released in the heart. It expands to cover the flap-like opening of the PFO from both sides. Over time, tissues grow over the device, permanently sealing the opening. This prevents blood clots from entering the left side of the heart and traveling to the brain. Implantation takes around an hour and patients can resume normal activities within a day.

Benefits of PFO Closure

Closing a PFO offers several benefits compared to medical management alone:

- Reduced risk of future stroke - Clinical studies show a 45-90% reduced risk of recurrent stroke after PFO closure compared to medical treatment.

- Earlier return to normal activities - As it is a minimally invasive procedure compared to open heart surgery, recovery is much faster. Patients can resume work within 2-3 days.

- Improved quality of life - By preventing future neurological events, PFO closure improves long term life quality, independence and productivity.

- Reduced need for blood thinners - For patients with a high stroke risk, PFO closure may eliminate or reduce long term need for anticoagulant medications that carry bleeding risks.

- Peace of mind - Closing the PFO channel results in long lasting closure, ensuring stroke risk is addressed at the anatomical level rather than just managed medically over time.

Patient Selection for PFO Closure

Not all PFO patients need closure, and careful selection is important. Ideal candidates are those who:

- Have had an otherwise unexplained stroke or transient ischemic attack (TIA).

- Have a PFO and one or more stroke risk factors like atrial septal aneurysm.

- Failed or are inappropriate candidates for medical management alone with blood thinners.

- Have had multiple or recurrent neurological events despite medication use.

It is generally not advised for patients with small PFOs without stroke history or other eligible criteria. A multidisciplinary team approach including cardiologists and neurologists is needed for patient evaluation and treatment decision making.

Safety of PFO Closure Devices

While very effective, PFO closure does have some risks like with any implant procedure:

- Possible device embolization or malposition requiring intervention

- Bleeding, infection, or arrhythmias from the catheter insertion site

- Rare cases of pericardial effusion or device erosion into heart chambers.

However, with experienced operators, complications are very low (1-2% rate). Appropriate patient selection also minimizes risks. Long term, these implanted devices have excellent durability and safety profiles up to 15 years after implantation.

Conclusion

In summary, PFO closure using the minimally invasive implant devices available is an important treatment option for reducing stroke recurrence risk in select patients. By sealing the opening permanently, it addresses the anatomical cause at its source. With a low side effect profile and high patient satisfaction, PFO closure provides an effective alternative to lifelong medical management of PFO associated stroke risk when indicated clinically.

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