PFO Closure Devices: A Game-Changer in Stroke Prevention and Treatment
Patent Foramen Ovale (PFO) Closure Devices |
What is a Patent
Foramen Ovale (PFO) Closure Devices?
A patent foramen ovale (PFO) is a normal opening between the two upper chambers
of the heart that failed to close after birth. In a normally developing fetus,
the foramen ovale allows blood to bypass the lungs. After birth, as the lungs
expand and the baby takes its first breath, the pressure changes cause the
flap-like tissue separating the left and right atria (the two upper chambers)
to close. In about 25% of adults, the flap doesn't always seal tightly leaving
a PFO.
Most people who have a PFO don't experience any problems. However, in some
cases a Patent
Foramen Ovale (PFO) Closure Devices allows blood clots to pass from the
right side of the heart to the left side and potentially cause a stroke. The
risk is higher for those who have had a stroke or transient ischemic attack
(TIA) before the age of 55. PFOs have also been associated with migraines with
aura in some studies.
Devices Used to Close a Patent Foramen
Ovale (PFO) Closure Devices
For patients who have had a stroke or TIA due to a PFO and have a high
recurrence risk, doctors may recommend closing the opening. This can help
prevent future blood clots from entering circulation and reduce the risk of
another stroke. There are a few different types of PFO closure devices that can
be used during a minimally invasive catheter procedure:
- Amplatzer PFO Occluder: This was the first PFO closure device approved by the
FDA in 2001. It has nitinol wire panels covered in a fabric that the device
expands into a disc shape to close the PFO opening. The panels seal against the
heart wall on either side of the PFO.
- Amplatzer Amulet PFO Occluder: An updated version of the original Amplatzer
device launched in 2017. It has a similar nitinol frame design but also
includes hooks to help anchor it in place and reduce risk of device
embolization after implantation.
- Gore CARDIOFORM Septal Occluder: A self-expanding nitinol mesh device covered
in PTFE material. One disc is deployed on the left atrial side and another on
the right atrial side to close the defect. This was approved by the FDA in
2015.
- Starflex Septal Repair implant: A nitinol single disc device covered in ePTFE
material. It has barbs or anchors around the edge to help secure it in the
septum wall and prevent movement after implantation. FDA approved in 2018.
- Figulla Flex II PFO Occluder: A self-expanding nitinol mesh device with two
discs made of braided nitinol wire that is then covered in ePTFE material. It
was approved for use in Europe but did not receive FDA approval in the United
States.
How is a PFO Closure Performed?
To close a PFO using one of these implantable devices, doctors perform a
catheter-based procedure called percutaneous PFO closure or percutaneous PFO
occlusion. The patient is placed under local anesthesia and conscious sedation.
Access is obtained through a small incision in the groin area. A catheter is
then threaded through blood vessels until it reaches the heart.
The size of the PFO opening is first measured using imaging like
transesophageal echocardiography (TEE). The appropriately sized device is then
loaded onto a catheter delivery system and threaded through the catheter into
the heart. Under TEE and fluoroscopy guidance, the right atrial disc of the
device is deployed inside the heart's right atrium. The catheter is then pulled
back so the left atrial disc deploys and sandwiches the PFO flap shut between
the two discs.
Proper positioning and closure of the defect is confirmed using TEE imaging
before removing the delivery catheter. The entire procedure usually takes about
an hour. Patients can usually go home the same day and recover for 1-2 weeks
with activities limited to prevent device dislodgement as tissue grows over it.
Follow up TEE is done to check healing and closure of the PFO at certain
intervals after the procedure.
Outcomes and Complications
Multiple randomized controlled clinical trials have shown PFO closure devices to
be more effective than medical treatment alone in reducing recurrent stroke or
transient ischemic attack (TIA) events among patients who had a previous stroke
due to a PFO. On average closure reduced the risk of repeat events by over 50%
in studies.
However, PFO closure does carry some
risks and potential complications, including:
- Device embolization or dislodgement: Around 1-2% risk the device may
detach partially or fully from the septum. This requires percutaneous or
surgical removal.
- Arrhythmias: Less than 1% chance of new atrial fibrillation, flutter or other
rhythm disturbances after PFO closure.
- Perforation of heart structures: Rare but possible perforation of the atria,
ventricle or vessels can occur from catheter, wire or device.
- Infection: Less than 1% chance of infection requiring antibiotics or device
removal.
- Bleeding complications: Around 3% risk of significant bleeding or bruising
from the vascular access site that requires treatment or transfusion.
- Thrombus formation: Small potential risk of thrombus (blood clot) forming on
the device surface that could embolize.
When performed by experienced operators, the rates of major complications are
relatively low. But long term device or tissue interactions are still not fully
understood given the devices have only been used widely for around 15 years.
Ongoing studies continue to evaluate long term safety. For properly selected
patients though, PFO closure has become an important treatment option.
PFO closure devices have proven effective in reducing recurrent stroke risk for
patients who have experienced an event due to a PFO defect. The minimally
invasive procedure can successfully seal the opening between the atria. While
complications are possible, outcomes are generally good when performed by
experienced heart teams. PFO closure remains an important therapeutic option
for select patients.
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