Przetrwały otwór owalny
Leczenie

Przetrwały otwór owalny (PFO) to ubytek w przegrodzie międzyprzedsionkowej obecny u 25-30% populacji, który może być przyczyną udaru kryptogennego poprzez zatorowość paradoksalną. Wskazania do interwencji obejmują udar mózgu u osób ≤60 lat, hipoksemię z przeciekiem prawo-lewym, nawracające incydenty zatorowe mimo leczenia farmakologicznego oraz PFO z tętniakiem przegrody lub dużym przeciekiem. Podstawową terapią jest farmakoterapia: leki przeciwpłytkowe (np. ASA 81-325 mg/dobę) u pacjentów po udarze niedokrwiennym lub TIA oraz leki przeciwkrzepliwe (np. warfaryna z docelowym INR 2-3, NOAC) u chorych z towarzyszącą żylną chorobą zakrzepowo-zatorową. Przezskórne zamknięcie PFO okluderem (np. Amplatzer Talisman, Gore Cardioform) jest preferowaną metodą interwencyjną, wykazującą skuteczność techniczną bliską 100% i całkowite zamknięcie ubytku u 93-96% pacjentów po roku. Najczęstszym powikłaniem jest przejściowe migotanie przedsionków (3,4%).

Przetrwały otwór owalny – charakterystyka

Przetrwały otwór owalny (ang. Patent Foramen Ovale, PFO) to ubytek w przegrodzie międzyprzedsionkowej serca, który występuje u około 25-30% populacji ogólnej. Jest to pozostałość po prawidłowym połączeniu między przedsionkami, które fizjologicznie występuje w okresie płodowym, umożliwiając przepływ krwi z prawego do lewego przedsionka z pominięciem płuc. W prawidłowych warunkach otwór ten zamyka się w ciągu kilku miesięcy po urodzeniu, jednak u części osób pozostaje drożny przez całe życie.12

U większości osób z PFO ubytek ten jest bezobjawowy i nie wymaga leczenia. Jednak w niektórych przypadkach PFO może być związany z poważnymi powikłaniami, w tym przede wszystkim z udarem kryptogennym (o nieznanej przyczynie) na skutek zatorowości paradoksalnej, kiedy to skrzeplina z układu żylnego przedostaje się przez PFO do krążenia systemowego.34

Wskazania do leczenia przetrwałego otworu owalnego

W większości przypadków PFO nie wymaga żadnego leczenia. Istnieją jednak określone sytuacje kliniczne, w których należy rozważyć interwencję terapeutyczną:56

  • Przebyty udar mózgu kryptogenny (o nieznanej przyczynie), szczególnie u osób poniżej 60. roku życia
  • Obniżone stężenie tlenu we krwi (hipoksemia) związana z przeciekiem prawo-lewym przez PFO
  • Nawracające incydenty zatorowe mimo stosowania leczenia farmakologicznego
  • PFO z towarzyszącym tętniakiem przegrody międzyprzedsionkowej i/lub dużym przeciekiem

78

Wskazania do zamknięcia PFO są najsilniejsze u pacjentów z udarem kryptogennym, gdy wykluczono inne potencjalne przyczyny udaru, a PFO uznano za prawdopodobny mechanizm przebytego incydentu naczyniowego.910

Metody leczenia przetrwałego otworu owalnego

Dostępne są trzy główne strategie terapeutyczne w leczeniu PFO: farmakoterapia, przezskórne zamknięcie PFO oraz chirurgiczne zamknięcie ubytku.11

Leczenie farmakologiczne

Farmakoterapia stanowi podstawową metodę leczenia u pacjentów z PFO, którzy przebyli incydent naczyniowo-mózgowy lub są narażeni na zwiększone ryzyko powikłań zakrzepowo-zatorowych. Stosowane są dwa główne rodzaje leków:1213

1415

Wybór konkretnego leku zależy od indywidualnych czynników ryzyka pacjenta. Zgodnie z aktualnymi wytycznymi, leczenie przeciwpłytkowe jest zalecane u pacjentów z PFO po udarze niedokrwiennym mózgu lub przemijającym ataku niedokrwiennym (TIA), natomiast leczenie przeciwkrzepliwe preferowane jest u osób z towarzyszącą żylną chorobą zakrzepowo-zatorową.1617

Przezskórne zamknięcie PFO

Przezskórne zamknięcie PFO przy użyciu specjalnego okludera jest obecnie preferowaną metodą leczenia interwencyjnego u pacjentów kwalifikujących się do zamknięcia ubytku. Procedura ta charakteryzuje się wysoką skutecznością i niewielkim odsetkiem powikłań.1819

Zabieg wykonywany jest w pracowni hemodynamiki w znieczuleniu miejscowym, często z dodatkiem płytkiej sedacji. Procedura polega na:2021

  1. Wprowadzeniu cewnika przez żyłę udową do prawego przedsionka
  2. Przeprowadzeniu cewnika przez otwór owalny do lewego przedsionka
  3. Implantacji specjalnego urządzenia zamykającego (okludera) w miejscu ubytku
  4. Kontroli echokardiograficznej i fluoroskopowej prawidłowego położenia okludera

Dostępne są różne typy okluderów, w tym m.in. Amplatzer Talisman PFO Occluder oraz Gore Cardioform. Urządzenia te składają się zwykle z dwóch dysków połączonych krótkim łącznikiem, które obejmują brzegi ubytku z obu stron przegrody międzyprzedsionkowej.2223

Skuteczność techniczna zabiegu wynosi blisko 100%, a całkowite zamknięcie ubytku obserwuje się u 93-96% pacjentów po roku od implantacji. Z czasem okluder ulega endotelializacji (pokryciu tkanką serca), co zapewnia trwałe zamknięcie ubytku.2425

Najczęstszym powikłaniem po przezskórnym zamknięciu PFO jest migotanie przedsionków, które występuje u około 3,4% pacjentów, jednak zwykle jest przejściowe i ustępuje samoistnie.2627

Chirurgiczne zamknięcie PFO

Chirurgiczne zamknięcie PFO polega na bezpośrednim zszyciu ubytku podczas operacji kardiochirurgicznej. Metoda ta jest obecnie rzadko stosowana jako samodzielny zabieg z powodu swojej inwazyjności i dostępności mniej inwazyjnych metod przezskórnych.2829

Wskazania do chirurgicznego zamknięcia PFO obejmują:3031

  • Konieczność jednoczesnego wykonania innego zabiegu kardiochirurgicznego (np. operacji zastawki)
  • Anatomiczne uwarunkowania uniemożliwiające zamknięcie przezskórne
  • Niepowodzenie próby zamknięcia przezskórnego

Zabieg może być wykonany techniką klasyczną (operacja na otwartym sercu) lub technikami małoinwazyjnymi, w tym z wykorzystaniem robotyki.3233

Skuteczność chirurgicznego zamknięcia PFO w zapobieganiu nawrotom udaru jest porównywalna z metodą przezskórną, jednak wiąże się z dłuższym okresem rekonwalescencji i większym ryzykiem powikłań okołooperacyjnych.34

Efektywność leczenia przetrwałego otworu owalnego

Badania naukowe wskazują na wyższą skuteczność zabiegowego zamknięcia PFO w porównaniu z samą farmakoterapią w zapobieganiu nawrotom udaru mózgu u pacjentów z przebytym udarem kryptogennym i PFO.3536

Wyniki badań klinicznych

Liczne badania kliniczne potwierdziły korzyści z przezskórnego zamknięcia PFO u wybranych pacjentów:3738

  • Badanie RESPECT wykazało 45% redukcję ryzyka nawrotu udaru niedokrwiennego w grupie pacjentów z zamkniętym PFO w porównaniu do grupy leczonej farmakologicznie
  • Metaanaliza badań wskazuje, że zamknięcie PFO okluderem Amplatzer Talisman PFO Occluder zmniejsza ryzyko nawrotu udaru niedokrwiennego nawet o 97% w porównaniu do leczenia zachowawczego
  • Korzyści z zamknięcia PFO są szczególnie wyraźne u pacjentów poniżej 60. roku życia oraz u osób z wysokim wynikiem w skali RoPE (Risk of Paradoxical Embolism), który wskazuje na prawdopodobny związek przyczynowy między PFO a udarem

394041

Na podstawie tych wyników w 2016 roku Amerykańska Agencja ds. Żywności i Leków (FDA) zatwierdziła stosowanie okludera Amplatzer PFO do przezskórnego zamknięcia PFO w celu zmniejszenia ryzyka nawrotu udaru niedokrwiennego u pacjentów, którzy przebyli udar kryptogenny związany z PFO.42

Aktualne wskazania i wytyczne

Na podstawie dostępnych dowodów naukowych, aktualne wytyczne zalecają:434445

  • U pacjentów w wieku ≤60 lat z udarem kryptogennym i PFO (bez innej zidentyfikowanej przyczyny udaru) z przeciekiem prawo-lewym, zamknięcie przezskórne PFO dodatkowo do terapii przeciwpłytkowej jest zalecane
  • U pacjentów w wieku ≤60 lat z udarem kryptogennym i PFO, którzy wymagają operacji kardiochirurgicznej z innych powodów lub u których zamknięcie przezskórne nie jest technicznie możliwe, zalecane jest chirurgiczne zamknięcie PFO
  • U pacjentów w wieku ≤60 lat z udarem kryptogennym i PFO, zalecana jest terapia przeciwpłytkowa, z wyjątkiem wybranych pacjentów z ostrą zakrzepicą żył głębokich, zatorowością płucną lub inną chorobą zakrzepowo-zatorową, którzy powinni otrzymać leczenie przeciwkrzepliwe przez kilka miesięcy lub bezterminowo

Postępowanie po zamknięciu przetrwałego otworu owalnego

Po zabiegu przezskórnego zamknięcia PFO pacjent wymaga odpowiedniego postępowania w celu zminimalizowania ryzyka powikłań i zapewnienia optymalnego wyniku leczenia.4647

Leczenie farmakologiczne po zabiegu

Po zamknięciu PFO zalecane jest następujące leczenie farmakologiczne:4849

  • Podwójna terapia przeciwpłytkowa (kwas acetylosalicylowy + klopidogrel) przez pierwsze 1-6 miesięcy po zabiegu
  • Następnie monoterapia kwasem acetylosalicylowym przez kolejne 6-12 miesięcy lub dłużej
  • Antybiotykoterapia profilaktyczna przed zabiegami stomatologicznymi lub chirurgicznymi (obejmującymi układ moczowy, przewód pokarmowy lub płuca) przez 6 miesięcy po zamknięciu PFO

Dokładny schemat leczenia przeciwpłytkowego może się różnić w zależności od indywidualnych czynników ryzyka pacjenta oraz preferencji ośrodka wykonującego zabieg.50

Kontrola po zabiegu

Po zamknięciu PFO konieczne są regularne wizyty kontrolne, które obejmują:5152

  • Echokardiografię przezklatkową (TTE) wykonaną przed wypisem ze szpitala w celu potwierdzenia prawidłowego położenia okludera
  • Wizytę kontrolną u kardiologa interwencyjnego po około 1 miesiącu od zabiegu
  • Echokardiografię przezklatkową lub przezprzełykową (TEE) po 3-6 miesiącach w celu oceny położenia okludera i potencjalnego rezydualnego przecieku
  • Dalsze kontrole kardiologiczne zgodnie z zaleceniami lekarza prowadzącego

W ciągu pierwszego roku po zabiegu wskazane jest również unikanie intensywnego wysiłku fizycznego oraz sportów kontaktowych, które mogłyby prowadzić do przemieszczenia implantowanego urządzenia.53

Specjalne sytuacje kliniczne w leczeniu PFO

PFO a migrena

Istnieją dane sugerujące związek między PFO a migreną z aurą, jednak dowody na skuteczność zamknięcia PFO w leczeniu migreny są niewystarczające. Obecnie zamknięcie PFO nie jest zalecane jako leczenie pierwszego rzutu w przypadku migreny.5455

PFO a choroba dekompresyjna u nurków

U nurków z PFO istnieje zwiększone ryzyko choroby dekompresyjnej. Badania obserwacyjne wykazały, że zamknięcie PFO u nurków rekreacyjnych z przebytą chorobą dekompresyjną zmniejsza ryzyko nawrotu objawów neurologicznych i całkowitej liczby zmian w mózgu w porównaniu z osobami, które kontynuowały nurkowanie bez zamknięcia PFO.5657

PFO z hipoksemią

W rzadkich przypadkach PFO może prowadzić do znaczącej hipoksemii na skutek dużego przecieku prawo-lewego. W takich sytuacjach zamknięcie PFO jest uzasadnione, zwłaszcza gdy hipoksemia nie odpowiada na leczenie zachowawcze.5859

Podsumowanie podejścia do leczenia przetrwałego otworu owalnego

Decyzja o leczeniu PFO powinna być podejmowana indywidualnie dla każdego pacjenta, uwzględniając:6061

  • Wiek pacjenta (największe korzyści z zamknięcia PFO dotyczą osób ≤60 roku życia)
  • Obecność udaru kryptogennego w wywiadzie
  • Wynik w skali RoPE (wyższy wynik wskazuje na większe prawdopodobieństwo związku przyczynowego między PFO a udarem)
  • Anatomię PFO (wielkość ubytku, obecność tętniaka przegrody międzyprzedsionkowej, wielkość przecieku)
  • Obecność innych czynników ryzyka sercowo-naczyniowego
  • Ryzyko związane z długotrwałym leczeniem przeciwzakrzepowym

Optymalne postępowanie w przypadku pacjentów z PFO wymaga ścisłej współpracy interdyscyplinarnej między kardiologiem, neurologiem i pacjentem, aby wybrać najlepszą strategię terapeutyczną dostosowaną do indywidualnych potrzeb i preferencji każdego chorego.6263

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  1. 10.04.2026
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Materiały źródłowe

  • #1 Patent Foramen Ovale (PFO) | American Heart Association
    https://www.heart.org/en/health-topics/congenital-heart-defects/about-congenital-heart-defects/patent-foramen-ovale-pfo
    A hole in your heart would seem to be the very definition of a „problem.” Yet more than a quarter of the population has one type of hole in the heart, called a patent foramen ovale (PFO), and for most people it causes no adverse health effects. In fact, the vast majority of those affected don’t even know it. […] PFOs, on the other hand, are normal before birth but may fail to close after birth. The foramen ovale is a hole in the wall between the left and right atria of every human fetus. This hole allows blood to bypass the fetal lungs, which cannot work until air is inhaled after birth. […] When it remains open, it is called a patent foramen ovale (“patent” means “open”). […] For the vast majority of the millions of people with a PFO, it is not a problem, even though a small amount of blood can leak from the left to the right atrium, causing a slight increase in blood flowing to the lungs.
  • #2
    https://scholars.duke.edu/individual/pub1435014
    Patent foramen ovale (PFO) is a cardiac anatomic structure frequently found in the general population, with an estimated prevalence of 25%-30%. PFO has been linked to increased risk for thromboembolism, including ischemic systemic and cerebrovascular events. […] To decrease the risk of recurrent cerebrovascular events in this population, multiple treatment strategies, including medical therapy, device closure, and surgical repair, have been initiated and studied. […] Although data on the medical management of cryptogenic stroke in the setting of PFO are limited, the available evidence supports the notion that both aspirin (81-325 mg/day) and warfarin (international normalized ratio goal 2-3) decrease the risk of recurrent cryptogenic stroke in patients with PFO, with the latter potentially achieving lower recurrence rates.
  • #3 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.
  • #4
    https://scholars.duke.edu/individual/pub1435014
    Patent foramen ovale (PFO) is a cardiac anatomic structure frequently found in the general population, with an estimated prevalence of 25%-30%. PFO has been linked to increased risk for thromboembolism, including ischemic systemic and cerebrovascular events. […] To decrease the risk of recurrent cerebrovascular events in this population, multiple treatment strategies, including medical therapy, device closure, and surgical repair, have been initiated and studied. […] Although data on the medical management of cryptogenic stroke in the setting of PFO are limited, the available evidence supports the notion that both aspirin (81-325 mg/day) and warfarin (international normalized ratio goal 2-3) decrease the risk of recurrent cryptogenic stroke in patients with PFO, with the latter potentially achieving lower recurrence rates.
  • #5 Patent foramen ovale – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/patent-foramen-ovale/diagnosis-treatment/drc-20353491
    Most people with a patent foramen ovale don’t need treatment. If a PFO is found when an echocardiogram is done for other reasons, a procedure to close the hole usually isn’t done. […] When treatment for a PFO is needed, it may include: Medicines, A catheter procedure to close the hole, Surgery to close the hole. […] Your doctor may recommend medicines to try to reduce the risk of blood clots crossing a patent foramen ovale. Blood thinners may be helpful for some people with a patent foramen ovale who’ve had a stroke. […] If you have a PFO and low blood oxygen levels or an unexplained stroke, you may need a procedure to close the hole. […] Closure of a patent foramen ovale to prevent migraines isn’t currently recommended as the first treatment. Closure of a patent foramen ovale to prevent recurrent stroke is only done after care providers trained in heart and nervous system disorders have said that the procedure will help you.
  • #6 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    Many guidelines related to patent foramen ovale (PFO) are available, including the following: […] Most patients with a patent foramen ovale as an isolated finding receive no particular treatment. However, closure may prevent paradoxical embolism and reduce the risk of recurrent stroke. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) with right to left shunt, percutaneous PFO closure in addition to antiplatelet therapy is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) who require cardiac surgery (eg, valve surgery) or are not amenable to percutaneous closure for technical reasons, then surgical closure of PFO is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO, antiplatelet therapy is recommended, except selected patients with acute deep venous thrombosis, pulmonary embolism, or other venous thromboembolism, who are treated with anticoagulation for several months or indefinitely.
  • #7 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    Many guidelines related to patent foramen ovale (PFO) are available, including the following: […] Most patients with a patent foramen ovale as an isolated finding receive no particular treatment. However, closure may prevent paradoxical embolism and reduce the risk of recurrent stroke. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) with right to left shunt, percutaneous PFO closure in addition to antiplatelet therapy is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) who require cardiac surgery (eg, valve surgery) or are not amenable to percutaneous closure for technical reasons, then surgical closure of PFO is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO, antiplatelet therapy is recommended, except selected patients with acute deep venous thrombosis, pulmonary embolism, or other venous thromboembolism, who are treated with anticoagulation for several months or indefinitely.
  • #8 Patent foramen ovale – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/patent-foramen-ovale/diagnosis-treatment/drc-20353491
    Most people with a patent foramen ovale don’t need treatment. If a PFO is found when an echocardiogram is done for other reasons, a procedure to close the hole usually isn’t done. […] When treatment for a PFO is needed, it may include: Medicines, A catheter procedure to close the hole, Surgery to close the hole. […] Your doctor may recommend medicines to try to reduce the risk of blood clots crossing a patent foramen ovale. Blood thinners may be helpful for some people with a patent foramen ovale who’ve had a stroke. […] If you have a PFO and low blood oxygen levels or an unexplained stroke, you may need a procedure to close the hole. […] Closure of a patent foramen ovale to prevent migraines isn’t currently recommended as the first treatment. Closure of a patent foramen ovale to prevent recurrent stroke is only done after care providers trained in heart and nervous system disorders have said that the procedure will help you.
  • #9 Patent Foramen Ovale (PFO): Symptoms & Causes | NewYork-Presbyterian
    https://www.nyp.org/heart/congenital-heart-disease/patent-foramen-ovale-pfo
    Patent foramen ovale (PFO) is a flap-like opening in the heart between the upper chambers. […] PFO is when the hole fails to close. […] However, some people experience symptoms and complications of PFO, such as migraine headaches in adults and an increased risk of blood clots or stroke. […] Heart specialists dont often need to diagnose or treat PFO in healthy patients. […] ASDs often need to be repaired whereas patients with PFO dont often need treatment. […] NewYork-Presbyterian provides world-renowned pediatric and adult cardiovascular care. Our multidisciplinary teams specialize in a range of heart conditions, including congenital heart issues such as PFO, aortic disease, pulmonary hypertension, and valvular heart disease. […] Our exceptional cardiologists are familiar with the symptoms of patent foramen ovale, and can offer comprehensive diagnosis and treatment options for you or your child.
  • #10 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.
  • #11 Patent Foramen Ovale (PFO): Symptoms, Causes & Treatment
    https://my.clevelandclinic.org/health/diseases/17326-patent-foramen-ovale-pfo
    Patent foramen ovale (PFO) is a small hole between the upper right and left chambers (atria) of your heart. This hole may let blood flow between the atria. PFO often has no symptoms. Many people dont need treatment unless theyre at risk of stroke or blood clots. Treatments include medications and closure of the hole with a catheter or surgery. […] Most people with patent foramen ovale wont need treatment. But your provider may recommend treatment if you have a history or high risk of strokes or blood clots. Treatments for PFO include: Medication to prevent blood clots, such as aspirin or warfarin. Catheterization, where your interventional cardiologist closes the flap with a long, thin tube (catheter). Your surgeon inserts the catheter into the large vein in your groin and advances it through the blood vessel to your heart. Then, they use a closure device to seal the flap. Studies have found catheterization better than surgery for treating PFO if youre under 60 years old. Heart surgery, where your surgeon makes an incision and stitches the flap closed. They may suggest surgery if catheterization wasnt successful. Your surgeon may use open-heart surgery or minimally invasive robotically assisted patent foramen ovale repair. They perform this surgery through small incisions in your chest.
  • #12 Patent Foramen Ovale | UMass Memorial Health
    https://www.ummhealth.org/health-library/patent-foramen-ovale
    Most PFOs need no treatment. People who have no risk factors for stroke or any history of traveling blood clots often don’t get treatment. Your healthcare provider may want to treat your PFO if you have had problems from these traveling blood clots, such as a stroke. […] Choices include: […] Antiplatelet medicines, such as aspirin to help prevent blood clots […] Anticoagulant medicines, such as warfarin to help prevent blood clots […] Closure of the PFO with a catheter-based procedure. A catheter is a long, thin tube inserted through a vessel. […] Closure of the PFO during heart surgery […] Ask your provider what treatment plan is best for you. […] Some people receive treatment for a PFO, especially if they have had a stroke because of it. Treatment may include medicine, procedures, or surgery.
  • #13 Patent foramen ovale – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/patent-foramen-ovale/diagnosis-treatment/drc-20353491
    Most people with a patent foramen ovale don’t need treatment. If a PFO is found when an echocardiogram is done for other reasons, a procedure to close the hole usually isn’t done. […] When treatment for a PFO is needed, it may include: Medicines, A catheter procedure to close the hole, Surgery to close the hole. […] Your doctor may recommend medicines to try to reduce the risk of blood clots crossing a patent foramen ovale. Blood thinners may be helpful for some people with a patent foramen ovale who’ve had a stroke. […] If you have a PFO and low blood oxygen levels or an unexplained stroke, you may need a procedure to close the hole. […] Closure of a patent foramen ovale to prevent migraines isn’t currently recommended as the first treatment. Closure of a patent foramen ovale to prevent recurrent stroke is only done after care providers trained in heart and nervous system disorders have said that the procedure will help you.
  • #14
    https://scholars.duke.edu/individual/pub1435014
    Patent foramen ovale (PFO) is a cardiac anatomic structure frequently found in the general population, with an estimated prevalence of 25%-30%. PFO has been linked to increased risk for thromboembolism, including ischemic systemic and cerebrovascular events. […] To decrease the risk of recurrent cerebrovascular events in this population, multiple treatment strategies, including medical therapy, device closure, and surgical repair, have been initiated and studied. […] Although data on the medical management of cryptogenic stroke in the setting of PFO are limited, the available evidence supports the notion that both aspirin (81-325 mg/day) and warfarin (international normalized ratio goal 2-3) decrease the risk of recurrent cryptogenic stroke in patients with PFO, with the latter potentially achieving lower recurrence rates.
  • #15 Patent Foramen Ovale (PFO): Diagnosis & Treatment | NewYork-Presbyterian
    https://www.nyp.org/heart/congenital-heart-disease/patent-foramen-ovale-pfo/treatment
    People who dont experience symptoms from patent foramen ovale usually dont require treatment. However, for patients with PFO who have had blood clots, strokes, or other serious complications, certain medicines and surgical procedures may be recommended. […] The most common treatments for patent foramen ovale are: […] Medications – Antiplatelets and anticoagulants (blood thinners) can be prescribed to help prevent blood clots […] Surgical closure with cardiac catheterization – The PFO hole can be closed by inserting a thin, flexible tube (catheter) through a blood vessel in the groin and up to the heart. The catheter has a small device on its tip used to plug up the hole. Surgical repair of the PFO is not often required, unless the surgery is done to repair another issue at the same time.
  • #16 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    Many guidelines related to patent foramen ovale (PFO) are available, including the following: […] Most patients with a patent foramen ovale as an isolated finding receive no particular treatment. However, closure may prevent paradoxical embolism and reduce the risk of recurrent stroke. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) with right to left shunt, percutaneous PFO closure in addition to antiplatelet therapy is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) who require cardiac surgery (eg, valve surgery) or are not amenable to percutaneous closure for technical reasons, then surgical closure of PFO is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO, antiplatelet therapy is recommended, except selected patients with acute deep venous thrombosis, pulmonary embolism, or other venous thromboembolism, who are treated with anticoagulation for several months or indefinitely.
  • #17 Management of Patent Foramen Ovale | USC Journal
    https://www.uscjournal.com/articles/update-management-patent-foramen-ovale-2017-indication-closure-and-literature-review?language_content_entity=en
    The updated 2014 American Heart Association/American Stroke Association (AHA/ASA) guidelines have a Class I, Level of Evidence (LOE) B indication for antiplatelet therapy in ischemic stroke/TIA patients with a PFO as well as a Class I, LOE A for anticoagulation in patients with an ischemic stroke/ TIA with a PFO and an established PFO. […] Despite medical therapy, the stroke recurrence rate in ischemia stroke patients with PFO is estimated at 4.5 % within a 4-year period. […] Therefore, in addition to medical therapy, the utility of secondary preventative treatment options such as percutaneous PFO closure has been a topic of debate. […] Observational data, including meta-analysis of observational studies on PFO closure therapy, point to the safety and low stroke recurrence rate compared to medical treatment alone.
  • #18 Patent foramen ovale – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/patent-foramen-ovale/diagnosis-treatment/drc-20353491
    Procedures to close a patent foramen ovale include: Device closure. In this procedure, the provider inserts a thin, flexible tube called a catheter into a blood vessel in the groin area. The catheter tip has a device to plug the PFO. The provider guides the equipment to the heart to close the opening. […] Surgical closure. In this heart surgery, the surgeon uses stitches to close the PFO. This surgery can be done using a very small incision. It may be done using robotic techniques.
  • #19 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    Primary technical success approaches 100% and complete closure is seen in 93-96% at one year. […] Individual randomised data show a relative risk reduction of up to 80% for recurrent strokes. […] The most frequent undesirable event following transcatheter percutaneous closure is AF in RCTs and observational trials. […] There are no current indications for surgical closure of a PFO as first-line treatment. […] PFO closure may be considered when there is the need for only temporary OAC or a high risk of recurrence despite permanent OAC. […] The management of patients with cryptogenic left circulation thromboembolism and PFO has been controversial, giving rise to heterogeneous strategies across different local realms in Europe.
  • #20 Patent Foramen Ovale Treatments | Northwestern Medicine
    https://www.nm.org/conditions-and-care-areas/neurosciences/comprehensive-stroke-centers/patent-foramen-ovale-pfo/treatments
    PFO treatments decrease the risk of stroke. The main treatment options include: Medication such as anticoagulants (blood thinners). They thin the blood to prevent blood clots. Minimally invasive catheter-based procedures to close the PFO. People who do not respond to medication may need a minimally invasive, catheter-based procedure. Your interventional cardiologist closes the PFO with a small closure device. This is done in a cardiac catheterization (cath) laboratory. During a PFO closure procedure, your physician inserts a flexible catheter or tiny tube into your body. They advance the catheter to your heart. There, your physician moves the catheter through the PFO. Next, they open and place the closure device. The closure device looks like two tiny umbrellas on either side of the PFO, blocking blood from passing through the PFO. The closure device will stay in your heart. The catheter will be removed. Over time, tissue grows in and around the closure device. This seals the PFO. A catheter-based procedure is less invasive than surgery. Your physician does minimally invasive, catheter-based procedures while your heart is beating. This takes away the need for a heart bypass machine and its risks. Patients treated with catheter-based procedures tend to heal quickly, within weeks compared to months. Their symptoms also improve much sooner. Traditional open-heart surgery is not often used for patients with PFO. Scientists are studying if implanted closure devices work better than medications to reduce the risk of recurrent stroke in patients who have had a stroke or TIA.
  • #21 Patent Foramen Ovale (PFO) | Conditions | UCSF Health
    https://www.ucsfhealth.org/conditions/patent-foramen-ovale-pfo
    A patent foramen ovale doesn’t need treatment unless it has caused a problem like a stroke or a TIA. In these cases, your doctor will recommend closing your PFO to reduce the risk of subsequent events. […] Minimally invasive PFO closures are performed by interventional cardiologists (cardiologists who specialize in catheter-based diagnoses and treatments) in our cardiac catheterization lab. You are sedated but not completely asleep during the procedure, which takes about an hour. The doctor makes a small incision in a large vein in your groin and then inserts a catheter (a long, thin, flexible tube) with a closure device on the tip. Guided by X-ray and ultrasound imaging, the doctor threads the catheter through blood vessels to reach the PFO. They then place the closure device over the PFO to permanently seal the opening between the two chambers. Once this repair is complete, the doctor removes the catheter. Following the procedure, your care team will monitor you in the recovery area for approximately four to six hours. Most people go home the same day. Before discharge, you’ll have another echocardiogram to check that the closure device is in the right place.
  • #22 Patent Foramen Ovale Treatment | PFO Closure
    https://www.structuralheart.abbott/patients/treatment/hole-in-heart-pfo-closure
    If you have had a stroke of unknown cause and have also been diagnosed with a patent foramen ovale (PFO) you may have had a PFO-associated stroke. For people with a PFO-associated stroke, PFO closure with the Amplatzer Talisman PFO Occluder is a treatment option to reduce the risk of another stroke. […] Your doctor can describe the risks and benefits and help you decide which option is right for you. […] A PFO occluder is a device that can be placed in your heart close to the PFO through a minimally-invasive, catheter-based technique, and is designed to stop blood flow through the PFO. […] With the Amplatzer Talisman PFO Occluder, your doctor may be able to significantly reduce the risk of stroke recurrence. Researched extensively in clinical trials, the Amplatzer Talisman PFO Occluder has shown up to a 97% relative risk reduction for recurrent ischemic stroke when compared to medical management therapy.
  • #23
    https://childrenshealth.congenital.org/?id=pfo3
    Because of the increased risk of stroke in persons with a PFO, treatment with anticoagulant (blood-thinning) medications such as aspirin and warfarin may be prescribed. However, there is evidence that the embolism occurs through the opening itself. Therefore, direct closure of the PFO is being increasingly performed in selected patients – especially those with a history of recurrent unexplained strokes due to presumed paradoxical embolism and where pharmaceutical treatment has been ineffective. […] PFO closure may be achieved through open heart surgery or through a transcatheter procedure using an occlusion device. The surgical approach involves the closing of the PFO with a double-continuous suture. This procedure is expensive and invasive and often painful. Therefore, the transcatheter approach is used whenever possible.
  • #24 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    Primary technical success approaches 100% and complete closure is seen in 93-96% at one year. […] Individual randomised data show a relative risk reduction of up to 80% for recurrent strokes. […] The most frequent undesirable event following transcatheter percutaneous closure is AF in RCTs and observational trials. […] There are no current indications for surgical closure of a PFO as first-line treatment. […] PFO closure may be considered when there is the need for only temporary OAC or a high risk of recurrence despite permanent OAC. […] The management of patients with cryptogenic left circulation thromboembolism and PFO has been controversial, giving rise to heterogeneous strategies across different local realms in Europe.
  • #25
    https://childrenshealth.congenital.org/?id=pfo3
    Devices used for PFO closure include the Amplatzer PFO occluder, and the CardioSeal or Helex devices. […] The transcatheter PFO occlusion procedure normally takes from 2 to 4 hours and is performed in a catheterization laboratory. The catheter is inserted in the femoral vein in the groin area, which is numbed with a local anesthetic. Sometimes, general anesthesia or sedation by IV is prescribed. […] It is very rare for the body to react negatively to the occlusion device. A few days after the procedure, the patient’s own body tissues will begin to envelope the closure device, a process which is usually complete within 6 months. Even though the PFO is closed by the device, patients are maintained on warfarin and/or aspirin because of the risk of recurrent stroke.
  • #26 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    The rate of recurrent stroke following surgical closure is 7-14% at 1-2 years. This is similar to that of percutaneous device closure of PFO. […] The most common complication of PFO device closure is new onset atrial fibrillation. PFO closure increases risk of atrial fibrillation or atrial flutter by 3.4% in one of the meta-analysis.
  • #27 Patent Foramen Ovale Treatment | University of Utah Health
    https://healthcare.utah.edu/cardiovascular/conditions/patent-foramen-ovale
    The PFO closure device stays in your heart long-term. Eventually, your own heart tissue grows around the device. The PFO closure procedure is extremely successful, with success rates of up to 99%. […] Very rarely, some people experience atrial fibrillation, or periods of irregular heartbeats, after PFO closure. Clinical trials have shown that these heart palpitations usually go away after a short period. Heart flutters after PFO closure only affect about 2% to 3% of patients. […] Our PFO Clinic combines the expertise of interventional cardiologists and vascular neurologists who work together to determine whether you need a PFO closure after having a stroke. We follow national guidelines and aim to provide you with the most effective treatment. You will meet with both of these specialists in one convenient visit. We will discuss all treatment options with you and provide evidence-based recommendations.
  • #28
    https://scholars.duke.edu/individual/pub1435014
    Surgical closure of PFO appears to be a safe approach; nevertheless, conflicting data exist regarding the efficacy of elimination of an interatrial shunt, and a valid concern for recurrent cerebrovascular events remains. […] As no direct comparison is currently available between the three main management approaches, there are no clear advantages of surgery over medical therapy or over percutaneous device closure. […] Accordingly, a surgical approach should be considered as the last therapeutic option, limited to select patients who sustained cryptogenic stroke with a high risk of recurrent events in whom both device closure and medical therapy have failed or are contraindicated.
  • #29 Treatment | SCAI – Seconds Count
    https://www.secondscount.org/condition/patent-foramen-ovale-pfo/treatment
    A less invasive option for closing the PFO is using a small occluder device inserted into the heart through a vein, known as a transcatheter closure of the PFO. […] While surgical repair of a PFO is feasible and effective, its rarely done as a stand-alone procedure because its an invasive surgerygenerally known as open heart surgery.
  • #30 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    If a patient experiences recurrent cryptogenic embolic stroke while on antiplatelet therapy and PFO was not closed, suggest PFO closure. […] Isolated patent foramen ovale (PFO) with no associated symptoms requires no treatment or follow-up. […] Antiplatelet therapy rather anticoagulation therapy is recommended for patients with PFO that is not closed with device in presence of ischemic stroke or transient ischemic attack. Antiplatelet therapy also is recommended for patients with PFO that is closed with device in presence of ischemic stroke or transient ischemic attack. […] Anticoagulation therapy is recommended for patients with PFO who are at high risk for venous thromboembolism and/or presence of acute deep venous thrombosis, pulmonary embolism. […] For patients aged 60 years or younger with PFO with cryptogenic embolic stroke who need cardiac surgery (ie, valve surgery or PFO that is not amenable to device closure for technical reasons), surgical closure via standard or minimally invasive (robotic) is a reasonable approach.
  • #31 Patent Foramen Ovale
    https://mydoctor.kaiserpermanente.org/mas/structured-content/Condition_Patent_Foramen_Ovale_-_CV_Surgery.xml?co=/regions/mas
    We may recommend closing the hole with surgery or a procedure. We do this if you: […] Suffer from a second stroke of unknown cause despite taking blood-thinning medication. […] Have low blood oxygen. This can happen because too much blood is passing from the right side of the heart to the left without picking up oxygen in the lungs. […] If you’re already having another type of heart surgery, we can close a PFO at the same time. […] These are the treatment options for closing a PFO. […] We may stitch the foramen ovale closed during open-heart surgery to repair other, more serious heart problems or defects. We may close the opening using robotic devices inserted into the chest through a small incision. […] Possible complications of open-heart surgery include infections and bleeding. Catheter-based procedures have largely replaced the use of open-heart surgery to close a PFO.
  • #32 Patent foramen ovale – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/patent-foramen-ovale/diagnosis-treatment/drc-20353491
    Procedures to close a patent foramen ovale include: Device closure. In this procedure, the provider inserts a thin, flexible tube called a catheter into a blood vessel in the groin area. The catheter tip has a device to plug the PFO. The provider guides the equipment to the heart to close the opening. […] Surgical closure. In this heart surgery, the surgeon uses stitches to close the PFO. This surgery can be done using a very small incision. It may be done using robotic techniques.
  • #33 Patent Foramen Ovale (PFO): Symptoms, Causes & Treatment
    https://my.clevelandclinic.org/health/diseases/17326-patent-foramen-ovale-pfo
    Patent foramen ovale (PFO) is a small hole between the upper right and left chambers (atria) of your heart. This hole may let blood flow between the atria. PFO often has no symptoms. Many people dont need treatment unless theyre at risk of stroke or blood clots. Treatments include medications and closure of the hole with a catheter or surgery. […] Most people with patent foramen ovale wont need treatment. But your provider may recommend treatment if you have a history or high risk of strokes or blood clots. Treatments for PFO include: Medication to prevent blood clots, such as aspirin or warfarin. Catheterization, where your interventional cardiologist closes the flap with a long, thin tube (catheter). Your surgeon inserts the catheter into the large vein in your groin and advances it through the blood vessel to your heart. Then, they use a closure device to seal the flap. Studies have found catheterization better than surgery for treating PFO if youre under 60 years old. Heart surgery, where your surgeon makes an incision and stitches the flap closed. They may suggest surgery if catheterization wasnt successful. Your surgeon may use open-heart surgery or minimally invasive robotically assisted patent foramen ovale repair. They perform this surgery through small incisions in your chest.
  • #34 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    The rate of recurrent stroke following surgical closure is 7-14% at 1-2 years. This is similar to that of percutaneous device closure of PFO. […] The most common complication of PFO device closure is new onset atrial fibrillation. PFO closure increases risk of atrial fibrillation or atrial flutter by 3.4% in one of the meta-analysis.
  • #35 Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
    https://ctv.veeva.com/study/medical-treatment-with-or-without-transcatheter-patent-foramen-ovale-closure
    Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. […] Several studies have provided promising preliminary data regarding PFO closure in older patients with cryptogenic stroke, with very low stroke recurrence rates at mid- to long-term follow-up. […] Several randomized trials have shown the beneficial effects of PFO closure vs. medical treatment in patients younger than 60 years with cryptogenic stroke and PFO. […] Current observational data suggest similar or even more marked effects on stroke recurrence prevention of PFO closure in older patients and would support the design of a randomized trial to provide definite evidence in this field. […] Therefore, the objective of the present study is to evaluate the efficacy of transcatheter PFO closure for preventing recurrent ischemic stroke (nonlacunar) events in patients 60 years diagnosed with a cryptogenic stroke and PFO.
  • #36 Patent Foramen Ovale (PFO) Procedure – Cheyenne Regional Medical Center
    https://www.cheyenneregional.org/service/heart-vascular-services/heart-vascular-treatment-options/patent-foramen-ovale-pfo/
    The U.S. Food and Drug Administration has approved transcatheter closure of PFOs to treat patients who have had a cryptogenic stroke. Studies show that PFO closure is superior to medications alone in preventing a second stroke. […] When a PFO is found in someone who has suffered a cryptogenic stroke, the PFO is often determined to be the cause after ruling out other competing causes.
  • #37 Evaluating Therapies to Prevent Future Stroke in Patients with Patent Foramen Ovale-Related Strokes — The SCOPE Study | PCORI
    https://www.pcori.org/research-results/2019/evaluating-therapies-prevent-future-stroke-patients-patent-foramen-ovale-related-strokes-scope-study
    A patent foramen ovale, or PFO, is a small hole between the top two chambers of the heart that didnt close correctly after birth. PFOs can raise the risk for stroke. For adults ages 1860, about 10 percent of strokes caused by a blocked artery are related to a PFO. Among these patients, questions remain about what treatment works best to prevent future strokes. […] In this study, the research team analyzed data from six clinical trials to compare two treatments for preventing future strokes among patients who had experienced a PFO-related stroke: […] Patients take medicines to prevent blood clots. […] A doctor inserts a medical device through a vein to the PFO. The device closes the PFO and remains in the heart permanently. Patients also take medicines to prevent blood clots. […] Compared with patients who took medicines alone, patients who also had surgery had a lower risk of future strokes.
  • #38 Patent Foramen Ovale (PFO) Closure: Procedure & Indications
    https://www.icrjournal.com/articles/patent-foramen-ovale-closure-state-art?language_content_entity=en
    Nonetheless, further randomised trials learned lessons from earlier neutral studies and have demonstrated that PFO closure is superior to medical therapy for the prevention of recurrent stroke. Early results from the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial were neutral for PFO closure but extended follow up of patients demonstrated a reduction in ischaemic stroke compared to medical therapy (HR 0.55; 95% CI [0.310.999]; p=0.046; number needed to treat [NNT] 45). […] The strict criteria of these studies are important and should be respected in clinical practice. There is little or no evidence for treatment of PFO outside these criteria, and there is no symptomatic benefit to closure in patients with cryptogenic stroke. Patients who meet trial criteria for closure should be considered for this treatment in preference to medical therapy.
  • #39 Evaluating Therapies to Prevent Future Stroke in Patients with Patent Foramen Ovale-Related Strokes — The SCOPE Study | PCORI
    https://www.pcori.org/research-results/2019/evaluating-therapies-prevent-future-stroke-patients-patent-foramen-ovale-related-strokes-scope-study
    Patients whose PFO was likely the cause of their stroke had a lower risk of future strokes with surgery plus medicines than with medicine alone, compared with patients whose PFO was not likely the cause of their stroke, based on the scoring systems. […] Patients who had surgery had a higher risk of irregular heartbeat events within 45 days of surgery. But most patients heartbeats went back to normal over time. Other safety outcomes like bleeding or blood clots didnt differ between the two treatments. […] Patients who had a PFO-related stroke and their doctors can use these results when considering treatments for preventing future strokes. […] This individual participant-level data meta-analysis compared the effectiveness and safety of medical therapy alone versus PFO closure plus medical therapy in preventing recurrent stroke in patients with PFO-associated cerebral ischemic events.
  • #40 Patent Foramen Ovale Treatment | PFO Closure
    https://www.structuralheart.abbott/patients/treatment/hole-in-heart-pfo-closure
    If you have had a stroke of unknown cause and have also been diagnosed with a patent foramen ovale (PFO) you may have had a PFO-associated stroke. For people with a PFO-associated stroke, PFO closure with the Amplatzer Talisman PFO Occluder is a treatment option to reduce the risk of another stroke. […] Your doctor can describe the risks and benefits and help you decide which option is right for you. […] A PFO occluder is a device that can be placed in your heart close to the PFO through a minimally-invasive, catheter-based technique, and is designed to stop blood flow through the PFO. […] With the Amplatzer Talisman PFO Occluder, your doctor may be able to significantly reduce the risk of stroke recurrence. Researched extensively in clinical trials, the Amplatzer Talisman PFO Occluder has shown up to a 97% relative risk reduction for recurrent ischemic stroke when compared to medical management therapy.
  • #41 Management of Patent Foramen Ovale | USC Journal
    https://www.uscjournal.com/articles/update-management-patent-foramen-ovale-2017-indication-closure-and-literature-review?language_content_entity=en
    The Closure I trial evaluated the STARFlex PFO closure system against the administration of warfarin, aspirin, or combined aspirin and warfarin. The Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial compared the AMPLATZER PFO Occluder with four treatment regimens: monotherapy with warfarin, aspirin or clopidogrel, or a combination of aspirin with extended-release dipyridamole. […] The final long-term results of the RESPECT trial were presented at the 2016 Transcatheter Technologies Annual Scientific Meeting in Washington, DC, and have since been published. […] In October 2016, the US Food and Drug Administration approved the AMPLATZER PFO Occluder for percutaneous transcatheter PFO closure to reduce the risk of recurrent ischemic stroke in patients, predominantly between 18 and 60 years, who have had a cryptogenic stroke due to presumed paradoxical embolism, as determined by a neurologist and cardiologist following evaluation excluding all other known causes of ischemic stroke. […] These three trials have shown exciting, encouraging and compelling evidence that PFO closure reduces the risk of recurrent stroke and provide strong supportive data for the ongoing debate on PFO closure in cryptogenic stroke.
  • #42 Management of Patent Foramen Ovale | USC Journal
    https://www.uscjournal.com/articles/update-management-patent-foramen-ovale-2017-indication-closure-and-literature-review?language_content_entity=en
    The Closure I trial evaluated the STARFlex PFO closure system against the administration of warfarin, aspirin, or combined aspirin and warfarin. The Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial compared the AMPLATZER PFO Occluder with four treatment regimens: monotherapy with warfarin, aspirin or clopidogrel, or a combination of aspirin with extended-release dipyridamole. […] The final long-term results of the RESPECT trial were presented at the 2016 Transcatheter Technologies Annual Scientific Meeting in Washington, DC, and have since been published. […] In October 2016, the US Food and Drug Administration approved the AMPLATZER PFO Occluder for percutaneous transcatheter PFO closure to reduce the risk of recurrent ischemic stroke in patients, predominantly between 18 and 60 years, who have had a cryptogenic stroke due to presumed paradoxical embolism, as determined by a neurologist and cardiologist following evaluation excluding all other known causes of ischemic stroke. […] These three trials have shown exciting, encouraging and compelling evidence that PFO closure reduces the risk of recurrent stroke and provide strong supportive data for the ongoing debate on PFO closure in cryptogenic stroke.
  • #43 Patent Foramen Ovale Treatment & Management: Approach Considerations, Medical Care, Surgical Care
    https://emedicine.medscape.com/article/156863-treatment
    Many guidelines related to patent foramen ovale (PFO) are available, including the following: […] Most patients with a patent foramen ovale as an isolated finding receive no particular treatment. However, closure may prevent paradoxical embolism and reduce the risk of recurrent stroke. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) with right to left shunt, percutaneous PFO closure in addition to antiplatelet therapy is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO (no other source of stroke) who require cardiac surgery (eg, valve surgery) or are not amenable to percutaneous closure for technical reasons, then surgical closure of PFO is recommended. […] In patients who are 60 years of age with cryptogenic embolic stroke and PFO, antiplatelet therapy is recommended, except selected patients with acute deep venous thrombosis, pulmonary embolism, or other venous thromboembolism, who are treated with anticoagulation for several months or indefinitely.
  • #44 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.
  • #45 SCAI Issues Official Guidelines for the Management of Patent Foramen Ovale | SCAI
    https://scai.org/scai-issues-official-guidelines-management-patent-foramen-ovale
    SCAI Issues Official Guidelines for the Management of Patent Foramen Ovale. A multidisciplinary guideline panel formulated 13 recommendations to address five PFO clinical scenarios. In most cases, PFO is benign and requires no treatment. However, it can cause serious complications under certain circumstances. These guidelines address five different scenarios where patients and clinicians may consider additional management of a PFO, including the following: […] Percutaneous PFO closure versus medical therapy (antiplatelet or anticoagulation or composite)/no therapy in adults without a prior PFO-associated stroke […] Percutaneous PFO closure versus antiplatelet therapy in adults with a prior PFO-associated stroke […] Percutaneous PFO closure versus anticoagulation therapy in adults with a prior PFO-associated stroke
  • #46 Patent Foramen Ovale (PFO) | Conditions | UCSF Health
    https://www.ucsfhealth.org/conditions/patent-foramen-ovale-pfo
    You’ll have a follow-up visit with the interventional cardiologist about one month after your procedure. You’ll also have regular checkups with your primary care provider and local cardiologist. To help prevent blood clots and reduce your stroke risk, you’ll need to take a daily aspirin for six months to a year and another blood-thinning medication for at least six months. For six months after the procedure, you’ll also need to take antibiotics anytime you have dental work or if you have surgery involving your bladder, stomach or lungs. During your clinic visit before the procedure, your doctor will provide you with more detailed follow-up information.
  • #47 Patent Foramen Ovale (PFO) Closure: What to Expect at Home | Kaiser Permanente
    https://healthy.kaiserpermanente.org/health-wellness/health-encyclopedia/he.patent-foramen-ovale-pfo-closure-what-to-expect-at-home.aco3375
    Your patent foramen ovale (PFO) closure was done to close a small hole in the area that separates the upper right and left chambers (atria) of the heart. The procedure can help prevent a stroke in some people. Your doctor used a thin, flexible tube called a catheter to place a small device that closes the PFO. […] Within the coming year, you will likely have follow-up tests to check that the device has closed off the PFO. […] Your doctor will likely prescribe a medicine that prevents blood clots. Be sure to get instructions about how to take your medicine safely. These medicines can cause serious bleeding problems. […] For 6 months after having the PFO closure, be sure to tell all of your doctors and your dentist that you have the device in your heart. This is important because you may need to take antibiotics before certain procedures to prevent infection. […] Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems.
  • #48 Patent Foramen Ovale (PFO) Closure
    https://my.clevelandclinic.org/health/procedures/pfo-closure
    Some researchers say a PFO closure doesnt reduce your stroke risk much more than medication. But others have found that having a catheter-based procedure for PFO closure and taking blood-thinning drugs like aspirin gives people a lower rate of stroke than people who received only aspirin. People who had a PFO closure had a risk of stroke at least 45% lower than people who took the medicine but didnt have a procedure.
  • #49 Patent Foramen Ovale (PFO) | Conditions | UCSF Health
    https://www.ucsfhealth.org/conditions/patent-foramen-ovale-pfo
    You’ll have a follow-up visit with the interventional cardiologist about one month after your procedure. You’ll also have regular checkups with your primary care provider and local cardiologist. To help prevent blood clots and reduce your stroke risk, you’ll need to take a daily aspirin for six months to a year and another blood-thinning medication for at least six months. For six months after the procedure, you’ll also need to take antibiotics anytime you have dental work or if you have surgery involving your bladder, stomach or lungs. During your clinic visit before the procedure, your doctor will provide you with more detailed follow-up information.
  • #50 SCAI Issues Official Guidelines for the Management of Patent Foramen Ovale | SCAI
    https://scai.org/scai-issues-official-guidelines-management-patent-foramen-ovale
    Percutaneous PFO closure plus lifelong anticoagulation versus anticoagulation alone in adults with a prior PFO-associated stroke […] Post-procedure management of patients undergoing percutaneous PFO closure with a regimen of one (1) month of aspirin plus clopidogrel followed by five (5) months of aspirin versus another antiplatelet regimen or anticoagulation. This document represents the first truly rigorous guideline document put forth by the SCAI to lend clarity to a field surrounded by controversy and aid in physician decision making for PFO associated conditions.
  • #51 Patent Foramen Ovale (PFO) | Conditions | UCSF Health
    https://www.ucsfhealth.org/conditions/patent-foramen-ovale-pfo
    You’ll have a follow-up visit with the interventional cardiologist about one month after your procedure. You’ll also have regular checkups with your primary care provider and local cardiologist. To help prevent blood clots and reduce your stroke risk, you’ll need to take a daily aspirin for six months to a year and another blood-thinning medication for at least six months. For six months after the procedure, you’ll also need to take antibiotics anytime you have dental work or if you have surgery involving your bladder, stomach or lungs. During your clinic visit before the procedure, your doctor will provide you with more detailed follow-up information.
  • #52 Patent Foramen Ovale (PFO) Closure: What to Expect at Home | Kaiser Permanente
    https://healthy.kaiserpermanente.org/health-wellness/health-encyclopedia/he.patent-foramen-ovale-pfo-closure-what-to-expect-at-home.aco3375
    Your patent foramen ovale (PFO) closure was done to close a small hole in the area that separates the upper right and left chambers (atria) of the heart. The procedure can help prevent a stroke in some people. Your doctor used a thin, flexible tube called a catheter to place a small device that closes the PFO. […] Within the coming year, you will likely have follow-up tests to check that the device has closed off the PFO. […] Your doctor will likely prescribe a medicine that prevents blood clots. Be sure to get instructions about how to take your medicine safely. These medicines can cause serious bleeding problems. […] For 6 months after having the PFO closure, be sure to tell all of your doctors and your dentist that you have the device in your heart. This is important because you may need to take antibiotics before certain procedures to prevent infection. […] Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems.
  • #53 Patent Foramen Ovale Treatment | University of Utah Health
    https://healthcare.utah.edu/cardiovascular/conditions/patent-foramen-ovale
    The PFO closure device stays in your heart long-term. Eventually, your own heart tissue grows around the device. The PFO closure procedure is extremely successful, with success rates of up to 99%. […] Very rarely, some people experience atrial fibrillation, or periods of irregular heartbeats, after PFO closure. Clinical trials have shown that these heart palpitations usually go away after a short period. Heart flutters after PFO closure only affect about 2% to 3% of patients. […] Our PFO Clinic combines the expertise of interventional cardiologists and vascular neurologists who work together to determine whether you need a PFO closure after having a stroke. We follow national guidelines and aim to provide you with the most effective treatment. You will meet with both of these specialists in one convenient visit. We will discuss all treatment options with you and provide evidence-based recommendations.
  • #54 Patent foramen ovale – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/patent-foramen-ovale/diagnosis-treatment/drc-20353491
    Most people with a patent foramen ovale don’t need treatment. If a PFO is found when an echocardiogram is done for other reasons, a procedure to close the hole usually isn’t done. […] When treatment for a PFO is needed, it may include: Medicines, A catheter procedure to close the hole, Surgery to close the hole. […] Your doctor may recommend medicines to try to reduce the risk of blood clots crossing a patent foramen ovale. Blood thinners may be helpful for some people with a patent foramen ovale who’ve had a stroke. […] If you have a PFO and low blood oxygen levels or an unexplained stroke, you may need a procedure to close the hole. […] Closure of a patent foramen ovale to prevent migraines isn’t currently recommended as the first treatment. Closure of a patent foramen ovale to prevent recurrent stroke is only done after care providers trained in heart and nervous system disorders have said that the procedure will help you.
  • #55 Patent Foramen Ovale (PFO) Closure: Procedure & Indications
    https://www.icrjournal.com/articles/patent-foramen-ovale-closure-state-art?language_content_entity=en
    A longitudinal, non-randomised follow-up study showed that PFO closure reduced both symptomatic neurological events and total brain lesions among recreational divers with PFO and decompression illness, compared with those who continued to dive without closure. […] The evidence for PFO closure is not strong enough to offer a routine recommendation for PFO closure in migraine with aura. […] The procedure can be undertaken in a standard catheter laboratory using fluoroscopic guidance and physiological monitoring. Patients undergoing this procedure will have a reduced long-term risk of stroke, but obtain no immediate symptomatic benefit from this procedure. Therefore, all possible steps to reduce complications should be taken. […] The procedure is undertaken from the femoral vein with ultrasound guidance for the puncture. Adequate anticoagulation (unfractionated heparin 80100 IU/kg) should be administered. […] The evidence base for its use is therefore very strong.
  • #56 Patent Foramen Ovale (PFO) Closure: Procedure & Indications
    https://www.icrjournal.com/articles/patent-foramen-ovale-closure-state-art?language_content_entity=en
    A longitudinal, non-randomised follow-up study showed that PFO closure reduced both symptomatic neurological events and total brain lesions among recreational divers with PFO and decompression illness, compared with those who continued to dive without closure. […] The evidence for PFO closure is not strong enough to offer a routine recommendation for PFO closure in migraine with aura. […] The procedure can be undertaken in a standard catheter laboratory using fluoroscopic guidance and physiological monitoring. Patients undergoing this procedure will have a reduced long-term risk of stroke, but obtain no immediate symptomatic benefit from this procedure. Therefore, all possible steps to reduce complications should be taken. […] The procedure is undertaken from the femoral vein with ultrasound guidance for the puncture. Adequate anticoagulation (unfractionated heparin 80100 IU/kg) should be administered. […] The evidence base for its use is therefore very strong.
  • #57
    https://www.aurorahealthcare.org/services/heart-vascular/conditions/patent-foramen-ovale
    Most of the time, you dont need to do anything about PFO. If you do need treatment, we often can repair the hole with a minimally invasive procedure. […] The good news is that we often dont need to close the patent foramen ovale or provide any other treatment. You can enjoy a completely normal, active and healthy life. But sometimes, your doctor may recommend PFO heart treatment. This might include: Cardiac catheterization: In this minimally invasive PFO heart treatment procedure, your doctor uses a specialized, thin tube called a catheter to close the hole with a small device. […] Surgery: If youre already having heart surgery for another reason, your surgeon may close the hole at the same time. […] Lifestyle changes: Your doctor will let you know if you should: Avoid activities that could limit your oxygen level, like traveling to high altitudes. Be careful when scuba diving as youre more likely to develop decompression sickness.
  • #58 Mayo Clinic Q and A: Treatment for patent foramen ovale – Mayo Clinic News Network
    https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-treatment-for-patent-foramen-ovale/
    A patient who has persistent low blood oxygen due to shunt through a patent foramen ovale also may benefit from closure. […] Closing a patent foramen ovale typically involves placing a device in the hole to hold the flap together. […] A less common approach involves a surgeon closing a patent foramen ovale by opening the heart and stitching the hole shut. […] Usually, however, these procedures are not necessary. If you are concerned about possible risks that could be associated with this heart defect, talk to your health care provider. But be reassured that a patent foramen ovale is harmless in most cases.
  • #59
    https://www.singhealth.com.sg/patient-care/conditions-treatments/patent-foramen-ovale
    Patent foramen ovale (PFO) can be closed by inserting a device through the blood vessels in the groin (percutaneous transcatheter approach). […] In certain circumstances, however, the doctor may recommend a procedure to close the PFO. […] PFO closure is a minimally invasive, catheter-based procedure that involves the use of a device called the „occluder” to close the PFO. […] Studies have shown that patients with stroke (aged between 18 and 60 years old) who are treated with PFO closure have a lower risk of recurrent stroke. […] However, not all PFOs need to be closed. The PFO device was approved in 2016 by the US Food and Drug Administration (FDA) based on 10-year results of a randomized study which involved patients. […] Other less common indications for closure include decompression illness in professional divers, cyanosis (mixing of deoxygenated [blue] blood in the left chambers causing breathlessness especially with certain posture.
  • #60 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.
  • #61 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention
    https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism
    For patients with the lowest probability, medical therapy should be considered. […] The diagnosis of PFO is required only for deciding on a treatment. […] A meta-analysis of observational studies showed a stronger relative association of PFO with cryptogenic stroke in patients. […] An atrial septal aneurysm (ASA) and/or a moderate-to-severe shunt were strongly associated with a causal role of PFO in patients with cryptogenic stroke in observational and randomised studies. […] A variety of medical treatments has been used, based upon data from secondary prevention studies for stroke in general and from studies on cryptogenic stroke in particular. […] No adequately dimensioned RCT has yet been published that has assessed the effectiveness of individual drugs specifically in PFO-associated cerebrovascular accidents.
  • #62 Patent foramen ovale – Symptoms, diagnosis and treatment | BMJ Best Practice US
    https://bestpractice.bmj.com/topics/en-us/951
    Patent foramen ovale (PFO) is a common finding, reported in approximately 10% of people undergoing contrast echo. […] Usually asymptomatic but may be associated with cryptogenic stroke. […] In patients younger than 60 years with PFO and cryptogenic stroke, percutaneous PFO closure with antiplatelet therapy is recommended. […] Multidisciplinary approach in the evaluation of patients with cryptogenic stroke and shared decision making by involving patients are essential in identifying the best management option. […] Routine closure of the PFO is not recommended in the presence of alternative mechanisms for CVA.
  • #63 Refining Treatment Decisions for Patent Foramen Ovale Associated with Strokelogo-32logo-40logo-60NEJM Journal WatchnejmJW_1L_RGB-b
    https://www.jwatch.org/na54425/2022/01/18/refining-treatment-decisions-patent-foramen-ovale
    Refining Treatment Decisions for Patent Foramen Ovale Associated with Stroke […] Patient and PFO characteristics affect likelihood of benefiting from PFO closure. […] Trials evaluating patent foramen ovale (PFO) closure for patients with stroke or transient ischemic attack have had varied results. Recent studies show a modest benefit for closure. […] These investigators pooled data from six trials that included 3740 patients (median age, 46 years; 55% men). They compared the stroke rate between patients assigned to medical treatment versus closure. […] The annual stroke risk was 1.09% with medical treatment and 0.47% with PFO closure. The treatment benefit was increased with a higher RoPE score (implying greater likelihood that the PFO was causal). […] This study provides useful estimates of which patients are likely to benefit from PFO closure and which patients are unlikely to benefit. […] Shared decision making among patients, stroke specialists, and cardiologists is strongly recommended.