Conditions

STROKE RISK FACTORS

Atrial fibrillation (AF) is associated with a 5-fold increase in the risk of ischemic stroke.1 Left atrial appendage (LAA) closure reduces the risk of stroke in non-valvular AF patients who are seeking an alternative to oral anticoagulants.2,3 Patent foramen ovale (PFO) is an embryonic defect associated with an increased risk of ischemic stroke.4 PFO closure combined with long-term antiplatelet therapy is recommended to prevent recurrent stroke in select patients.5

AF AND THE LEFT ATRIAL APPENDAGE

Because the upper chambers of the heart (atria) are unable to contract properly in patients with atrial fibrillation (AF), clots are able to form. A common site for clot formation is the left atrial appendage (LAA), which is attached to the left atrium. More than 90% of strokes in people with non-valvular AF (NVAF) are caused by blood clots formed in the LAA.6,7

AF AND STROKE ARE OFTEN CONNECTED

90%

90% ARE CAUSED BY CLOTS FORMED IN THE LAA7

5x

5X HIGHER RISK FOR PATIENTS WITH AF1

1 in 7

1 IN 7 ARE
CAUSED BY AF8

Characteristics of strokes caused by AF1:

AF AND THE CHALLENGES OF MEDICATION

Many patients at risk of stroke want an alternative to oral anticoagulants (OACs, for example, warfarin) and non-vitamin K oral anticoagulants (NOACs).9

40%

40% DO NOT TAKE OACS (NOACS OR WARFARIN)9,10

25%

25% DISCONTINUATION
RATE (NOACS)9,11


CHALLENGES OF NOACS AND WARFARIN INCLUDE9,11:

  • Significant bleeding risks
  • Significant non-compliance rates
  • Regular INR monitoring (warfarin)
  • Food and drug interaction issues (warfarin)
  • Complicates surgical procedures
  • High cost (NOACs)
     

LAA OCCLUSION IS AN ALTERNATIVE TO LONG-TERM MEDICATION FOR REDUCING RISK OF STROKE

Surgery to remove or tie-off the LAA is highly invasive.

  • Typically reserved for patients undergoing cardiac surgery for concomitant conditions.
  • Complete closure rates range from 0% to 100%.9

Transcatheter occlusion of the LAA is minimally-invasive.

  • Closure rates are 98.9% with the Amplatzer™ Amulet™ LAA Occluder.2,3

PATENT FORAMEN OVALE (PFO)

The foramen ovale is vital for fetal circulation, when blood returning to the right atrium is shunted through to the left atrium. Post-birth, the foramen ovale closes spontaneously in most people, but patent foramen ovale (PFO) occurs in about 25% of the population.12

Most people with a PFO are asymptomatic. But an atrial septal aneurysm may open the PFO with every heartbeat, thereby increasing the possibility for thrombus to pass from the venous to arterial system, which can cause a stroke.13

PFO CLOSURE: BEHIND THE NUMBERS

25%

ISCHEMIC STROKES ARE OF UNKNOWN CAUSE14

25%

ISCHEMIC STROKES ARE OF UNKNOWN CAUSE14

50%

Of patients with an ischemic stroke of unknown cause have a PFO13

20.4%

Patients with a PFO and a prior ischemic stroke of unknown cause are at risk for recurrent stroke15 - a 20.4% rate of recurrent embolic event at 2 years16

59%

Recurrent stroke risk reduction after
PFO closure5

PFO-ASSOCIATED STROKE

A group of physicians with extensive knowledge of stroke and PFO have brought attention to the fact that new data indicate a need to update the classification schemes of the causative mechanism in stroke. Given the superiority of PFO closure over medical management in select patients, new nomenclature should be used when looking at causation–and that is “PFO-associated stroke.”  Learn more about the rationale behind changing the causation classification.17

DETERMINING PFO
CAUSATION OF STROKE

Characteristics that are strongly associated with a causal role of PFO in an ischemic stroke of unknown cause are18:

  • Atrial septal aneurysm and/or a moderate-to-severe shunt
  • Atrial septal hypermobility
  • PFO size

The presence of other risk factors does not exclude PFO as the causative factor, but PFO is more likely when patients are young and lack other risk factors. Determining whether a patient’s stroke is related to a PFO should involve a multidisciplinary team including a neurologist, a cardiologist, and other health professionals trained in the care of patients with stroke.13

RESPECT TRIAL
LONG-TERM DATA19

The RESPECT trial was conducted at 69 centers across the U.S. and Canada. Alone among PFO closure studies, RESPECT included patients on anticoagulation therapy, providing a real-world cross section of patients. This trial has the most extensive follow-up data among all PFO closure studies; it spanned 13 years overall with 5,810 patient-years of safety follow-up. The RESPECT trial also revealed low rates of serious atrial fibrillation with the closure device, consistent with medical therapy.

COMPELLING DATA RESULTED IN POSITIVE GUIDELINES RECOMMENDING PFO CLOSURE

Long-term data from the both the RESPECT trial19 and REDUCE trial,20 as well as data from the CLOSE trial,21 have revealed that with attentive patient selection, transcatheter PFO closure significantly reduces the risk of recurrent stroke compared with medical therapy in patients with an ischemic stroke of unknown cause—with no increased risk of serious adverse events or influence on major bleeding.13

GUIDELINES AND RECOMMENDATIONS

  • Society for Cardiovascular Angiography & Interventions (SCAI) – Guidelines for the Management of Patent Foramen Ovale – 2022

    Recommendation: In patients between the ages of 18 and 60 with a prior PFO-associated stroke, the SCAI guideline panel recommends PFO closure rather than antiplatelet therapy alone (strong recommendation, moderate certainty of evidence).

    This recommendation is independent of patient anatomy (i.e., presence of ASA, size of shunt).
    A RoPE score of ≥ 7 may identify patients who are likely to receive greater benefit from PFO closure.

    These guidelines were developed by SCAI, with representation from the American Academy of Neurology (AAN).

  • American Heart Association/American Stroke Association – Guideline for the prevention of stroke in patients with stroke and transient ischemic attack22 - 2021

    Recommendation: In patients 18 to 60 years of age with a non-lacunar ischemic stroke of undetermined cause, despite a thorough evaluation and a PFO with high-risk anatomic features, it is reasonable to choose closure with a transcatheter device and long-term antiplatelet therapy over antiplatelet therapy alone for preventing recurrent stroke.  (Recommendation level 2b, level of evidence B-R).

  • American Academy Of Neurology – Practice advisory patent foramen ovale and secondary stroke prevention5 – 2020

    Recommendation: In patients younger than 60 years with a PFO and an embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (reduction of stroke recurrence) and risks (procedural complication and atrial fibrillation) (Level C).

  • Asian-Pacific Consensus Statement23 - 2020

    With most of the evidence on PFO closure being obtained from Caucasian patients, a consensus statement was developed by Asian-Pacific clinical experts, accounting for the specific stroke and bleeding characteristics of Asian-Pacific patients and the specific Asian-Pacific context.

    Key aspects of this consensus statement include:

    • Regarding indications for PFO closure, follow international/global guidelines.
    • Ensure that patients with recent embolic stroke of undetermined source (ESUS) are screened for PFO, using imaging modalities that are readily available in the hospital and on which the staff is best trained and most experienced (e.g. TTE, contrast TCD, TEE, ICE). Contrast TCD is widely available in the Asian-Pacific region and may be used as a first screening tool, followed by confirmation using TEE or TTE with bubble contrast. 
    • ESUS patients with significant PFO should undergo PFO closure as early as possible. 

    It was emphasized that clinical evidence for the above aspects should be collected among Asian-Pacific patients.

  • Japanese Guidance Document24 – 2019

    The Japan Stroke Society, The Japanese Circulation Society and Japanese Association of Cardiovascular Intervention and Therapeutics came together to review the evidence on PFO closure and recommend the following when it comes to selecting the appropriate patient for PFO closure:

    Indication criteria for percutaneous closure of PFO for the purpose of stroke recurrence prevention:

    1. Indispensable condition: Implementation of the intervention will be considered in case of satisfaction of all items described below:
      1. Patients who meet the diagnosis criteria for PFO related cryptogenic stroke
      2. Patients in whom antithrombotic therapy can be conducted during a certain period after percutaneous closure implementation
      3. Patients <60 years of age in principle
      4. Female patients who are not pregnant or do not want to become pregnant within a year
    2. Recommendation condition: Implementation of the intervention will be recommended in case of satisfaction of all aforementioned items and any items described below:
      1. The presence of high risk PFO in terms of function/anatomy such as:
        1. Large volume of shunt
        2. Concomitant atrial septal aneurysm (ASA)
        3. Concomitant Eustachian valve (EV)
        4. Concomitant Chiari network
        5. Right-left shunt found at rest (without Valsalva maneuver)
      2. Onset of the aforementioned type of cryptogenic stroke during appropriately conducted antithrombotic therapy.
  • German Guidelines – cryptogenic stroke and patent foramen ovale25 – 2018

    Interventional PFO closure should be performed in patients aged 16 to 60 years (after extensive neurological and cardiological diagnostic work-up) with a history of cryptogenic ischaemic stroke and patent foramen ovale, with moderate or extensive right-to-left shunt. Recommendation level A, Evidence level I.

  • BMJ Rapid Recommendations26 – 2018

    Among patients younger than age 60 who have had a cryptogenic ischemic stroke thought to be secondary to PFO (due to absence of other etiologies):

    • Strong recommendation—among patients in whom anticoagulation is contraindicated or declined—to provide PFO closure + antiplatelet therapy, vs antiplatelet therapy alone
    • Weak recommendation—among patients who are open to all options—to provide PFO closure + antiplatelet therapy vs anticoagulant therapy
    • Weak recommendation—among patients in whom closure is contraindicated or declined—to provide anticoagulant therapy vs antiplatelet therapy
       
  • European Position Paper18 – 2018

    Among patients age 18-65 who have had a cryptogenic ischemic stroke cryptogenic stroke, TIA, or systemic embolism thought to be secondary to PFO due to absence of other etiologies:

    • Recommend percutaneous PFO closure
  • Canadian Guidelines27 – 2017

    For carefully-selected patients with a recent ischemic stroke or TIA attributed to a PFO, PFO device closure plus long-term antiplatelet therapy is recommended over long-term antithrombotic therapy alone, provided all the following criteria are met: [Evidence Level A]:

    1. Age 18–60 years;
    2. The diagnosis of the index stroke event is confirmed by imaging as a nonlacunar embolic ischemic stroke or a TIA with positive neuroimaging or cortical symptoms;
    3. The patient has been evaluated by a neurologist or clinician with stroke expertise, and the PFO is felt to be the most likely cause for the index stroke event following a thorough etiological evaluation to exclude alternate etiologies.

The information provided is not intended for medical diagnosis or treatment or as a substitute for professional advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.
 

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