From patients' first moments to their later years

 

 

Patent Foramen Ovale (PFO)1


 

Prior to birth, there is a channel between the right and left sides of the heart that allows blood from the veins to bypass the lungs; this channel is called the foramen ovale and is vital for foetal circulation. Postnatally, the foramen ovale closes spontaneously in most people, but patent foramen ovale (PFO) occurs in about 25% of the population.1


 

PFO and Stroke Risk2

Most people with PFO are asymptomatic. But an atrial septal aneurysm may open the PFO, thereby increasing the possibility for thrombus to pass from the venous to the arterial system and the brain, which can result in a stroke.2 

 


 

The Burden of Stroke^2-6


 


 

*The testimonials does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others. 

References

1. Homma S, and Sacco R. Patent foramen ovale and stroke. Circulation. 2005;112:1063-1072.

2. Mojadidi MK, et al. Cryptogenic stroke and patent foramen ovale. J Am Coll Cardiol. 2018;71(9):1035-1043.

3. American Heart Association/American Stroke Association. Understanding Diagnosis and Treatment of Cryptogenic Stroke. 2015.

4. Li L, et al. Incidence, outcome, risk factors, and long-term prognosis of cryptogenic transient ischaemic attack and ischaemic stroke: a population-based study. Lancet Neurol. 2015;14:903–913. 

5. Kernan WN, et al. AHA/ASA guidelines for the prevention of stroke in patients with stroke and transient ischemic attack. Stroke. 2014;45:2160-2236.

6. Mas J-L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-21.

7. Ionita CC, et al. What proportion of stroke is not explained by classic risk factors? Prev Cardiol. 2005;8(1):41-46.

8. Handke M, et al. Patent foramen ovale and cryptogenic stroke in older patients. N Engl J Med. 2007;357:2262-8.


 

Treatment Options for PFO

Prioritising Prevention

There are challenges in determining causation and treatment for cryptogenic stroke. Yet nearly half of patients with cryptogenic stroke have a patent foramen ovale (PFO).1 Neurologists and other referring physicians, who represent the primary point of care for recurrent stroke prevention, may consider these factors in treatment planning:

  • IS THE STROKE CRYPTOGENIC?

    Rule out known causes

  • WHAT THERAPY OPTIONS ARE AVAILABLE?

    Consider age and medical history

  • IS THERE A POSSIBILITY OF PFO?

    Determine the likelihood of paradoxical embolism


 

A cardiologist can then determine if the patient has a PFO and and what treatment options are suitable.

Determining PFO Causation of Stroke

Causes:2

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.1

Ruling Out Left Atrial Appendage (LAA) Involvement

It is important to identify whether atrial fibrillation is present, since recurrences of left circulation embolism are often due to LAA thrombosis. In certain patients at high risk for atrial fibrillation, insertable cardiac monitor use for 6 months can reasonably rule out LAA involvement before proceeding with PFO closure.3

A Relatively Young Patient Population Affected7,8

  • Cryptogenic stroke is common in patients under 45 years of age
  • PFO is strongly associated with cryptogenic stroke in patients younger than 55 years

PFO Closure vs. Medical Therapies1,4-7

59% RRR

of recurrent stroke with PFO-closure vs medical management4

Long-term data from the RESPECT,5 CLOSE,6 and REDUCE trials,7 have revealed that with attentive patient selection, transcatheter PFO closure significantly reduces the risk of recurrent stroke compared with medical therapy in patients with cryptogenic stroke—with no increased risk of serious adverse events or influence on major bleeding.1

Transcatheter PFO Closure

Transcatheter PFO closure is a minimally-invasive procedure that reduces the risk of recurrent ischaemic stroke and offers an excellent safety profile.

References

 

1. Mojadidi MK, et al. Cryptogenic stroke and patent foramen ovale. J Am Coll Cardiol. 2018;71(9):1035-1043.

2. Pristipino C, et al. European position paper on the management of patients with patent foramen ovale. EuroIntervention. 2019;14:1389-1402.

3. Kuijpers T, et al. Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline. BMJ. 2018;362:k2515.

4. Messé SR, et al. Practice advisory update summary: Patent foramen ovale and secondary stroke prevention. Neurology® 2020;94:1-10.

5. Saver JL, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032. 

6. Mas J-L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-1021 and supplementary appendix.

7. Søndergaard L, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042.  

Guidelines and Recommendations


 

The Australian Clinical Guidelines for Stroke Management strongly recommend PFO closure in ischaemic stroke patients aged <60 in whom a patent foramen ovale is considered the likely cause of stroke after thorough exclusion of other aetiologies (causes).1


 

References

1. Stroke Foundation. Clinical Guidelines for Stroke Management. Available at https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-StrokeManagement. Accessed April 2022.

Atrial Fibrillation & Risk of Stroke1,2


 

The majority of embolic strokes in patients with non-valvular atrial fibrillation (AF) are caused by thrombi (clots). This is because the upper chambers of the heart (atria) are unable to contract properly in these patients, allowing clots to form. A common site for clot formation is the left atrial appendage (LAA), which is attached to the left atrium.


 

AF and Stroke are Often Connected1-5

Characteristics of Strokes Caused by AF:4

More Severe
 

~2x Higher Mortality Rate Within 1 Year

Greater Disability

*The testimonials does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others. 

References

1. Yaghi S, et al. Left atrial appendage function and stroke risk. Stroke. 2015;46:3554-3559.

2. Blackshear JL, et al. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Annals of Thoracic Surg. 1996;61:755-759.

3. Fuster V, et al. ACC/AHA/ESC Practice Guidelines. Circulation. 2006;114:700-752.

4. Heart Rhythm Society. (2019). Complications from Atrial Fibrillation. Accessed April 21, 2021.

5. Suradi HS, et al. Left atrial appendage closure: outcomes and challenges. Neth Heart J. 2017;25:143-151. 

Treatment Options for Atrial Fibrillation (AF)


 

The Challenges of Medical Therapies1-3

Many patients at risk of stroke want an alternative to oral anticoagulation (OACs, for example, warfarin), and non-vitamin K oral anticoagulants (NOACs).1


 

NOACS and Warfarin Include:1-3

Significant bleeding risks

Regular INR monitoring (warfarin)

Significant non-compliance rates

 

Food and drug interaction issues (warfarin)

 

 

Regular INR monitoring (warfarin)

 

Complicates surgical procedures

 

 

High cost (NOACs)

 

Left Atrial Appendage (LAA) Occlusion is an Alternative to Long-Term Medication for Reducing Risk of Stroke

Surgery  

 

  • Surgery involves the removal or tying-off of the LAA and is a highly invasive procedure.
  • Typically reserved for patients undergoing cardiac surgery for concomitant conditions.
  • Complete closure rates range from 0% to 100%.1

 

 

Transcatheter Occlusion of the LAA

 

  • Transcatheter occlusion of the LAA is minimally-invasive.
  • The AmplatzerTM Amulet LAA occluder is designed to provide a complete seal, with its ability to conform to the inner wall of the LAA.
  • Closure rates are 98.9% with the AmplatzerTM Amulet LAA Occluder.4,5

 


 


 


 

References

1. Suradi HS, et al. Left atrial appendage closure: outcomes and challenges. Neth Heart J. 2017;25:143-151.

2. Baman JR, et al. Percutaneous left atrial appendage occlusion in the prevention of stroke in atrial fibrillation: a systematic review. Heart Failure Rev. 2018;23:191–208.

3. Kakkar AK, et al. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLOS ONE. 8(5):e63479.

4. Amplatzer Amulet LAA Occluder IFU, 2021.

5. Lakkireddy D, et al. Amplatzer Amulet Left Atrial Appendage Occluder versus Watchman device for stroke prophylaxis (Amulet IDE): A randomized controlled trial. Circulation. 2021;144(19):1543-1552. 

Atrial Fibrillation (AF) Guidelines1

In Australia, transcatheter occlusion of the left atrial appendage, and cardiac catheterisation performed by the same practitioner, is indicated for stroke prevention in patients with non-valvular atrial fibrillation, if:

(a) the patient is at increased risk of thromboembolism demonstrated by:

(i) a prior stroke (whether of an ischaemic or unknown type), transient ischaemic attack or non-central nervous system systemic embolism; or

(ii) at least 2 of the following risk factors:

(A) an age of 65 years or more;

(B) hypertension;

(C) diabetes mellitus;

(D) heart failure or left ventricular ejection fraction of 35% or less (or both);

(E) vascular disease (prior myocardial infarction, peripheral artery disease or aortic plaque); and

(b) the patient has an absolute and permanent contraindication to oral anticoagulation (confirmed by written documentation that is provided by a medical practitioner, independent of the practitioner rendering the service); and

(c) the service is not associated with a service to which item 38200, 38203, 38206 or 38254 applies

Eligibility Requirements2

This item is intended for use in patients where an independent medical practitioner has documented an absolute and permanent contraindication to oral coagulation. The medical practitioner who has documented this contraindication should not have been involved in any decision to provide the service or the actual provision of the service, and is not engaged in the same or a similar group of practitioners.

 

The following list provides examples of the conditions for which this item is intended:

  • A previous major bleeding complication experienced whilst undergoing treatment with oral anticoagulation therapy without remedial cause, or
  • History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding, or
  • Chronic, irreversible, recurrent gastrointestinal bleeding of any cause (eg, radiation proctitis, gut angiodysplasia, hereditary haemorrhagic telangiectasia, gastric antral vascular ectasia (GAVE), portal hypertensive gastropathy, refractory radiation proctitis, obscure source), or
  • Life-long spontaneous impairment of haemostasis, or
  • A vascular abnormality predisposing to potentially life threatening haemorrhage, or
  • Irreversible hepatic disease with coagulopathy and increased bleeding risk (Child Pugh B and C), or
  • Receiving concomitant medications with strong inhibitors of both CYP3A4 and P-glycoprotein (P-gp), or
  • Severe renal impairment defined as creatinine clearance (CrCL) < 15 ml/min or undergoing dialysis and where warfarin is inappropriate, or
  • Known hypersensitivity to the direct oral anticoagulant (DOAC) or to any of the excipients.

 

This item is not intended for use in patients with a relative contraindication to oral anticoagulation.


 


 

References

1. Stroke Foundation. Clinical Guidelines for Stroke Management. Available at https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-StrokeManagement. Accessed April 2022.

2. Medicare Benefits Schedule. Available at http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=38276&qt=item. Accessed Accessed April 2022.

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