Hole in the heart and stroke study shows significant benefit for PFO closure over medical therapy.

Results of the 10 year extended follow up for the RESPECT trial were released in San Francisco in October 2015. The trial is the largest randomised PFO (Patent Foramen Ovale) trial in history with the longest follow up now reaching 10 years (5 yr mean), involving 980 patients to evaluate secondary stroke prevention.

The study looked at patients (18-60 years of age) with a hole in the heart (PFO) who had a stroke. Patients were assigned to medical therapy (blood thinners) or PFO closure via keyhole surgery with Amplatz PFO Occluder.

The study showed that closing the hole in the heart was safe and resulted in a 70% reduction in reduction of unexplained strokes. This research confirms the long held beliefs that PFO closure for young stroke is both safe and effective against preventing further stroke events.

For a more detailed analysis of the RESPECT trial please click here


Amplatzer PFO Occluder is superior to medical management.

RESPECT – Stroke and PFO Trial 10 yr results released


Results of the 10 year extended follow up for the RESPECT trial were released in San Francisco in October 2015. The trial is the largest randomised PFO trial in history with the longest follow up now reaching 10 years (5 yr mean), involving 980 patients to evaluate secondary stroke prevention.

What patients were involved?

  • Patients with a PFO who have a cryptogenic stroke (stroke of unknown cause) in the last 270 days.
  • Patients were randomised in to receiving the Amplatzer PFO Occluder (n=499) or receiving structured medical management (n=481)

Who was excluded?

  • Patients aged <18 years or >60 years
  • Patients with identified stroke cause
  • Patients who were unable to discontinue anticoagulants (PFO closure patients had to cease Aspirin and other anticoagulants after 3 months)


Compared to the medical management at 10 year follow up (5 year mean) there was a:

  • 75% relative risk reduction in patients with significant PFO’s or atrial septal aneurysm (p=0.007)
  • 70% relative risk reduction in patients having PFO closure (p=0.004)
  • 52% relative risk reduction for all causes of stroke (p=0.035)
  • The procedure is safe with no major procedural complications
    • Major vascular complication (0.9%), device explant (0.4%)

11% of patients assigned to the medical management arm left the trial due to having off-label PFO closure. This means stroke patients actively sort PFO closure elsewhere when they discovered they did not get the PFO closure procedure.

  • Safe and highly effective procedure for stroke prevention in young patients with large PFO
  • Stroke and recurrent stroke is a life long accumulative risk. Published rates of stroke in patients with untreated PFO range between 1-2% per year.

RESPECT – Stroke Comparing PFO Closure to Established Current Standard of Care Treatment


Patient support group

Have you been diagnosed with a PFO and need to get in touch with others in the same situation?

The USA based PFO Research Foundation has a Facebook page to help patients, friends and relatives to connect with others from around the world.

It is a support group and is not moderated by specialist Doctors, so if you have specific medical questions these are always best directed to your health care provider.

It is a closed group,  but you can request to join.


Over $11,000 raised by Rule Number ‘5’ in the Gibb Challenge 2015

A great big thank you and congratulations goes out to the team ‘Rule Number 5′ raising over $11,000 AUD for the PFO Research Foundation

Megan from the team has kindly written the following summary for our website.

What a challenge! An incredible experience and a great fundraiser for two great causes.

Guess what: we have a touch over $11 000 for the PFO Foundation!!!!!

I am absolutely blown away by the support we have had from Qld through to WA. The people of Broome and the wider Gibb Community are now definitely more aware of PFO, how it affects patients and how great life can be on the other side. Personally, there is no way I could have completed this challenge without the team at Sharpe Cardiology and am so, so grateful that I was encouraged by Ross and my mother, Marlene to have the surgery in December 2013.

The challenge was 700kms of corrugated, hilly, dusty road from Derby to El Questro Station. We completed the challenge as a relay team of 5- myself, Kyle, Cass, Hilary and Aaron. It was freezing cold for the first 2 nights and it reached 38 degrees during the day. We rode for approximately 10kms at a time, the first day 230kms the next three averaging 140kms, the final day was 50kms. A Gibb highlight was when we made it into the ‘Group B’ starting group. This meant that we were in the starting group each morning with the fastest teams on the Challenge!! There were 3 other groups behind us. We were rewarded with cool, creek crossings at the end of each day before we set up camp. We ate with 400 other riders, volunteers and supporters driving vehicles for their teams and our bathroom and toilet was either non-existent, from a bucket or until the last 2 days when we had communal bathrooms.

We slept in SKINS to help the legs recover each night, woke at the crack of dawn each day to pack up camp, ate dehydrated mangoes and raspberries for fuel and sang to each other to psych ourselves up before our next riding stint.We got flat tyres, bent derailleurs and had to modify the way we tied our bikes down because the road was so rough the bikes were bouncing out! The comradeship between teams- whether known to us or not, was incredible. The mateship between teammates unforgettable. The banter on the UHF radio making the long kilometres bearable. Overall, one of the best experiences I have ever had. We will be back.

We wore the PFO Logo on our jerseys and explained our charity to fellow Gibbers. It was announced to the crowd at Ellenbrae Station what PFO is and the aim behind the Foundation. It has been in the Broome Paper and spread over the internet via our Facebook Page. We are still wearing our jerseys on rides now, answering questions that come our way. We hope our donation to the PFO Foundation will aide research for future and current PFO patients. This foundation is one close to my ‘heart’ and both my family and I will continue to support in the years to come. We’d like to thank our major sponsors again- Charlie’s Service Centre Millmerran, Pool Wisdom Broome, Envisage Building Solutions Kunnanurra, Marlene Erbs Snr Millmerran, Broome Veterinary Clinic, Landmark Broome, Ross Sharpe and Family and Dan Traves and Family.

Also a great big thank you to Broome Air Services air dropped our Jerseys to Home Valley Station which was Day 4 of the challenge after Australia Post stuffed the delivery up! Pete from BAS did this out of kindness and we are incredibly grateful for his generosity. Thanks again BAS!

We are currently putting together our photos and creating a movie of GO PRO videos and photos which we will share with you once complete. For now- please see the Rule #5 Facebook page for an album of photos.

What is a migraine?

There are important distinctions between headache and migraine.

Headache disorders are amongst the top ten causes of disability in Europe.

Three of these (migraine, tension-type headache and medication-overuse headache) are important in primary care because they are common and responsible for almost all headache related burden.

A fourth headache disorder (cluster headache) is also important because it is severely painful, treatable but often misdiagnosed. (extract from WHO publication)

Migraine is a common disabling primary headache disorder. According to the World Health Organisation (WHO) in the Global Burden of Disease Survey 2010, migraine was ranked as the third most prevalent disorder and seventh-highest specific cause of disability worldwide. It’s high prevalence impacts significantly on the personal and socio-economic.

Continue Reading

Key Adviser appointed to PFO Research Foundation – Australia

We are very excited to announce that Ms Bray Patrick-Lake has agreed to be a Principal Adviser to our PFO Research Foundation.

As many people would know Bray established the USA based PFO Research Foundation in 2010 in response to the lack of definitive scientific information regarding the condition of patent foramen ovale (PFO) after being a patient in an aborted clinical trial.  Ms. Patrick-Lake has served as a patient representative at the FDA on a variety of advisory committees and panels. She also moderates a very successful online Facebook support group for patient with PFO with over 1000 members from around the world.

Ms. Patrick-Lake has just recently been appointed as the co-chair for the Advisory Committee to the NIH Director and President Barack Obama called the Precision Medicine Initiative (PMI). This is a bold new enterprise to revolutionise medicine and generate the scientific evidence needed to move the concept of precision medicine into every day clinical practice.

We are very excited that Bray has come on board. We certainly value her level of expertise and commitment to raising the profile of Patent Foramen Ovale (PFO) and the diseases that are associated with it.