Heart Defect Procedure Reduces Stroke By 73%

news headlines

email to a friend

printer friendly

Heart Defect Procedure Reduces Stroke By 73%

Main Category: Stroke
Also Included In: Cardiovascular / Cardiology
Article Date: 22 Mar 2013

A procedure to close a heart defect that most people are born with can decrease the risk of recurrent stroke by 73 percent, according to new data published in the New England Journal of Medicine.

The findings came from an eight year study called the RESPECT trial (Randomized Evaluation of recurrent Stroke comparing PFO closure to Established Current standard of care Treatment). It was made to test the superiority of the AMPLATZER PFO device in the treatment of cryptogenic stroke patients compared with current medical management.

In a healthy developing fetus, the foramen oval permits oxygenated blood from the placenta to skip over the lungs. This small, flap-like entrance generally closes immediately after birth. However, when the flap stays open or patent - it is called a patent foramen oval (PFO).

A PFO can sometimes let dangerous clots go from the right side of the heart to the left, move up to the brain, and result in a stroke. Treatment normally consists of a minimally-invasive procedure conducted by a cardiologist to permanently close the PFO.

A Handy Device That Closes The Passageway

The device used during the study - AMPLATZER PFO Occluder - is a double-disc device made of polyester fabric and Nitinol mesh. It is placed into the PFO to close the passageway between the left and right atria. The device is successful in preventing a clot from traveling from one side to the other and possibly to the brain where it can result in a stroke.

The current trial revealed that the device safely closed the PFO. No differences were seen between medical management and device treatment in the incidence of:

transient ischemic attack
major bleeding
atrial fibrillation
cardiac thrombus
pulmonary embolism

There were also no serious side effects reported that were associated with the device.

The RESPECT Trial

The trial aimed to determine the most effective treatment for patients with cryptogenic stroke. The trial started in 2003 and recruited 980 patients from 69 medical centers in Canada and the U.S.

All participants had suffered a stroke verified by MRI and categorized as cryptogenic before starting the trial. The patients' average age was 46 years .

The subjects were randomly assigned to one of two groups. One group received the AMPLATZER PFO Occluder and standard of care medical management. The second group was treated using the current standard of care alone. Patients were analyzed at one, six, twelve, eighteen, and twenty-four months, and yearly after that.

AMPLATZER PFO Proven Effective

Results revealed that the device:

Decreases stroke risk up to 73%.
Gives greater risk reduction than medical interventions like warfarin or antiplatelet.
Decreases the size of stroke endured with 69% of patients in the medication portion of the trial suffering moderate, large, or massive recurrent strokes, compared to only 14% in the device group.

The experts also found:

PFO closure with the AMPLATZER PFO Occluder had a very low risk of device- or procedure-related complications.
Outcomes of the RESPECT trial are significant for the treatment of patients with a history of cryptogenic stroke and PFO - many of whom are young to middle age.

In a separate study earlier this month, researchers revealed that people with blocked heart arteries are more likely to have a stroke.

Additionally, another study suggested that antioxidants do not have a positive effect on preventing diseases like dementia and stroke, contradicting other previous research.

Written by Kelly Fitzgerald
Copyright: MediLexicon International Ltd

Original article posted on Medical News Today.
Articles not to be reproduced without permission of Medical News Today

Medical News Today publishes the latest health news and health videos for consumers and health professionals. It has a searchable archive of over 100,000 health news articles.

< back to medical news

For any corrections of factual information, or to contact the editors please use our feedback form.

Send your press releases to