PFO device closure in cerebrovascular events version 1
Research type
Research Study
Full title
PFO device closure benefits in prevention of recurrence of cryptogenic TIAs and strokes
IRAS ID
155304
Contact name
Tara Bharucha
Contact email
Sponsor organisation
R & D department-Southampton General Hospital
Duration of Study in the UK
1 years, months, days
Research summary
Patent foramen ovale (PFO) is an embryonic defect in the inter-atrial septum, which may or may not be associated with an atrial septal aneurysm. PFO is found in 24% of healthy adults, but in 38% of patients with cryptogenic stroke (a stroke which occurs without an identifiable cause), suggesting a link between PFO and cryptogenic stroke (30-40% of all strokes). Analysis of some case-control studies largely confirmed the association of PFO with stroke, especially in patients younger than 55 years of age, but this association, and its implications in the general population still remain disputed. Lack of definitive evidence has led to limited recommendations and guidelines, which exist mostly on a localised basis, and considered on individual circumstances.
Embolization from a thrombus present in the venous system or part of left atrium is the major mechanism linking PFO and stroke. Treatments include medical therapy such as antiplatelet agents or vitamin K antagonists, percutaneous device closure, or open surgical repair.
Comparison of five retrospective studies evaluating various options (antiplatelet therapy, warfarin, or surgery) suggested that warfarin was superior to antiplatelet therapy and comparable to surgical PFO closure for the prevention of recurrent cerebral ischemic events. The development of interventional technologies in recent years has shown that PFO device closure is a feasible and relatively safe option, with a high implant success rate and a low incidence of complications. However, controversy persists regarding whether PFO closure should be considered the treatment of choice for presumed paradoxical embolism via a PFO.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0016
Date of REC Opinion
14 Jan 2015
REC opinion
Unfavourable Opinion