2013, Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke, NEJM
RESPECT Trial Key Points:
- Patients with cryptogenic stroke have higher incidence of PFO compared to general population. This led to the concept that closing PFO might be beneficial in terms of preventing recurrence of stroke in this population.
- The initial CLOSURE I trial showed no benefits of closing PFO percutaneously. In contrast, RESPECT trail showed benefits of PFO closure with the Amplatzer device.
- Patients deriving the maximum benefit from PFO closure were those with high grade shunt with presence of left atrial aneurysm.
- CLOSE and REDUCE are two more recent trials that show similar benefits of PFO closure over medical management.
Guideline changes based on the RESPECT Trial:
The last AHA/ASA guidelines were from 2014 which were published based on results of CLOSURE I and RESPECT trial. They recommended:
For patients with an ischemic stroke or TIA and a PFO who are not on anticoagulation therapy, antiplatelet therapy is recommended. (Class I, LOE B)
For patients with an ischemic stroke or TIA and both a PFO and a venous source of embolism, anticoagulation is indicated, depending on stroke characteristics. (Class I, LOE A). When anticoagulation is contraindicated, an inferior vena cava filter is reasonable. (Class IIa, LOE C).
For patients with a cryptogenic ischemic stroke or TIA and a PFO without evidence for DVT, available data does not support a benefit for PFO closure. (Class III, LOE A)
In the setting of PFO and DVT, PFO closure by a transcatheter device might be considered, depending on the risk of recurrent DVT. (Class IIb, LOE C)http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@smd/documents/downloadable/ucm_462196.pdf