Annals of Internal Medicine | 2019
Guideline: 8 professional organizations recommend percutaneous closure of patent foramen ovale in selected patients
Abstract
Guideline scope Management of patients with patent foramen ovale (PFO) and left circulation thromboembolisms. Guideline development methods 8 European scientific societies collaborated to create an official position paper for the diagnosis and management of PFOs. An evidence synthesis team performed relevant systematic reviews to March 2018 for each of many topic questions. A task force comprised members chosen by each scientific body plus external international experts; working groups addressed specific questions and wrote the corresponding draft statements. The evidence synthesis team and task force graded the quality of evidence together using the GRADE approach. The final position paper was edited in 3 rounds by task force members and endorsed by the scientific societies. Recommendations Selected strong statements supported by level A evidence are shown in the Table. The committee made 7 position statements for PFO diagnosis, 8 for drug therapy and follow-up after percutaneous closure, 6 for the general management of PFO-associated syndromes, 18 for the assessment of the PFO role in left circulation thromboembolism, and 13 for the evaluation and treatment of concurrent diseases. Conclusion It is the position of 8 professional societies that percutaneous closure of patent foramen ovale (PFO) should be done in carefully selected patients 18 to 65 years of age who have confirmed cryptogenic stroke, transient ischemic attack, or systemic embolism and high estimated probability of a causal role of the PFO. Selected strong statements supported by level A evidence for diagnosis and management of patent foramen ovale (PFO)* Statement types Position statements PFO diagnosis For best accuracy in PFO diagnosis, combine the use of different techniques. Assessment of PFO role in left circulation thromboembolism No single clinical, anatomical, or imaging characteristic provides a quantitative estimate of the likelihood of a PFO causal role or risk for recurrence. If PFO is considered to play a pathogenic role in an embolism, the episode should no longer be classified as cryptogenic. Atrial septal aneurysm, shunt severity, and atrial septal hypermobility can be linked to a causal role of PFO. Risk for recurrent embolism in unselected patients with PFO is low. Management after percutaneous closure of PFO Choice of the type of antiplatelet drug in follow-up is currently not established. * Strong statements are definitely affirmative and should be done. Level A evidence is supported by data derived from multiple randomized controlled trials or meta-analyses. Commentary The position paper by Pristipino and colleagues presents 52 position statements, many of which are strong and/or supported by level A evidence. The position statements emphasize the importance of patient selection for the evaluation and management of patients with PFOs. Percutaneous closure of PFO in cryptogenic stroke is recommended for selected patients 18 to 65 years of age. However, 5 of the 6 randomized clinical trials of PFO closure included only patients 60 years with a mean age <50 years. The role of PFO closure in older patients, who are more likely to have other causes of stroke, such as undetected atrial fibrillation, is less certain than in younger patients. Further studies are needed to investigate the benefit of PFO closure in patients >60 years as well as areas of management not supported by level A evidence. Transcranial Doppler ultrasonography is a good strategy for screening for an intracardiac shunt given the lower sensitivity of transthoracic echocardiography and the higher cost and risks associated with transesophageal echocardiography (1). Patient selection for these procedures is key. The trials analyzed in this position statement strongly suggest that closure of PFOs with a large shunt and/or associated atrial septal aneurysm reduces stroke risk. It is uncertain whether PFOs lacking these features should also be closed. Data presented in the supplementary materials suggest that closure may be less beneficial for patients receiving anticoagulants than for those receiving antiplatelet agents. Despite the reduced risk for stroke after PFO closure shown in clinical trials, caution must be exercised due to the high prevalence (about 25%) of PFO in the general population (2). As stated in the position paper (level A evidence), The risk of recurrent embolism in unselected patients with PFO is low.