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SCAI Guidelines for the Management of Patent Foramen Ovale
Clifford J Kavinsky1, Molly Szerlip2, Andrew M Goldsweig3
1Rush University Medical Center, Chicago, Illinois.
Insights
Patent foramen ovale (PFO) guidelines offer recommendations for patient selection for PFO closure to prevent stroke and other conditions. These guidelines address various clinical scenarios and identify future research needs.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Guidelines
Background:
- Patent foramen ovale (PFO) is a common congenital heart structure in adults, usually benign.
- PFO can lead to serious complications in specific circumstances.
Purpose of the Study:
- To provide evidence-based guidelines for the management of Patent Foramen Ovale (PFO).
- To support patients, clinicians, and stakeholders in PFO management decisions.
Main Methods:
- A multidisciplinary panel convened by the Society for Cardiovascular Angiography and Interventions (SCAI) developed the guidelines.
- The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used, including systematic reviews and evidence synthesis.
- Recommendations were formulated based on evidence and contextual factors.
Main Results:
- Thirteen recommendations were established to address five distinct clinical scenarios involving PFO.
- Key recommendations focus on patient selection for PFO closure to prevent stroke.
Conclusions:
- The guidelines address PFO closure for stroke prevention, including in populations not typically studied in randomized trials.
- The role of PFO closure in preventing migraines and decompression illness is also considered.
- Future research priorities for advancing PFO management have been identified.
Background:
Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances.
Objective:
These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO.
Methods:
SCAI convened a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the guideline-development process. Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the guideline panel formulated and prioritized clinical questions in population, intervention, comparison, outcome (PICO) format. A separate technical review team of clinical and methodological experts conducted systematic reviews of the evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to formulate recommendations and supporting remarks informed by the results of the technical review and additional contextual factors described in the GRADE evidence-to-decision framework.
Results:
The panel agreed on 13 recommendations to address variations on 5 clinical scenarios.
Conclusions:
Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. The panel has also identified future research priorities to advance the field.
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