MedicalResearch.com Interview with:
Akram Elgendy MD
Division of Cardiovascular Medicine
University of Florida
MedicalResearch.com: What is the background for this study?
Response: Recent clinical trials have demonstrated that percutaneous patent foramen ovale closure is associated with lower risk of stroke recurrence in cryptogenic stroke patients. However, new-onset atrial fibrillation (AF) has been reported as a safety concern. To better understand the risk of new-onset AF, we performed a meta-analysis of PFO closure trials in patients with cryptogenic stroke and migraine.
MedicalResearch.com: What are the main findings?
Response:This study demonstrated that patent foramen ovale closure is associated with a four-fold increased risk of new-onset (3.2% vs 0.47%, p <0.001), however post closure atrial fibrillation occurs early (within 45 days post closure), is transient with no documented recurrence in 76% of the patients, and the incidence of stroke presumably related to device-associated AF is 0.1%.
MedicalResearch.com: What should readers take away from your report?
Response: Percutaneous patent foramen ovale closure is associated with increased risk of new-onset atrial fibrillation; however, the overall incidence of post closure atrial fibrillation is low, usually occurs early, transient with no documented recurrence, and rarely causes stroke.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Future research should focus on the underlying individual risk factors that might contribute to the development of atrial fibrillation post percutaneous PFO closure.
MedicalResearch.com: Is there anything else you would like to add?
Response: Our study demonstrated that the risk of new-onset AF is not increased with the use of the Amplatzer patent foramen ovale occluder.
Disclosures: Dr. Tobis has served as a consultant for St. Jude Medical and W.L. Gore; as a co-investigator of the RESPECT trial; on the Steering committee of the PREMIUM trial; and as a proctor for Cardiac Dimensions. Dr. Meier has received speaker fees from Abbott; and as a co-primary investigator of the PC and PRIMA trials. All other authors report no disclosures or conflicts of interest.
Percutaneous PFO closure is associated with increased risk of new-onset atrial fibrillation; however, the overall incidence of post closure atrial fibrillation is low.
EuroIntervention Published on 16 October 2018
Akram Y Elgendy; Islam Y Elgendy; Mohammad K Mojadidi; Ahmed N Mahmoud; Julia S Barry; Hani Jneid; Siddharth A Wayangankar; Jonathan M Tobis; Bernhard Meier;
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