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The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke Advances in Interventional Cardiology
Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent For...
Source: Circulation: Cardiovascular Interventions - March 16, 2018 Category: Cardiology Authors: Wiktor, D. M., Carroll, J. D. Tags: Secondary Prevention, Treatment, Ischemic Stroke Advances in Interventional Cardiology Source Type: research

PFO Closure for Cryptogenic Stroke: A Review and Clinical Treatment Algorithm
We describe the historical context of PFO closure and review the observational and randomized control trial evidence in this field, culminating in the recent Food and Drug Administration approval of the first dedicated closure device for PFO. Guidelines and consensus statements are discussed, and a novel treatment algorithm is proposed. Future directions in PFO closure will include new devices, further data from completed and upcoming clinical trials, and potential expansion into other disease states associated with PFO.
Source: Cardiology in Review - June 6, 2017 Category: Cardiology Tags: Review Articles Source Type: research

Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the Amplatzer Patent Foramen Ovale Occluder
On May 24, 2016, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to consider a premarket approval (PMA) application for the Amplatzer Patent Foramen Ovale (PFO) Occluder based on the results of the pivotal RESPECT trial1. In this prospective randomized multicenter open-label trial, patients with a prior cryptogenic stroke and a PFO were randomized 1:1 to “best” medical therapy or PFO closure using the Amplatzer PFO Occluder with at least 6 months of post implant antiplatelet therapy.
Source: The American Journal of Cardiology - September 28, 2016 Category: Cardiology Authors: Toby Rogers, Michael Slack, Ron Waksman Source Type: research