Davor Vukadinović1, Bruno Scheller2, Christian Ukena2, Sebastian Ewen2, Felix Mahfoud2, Michael Böhm2. 1. Klinik Für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Universitätsklinikum Des Saarlandes, Universität Des Saarlandes, Saarland University, Kirrberger Strasse, 66421, Homburg/Saar, Germany. Davor.Vukadinovic@uks.eu. 2. Klinik Für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Universitätsklinikum Des Saarlandes, Universität Des Saarlandes, Saarland University, Kirrberger Strasse, 66421, Homburg/Saar, Germany.
Abstract
BACKGROUND: Atrial fibrillation (AF) represents a frequent complication in patients after interventional closure of patent foramen ovale (PFO). We aimed to compare the incident rate and risk of AF between Amplatzer PFO and GORE (Helex and CARDIOFORM Septal Occluder) device by analyzing the data from randomized trials. METHODS: We included all randomized studies which reported the rate of AF after PFO closure using Amplatzer or GORE occluder in patients suffering cryptogenic stroke and compared the risk of AF between the two devices. PubMed and Cochrane library were searched for eligible studies published until July 2020. RESULTS: Rate of all cases of incident AF from randomized trials with Amplatzer in the interventional group was 3.93% (30/763) vs. 1.46% (11/751) in the respective medical group (RR of 2.57, 95% CI 1.31-5.03, p = 0.006). The incidence of incident AF from randomized trial with GORE device was 6.57% (29/441) vs. 0.44% (1/223) in the respective medical group (RR of 14.66, 95% CI 2.01-106.95, p = 0.008). The p for interaction between the two devices regarding risk of AF was 0.10. CONCLUSIONS: The results suggest lower risk expressed by lower rate of incident AF after PFO closure using Amplatzer PFO Occluder when compared with GORE Occluder. However, these findings are derived from secondary analyses and should be scrutinized using appropriate screening tool for AF following PFO closure in adequately powered randomized clinical trial with a head-to-head design that compares the two devices.
BACKGROUND: Atrial fibrillation (AF) represents a frequent complication in patients after interventional closure of patent foramen ovale (PFO). We aimed to compare the incident rate and risk of AF between Amplatzer PFO and GORE (Helex and CARDIOFORM Septal Occluder) device by analyzing the data from randomized trials. METHODS: We included all randomized studies which reported the rate of AF after PFO closure using Amplatzer or GORE occluder in patients suffering cryptogenic stroke and compared the risk of AF between the two devices. PubMed and Cochrane library were searched for eligible studies published until July 2020. RESULTS: Rate of all cases of incident AF from randomized trials with Amplatzer in the interventional group was 3.93% (30/763) vs. 1.46% (11/751) in the respective medical group (RR of 2.57, 95% CI 1.31-5.03, p = 0.006). The incidence of incident AF from randomized trial with GORE device was 6.57% (29/441) vs. 0.44% (1/223) in the respective medical group (RR of 14.66, 95% CI 2.01-106.95, p = 0.008). The p for interaction between the two devices regarding risk of AF was 0.10. CONCLUSIONS: The results suggest lower risk expressed by lower rate of incident AF after PFO closure using Amplatzer PFO Occluder when compared with GORE Occluder. However, these findings are derived from secondary analyses and should be scrutinized using appropriate screening tool for AF following PFO closure in adequately powered randomized clinical trial with a head-to-head design that compares the two devices.
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